BMJ Open

Gynaecological follow-up of adolescent and young adult cancer survivors: a comparative cohort study

Objective To assess whether gynaecological follow-ups among adolescent and young adult (AYA) cancer survivors are less compliant with recommendations than those without a history of AYA cancer. Design A retrospective national cohort study with exposed–unexposed design was conducted using the French National Health Data System. Setting The exposed group included AYAs who underwent cancer treatment in France between 2012 and 2014 and was matched in a 1:1 ratio with the unexposed group of AYAs without cancer or chronic disease. Participants A total of 7312 AYAs initiated cancer treatment during the specified period. After applying exclusion criteria, 3663 AYAs were matched to unexposed AYAs. Primary and secondary outcomes measures The primary outcome was compliance with gynaecological follow-up recommendations, including gynaecological consultation, sexually transmitted infections screening and cervical cancer screening. Secondary outcomes involved assessing each component of the follow-up, along with human papillomavirus vaccination coverage. Results Exposed AYAs were significantly more likely to comply with gynaecological follow-up guidelines, with a compliance rate of 23.2%, compared with 16.5% among unexposed AYAs (OR 1.53, 95% CI 1.36 to 1.70; p<0.001). When each component of the primary outcome was analysed separately, compliance rates remained significantly higher among those exposed than among those unexposed AYAs. Regarding human papillomavirus vaccination, exposed AYAs displayed higher coverage, with a significantly greater proportion having initiated a catch-up schedule (28.1% vs 18.5%). Conclusion AYA cancer survivors were more likely to have gynaecological follow-up compliant with recommendations, including gynaecological consultations, sexually transmitted infections and cervical cancer screenings.

Descriptive epidemiology of gynaecological cancers in southern Ethiopia: retrospective cross-sectional review

ObjectiveTo determine the epidemiology of gynaecological cancer among patients treated at Hawassa University Comprehensive and Specialized Hospital (HUCSH) from 2013 to 2019.DesignA retrospective cross-sectional review.Setting, participants, and outcome measureA total of 3002 patients’ cards with a diagnosis of cancer at a tertiary hospital named HUCSH were reviewed between February and May 2020. HUCSH is the only oncological care centre in the southern region of Ethiopia. Of this all-gynaecological cancer charts were extracted and descriptive and trend analyses were done. The review was conducted between February and May 2020.ResultOut of all 3002 cancer cases, 522 (17.4%) cases of gynaecological cancers were identified in 7 years. Cervical cancer accounted for 385 (73.8%) of all gynaecological cancers in this study, the next most common gynaecological cancers were ovarian cancer 55(10.5%) and endometrial cancer 51(9.8%), respectively. The mean (SD) age was 44.84 (12.23). Trends of all identified gynaecological cancers showed continuous increments of caseload year to year. Since 2016 increment of cervical cancer is drastically vertical compared with others.ConclusionDespite the limited use of a registration and referral system in primary health institutions, the burden of gynaecological cancers has increased over time. Treatment steps should be taken as soon as possible after a cancer diagnosis to prevent the disease from progressing.

Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer (NACI Study): a study protocol of a prospective, single-arm, phase II trial

Introduction Neoadjuvant chemotherapy (NACT) is an emerging approach for locally advanced cervical cancer (LACC). However, the clinical response and postoperative adjuvant radiation or chemoradiation trimodality treatment resulted in controversy. PD-1 inhibitors have shown promising role in recurrent or metastatic cervical cancer, and there is preclinical evidence of the activation and synergistic effects of NACT on PD-1 inhibitors. This study aims to evaluate the efficacy and safety of the preoperative PD-1 inhibitor camrelizumab combined with NACT for LACC. Methods and analysis The study is designed as a multicentre, open-label, single-arm, prospective phase II study. A total of 82 patients will receive neoadjuvant chemo-immunotherapy, defined as one cycle of cisplatin (75–80 mg/m 2 , intravenously) plus nab-paclitaxel (260 mg/m 2 , intravenously) NACT and subsequent two cycles of camrelizumab (200 mg, intravenously) combined with NACT. After neoadjuvant chemo-immunotherapy, patients exhibiting complete response and partial response will undergo radical surgery and subsequent adjuvant therapy. In contrast, patients with stable disease and progressive disease will transfer to concurrent chemoradiotherapy (CCRT). Following surgery, patients will receive adjuvant CCRT or radiotherapy. The primary endpoint is the objective response rate. The secondary endpoints are the pathological complete response, patients requiring postoperative adjuvant therapy, safety of neoadjuvant chemo-immunotherapy, surgical complication, event-free survival, and overall survival. An additional aim is to dynamically evaluate peripheral immune responses and local immunological microenvironments and their association with neoadjuvant immunotherapy. Ethics and dissemination This trial was approved by the Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (S2020-112). This study is among the first to evaluate the efficacy and safety of neoadjuvant chemo-immunotherapy in LACC. The findings of this research will promote neoadjuvant anti-PD-1 immunotherapy with radical surgery as a new therapeutic strategy. Trial registration number ClinicalTrials.gov Registry ( NCT04516616 ).

Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study)

Introduction Colposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women. Methods and analysis A randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in the cervical biopsies; the proportion of diagnostics cone biopsies; the patients’ report on possible side effects and compliance to the pretreatment. Ethics and dissemination The study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions’ Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study’s EudraCT number is (1-23-456; 2022-000269-42) and it is registered on www.clinicaltrials.gov . The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences. Trial registration number NCT05283421 .

Towards a cervical cancer-free future: women’s healthcare decision making and cervical cancer screening uptake in sub-Saharan Africa

Objective We investigated the association between women’s healthcare decision making and cervical cancer screening uptake in sub-Saharan Africa. Design Secondary data from the Demographic and Health Surveys of six countries in sub-Saharan Africa were used. We employed multilevel binary logistic regression modelling. Setting Sub-Saharan Africa. Participants Women aged 15–49 years in Benin (n=5282), Côte d’Ivoire (n=1925), Cameroon (n=7558), Kenya (n=6696), Namibia (n=1990) and Zimbabwe (n=5006). Primary outcome measures Cervical cancer screening uptake. Results The overall prevalence of cervical cancer screening across the six sub-Saharan African countries was 13.4%. Compared with women whose healthcare decisions were made solely by husbands/partners/someone else, the likelihood of cervical cancer screening uptake was significantly higher among women who took healthcare decisions in consultation with their husbands/partners (aOR=1.38; 95% CI 1.19 to 1.59), but highest among those who made healthcare decisions alone (aOR=1.66; 95% CI 1.44 to 1.91). Women aged between 40 and 45 years (aOR=5.18; 95% CI 3.15 to 8.52), those with higher education (aOR=2.13; 95% CI 1.57 to 2.88), those who had ever heard of cervical cancer (aOR=32.74; 95% CI 20.02 to 53.55), read newspaper or magazine at least once a week (aOR=2.11; 95% CI 1.83 to 2.44), listened to the radio at least once a week (aOR=1.35; 95% CI1.18 to 1.52) and those in households with richest wealth index (aOR=1.55; 95% CI 1.20 to 2.00) had significantly higher odds of screening for cervical cancer compared to their counterparts. Conclusion Women who are able to make autonomous healthcare decisions and those who practice shared decision making are more likely to uptake cervical cancer screening. Therefore, policy interventions should focus on empowering women to be able to take autonomous healthcare decisions or shared decision making while targeting subpopulations (ie, multiparous and rural-dwelling women, as well as those in other religious affiliations aside from Christianity) that are less likely to uptake cervical cancer screening. Also, the radio and print media could be leveraged in raising awareness about cervical cancer screening to accelerate cervical cancer screening uptake in sub-Saharan Africa.

Risk-reducing salpingo-oophorectomy among diverse patients with BRCA mutations at an urban public hospital: a mixed methods study

Objectives To assess the association of socioeconomic demographics with recommendation for and uptake of risk-reducing bilateral salpingo-oophorectomy (rrBSO) in patients with BRCA1 and BRCA2 ( BRCA1/2 ) mutations. Design Retrospective cohort, semistructured qualitative interviews. Setting and participants BRCA1/ 2 mutation carriers at an urban, public hospital with a racially and socioeconomically diverse population. Intervention None. Primary and secondary outcomes The primary outcomes were rate of rrBSO recommendation and completion. Secondary outcomes were sociodemographic variables associated with rrBSO completion. Results The cohort included 167 patients with BRCA1/2 mutations of whom 39% identified as black (n=65), 35% white (n=59) and 19% Hispanic (n=32). Over 95% (n=159) received the recommendation for age-appropriate rrBSO, and 52% (n=87) underwent rrBSO. Women who completed rrBSO were older in univariable analysis (p=0.05), but not in multivariable analysis. Completion of rrBSO was associated with residence in zip codes with lower unemployment and documented recommendation for rrBSO (p<0.05). All subjects who still received care in the health system (n=79) were invited to complete interviews regarding rrBSO decision-making, but only four completed surveys for a response rate of 5.1%. Themes that emerged included menopause, emotional impact and familial support. Conclusions In this understudied population, genetic counselling and surrogates of financial health were associated with rrBSO uptake, highlighting genetics referrals and addressing social determinants of health as opportunities to improve cancer prevention and reduce health inequities. Our study demonstrates a need for more culturally centred recruiting methods for qualitative research in marginalised communities to ensure adequate representation in the literature regarding rrBSO.

Beyond BRCA: A scoping review of person-centred care for women diagnosed with a BRCA gene mutation

Objectives Women diagnosed with BRCA1/2 mutations face significantly elevated lifetime risks of breast and ovarian cancer. Due to the distinctive biopsychosocial implications of a BRCA diagnosis, the care trajectory for these women is highly personalised, yet their care needs frequently remain unmet. The aim was to provide a first overview of the evidence of women’s experiences with person-centred care (PCC) within BRCA care and their needs for further PCC implementation. Design A scoping review, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews, was conducted. Data sources Medline, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL Plus and Google Scholar were searched for literature published between January 2004 and February 2024. Eligibility criteria Peer-reviewed, primary studies on BRCA and PCC using quantitative, qualitative and mixed-methods designs were eligible. The criteria were iteratively refined to include publications based on samples that were >80% female and >80% BRCA positive. Data extraction and synthesis Titles and abstracts were screened with ASReview, a validated AI-driven tool. Data on PCC evidence and needs were extracted based on the eight Picker Principles of PCC and synthesised by describing themes within each principle. Results Of the 3801 articles identified as potentially relevant, 18 were included in the review. PCC needs were more prevalent than evidence of their implementation. Most of women’s positive experiences with PCC focused on ‘clear information, communication and support for self-care’, while limited to no evidence existed for other principles. The highest needs were found for increased ‘emotional support, empathy and respect’, ‘attention to physical and environmental needs’, and ‘clear information, communication and support for self-care’. All articles reported demands for more holistic, yet personalised care, though PCC was not mentioned explicitly. Conclusions This review suggests a person-centred approach is relevant to improving the standard of BRCA care for women. The first evidence of women’s experiences with PCC demonstrates how care delivered with sensitivity and respect for individual backgrounds can support women throughout their BRCA trajectory. Yet, substantial unmet needs remain among female BRCA carriers, highlighting the importance of further research and PCC implementation to enhance the quality of postdiagnostic care.

Understanding the needs and experiences of young cancer patients, caregivers and healthcare professionals in the UK following childhood fertility tissue preservation (FTP): a qualitative study informed by patient and public involvement and engagement

Background Childhood cancer treatment can cause subfertility in adulthood. Ovarian or testicular tissue preservation is a rapidly evolving field with significant potential benefits. However, the establishment of patient-centred reproductive survivorship pathways remains a challenge in clinical settings due to a lack of robust evidence to inform its development. Patient and public involvement and engagement (PPIE) consultation may help ensure that future studies align with patient needs and that tailored survivorship care pathways are developed for young people with preserved fertility tissue. Aim This PPIE consultation aimed to identify priority areas for future research that would support the development of a tailored survivorship care pathway for childhood cancer survivors who have preserved tissue for future fertility. Methods Recruitment occurred through national networks, including collaborations with advocacy groups such as Candlelighters and clinical networks. Data were collected via telephone or online unstructured interviews, with some supplementary email exchanges. Thematic analysis was used to identify emergent themes. The Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 guidelines were used to help guide PPIE. Setting An online focus group and/or a one-to-one interview with e-mail interactions. Participants In total, 12 unique participants took part in a focus group and/or interview. Participants included parents of children who had stored tissue, young adult cancer survivors with stored tissue and five clinicians from the leading National Health Service (NHS) centres in the UK. Results Six key themes emerged that highlighted unmet needs and priority areas for research: (1) Lack of communication and information; (2) unmet needs in follow-up care; (3) emotional impact and psychological support; (4) importance of patient and parental involvement; (5) desire for information and education; and (6) long-term concerns and support. Parents, young adults and healthcare clinicians found talking about fertility issues difficult. They noted that consistency of care, education resources and access to emotional support were important areas where improvements could be made. We used thematic analysis to help identify patterns in the data, and we used the Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 reporting guidelines for PPIE work. Conclusions PPIE provided valuable insights into the experiences of childhood cancer survivors with preserved fertility tissue, their parents and clinicians, highlighting priority areas to guide future research and ensure it addresses the concerns of care recipients. Our findings suggest that childhood cancer survivors who preserve tissue for future fertility need personalised follow-up care with information and psychological support. A larger sample of participants, studied using a qualitative research design, is needed to capture the full range of experiences, needs and preferences and to ensure that care is inclusive and relevant to the wider population.

Participants’ perspectives of the advanced ovarian cancer biomarker study VALTIVE1: a qualitative study

Objectives VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test. Design This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis. Settings Cancer treatment sites in the UK. Participants Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites. Results Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects. Conclusion A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials. Trial registration number NCT04523116 .

Decision aids for female BRCA mutation carriers: a scoping review

Objectives Women who inherit a pathogenic BRCA1 or BRCA2 mutation are at substantially higher risk of developing breast and ovarian cancer than average. Several cancer risk management strategies exist to address this increased risk. Decisions about which strategies to choose are complex, personal and multifactorial for these women. Decision aids (DAs) are tools that assist patients in making health-related decisions. The aim of this scoping review was to map evidence relating to the development and testing of patient DAs for cancer unaffected BRCA mutation carriers. Design Scoping review conducted according to the Joanna Briggs Institute’s (JBI’s) scoping review methodological framework. Data sources MEDLINE, EMBASE, CINAHL, Web of Science. No restrictions applied for language or publication date. A manual search was also performed. Eligibility criteria for selecting studies Studies on DAs for cancer risk management designed for or applicable to women with a pathogenic BRCA1 or BRCA2 mutation who are unaffected by breast or ovarian cancer. Data extraction and synthesis Data were extracted using a form based on the JBI instrument for extracting details of studies’ characteristics and results. Data extraction was performed independently by two reviewers. Extracted data were tabulated. Results 32 evidence sources relating to development or testing of 21 DAs were included. Four DAs were developed exclusively for cancer unaffected BRCA mutation carriers. Of these, two covered all guideline recommended risk management strategies for this population though only one of these was readily available publicly in its full version. All studies investigating DA effectiveness reported a positive effect of the DA under investigation on at least one of the outcomes evaluated, however only six DAs were tested in randomised controlled trials. Conclusion This scoping review has mapped the landscape of the literature relating to developing and testing, DAs applicable to cancer unaffected BRCA mutation carriers.

Fertility-sparing surgery versus radical surgery for micropapillary serous borderline ovarian tumours: a systematic review protocol

IntroductionMicropapillary serous borderline ovarian tumours (MP-SBOTs) are an aggressive subtype of serous borderline ovarian tumours (SBOTs). Surgery is the mainstay of treatment. Radical surgery (RS, including debulking) is an alternative. However, for patients who are of reproductive age, another treatment option is fertility-sparing surgery (FSS). Up to now, the best surgical approach for MP-SBOTs and whether different procedures will have an impact on postoperative recurrence are still up for debate. This protocol outlines a systematic review and meta-analysis to investigate whether FSS adversely affected outcomes compared with RS in patients with MP-SBOTs. Additionally, we will do a prognosis analysis of BOTs with no microcapillary pattern and MP-SOBTs, if possible.Methods and analysisThis protocol will consider non-randomised studies comparing outcomes in patients with MP-SBOTs treated with RS or FSS. The following databases will be searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE, Embase Medline, PubMed, Web of Science, China Biological Medicine Database, China National Knowledge Infrastructure and Wan Fang database. We will try our best to search the grey literature to avoid missing crucial research. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. Risk of Bias in Non-randomised Studies of intervention will be used to assess non-randomized studies. We will assess the certainty of the evidence using the GRADEpro methodology and describe the degree of certainty of our results using suggested wording based on the GRADEpro assessment. We will conduct a meta-analysis and offer summary statistics for each result if there is enough data available. Instead, we will report the findings narratively where the data do not permit a statistical assessment.Ethics and disseminationEthics approval was not required for this study. Results will be published through a peer-reviewed publication and communicated at scientific events once complete.PROSPERO registration numberCRD42023439136.

What are the barriers and facilitators to help-seeking behaviour for symptoms in patients with ovarian cancer in China? A qualitative study

Objectives To explore the barriers and facilitators to help-seeking behaviour for symptoms among patients with ovarian cancer in China. Design This semistructured interview-based study used a descriptive phenomenological research method. Setting The study was conducted in China. Participants 17 patients with ovarian cancer were selected based on the principle of maximum differentiation. Outcome measures and analysis The study followed the consolidated criteria for reporting qualitative research. Data were analysed using the Colaizzi’s seven-step method. Results Three main themes were identified: (1) low level of symptom perception and cancer risk awareness: unawareness of early non-specific symptoms, mistaken attribution of symptoms and delay caused by a previous diagnosis of benign tumours; (2) cognitive factors influencing help-seeking behaviour: positive health beliefs, perceived benefits of help-seeking, previous adverse medical experiences, stigma and restrained self-disclosure and medical treatment accompanied by distress and (3) practical factors affecting help-seeking behaviour: time pressure caused by social role burden, financial burden, lack of informal carers and mismatch between medical resources and patients’ needs. Conclusion This study shows that help-seeking behaviour for symptoms among patients with ovarian cancer is not valued. The importance of early symptom recognition, the psychosocial needs of patients and practical barriers must be considered to develop interventions to promote help-seeking behaviour.

Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial

Introduction The prognosis for epithelial ovarian cancer (EOC) is exceedingly poor, with patients diagnosed with stage III/IV tumours typically offered cytoreductive surgery in conjunction with chemotherapy as a standard treatment option. This approach is intended to reduce the risk of surgery and address ovarian cancers that are not amenable to surgical intervention. A promising alternative and important treatment option is neoadjuvant chemotherapy (NACT) in conjunction with interstitial tumour cytoreductive surgery. The combination of neoadjuvant immunotherapy with chemotherapy has recently demonstrated remarkable efficacy, particularly in melanoma and lung cancer, with notable pathological responses and therapeutic benefits in tumour tissue. The NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr(NAIVE) study aims to assess the clinical efficacy and safety of NACT in combination with tislelizumab (a monoclonal antibody for programmed cell death protein 1) for advanced EOC. Methods and analysis The NAIVE study is an investigator-initiated, prospective, single-centre, open-label, randomised controlled trial for advanced EOC with the International Federation of Gynaecology and Obstetrics (FIGO) stage IIIc with a Suidan CT score of 3 or greater or a Fagotti laparoscopic score of 8 or greater; or FIGO stage IV. The primary endpoint of the study is the 1-year progression-free survival (PFS) rate, measured as the percentage of patients who are free of tumour progression or death for 1 year after receiving the first dose of study drug. The secondary endpoints encompassed the R0 resection rate, the clinical response rate and other relevant metrics. Enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental arm, which will receive neoadjuvant platinum-based chemotherapy in combination with tislelizumab, or the control arm, which will receive neoadjuvant platinum-based chemotherapy. The study will enrol 40 patients, with enrolment scheduled to start in April 2021 and complete in April 2025, given a 1-year PFS rate of 60%. The study will provide new evidence regarding the clinical efficacy and safety of NACT in combination with tislelizumab for advanced ovarian cancer. The results will contribute to a deeper understanding of the clinical effects, safety profile and fundamental immunological processes. The findings will contribute to the growing body of evidence in support of the incorporation of immunotherapy into the treatment paradigm for ovarian cancer, thus facilitating the development of more personalised and efficacious therapeutic modalities. Ethics and dissemination This trial has received ethical approval from the Institutional Ethics Committee of the Second Affiliated Hospital of the Medical College of Zhejiang University. Presentations at scientific and professional meetings and publication in peer-reviewed journals will disseminate the results of the study. Trial registration number NCT04815408 .

Controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: study protocol for a randomised controlled trial

Introduction Multimodal anticancer therapies greatly damage the fertility of breast cancer patients, which raises urgent demand for fertility preservation. The standard options for fertility preservation are oocyte and embryo cryopreservation; both require controlled ovarian hyperstimulation (COH). However, there are safety concerns regarding breast cancer relapse due to the elevated serum estradiol levels during COH. Serum estradiol levels can be effectively decreased with the highly specific aromatase inhibitor letrozole. Letrozole is still uncommonly used during COH for fertility preservation, which has only been reported in a few studies, and the evidence of oocyte retrieval during ovarian stimulation and short-term safety from the perspective study is insufficient. As a result, this study will compare the efficacy of ovarian stimulation and the short-term safety of letrozole COH and non-letrozole COH protocols for preserving fertility in patients with breast cancer. Methods and analysis This is an open-label, multicentre RCT being conducted in five Chinese reproductive medical centres. 64 eligible patients diagnosed with breast cancer will be randomly assigned (1:1) to the letrozole or non-letrozole group during their COH cycles. The primary outcome is the number of mature oocytes. The secondary outcomes are the number of high-quality embryos, incidence of ovarian hyperstimulation syndrome(OHSS) and recurrence rate of breast cancer. Ethics and dissemination Ethical approval was obtained from the Ethics Review Committee of Guangdong Provincial People’s Hospital (KY-Q-2023-840-02). Written informed consent will be obtained from each participant. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publications. Trial registration number ChiCTR2300078625

Burden of cancer attributable to sedentary behaviour in Germany: an epidemiological analysis of survey data

ObjectivesSedentary behaviour (SB) is associated with increased risks of breast, colorectal, endometrial, ovarian and rectal cancers. However, the number of cancer cases attributable to SB in Germany and the associated costs are unknown.SettingNumbers and proportions (population-attributable fractions, PAF) of new cancer cases attributable to SB with published risk estimates for Germany for the years 2024, 2030 and 2040.ParticipantsSex-specific and age-specific population projections, national cancer incidence and exposure data. Primary and secondary outcome measures: new cancer cases attributable to SB and healthcare costs associated with cancer cases attributable to SB in Germany for the year 2024.ResultsEstimated numbers of cancers attributable to SB are projected to be up to 7612 cases (6% of total cancer cases) in 2024, up to 7899 cases (6%) in 2030 and up to 8245 cases (6%) in 2040. The PAF attributable to SB in women is 3% for breast cancer, 8% for colon cancer, 9% for both endometrial and ovarian cancers and 2% for rectal cancer. In men, the PAF is 9% for colon cancer and 3% for rectal cancer. In 2024, the estimated costs of SB-attributable cancers are €270 million for colon cancer, €51 million for rectal cancer, €234 million for breast cancer and €242 million for female genital cancers.ConclusionsA considerable number of cancer cases can be attributed to SB, which also imposes a large health economic burden. Implementing effective prevention measures, such as workplace, school or commuting interventions, is needed to reduce the incidence of cancer attributable to this modifiable risk factor.

Population-based cancer incidence and mortality rates and ratios among adults with intellectual disabilities in Scotland: a retrospective cohort study with record linkage

Objective To provide contemporary data on cancer mortality rates within the context of incidence in the population with intellectual disabilities. Methods Scotland’s 2011 Census was used to identify adults with intellectual disabilities and controls with records linked to the Scottish Cancer Registry and death certificate data (March 2011–December 2019). The control cohort without intellectual disabilities and/or autism were used for indirect standardisation and calculation of crude incident rates/crude mortality rates, and age–sex standardised incident rate ratios/standardised mortality ratios (SIR/SMR), with 95% CIs. Results Adults with intellectual disabilities were most likely diagnosed cancers of digestive, specifically colorectal (14.2%), lung (9.3%), breast (female 22.9%), body of the uterus (female 9.3%) and male genital organs (male 17.6%). Higher incident cancers included metastatic cancer of unknown primary origin (female SIR=1.70, male SIR=2.08), body of uterus (female SIR=1.63), ovarian (female SIR=1.59), kidney (female SIR=1.85) and testicular (male SIR=2.49). SMRs were higher, regardless of a higher, similar or lower incidence (female SMR=1.34, male SMR=1.07). Excess mortality risk was found for colorectal (total SMR=1.54, male SMR=1.59), kidney (total SMR=2.01 u, female SMR=2.85 u), female genital organs (SMR=2.34 (ovarian SMR=2.86 u, body of uterus SMR=2.11), breast (female SMR=1.58) and metastatic cancer of unknown primary origin (female SMR=2.50 u, male SMR=2.84). Conclusions Adults with intellectual disabilities were more likely to die of cancer than the general population. Reasons for this may include later presentation/diagnosis (so poorer outcomes), poorer treatment/compliance or both. Accessible public health approaches are important for people with intellectual disabilities, and healthcare professionals need to be aware of the different cancer experiences faced by this population.

Using polygenic risk modification to improve breast cancer prevention: study protocol for the PRiMo multicentre randomised controlled trial

Introduction Established personal and familial risk factors contribute collectively to a woman’s risk of breast or ovarian cancer. Existing clinical services offer genetic testing for pathogenic variants in high-risk genes to investigate these risks but recent information on the role of common genomic variants, in the form of a Polygenic Risk Score (PRS), has provided the potential to further personalise breast and ovarian cancer risk assessment. Data from cohort studies support the potential of an integrated risk assessment to improve targeted risk management but experience of this approach in clinical practice is limited. Methods and analysis The polygenic risk modification trial is an Australian multicentre prospective randomised controlled trial of integrated risk assessment including personal and family risk factors with inclusion of breast and ovarian PRS vs standard care. The study will enrol women, unaffected by cancer, undergoing predictive testing at a familial cancer clinic for a pathogenic variant in a known breast cancer (BC) or ovarian cancer (OC) predisposition gene ( BRCA1 , BRCA2 , PALB2 , CHEK2 , ATM , RAD51C , RAD51D ). Array-based genotyping will be used to generate breast cancer (313 SNP) and ovarian cancer (36 SNP) PRS. A suite of materials has been developed for the trial including an online portal for patient consent and questionnaires, and a clinician education programme to train healthcare providers in the use of integrated risk assessment. Long-term follow-up will evaluate differences in the assessed risk and management advice, patient risk management intentions and adherence, patient-reported experience and outcomes, and the health service implications of personalised risk assessment. Ethics and dissemination This study has been approved by the Human Research Ethics Committee of Peter MacCallum Cancer Centre and at all participating centres. Study findings will be disseminated via peer-reviewed publications and conference presentations, and directly to participants. Trial registration number ACTRN12621000009819.

Examining the impact of age on chemotherapy completion in epithelial ovarian, fallopian tube and primary peritoneal cancer: a retrospective cohort study in Thailand

ObjectiveTo explore the difference in chemotherapy completion and reasons for discontinuation between older (≥70 years) and younger (<70 years) patients.DesignRetrospective cohort study.SettingSingle tertiary centre in Thailand.ParticipantsThe patients who received chemotherapy from 1 January 2009 to 30 June 2021 were included and followed up until 30 June 2022. Of the 757 patients with epithelial ovarian, fallopian tube and primary peritoneal cancer (EOC), 108 were in the older group and 649 were in the younger group.Primary and secondary outcome measuresThe difference in chemotherapy completion, the association between younger and older patients and early discontinuation of chemotherapy.ResultsThe proportion of chemotherapy completion was significantly lower in older versus younger patients (84.3% versus 92.6%, p=0.007). Excluding discontinuation due to disease progression, the chemotherapy completion was comparable (93.5 versus 95.7%, p=0.456). Dose reduction and grade 3–4 hematotoxicity occurred more often in the older group. The univariable logistic regression model showed that older age (≥70 years) was significantly associated with early chemotherapy discontinuation (OR 2.39; 95% CI 1.29–4.24). However, after adjusting for potential confounders, age was not significantly associated with early discontinuation (OR 1.20; 95% CI 0.54–2.66). Multiple comorbidities and types of surgery were identified as independent risk factors for chemotherapy discontinuation.ConclusionThe completion of chemotherapy was observed in a majority of older adults with EOC. Age is not the only determinant of chemotherapy completion. Comorbidity and disease status are crucial for determining chemotherapy discontinuation.

Nomogram incorporating log odds of positive lymph nodes improves prognostic prediction for ovarian serous carcinoma: a real-world retrospective cohort study

ObjectivesOvarian serous carcinoma (OSC) is a major cause of gynaecological cancer death, yet there is a lack of reliable prognostic models. To address this, we developed and validated a nomogram based on conventional clinical characteristics and log odds of positive lymph nodes (LODDS) to predict the prognosis of OSC patients.SettingA Real-World Retrospective Cohort Study from the Surveillance, Epidemiology and End Results programme.ParticipantsWe obtained data on 4192 patients diagnosed with OSC between 2010 and 2015. Eligibility criteria included specific diagnostic codes, OSC being the primary malignant tumour and age at diagnosis over 18 years. Exclusion criteria were missing information on various factors and unknown cause of death or survival time.Primary and secondary outcome measuresThe primary outcome were overall survival (OS) and ovarian cancer-specific survival (OCSS).ResultsFor OS and OCSS outcomes, we selected 7 and 5 variables, respectively, to establish the nomogram. In the training and validation cohorts, the C index for OS or OCSS was 0.716 or 0.718 and 0.731 or 0.733, respectively, with a 3-year time-dependent area under the curve (AUC) of 0.745 or 0.751 and a 5-year time-dependent AUC of 0.742 or 0.751. Calibration curves demonstrated excellent consistency between predicted and observed outcomes. The Net Reclassification Index, integrated discrimination improvement and decision curve analysis curves indicated that our nomogram performed better than the International Federation of Gynaecology and Obstetrics (FIGO) staging system in predicting OS and OCSS for OSC patients in both the training and validation cohorts.ConclusionOur nomogram, which includes LODDS, offers higher accuracy and reliability than the FIGO staging system and can predict overall and OCSS in OSC patients.

Effectiveness and safety of nintedanib in prevention of pulmonary fibrosis induced by bleomycin in malignant ovarian germ cell tumour: study protocol for a randomised, double-blind, placebo-controlled trial

Introduction Bleomycin is a crucial and irreplaceable chemotherapy regimen for malignant ovarian germ cell tumours (MOGCTs) but its toxicities especially pulmonary fibrosis have limited the dose of treatment efficacy and decreased the patients’ quality of life (QoL). Nintedanib has been approved for treating progressive fibrosing interstitial lung diseases and has shown potential anti-tumour effects. This study aims to evaluate the effectiveness and safety of nintedanib in the prevention of pulmonary fibrosis induced by bleomycin in MOGCTs patients. Methods and analysis This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. We will enrol a total of 128 patients who will be randomly assigned to the nintedanib group and placebo group in a 1:1 ratio. Standard bleomycin, etoposide and cisplatin chemotherapy will be given to each MOGCT patient. In addition, patients assigned to nintedanib and the control group will be given oral nintedanib 150 mg two times per day and placebo one tablet two times per day until 1 month after the last cycle of bleomycin therapy, respectively. The primary outcome is the decline of forced vital capacity (FVC). The secondary outcomes are the decline of other pulmonary function indices (forced expiratory volume in 1 s; FVC pred%, carbon monoxide diffusion capacity) and the patients’ QoL, oncological and fertility outcomes. We will use electronic case report forms to record all the participants’ data and SPSS V.27.0/STATA V.16.0/Graphpad Prism V.8.0 to conduct statistical analysis. Ethics and dissemination The Ethics Committee of Peking Union Medical College Hospital has approved the study (I-23PJ400). Written informed consent will be obtained from all participants/guardians. Study results will be submitted to peer-reviewed medical journals for publication and presented at academic conferences. Trial registration number ChiCTR2300070492.

Diagnostic accuracy of endometrial sampling tests for detecting endometrial cancer: a systematic review and meta-analysis

Objectives To determine the diagnostic accuracy of different endometrial sampling tests for detecting endometrial carcinoma. Design Systematic review and meta-analysis of studies of diagnostic accuracy. Data sources Cochrane Library, MEDLINE/PubMed, CINAHL, Web of Science and Scopus, from the date of inception of the databases to 18 January 2023. Additionally, the reference lists of included studies and other systematic reviews were thoroughly searched. Eligibility criteria We included published cross‐sectional studies that evaluated any endometrial sampling test (index tests) in women (participants) with clinical suspicion of endometrial carcinoma (target condition) in comparison with histopathology of hysterectomy specimens (reference standard). We excluded case–control and case series studies. No restrictions on language or date of publication were applied. Data extraction and synthesis Two independent reviewers extracted study data and assessed study quality using the revised quality assessment tool for diagnostic accuracy studies (QUADAS-2). We used bivariate diagnostic random-effects meta-analysis and presented the results in a summary receiver operating characteristic curve. We assessed the certainty of evidence as recommended by the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. Results Twelve studies (1607 participants), published between 1986 and 2022, contributed data to the meta-analysis results. Seven studies were judged to be at a low risk of bias in all domains and all studies had low applicability concerns. The most studied index tests were Pipelle and conventional dilation and curettage (D&C). The sensitivity, specificity, positive likelihood ratio and negative likelihood ratio (95% CIs) for Pipelle were 0.774 (0.565 to 0.900), 0.985 (0.927 to 0.997), 97.000 (14.000 to 349.000) and 0.241 (0.101 to 0.442) and for conventional D&C were 0.880 (0.281 to 0.993), 0.984 (0.956 to 0.995), 59.300 (14.200 to 153.000) and 0.194 (0.007 to 0.732), respectively. Conclusion High certainty evidence indicates that endometrial sampling using Pipelle or conventional D&C is accurate in diagnosing endometrial cancer. Studies assessing other endometrial sampling tests were sparse. Trial registration number https://osf.io/h8e9z.

Tirzepatide for fertility-sparing treatment in obese/overweight patients with endometrial cancer and atypical hyperplasia: a phase II single-arm clinical trial protocol

Introduction Approximately 3–5% of patients with endometrial cancer (EC) are diagnosed under the age of 40 years, with 70% of these individuals being nulliparous. Consequently, fertility-sparing treatment for eligible young patients with endometrial lesions is increasingly being accepted. Obesity is a well-known factor closely associated with the incidence and prognosis of endometrial lesions. As obesity rates rise, weight loss interventions become particularly important in the treatment of these patients. Tirzepatide is currently the most effective glucagon-like peptide-1 receptor agonist for weight control. This trial aims to explore the synergistic effects and safety of tirzepatide combined with standard fertility-preserving treatment for endometrial lesions. Methods and analysis This single-arm, phase II clinical trial aims to evaluate the efficacy and safety profile of tirzepatide as an adjunctive therapy to standard fertility-sparing treatment in obese or overweight patients with atypical hyperplasia (AH) or EC. The study will enrol a total of 45 patients, each receiving a combination of standard fertility-sparing treatment for EC and AH alongside tirzepatide. The primary outcomes include the reversal rate and time to remission (in months) of endometrial lesions, which are determined through endometrial pathology sampling every 3 months, as well as the percentage of weight reduction. Secondary objectives include evaluating changes in body morphology and composition, alterations in metabolic parameters during the study, as well as reproductive outcomes and the rate of tumour recurrence during follow-up. Ethics and dissemination This study has received approval from the Ethics Committee of Peking Union Medical College Hospital (I-25PJ1055). Written informed consent will be obtained from all participants. The trial results will be disseminated through peer-reviewed medical journals and presented at an academic conference. Trial registration number ChiCTR2500102009.

Clinicopathological and prognostic significance of the microcystic elongated and fragmented pattern in endometrial cancer: a systematic review and meta-analysis

Objective The presence of the microcystic elongated and fragmented (MELF) pattern, distinguished by its microcystic, elongated and fragmented attributes, constitutes a common manifestation of myometrial invasion (MI) within endometrial carcinoma. However, the prognostic significance of this pattern has not been definitively established. Consequently, this research aimed to clarify the prognostic implications of the MELF pattern for individuals diagnosed with endometrial carcinoma. Design Systematic review and meta-analysis of observational clinical studies. Data sources An extensive review of the literature was conducted using reputable databases such as PubMed, Embase, Web of Science and the Cochrane Library, covering the period from January 2003 to October 2023. Search terms encompassed endometrial cancer and the MELF pattern. Eligibility criteria for selecting studies The inclusion criteria were patients who had undergone hysterectomy and whose pathology confirmed endometrial endometrioid carcinoma, with or without MELF infiltration. Data extraction and synthesis Two reviewers performed data extraction separately. The quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS). Stata V.17.0 software was used for statistical analysis. Results The meta-analysis incorporated 16 retrospective cohort studies. Employing a fixed-effects approach, the analysis demonstrated an association of the MELF pattern with reduced overall survival (HR 2.21, 95% CI 1.50–3.25, p=0.000) and lower disease-free survival rates among patients with endometrial cancer (HR 1.72, 95% CI 1.17 to 2.55, p=0.006). Furthermore, aggregated data revealed a linkage between the MELF pattern and significant MI, nodal metastasis, involvement of the lymphovascular space, penetration of the cervical stroma and progression to advanced stages of endometrial carcinoma. Conclusion The MELF pattern serves as a significant adverse prognostic factor in endometrial cancer, warranting increased attention.

Clinicopathological characteristics and survival outcomes of women aged ≤45 and >45 years with endometrial adenocarcinoma in tertiary referral hospital: a 21-year cohort study

Objective This study aimed to compare clinicopathological characteristics and oncological outcomes in patients with endometrial cancer aged ≤45 and >45 years, with a focus on identifying distinct traits and prognostic factors in younger patients. Design A retrospective cohort study. Setting The study was conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, with a restricted study population from 1996 to 2016. Participants A total of 1114 patients diagnosed with endometrial cancer and underwent surgery were strictly selected, excluding those who had received primary radiotherapy or had uterine sarcoma. Among the population, 188 patients (16.9%) were ≤45 years old and 926 patients (83.1%) were >45 years old. Outcome measures The primary outcome measures were disease-free survival (DFS) and overall survival (OS) at 5, 10 and 15 years, with an analysis of survival rates based on patient age groups and prognostic factors. Results Younger patients (≤45 years) displayed significantly higher rates of obesity, nulliparity and polycystic ovary syndrome (PCOS), as well as favourable pathological characteristics such as well-differentiated tumours and lower rates of myometrial invasion. They also exhibited better long-term survival outcomes, the DFS rates at 5, 10 and 15 years were 89.6% (95% CI: 84.0 to 98.3), 85.9% (95% CI: 79.0 to 90.6) and 76.8% (95% CI: 63.3 to 85.9), respectively, compared with 77.6% (95% CI: 74.6 to 80.2), 69.2% (95% CI: 65.6 to 72.5) and 53.5% (95% CI: 48.0 to 58.6) in the older group. Similarly, the OS rates at 5, 10 and 15 years were 94.7% (95% CI: 90.1 to 97.2), 91.7% (95% CI: 85.4 to 95.3) and 74.0% (95% CI: 51.7 to 87.2), respectively, compared with 86.9% (95% CI: 84.4 to 89.0), 76.6% (95% CI: 73.0 to 79.7) and 60.7% (95% CI: 55.0 to 65.8) in the older group. Independent prognostic factors consist of non-endometrioid histology, involvement of the lower uterine segment and cervix, omental metastasis, lymphovascular invasion and advanced stage. Conclusions Young patients with endometrial cancer exhibit distinct favourable clinicopathological characteristics associated with better oncological outcomes compared with older patients. However, certain aggressive disease features should be taken into consideration as they have a negative influence on prognosis significantly. These insights emphasise the need for targeted management strategies and further research.

Safety of diagnostic hysteroscopy for the investigation of type II endometrial cancer: systematic review with meta-analysis

AimThe goal of this study is to evaluate the safety of diagnostic hysteroscopy (HSC) in type II endometrial cancer (EC).MethodsWe searched PubMed, the Cochrane Library and the Chinese Medical Journal Full-Text Database until December 2023. Eligible trials were all cohort studies in which patients were allocated to diagnostic HSC group or dilation and curettage (D&C) group. Quality assessments of eligible studies were performed using the Newcastle–Ottawa scales. Risk ratios (RRs) with 95% CIs were calculated as a measure of effects.ResultsThree trials were included in our analysis, which were all retrospective cohort studies. 696 patients with histologically proven type II EC were allocated to HSC or D&C before surgery. 257 patients underwent preoperative HSC, and 439 patients underwent D&C. The positive peritoneal cytology rate did not statistically differ between the groups (RR, 1.9; 95% CI, 1.00 to 3.61; p=0.05). There was no significant difference in the incidence of International Federation of Gynecology and Obstetrics (FIGO) stage between the HSC and D&C groups (stage I/II: RR, 1.08; 95% CI, 0.95 to 1.24; p=0.25; stage III/IV: RR, 0.82; 95% CI, 0.62 to 1.09; p=0.18). There was no significant difference in recurrence between the HSC and D&C groups (RR, 0.92; 95% CI, 0.66 to 1.32; p=0.66); the heterogeneity of the two included studies was acceptable (p=0.54, I2=0%).ConclusionsPreoperative HSC in patients with type II EC does not increase the risk for cancer cell dissemination within the peritoneal cavity. Preoperative HSC does not progress the FIGO staging in patients with type II EC and does not increase the risk of tumour recurrence. There is no reason to avoid HSC for the diagnosis of type II EC currently. However, type II tumours generally are less well differentiated and have poorer prognoses than type I tumours. More prospective and adequately powered trials are required to clarify whether preoperative HSC in patients with type II EC is safe.

Association between domain-specific sedentary behaviour and endometrial cancer: a systematic review and meta-analysis

Objective Sedentary behaviour is associated with increased cancer risk. We aim to assess the associations of domain-specific and total sedentary behaviour with risk of endometrial cancer, with additional attention paid to potential differences in adjustment strategy for obesity and physical activity. Design A systematic review and meta-analysis was conducted in accordance with the guidelines of Preferred Reporting Items for Systematic Reviews (PRISMA) and Meta-Analyses and the Meta-analysis of Observational Studies in Epidemiology (MOOSE). Data sources PubMed, Embase and MEDLINE databases were searched up to 28 February 2023, supplemented by grey literature searches. Eligibility criteria for selecting studies Observational human studies evaluating the association between sedentary behaviour and endometrial cancer. Data extraction and synthesis Two reviewers extracted data and conducted the quality assessment based on Newcastle-Ottawa Scale (NOS) independently. We used a random-effects model with inverse variance approach to pool the estimates. The extent of heterogeneity was quantified with the I 2 statistics. Results Sixteen studies were included in the systematic review. Fourteen studies involving 882 686 participants were included in the meta-analysis. The pooled relative risks (RRs) for high versus low level of overall sedentary behaviour was 1.28 (95% CI: 1.14 to 1.43; I 2 =34.8%). The increased risk regarding specific domains was 1.22 (95% CI: 1.09 to 1.37; I 2 =13.4%, n=10) for occupational domain, 1.34 (95% CI: 0.98 to 1.83; I 2 =53.7%, n=6) for leisure-time domain and 1.55 (95% CI: 1.27 to 1.89; I 2 =0.0%, n=2) for total sedentary behaviour. Larger pooled RRs were observed among studies with adjustment for physical activity and studies without adjustment for body mass index. Conclusions Higher levels of sedentary behaviour, total and occupational sedentary behaviour in particular, increase the risk of endometrial cancer. Future studies are needed to verify domain-specific associations based on objective quantification of sedentary behaviour, as well as the interaction of physical activity, adiposity and sedentary time on endometrial cancer.

Laparoscopic continuous seromuscular circumsuture for myomectomy: a real-world, retrospective, East-Asian cohort study

ObjectiveThis study aimed to introduce a novel laparoscopic haemostasis for myomectomy and investigate the independent risk factors for uterine fibroid recurrence.DesignA retrospective cohort study.SettingFollowing strengthening the reporting of observational studies in epidemiology (STROBE) criteria, a retrospective study of prospectively collected available data of the consecutive patients who underwent the myomectomy in the department of obstetrics and gynaecology of the single centre between February 2018 and December 2020.Participants177 patients who underwent laparoscopic myomectomy resection were enrolled in the present cohort study.Materials and methodsPatients were classified into two groups according to their different methods of haemostasis in laparoscopic surgery. Recurrence-free survival was compared between the groups during an average follow-up of nearly 2 years.ResultsOf the 177 patients from 672 consecutive patients in the retrospective cohort, laparoscopic circular suture and baseball suture were carried out in 102 (57.6%) and 75 (42.4%) patients, respectively. The total amount of blood lost during surgery varied significantly (37.6 vs 99.5 mL) (p<0.001). Univariable analyses identified that age ≥40 years, position at intramural myoma, multiple fibroids and largest fibroid volume ≥50 mm3(HR 2.222, 95% CI 1.376 to 3.977, p=0.039; HR 3.625, 95% CI 1.526 to 6.985, p=0.003; HR 3.139, 95% CI 1.651 to 5.968, p<0.001; HR 2.328, 95% CI 0.869 to 3.244, p=0.040, respectively) are independent risk factor of the recurrence of uterine fibroids. The formula of the nomogram prediction model was established as the practical clinical tool.ConclusionThe laparoscopic continuous seromuscular circumsuture for myomectomy can effectively reduce the amount of surgical bleeding and accelerate the perioperative recovery for surgical safety. The main factors affecting the recurrence of uterine fibroids were age, location, number and volume of uterine fibroids. The nomogram can more straightforwardly assist clinicians to determine the risk of recurrence after laparoscopic myomectomy.

Oncological safety of hysteroscopy in the diagnosis of stage I endometrial cancer: protocol for a systematic review and meta-analysis

Background The oncological safety of diagnostic hysteroscopy in patients with stage Ⅰ endometrial cancer remains uncertain and conflicting. The aim of the proposed systematic review and meta-analysis is to summarise the available evidence examining the association between diagnostic hysteroscopy and the prognosis of stage Ⅰ endometrial cancer and to statistically synthesise the results of relevant studies. Methods and analysis Systematic searches of PubMed/MEDLINE, Embase, Cochrane Library and Web of Science will be undertaken using prespecified search strategies. Two authors will independently conduct eligible studies selection process, perform data extraction and appraise the quality of included studies. Original case–control studies, cohort studies and randomised controlled trails published in English will be considered for inclusion. The outcomes of interest will be 5-year recurrence-free survival, disease-specific survival and overall survival. Meta-analyses will be performed to calculate pooled estimates. Ethics and dissemination Our study will be based on published data, and thus there is no requirement for ethics approval. The results will be shared through publication in a peer-reviewed journal and presentations at academic conferences. PROSPERO registration number CRD42020193696.

Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial

Introduction The follow-up adherence after treatment for a positive screening test is critical for preventing the development of screen‐detected abnormalities in cervical cancer. Yet, this poses a major challenge in developing countries like Ethiopia, emphasising the urgency for intervention strategies. Our trial aims to assess which strategies would be effective in improving adherence to follow-up after suspicious cervical lesion treatment in Ethiopia. Thus, the objective of this study is to evaluate key interventions to improve the follow-up adherence rate among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. Method and analysis We will employ a pragmatic randomised control trial study design, using Consolidated Standards of Reporting Trials guidelines for reporting and a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for developing the protocol, to evaluate intervention effectiveness. These interventions are: (a) structured nurses-led telephone call reminders, (b) home-visit reminders led by health extension workers and (c) application-based automated short message service text reminders. The standard care involves only receiving oral follow-up advice and a baseline follow-up card. The planned start date is 1 November 2024, with an anticipated end date of 1 November 2025. Our study will include women aged 30–49 who are HIV-negative and those over 25 who are HIV-positive, and who have been treated for suspicious cervical lesions after a positive visual inspection with acetic acid (VIA) screening, as per Ethiopian Ministry of Health guidelines for cervical cancer screening eligibility. The required sample size is 460, with 115 participants per arm. Study participants in the intervention group will receive the stated interventions plus the standard care, while the control group will receive only the standard care. The interventions will be delivered three times annually: 4 months from baseline, then at 8 months and finally at 12 months before the appointment due date. The primary outcome of our study is the proportion of adherence to follow-up recommendations, which will be measured by rescreening (VIA) after 1 year (11–13 months after the first screening). Descriptive statistics, χ2 test (Fisher’s exact test), binary logistic regression analysis and intention-to-treat will be used to describe and interpret the results. Ethics and dissemination The trial protocol has been approved by the institutional review board of Addis Ababa University with protocol number (008/24/SPH). Trial results will be disseminated to study participants, national and international audiences through workshops, conferences and publications in reputable journals. Trial registration number NCT06515301.

Neoadjuvant therapy or upfront surgery in advanced endometrial cancer: a systematic review protocol

Introduction There is no consensus on the optimal treatment strategy for people with advanced endometrial cancer. Neoadjuvant therapies such as chemotherapy and radiotherapy have been employed to try to reduce the morbidity of surgery, improve its feasibility and/or improve functional performance in people considered unfit for primary surgery. The objective of this review is to assess whether neoadjuvant chemotherapy or radiotherapy improves health outcomes in people with advanced endometrial cancer when compared with upfront surgery. Methods and analysis This review will consider both randomised and non-randomised studies that compare health outcomes associated with the neoadjuvant therapy and upfront surgery in advanced endometrial cancer. Potential studies for inclusion will be collated from electronic searches of OVID Medline, Embase, international trial registries and conference abstract lists. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. The methodological quality of the studies will be assessed using the Risk of Bias 2 and Risk of Bias in Non-randomised Studies of Interventions tools. If appropriate, we will perform a meta-analysis and provide summary statistics for each outcome. Ethics and dissemination Ethics approval was not required for this study. Once complete, we will publish our findings in peer-reviewed publications, via conference presentations and to update relevant practice guidelines.

DEveloping Tests for Endometrial Cancer deTection (DETECT): protocol for a diagnostic accuracy study of urine and vaginal samples for the detection of endometrial cancer by cytology in women with postmenopausal bleeding

Introduction Postmenopausal bleeding (PMB), the red flag symptom for endometrial cancer, triggers urgent investigation by transvaginal ultrasound scan, hysteroscopy and/or endometrial biopsy. These investigations are costly, invasive and often painful or distressing for women. In a pilot study, we found that voided urine and non-invasive vaginal samples from women with endometrial cancer contain malignant cells that can be identified by cytology. The aim of the DE veloping T ests for E ndometrial C ancer de T ection (DETECT) Study is to determine the diagnostic test accuracy of urine and vaginal cytology for endometrial cancer detection in women with PMB. Methods and analysis This is a multicentre diagnostic accuracy study of women referred to secondary care with PMB. Eligible women will be asked to provide a self-collected voided urine sample and a vaginal sample collected with a Delphi screener before routine clinical procedures. Pairs of specialist cytologists, blinded to participant cancer status, will assess and classify samples independently, with differences settled by consensus review or involving a third cytologist. Results will be compared with clinical outcomes from standard diagnostic tests. A sample size of 2000 women will have 80% power to establish a sensitivity of vaginal samples for endometrial cancer detection by cytology of ≥85%±7%, assuming 5% endometrial cancer prevalence. The primary objective is to determine the diagnostic accuracy of urogenital samples for endometrial cancer detection by cytology. Secondary objectives include the acceptability of urine and vaginal sampling to women. Ethics and dissemination This study has been approved by the North West–Greater Manchester West Research Ethics Committee (16/NW/0660) and the Health Research Authority. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via charity websites. Trial registration number ISRCTN58863784 .

Economic evaluation of different routes of surgery for the management of endometrial cancer: a retrospective cohort study

ObjectivesThe benefits of minimally invasive surgery (MIS) for endometrial carcinoma (EC) are well established although the financial impact of robotic-assisted hysterectomy (RH) compared with laparoscopic hysterectomy (LH) is disputed.DesignRetrospective cohort study.SettingEnglish National Health Service hospitals 2011–2017/2018.Participants35 304 women having a hysterectomy for EC identified from Hospital Episode Statistics.Primary and secondary outcome measuresThe primary outcome was the association between route of surgery on cost at intervention, 30, 90 and 365 days for women undergoing an open hysterectomy (OH) or MIS (LH/RH) for EC in England. The average marginal effect was calculated to compare RH versus OH and RH versus LH which adjusted for any differences in the characteristics of the surgical approaches. Secondary outcomes were to analyse costing data for each surgical approach by age, Charlson Comorbidity Index (CCI) and hospital MIS rate classification.ResultsA total of 35 304 procedures were performed, 20 405 (57.8%) were MIS (LH: 18 604 and RH: 1801), 14 291 (40.5%) OH. Mean cost for LH was significantly less than RH, whereas RH was significantly less than OH at intervention, 30, 90 and 365 days (p<0.001). Over time, patients who underwent RH had increasing CCI scores and by the 2015/2016 year had a higher average CCI than LH. Comparing the cost of LH and RH against CCI score identified that the costs closely reflected the patients’ CCI. Increasing disparity was also seen between the MIS and OH costs with rising age. When exploring the association between provider volume, MIS rate and surgical costs, there was an association with the higher the MIS rate the lower the average cost.ConclusionsFurther research is needed to investigate costs in matched patient cohorts to determine the optimum surgical modality in different populations.

Surgical trends, outcomes and disparities in minimal invasive surgery for patients with endometrial cancer in England: a retrospective cohort study

Objective To examine surgical outcomes and trends in the implementation of minimally invasive surgery (MIS) use for endometrial cancer (EC). Design Retrospective cohort study. Setting English National Health Service hospitals 2011–2017/2018. Population 35 304 patients having a hysterectomy for EC identified from Hospital Episode Statistics. Methods Univariate and multivariate analyses compared MIS to open hysterectomy (OH) by assessing the association between demographic, clinical and hospital characteristics by using logistic regression. A propensity score was created, to control for confounding factors including demographics, clinical and hospital characteristics, from a logistic regression which enabled the inverse probability weighting of treatment to be applied in order to compare outcomes of treatment. Main outcome measures The association between route of surgery on perioperative morbidity and mortality. Results The MIS rate rose from 40.3% in 2011 to 68.7% in 2017/2018, however, there was significant geographical variation (p<0.001). The overall 90-day mortality was significantly higher with OH versus MIS (OR 0.34, 95% CI 0.18 to 0.62, p=0.0002). MIS rates were significantly lower in patients from the lowest socioeconomic group (LSEG) compared with patients from the highest group (HSEG) (55.4% vs 59.9%, p<0.01), and in the black population as compared with white and Asian populations (40.4% vs 58.6% and 56.0%, p<0.0001). When patients from LSEG and black patients were treated in hospitals with high MIS rates, the MIS rate increased close to that of the HSEG and white patients (81.0% and 74.1% vs 83.2% and 82.6%). Conclusions Further investigation is needed to understand the barriers to MIS and improve access so that as many patients as possible can benefit from the reduced morbidity/mortality associated with MIS.

Generating high-quality data abstractions from scanned clinical records: text-mining-assisted extraction of endometrial carcinoma pathology features as proof of principle

Objective Medical research studies often rely on the manual collection of data from scanned typewritten clinical records, which can be laborious, time consuming and error prone because of the need to review individual clinical records. We aimed to use text mining to assist with the extraction of clinical features from complex text-based scanned pathology records for medical research studies. Design Text mining performance was measured by extracting and annotating three distinct pathological features from scanned photocopies of endometrial carcinoma clinical pathology reports, and comparing results to manually abstracted terms. Inclusion and exclusion keyword trigger terms to capture leiomyomas, endometriosis and adenomyosis were provided based on expert knowledge. Terms were expanded with character variations based on common optical character recognition (OCR) error patterns as well as negation phrases found in sample reports. The approach was evaluated on an unseen test set of 1293 scanned pathology reports originating from laboratories across Australia. Setting Scanned typewritten pathology reports for women aged 18–79 years with newly diagnosed endometrial cancer (2005–2007) in Australia. Results High concordance with final abstracted codes was observed for identifying the presence of three pathology features (94%–98% F-measure). The approach was more consistent and reliable than manual abstractions, identifying 3%–14% additional feature instances. Conclusion Keyword trigger-based automation with OCR error correction and negation handling proved not only to be rapid and convenient, but also providing consistent and reliable data abstractions from scanned clinical records. In conjunction with manual review, it can assist in the generation of high-quality data abstractions for medical research studies.

Cost-effectiveness of human papillomavirus (HPV) vaccination in Tunisia: a modelling study

Objectives The objective of this study is to assess the cost utility of the implementation of the human papillomavirus (HPV) vaccination programme in Tunisia in addition to the current cytology screening strategy. This study is very important to guide health policy decision-makers and to help them allocate their scarce healthcare resources. Design We used a previously described Markov model on the Online Cost Effectiveness Analysis tool programmed with R Software. The Markov cohort model was used to simulate the natural history of HPV infection and cervical cancer for a cohort of 100 000 females aged from 10 to 84 years. The model was calibrated with Tunisian parameters to calculate the long-term health benefits and costs of different cervical cancer preventive strategies in Tunisia. Outcome measures The primary outcome was the incremental cost-effectiveness ratio (ICER) of the implementation of HPV vaccination to the current cytology screening strategy to fight against cervical cancer. The ICER was calculated per life-years saved and per quality-adjusted life-year (QALY) gained, expressed in 2020 US$. Thresholds were fixed at one to three times the gross domestic product (GDP). One-way sensitivity analyses were carried out concerning the coverage rate of the cytology screening and vaccination as well as for the vaccination cost and doses. Results Compared with screening alone, the combined strategy predicted an ICER of US$1920.8 year of life saved and US$2239.3/QALY which is still lower than the GDP per capita of Tunisia in 2020 (US$3319). Sensitivity analysis showed that the cost-effectiveness of adding vaccination to the existing screening programme did not exceed the GDP per capita by varying the cost per dose upwards to US$45 (ICER would be US$2910/QALY) and vaccination coverage up to 100% (ICER of US$3245/QALY). However, the combined strategy exceeds the GDP per capita threshold when the cytological screening coverage rises to 70%, causing the ICER to rise to US$4787/QALY. Conclusion This study showed that compared with screening alone, the implementation of HPV vaccination in addition to the current cytology screening programme in Tunisia would be considered cost-effective on the basis of the threshold GDP per capita. Improvement of the current screening programme itself also remains important and provides further potential to achieve optimal cervical cancer prevention strategies.

Pregnancy outcomes among women with and without HIV infections who underwent excisional treatment for high-grade cervical intraepithelial neoplasia: a retrospective cohort study in low-resource settings

Objective The standard treatment for high-grade squamous intraepithelial lesions is excisional involving the uterine cervix, while surveillance is an acceptable approach for low-grade squamous intraepithelial lesions. There is controversy about excisional treatment on pregnancy outcomes. The objective of this study was to determine pregnancy outcomes in women living with and without HIV who underwent excisional treatment for high-grade cervical intraepithelial lesions. Design This retrospective cohort study compared the pregnancy outcomes of women with and without HIV who were or were not treated for cervical intraepithelial lesions. A cohort of 488 women with and without HIV infection who did or did not receive excisional treatment for cervical intraepithelial lesions between 2009 and 2022 was enrolled. Adverse pregnancy outcomes (preterm delivery and pregnancy loss) in women with and without HIV, untreated or treated for cervical dysplasia, were recorded and analysed. The significance of the obtained results was judged at the 5% level. Study settings The study was conducted at all Academic Model Providing Access to Healthcare-Kenya satellite sites, which offer cervical cancer screening and treatment for cervical dysplasia in western Kenya. The Moi Teaching and Referral Hospital was also included. Participants A cohort of 488 women aged between 20 years and 49 years, with and without HIV, diagnosed and treated for high-grade cervical intraepithelial neoplasia, and those followed up for low-grade cervical intraepithelial neoplasia between 2009 and 2022, were included. Outcomes measured The study was interested in adverse pregnancy outcomes, particularly pregnancy loss and preterm delivery following cervical excision treatment for high-grade cervical intraepithelial lesions. Results After adjustment for confounding factors, excisional treatment involving the uterine cervix—particularly cold knife conisation—was associated with higher odds of adverse pregnancy outcomes (OR 13.1; 95% CI 1.1 to 137.1; p=0.032). A prior history of adverse pregnancy outcomes was also strongly associated with subsequent adverse outcomes after treatment (OR 37.7; 95% CI 13.8 to 102.7; p<0.001). In contrast, maternal HIV infection was not independently associated with adverse pregnancy outcomes after adjustment (p=0.125). Conclusion Adverse pregnancy outcomes after excisional treatment of the uterine cervix for high-grade squamous intraepithelial lesions are multifactorial and were associated with cold knife conisation and prior adverse pregnancy outcomes, while maternal HIV infection was not independently associated with adverse outcomes.

Epidemiological features of uterine fibroid-associated imaging changes in Chinese women of reproductive age: a retrospective study

Objectives To investigate uterine fibroid (UF)-associated imaging changes, and their prevalence, incidence and potential risk factors in the Chinese population. Design This was a retrospective observational study using health examination data. Setting A physical examination centre in Nanchong, China, between October 2017 and December 2020. Participants A total of 33 915 Chinese women older than 15 years of age underwent uterine imaging during the study period. Primary and secondary outcome measures This study identified entries of UF-associated imaging changes through a two-round expert consultation and calculated prevalence and incidence of UF-associated imaging changes. Logistic regression estimated the association (OR, 95% CI of body mass index, high blood pressure (HBP), blood lipid profile, and fasting blood glucose level) with UF-associated imaging changes. Age-stratified (≤40 years and >40 years) risks were ascertained. Results Besides the entry ‘Potential UF’, 17 other entries of UF-associated imaging changes screened by the expert consultation were included, involving a total of 46 864 records (n=33 915), and crude prevalence=25.18%; crude incidence density/1000-woman-years=63.28. Incidence and prevalence increased with age during reproductive age (15–49 years) and decreased thereafter. The greatest burden was in women aged 40–54 years, the prevalence was 38.60%–45.38% and the incidence was 14.73%–17.96%. In the incident younger population (age ≤40 years), overweight (OR: 1.48, 95% CI 1.03 to 2.14) and HBP (OR: 2.16, 95% CI 1.10 to 4.24) were associated with a higher risk for UF-associated imaging changes; in the >40 years group, no association was observed. Conclusion UF incidence and prevalence in Asians were higher than previously reported, showed age-related increase in reproductive age, and UF incidence increased with overweight and HBP in ≤40-year-old participants. Variation in UF burden and factors with higher risk noted in different age ranges, and the correlations identified in younger women make it possible for early preventive measures for women with a higher risk of UF.

Head-to-head comparison of the RMI and ADNEX models to estimate the risk of ovarian malignancy: a systematic review and meta-analysis of external validation studies

Objectives Assessment of Different NEoplasias in the adneXa (ADNEX) and Risk of Malignancy Index (RMI) are models that estimate the risk of malignancy in ovarian masses based on clinical and ultrasound information. The aim is to perform a meta-analysis of studies that compared the performance of the two models in the same patients (‘head-to-head comparison’). Design Systematic review and meta-analysis. Data sources Systematic literature search from publication of ADNEX model (15/10/2014) up to 31/07/2024 in Embase, Web of Science, Scopus, Medline (via PubMed) and EuropePMC. Eligibility criteria for selecting studies We included all studies that externally validated the performance of ADNEX (with or without CA125) and RMI on the same data. Data extraction and synthesis Two independent reviewers extracted data using a standardised extraction sheet. We assessed risk of bias using PROBAST. We performed random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and clinical utility (net benefit, relative utility and probability of being useful in a hypothetical new centre) at thresholds commonly used clinically (10% risk of malignancy for ADNEX, 200 for RMI). Results We included 11 studies comprising 8271 tumours. Most studies were at high risk of bias. The summary AUC to distinguish benign from malignant tumours in operated patients for ADNEX with CA125 was 0.92 (95% CI 0.90 to 0.94) and for RMI it was 0.85 (0.81 to 0.89). Sensitivity and specificity for ADNEX with CA125 were 0.93 (0.90 to 0.96) and 0.77 (0.71 to 0.81) and for RMI, they were 0.61 (0.56 to 0.67) and 0.92 (0.89 to 0.94). The probability of the test being useful in a hypothetical new centre in operated patients was 96% for ADNEX with CA125 and 15% for RMI at the selected thresholds. Conclusions ADNEX has better discrimination and clinical utility than RMI.

Breast and cervical cancer care in Ghana: a qualitative exploratory study of stakeholder perspectives on National Health Insurance Scheme coverage

Background Breast and cervical cancers are among the most commonly diagnosed cancers in Ghana and impose substantial financial burden on households. Although diagnosis and treatment for these cancers are included in the National Health Insurance Scheme (NHIS) benefits package, stakeholders report limitations in the scope and implementation of coverage, leading to out-of-pocket payments and potential delays in care. Objectives To characterise NHIS coverage for breast and cervical cancer care and to explore challenges affecting implementation from the perspectives of key stakeholders. Design Qualitative exploratory study using semi-structured key informant interviews and a focused desk review of national guidelines and NHIS policy documents. Participants 12 key informants were purposively sampled based on roles in cancer policy, financing or service delivery. Results Although the NHIS officially lists coverage for consultation, diagnosis, radiotherapy and selected chemotherapy medications, participants reported that these benefits are not fully realised in practice. Respondents described persistent out-of-pocket payments for breast and cervical cancer services due to incomplete or delayed reimbursement of screening and diagnostic costs, limited inclusion of costly imaging procedures and the exclusion of some essential and innovative therapies, including immunotherapy. Delayed NHIS reimbursement was cited as a recurrent problem that constrains facility cash flow and contributes to co-payments at the point of care. Stakeholders also highlighted misalignment between NHIS reimbursement tariffs and actual service costs, which discourages some facilities from providing certain listed services and thereby limits patient access. Conclusion NHIS coverage for breast and cervical cancer care still contains significant gaps, particularly in preventive services and access to advanced therapies. Policy actions should focus on strengthening preventive coverage (including screening and human papillomavirus vaccination), aligning tariffs with service costs, ensuring timely reimbursements and updating the medicines list through transparent, evidence-informed review processes.

HPV vaccine awareness and uptake in rural Indigenous communities in Guatemala: a cross-sectional study

Objectives To assess human papillomavirus (HPV) vaccine awareness and uptake among caregivers in rural Indigenous communities in Guatemala and to identify sociodemographic predictors of vaccine unawareness and non-uptake. Methods This cross-sectional survey was conducted across 12 rural Indigenous communities in Guatemala’s Central Highlands. Using a community-engaged research approach, trained multilingual health workers administered surveys in Spanish, Kaqchikel or K’iche’. Eligible participants were adults who served as primary caregivers to children. The survey assessed HPV vaccine awareness, vaccine attitudes and uptake among those with daughters aged 8 or older. Logistic regression was used to examine predictors of vaccine unawareness and bivariate analysis explored differences in vaccine uptake. Results Among 602 participants (92.5% identified as Indigenous), 95% expressed willingness to vaccinate a child against cervical cancer, yet only 56% had heard of the HPV vaccine. Of the 175 participants with eligible daughters, only 33.7% reported vaccination. Indigenous identity, older age and illiteracy were significantly associated with HPV vaccine unawareness. Speaking an Indigenous language at home was associated with greater awareness. Departmental differences were significant: participants from Sololá were more likely to be unaware of the vaccine, while those from Sacatepéquez had higher awareness and uptake. Community partners noted that access to information, geographic connectivity and social desirability may influence both awareness and response accuracy. Conclusions Despite strong willingness to vaccinate, significant knowledge gaps persist among Indigenous caregivers. Tailored, community-informed education strategies—delivered through trusted channels and adapted linguistically and culturally—are urgently needed to increase awareness and uptake of the HPV vaccine in underserved Guatemalan communities.

Culturally adapting and evaluating an evidence-based communication intervention with HPV self-sampling to improve cervical cancer screening among women living with HIV in Ghana: a mixed-methods study

Objectives We aimed to refine and culturally adapt an evidence-based communication intervention (EBCI), which consists of the 3R message framing model (Reframe, Reprioritise, Reform) and human papillomavirus self-sampling (HPVSS) for use in a teaching hospital in Ghana, and evaluated its acceptability, feasibility, appropriateness and adoption potential among stakeholders. Design Convergent mixed-methods design. Setting The study was conducted at a teaching hospital and its surrounding communities in the Central Region of Ghana. Participants A 36-member stakeholder advisory board comprising women living with HIV (WLHIV) (n = 14), healthcare providers (HCPs) (n = 11) and community members (n = 11) participated in Nominal Group Technique sessions to adapt the intervention. The adapted EBCI was subsequently evaluated by 45 participants (WLHIV=30 and HCPs=15). Outcome measures included key characteristics of the EBCI, acceptability, feasibility, appropriateness and its potential for adoption, which were assessed using validated Likert-type scales and structured interview guides. Results Core components of the intervention (HPVSS+3R) were retained. Hospitals and community pharmacies were the preferred self-sampling venues (97%). WhatsApp audio in English and Fante/Akan was the most favoured delivery mode for 3R messages (81%). Evaluation results revealed high acceptability (mean=22.84), feasibility (mean=22.40) and adoption (mean=21.73) on a 5–25 point scale, as well as appropriateness (mean=13.3) on a 3–15 point scale. Qualitative findings highlighted convenience, privacy, empowerment and cultural relevance, which reduced fear and increased participant engagement. Conclusion The adapted EBCI demonstrated high acceptability, feasibility, appropriateness and adoption potential among key stakeholders, supporting its integration into the Ghanaian health systems to advance cervical cancer elimination goals. Trial registration number NCT06739772 .

Treatment patterns, care delays and outcomes in advanced cervical cancer: study protocol for a mixed retrospective and prospective single-centre cohort in South Africa

Introduction Cervical cancer (CaCx) is a leading cause of cancer-related deaths among women in South Africa, often presenting at advanced stages and requiring chemoradiotherapy. In South Africa, the burden is disproportionately high among women living with HIV, with limited access to radiotherapy further compounding treatment challenges. Despite this documented disparity, limited data exist on patients in a South African context. This protocol describes the research methodology to assess patterns of care, treatment delays, interruptions and survival outcomes in patients with advanced CaCx, addressing an urgent need for local data in low-income and middle-income countries to provide evidence-based improvements in care. Methods and analysis The Cervical Cancer Cohort at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH-CCC), initiated in 2023, is a mixed retrospective and prospective single-centre study investigating the characteristics, challenges and outcomes of patients with advanced CaCx. It includes women aged ≥18 years with a histopathological diagnosis of stage IB3–IVA CaCx treated at CMJAH Radiation Oncology. The retrospective component covers data from September 2018 to August 2023. Data collection is complete and the team is currently conducting quality control. The prospective component began in October 2023 and aims to enrol participants over 2 years, with follow-up for up to 3 years. The study is ongoing, and an extension for continued enrolment beyond September 2025 is being sought. Participants provide baseline data on demographics, socioeconomic status, cultural influences and healthcare access, with updates every 3 months. When necessary, the next of kin provides follow-up information. The study aims to inform strategies to improve outcomes and reduce the CaCx burden in South Africa. Ethics and dissemination Ethics approval for this study was obtained from the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, South Africa, with an ethical clearance certificate (MM221001 MED22-09-085). The results will be widely distributed through presentations at national and international conferences and published in peer-reviewed open-access journals, ensuring wide access to the results.

Understanding preferences for self-sampling in a national cervical screening programme: a protocol for a discrete choice experiment

Introduction The National Health Service Cervical Screening Programme (NHSCSP) currently involves a healthcare professional collecting a cervical sample in a healthcare setting. This method of screening has barriers associated with access to screening appointments and the poor acceptability of the speculum examination. Primary screening through HPV testing has led to the development of self-sampling screening methods including vaginal and urine self-sampling, with many UK studies comparing these screening methods with the current NHSCSP. It is not known what features of self-sampling influence individuals’ preferences and cervical screening uptake. To understand these preferences, we plan to undertake a discrete choice experiment (DCE). This protocol aims to describe the steps taken to design the DCE and the proposed approach to fielding the DCE to identify preferences for different sampling approaches in cervical screening. Methods and analysis An online survey comprising a DCE was designed to understand preferences of individuals for self-sampling methods within the NHSCSP. Attributes and levels for the DCE were generated through an iterative process including a literature review of qualitative studies about self-sampling cervical screening methods, input from cervical screening clinical experts and a patient and public involvement group (n=6). A D-efficient design was used to create choice sets for the DCE survey. Regression-based analysis will be used to estimate the impact of each attribute and level on individual choices. Ethics and dissemination This study has been approved by The University of Manchester Proportionate Research Ethics Committee (2024-20767-37669). The results of the DCE will be submitted for publication in a relevant peer review journal and the results will be presented at national and international conferences. Data statement There are no data associated with this protocol. The data produced by this study and analysis scripts will be made available in a public repository following publication of the study.

Knowledge and attitude of parents towards the human papillomavirus vaccine for their daughters and associated factors in Debre Tabor town, northwest Ethiopia: a community-based cross-sectional study

Objective This study aims to assess parents’ knowledge and attitude towards the human papillomavirus (HPV) vaccination of their daughters and the associated factors in Debre Tabor town, northwest Ethiopia. Design A community-based cross-sectional study. Setting Debre Tabor town, Northwest Ethiopia. Participants A total of 702 participants were included in the study, with a response rate of 98.2%. Three out of the six kebeles in the town were randomly selected, and participants within the selected kebeles were recruited through a cluster sampling technique. An interviewer-administered structured questionnaire was used to collect data from 15 December 2021 to 15 February 2022. Primary and secondary outcome measures Parents’ level of knowledge and attitude towards the HPV vaccination of their daughters, and the associated factors. Results In the study, parents’ knowledge and attitude towards HPV vaccination were found to be 46.4% (95% CI 42.7% to 50.1%) and 61.5% (95% CI 58.0% to 65.2%), respectively. Parents with a higher level of education (adjusted OR (AOR)=2.27; 95% CI 1.39 to 3.69), media exposure (AOR=3.36; 95% CI 1.21 to 9.33) and a good attitude towards the HPV vaccine (AOR=8.81; 95% CI 5.78 to 13.44) were significantly associated factors that affect parents’ level of knowledge. Positive subjective norms (AOR=1.53; 95% CI 1.01 to 2.31) and perceived behavioural control towards the HPV vaccine (AOR=3.48; 95% CI 2.37 to 5.10) had statistically significant associations with parents’ attitude. Conclusions In this study, more than half of parents had poor knowledge of the HPV and its vaccination, while the majority of the participants showed a favourable attitude to the vaccine. Educational attainment, media exposure and a positive attitude were significantly associated with parental knowledge, and parents’ attitude was positively influenced by subjective norms and perceived behavioural control. This suggests a need to increase the parents’ level of awareness through educational interventions, particularly via media and community engagement. To improve the acceptance and uptake of the HPV vaccination, it is important to address negative attitudes and common misconceptions among parents on the safety, efficacy and necessity of the vaccine for their daughters.

Preferred labels and language to improve communication about lesions at low risk of progressing to cancer: qualitative interviews with patients and physicians

Objectives We explored how to improve communication about low-risk lesions including labels, language and other strategies. Design Qualitative description and thematic analysis to examine the transcripts of telephone interviews with patients who had low-risk lesions and physicians; and mapping to Communication Accommodation Theory to interpret themes. Setting Canada Participants 15 patients: 6 (40%) bladder, 5 (33%) prostate and 4 (27%) cervix lesions; and 13 physicians: 7 (54%) cervix, 3 (23%) bladder and 3 (23%) prostate lesions. Main outcome measures Patient and physician views of labels, language and other strategies to improve communication about low-risk lesions. Results Patients and clinicians held discordant views about low-risk lesion label impact, preferences and rationale. All labels prompted confusion and anxiety among patients. In contrast, physicians perceived that patients understood that labels they used across all label categories (abnormal, precursor-to-cancer and cancer) implied low risk for cancer progression. Patients preferred abnormal cells, particularly when first learning of their diagnosis, and desired additional information to distinguish their diagnosis from cancer and justify treatment. In contrast, physicians favoured precursor-to-cancer and cancer labels out of habit, to match labels that patients saw elsewhere (online, charts) and to convince patients to attend follow-up and treatment visits. However, patients and physicians largely agreed on the need for 16 strategies that could improve communication about low-risk lesions including language (eg, plain language, situate low-risk lesions on cancer spectrum) and complementary communication strategies (eg, longer appointments, visual aids, connect patients with support services or groups). Conclusions The findings build on prior research by revealing that modifying labels is not the only or best strategy needed to improve communication about low-risk lesions. Ongoing research should examine how best to implement the strategies recommended by patients and physicians.

Perceived risk of human papillomavirus infection and cervical cancer: a qualitative study among Ethiopian women

Objectives The main objective of this study was to explore and describe perceived risk of women towards Human Papillomavirus (HPV) infection and cervical cancer (CC) in Adama, Ethiopia. Perception of women towards CC screening was also investigated. Design A qualitative exploratory, descriptive and contextual research design was employed. The health belief model (HBM) theoretical framework guided the study. Data were collected through focus group discussions (FGDs) using open-ended, unstructured questions and analysed using a theory-driven thematic analysis with the use of the key constructs of the HBM. Setting The study was conducted from 1 to 30 October 2023 at three selected public health facilities in Adama, where CC screening service is being offered. Participants Thirty (10 from each public health facility) 25–49 years women were purposefully selected and participated in the FGDs until data saturation was reached. Information-rich women, believed to have some awareness about the topics to be discussed and could have the ability to clearly articulate their experience during the FGDs, were selected. Result There was low perceived susceptibility but high perceived severity of HPV infection and CC. Early detection of symptoms, getting treated in time and prevention of CC were the major perceived benefits recognised in the study. Fear of the result and negative influence from peers were perceived barriers identified. With regard to self-efficacy, all the participants had full confidence to be screened. Participants’ cues to action include recommendation from health workers and perceived bad experiences previously happened on others. Conclusions There was low perceived susceptibility but high perceived severity of HPV infection and CC. Awareness creation campaigns about HPV infection and CC are crucial.

Challenges and facilitators in pathways to cancer diagnosis in Southern Africa: a qualitative study

Objectives To explore healthcare workers’ (HCWs) experiences, barriers and facilitators in managing patients with symptoms of possible breast, cervical or colorectal cancer. Design A qualitative in-depth interview study with HCWs managing patients with breast, cervical and colorectal cancer symptoms. We also conducted workshops with a group of HCWs to check the credibility of the interview findings. Setting The study was conducted with staff working in primary, secondary and tertiary public health facilities in the Eastern and Western Cape in South Africa (SA), and Harare and Bulawayo and their referral provinces in Zimbabwe. Participants HCWs with experience in managing patients with symptoms of possible breast, cervical or colorectal cancer were recruited for the study. Participants were purposively sampled based on region, healthcare level and job role. A total of 56 participants (26 in SA and 30 in Zimbabwe) participated in the in-depth interviews. 26 (12 in SA and 14 in Zimbabwe) participated in four clinical advisory group workshops across both countries. Results Drawing on the Model of Pathways to Treatment, HCWs’ perceptions of patient-level factors influencing the diagnostic interval included financial limitations, patients’ absence and delays in attendance. Healthcare provider and system factors included: challenges with referral and feedback systems; training needs; low awareness of protocols and guidelines; inappropriate and suboptimal clinical assessments; and broader socioeconomic factors and resource limitations. Conclusion Improving the timely diagnosis of breast, cervical and colorectal cancer in Southern Africa necessitates targeted strategies that address both patient-related, provider and health-system delays.

Cervical precancer thermal ablation versus LLETZ excision comparative efficacy study in WLWH (TALL Study): protocol for a randomised clinical trial in South Africa

Background Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies. Methods Randomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events. Ethics and dissemination The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination. Trial registration number Pan African Clinical Trial Registry: PACTR202504820339039.

Stakeholder perspectives on HPV vaccination uptake among Aboriginal and Torres Strait Islander adolescents via the school immunisation programmes in Queensland: a qualitative study

Introduction Aboriginal and Torres Strait Islander women experience inequitable cervical cancer outcomes including higher incidence and mortality rates than other Australian women. Cervical cancer can be prevented through human papillomavirus (HPV) vaccination, which is primarily delivered through school immunisation programmes and found to be very effective. However, Aboriginal and Torres Strait Islander adolescents have lower rates of HPV vaccination uptake compared with non-Indigenous adolescents. Objectives This study explored the perspectives and experiences of HPV vaccination programme providers and school staff involved in the delivery of school-based HPV vaccination programmes for Aboriginal and Torres Strait Islander adolescents in Queensland. Design This qualitative project recruited 10 maximally diverse schools to participate. We purposively invited immunisation programme providers and school staff associated with delivering or supporting and used a snowballing approach to recruitment. We used an Indigenist Research approach and an ecological model for health to centre Aboriginal and Torres Strait Islander experiences and priorities. Participants We interviewed 18 immunisation programme providers and school staff involved in delivery between 2020 and 2022. Interview topics included programme delivery and processes, engagement with Aboriginal and Torres Strait Islander adolescents and caregivers, factors impacting uptake and completion, and suggestions for improvement. Results Stakeholders highlighted multilayered challenges navigating a school-based immunisation programme across health and education sectors, especially within the context of the COVID-19 pandemic. This included logistical barriers around programme coordination and scheduling, roles and responsibilities, and communication issues between schools, programme providers, caregivers and adolescents. Four themes were identified: (1) co-ordination of the clinic between schools and programme providers, (2) supporting Aboriginal and Torres Strait Islander families through the vaccination pathway, (3) HPV vaccination resources and (4) COVID-19 disruptions to HPV vaccination programme. Conclusions The findings suggest a need for better communication and coordination of the school-based clinic, including consideration of staff capacity and school resources; enhanced linkages with and support for Aboriginal and Torres Strait Islander student support staff and community organisations who play a critical role in supporting adolescents’ vaccination, and flexible methods of consent supported by culturally appropriate resources. These findings informed recommendations for improved practice and will contribute towards reaching Australia’s cervical cancer elimination targets.

Postnatal instead of normally-timed cervical screening (PINCS-1): a protocol for a feasibility study of paired-sample cervical screening and urine self-sampling at 6 weeks and 12 weeks postnatal in the UK

Introduction Cervical screening rates in the UK are falling, limiting our ability to prevent cervical cancer. Peak incidence of cervical cancer coincides with average age of childbirth, and women with young children are less likely to be screened. Current UK guidelines advise waiting 12 weeks after delivery to perform cervical screening, but this recommendation is not based on evidence from the era of liquid-based cytology or high-risk human papillomavirus (HPV) testing. New mums suggested offering cervical screening at 6 weeks postdelivery, in conjunction with the postnatal check-up with the general practice team in primary care. This study aims to assess the feasibility and acceptability of a paired-sample study design for cervical screening at 6 weeks and 12 weeks postnatal. Methods and analysis A study of 100 participants will be performed to assess feasibility and acceptability of cervical screening at both 6 weeks and 12 weeks postnatal, with urine self-sampling using a Colli-pee collection device at each time point. This will inform whether women are prepared to undergo cervical screening at 6 weeks postnatal and the feasibility of a future pair-wise diagnostic test accuracy (of HPV and abnormal cervical cytology) study or whether alternative study designs are needed. Participants must be aged 24.5–64 years old and eligible for the National Health Service Cervical Screening Programme (NHS CSP). At each appointment, participants will complete a questionnaire about their experience and thoughts regarding screening. Substudies ask participants who withdraw or decline to participate their reasons, to identify barriers. The study will be closed for recruitment once 100 participants have completed the 6-week screen in Postnatal Instead of Normally-Timed Cervical Screening (PINCS-1) or if recruitment is poor and 50% not recruited by 6 months, indicating that a paired-sample design is not feasible. Ethics and dissemination Ethical approval for PINCS-1 was given by the Stanmore Research Ethics Committee. The results, including participant feedback at each stage, built into the trial design, will inform the design of large studies to determine accuracy and clinical impact of cervical screening at 6 weeks postnatal, identifying whether giving choice (eg, from timing of appointments and/or offering self-sampling) will improve screening uptake. Data will inform the sample size needed for future studies to have adequate power. Results will also inform future NHS CSP management. Results will be shared via scientific publication and via conventional and social media channels accessed by young women. Trial registration number ISRCTN10071810 .

TOURISM study (Treatment Outcomes in UteRIne SarcoMa): a 10-year retrospective evaluation of practice in the UK

Background Although rare, uterine sarcomas account for a high proportion of uterine cancer mortality. Treatment options and robust trial data are limited. Objectives The TOURISM study (Treatment Outcomes in UteRIne SarcoMa) is a UK-wide study by the National Oncology Trainees Collaborative for Healthcare Research which aimed to characterise this patient cohort. Design A retrospective descriptive cohort study. Patients with carcinosarcomas/mixed Mullerian tumours, non-uterine gynaecological sarcomas and uterine metastases were excluded. Routine clinical data, including general patient demographics, diagnosis, treatment and outcomes, were collated and pseudonymised. Setting Patients diagnosed with uterine sarcoma in the UK National Health Service between 1 January 2008 and 31 December 2017 were identified from electronic records. Participants A total of 406 patients from eight centres were eligible for inclusion. Results The median age at diagnosis was 56 years, with leiomyosarcoma the most common diagnosis (54.4%). The majority (57.9%) were diagnosed at the International Federation of Gynecology and Obstetrics stage I, with 19.7% diagnosed at stage IV. Nearly half (45.2%) of the patients received at least one line of chemotherapy, of which most (81.0%) received doxorubicin first-line. In the stage I group 7.4% received adjuvant chemotherapy and 15.0% received adjuvant radiotherapy. Median overall survival was 37 months; however, survival varied significantly by stage at diagnosis (stage I: 105 months; stage II: 33 months; stage III: 19 months; stage IV: 14 months). Conclusions Our data highlight the diversity in patient management in uterine sarcoma and a marked survival advantage for patients diagnosed with stage I disease. These data highlight the importance of a multidisciplinary approach and describe real-world trends in systemic therapies, radiotherapy and surgical treatment in this rare cancer type.

Understanding cervical cancer prevention in Africa: a qualitative systematic review of the role of men

Background Cervical cancer (CC) is a preventable noncommunicable disease if detected early through screening for precancers and appropriately managed. The causal link with high-risk human papillomavirus infection is established, making elimination possible through the WHO multipronged 90:70:90 strategy. However, practical CC elimination efforts need to address issues within the sociocultural context that can facilitate or hinder prevention strategies. In this regard, the role of men in promoting reproductive health, especially in Africa, cannot be overemphasised. Objective This systematic review examined the extent of involvement of men in CC prevention in Africa and its impact on the WHO CC elimination strategy. Methods A comprehensive search for relevant literature was conducted from 2008 to 2023 in the following electronic databases: Embase, Medline, Global Health, APA PsycINFO, Scopus, Web of Science, CINAHL Plus and the WHO website. Eligible studies explored the views of n=592 men. Screening of abstracts and titles, data extraction and quality assessment were performed in duplicate. A narrative synthesis was performed, as developed by the Economic and Social Research Council Methods Programme, to synthesise the qualitative data. Results Out of the 1961 studies identified through the electronic database search, 16 met all inclusion criteria. This review revealed varying levels of awareness of CC among men; while some had little to no knowledge, others demonstrated a comprehensive understanding. Gaps in knowledge and perception of CC were evident across studies. Both individual and systemic challenges shaped the perspectives of men on screening as a preventive measure, resulting in a range of attitudes and concerns regarding human papillomavirus vaccination. Though male participation in CC prevention was generally low, it was noted that males were willing to play an active role in CC screening and vaccination by supporting the process. Men believed that aggressive education and awareness creation among men were required. Conclusions This review highlights the need for targeted interventions to improve awareness, knowledge and perception of CC among men. Such efforts are essential to help men recognise their crucial role in supporting CC elimination within the African context. PROSPERO registration number The review protocol was registered on 26 June 2023 in PROSPERO with registration number CRD42023437100.

Building HPV vaccine confidence through codesigned interventions with and for healthcare workers in Nigeria: protocol for a pilot cluster randomised controlled trial

Introduction The human papillomavirus (HPV) vaccine can effectively prevent cervical cancer, yet HPV vaccine uptake is particularly low in some low-income settings, due to supply and vaccine confidence barriers. HPV vaccine confidence has also been found to be lacking among healthcare workers in some countries, including Nigeria. Nigeria has a long history of low vaccine confidence in some parts of the country. HPV vaccine rumours and concerns have been observed throughout the country, including among healthcare workers. Interventions that specifically address healthcare workers’ vaccine confidence are limited, since vaccine confidence is often assumed among this group. The aim of our pilot cluster randomised control trial (cRCT) is to evaluate the feasibility of conducting a trial that evaluates codesigned interventions to improve HPV vaccine confidence in healthcare workers and the acceptability and feasibility of delivering this intervention. Methods and analysis This is a 3-arm pilot cRCT, using a mixed-methods approach to assess the feasibility of the trial design, alongside the feasibility and acceptability of intervention delivery in two states in Nigeria (Jigawa and Oyo). We will implement two interventions: one with a focus on digital delivery, and one with an HPV champion present at a health facility. Both will be compared with a control arm, providing standard information on HPV vaccine only. Overall, 12 trial clusters (six in Jigawa and six in Oyo), defined as government primary healthcare facilities, will be randomised using a 1:1:1 ratio, stratified by state. All healthcare workers within these facilities will be eligible to take part in the intervention and evaluation. The primary outcome of interest will be intervention uptake, as a measure of subsequent trial feasibility given concerns around contamination in control clusters. This will be assessed through an endline healthcare worker survey. Intervention feasibility and acceptability will be assessed through quantitative intervention monitoring and qualitative interviews with healthcare workers. Ethics and dissemination We received approval from Jigawa State Ethics Committee (ref: JGHREC/2023/151), Jigawa Ministry of Health (ref: MOH/PH/PHRAT/MN/23/003), Oyo State Research Ethics Review Committee (ref: AD/13/479/362A), The University of Ibandan and University College Hospital Research Ethics Committee (UI/UCH Ethics Committee) (ref: UI/EC/23/308) and from the Swedish National Ethics Review Board (2023-04772-01-471058). Data will be presented in manuscript form and submitted to relevant conferences for dissemination. Registration details The pilot trial has been registered with ISRCTN—the UK’s Clinical Study Registry, registration number ISRCTN37847119 .

Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in Denmark

Introduction Colposcopy is a standard procedure for evaluating cervical abnormalities and collecting cervical biopsies. The procedure is associated with intra- and inter-observer variation. A colposcopic scoring system, Swedescore, has been designed to standardise and facilitate colposcopy training. Swedescore has performed well in a routine clinical setting when used by expert colposcopists to find or exclude high-grade lesions. Danish clinical guidelines for colposcopy differ from other countries, as they recommend collecting four cervical biopsies in all women regardless of risk factors or colposcopy findings. Swedescore has never been examined to assess the reduction of cervical biopsies in a real-world clinical setting. This study aims to investigate whether the implementation of Swedescore can optimise the diagnostic work-up for whom the collection of biopsies can be safely omitted or reduced. Methods and analysis The design is a clinical multicentre non-randomised intervention study in Denmark. According to a power calculation, we will need to include 586 women referred for colposcopy. Colposcopy with Swedescore will be compared with conventional colposcopy with no Swedescore. Cervical biopsies will be divided into two separate vials (target and random biopsies). The primary outcome will be normal or cervical intraepithelial neoplasia grade 1 detected in cervical biopsies. χ 2 and logistic regression will be used to compare estimates between arms. Ethics and dissemination The study protocol has been submitted to the Ethical Committee in Central Denmark region and is not notifiable to the Committee (j.no.: 1-10-72-124-22). Results will be published in a peer-reviewed journal and presented at scientific meetings. Trial registration number NCT05870787 . Protocol version Version 3 (date 12. November 2024).

Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore’s primary care settings: a study protocol

Introduction Cervical cancer remains a significant public health concern in Singapore, with current screening rates at 43%, well below the national target of 70%. In 2019, human papillomavirus (HPV) DNA testing was introduced into the national cervical cancer screening programme, but barriers to participation include embarrassment, privacy concerns and discomfort with clinician-sampled tests. Self-sampled HPV DNA testing offers a promising alternative by providing more privacy and convenience. This study aims to evaluate the impact of including self-sampled HPV DNA testing as an alternative to clinician-sampling on screening uptake, clinical outcomes and cost-effectiveness in primary care. Methods and analysis This pragmatic, open-label, two-arm randomised controlled trial employs a Zelen design. A total of 650 women aged 30–69 who are due for cervical cancer screening will be recruited from National Healthcare Group Polyclinics in Singapore. Participants will be randomly assigned to either the intervention arm (offering both self-sampling and clinician-sampling) or the usual care arm (clinician-sampling only). The primary outcome is the proportion of participants in each arm detected with high-risk HPV. Secondary outcomes include the proportion of participants in each arm who undergo cervical cancer screening (uptake), are referred for colposcopy and are detected with CIN 2/3 or cervical cancer, as well as cost-effectiveness. Acceptability and feasibility of self-sampling will be evaluated through post-screening questionnaires. Ethics and dissemination Ethical approval was granted by the National Healthcare Group Domain Specific Review Board. Study results will be disseminated through peer-reviewed journals, healthcare conferences and shared with policymakers to guide potential inclusion of self-sampling in Singapore’s national cervical cancer screening programme. Findings from this trial will provide crucial evidence for the potential inclusion of self-sampling in Singapore’s national cervical cancer screening programme, which could increase screening rates and improve public health outcomes. Trial registration number ClinicalTrials.gov: NCT06528184 .

SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial

IntroductionSalpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy.Methods and analysisIn SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes areany complicationup to 8 weeks postoperatively, andage at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1 year after surgery.Ethics and disseminationPerforming salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316–18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks.Trial registration numberNCT03860805.

Socioeconomic inequality in cervical cancer screening uptake among women in sub-Saharan Africa: a decomposition analysis of Demographic and Health Survey data

Objective To examine socioeconomic inequalities in the use of cervical cancer screening among women in sub-Saharan Africa. Design Secondary data from the Demographic and Health Survey data in sub-Saharan Africa. Setting Sub-Saharan Africa. Participants Women aged 15–64 years. Outcome measures Socioeconomic inequalities in cervical cancer screening uptake and the pooled prevalence of cervical cancer screening. Results The pooled prevalence of cervical cancer screening among women in sub-Saharan African countries was 10.51% (95% CI: 7.54% to 13.48%). Cervical cancer screening uptake showed a significant pro-rich distribution of wealth-related inequalities, with a weighted Erreygers normalised concentration index of 0.084 and an SE of 0.003 (p value <0.0001). This finding suggests that disparities in cervical cancer screening uptake among women are related to wealth. Decomposition analysis revealed that the wealth index, educational status, place of residence and media exposure were the most important factors contributing to this pro-rich socioeconomic inequality in cervical cancer screening. Conclusion This study emphasises the importance of addressing modifiable factors such as improving educational opportunities, increasing media exposure accessibility in households and improving the country’s economy to reduce wealth disparities and improve cervical cancer screening uptake among women.

Factors associated with cervical cancer screening among women of reproductive age in Moshi municipality, Kilimanjaro, Tanzania: a cross-sectional study

Objective Screening for cervical cancer has been a globally advocated preventive strategy to reduce cervical cancer morbidity and mortality. This study aimed to describe the prevalence and barriers of cervical cancer screening, and to determine factors associated with cervical cancer screening among women of reproductive age in Moshi municipality, northern Tanzania. Design We conducted a cross-sectional study between August and September 2020. Setting Moshi municipality, Kilimanjaro, Tanzania. Participants Women of ages 15–49 years who live in Moshi municipality. Results A total of 300 women participated in the study and 22.7% had ever been screened for cervical cancer. Women below the age of 30 years had 87% lower odds of screening for cervical cancer compared with those aged 30 years and above (OR 0.13; 95% CI 0.04, 0.43). Women who had never heard about cervical cancer had 94% (OR 0.06; 95% CI 0.01, 0.51) lower odds of screening compared with those who ever heard about the disease. In comparison to married women, those who identified as single had 71% lower odds of screening for cervical cancer (OR 0.29; 95% CI 0.10, 0.73). Women without formal education or with only primary-level education had 72% lower odds of screening for cervical cancer compared with those with college or university education (OR 0.28; 95% CI 0.08, 0.98). A lack of awareness on where to screen and a lack of comprehensive knowledge about cervical cancer were reported as screening barriers among those who had never been tested. Conclusion Only one in five women have ever been screened for cervical cancer, despite the majority having heard about the disease. Overall knowledge of cervical cancer was low, with many women unaware of its causes, risk factors and preventive measures. Key barriers to screening included a lack of awareness and insufficient medical advice. Factors significantly associated with lower odds of screening were being under age of 30 years, not having heard about cervical cancer, having no formal or only primary education and being single. There is an urgent need for community-based interventions to increase awareness and education about cervical cancer and to improve access to screening services, especially for younger, less educated and single women.

Barriers to early diagnosis and treatment of cervical cancer in Addis Ababa, Ethiopia: qualitative study

Objective Cervical cancer remains the most diagnosed and deadly cancer among women in low and middle income countries, including Ethiopia, although it can be controlled if detected and treated early. However, research on contextual barriers to early diagnosis and treatment of cervical cancer is limited in Ethiopia. This study aimed to describe the lived experience of the patients and to explore the barriers to early diagnosis and treatment of cervical cancer. Design We conducted a phenomenological qualitative study, which was part of a larger mixed-methods study. Setting Tikur Anbesa Specialised Comprehensive Hospital, Addis Ababa, Ethiopia. Participants 24 purposively selected patients with diagnostic delay and 16 patients with treatment delay were interviewed using an in-depth interview guide (IDI). Results Two broad themes and seven sub-themes to explain the barriers to early diagnosis and treatment of cervical cancer emerged. These themes and sub-themes include patient related barriers (inadequate knowledge, visits to traditional healers and practice of religious rituals as a solution for illness, poor adherence to the treatments and fear of side effects, and financial hardships) and provider related barriers (limited access to diagnostic and treatment infrastructure, inadequate training of healthcare providers and poor quality of care). Conclusions The findings of the study underscore the need to reinforce awareness among patients and the community, scale up the screening, diagnostic and treatment infrastructure, and advocate for quality of care in the healthcare facilities in Ethiopia to promote early diagnosis and treatment of cervical cancer.

Knowledge and attitudes towards cervical cancer and screening among migrant women: a qualitative study in Portugal

Objective To explore the perceptions of migrant women, healthcare professionals and community workers regarding migrant women’s knowledge and attitudes about cervical cancer (CC) and screening and how these influence cervical cancer screening (CCS) uptake. Design Qualitative study with seven focus groups, using a semistructured guide. Setting Five focus groups were conducted online and two in community associations in Lisbon, Portugal. Participants This study included 23 migrant women, 12 healthcare professionals and 10 community workers. Results A lack of knowledge and negative attitudes towards screening among migrants were discussed as important factors leading to a lower CCS uptake. For participants, many migrant women are unaware of the disease and CCS. Feelings of uneasiness related to screening and reservation from their husbands towards consultations underlie negative attitudes towards CCS. Disparities among migrant women regarding uptake of CCS rooted on sociocultural factors were highlighted, with women from African origin and older tending to engage less. Healthcare professionals were identified as the preferred source of information; nevertheless, difficulties in delivering information on sensitive topics were reported by professionals. Additionally, participants agreed that peers and social networks may play a role in promoting screening among communities. Conclusions Healthcare professionals and community actors are paramount to promote CCS among migrant women, especially through culturally adapted awareness interventions and health-promoting activities engaging local communities and social networks of women. Training on cross-cultural communication skills of healthcare professionals may contribute to improving migrant women’s knowledge and uptake of CCS.

Spatiotemporal dynamics and prevention strategies of cervical cancer incidence in Addis Ababa, Ethiopia: an ecological study

Objective This study analysed the spatial and temporal patterns of cervical cancer incidence in Addis Ababa from 2012 to 2021. Design An ecological study was conducted from 1 September to 30 November 2023 to examine the spatiotemporal trends of cervical cancer incidence. Setting The research was conducted in Addis Ababa, the capital city of Ethiopia. Participants Included were all patients with clinically and/or histopathologically confirmed diagnoses of cervical cancer. Data analysis The study employed advanced analytical tools including R programming, Quantum Geographic Information System V.3.36.0, GeoDa V.1.2.2 and System for Automated Geoscientific Analyses GIS V.9.3.2. Techniques such as Bayesian empirical testing with a block weighting matrix for hotspot identification, Global Moran’s I for spatial autocorrelation, nearest neighbour imputation and universal Kriging interpolation were used to manage data gaps. Joinpoint trend analysis and direct age-standardised incidence rate (ASIR) using the Segi’s World standard population was applied to compare trends across subcities. A statistical significance threshold was set at p<0.05. Results Between 2012 and 2021, a total of 2435 new cervical cancer cases were recorded in the Addis Ababa City Population-based Cancer Registry, with significant spatial clustering observed in Nifas Silk Lafto, Bole, Kirkos as well as parts of Gulele and Yeka sub cities (z score>1.96) in 2018. The citywide age-standardised incidence rate varied from 19 to 26 cases per 100 000 women-years during 2013 and 2016, respectively. Subcity trends varied significantly, with increases and decreases noted in Akaki Kality and Kolfe Keraniyo over different periods while Bole subcity showed modest increase at 4.2% APC (95% CI: 0.6% to 7.9%; p=0.026). Conclusion The study highlights substantial fluctuations in ASIR and significant geographic disparities in cervical cancer throughout Addis Ababa. To address these challenges, the implementation of school-based human papillomavirus vaccination programmes, alongside targeted interventions, active campaigns and sustained surveillance, is critical. These strategies are essential to effectively reduce the cervical cancer burden and improve health outcomes in the community.

Cost-effectiveness of robotic surgery compared to conventional laparoscopy for the management of early-stage cervical cancer: a model-based economic evaluation in China

Objectives The aim of this study is to assess cost-effectiveness of robotic radical hysterectomy (RRH) vs laparoscopic radical hysterectomy (LRH) in early-stage cervical cancer (ECC). Design Model-based cost-effectiveness analysis. Setting Based on long-term survival data, a three-state Markov model was constructed using TreeAge Pro 2022 to simulate the possible recurrence of ECC. Data on clinical efficacy and costs were derived from published literature and local databases. Participants A hypothetical cohort of 1000 individuals diagnosed with early-stage cervical cancer (FIGO 2009 stages<IIB) who underwent RRH or LRH management. Outcome measures The study endpoints were quality-adjusted life years (QALYs), total costs (in Chinese renminbi (RMB) adjusted to 2023-year values using the Consumer Price Index) and incremental cost-effectiveness ratio (ICER). A willingness-to-pay threshold of 268 074 RMB per QALY was used to assess cost-effectiveness. Results Robotic group gained more 4.84 QALYs than the laparoscopic group, but total costs for robotic strategy are substantially higher, with the incremental costs of 1 031 108 RMB. The ICER of robotic strategy is 213 054 RMB per QALY. Outcomes were robust in most one-way sensitivity and probabilistic sensitivity analyses. Conclusions Robotic strategy is on the efficient frontier but incurs substantial initial cost. Our findings indicated that this strategy is a cost-effective treatment option for ECC patients if assessed over a time horizon of patients’ lifetime. This study underscores the need for long-term clinical trials in early-stage cervical cancer patients with follow-up data that capture financial and quality-of-life end points.

Study protocol of Elective Para-aortic and pelvic versus Pelvic only Irradiation in pelvic node positive Cervical cancer: a multicentric open labelled phase III randomised controlled trial (EPIC Study)

Introduction The revision of International Federation of Gynaecology and Obstetrics staging in 2018 with recommendations to include cross-sectional imaging and a separate stage for node positive disease have opened a lot of uncertainties in implementing the correct treatment approach in these patients. While studies have suggested higher chances of occult para-aortic lymph node (PALN) even with advanced imaging, especially in pelvic node positive disease which tend to recur after pelvic radiation therapy. This study intends to study these patients and isolate the subset who will benefit most from elective PALN irradiation. Methods and analysis This is an ongoing multicentric phase III randomised controlled trial with a sample size of 274 subjects in two arms (137 in each arm) to determine the superiority of limited elective para-aortic irradiation compared with no irradiation. Arm one includes radiation to the lower PALN and pelvis; Arm two includes radiation to the pelvis. Concurrent chemotherapy followed by brachytherapy is standard in both arms. Patients with cervical cancer and radiologically positive pelvic LNs aged>18 years and<70 years are screened for the study. The primary endpoint of this study is 3-year disease-free survival. The secondary endpoints include 3-year para-aortic recurrence-free survival, 3-year distant metastasis-free survival, 3-year overall survival, acute and late toxicity, quality of life. Translational study to evaluate systemic immune response by FAPI-PETCT (fibroblast activator protein inhibitor positron emission tomography) and assessment of p16, L1 cell adhesion molecule (L1CAM) and protein death ligand-1 (PDL-1) expression by immunohistochemistry. Ethics and dissemination The study has been approved by the institutional ethics committee and will be routinely monitored according to standard guidelines. The results of the study will be published in peer-reviewed scientific journals, presented at conferences and submitted to regulatory authorities. Trial registration number The study was registered on 17 January 2022 under CTRI/2022/01/039495 ( http://ctri.nic.in ).

Exploring intersectional determinants of, and interventions for, low uptake of human papillomavirus vaccine in sub-Saharan Africa: a scoping review protocol

Introduction Cervical cancer is the most diagnosed cancer and the leading cause of cancer-related death in 36 low- and middle-income countries, with the majority located in sub-Saharan Africa (SSA), South America and Southeastern Asia. The highest regional incidence and mortality occur in SSA. Despite the high efficacy and cost-effectiveness of the human papillomavirus (HPV) vaccine in preventing cervical cancer, its uptake remains unacceptably low in SSA. This scoping review aims to integrate evidence from SSA on social determinants of HPV vaccine uptake with complementary evidence on interventions to promote its uptake. Methods and analysis The proposed review will be conducted following the guidelines of the Joanna Briggs Institute Scoping Review Methodology Group. Additionally, a sequential explanatory design will guide the integration of determinant evidence with intervention evidence. This scoping review will be reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist. Six databases, PubMed/MEDLINE, LIVIVO, Google Scholar, BASE (Grey Literature), preprint databases (eg, OSF and medRxiv) and African Journals Online will be searched, with results limited to English language publications and those published from 2006 to 2024. Two forms will be used for data extraction from determinant and intervention studies by two independent reviewers. A narrative summary of evidence from both determinant and intervention studies will be conducted. Furthermore, a multilevel analysis will be conducted to explore the intersections of determinants across socioecological levels of health behaviour. A further integrative cross-study analysis of results from determinant and intervention studies will be conducted, where the determinant evidence will be used to interrogate the intervention evidence. Data will be presented in tables and matrices. Ethics and dissemination No ethical approval will be required for this study because it will be based on data collected from publicly available records. The review results will be disseminated widely through a peer-reviewed publication and other forums such as workshops, conferences and meetings with local health administrators, policymakers and other wider stakeholder engagements.

Adherence to cervical cancer screening in France: factors influencing the healthcare professionals’ decisions—a qualitative study

Objective To understand what leads to the non-adherence to the cervical cancer screening (CCS) recommendations during a consultation. Design For this qualitative study, in-depth semistructured interviews were carried out with French healthcare professionals. An interview guide was developed and tested. It included the following themes: CCS recommendations, patients’ profiles, relationship with patients, emotional work, over-screening and under-screening. Interviews were carried out until data saturation (no new data, theoretical diversity reached). The grounded theory was used for data analysis. Participants Gynaecologists, midwives and general practitioners (GPs). The sample diversity was achieved using the following criteria: place of work, type of healthcare profession, type of patients, private-sector or hospital professional. Setting Interviews were conducted between July and December 2022 in six regions in France. Results In-depth semistructured interviews were carried out with 15 midwives, 24 GPs and 11 gynaecologists from six French regions. Their analysis highlighted that the following factors contributed to the non-adherence to the CCS recommendation: burden of caring for family members for some women, adhesion to the principle of yearly screening by healthcare professionals and patients, need of negotiating the respect of the CCS recommendations, use of emotions, and arbitration to prioritise what is needed for good health maintenance. The search for mutual emotional comfort led some healthcare professionals to adopt attitudes towards the CCS that avoid positioning conflicts, even if this means departing from the recommendations. Conclusion CCS can be correctly performed if healthcare professionals and patients agree on the need of actively taking care of their health, which is difficult for women from lower sociocultural backgrounds. During the one-to-one meeting with their patients, healthcare professionals may find difficult to apply the CCS recommendations, although they know and agree with them.

Knowledge and acceptability of the human papillomavirus vaccine and associated factors among adolescent girls in public primary schools in Dessie Town, South Wollo, Northeast Ethiopia, 2020: A cross-sectional study

Objective To assess the knowledge and acceptability of the human papillomavirus (HPV) vaccine and the associated factors among adolescent girls in public primary schools in Dessie Town, South Wollo, Northeast Ethiopia in 2020. Design, participants and methods This was an institutional cross-sectional study conducted from 1 November to 30 November 2020 among 844 adolescent girls. A systematic random sampling method was used to select participants, who completed a pretested, self-administered questionnaire. Data were entered into EpiData V.4.6 and exported to SPSS V.25 for analysis. A binary logistic regression model identified the contributing factors to HPV vaccine knowledge and acceptance. Adjusted OR (AOR) and 95% CI computed at p<0.05 were used to assess significance levels. Main outcome measures The primary outcomes of interest were knowledge and acceptability of the HPV vaccine. Results The HPV vaccine is known and acceptable to 47% and approximately 43% of the respondents, respectively. Age (AOR=3.51, 95% CI 1.62 to 7.6), father’s educational level (AOR=2.62, 95% CI 1.57 to 4.38) and parent–child communication about sex and reproductive health (AOR=1.94, 95% CI 1.36 to 2.76) were associated with knowledge of the HPV vaccine. Acceptance of the HPV vaccine was significantly influenced by fathers’ educational level (AOR=1.88, 95% CI:1.02 to 3.29), knowledge of Pap smear tests (AOR=2.54, 95% CI 1.79 to 3.62) and knowledge of the HPV vaccine (AOR=5.30, 95% CI 3.77 to 7.73). Conclusion In this study, there was generally good and high acceptance of the HPV vaccine, respectively, compared with a study conducted in Southwest Ethiopia. The study, however, had limitations in terms of recall bias, assessment of coverage/effectiveness over time and generalisability due to the institutional sample used.

High-grade cervical disease and cervical cancer in women aged 50 years and older compared with younger women: examining prevalence by HIV status in two large prospective cohorts in Botswana

Objectives International guidelines recommend cervical screening cessation at age 50 following two consecutive negative screens. However, many women aged 50 and older in low-income and middle-income countries (LMICs) have not had prior opportunity to screen. We examine the prevalence of cervical dysplasia and cervical cancer stage in Botswana women aged 50+ compared with 30–49, stratified by HIV status. Design Secondary analysis of data from two prospective cohort studies. Setting The screening cohort was recruited at health facilities in South East District. The cancer cohort was recruited from the primary public tertiary referral hospital and a private hospital in Gaborone, Botswana. Participants The screening cohort included 2570 women aged 30 and older recruited from February 2021 to August 2022. Screening eligibility included anyone with a cervix and without a prior history of cervical cancer. The cancer cohort included 1520 patients diagnosed with cervical cancer who sought care at the facilities where recruitment took place from January 2015 to December 2022. Primary and secondary outcome measures The prevalence of cervical intraepithelial neoplasia (CIN)2+ and cancer stage at diagnosis was compared across age groups, stratified by HIV status. Prevalence ratios were calculated for the association between age and CIN2+/CIN3+via log-binomial regression. Results The prevalence of CIN2+ was similar between 30–49 years old and 50+, both among women with HIV (WWH, 15.9% and 19.3%, respectively) and without HIV (13.3% and 10.4%, respectively). Similar findings were found when CIN3+ was used as the outcome. There were no statistically significant differences in prevalence ratios (PRs) across age groups for CIN2+ (adjusted PR (aPR) WWH 1.1 (95% CI 0.80 to 1.6); aPR HIV− 0.78 (95% CI 0.45 to 1.4) nor CIN3+ (aPR WWH 1.1 (95% CI 0.70 to 1.6); aPR HIV− 0.81 (95% CI 0.40 to 1.7)). Nearly half of cervical cancer diagnoses were made in women 50+; three-quarters of cases in women without HIV were diagnosed at 50+ years. Conclusions Our findings demonstrate the prevalence of high-grade cervical dysplasia and cervical cancer remains high beyond age 50 in both women with and without HIV in an LMIC context with high HIV prevalence. Screening women 50+ will allow treatment for cervical dysplasia and may provide early diagnosis of curable cervical cancer. These findings support the rapid introduction of high-performance cervical screening to increase access for women 50+. Trial registration number NCT04242823.

Status and influencing factors of knowledge, attitudes and practices relating to screening for breast and cervical cancer among rural women aged 40–65 years in China: a cross-sectional study

Objectives The objectives are to investigate the status of knowledge, attitudes and practices (KAP) and to identify factors related to KAP towards breast and cervical cancer screening among rural Chinese women aged 40–65 years. Design and setting This cross-sectional study was conducted from July to September 2020 in rural areas of eastern China. Participants This study involved 301 rural women aged 40–65 years. Variables and outcomes The questionnaire included demographic information and the KAP related to breast and cervical cancer screening. Multivariate linear regression analysis was used for the multifactor analysis. Results A total of 301 rural women aged 40–65 years participated in the survey. The overall score of KAP was (62.41±11.24), and the scores of each KAP domain relating to screening for breast and cervical cancer among participants in rural areas were (1.82±0.97), (44.52±7.20) and (16.06±4.56), respectively. The following factors were significantly associated with the total KAP Score relating to breast and cervical cancer screening among rural women aged 40–65 years, explaining 35% of the variance (p<0.001): aged 50–54 (β = −0.160, 95% CI −7.403 to −0.794), aged 55–59 (β = −0.266, 95% CI −10.763 to −3.757), aged 60–65 (β = −0.243, 95% CI −12.504 to −4.331), junior high school (β = 0.186, 95% CI 1.287 to 7.064), housewife (β = 0.172, 95% CI 0.849 to 6.868), other work (β = 0.171, 95% CI 3.818 to 15.044), annual household income ranging from 50 000 to 79 999 (β = 0.281, 95% CI 3.887 to 10.458) and annual household income≥80 000 (β = 0.330, 95% CI 4.735 to 11.554). Conclusions The status of KAP related to breast and cervical cancer screening still requires improvement. Measures to enhance the participation of the two-cancer screening should be provided to rural women aged between 50 and 65 years with lower education level and lower annual household income, especially women who are farmers.

Uterine fibroids and Black people of African descent globally: a scoping review protocol

IntroductionEvidence suggests that when adjusted for age and other factors such as Body Mass Index, age of first pregnancy, years since last pregnancy and alcohol consumption, Black women are three times more likely to suffer from fibroids compared with the general population. When compared with the general population, Black women experience larger uterine fibroids with an earlier onset and more frequent and severe symptoms debilitating symptoms. Reported symptoms include pelvic pain, bladder issues, and heavy and/or abnormal menstrual bleeding. For Black women in perimenopause or menopause, uterine fibroids are more likely to continue growing rather than slow or cease. To design empirical research that addresses the issue of uterine fibroids among Black people of African descent, it is important to understand the current state of literature on this issue. The objectives of this scoping review are to understand and describe the extent and type of literature available regarding Black people of African descent with uterine fibroids globally, to identify the gaps within existing literature, and to provide recommendations for future research.Methods and analysisThis scoping review will be conducted in accordance with JBI scoping review methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. Eligibility criteria for this review include sources that involve Black people of African descent who have uterine fibroids. This review is global in context and does not include jurisdictional, geographical, regional or study setting restrictions. A comprehensive search strategy developed in collaboration with a health sciences librarian will be used to identify and retrieve relevant peer-reviewed and grey literature. Databases including CINAHL (EBSCO), MEDLINE (Ovid), Embase (Elsevier), Gender Studies Database (EBSCO), Scopus (Elsevier) and LILACS (VHL) will be searched from inception to January 2024. Unpublished studies and grey literature searches will include The Society for Women’s Health Research, Black Women’s Health Imperative, ProQuest Dissertations and Theses Global (ProQuest), Open Access Theses and Dissertations (OATD.org) and Google search. All relevant sources will be uploaded to Covidence and undergo title and abstract screening by two independent team members. Selected sources will then undergo full-text review by two independent team members. Sources meeting the eligibility criteria will undergo extraction by two independent team members. Thematic analysis will be used to classify the extracted data points into categories according to the purpose or objective of the source, the methods used, the geographical region or jurisdiction of the source, key findings and recommendations. The synthesis of results will align with the review objective and question using charts or tables where necessary.Ethics and disseminationThis scoping review does not require ethical approval. Dissemination of the review results includes the publication of a full report in a peer-reviewed journal as well as presenting the review results at local, national and international conferences. The results of the scoping review will also be disseminated through community events and social media using infographics and brochures.

Qualitative exploration of uterine cancer care for lesbian, gay, bisexual, trans and queer (LGBTQ+) patients in the UK: shifting from equality to equity

ObjectivePatients identifying as lesbian, gay, bisexual, transgender and/or queer/questioning (LGBTQ+) report significant disparities in cancer care and are disproportionally affected by a cancer diagnosis on a number of health-related indicators. This study aimed to explore uterine cancer (UC) care from the perspectives of LGBTQ+ patients and stakeholders, to identify this population’s care needs, which have been underprioritised thus far.Methods and analysisQualitative interview data were collected from three cohorts of participants: LGBTQ+ UC patients, partners of UC patients and stakeholders who provide advocacy and/or support within the UC care pathway, including healthcare professionals (HCPs). Semi-structured qualitative interviews were conducted and data were analysed using inductive reflexive thematic analysis.ResultsFifteen participants (three patients, one partner, eight HCPs and three cancer support charity representatives) were recruited. Data analysis identified themes which represented participants’ reflections on the relevance and opportunities for identity disclosure during the diagnostic pathway; feelings and implications of not fitting into the gynaecological cancer environment and, opportunities and challenges surrounding HCP education, and protocolled sexual and gender identity data collection.ConclusionUC patients who identify as LGBTQ+ have specific care needs and considerations, particularly related to transvaginal procedures and survivorship. Opportunities for disclosure of patients’ LGBTQ+ identity during the UC care pathway are essential for these needs to be recognised. Despite this, there are conflicting agendas between HCPs and stakeholders on the best approach to integrate disclosure processes. The current findings highlight the need for public health agendas and clinical services to address the needs of LGBTQ+ UC patients.

Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh

Objectives This study aimed to determine the prevalence of cervical high-risk human papillomavirus (hrHPV) in a community-based setting and its risk factors association in women living in hard-to-reach areas in Bangladesh. Design A cross-sectional study Setting The study was carried out in six subdistricts, located in hard-to-reach and climate-impacted regions of Bangladesh. Participants A total of 8000 married women aged 30–60 years were invited for screening. Women who were unable to give consent, were pregnant or had a hysterectomy with removal of the cervix, previous screening less than 5 years, or treatment of the cervix or had symptoms of potential cervical cancer were excluded. Interventions A community-based hrHPV self-collected screening for cervical cancer was conducted from June 2022 to July 2023. Main outcome measures Prevalence of cervical hrHPV and risk factor association. Results 11 127 women were eligible for screening; 7850 women submitted hrHPV self-swabs, 7828 valid HPV test results were reported and 164 women (2.1%) tested hrHPV positive. Women living in the North were 2.1 times more likely to be hrHPV positive compared with women living in the South (adjusted OR (AOR)=2.1, 95% CI: 1.5 to 3.8, p=0.023) and widowed women were 3.0 times more likely to be hrHPV positive than married women (AOR=3.0, 95% CI: 1.7 to 5.3, p=0.001). Another risk factor associated with testing hrHPV positive was the use of hormonal contraceptives for 5 years and above (AOR=7.0, 95% CI: 2.0 to 24.4, p=0.002). Conclusion The study identified a low overall prevalence of hrHPV infection (2.1%) among women in hard-to-reach areas in Bangladesh, with some regional variations. Higher prevalence was observed in widowed compared with married women and among women reporting more than 5 years of hormonal contraceptive use. This study shows no evidence of particularly high-risk groups in hard-to-reach areas in Bangladesh. The findings support the feasibility of implementing a nationwide hr-HPV-based self-sampling strategy as a viable approach to reach WHO targets for reducing the burden of cervical cancer. Recommendation for policymakers to support future research to identify hrHPV prevalence among women in comparable groups in other geographically remote areas in Bangladesh. Trial registration number NCT05234112 .

Associations of Pap test utilisation with comorbidity and functional impairment among middle-aged non-Hispanic black women in the USA: a cross-sectional analysis of the 2018 BRFSS data

Objectives Limited evidence exists on the association of Pap test utilisation with comorbidity and functional impairment among middle-aged non-Hispanic black (NHB) women in the USA. We aimed to assess whether middle-aged NHB women with a higher burden of comorbidity and functional impairment have a lower rate of Pap test utilisation. Design Nationwide cross-sectional survey in the USA. Setting 2018 Behavioral Risk Factor Surveillance System. Participants 6359 middle-aged NHB women. Exposures and outcome The primary exposures were comorbidity and functional impairment. The outcome of interest was whether a woman reported having a Pap test in the last 3 years. Data analysis We fit unadjusted and multivariable logistic regression models to calculate ORs and 95% CI for comorbidity and functional impairment. Sensitivity analysis was restricted to women without a history of hysterectomy or cancer. We added interaction terms between exposures and age, as well as lifestyle indicators. Results Of the 6359 women, 4141 (65.1%) had comorbidity and 2429 (38.2%) had functional impairment. Middle-aged NHB women with comorbidity (≥2 vs 0, aOR=0.72, 95% CI=0.61 to 0.85, p trend<0.01) or functional impairment (≥2 vs 0, aOR=0.69, 95% CI=0.57 to 0.83, p trend<0.01) had a lower rate of Pap test utilisation compared with healthier counterparts, regardless of histories of hysterectomy and prior cancer. The analyses for age and lifestyle indicators subgroup difference indicated no statistically significant effect (p interaction>0.05). However, the magnitude of these associations was stronger among women with adverse lifestyle factors (eg, comorbidity ≥2 v.s. 0, aOR=0.53, 95% CI=0.40, to 0.71; functional impairment ≥2 v.s. 0, aOR=0.35, 95% CI=0.16, to 0.72 among binge drinkers). Conclusion Comorbidity or functional impairment could be a potential barrier to Pap test utilisation among middle-aged NHB women in the USA. Our study highlights the importance of implementing targeted intervention programmes and prioritised health resource allocation to promote Pap test utilisation. Cohort studies with clear temporality and indicators reflecting disease severity will be essential for further understanding this association.

Development and preliminary evaluation in community mental health teams of a cervical screening informed-choice tool for women with severe mental illness in England: a mixed-method study

Objectives Women with severe mental illness (SMI) face barriers to cervical cancer screening, leading to lower participation and poorer outcomes. This research aimed to develop and test an informed-choice tool to help women with SMI make informed decisions about screening attendance. Design The tool was developed using a realist review of physical health interventions and a systematic review of informed-choice tools for people with SMI. A mixed-methods approach informed its development. Usability and acceptability were assessed through semistructured interviews and the think-aloud method with service users (n=18), clinicians (n=16) and key informants. A preliminary proof-of-concept (n=25) evaluated the impact on decisional conflict—the uncertainty around making value-sensitive choices. Setting and participants Conducted in two National Health Service (NHS) Mental Health Trusts (urban and rural). Participants included women with SMI accessing secondary mental healthcare, clinicians and service user groups. A key informants’ group guided clinical content. Intervention A cervical screening informed-choice leaflet and an accompanying video. Results The tool was usable and acceptable, especially for women overdue or never screened. It may reduce decisional conflict and increase screening uptake, potentially improving survival. An National Institute for Health and Care Research (NIHR)-funded feasibility trial (Impr o ving u pt ake of cerv i cal screening in people with severe m ental i llne s s (OPTMISE)) is underway. The current UK government guidance on Support for people who find it hard to attend cervical screening due to having a mental health condition or having experienced trauma or abuse is based on this research. Conclusions Future research may involve further assessments of the real-world impact of the tool and its adaptation to other health-related decisions.

Willingness of healthcare providers to perform population-based cancer screening: a cross-sectional study in primary healthcare institutions in Tianjin, China

Objective To evaluate the willingness of healthcare providers to perform population-based screening in primary healthcare institutions in China. Methods Healthcare providers of 262 primary healthcare institutions in Tianjin were invited to fill out a questionnaire consisting of demographic characteristics, workload, and knowledge of, attitude towards and willingness to perform breast, cervical and colorectal cancer screening. Willingness to screen was the primary outcome. Multilevel logistic regression models were conducted to analyse the determinants of healthcare providers’ willingness to screen. ORs and 95% CIs were estimated. Results A total of 554 healthcare providers from 244 institutions answered the questionnaire. 67.2%, 72.1% and 74.3% were willing to perform breast, cervical and colorectal cancer screening, respectively. A negative attitude towards screening was associated with a low willingness for cervical (OR=0.27; 95% CI 0.08, 0.94) and colorectal (OR=0.08; 95% CI 0.02, 0.30) cancer screening, while this was not statistically significant for breast cancer screening (OR=0.30; 95% CI 0.08, 1.12). For breast, cervical and colorectal cancer screening, 70.1%, 63.8% and 59.0% of healthcare providers reported a shortage of staff dedicated to screening. A perceived reasonable manpower allocation was a determinant of increased willingness to perform breast (OR=2.86; 95% CI 1.03, 7.88) and colorectal (OR=2.70; 95% CI 1.22, 5.99) cancer screening. However, this was not significant for cervical cancer screening (OR=1.76; 95% CI 0.74, 4.18). Conclusions In China, healthcare providers with a positive attitude towards screening have a stronger willingness to contribute to cancer screening, and therefore healthcare providers’ attitude, recognition of the importance of screening and acceptable workload should be optimised to improve the uptake of cancer screening.

Influence of stage and age on survival of patients with vulvar cancer in Germany: a retrospective study

Objectives To evaluate the 5-year survival rate of patients with vulvar cancer, taking into account prognostic factors (International Federation of Gynecology and Obstetrics (FIGO) stage and age) and the influence of lymph node involvement and tumour size as well as the correlation between FIGO stage and age at onset. Design Retrospective cohort study. Setting German cancer registries. Participants The study included 17 017 patients diagnosed with vulvar cancer between 2004 and 2014 with follow-up until 2017. Exclusion criteria were incomplete documentation, age<18 years and death certificate only. Primary and secondary outcome measures The primary outcome was overall and relative survival according to FIGO stage and age and the distribution of FIGO stages by age group. Secondary outcomes analysed were tumour size and lymph node status as risk factors for mortality. Results The median age at diagnosis was 70 years. The overall 5-year survival rate was 69.5% (95% CI: 68.7% to 70.3%). The 5-year relative survival rates ranged from 91.9% (95% CI: 90.5% to 93.3%) to 21.3% (95% CI: 15.6% to 27.0%) for FIGO I to FIGO IVB and from 89.2% (95% CI: 87.6% to 90.8%) to 68.0% (95% CI: 65.3% to 70.7%) for age groups <55 to >75 years. Younger patients were significantly more often diagnosed with a low FIGO stage (p<0.001). Lymph node status and tumour size were independent factors influencing survival (HR: 1.79 (95% CI: 1.73 to 1.84; p<0.001) and 1.88 (95% CI: 1.80 to 1.96); p<0.001, respectively). The median follow-up time was 57 months. Conclusion Notably, the steepest decline in survival occurred within the first 3 years after diagnosis. Patients with the highest FIGO stages and those in the oldest age group had the worst survival rates. Furthermore, patients in the oldest age group were more likely to be diagnosed at higher stages. Lymph node status and tumour size were additional independent prognostic factors for mortality.

Working towards a comprehensive understanding of HPV and cervical cancer among Indigenous women: a qualitative systematic review

Rationale Indigenous peoples carry a disproportionate burden of infectious diseases and cancers and are over-represented among the socially disadvantaged of most countries. Human papillomavirus (HPV) is a risk factor and causative agent of cervical, oropharyngeal and other cancers. Recent literature shows evidence of Indigenous populations being at increased risk of HPV infections and its associated cancers. Objective This is a qualitative systematic review. The objective of this study was to explore the experiences and barriers Indigenous women face in relation to HPV awareness, knowledge and cervical screening, in order to better understand factors that may mitigate against or facilitate prevention efforts for HPV infection and associated cancers. Methods Two investigators independently searched MEDLINE, PubMed, SCOPUS and Web of Science databases (for articles published from inception until 30 June 2020) using a prespecified search strategy to identify qualitative studies on narratives of Indigenous women regarding HPV infection awareness, knowledge and cervical screening, across all geographic and income-level settings. Using a ‘meta-study’ approach, a social ecological model of cervical screening, infection and associated cancer prevention among Indigenous populations was formulated. Results Five core themes were identified and formulated within the social ecological model; intrapersonal factors, interpersonal factors, institutional/organisational factors, sociocultural/community factors and public policy. These collectively formed the proposed social ecological model of HPV infection awareness and cervical cancer prevention among Indigenous women. This model has been synthesised by taking into account personal stories of Indigenous women and healthcare workers, thus offering a more nuanced, organised, structured and culturally sensitive approach to policy translation. Conclusion The social ecological model of HPV infection awareness and cervical cancer prevention among Indigenous women offers a holistic and practical approach for Indigenous health policy makers. It clearly addresses the high risk of Indigenous populations at a global level in experience of both HPV infection and HPV-related cancers. PROSPERO registration number CRD42020207643.

Assessing knowledge, attitudes and belief toward HPV vaccination of parents with children aged 9–14 years in rural communities of Northwest Cameroon: a qualitative study

Background Human papilloma virus (HPV) vaccination is essential for the WHO cervical cancer elimination initiative. In Cameroon, HPV vaccine uptake is currently 5%. To assess the knowledge, beliefs and attitudes of parents of young girls aged 9–14 years about HPV vaccines within rural communities in the Northwest Region of Cameroon. Methods During January–May 2022, we conducted 45 one-on-one interviews using a semistructured interview guide in the localities of Mbingo, Njinikom and Fundong. Participants were parents of girls aged 9–14 years who speak English or Pidgin English. Healthcare workers were excluded. The interviews were recorded, transcribed and analysed using ATLAS.ti V.9. Member checking was conducted presenting our findings and getting feedback from a focus group of parents. Results Thirty-five mothers and 10 fathers were interviewed with a mean age of 42 years. Ninety-one per cent of parents had ever been vaccinated. Seventy-seven per cent had no or only primary school education. Thirty-two parents (71.12%) had daughters who had not been vaccinated against HPV. The themes identified include: perceived effectiveness of the HPV vaccine, affective behaviour (how they feel about the vaccine), accessibility (ability to get the vaccine), intervention coherence, ethicality (including parental informed consent), opportunity cost (future potential financial implications of cancer prevention), decision-making in the home (predominantly paternalistic), self-efficacy (extent to which education initiatives were effective) and quality initiatives (use of village infrastructure including fons/qwifons, village crier, healthcare worker presenting at the njangi house, schools and churches). Member checking with 30 women from two other communities confirmed our findings. Conclusions Lack of awareness concerning the availability and purpose of the HPV vaccination was prevalent. Use of mainstream media and top-down health education activities are not effective. Novel approaches should engage local community health workers and use established community social and leadership structures. Trial registration number ClinicalTrials.gov Registry ( NCT05325138 ).

Cancer Loyalty Card Study (CLOCS): feasibility outcomes for an observational case–control study focusing on the patient interval in ovarian cancer

ObjectivesOvarian cancer symptoms are often non-specific and can be normalised before patients seek medical help. The Cancer Loyalty Card Study investigated self-management behaviours of patients with ovarian cancer prior to their diagnosis using loyalty card data collected by two UK-based high street retailers. Here, we discuss the feasibility outcomes for this novel research.DesignObservational case–control study.SettingControl participants were invited to the study using social media and other sources from the general public. Once consented, control participants were required to submit proof of identification (ID) for their loyalty card data to be shared. Cases were identified using unique National Health Service (NHS) numbers (a proxy for ID) and were recruited through 12 NHS tertiary care clinics.ParticipantsWomen in the UK, 18 years or older, with at least one of the participating high street retailers’ loyalty cards. Those with an ovarian cancer diagnosis within 2 years of recruitment were considered cases, and those without an ovarian cancer diagnosis were considered controls.Primary outcome measuresRecruitment rates, demographics of participants and identification of any barriers to recruitment.ResultsIn total, 182 cases and 427 controls were recruited with significant differences by age, number of people in participants’ households and the geographical region in the UK. However, only 37% (n=160/427) of control participants provided sufficient ID details and 81% (n=130/160) matched retailers’ records. The majority of the participants provided complete responses to the 24-Item Ovarian Risk Questionnaire.ConclusionsOur findings show that recruitment to a study aiming to understand self-care behaviours using loyalty card data is challenging but feasible. The general public were willing to share their data for health research. Barriers in data sharing mechanisms need to be addressed to maximise participant retention.Trial registration numberISRCTN14897082, CPMS 43323,NCT03994653.

Maintenance with niraparib in patients with stage III, stage IV, chemo-naïve recurrent or platinum-sensitive recurrent uterine serous carcinoma: study protocol for a phase II clinical trial

Introduction Uterine serous carcinoma (USC) accounts for 40% of endometrial cancer-related deaths. The standard of care for stages III and IV USC yields a 20%–30% survival at 2 years and a 10%–20% survival at 3–5 years. Recent advances in the second-line treatment of advanced or recurrent USC are rapidly evolving. Targeted therapeutic approaches with the use of lenvatinib plus pembrolizumab, as well as the use of trastuzumab deruxtecan, offer new hope for successful second-line therapies for patients. However, further investigation into novel targeted therapeutic approaches is warranted, given the high burden of disease associated with this aggressive histological subtype. USC shares clinical and genomic similarities with epithelial ovarian cancer, suggesting a correlation with ‘BRCAness’. Niraparib, a potent PARP1 and PARP2 inhibitor, was shown to have a positive impact on platinum-sensitive recurrent ovarian cancer, regardless of the presence or absence of BRCA status. Our hypothesis is that patients with stage III, stage IV and platinum-sensitive recurrent USC receiving niraparib maintenance in addition to standard therapy for USC may have an improved progression-free survival. Methods and analysis Participating sites include the primary site, Northwell Health Zucker Cancer Centre, and secondary site, Rutgers Cancer Institute of NJ. Females over the age of 18 with stage III, stage IV or platinum-sensitive recurrent USC will be recruited and enrolled based on inclusion/exclusion criteria. 24 subjects will be enrolled during phase 1 and 21 subjects will be enrolled during phase 2, over a total of 3 years. Patients will receive an individualised dose of niraparib daily every 28 days per cycle for 1 year or until progression of disease. Follow-up of disease status will continue for 5 years poststudy treatment. This phase II clinical trial will employ a Simon two-stage minimax design to test the null hypothesis that the 1 year response rate is <20% versus the alternative hypothesis that the 1 year response rate is ≥40%, with alpha=0.05 and power=0.90. Ethics and dissemination Ethical approval was granted by Northwell Health Cancer Institute institutional review board (reference number: 19–0380) and PRMS. Alongside journal publications, results will be available publicly on completion of the study as approved by the sponsor investigator. Trial registration number NCTN04080284

Clinical outcome of advanced or recurrent endometrial carcinoma treated with chemotherapy: a French observational retrospective cohort: the ENDOVIE study

Objective Advanced or recurrent endometrial carcinoma (EC) represents a significant clinical challenge. This study aimed to evaluate patient (age and comorbidities) and disease (histological subtypes and stages) characteristics, treatment patterns and survival outcomes in a real-world French healthcare setting. Methods and analysis In this national, multi-centre, retrospective observational cohort study, 200 patients with advanced or recurrent EC receiving first- or second-line chemotherapy during the year 2019 were analysed. Data collected included baseline characteristics, treatment regimens, real-world progression-free survival (rwPFS) and overall survival (OS). Results 127 and 73 were included in the first and second lines, respectively. Endometrioid carcinoma was the most represented histological subtype (62.0%). Patients in the first line, of whom 31.5% had FIGO (Fédération Internationale de Gynécologie Obstétrique) IVB disease, mainly received a combination of carboplatin and paclitaxel (78.0%), while 131 patients receiving second-line therapy were mainly administered anthracycline (54.2%). Median rwPFS and OS were, respectively, 8.5 and 13.2 months for patients receiving first-line therapy and 4.0 and 9.4 months for patients receiving second-line therapy. In Cox analyses, a diagnosis of carcinosarcoma, the presence of liver metastases and stage IVB disease were associated with worse survival outcomes for patients recieving first-line chemotherapy. Non-platinum chemotherapy and liver metastases were associated with poorer survival in patients receiving second-line chemotherapy. Conclusions This study highlights the landscape of metastatic EC treatment in a real-world French setting before the availability of PD1 inhibitors, emphasising the discrepancy between clinical trial data and real-world outcomes. It underscores the necessity for further real-world studies to complement clinical trials for a comprehensive understanding of metastatic EC management.

Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study

Introduction Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic. Methods and analysis In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis. Ethics and dissemination Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. Trial registration number DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.

Analysis of the disease burden of malignancies in the female reproductive system in China from 1990 to 2019: an age-period-cohort study and joinpoint analysis

Objective To analyse the trend of the disease burden of common malignancies of the female reproductive system and the influence of age, period and birth cohort in China from 1990 to 2019. Design We used the joinpoint model based on the global burden of disease (GBD 2019) database to explore the trend of the burden of common malignancies of the female reproductive system in China from 1990 to 2019, and further analyzed the impact of age, period, and birth cohort using the age-period-cohort model. Setting GBD data from 1990 to 2019. Participants Data were publicly available and individuals were not involved. Main outcomes Outcomes included age standardised incidence rate, standardised mortality, standardised disability-adjusted life year (DALY), annual percentage change, average annual percentage change, age (period, cohort) effect coefficient, relative coefficient and SE. Akchi information criterion and Bayesian information criterion were used to estimate model goodness of fit. Results From 1990 to 2019, the standardised incidence and prevalence of cervical cancer and endometrial cancer increased, while the standardised mortality and DALY rate decreased. The standardised incidence, prevalence, mortality and DALY rates of ovarian cancer increased. The risk of cervical cancer, ovarian cancer and endometrial cancer increased first and then decreased with age, reaching its peak at ages 55, 70 and 55, respectively, while the risk of death increased with age. The risk of the onset and death of cervical cancer and ovarian cancer increased with the period, while those of endometrial cancer increased first and then decreased. The cohort with later female reproductive system malignancies had a lower risk of morbidity and mortality than the previous cohort. Conclusion From 1990 to 2019, the disease burden of malignant tumours in the female reproductive system in China was high. Relevant departments should pay attention to the prevention and treatment of malignant tumours in the reproductive system. Middle-aged and elderly women are the key target group for prevention and control.

Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for primary advanced or recurrent endometrial cancer: a prospective single-arm open-label phase II clinical trial

IntroductionRecently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.Methods and analysisIn this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.Ethics and disseminationThe study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.Trial registration numberNCT06066216.

Medroxyprogesterone acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and endometrial carcinoma: trial protocol for a prospective, randomised, open, blinded-endpoint design, dose-response trial (FELICIA trial)

Introduction Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC). However, the results of three meta-analyses revealed a high remission rate, as well as an association with a high rate of relapse. We previously conducted a phase II of medroxyprogesterone acetate (MPA) plus metformin as a fertility-sparing treatment for AEH and EC patients, and reported that metformin inhibited disease relapse after remission. Methods and analysis A randomised, open, blinded-endpoint design phase IIb dose response trial was planned to commence in July 2019. The trial aims to identify the appropriate dose of metformin to be combined with MPA therapy for fertility-sparing treatment of patients with AEH and EC. The primary endpoint of the trial is the 3-year relapse-free survival (RFS) rate. The secondary endpoints are RFS rate, the overall rate of response to MPA therapy, the conception rate after treatment, the outcome of pregnancy, toxicity evaluation and changes in insulin resistance and body mass index. A total of 120 patients will be enrolled from 15 Japanese institutions within a 2.5-year period and followed up for at least 3 years. Ethics and dissemination The protocol was approved by the institutional review board at Chiba University Hospital and boards at 14 other institutions. The trial will be conducted according to the principles of the World Medical Association’s Declaration of Helsinki and in accordance with Good Clinical Practice (GCP) standards. The trial findings will be published in a peer-reviewed journal. Trial registration number Japan Registry of Clinical Trials (jRCT2031190065).

Follow-up rescreening uptake and persistent positive rates among women after positive cervical cancer screening results in Ethiopia: a longitudinal cross-sectional study

Objective To assess cervical cancer screening positivity rates, follow-up rescreening uptake 1 year after treatment and persistent positivity among women with initial positive screening results in Ethiopia. The study also explored reasons for loss to follow-up and preferences for reminder strategies. Design Longitudinal cross-sectional study. Settings 10 primary healthcare facilities in Oromia and southern and central Ethiopia. Participants From November 2022 to April 2024, 17 586 women screened for cervical cancer. Of these 768 (4.4%) had positive screening results, and 515 women treated at the primary level were included to assess follow-up rescreening uptake. An additional 139 women who did not return for follow-up were interviewed to identify reasons for non-uptake and reminder preferences. Result Of the 515 women included in the analysis, 179 (34.8%, 95% CI: 30.6% to 38.8%) returned for follow-up rescreening. Among those re-screened, the persistent visual inspection with acetic acid (VIA) positivity rate was 16.1% (95% CI: 11.0% to 21.7%). Factors significantly associated with follow-up rescreening uptake included age over 40 (adjusted OR (AOR): 2.5; 95% CI: 1.34 to 5.00), urban residence (AOR: 1.7; 95% CI: 1.15 to 2.58), secondary or higher education (AOR: 2.0; 95% CI: 1.06 to 4.12) and HIV-positive status (AOR: 2.4; 95% CI: 1.27 to 4.87). Among the 139 women contacted, the main reasons for non-uptake were lack of time, forgetting appointments, visiting another facility and pregnancy. Regarding preferred reminders, 93% favoured text messages and all agreed to phone calls or home visits. Conclusion One-third of women adhered to follow-up rescreening after a positive cervical cancer screening in Ethiopia, revealing a considerable gap since those women had a three times higher chance of being VIA positive compared with the first screening. Older age, urban residence, higher education and HIV-positive status were significantly linked to follow-up rescreening uptake. Addressing barriers such as time constraints and forgotten appointments through tailored reminder strategies is essential for improving the follow-up rescreening uptake. Contextualised interventions can strengthen rescreening for finding those women at very high risk for cervical lesions and strengthen cervical cancer prevention in Ethiopia. Trial registration number NCT06515301 .

Evaluating the psychometric measurement properties of patient-reported outcome measures for uterine fibroids using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines: a systematic review

Objectives To systematically evaluate the psychometric measurement properties of existing patient-reported outcome measures (PROMs) for uterine fibroids using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and to provide recommendations for the most appropriate tools in clinical and research settings. Design Systematic review using the COSMIN guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Data sources The Medline, CINAHL, Embase and Web of Science databases were searched for relevant studies published up to 28 February 2025. Eligibility criteria were studies that targeted patients with uterine fibroids using a PROM instrument and were published as full-text, English-language articles in peer-reviewed journals. Studies that used only a portion or an unvalidated short form of the PROMs, non-English publication or non-peer-reviewed formats were excluded. Data extraction and synthesis Two independent reviewers extracted the data using EndNote V.X9 (Clarivate, London, UK). The PROM quality assessment adhered to the COSMIN guidelines. The level of evidence for the psychometric properties of each PROM was determined using a modified GRADE approach. Results Of 678 records retrieved in the literature search, 11 were included. Six uterine fibroid-specific PROMs were identified and evaluated according to the COSMIN guidelines. The Uterine Fibroid Symptom and Quality of Life (UFS-QoL) and the Bleeding and Pelvic Discomfort Scale (BPD) received class A recommendations (recommended) for sufficient content and structural and internal consistency. However, four other PROMs, namely the Perioperative Anxiety Scale for Uterine Fibroids, Fibroid Symptom Diary, Uterine Fibroid Daily Bleeding Diary and Menstrual Pictogram Superabsorbent Polymer-containing Version 3, received class B recommendations (further research required) due to poor measurement properties, including inadequate reliability and unquantified measurement error. Conclusion The results of the present study fill a knowledge gap in the systematic and comprehensive evaluation of uterine fibroid-related PROMs. These findings provide valuable insights and recommendations for clinicians and researchers seeking reliable PROMs for this patient population. The UFS-QoL and BPD were classified as ‘A’ and were recommended, demonstrating the potential to promote outcome measurements in future studies. PROSPERO registration number CRD42023474806.

Effect of medical-grade honey (L-Mesitran) for cervical intraepithelial neoplasia II: protocol for a multicentre cohort pilot study (HONEY FOR CIN II study)

Introduction High-grade squamous intraepithelial lesions are caused by persistent high-risk human papillomavirus (hr-HPV) infections and are subdivided into cervical intraepithelial neoplasia (CIN) lesions: CIN II (moderate) and CIN III (severe). Current treatment options for CIN II include large loop excision of the transformation zone, imiquimod and expectant management. Each treatment option has its drawbacks, and therefore, a non-invasive treatment is desirable. Preliminary evidence shows that medical-grade honey (MGH) has antiviral activity and might be able to modulate the vaginal microbiome, reduce local inflammation or directly influence the intralesional immune response within cervical tissues. Therefore, this study aims to investigate the possible effect of MGH on hr-HPV clearance and to investigate the possible underlying mechanisms contributing to the regression of CIN II lesions. Methods and analysis This study is performed in the Zuyderland Medical Centre and Maastricht University Medical Centre+. A total of 60 eligible women with newly histologically confirmed CIN II will receive MGH (L-Mesitran Soft) for intravaginal use for 6 months. The primary objective is to investigate the effect of MGH on the hr-HPV clearance after 6 months. Secondary aims are the effect of MGH on the regression of CIN II lesions, clearance of hr-HPV at 12 and 24 months and the role of the vaginal microbiome, local immune system and intravaginal inflammatory status in response to MGH. Moreover, data on quality of life, side effects and compliance will be collected. Ethics and dissemination Ethical approval from the Medical Ethics Review Committee of the Zuyderland Medical Centre Heerlen has been obtained (NL86044.096.24 on 24 April 2024). The results will be presented to researchers and healthcare professionals through conferences, meetings and publications in international journals. Trial registration number NCT06219018.

Human papillomavirus vaccine uptake and associated factors among in-school adolescent girls in Harari regional state, Eastern Ethiopia: a cross-sectional study

Objective The Human Papillomavirus (HPV) vaccine has offered a great promise to reduce the cervical cancer burden, yet its uptake remains limited, and the current evidence is mixed and inconclusive. This study aims to assess HPV vaccine uptake and its associated factors among adolescent school girls. Design A school-based cross-sectional study. Setting Schools in Harari regional state, Eastern Ethiopia. Participants total of 416 female adolescent students, from 1 April 2024 to 30 April 2024. Outcome Uptake of HPV vaccination. Methods A multi-stage sampling technique was used to select study participants. A structured interviewer-administered questionnaire was used for data collection. The collected data were entered into Epidata V.3.1 and analysed by using STATA V.17.0. A logistic regression model was used to assess the associations between dependent and independent variables. An adjusted OR with 95% CIs was used to declare a significant association. Result Adolescent girls’ uptake of the HPV vaccine was 49.26% (95% CI 42.65% to 56.59%) Being urban residents (AOR=2.59; 95% CI 1.61 to 4.18), having a government-employed mother (AOR=2.60; 95% CI 1.12 to 6.05), availability of health promotion in their vicinity (AOR=4.17; 95% CI 2.01 to 8.66), having a good knowledge of cervical cancer and HPV infection (AOR=1.64; 95% CI 1.05 to 2.57) were significantly associated with uptake of HPV vaccine Conclusion Nearly half of the eligible in-school adolescent girls received the HPV vaccine. Being an urban resident, having a government-employed mother, the availability of health promotion in their vicinity, and having a good knowledge of cervical cancer and HPV infection were significantly associated with the uptake of HPV vaccination. Expanding health promotion and raising awareness of cervical cancer and HPV infection among rural adolescents could increase HPV vaccine uptake.

High-risk human papillomavirus infection (HPV 16/18) and its determinants among women in East Gojjam Zone, Northwest Ethiopia: a population-based cross-sectional study, 2021

Objective This study aimed to assess high-risk human papillomavirus (HPV) infection (HPV 16/18) and its determinants among women in East Gojjam Zone, Northwest Ethiopia. Design An institutional-based cross-sectional study. Setting and participants The study was conducted among 337 women screened for cervical cancer in two hospitals in East Gojjam Zone from February to April 2021 gregoriean calander. Results The prevalence of HPV infection was 14.2% (95% CI: 10.7% to 18.1%). The mean age of the respondents was 36.7±9.1 years. Women in the age group of 55–65 years (adjusted OR (AOR)=7.91, 95% CI: 1.95 to 32.09), early initiation of sexual intercourse (AOR=5.36, 95% CI: 1.58 to 18.13), history of sexually transmitted infection (STI) (AOR=3.52, 95% CI: 1.27 to 9.72), HIV positive status (AOR=6.8, 95% CI: 1.99 to 23.54) and number of lifetime sexual partners (AOR=4.37, 95% CI: 1.15 to 17.3) were important independent factors associated with the presence of oncogenic HPV infection. Conclusion and recommendation We found a relatively low prevalence of high-risk HPV infection. Age, early initiation of sexual intercourse at less than 18 years, history of STI, being HIV seropositive and multiple sexual partners were important factors for high-risk HPV infection. Women aged >46 years, women with early initiation of sex, a history of STI, being HIV positive and a history of multiple sexual partners should be encouraged to be screened and vaccinated for HPV infection. Wider-ranging studies are also needed in HPV-infected women in association with the cervical lesion.

p16 expression and its correlation with the clinical pathological characteristics of patients with cervical cancer: a systematic review and meta-analysis

Objectives Overexpression of p16 has been documented in a variety of human tumours. Nonetheless, the association between p16 overexpression and the clinicopathological characteristics of patients with cervical cancer remains a subject of debate. This meta-analysis sought to systematically assess the relationship between p16 expression and the clinicopathological features of patients with cervical cancer. Design Systematic review and meta-analysis. Data sources The PubMed, Embase, Cochrane Library (Central), Web of Science (SCI Expanded), and Chinese databases (CNKI, VIP, Wanfang and CBM) were searched through 1 March 2024. Eligibility criteria for selecting studies Case‒control studies examining the association between p16 expression and cervical cancer were analysed to evaluate whether p16 expression was correlated with the clinicopathological characteristics of patients with cervical cancer. Data extraction and synthesis Two independent reviewers employed standardised methods to search, screen and code the included studies. The risk of bias was evaluated using the Cochrane Collaboration tools and the Newcastle-Ottawa Scale. Statistical analyses and data processing were conducted using Review Manager V.5.4, which included heterogeneity tests and sensitivity analyses. Additionally, STATA V.16.0 was used for further sensitivity analyses of the included studies, and publication bias was assessed using Begg’s test. Conclusions The p16 protein is strongly associated with the onset and progression of cervical cancer and serves as a valuable biomarker for its early detection and diagnosis. PROSPERO registration number CRD42024546241.

Knowledge, attitudes and practices regarding cervical cancer screening among women in the Dindaeng community, Bangkok, Thailand: a cross-sectional community-based study

Objectives To assess knowledge, attitudes and practices regarding cervical cancer screening among women in Bangkok’s Dindaeng community and identify factors influencing screening uptake. Design Cross-sectional, community-based survey. Setting Primary care level; conducted in a high-density, low-income urban community in Bangkok, Thailand. Participants A total of 450 women aged 25–65 years were recruited using convenience sampling. After excluding ineligible participants (eg, prior hysterectomy), 428 women completed the questionnaire. All participants were literate in Thai and resided in the study area. Primary and secondary outcome measures The primary outcome was a history of cervical cancer screening (ever screened vs never screened). Secondary outcomes included frequency of screening, barriers to screening and level of knowledge regarding cervical cancer and human papillomavirus (HPV). Results Among 428 participants (mean age 47.9±11.2 years), 65.4% reported ever having been screened, but only 19.1% adhered to regular screening intervals. The most common barriers to screening were the absence of symptoms (54.7%) and fear of the procedure (42.1%). Only 31.8% correctly identified HPV as the cause of cervical cancer, and 23.8% were aware of the HPV vaccine. Higher knowledge scores were associated with having fewer children (adjusted OR (AOR) = 10.71; 95% CI: 1.29 to 89.12), while oral contraceptive use was negatively associated with high knowledge scores (AOR=0.14; 95% CI: 0.03 to 0.74). Conclusions Despite a moderate rate of screening uptake, consistent adherence and knowledge regarding cervical cancer and its prevention remain suboptimal. Targeted community health education and structural interventions are needed to improve awareness and promote regular screening in low-income urban settings.

Comparing treatment strategies for placental site trophoblastic tumour (PSTT): study protocol for a systematic review and network meta-analysis

Introduction Placental site trophoblastic tumour (PSTT) is a rare type of gestational trophoblastic malignancy. Despite different guidelines recommending surgery, chemotherapy or immunotherapy, there has been no optimal first-line treatment owing to its rarity. Direct comparisons of efficacy and safety across interventions remain limited. We aim to perform a systematic review and network meta-analysis (NMA) to explore each PSTT treatment and to help develop individualised, evidence-based clinical decisions. Methods and analysis This systematic review, registered on PROSPERO and adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-P 2015 guidelines, will evaluate all available treatments for PSTT. Databases (PubMed, Scopus, Embase, Web of Science) will be searched from inception to 31 May 2025 using Medical Subject Headings terms and keywords related to PSTT. The inclusion criteria will be studies reporting confirmed PSTT patients and treatment outcomes; the exclusion criteria will be non-human studies, abstracts and reviews. Two researchers will independently screen studies, resolving discrepancies via discussion or a third reviewer. Manual reference checks will complement searches. Data on study characteristics, interventions (chemotherapy, surgery or other treatments) and outcomes (overall survival (OS), progression-free survival, adverse events, fertility) will be extracted. The primary outcome will be the OS. Quality will be assessed using the Newcastle-Ottawa Scale (NOS) for observational studies and V.2 Cochrane Risk of Bias Assessment Tool (RoB 2) for randomised controlled trials. Statistical analyses will be conducted via Review Manager 5.4.1 and Stata 16.0. The ORs, along with 95% CIs will be calculated with random-effects or fixed-effects models depending on the heterogeneity between studies. The sensitivity analyses and publication bias (funnel plots, Begg’s/Egger’s tests) will be assessed if indicated. Ethics and dissemination As this study analyses previously published data, no additional ethical approval is required, nor will patient safety be compromised. The collected results will be submitted for publication in a peer-reviewed journal following PRISMA-NMA guidelines. No datasets will be generated or analysed during the current study. PROSPERO registration number CRD420251013082.

Impact of an educational physiotherapy-yoga intervention on perceived stress in women treated with brachytherapy for cervical cancer: a randomised controlled mixed study protocol (KYOCOL)

Introduction Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT. Methods and analysis KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT. Ethics and dissemination This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal. Trial registration number NCT06263283 .

Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study

Introduction Cervical cancer, a major global health concern, is primarily caused by human papillomavirus (HPV) infection. Although cervical intraepithelial neoplasia grade 2 (CIN2), a precancerous lesion, exhibits high spontaneous regression rates (50%–60%), particularly in younger women, current clinical management lacks accurate risk stratification. This study examines HPV integration status as a prognostic biomarker in women aged 18–45 diagnosed with CIN2, with the objective of developing a predictive tool for personalised therapeutic strategies and minimising overtreatment in this high-regression population. Method and analysis This multicentre cohort study will be implemented across 20 tertiary Grade A hospitals in China, encompassing eastern, western, central and northern regions. It will recruit 240 CIN2 patients, collecting sociodemographic, lifestyle and medical history data via questionnaires. Clinical examinations will be performed at baseline and follow-up. Disease regression ((to cervical intraepithelial neoplasia grade 1 [CIN1] or lower)) and non-regression (persistent CIN2 or progression) will be evaluated. Prognostic factors will be analysed using Cox proportional hazards models, adjusting for confounders such as age, weight and socioeconomic status. Ethics and dissemination The cohort study protocol and informed consent procedures adhere to the Declaration of Helsinki and pertinent Chinese clinical research regulations. Ethical approval has been obtained from the Clinical Research Review Committee of the Fujian Maternal and Child Health Hospital (2022KYLLR01018) and from the participating hospitals. Written informed consent is secured from all participants prior to enrolment, with detailed information provided regarding study objectives, procedures, potential risks and benefits and participants’ rights. Results will be published in peer-reviewed scientific journals, presented at academic meetings and conferences and released to the public through press releases. Trial registration number ClinicalTrials.gov ( NCT05282095 ); Pre-results.

Cervical cancer screening by cotesting method for Vietnamese women 25–55 years old: a cost-effectiveness analysis

Background Cervical cancer (CC) is preventable through regular screening and vaccination against human papillomavirus (HPV). However, CC remains a significant public health issue in low-income and middle-income countries (LMICs) like Vietnam, where financial constraints hinder the widespread implementation of HPV vaccination and screening programmes. Currently, Vietnam lacks both a national CC screening intervention and an HPV vaccination programme for women and girls. To date, cost-effectiveness studies evaluating CC screening methods in Vietnam remain limited. Objectives To evaluate the cost-effectiveness of two CC screening strategies for Vietnamese women aged 25–55 years: (1) cotesting combining cytology and HPV testing conducted three times at 5 year intervals (intervention) and (2) cytology-based screening conducted five times at 2 year intervals (comparator). The objective is to provide evidence to inform policy and clinical practice in Vietnam. Design Cost-effectiveness analysis using a Markov model with 1 year cycles to simulate the natural progression of CC. Setting The Vietnamese healthcare system, modelled from the provider’s perspective, with parameters adapted to the local context through expert consultations. Participants A simulated cohort of Vietnamese women aged 25–55 years. Interventions The intervention involved cotesting (cytology and HPV testing) three times at 5 year intervals. The comparator was cytology-based screening conducted five times at 2 year intervals. Primary and secondary outcome measures The primary outcome measure was quality-adjusted life years (QALYs). Costs and cost-effectiveness ratios were assessed using Vietnam’s gross domestic product (GDP) per capita as the cost-effectiveness threshold (1–3 times GDP per capita). Sensitivity analyses (one-way deterministic and probabilistic) were conducted to account for uncertainties. Results The cotesting strategy was less effective and more costly than cytology-based screening across all age groups. Cotesting resulted in higher costs and fewer QALYs than the comparator. Probabilistic sensitivity analyses confirmed that cotesting was not cost-effective under current conditions in Vietnam. Conclusions Cytology-based screening conducted five times at 2 year intervals is a more cost-effective option for CC screening in Vietnamese women aged 25–55 years. The cotesting strategy cannot be recommended due to its higher cost and lower effectiveness.

Impact of human papillomavirus age-related prevalence and vaccination levels on interpretation of cervical screening modalities: a modelling study

Objective Cervical screening is a life-saving intervention, which reduces the incidence of and mortality from cervical cancer in the population. Human papillomavirus (HPV) based screening modalities hold unique promise in improving screening accuracy. HPV prevalence varies markedly by age, as does resultant cervical intraepithelial neoplasia (CIN), with higher rates recorded in younger women. With the advent of effective vaccination for HPV drastically reducing prevalence of both HPV and CIN, it is critical to model how the accuracy of different screening approaches varies with age cohort and vaccination status. This work establishes a model for the age-specific prevalence of HPV factoring in vaccine coverage and predicts how the accuracy of common screening modalities is affected by age profile and vaccine uptake. Design Modelling study of HPV infection rates by age, ascertained from European cohorts prior to the introduction of vaccination. Reductions in HPV due to vaccination were estimated from the bounds predicted from multiple modelling studies, yielding a model for age-varying HPV and CIN grades 2 and above (CIN2+) prevalence. Setting Performance of both conventional liquid-based cytology (LBC) screening and HPV screening with LBC reflex (HPV reflex) was estimated under different simulated age cohorts and vaccination levels. Participants Simulated populations of varying age and vaccination status. Results HPV-reflex modalities consistently result in much lower incidence of false positives than LBC testing, with an accuracy that improves even as HPV and CIN2+ rates decline. Conclusions HPV-reflex tests outperform LBC tests across all age profiles, resulting in greater test accuracy. This improvement is especially pronounced as HPV infection rates fall and suggests HPV-reflex modalities are robust to future changes in the epidemiology of HPV.

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial

IntroductionEpidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. TheExercise duringCHemotherapy forOvarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer.Methods and analysisParticipants (target sample size: n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either theexercise intervention(plus usual care) orusual carealone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage.Ethics and disseminationEthics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences.Trial registration numberAustralian New Zealand Clinical Trial Registry (ANZCTRN12614001311640;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367123&isReview=true).

Perspectives of HPV vaccination among young adults: a qualitative systematic review and evidence synthesis protocol

Introduction Human papillomavirus (HPV) is the causative agent of nearly all cervical cancers. Despite the proven safety and efficacy of HPV vaccines in preventing HPV-related cancers, the global vaccine coverage rate is estimated to only be 15%. HPV vaccine coverage rates are more actively tracked and reported for adolescents 17 years and younger but there is still a critical window of opportunity to intervene and promote HPV vaccination among young adults aged 18–26 years who are still eligible to be vaccinated. This protocol for a qualitative evidence synthesis aims to review perspectives of HPV vaccination among young adults (18–26 years) and identify facilitators and barriers that influence HPV vaccination uptake and decision-making. Methods and analysis Seven databases will be searched from 1 January 2006 to the date of final search. For inclusion, studies must report HPV vaccination perspectives of young adults aged 18–26 years and use qualitative study methods or analysis techniques. Studies will be screened in a two-stage process guided by the eligibility criteria. Final included studies will be evaluated for methodological strengths and limitations using the Critical Appraisal Skills Programme quality assessment tool for qualitative studies. After data extraction, framework analysis will be used to analyse the data applying the socioecological model. Finally, the Grading of Recommendations Assessment, Development and Evaluation - Confidence in the Evidence from Reviews of Qualitative research will be applied to evaluate the confidence in synthesised qualitative findings. The methodology of this review follows the Cochrane Handbook guidelines on qualitative evidence syntheses. Ethics and dissemination Formal ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publications, conference presentations and professional networks. PROSPERO registration number CRD42023417052.

Gap analysis of service quality and associated factors at the oncology center of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2022: a cross-sectional study

Objective To measure the gap between expectations of patients with cancer for oncology services and their perceptions of the actual service and to identify associated factors at the oncology centre of Tikur Anbessa Specialized Hospital, Ethiopia. Design An institutional-based cross-sectional study design was conducted using the service quality (SERVQUAL) tool from March to April 2022 on a sample of 256 hospitalised patients with cancer at the oncology centre of Tikur Anbessa Specialized Hospital. A paired Wilcoxon test and Kruskal-Wallis tests were used to determine the statistically significant difference between expectation and perception and to quantify the strength of association between the level of gap in the quality of oncology service and dependent variables, respectively. Results Out of 256 patients with cancer included in the study, all of them agreed and participated, making the response rate 100%. The overall gap in service quality explained by the mean and SD is −1.42 (±0.41). The overall score for expectation and perception is 4.24 (±0.31) and 2.82 (±0.37), respectively. Being female, age greater than 65, having a college degree and above, being a patient with cervical cancer, patients with stage 4 cancer and patients who waited for more than 12 months for radiotherapy were found to have a statistically significant higher expectation compared with their perceived care in one or more dimensions of the SERVQUAL tool. Conclusion Patient perceptions of the quality of service they received were lower than their expectations of the quality of service in all service quality aspects at Tikur Anbessa Specialized Hospital’s oncology centre, implying unmet quality expectations from the oncology service users, with tangibility, assurance and empathy being the dimensions with the highest gap recorded, respectively. Therefore, the hospital and other stakeholders should strive to exceed patient expectations and the overall quality of care.

Integration of cervical cancer screening into healthcare facilities in low- and middle-income countries: a scoping review protocol

Background Cervical cancer is the fourth most common malignancy in women, with 90% of deaths in low- and middle-income countries. Integrating cervical cancer screening services into healthcare facilities is crucial for overcoming the disease. Thus, this review aims to map existing evidence and identify barriers and facilitators in low- and middle-income countries. Methods The scoping review will employ a five-step framework as proposed by Arksey and O’Malley. These are (1) formulating the research questions, (2) identifying relevant studies, (3) selecting eligible studies, (4) charting the data, and (5) collating, summarising and reporting the results. Five databases (MEDLINE, Maternity and Infant Care, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science) will be systematically searched. Grey literature will also be searched. Data will be extracted, charted, synthesised and summarised. Ethics and dissemination This review does not require ethics approval. Findings will be disseminated through peer-reviewed publications, policy briefs and conference presentations.

Trends in incidence and mortality for gynaecological cancers in Southeastern China during 2011–2020: a retrospective analysis of registry data

Objectives This study aimed to investigate the changes in the incidence and mortality trends of ovarian cancer (OC), cervical cancer (CC) and uterine cancer (UC) in the Fujian Province, southeastern China. Design Provincial, population-based, retrospective observational study. Setting Fujian province, southeastern China between 2011-2020. Participants From 2011 to 2020, 6178 new cases and 2037 deaths caused by 3 gynaecological cancers were eligible for analysis. Primary and secondary outcome measures The primary outcome measures were the incidence and mortality rates, including the age-standardised incidence rate (ASIR) and age-standardised mortality rate (ASMR), of three gynaecological cancers. The secondary outcome measure was the prevalence (average annual per cent changes (AAPC)). Results The incidence of all three gynaecological cancers increased from 2011 to 2020. CC had the slowest upward trend, with an AAPC of 2.54% over the period. However, it had the highest ASIR among the 3 cancers in 2020 (10.41/100 000). UC showed a rapid increase, with an AAPC of 15.15% from 2016 to 2020. While the mortality rate of UC remained stable, both CC and OC also exhibited rising trends, with the CC having the highest ASMR (3.05/100 000) in 2020. The ASMR for CC increased rapidly, with the highest AAPC of 5.51%. Conversely, changes in the ASMR for UC were not statistically significant (p=0.601). Moreover, high incidence rates were more common among perimenopausal women and older participants in the respective cancer groups where the increased mortality was observed. Conclusions Gynaecological cancer burden remains a public health issue in Fujian Province, with an increasing incidence. Improving the healthcare system and promoting a healthy lifestyle should be highlighted to reduce the cancer burden.

Pre-post feasibility trial of a telephone-delivered exercise intervention for patients during chemotherapy for recurrent ovarian cancer: the ECHO-R trial protocol

Introduction The benefits of exercise in reducing treatment-related morbidity and improving quality of life following a primary diagnosis of cancer have been well documented and have led to exercise being recommended by oncology societies for all people with a cancer diagnosis. However, these recommendations are derived from research typically involving cohorts with more common cancers and relatively good prognosis, such as breast and prostate. Evidence from these cancers may not apply to women with recurrent ovarian cancer. Therefore, the primary objective of this trial is to evaluate the feasibility and safety of a home-based, telephone-delivered exercise intervention for women undergoing chemotherapy for recurrent ovarian cancer. Methods and analysis The Exercise During Chemotherapy for Recurrent Ovarian Cancer (ECHO-R) trial is a single-arm, phase II, pre/postintervention trial of a 6-month, telephone-delivered exercise intervention (consistent with recommended exercise oncology prescription). The target sample size is 80 women who are currently undergoing (or are scheduled to receive) chemotherapy for recurrent ovarian cancer. Recruitment is through participating hospital sites in Queensland, Australia, or via self-referral. The exercise intervention comprises 12 telephone sessions over a 6-month period delivered by trial-trained exercise professionals and supplemented (where feasible) by five sessions face to face. Exercise prescription is individualised and works towards an overall goal of achieving a weekly target of 150 min of moderate-intensity, mixed-mode exercise. Assessments via self-administered survey and physical fitness and function tests occur at baseline and then at 6 and 9 months postbaseline. Data to inform feasibility and safety are recorded as case notes by the exercise professional during each session. Ethics and dissemination Ethics approval for the ECHO-R trial was granted by the Metro North Human Research Ethics Committee (HREC/2020/QRBW/67223) on 6 November 2020. Findings from the trial are planned to be disseminated via peer-reviewed publications and both national and international exercise and oncology conferences. Trial registration number ACTRN12621000042842.

Development and validation of a prognostic nomogram for predicting cancer-specific survival in advanced endometrial carcinoma after surgery: a retrospective analysis of the SEER Database

Objective We aimed to construct and validate a prognostic nomogram to predict cancer-specific survival (CSS) after surgery in patients with advanced endometrial carcinoma (EC). Design Retrospective cohort study. Setting and participants The Surveillance, Epidemiology, and End Results (SEER) Database contains cancer incidence and survival data from population-based cancer registries in the USA. A total of 5445 patients from the SEER Database diagnosed with advanced EC between 2004 and 2015 were included and randomised 7:3 into a training cohort (n=3812) and a validation cohort (n=1633). Outcome measure CSS. Results The nomograms for CSS included 10 variables (positive regional nodes, age, tumour size, International Federation of Gynecology and Obstetrics (FIGO) stage, grade, ethnicity, income, radiation, chemotherapy and historical stage) based on the forward stepwise regression results. They revealed discrimination and calibration using the concordance index (C-index) and area under the time-dependent receiver operating characteristic curve, with a C-index value of 0.7324 (95% CI=0.7181 to 0.7468) and 0.7511 (95% CI=0.7301 to 0.7722) for the training and validation cohorts, respectively. Using calibration plots, a high degree of conformance was shown between the predicted and observed results. Additionally, a comparison of the nomogram and FIGO staging based on changes in the C-index, net reclassification index and integrated discrimination improvement demonstrated that the nomogram had better accuracy and efficacy. Conclusions We successfully constructed an accurate and effective nomogram to predict CSS in patients with advanced EC, which may help clinicians determine optimal individualised treatment strategies for patients with advanced EC. The predictive performance of the nomogram was evaluated thoroughly, but only internally. Therefore, further validation using different data sources is warranted in future related studies.

Precancerous cervical lesion screening acceptance among women in Eastern Ethiopia

Objective This study assessed perceived barriers, precancerous cervical lesion screening acceptance, and associated factors among women in Eastern Ethiopia. Setting This study was conducted in Hiwot Fana Specialized Hospital and Jugal Hospital. Study design This study is a facility-based cross-sectional study. Study participants This study included 1181 women aged 25–49 years. Bivariate and multivariable logistic regression was used to evaluate the relationship between variables and control confounders. Results Nearly half of the participants (587 or 49.7%) agreed to be screened for precancerous cervical lesions. Seventy-six per cent of those checked were negative for visual inspection with acetic acid, 18.5% were positive, and 5.7% had cancer-like lesions. In multivariable analysis, fear of discomfort from the screening procedure, having a male screener, and embarrassment were the perceived barriers that were inversely associated with screening acceptance. Conclusions The uptake of the screening service in the study area was not satisfactory, indicating that the programme was underutilised in the area.

Added value of electrical impedance spectroscopy in adjunction of colposcopy: a prospective cohort study

Objective To assess whether electrical impedance spectroscopy (EIS) as an adjunctive technology enhances the performance of colposcopy. Design Prospective cohort study. Setting University Hospital colposcopy clinic. Participants Colposcopy with EIS for 647 women and conventional colposcopy for 962 women. Interventions Comparison of the performance of colposcopy by referral cervical cytology in two cohorts, with and without EIS as an adjunctive technology. Outcome measures Prevalence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), diagnostic testing accuracy to detect CIN2+ with and without EIS and their relative differences between cohorts. Results The prevalence of CIN2+ varied between the cohorts according to referral cytology: 17.0% after abnormal squamous cells of unknown significance referral cytology in EIS cohort and 9.1% in the reference cohort, 16.5% and 18.9% after low-grade squamous intraepithelial lesion (LSIL), 44.3% and 58.2% after atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (HSIL) (atypical squamous cells that cannot exclude HSIL), and 81.9% and 77.0% after HSIL cytology, respectively. Sensitivity to detect CIN2+ was higher in the EIS cohort, varying from 1.79 (95% CI 1.30 to 2.45) after LSIL referral cytology to 1.16 (95% CI 1.09 to 1.23) after HSIL referral cytology, with correspondingly lower specificity after any referral cytology. Conclusions Colposcopy with EIS had overall higher sensitivity but lower specificity to detect CIN2+ than conventional colposcopy. CIN2+ prevalence rates were, however, not consistently higher in the EIS cohort, suggesting innate differences between the cohorts or truly lower detection rates of CIN2+ for EIS, highlighting the need for randomised controlled trials on the effectiveness of EIS.

Establishment of prediction models to predict survival among patients with cervical cancer based on socioeconomic factors: a retrospective cohort study based on the SEER Database

Objective To construct and validate predictive models based on socioeconomic factors for predicting overall survival (OS) in cervical cancer and compare them with the American Joint Council on Cancer (AJCC) staging system. Design Retrospective cohort study. Setting and participants We extracted data from 5954 patients who were diagnosed with cervical cancer between 2007 and 2011 from the Surveillance, Epidemiology, and End Results Database. This database holds data related to cancer incidence from 18 population-based cancer registries in the USA. Outcome measures 1-year and 5-year OS. Results Of the total 5954 patients, 5820 patients had 1-year mortality and 5460 patients had 5-year mortality. Lower local education level [Hazard ratios (HR): 1.15, 95% confidence interval (CI): 1.04 to 1.27, p= 0.005] and being widowed (HR 1.28, 95% CI 1.06 to 1.55, p=0.009) were associated with a worse OS for patients with cervical cancer. Having insurance (HR 0.75, 95% CI 0.62 to 0.90, p=0.002), earning a local median annual income of ≥US$56 270 (HR 0.83, 95% CI 0.75 to 0.92, p<0.001) and being married (HR 0.79, 95% CI 0.69 to 0.89, p<0.001) were related to better OS in patients with cervical cancer. The predictive models based on socioeconomic factors and the AJCC staging system had a favourable performance for predicting OS in cervical cancer compared with the AJCC staging system alone. Conclusion Our proposed predictive models exhibit superior predictive performance, which may highlight the potential clinical application of incorporating socioeconomic factors in predicting OS in cervical cancer.

Exploring HPV vaccine knowledge, attitudes, barriers and information sources among parents, health professionals and teachers in Kazakhstan: a mixed-methods study protocol

Introduction Human papillomavirus (HPV) is a prevalent sexually transmitted infection linked to certain types of malignant neoplasms, notably cervical cancer (CC). In Kazakhstan, a high prevalence of high oncogenic HPV types (HR-HPV) has been observed, and CC ranks as the second most common malignancy among women with a crude incidence rate of 18.3 cases per 100 000 women. The HPV vaccine, developed as the primary prevention measure against HPV infection, including the most prevalent HR-HPV, received approval from the WHO in 2009. In 2014, Kazakhstan initiated HPV vaccination as a pilot project in four sub-national regions; however, it was later in 2017 discontinued due to widespread parental refusal influenced by negative media reports. This study aims to examine knowledge, attitudes, information sources, barriers to HPV vaccination and factors associated with HPV vaccination hesitancy among different target groups in Kazakhstan prior to the HPV vaccine re-launch announced by the Ministry of Health. Methods and analysis This mixed-method-designed research comprises quantitative and qualitative components. Data on HPV awareness, attitudes towards HPV vaccination and sources of information will be collected through an online survey administered by parents and legal guardians, health professionals, and schoolteachers in the Republic of Kazakhstan between January 2023 and January 2024. Additionally, qualitative data on Kazakhstani parental beliefs and attitudes toward HPV vaccination will be collected through online focus group discussions. Ethics and dissemination of results The study has been approved by the local ethics committee at the Kazakhstan Medical University “Higher School of Public Health” (KMU “KSPH”) (No. 138 of 31.05.2021). The results will be reported in publications, at conferences among researchers and healthcare and school education professionals in Kazakhstan, and internationally.

Usage of cervical cancer screening services among HIV-positive women in Southern Ethiopia: a multicentre cross-sectional study

Objectives To assess the usage of cervical cancer screening services and associated factors among HIV-positive women on antiretroviral treatment in Southern Ethiopia in 2020. Design A multicentre cross-sectional study. Setting The study was conducted in Wolaita Sodo University Teaching Referral Hospital and Sodo Health Centre, Southern Ethiopia, from 1 July 2020 to 30 September 2020. Participants Four hundred and seventeen HIV-positive women on antiretroviral treatment attending public health facilities were approached during the study period. A multivariable binary logistic regression model was carried out to identify independent factors associated with the usage of cervical cancer screening services, and a p value<0.05 was used to declare statistical significance. Results The uptake of cervical cancer screening services among HIV-positive women was 27.8% with a 95% CI of 24.2% to 33.1%. Married women and women reporting a high level of perceived barriers were 75% and 66% less likely to receive cervical cancer screening services, adjusted OR (AOR)=0.25; 95% CI: 0.07 to 0.93, and AOR=0.34; 95% CI: 0.12 to 0.98, respectively. Whereas, being a government employee, AOR=3.85; 95% CI: 1.31 to 11.3, sexual debut before the age of 20, AOR=2.39; 95% CI: 1.09 to 5.26, using modern contraceptives, AOR=2.43; 95% CI: 1.05 to 5.65, having a high perceived self-efficacy, AOR=4.42; 95% CI: 1.79 to 10.89 and having a high perceived benefit of cervical cancer screening services, AOR=12.23; 95% CI: 2.22 to 67.35 were significantly associated with the usage of cervical cancer screening services. Conclusions The usage of cervical cancer screening services among HIV-positive women remains low in this setting. Married HIV-positive women and those with a high perceived barrier were associated with low uptake of cervical cancer screening services. Being a government employee, having an early sexual experience, using modern contraceptives, having a high perceived self-efficacy and having a high perceived benefit were identified as factors associated with increased uptake of cervical cancer screening services.

Two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling: an economic evaluation

Objective To compare the costs and effects of three sampling strategies for human papillomavirus (HPV) primary screening. Design Cost-consequence analysis from a health system perspective using a deterministic decision tree model. Setting England. Participants A cohort of 10 000 women aged 25–65 years eligible for the National Health Service Cervical Screening Programme (NHSCSP). Methods The model was based on the NHSCSP HPV primary screening pathway and adapted for self-sampling. It used a 3-year cycle: routine screening (year 1) and recall screening (years 2/3). Parameter inputs were informed using published studies, NHSCSP reports and input from experts and manufacturers. Costs were from 2020/2021, British pound sterling (£). Interventions Three sampling strategies were implemented: (1) routine clinician-collected cervical sample, (2) self-collected first-void (FV) urine, (3) self-collected vaginal swab. The hypothetical self-sampling strategies involved mailing women a sampling kit. Main outcome measures Primary outcomes: overall costs (for all screening steps to colposcopy), number of complete screens and cost per complete screen. Secondary outcomes: number of women screened, number of women lost to follow-up, cost per colposcopy and total screening costs for a plausible range of uptake scenarios. Results In the base case, the average cost per complete screen was £56.81 for clinician-collected cervical sampling, £38.57 for FV urine self-sampling and £40.37 for vaginal self-sampling. In deterministic sensitivity analysis, the variables most affecting the average cost per screen were the cost of sample collection for clinician-collected sampling and the cost of laboratory HPV testing for the self-sampling strategies. Scaled to consider routine screening in England, if uptake in non-attenders increased by 15% and 50% of current screeners converted to self-sampling, the NHSCSP would save £19.2 million (FV urine) or £16.5 million (vaginal) per year. Conclusion Self-sampling could provide a less costly alternative to clinician-collected sampling for routine HPV primary screening and offers opportunities to expand the reach of cervical screening to under-screened women.

Protocol for a systematic review and meta-analysis of the diagnostic test accuracy of host and HPV DNA methylation in cervical cancer screening and management

Introduction Human papillomavirus (HPV) is necessary but not sufficient for cervical cancer development. During cervical carcinogenesis, methylation levels increase across host and HPV DNA. DNA methylation has been proposed as a test to diagnose cervical intraepithelial neoplasia (CIN); we present a protocol to evaluate the accuracy of methylation markers to detect high-grade CIN and cervical cancer. Methods and analysis We will search electronic databases (Medline, Embase and Cochrane Library), from inception, to identify studies examining DNA methylation as a diagnostic marker for CIN or cervical cancer, in a cervical screening population. The primary outcome will be to assess the diagnostic test accuracy of host and HPV DNA methylation for high-grade CIN; the secondary outcomes will be to examine the accuracy of different methylation cut-off thresholds, and accuracy in high-risk HPV positive women. Our reference standard will be histology. We will perform meta-analyses using Cochrane guidelines for diagnostic test accuracy. We will use the number of true positives, false negatives, true negatives and false positives from individual studies. We will use the bivariate mixed effect model to estimate sensitivity and specificity with 95% CIs; we will employ different bivariate models to estimate sensitivity and specificity at different thresholds if sufficient data per threshold. For insufficient data, the hierarchical summary receiver operating curve model will be used to calculate a summary curve across thresholds. If there is interstudy and intrastudy variation in thresholds, we will use a linear mixed effects model to calculate the optimum threshold. If few studies are available, we will simplify models by assuming no correlation between sensitivity and specificity and perform univariate, random-effects meta-analysis. We will assess the quality of studies using QUADAS-2 and QUADAS-C. Ethics and dissemination Ethical approval is not required. Results will be disseminated to academic beneficiaries, medical practitioners, patients and the public. PROSPERO registration number CRD42022299760.

Mapping health service coverage inequalities in Africa: a scoping review protocol

Introduction Addressing inequities in health service coverage is a global priority, especially with the resurgence of interest in universal health coverage. However, in Africa, which has the lowest health service coverage index, there is limited information on the progress of countries in addressing inequalities related to health services. Thus, we seek to map the evidence on inequalities in health service coverage in Africa. Methods and analysis We will conduct a scoping review following the Joanna Briggs Institute Manual for Evidence Synthesis. We preregistered this protocol with the Open Science Framework on 26 July 2022 ( https://osf.io/zd5bt ). We will consider any empirical research that assesses inequalities in relation to services for reproductive, maternal, newborn and child health (eg, family planning), infectious diseases (eg, tuberculosis treatment) and non-communicable diseases (eg, cervical cancer screening) in Africa. We will search MEDLINE, Embase, Web of Science, CINAHL, PsycINFO and Cochrane Library from their inception onwards. We will also hand-search Google and Global Index Medicus, and screen reference lists of relevant studies. We will evaluate studies for eligibility and extract data from included studies using pre-piloted and standardised forms. We will further extract a core set of health service coverage indicators, which are disaggregated by place of residence, race/ethnicity/culture, occupation, gender, religion, education, socioeconomic status and social capital plus equity stratifiers. We will summarise data using a narrative approach involving thematic syntheses and descriptive statistics. We will report our findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Ethics and dissemination Ethical approval is not required as primary data will not be collected. This work will contribute to identifying knowledge gaps in the evidence of inequalities in health service coverage in Africa, and propose strategies that could help overcome current challenges. We will disseminate our findings to knowledge users through a publication in a peer-reviewed journal and organisation of workshops.

Age-specific and genotype-specific carcinogenic human papillomavirus prevalence in a country with a high cervical cancer burden: results of a cross-sectional study in Estonia

Objectives To describe age-specific and type-specific carcinogenic human papillomavirus (HPV) prevalence prior to large-scale effect of HPV vaccines in Estonia and to analyse the risk factors associated with carcinogenic HPV. Design Cross-sectional study using self-administered questionnaire and self-collected vaginal swabs for detection of HPV infection. Setting Estonian Biobank database. Participants Stratified random sample of women aged 30–33, 57–60 and 67–70 years living in one of the three largest counties in Estonia. Of 3065 women approached, 1347 (43.9%) returned questionnaires and specimens for HPV DNA detection. Outcome measures HPV prevalence and fully adjusted ORs with 95% CIs for risk factors. Results HPV prevalence was highest among women aged 30–33 years (18.7%; 95% CI 15.8 to 21.9) followed by those aged 67–70 years (16.7%; 95% CI 12.4 to 22.0) and 57–60 years (10.2%; 95% CI 7.8 to 13.3). HPV16 and HPV56 were the most common among women aged 30–33 years (both 4.0%; 95% CI 2.7 to 5.9), and HPV68 was the most common among women aged 57–60 years (2.8%; 95% CI 1.5 to 4.7) and 67–70 years (6.4%; 95% CI 3.6 to 10.4). Vaccination with nonavalent vaccine would have halved the carcinogenic HPV prevalence among women aged 30–33 years. The odds of infection with carcinogenic HPV were higher among women with six or more sexual partners among younger (OR 2.99; 95% CI 1.54 to 5.81) and older (OR 3.80; 95% CI 1.25 to 11.55) women and lower (OR 0.35; 95% CI 0.17 to 0.72) among younger married women. Conclusions This study demonstrated U-shaped age-specific genotype profile of carcinogenic HPV prevalence, indicating that public health providers should focus on developing exit strategies for the cervical cancer screening programme in Estonia with a possible extension of HPV testing beyond the current screening age of 65 years. Generalisability of the findings of this study may be affected by the low response rate.

Knowledge and practice of cervical cancer screening and its associated factors among women attending maternal health services at public health institutions in Assosa Zone, Benishangul-Gumuz, Northwest Ethiopia, 2022: a cross-sectional study

Background Cervical cancer ranks as the second most frequent cancer among all women in Ethiopia and the second most frequent cancer among women between 15 and 44 years of age, resulting in over 4884 moralities annually. Although there is a focus on health promotion through teaching and screening in Ethiopia’s intended transition toward universal healthcare, there is little information available on baseline levels of knowledge and screening uptake related to cervical cancer. Objectives This study explored the levels of knowledge and screening rates of cervical cancer along with its associated factors among women of reproductive age in Assosa Zone, Benishangul-Gumuz, Ethiopia in 2022. Methodology A facility-based cross-sectional study was conducted. A systematic sampling technique was used to select 213 reproductive-age women from selected health institutions, from 20 April 2022 to 20 July 2022. A validated and pretested questionnaire was used for data collection. Multi-logistic regression analyses were done to identify factors independently associated with cervical cancer screening. Adjusted OR with 95% CI was estimated to measure the strength of association. The level of statistical significance was declared at a p value of <0.05. The results were presented in tables and figures. Result Knowledge of cervical cancer screening in this study was 53.5%, and 36% of respondents had practised cervical cancer screening. Family history of cervical cancer (AOR)=2.5, 95% CI (1.04 to 6.44)), place of residence (AOR=3.68, 95% CI (2.23, 6.54)) and availability of health services at nearby (AOR=2.03, 95% CI (1.134, 3.643)) were significantly associated with knowledge of cervical cancer screening, while educational status (AOR=2.811, 95% CI (1.038 to 7.610)), knowing someone diagnosed with cervical cancer (AOR=8.3, 95% CI (2.4, 28.69)), Knowledge of cervical cancer(AOR=2.17, 95%CI(1.077, 4.384) and feeling feeling at risk (AOR=3.26 95% CI (1.52, 5.04)) were associated with the practice of cervical cancer screening. Conclusion and recommendation Knowledge and practice of cervical cancer screening in this study were low. Therefore, the reproductive women must be encouraged to have early cervical cancer screening at precancerous stage by informing their susceptibility to cervical cancer.

Knowledge and perspectives of the new National Cervical Screening Program: a qualitative interview study of North Queensland women—‘I could be that one percent’

ObjectivesTo investigate women’s understanding and attitudes towards the National Cervical Screening Program (NCSP) and to explore methods to improve screening participation.DesignSemi-structured face-to-face interviews were conducted through convenience and snowball sampling. Thematic analysis occurred using the interpretivist framework.SettingA private general practice in North Queensland.ParticipantsWomen between the ages of 18 and 74 who attended the general practice were eligible to participate. Fourteen women between 20 and 58 years old were interviewed.ResultsParticipants were concerned that the new NCSP would miss cancer due to longer screening intervals and reliance on primary human papilloma virus (HPV) testing. They believed that young women are at increased risk of cervical cancer, due to perceived HPV vaccine ineffectiveness and parent objection to vaccination. Most participants were not agreeable to self-sampling and preferred their doctor to perform screening. Personal and practitioner beliefs influenced a woman’s screening participation. Personal factors include being healthy for themselves and their family, previous abnormal smears and family history of cancer. Emphasis was placed on feeling ‘comfortable’ with their practitioner which included patient rapport and gender preference. Proposed methods to improve cervical screening included education programmes, advertising campaigns, general practitioner interventions and improving accessibility.ConclusionsIt is apparent that women are hesitant about the new NCSP. However, when provided with additional information they were more amenable to the changes. This highlights the need to improve awareness of cervical screening and the new NCSP.

Diabetes mellitus and the risk of ovarian cancer: a systematic review and meta-analysis of cohort and case–control studies

Objective Emerging evidence from observational studies (cohort and case–control studies) suggests that a history of diabetes mellitus (DM) has been linked to increased risk of ovarian cancer (OC), but the association between them remains inconclusive. The aim of this systematic review and meta-analysis of observational studies was to clarify this association. Design Systematic review and meta-analysis. Methods We searched PubMed, Embase and the Cochrane library databases published from the inception through 9 April 2020 without language restriction. Observational studies that evaluated the correlation between DM and the incidence of OC were included in our study. Relative risk (RR) with 95% CI was pooled by use of a random-effects model. Results A total of 36 epidemiological articles, including 9 case–control and 27 cohort studies, were finally enrolled, consisting of 14 496 incident cases of OC. Synthesised RRs of developing OC by history of DM were 1.20 (95% CI=1.10 to 1.31) for all eligible studies, 1.08 (95% CI=0.77 to 1.53) for case–control studies and 1.22 (95% CI=1.11 to 1.33) for cohort studies. The above-mentioned positive association persisted across most of subgroup analyses, whereas it was not significant among studies from North American and European countries, level of unadjusted, and patients with low-quality and gestational DM group. The cumulative meta-analysis and sensitivity analysis showed pooled effect was stable and reliable, and no apparent publication bias was identified in this study. Conclusions Our study found weaker but still association between DM and OC risk. However, further well-designed prospective studies that control for potential confounders are warranted.

Ovarian Cancer Epidemiology, Healthcare Access and Disparities (ORCHiD): methodology for a population-based study of black, Hispanic and white patients with ovarian cancer

IntroductionLess than 40% of patients with ovarian cancer (OC) in the USA receive stage-appropriate guideline-adherent surgery and chemotherapy. Black patients with cancer report greater depression, pain and fatigue than white patients. Lack of access to healthcare likely contributes to low treatment rates and racial differences in outcomes. The Ovarian Cancer Epidemiology, Healthcare Access and Disparities study aims to characterise healthcare access (HCA) across five specific dimensions—Availability, Affordability, Accessibility, Accommodation and Acceptability—among black, Hispanic and white patients with OC, evaluate the impact of HCA on quality of treatment, supportive care and survival, and explore biological mechanisms that may contribute to OC disparities.Methods and analysisWe will use the Surveillance Epidemiology and Ends Results dataset linked with Medicare claims data from 9744 patients with OC ages 65 years and older. We will recruit 1641 patients with OC (413 black, 299 Hispanic and 929 white) from cancer registries in nine US states. We will examine HCA dimensions in relation to three main outcomes: (1) receipt of quality, guideline adherent initial treatment and supportive care, (2) quality of life based on patient-reported outcomes and (3) survival. We will obtain saliva and vaginal microbiome samples to examine prognostic biomarkers. We will use hierarchical regression models to estimate the impact of HCA dimensions across patient, neighbourhood, provider and hospital levels, with random effects to account for clustering. Multilevel structural equation models will estimate the total, direct and indirect effects of race on treatment mediated through HCA dimensions.Ethics and disseminationResult dissemination will occur through presentations at national meetings and in collaboration with collaborators, community partners and colleagues across othercancer centres. We will disclose findings to key stakeholders, including scientists, providers and community members. This study has been approved by the Duke Institutional Review Board (Pro00101872). Safety considerations include protection of patient privacy. All disseminated data will be deidentified and summarised.

Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy

Introduction As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer. Methods and analysis Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy. Ethics and dissemination This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in international peer-reviewed journals. Trial registration number Netherlands Trial Registry (NTR6300).

Qualitative evaluation of a codesigned faith-based intervention for Muslim women in Scotland to encourage uptake of breast, colorectal and cervical cancer screening

ObjectivesThis pilot study aimed to evaluate the acceptability of a codesigned, culturally tailored, faith-based online intervention to increase uptake of breast, colorectal and cervical screening in Scottish Muslim women. The intervention was codesigned with Scottish Muslim women (n=10) and underpinned by the reframe, reprioritise and reform model and the behaviour change wheel.SettingThe study was conducted online, using Zoom, due to the COVID-19 pandemic.ParticipantsParticipants (n=18) taking part in the intervention and subsequently in its evaluation, were Muslim women residing in Scotland, recruited through purposive and snowball sampling from a mosque and community organisations. Participants were aged between 25 years and 54 years and of Asian and Arab ethnicity.DesignThe study’s codesigned intervention included (1) a peer-led discussion of barriers to screening, (2) a health education session led by a healthcare provider, (3) videos of Muslim women’s experiences of cancer or screening, and (4) a religious perspective on cancer screening delivered by a female religious scholar (alimah). The intervention was delivered twice online in March 2021, followed 1 week later by two focus groups, consisting of the same participants, respectively, to discuss participants’ experiences of the intervention. Focus group transcripts were analysed thematically.ResultsParticipants accepted the content and delivery of the intervention and were positive about their experience of the intervention. Participants reported their knowledge of screening had increased and shared positive views towards cancer screening. They valued the multidimensional delivery of the intervention, appreciated the faith-based perspective, and in particular liked the personal stories and input from a healthcare provider.ConclusionParticipatory and community-centred approaches can play an important role in tackling health inequalities in cancer and its screening. Despite limitations, the intervention showed potential and was positively received by participants. Feasibility testing is needed to investigate effectiveness on a larger scale in a full trial.

Cohort profile: Scotland’s record-linkage e-cohorts of people with intellectual disabilities, and autistic people (SCIDA)

Purpose To investigate health, mortality and healthcare inequalities experienced by people with intellectual disabilities, and autistic people, and their determinants; an important step towards identifying and implementing solutions to reduce inequalities. This paper describes the cohorts, record-linkages and variables that will be used. Participants Scotland’s Census, 2011 was used to identify Scotland’s citizens with intellectual disabilities, and autistic citizens, and representative general population samples with neither. Using Scotland’s community health index, the Census data (demography, household, employment, long-term conditions) were linked with routinely collected health, death and healthcare data: Scotland’s register of deaths, Scottish morbidity data 06 (SMR06: cancer incidence, mortality, treatments), Prescribing Information System (identifying asthma/chronic obstructive pulmonary disease; angina/congestive heart failure/hypertension; peptic ulcer/reflux; constipation; diabetes; thyroid disorder; depression; bipolar disorders; anxiety/sleep; psychosis; attention deficit hyperactivity disorder; epilepsy; glaucoma), SMR01 (general/acute hospital admissions and causes, ambulatory care sensitive admissions), SMR04 (mental health admissions and causes), Scottish Care Information–Diabetes Collaboration (diabetic care quality, diabetic outcomes), national bowel screening programme and cervical screening. Findings to date Of the whole population, 0.5% had intellectual disabilities, and 0.6% were autistic. Linkage was successful for >92%. The resultant e-cohorts include: (1) 22 538 people with intellectual disabilities (12 837 men and 9701 women), 4509 of whom are children <16 years, (2) 27 741 autistic people (21 390 men and 6351 women), 15 387 of whom are children <16 years and (3) representative general population samples with neither condition. Very good general health was reported for only 3389 (15.0%) people with intellectual disabilities, 10 510 (38.0%) autistic people, compared with 52.4% general population. Mental health conditions were reported for 4755 (21.1%) people with intellectual disabilities, 3998 (14.4%) autistic people, compared with 4.2% general population. Future plans Analyses will determine the extent of premature mortality, causes of death, and avoidable deaths, profile of health conditions and cancers, healthcare quality and screening and determinants of mortality and healthcare.

Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis

Introduction Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditions, and women experiencing these symptoms have been shown to self-manage them using over-the-counter medication. Results from a recent proof-of-concept study suggest there may be an increase in the purchases of painkillers and indigestion medication 10–12 months before ovarian cancer diagnosis. We propose a case–control study, as part of a larger project called the Cancer Loyalty Card Study (CLOCS), to investigate whether a significant change in medication purchases could be an indication for early signs of ovarian cancer, using data already collected through store loyalty cards. Methods and analysis Using a retrospective case–control design, we aim to recruit 500 women diagnosed with ovarian cancer (cases) and 500 women without ovarian cancer (controls) in the UK who hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. In order to assess ovarian cancer risk in participants and their purchase patterns, we will collect information from participants on ovarian cancer risk factors and clinical data including symptoms experienced before diagnosis from recruited women with ovarian cancer. Ethics and dissemination CLOCS was reviewed and approved by the North West-Greater Manchester South Research Ethics Committee (19/NW/0427). Study outcomes will be disseminated through academic publications, the study website, social media and a report to the research sites that support the study once results are published. Trial registration number ISRCTN 14897082, CPMS 43323, NCT03994653 .

Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness

Introduction There is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery. Primary objectives To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis. Secondary objectives To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost–utility analysis. Methods and analysis We will perform a systematic review of literature by updating the searches from MEDLINE, Embase, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost–utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting. Ethics and dissemination This project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal. PROSPERO registration number CRD42019130504.

Laparoendoscopic single-site surgery compared with conventional laparoscopic surgery for benign ovarian masses: a systematic review and meta-analysis

Objective We aimed to evaluate the safety, efficiency and preferred indication for laparoendoscopic single-site surgery (LESS) compared with conventional laparoscopic (CL) surgery for benign ovarian masses. Design A systemic review and cumulative meta-analysis were performed in line with the criteria of Grading of Recommendations Assessment, Development and Evaluation: levels of evidence and grades of recommendation. Data sources We comprehensively searched the electronic databases including PubMed, Medline, Embase and the Cochrane Library in November 2018. Eligibility criteria for selecting studies We included all randomised controlled trials (RCTs) and retrospective studies published in recent 10 years, which investigated the performance of LESS versus CL in patients at all ages with benign ovarian masses. Results Four RCTs and nine retrospective studies published in recent decade including 1542 cases (744 cases for LESS and 798 cases for CL) were identified. Perioperative complication was consisted of intraoperative and postoperative complications, including ileus, wound infection or dehiscence and incisional hernia. Although LESS has less postoperative analgesic consumption (46.78% and 79.25%; OR: 0.49; 95% CI: 0.33 to 0.74, p<0.001) and shorter hospital stay (weighted mean difference (WMD): −0.24 days; 95% CI: −0.35 to −0.14; p<0.001), CL has less perioperative complications (6.59% and 2.85%; OR: 2.08; 95% CI: 1.05 to 4.11, p=0.04) and shorter operative time (WMD: 3.43 min; 95% CI: −0.03 to 6.88; p=0.05). Body mass index, history of previous abdominal surgery, size of adnexal mass, estimated blood loss and postoperative pain scores did not differ significantly between two techniques. Conclusions The indications of LESS for benign ovarian masses are similar to CL and it has better postoperative recovery. However, with less perioperative complications, CL surgery is safer than LESS.

Geographic barriers to gynaecological cancer care in Indonesia: a geospatial and infrastructure analysis

Objective This study aimed to identify underserved regions and evaluate the population coverage based on travel time and distance to hospitals with gynaecologic oncologists in Indonesia. Methods The travel time and distance to hospitals with gynaecologic oncologists were evaluated using the Quantum Geographic Information System. Data from 139 gynaecologic oncologists and their affiliated hospitals were obtained from the Indonesian Society of Gynecologic Oncologists (November 2024) and cross-referenced with the Ministry of Health records. The female population density data were sourced from Facebook’s high-resolution settlement layer. Isochrones were generated to estimate travel times and distances using zonal statistics, which facilitated the calculation of population coverage. Results A total of 139 gynaecologic oncologists were identified nationwide, practising in 243 hospitals (7.6% of the 3202 hospitals in Indonesia), with a concentration in Java (60.4%). 11 of the 38 provinces lack sub-specialists. Population coverage varies sharply: the travel time to a hospital with gynaecologic oncologists is ≤2 hours for 79.1% of women in Java, compared with 4.9% in Papua; overall, 34.4% reside more than 100 km away from hospitals with gynaecologic oncologists. Hospitals with gynaecologic oncologists are predominantly urban class B general hospitals, and 83.1% participate in the National Health Insurance Schemes. Exploratory district-level correlations showed positive associations between the number of such hospitals and total female population (r=0.44, p<0.001), female life expectancy (r=0.29, p<0.001), per-capita expenditure (r=0.54, p<0.001), female population density (r=0.68, p<0.001), female Human Development Index (r=0.4, p<0.001) and a negative association with land area size (r=–0.15, p<0.001). Conclusions Gynaecological oncology services in Indonesia remain heavily concentrated in Java, leaving nearly one-fifth of women residing more than 100 km away. The travel time is greater than 2 hours for many. Targeted expansion of the gynaecologic oncologists workforce, diagnostic and treatment infrastructure, and sustainable financing mechanisms are required to close these gaps.

Lived experiences of gynaecological cancer survivors in Oman: a qualitative study

Objective A significant number of patients with gynaecological cancers survive their disease and are considered cured. However, the diagnosis of cancer and its treatment can affect quality of life adversely. We sought to explore the lived experiences of women surviving gynaecological cancers in Oman. Methods Omani patients with gynaecological cancers who had completed their treatment more than 1 year ago and were following up in the medical oncology clinic at a major cancer centre in Oman were interviewed. A qualitative study design was employed using face-to-face semistructured individual interviews. To prevent recall bias, women diagnosed with cancer within the past 5 years only were included. The sample size was determined using data saturation, where data collection revealed no new information. All interviews were tape recorded and transcribed verbatim. Transcripts were analysed using a standardised thematic analysis approach. Results Four main themes emerged: ‘Beliefs and attitudes’; ‘Living with Treatment Complications’; ‘Living with cancer’ and ‘Coping with the Cancer Journey’. Conclusions The diagnosis of cancer had a profound effect on the lives of women with gynaecological cancer. The diagnosis negatively affected their lives throughout their cancer journey due to social role changes, fertility and sexual problems. Religion and social support played major roles in coping with the disease. This is the first study describing the lived experiences of Muslim and Omani survivors of gynaecological cancers and may help to determine their survivorship needs.

Efficacy and safety of rivaroxaban in preventing venous thromboembolism in postoperative patients with gynecological malignancies: protocol for a randomised controlled open-label trial (G-alfalfa trial)

Introduction Compared with the guideline-recommended use of low-molecular weight heparin (LMWH) for 28 days to prevent venous thromboembolism (VTE) after cytoreductive surgery, oral rivaroxaban avoids the pain and inconvenience of daily injections and reduces medical expenses. The proposed randomised controlled trial (RCT) aims to compare the efficacy and safety of rivaroxaban and enoxaparin in preventing VTE in patients after surgery for gynaecological malignancies and to provide a reference for clinical medication prevention. Methods and analysis This is a single-centre, randomised, controlled, open-label and assessor-blind clinical trial. Patients undergoing surgery for gynaecological malignancies will be randomly assigned in a 1:1 ratio to an oral rivaroxaban study group and a subcutaneous injection enoxaparin control group for anticoagulant prophylaxis. The medication administration begins 12–24 hours after surgery and continues for 28 days, with a 30-day follow-up after surgery. Clinical events during the treatment and the follow-up period will be observed. The primary endpoint will be any VTE. Secondary endpoints will be any bleeding event, medication compliance rate, rivaroxaban pharmacokinetics and pharmacogenomics. The sample size required for the G-alfalfa trial is derived based on power calculations of the VTE incidence in the two intervention regimens in previous literature. Ethics and dissemination This study was approved by the Ethics Committee of Fujian Maternal and Child Health Hospital on 2 April 2024 (Approval No.:2023KY174-03). The results of the trial will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Trial registration number Chinese Clinical Trial Registry (ChiCTR) 2300078535.

Patterns of peritoneal dissemination and response to systemic chemotherapy in common and rare peritoneal tumours treated by cytoreductive surgery: study protocol of a prospective, multicentre, observational study

Introduction Despite optimal patient selection and surgical effort, recurrence is seen in over 70% of patients undergoing cytoreductive surgery (CRS) for peritoneal metastases (PM). Apart from the Peritoneal Cancer Index (PCI), completeness of cytoreduction and tumour grade, there are other factors like disease distribution in the peritoneal cavity, pathological response to systemic chemotherapy (SC), lymph node metastases and morphology of PM which may have prognostic value. One reason for the underutilisation of these factors is that they are known only after surgery. Identifying clinical predictors, specifically radiological predictors, could lead to better utilisation of these factors in clinical decision making and the extent of peritoneal resection performed for different tumours. This study aims to study these factors, their impact on survival and identify clinical and radiological predictors. Methods and analysis There is no therapeutic intervention in the study. All patients with biopsy-proven PM from colorectal, appendiceal, gastric and ovarian cancer and peritoneal mesothelioma undergoing CRS will be included. The demographic, clinical, radiological, surgical and pathological details will be collected according to a prespecified format that includes details regarding distribution of disease, morphology of PM, regional node involvement and pathological response to SC. In addition to the absolute value of PCI, the structures bearing the largest tumour nodules and a description of the morphology in each region will be recorded. A correlation between the surgical, radiological and pathological findings will be performed and the impact of these potential prognostic factors on progression-free and overall survival determined. The practices pertaining to radiological and pathological reporting at different centres will be studied. Ethics and dissemination The study protocol has been approved by the Zydus Hospital ethics committee (27 July, 2020) and Lyon-Sud ethics committee (A15-128). Trial registration number CTRI/2020/09/027709; Pre-results.

Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England

Introduction Persistent infection with high-risk human papillomavirus (HPV) is the causal agent of several cancers including cervical, anal and oropharyngeal cancer. Transgender men and transmasculine non-binary (TMNB) people with a cervix are much less likely to undergo cervical cancer screening than cisgender women. Transgender women and transfeminine non-binary (TWNB) people assigned male at birth may be at increased risk of HPV. Both TMNB and TWNB people face many barriers to HPV testing including medical mistrust due to stigma and discrimination. Methods and analysis The Self-TI Study (Self-TI) is a pilot study designed to measure acceptability and feasibility of HPV self-testing among transgender and non-binary people in England. TMNB people aged 25–65 years, with at least 1 year of testosterone, and TWNB people, aged 18 years and over, are eligible to participate. Participants self-collect up to four samples: an oral rinse, a first void urine sample, a vaginal swab (if applicable) and an anal swab. TMNB participants are asked to have an additional clinician-collected cervical swab taken following their routine Cervical Screening Programme sample. TWNB people are asked to take a self-collection kit to perform additional self-collection at home and mail the samples back to the clinic. Acceptability is assessed by a self-administered online survey and feasibility is measured as the proportion of samples returned in the clinic and from home. Ethics and dissemination Self-TI received ethical approval from the Research Ethics Committee of Wales 4 and ethical review panel within the Division of Cancer Epidemiology and Genetics at the US National Cancer Institute. Self-TI was coproduced by members of the transgender and non-binary community, who served as authors, collaborators and members of the patient and public involvement (PPI) group. Results of this study will be shared with the community prior to being published in peer-reviewed journals and the PPI group will help to design the results dissemination strategy. The evidence generated from this pilot study could be used to inform a larger, international study of HPV self-testing in the transgender and non-binary community. Trial registration number NCT05883111 .

Exploring awareness, attitudes and clinical practices of Ukrainian health professionals regarding human papillomavirus and vaccination: a qualitative study

Introduction Cervical cancer, a preventable disease, remains a significant public health issue in Ukraine, characterised by low human papillomavirus (HPV) vaccination rates and systemic healthcare challenges exacerbated by the ongoing war. To improve the situation with HPV vaccination, understanding the perspective of healthcare professionals (HCPs) is crucial. Aim This study aimed to assess the knowledge, awareness and clinical practices of Ukrainian HCPs regarding HPV, HPV-related diseases and vaccination. It sought to identify their readiness to recommend vaccination, the barriers they face and the impact of the full-scale Russia–Ukrainian war on these aspects. Methods A qualitative exploratory study was conducted using the Knowledge, Attitude and Practice (KAP) framework. Data were collected through 12 focus group discussions, 10 in-depth semistructured interviews and short questionnaires with 60 HCPs (gynaecologists, paediatricians, general practitioners, nurses and key decision-makers) across four macroregions of Ukraine in July 2023. A descriptive thematic analysis was performed on the transcribed data. Results The study found support for HPV vaccination among HCPs, who recognise it as a critical cancer prevention tool. However, significant barriers impede its implementation. These include organisational challenges like the vaccine’s high cost and non-mandatory status, professional issues such as knowledge gaps and prevalent misconceptions (eg, belief in natural immunity, doubts about vaccine safety), particularly among non-gynaecological specialists, and low public awareness of the HPV–cancer link. The war has intensified these barriers by shifting priorities and disrupting services, yet it has also paradoxically increased vaccine awareness among Ukrainians who have been abroad. Conclusion The successful rollout of Ukraine’s national HPV vaccination programme requires a comprehensive strategy. Merely adding the vaccine to the schedule is insufficient. It must be accompanied by robust state funding to ensure it is free, a large-scale public information campaign to combat misinformation and raise awareness and targeted continuing medical education to close knowledge gaps and empower HCPs to recommend the vaccine confidently.

County-level colposcopy attendance in China’s national cervical cancer screening programme: a cross-sectional ecological study of Fujian province

Objectives This study aims to analyse the county-level spatiotemporal disparities in colposcopy non-attendance rates and to explore their associated factors in Fujian, China. Design A county-level observational study. Setting This study was conducted using data from the Fujian Provincial Maternal and Child Health Information System and Statistical Yearbooks, from 2021 to 2023. Participants Data from 60 counties in Fujian province across 3 years (2021–2023) were included, comprising 1080 county-age group-year observations. Counties from Xiamen Municipality were excluded due to data unavailability. Primary and secondary outcome measures The primary outcome was the county-level colposcopy non-attendance rate. Secondary outcomes included the Theil indices (measuring inequality) and the geographically varied associations of factors (eg, population density and transportation network density) with non-attendance. Results The average county-level colposcopy non-attendance rate in Fujian decreased from 24.41% in 2021 to 16.52% in 2023. The Theil-T and Theil-L indices of county-level non-attendance rates across the 3 years were 0.31 and 0.24, respectively. Lower population density was associated with higher rates of colposcopy non-attendance in the west of Fujian, while higher transportation network density and a larger per capita number of healthcare professionals were associated with higher rates of non-attendance, particularly in the west. Over time, the effects of these factors weakened. Three clusters of the coefficients were identified. Conclusions While colposcopy non-attendance rates have declined in recent years in Fujian, the persistent geographical disparity shown in this study indicates the importance of addressing service and information gaps. It is likely helpful to integrate the information system and service delivery across counties in cervical screening programmes to address the effects of potentially higher mobility and low population density in western Fujian. Considering the geographically varied effects of such factors, we also suggested a classified approach be adopted to improve colposcopy attendance.

Effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low-income and middle-income countries: a systematic review

Objectives To systematically synthesise available evidence on the nature and effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low and middle-income countries (LMICs). Design A systematic review of published evidence. The review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses. Data sources A comprehensive search of published literature was conducted. In addition, relevant grey literature sources and bibliographical references of included studies were searched for potentially eligible evidence. Study selection Studies published between January 2010 and November 2020 were eligible for inclusion. To be eligible, studies had to report on interventions/strategies targeted at women, the general public or healthcare workers, aimed at improving the timely diagnosis of breast and/or cervical cancers in LMIC settings. Data extraction and synthesis Literature search, screening, study selection, data extraction and quality appraisal were conducted by two independent reviewers. Evidence was synthesised and reported using a global taxonomy framework for early cancer diagnosis. Results From the total of 10 593 records identified, 21 studies conducted across 20 LMICs were included in this review. Most of the included studies (16/21) focused primarily on interventions addressing breast cancers; two focused on cervical cancer while the rest examined multiple cancer types. Reported interventions targeted healthcare workers (12); women and adolescent girls (7) and both women and healthcare workers (3). Eight studies reported on interventions addressing access delays; seven focused on interventions addressing diagnostic delays; two reported on interventions targeted at addressing both access and diagnostic delays, and four studies assessed interventions addressing access, diagnostic and treatment delays. While most interventions were demonstrated to be feasible and effective, many of the reported outcome measures are of limited clinical relevance to diagnostic timeliness. Conclusions Though limited, evidence suggests that interventions aimed at addressing barriers to timely diagnosis of breast and cervical cancer are feasible in resource-limited contexts. Future interventions need to address clinically relevant measures to better assess efficacy of interventions. PROSPERO registration number CRD42020177232.

Scoping review protocol on the perception and attitude of women on methods for collecting cervicovaginal samples for human papillomavirus testing in sub-Saharan Africa

Introduction Sub-Saharan Africa (SSA) regions have the highest burden of cervical cancer (CC), accounting for nearly a quarter of global mortality. Many women in SSA are reluctant to access CC screening because they are uncomfortable exposing their private parts to healthcare providers. The perception of women who have experienced self-sampling in SSA is yet to be reviewed. This scoping review will explore the literature on the perception and attitude of women towards methods of collecting cervicovaginal samples for human papillomavirus (HPV) testing in SSA. Methods and analysis An extensive search using the Arksey and O’Malley framework will be conducted. The search criteria will be limited to original research conducted in community or clinical settings in SSA within the last 10 years. Four databases, namely, PUBMED, Cochrane, African Journals Online and Google Scholar, will be searched. Two independent persons (UIAB and DOO) will screen the titles and abstracts and later full texts using population, intervention, comparison and outcome criteria. IOMB will serve as a tiebreaker whenever there is no agreement on the choice of eligibility criteria. The screening process will be presented using Preferred Reporting Items for Systematic Reviews and Meta-Analyses for the scoping review flow format. The descriptive analysis of eligible studies for scoping reviews will be summarised. We will describe themes of attitude and perception covering pain, embarrassment, privacy and comfortability, willingness to self-sample, anxiety and confidence. Ethics and dissemination This is a scoping review protocol and does not require ethical approval. Findings from this review will be disseminated through peer-reviewed publications, the production of policy briefs, and presentations at local and international conferences.

Magnitude and histopathological patterns of gestational trophoblastic disease in Africa: a systematic review and meta-analysis

Objectives Gestational trophoblastic disease, characterised by abnormal proliferation of trophoblastic tissue in the placenta during pregnancy, contributes to maternal morbidity and mortality. This study aimed to estimate the pooled prevalence and histopathological patterns of gestational trophoblastic disease in Africa, where previous studies have reported inconsistent findings. Design Systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Data sources We searched PubMed, ScienceDirect, Hinari and Google Scholar for studies published between January 2000 and January 2024. Eligibility criteria Institution-based observational studies from African countries reporting the prevalence and/or histopathological patterns of gestational trophoblastic disease, using total deliveries as the denominator. Data extraction and synthesis Data were extracted into Excel and analysed using Stata V.17. Pooled estimates were calculated using a random-effects model with Knapp-Hartung adjustment. Heterogeneity was assessed with Cochran’s Q test and the I² statistic, and study quality was evaluated using the Joanna Briggs Institute tool. Results Of the 2252 studies identified, 33 were included, comprising 2885 gestational trophoblastic disease cases from eight countries. The pooled prevalence of gestational trophoblastic disease in Africa was 4.35 per 1000 deliveries (95% CI 3.26 to 5.45, I 2 =99.8%). The pooled prevalence of hydatidiform mole, invasive mole and choriocarcinoma in Africa was 3.49 per 1000 deliveries (95% CI 2.45 to 4.52, I 2 =99.7%), 0.47 per 1000 deliveries (95% CI 0.14 to 0.79, I 2 =72.2%) and 0.97 per 1000 deliveries (95% CI 0.54 to 1.40, I 2 =99.1%), respectively. Conclusion This review indicated the prevalence of gestational trophoblastic disease was high. Hydatidiform mole was the predominant histopathological pattern observed. Routine antenatal screening is needed for early detection. Further research should be conducted to identify risk factors and evaluate strategies for the prevention and management of the disease. PROSPERO registration number CRD42024504268.

Prognostic significance of tumour-infiltrating T lymphocytes in ovarian cancer: a protocol for systematic review and meta-analysis

Introduction Ovarian cancer remains a significant clinical challenge due to its aggressive nature and high mortality rate. Tumour-infiltrating lymphocytes (TILs) play a critical role in the tumour microenvironment, influencing treatment response and patient survival across various cancer types, including ovarian cancer. A systematic review is warranted to consolidate evidence on TILs as prognostic biomarkers in ovarian cancer, with the goals of integrating them into clinical practice to enhance patient outcomes. This study aims to assess the prognostic significance of TILs in ovarian cancer. Methods and analysis A comprehensive literature search will be conducted across multiple databases, including PubMed, Embase, Web of Science, Scopus, Cochrane Library, CINAHL, ScienceDirect and LILACS. No restrictions regarding publication date or language will be applied. Original studies evaluating the role of TILs in women with ovarian cancer will be considered for inclusion. Two independent authors will screen titles and abstracts, and any discrepancies will be resolved through discussion with a third author. The risk of bias in included studies will be assessed using the Quality in Prognosis Studies (QUIPS) tool. Data synthesis will be performed using R software (V.4.3.1). Ethics and dissemination This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO registration number CRD42024543955.

Performance ofCADM1, MALandmiR124-2methylation as triage markers for early detection of cervical cancer in self-collected and clinician-collected samples: an exploratory observational study in Papua New Guinea

ObjectiveWHO recommends human papillomavirus (HPV) testing for cervical screening, with triage of high-risk HPV (hrHPV) positive women. However, there are limitations to effective triage for low-resource, high-burden settings, such as Papua New Guinea. In this exploratory study, we assessed the performance of host methylation as triage tools for predicting high-grade squamous intraepithelial lesions (HSIL) in self-collected and clinician-collected samples.DesignExploratory observational study.SettingProvincial hospital, same-day cervical screen-and-treat trial, Papua New Guinea.Participants44 hrHPV+women, with paired self/clinician-collected samples (4 squamous cell carcinomas (SCC), 19 HSIL, 4 low-grade squamous intraepithelial lesions, 17 normal).Primary and secondary outcome measuresMethylation levels ofCADM1, MALandmiR124-2analysed by methylation-specific PCRs against the clinical endpoint of HSIL or SCC (HSIL+) measured using liquid-based-cytology/p16-Ki67 stain.ResultsIn clinician-collected samples,MALandmiR124-2methylation levels were significantly higher with increasing grade of disease (p=0.0046 and p<0.0015, respectively).miR124-2was the best predictor of HSIL (area under the curve, AUC 0.819) whileMALof SCC (AUC 0.856). In self-collected samples,MALbest predicted HSIL (AUC 0.595) whilemiR124-2SCC (AUC 0.812). CombinedmiR124-2/MALmethylation yielded sensitivity and specificity for HSIL+ of 90.5% (95% CI 69.6% to 98.8%) and 70% (95% CI 45.7% to 88.1%), respectively, in clinician-collected samples, and 81.8% (95% CI 59.7% to 94.8%) and 47.6% (95% CI 25.7% to 70.2%), respectively, in self-collected samples.miR124-2/MALplus HPV16/HPV18 improved sensitivity for HSIL+ (95.2%, 95% CI 76.2% to 99.9%) but decreased specificity (55.0%, 95% CI 31.5% to 76.9%).ConclusionmiR124-2/MALmethylation is a potential triage strategy for the detection of HSIL/SCC in low-income and middle-income country.

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

Introduction Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens ( Schistosoma haematobium (Sh )). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia. Methods and analysis This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15–50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. Ethics and dissemination The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

Pursuance of a Yoruba name for cervical cancer in Southwest Nigeria: a case study

Objectives Participants’ comprehension of research process affects the quality of research output, which is the reason why translation of research instruments into local languages is standard practice. Literature has consistently reported that in Africa, knowledge about cervical cancer is low but paradoxically, expressed, and actual uptake of human papillomavirus vaccine for its prevention is high. This study explored the Yoruba names of cervical cancer among Yoruba people in Ibadan, Nigeria to guide the translation of cervical cancer research instruments to Yoruba language. Design Exploratory case study design was used and data were obtained with 10 in-depth interviews and four focused group discussions. Data were analysed using content analysis. Settings The study took place in Ibadan North local government area, Southwest Nigeria. Participants These were 4 traditional healers, 3 Yoruba linguists, 3 public health educators and 38 parents of adolescents. Measures These were Yoruba names for cervical cancer and their meanings. Results Participants were aware of cervical cancer but only the traditional healers and public health educators had names for it. These names were highly varied. The public health educators gave names that were linked with different parts of the female reproductive system and external genital which were actually different medical conditions. Each traditional healer also had different names for cervical cancer, which either described the female body parts, or symptoms of female genital infections. These various names can lead to unnecessary misconceptions and misinformation about cervical cancer, its prevention, management, and research. Conclusions There was no consensus Yoruba name for cervical cancer among the study participants. Efforts to educate the Yoruba speaking populace about cervical cancer, its prevention, management and participation in its research can be frustrated if a generally accepted Yoruba name is not provided for this cancer. Stakeholders’ collaboration is required to get an appropriate Yoruba name for cervical cancer.

Protocol for exploring health promoter-led mental wellness initiatives for early prevention, screening and quality of life in patients with cervical cancer of rural Eastern Cape, South Africa: a mixed-methods study

Introduction Cervical cancer is in the top five list of highly prevalent cancers. It contributes to millions of premature deaths globally. Low- and middle-income countries like those in sub-Saharan Africa are among the worst affected despite the preventable nature of the disease. The disease is caused by the human papillomavirus, a sexually transmitted infection for which an effective vaccine exists. This study aims to determine the effectiveness of a health promoter-led intervention on early screening, prevention and quality-of-life improvement among patients with cervical cancer. Methods and analysis The study will be conducted in South Africa’s Eastern Cape province. The study will employ an exploratory sequential mixed-methods design, comprising four qualitative and quantitative substudies. For qualitative substudies, purposive sampling will select 20 cervical patients, and two to four focus group discussions will be conducted with health workers in the oncology units of two referral hospitals. Patients with a cervical cancer diagnosis will consent to participate in a survey on their quality of life and their mental health status, specifically screening for depression and anxiety. An equal number of patients (64) will be allocated to the two quantitative study arms. For substudies 1 and 2, in-depth interviews and focus group discussions will be conducted using a semistructured interview guide. The data will be audio recorded, transcribed verbatim and entered into NVivo V.15 for data analysis. For substudies 3 and 4, data will be collected using validated tools such as the WHO-Quality of Life tool to assess the quality of life of cervical cancer survivors, the Generalized Anxiety Disorder version 7 scale and the Patient Health Questionnaire version 9 for anxiety and depression. Data will be captured in Microsoft Excel and exported to SPSS V.29 software (Statistical Package for the Social Sciences). The study will use descriptive analyses of intervention participants’ responses using means, SDs, medians and IQRs, depending on the normality of the distribution. Ethics and dissemination The ethical clearance (protocol reference number: WSU HREC 023/2025) was approved by the Walter Sisulu University, Faculty of Medicine and Health Sciences, Ethics and Biosafety Committee, and access approval (reference number: EC_202503_022) was granted by the Eastern Cape Provincial Health Research Committee. Trial registration number PACTR202507608317068.

Study protocol for Adaptive ChemoTherapy for Ovarian cancer (ACTOv): a multicentre phase II randomised controlled trial to evaluate the efficacy of adaptive therapy (AT) with carboplatin, based on changes in CA125, in patients with relapsed platinum-sensitive high-grade serous or high-grade endometrioid ovarian cancer

Introduction Adaptive ChemoTherapy for Ovarian cancer (ACTOv) is a phase II, multicentre, randomised controlled trial, evaluating an adaptive therapy (AT) regimen with carboplatin in women with relapsed, platinum-sensitive high-grade serous or high-grade endometrioid cancer of the ovary, fallopian tube and peritoneum whose disease has progressed at least 6 months after day 1 of the last cycle of platinum-based chemotherapy. AT is a novel, evolutionarily informed approach to cancer treatment, which aims to exploit intratumoral competition between drug-sensitive and drug-resistant tumour subpopulations by modulating drug dose according to a patient’s own response to the last round of treatment. ACTOv is the first clinical trial of AT in this disease setting. Methods and analysis 80 patients will be randomised 1:1 to standard therapy (control) or AT (investigational) arms. The starting and maximum carboplatin dose in both arms is area under the curve (AUC) ×5 according to absolute nuclear medicine glomerular filtration rate. The AT regimen will modify the carboplatin dose according to changes in the serum biomarker CA125, a proxy measure of total tumour burden. Patients will receive treatment intravenously every 21 days for a maximum of 6 and 12 cycles in the control and investigational arms, respectively. The primary endpoint is modified progression-free survival (investigator-assessed using RECIST 1.1 (Response Evaluation Criteria in Solid Cancers) compared with the baseline prerandomisation scan rather than the radiological nadir), clinical progression or death from any cause. Secondary endpoints will include acceptability, deliverability, compliance, toxicity, CA125, quality of life and overall survival. ACTOv is open to National Health Service hospitals throughout the UK, recruitment is anticipated to take 36 months across 10 sites and will be managed by the Cancer Research UK and University College London Cancer Trials Centre. Ethics and dissemination The trial has been reviewed and received approval from the London—Dulwich Research Ethics Committee (REC). Results of the trial will be disseminated through publication in peer-reviewed journals. Trial registration number NCT05080556 .

How can cervical screening meet the needs of vulnerable women? A qualitative comparative study with stakeholder perspectives from seven European countries

Objective This study explored and compared stakeholder perspectives on enhancements to cervical cancer screening for vulnerable women across seven European countries. Design In a series of Collaborative User Boards, stakeholders were invited to collaborate on identifying facilitators to improve cervical cancer screening. Setting This study was part of the CBIG-SCREEN project which is funded by the European Union and targets disparities in cervical cancer screening for vulnerable women ( www.cbig-screen.eu ). Data collection took place in Bulgaria, Denmark, Estonia, France, Italy, Portugal and Romania. Participants Represented stakeholders at various levels, including user representatives (vulnerable women), healthcare professionals, social workers, programme managers and decision makers. Methods 14 meetings lasting 2 hours each were held in these seven countries between October 2021 and June 2022. The meetings were audio or video recorded, transcribed and translated into English for qualitative framework analysis. Results We engaged 120 participants in the Collaborative User Boards. Proposed solutions targeted both provider and system levels. In all countries, fostering trusting relationships between vulnerable women and social or healthcare professionals, coupled with community outreach for awareness and access to testing was a consistent recommendation. Participants in Estonia, Denmark, France, Italy, Portugal and Romania advocated for tailoring healthcare services to meet the unique needs of vulnerable populations through a holistic approach. In Bulgaria and Romania, participants advocated for the need to secure free access, from screening to follow-up, and emphasised the need for organised screening with target population screening registries. Conclusion The study offers insights into stakeholders' recommendations for enhancing cervical cancer screening services for vulnerable women across seven European countries. Despite variations in the implementation level of population-based screening programmes, the imperative to optimise outreach and proximity work to improve cervical cancer screening resonated across all countries.

Factors influencing postoperative urinary retention after radical hysterectomy for cervical cancer: development and validation of a predictive model in a prospective cohort study in Southwest China

Objectives To explore influencing factors for postoperative urinary retention (POUR) in cervical cancer patients and construct and validate a POUR prediction model. Design A prospective cohort study. Setting A large tertiary hospital specialised in child and maternal healthcare in Southwest China. Participants 1101 patients undergoing cervical cancer surgery at our hospital were enrolled in the analytic cohort between 1 July 2022 and 31 July 2023. Another 205 patients were enrolled in the external validation cohort between 1 August 2023 and 31 October 2023. Demographics and disease-related information were collected to construct a risk prediction model by logistic regression. Univariate analyses and a multivariate logistic regression analysis were conducted to determine possible influencing factors. The discrimination and accuracy of the model were assessed by the area under the curve (AUC) and the concordance index, respectively. Results Univariate analysis identified duration of surgery, intraoperative bleeding, presence of diabetes, hypertension, ureteral adhesion, wound healing classification, preoperative radio/chemotherapy, category of Body Mass Index, history of urinary diseases, history of caesarean section, postoperative urinary infection and use of analgesia pumps as potential influencing factors (p<0.05). Diabetes, wound healing classification, presurgery radio/chemotherapy, postoperative urinary infection, use of analgesia pumps and pain numerical rating score were founded to be significant factors influencing the occurrence of POUR in cervical cancer patients (p<0.05). A POUR prediction model constructed using the factors demonstrated excellent prediction power, with an AUC of 0.897 (95% CI, 0.877 to 0.916, p<0.001). The sensitivity of the model at the optimal threshold was 0.591, with specificity being 0.747. The receiver operating characteristic curve indicated a good performance of the model. Conclusions Presence of diabetes mellitus, wound healing classification, presurgery radio/chemotherapy, postoperative urinary infection, use of analgesia pumps and pain numerical rating score are factors influencing occurrence of POUR in cervical cancer patients. The POUR prediction model developed demonstrates good predictive power and is promising for clinical utility.

Prevalence and management of ectopic and molar pregnancies in 17 countries in Africa and Latin America and the Caribbean: a secondary analysis of the WHO multi-country cross-sectional survey on abortion

Introduction There are limited global data on ectopic pregnancy (EP) and molar pregnancy (MP), making it important to understand their epidemiology and management across different regions. Our study aimed to describe their prevalence for both conditions, severity of their complications and management among women in selected health facilities across 17 countries in Africa and Latin America and the Caribbean (LAC). Methods This is a secondary analysis of the WHO multi-country survey on abortion. Data were collected from 280 healthcare facilities across 11 countries in Africa and 6 in LAC. Sociodemographic information, signs and symptoms, management and clinical outcomes were extracted from medical records. Facility-level data on post-abortion care (PAC) capabilities were also collected, and facilities were classified accordingly. χ 2 or Fisher’s exact tests were used to compare categorical data. Results The total number of women with EP and MP across both regions was 9.9% (2 415/24 424) where EP accounted for 7.8% (1 904/24 424) and MP for 2.1% (511/24 424). EP presented a higher severity of complications than MP. At admission, 49.8% of EP had signs of peritoneal irritation. The most common surgical management for EP was laparotomy (87.2%) and for MP, uterine evacuation (89.8%). Facilities with higher scores in infrastructure and capability to provide PAC more frequently provided minimal invasive management using methotrexate/other medical treatment (34.9%) and laparoscopy (5.1%). Conclusion In Africa and LAC, EP and MP cause significant maternal morbidity and mortality. The disparity in the provision of good quality care highlights the need to strengthen the implementation of evidence-based recommendations in the clinical and surgical management of EP and MP.

Cohort profile: a nationwide study in Dutch CHEK2 c.1100delC families using the infrastructure of the HEreditary Breast and Ovarian cancer study Netherlands – Hebon-CHEK2

Purpose CHEK2 c.1100delC is associated with an increased breast cancer risk in women. While this variant is prevalent in the Netherlands (1% in the general population), knowledge of aetiology and prognosis of breast cancer and other tumours in CHEK2 c.1100delC carriers is lacking. The nationwide HEreditary Breast and Ovarian cancer study the Netherlands (Hebon) cohort aims to answer study questions in families with an increased risk of breast cancer and ovarian cancer. While initially focusing on BRCA1/2 -variant families, Hebon gradually expanded to include pathogenic variants in other genes associated with breast and/or ovarian cancer over time. This provides an excellent setting to establish a cohort to ultimately study the impact of CHEK2 c.1100delC on cancer risk prediction and surveillance, breast cancer treatment and prognosis. Participants We invited all heterozygous and homozygous CHEK2 c.1100delC indexes and tested female relatives. 1802 women were included, of whom 1374 were heterozygotes and 938 were breast cancer cases. Pedigrees were collected from all clinical genetic departments. Furthermore, participants completed a detailed questionnaire on hormonal and lifestyle factors, family history, cancer diagnosis and treatment. Findings to date Mean age at study inclusion was 53 years. Linkage with the Netherlands Cancer Registry showed a younger age at diagnosis in homozygotes (mean age 41.7 years) and heterozygotes (47.9 years) than non-carriers (51.2 years). Furthermore, carriers were more often diagnosed with grade 2, oestrogen receptor-positive breast cancer and more often developed contralateral breast cancer than non-carriers. Most women consumed alcohol regularly and about half never smoked. Future plans Further data linkages with the Netherlands Cancer Registry will allow prospective follow-up and breast cancer risk assessment in unaffected women at the time of genetic testing, risk of contralateral breast cancer and survival in patients with breast cancer. Also, linkage with the nationwide network and registry of histopathology and cytopathology in The Netherlands (PALGA) allows us to retrieve tumour samples to study tumourigenesis.

Examining the availability and readiness of health facilities to provide cervical cancer screening services in Nepal: a cross-sectional study using data from the Nepal Health Facility Survey

Objective We assessed the availability and readiness of health facilities to provide cervical cancer screening services in Nepal. Design Cross-sectional study. Setting We used secondary data from a nationally representative 2021 Nepal Health Facility Survey, specifically focusing on the facilities offering cervical cancer screening services. Outcome measures We defined the readiness of health facilities to provide cervical cancer screening services using the standard WHO service availability and readiness assessment manual. Results The overall readiness score was 59.1% (95% CI 55.4% to 62.8%), with more equipment and diagnostic tests available than staff and guidelines. Public hospitals (67.4%, 95% CI 63.0% to 71.7%) had the highest readiness levels. Compared with urban areas, health facilities in rural areas had lower readiness. The Sudurpashchim, Bagmati and Gandaki provinces had higher readiness levels (69.1%, 95% CI 57.7% to 80.5%; 60.1%, 95% CI 53.4% to 66.8%; and 62.5%, 95% CI 56.5% to 68.5%, respectively). Around 17% of facilities had trained providers and specific guidelines to follow while providing cervical cancer screening services. The basic healthcare centres (BHCCs) had lower readiness than private hospitals. Facility types, province and staff management meetings had heterogeneous associations with three conditional quantile scores. Conclusion The availability of cervical cancer screening services is limited in Nepal, necessitating urgent action to expand coverage. Our findings suggest that efforts should focus on improving the readiness of existing facilities by providing training to healthcare workers and increasing access to guidelines. BHCCs and healthcare facilities in rural areas and Karnali province should be given priority to enhance their readiness.

What are the barriers towards cervical cancer screening for vulnerable women? A qualitative comparative analysis of stakeholder perspectives in seven European countries

Objectives The aim of this study was to map and compare stakeholders’ perceptions of barriers towards cervical cancer screening for vulnerable women in seven European countries. Design In Collaborative User Boards, stakeholders were invited to participate to identify barriers towards participation in cervical cancer screening. Setting The study is nested in the European Union-funded project CBIG-SCREEN which aims to tackle inequity in cervical cancer screening for vulnerable women ( www.cbig-screen.eu ). Data collection took place in Bulgaria, Denmark, Estonia, France, Italy, Portugal and Romania. Participants Participants represented micro-level stakeholders covering representatives of users, that is, vulnerable women, meso-level stakeholders covering healthcare professionals and social workers, and macro-level stakeholders covering programme managers and decision-makers. Methods Across the seven countries, 25 meetings in Collaborative User Boards with a duration of 2 hours took place between October 2021 and June 2022. The meetings were video recorded or audio recorded, transcribed and translated into English for a qualitative framework analysis. Results 120 participants took part in the Collaborative User Boards. Context-specific barriers were related to different healthcare systems and characteristics of vulnerable populations. In Romania and Bulgaria, the lack of a continuous screening effort and lack of ways to identify eligible women were identified as barriers for all women rather than being specific for women in vulnerable situations. The participants in Denmark, Estonia, France, Italy and Portugal identified providers’ lack of cultural and social sensitivity towards vulnerable women as barriers. In all countries, vulnerable women’s fear, shame and lack of priority to preventive healthcare were identified as psychological barriers. Conclusion The study provides an overview of stakeholders’ perceived barriers towards vulnerable women’s cervical cancer screening participation in seven European countries. The organisation of healthcare systems and the maturity of screening programmes differ between countries, while vulnerable women’s psychological barriers had several similarities.

E xploratory study of using M agnetic resonance P rognostic I maging markers for R adiotherapy I n C ervix cancer (EMPIRIC): a prospective cohort study protocol

Introduction Radical chemoradiotherapy represents the gold standard for locally advanced cervical cancer. However, despite significant progress in improving local tumour control, distant relapse continues to impact overall survival. The development of predictive and prognostic biomarkers is consequently important to risk-stratify patients and identify populations at higher risk of poorer treatment response and survival outcomes. Exploratory study of using Magnetic resonance Prognostic Imaging markers for Radiotherapy In Cervix cancer (EMPIRIC) is a prospective exploratory cohort study, which aims to investigate the role of multiparametric functional MRI (fMRI) using diffusion-weighed imaging (DWI), dynamic contrast-enhanced (DCE) and blood oxygen level-dependent imaging (BOLD) MRI to assess treatment response and predict outcomes in patients undergoing radical chemoradiotherapy for cervical cancer. Methods and analysis The study aims to recruit 40 patients across a single-centre over 2 years. Patients undergo multiparametric fMRI (DWI, DCE and BOLD-MRI) at three time points: before, during and at the completion of external beam radiotherapy. Tissue and liquid biopsies are collected at diagnosis and post-treatment to identify potential biomarker correlates against fMRI. The primary outcome is to evaluate sensitivity and specificity of quantitative parameters derived from fMRI as predictors of progression-free survival at 2 years following radical chemoradiotherapy for cervical cancer. The secondary outcome is to investigate the roles of fMRI as predictors of overall survival at 2 years and tumour volume reduction across treatment. Statistical analyses using regression models and survival analyses are employed to evaluate the relationships between the derived parameters, treatment response and clinical outcomes. Ethics and dissemination The EMPIRIC study received ethical approval from the NHS Health Research Authority (HRA) on 14 February 2022 (protocol number RD2021-29). Confidentiality and data protection measures are strictly adhered to throughout the study. The findings of this study will be disseminated through peer-reviewed publications and scientific conferences, aiming to contribute to the growing body of evidence on the use of multiparametric MRI in cervical cancer management. Trial registration number NCT05532930 .

Status and treatment of patients with uterine fibroids in hospitals in central China: a retrospective study from 2018 to 2021

ObjectiveTo evaluate the hospitalised patients with uterine fibroids (UFs) and describe treatment patterns in hospital-treated patients in central China from 2018 to 2021.DesignA retrospective analysis.SettingThe gynaecology departments of class A and class B secondary and tertiary hospitals in Hubei Province, China.Participants101 008 patients diagnosed with UFs from 1 January 2018 to 31 December 2021.ResultsThe hospitalised patients with UFs increased with age, reaching a peak at ages 45–49 years and then gradually decreasing. Among these patients, 19.05% had anaemia symptoms. Women aged 25–29 years were more likely to be treated with laparoscopic myomectomy (62.22%), while women aged 20–24 years tend to choose open myomectomy (34.58%). Women over age 45 years who had entered perimenopause tended to be treated with laparoscopic hysterectomy (64.85% for those aged 65–69 years). Patients with fibroid with moderate-to-severe anaemia mostly chose hysterectomy. As a whole, the proportion of patients who chose laparoscopic hysterectomy was similar to that of patients who chose laparoscopic myomectomy (31.38% vs 31.14%). Only 2.08% of UFs were treated with high-frequency MRI-guided focused ultrasound surgery (MRgFUS). The number of patients who choose laparoscopic surgery or MRgFUS treatment was increasing year by year. After stratifying by hospital grade, we found that women treated at class A tertiary hospitals were more likely to have laparoscopic than open surgery (66.12% vs 31.26%). At class B secondary hospitals, 61.9% of the patients underwent myomectomy. By contrast, hysterectomy was used to treat the majority of patients at class A secondary hospitals and class B tertiary hospitals (57.79% and 57.57%, respectively). Use of MRgFUS was mainly concentrated within class A tertiary hospitals.ConclusionUFs affect mainly women in childbearing period. Most patients chose to receive treatment at class A tertiary hospitals, among which laparoscopic myomectomy was the mainstream surgical method for patients in Hubei Province.Trial registration numberNCT05840042.

Efficacy and safety of therapeutic HPV vaccines to treat CIN 2/CIN 3 lesions: a systematic review and meta-analysis of phase II/III clinical trials

Objectives We aim to assess the efficacy and safety of therapeutic human papillomavirus (HPV) vaccines to treat cervical intraepithelial neoplasia of grade 2 or 3 (CIN 2/3). Design Systematic review and meta-analysis, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. Data sources PubMed, Embase, Web of Science, Global Index Medicus and CENTRAL Cochrane were searched up to 31 January 2022. Eligibility criteria Phase II/III randomised controlled trials (RCTs) and single-arm studies reporting the efficacy of therapeutic vaccines to achieve regression of CIN 2/3 lesions were included. Studies evaluating only safety and side effects of the vaccine were excluded. Data extraction and synthesis Two independent reviewers extracted data and evaluated study quality. A random-effect model was used to pool the proportions of regression and/or HPV clearance. Results 12 trials met the inclusion criteria. Out of 734 women (all studies considered) receiving therapeutic HPV vaccine for CIN 2/3, 414 regressed to normal/CIN 1 with an overall proportion of regression of 0.54 (95% CI 0.39 to 0.69) for vaccinated group; 166 women (from five RCTs) receiving placebo only achieving a pooled normal/CIN 1 regression of 0.27 (95% CI 0.20 to 0.34). When including only the five two-arm studies, the regression proportion for the 410 vaccine group participants was higher than that of the 166 control group participants (relative risk (RR) 1.52; 95% CI 1.14 to 2.04). The pooled proportion of high-risk human papillomavirus (hrHPV) clearance was 0.42 (95% CI 0.32 to 0.52) in the vaccine group (six studies with a total of 357 participants) and 0.17 (95% CI 0.11 to 0.26) in the control group (three RCTs with a total of 104 participants). Based on these three RCTs, the hrHPV clearance was significantly higher in the vaccinated group (250 participants) compared with the control group (RR 2.03; 95% CI 1.30 to 3.16). Similar results were found regarding HPV 16/18 clearance. No significant unsolicited adverse events have been consistently reported. Conclusions The efficacy of the therapeutic vaccines in the treatment of CIN 2/3 was modest. Implementation issues such as feasibility, acceptability, adoption and cost-effectiveness need to be further studied. PROSPERO registration number CRD42022307418.

Women’s perception of barriers and facilitators of cervical cancer Pap smear screening: a qualitative study

ObjectiveAlthough Pap smear (PS) is considered the best standard in detecting cervical cancer, adherence to timely and regular PS is often lower than global standards in developing countries. Thus, the present study aimed to identify barriers and facilitators of adherence to cervical cancer screening in Mashhad, Iran.DesignA qualitative content analysis was done from July to December 2022 using semistructured in-depth interviews.SettingThe study was conducted in health centres in Mashhad, Iran.ParticipantsA sample of 36 married women aged 18–70 years was selected using a purposive sampling, with maximum diversity.ResultsThe mean age of participants was 42.8±7.6 years. Among all, 66.7% had the PS test at least once; only 8.3% regularly had the test. The qualitative content analysis led to the extraction of four major themes: (1) individual challenges, (2) environmental limitations, (3) individual motivators, and (4) supportive and efficient environments. The most significant barriers were psychological stress, unhealthy attitudes, insufficient information, cultural issues and insufficient healthcare services. Facilitators included an active and efficient healthcare system, advice and support of important others, and positive emotions and individual beliefs.ConclusionsParticipants' perceptions showed that the main factors influencing the PS testing were supportive environments, individual motivators, individual challenges and environmental limitations. To encourage women to take the PS and reduce barriers, it may be necessary to revise current health system policies, promote individual and public awareness, reduce psychological stress and correct negative beliefs and attitudes.

Comparison of conventional, doppler and contrast-enhanced ultrasonography in differential diagnosis of ovarian masses: a systematic review and meta-analysis

Objectives To assess the value of conventional, Doppler and contrast-enhanced ultrasonography (CEUS) (conventional ultrasonography (US), Doppler US and CEUS) for diagnosing ovarian cancer. Design Systematic review and meta-analysis. Data sources PubMed, Embase and the Cochrane Library were conducted for studies published until October 2021. Eligibility criteria Studies assessed the diagnostic value of conventional US, Doppler US or CEUS for detecting ovarian cancer, with no restrictions placed on published language and status. Data extraction and synthesis The study selection and data extraction were performed by two independent authors. The sensitivity, specificity, positive and negative likelihood ratio (PLR and NLR), diagnostic OR (DOR) and area under the receiver operating characteristic curve (AUC) were pooled using the bivariate generalised linear mixed model and random effects model. Results The meta-analysis included 72 studies and involved 9296 women who presented with ovarian masses. The pooled sensitivity, specificity, PLR, NLR, DOR and AUC for conventional US were 0.91 (95% CI: 0.87 to 0.94) and 0.87 (95% CI: 0.82 to 0.91), 6.87 (95% CI: 4.98 to 9.49) and 0.10 (95% CI: 0.07 to 0.15), 57.52 (95% CI: 36.64 to 90.28) and 0.95 (95% CI: 0.93 to 0.97), respectively. The sensitivity, specificity, PLR, NLR, DOR and AUC for Doppler US were 0.93 (95% CI: 0.91 to 0.95) and 0.85 (95% CI: 0.80 to 0.89), 6.10 (95% CI: 4.59 to 8.11) and 0.08 (95% CI: 0.06 to 0.11), 61.76 (95% CI: 39.99 to 95.37) and 0.96 (95% CI: 0.94 to 0.97), respectively. The pooled sensitivity, specificity, PLR, NLR, DOR and AUC for CEUS were 0.97 (95% CI: 0.92 to 0.99) and 0.92 (95% CI: 0.85 to 0.95), 11.47 (95% CI: 6.52 to 20.17) and 0.03 (95% CI: 0.01 to 0.09), 152.11 (95% CI: 77.77 to 297.51) and 0.99 (95% CI: 0.97 to 0.99), respectively. Moreover, the AUC values for conventional US (p=0.002) and Doppler US (p=0.005) were inferior to those of CEUS. Conclusions Conventional US, Doppler US and CEUS have a relatively high differential diagnostic value for differentiating between benign and malignant ovarian masses. The diagnostic performance of CEUS was superior to that of conventional US and Doppler US.

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol

Introduction The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa. Methods and analysis We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis. Ethics and dissemination Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal. Trial registration number NCT03931083 ; Pre-results.

Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial

Background Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60–75 mg/m 2 ) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m 2 , Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events. Ethics approval and dissemination This study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (approval number: 2020-ky-050). Results will be submitted to peer-reviewed journals and presented at national and international conferences. Trial registration number ChiCTR2000038173.

Decision aids for female BRCA mutation carriers: a scoping review protocol

Introduction Women who inherit a pathogenic mutation in Breast Cancer Susceptibility Genes 1 or 2 (BRCA1 or BRCA2) are at substantially higher risk of developing breast and ovarian cancer than the average woman. Several cancer risk management strategies exist to address this increased risk. Decisions about which risk management strategies to choose are complex, personal and multifactorial for these women. This scoping review will map evidence relevant to cancer risk management decision making in BRCA mutation carriers without a personal history of cancer. The objective is to identify and describe the features of patient decision aids that have been developed for BRCA mutation carriers. This information may be beneficial for designing new decision aids or adapting existing decision aids to support decision making in this population. Methods and analysis This scoping review will be conducted according to the Joanna Briggs Institute’s scoping review methodological framework. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used for guidance. Studies on decision aids for women with a BRCA mutation who are unaffected by breast or ovarian cancer will be considered for inclusion. Five electronic databases will be searched (MEDLINE, EMBASE, Cochrane Library, CINAHL, Web of Science) with no restrictions applied for language or publication date. Studies for inclusion will be selected independently by two review authors. Data will be extracted using a predefined data extraction form. Findings will be presented in tabular form. A narrative description of the evidence will complement the tabulated results. Ethics and dissemination Ethical approval for conducting this scoping review is not required as this study will involve secondary analysis of existing literature. Findings will be published in a peer-reviewed journal and presented at relevant conferences.

Evaluation of two population screening programmes for BRCA1/2 founder mutations in the Australian Jewish community: a protocol paper

Introduction People of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA -Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia. Methods and analysis To rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared. Ethics and dissemination Institutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.

Women’s priorities towards ovarian cancer testing: a best–worst scaling study

Objective To investigate the importance of key characteristics relating to diagnostic testing for ovarian cancer and to understand how previous test experience influences priorities. Design Case 1 best–worst scaling embedded in an online survey. Setting Primary care diagnostic testing in England and Wales. Participants 150 women with ovaries over 40 years old living in England and Wales. Methods We used best–worst scaling, a preference-based survey method, to elicit the relative importance of 25 characteristics relating to ovarian cancer testing following a systematic review. Responses were modelled using conditional logit regression. Subgroup analysis investigated variations based on testing history. Main outcome measures Relative importance scores. Results ‘Chance of dying from ovarian cancer’ (0.380, 95% CI 0.26 to 0.49) was the most important factor to respondents, closely followed by ‘test sensitivity’ (0.308, 95% CI 0.21 to 0.40). In contrast, ‘time away from usual activities’ (−0.244, 95% CI −0.33 to −0.15) and ‘gender of healthcare provider’ (−0.243, 95% CI −0.35 to −0.14) were least important to respondents overall. Women who had previously undergone testing placed higher importance on certain characteristics including ‘openness of healthcare providers’ and ‘chance of diagnosing another condition’ at the expense of reduced emphasis on characteristics such as ‘pain and discomfort’ and ‘time away from usual activities’. Conclusions The results clearly demonstrated items at the extreme, which were most and least important to women considering ovarian cancer testing. Differences in priorities by testing history demonstrate an experience effect, whereby preferences adapt over time based on evidence and experience. Acknowledging these differences helps to identify underlying barriers and facilitators for women with no test experience as well as shortcomings of current service based on women with experience.

Information needs among women taking part in primary HPV screening in England: a content analysis

Objectives Introducing primary human papillomavirus (HPV) testing to cervical screening programmes means changes to the results women receive. We explored additional information needs among women undergoing HPV primary screening. Design Women were sent a postal questionnaire shortly after receiving their results and 6 and 12 months later. Each questionnaire asked if women had any unanswered questions about cervical screening or HPV testing. Free-text responses constituted the data. Themes were identified using content analysis. Setting National Health Service (NHS) Cervical Screening Programme, England. Participants 381 women who recorded one or more free-text responses. Results The most common theme represented women’s emotional responses and attempts to understand their results. This theme was raised by 45% of women overall, but was as high as 59% in the HPV cleared group. General questions about the cause and epidemiology of HPV were raised by 38% of women and were more common among those testing HPV positive with normal cytology (52%). Questions about the purpose and procedure for HPV testing were most common among HPV-negative women (40%, compared with 16%–24% of the other results groups). Questions about future implications of test results were raised by 19% of women, and this theme was most common among those with persistent HPV. Conclusions Despite provision of information alongside screening invitations, women can still have unanswered questions following receipt of their results. Details about the epidemiology of HPV and why cervical screening procedures are changing should be included with screening invitations. Some results groups may benefit from additional tailored information with their results letter.

Surgical candidacy and treatment initiation among women with cervical cancer at public referral hospitals in Kampala, Uganda: a descriptive cohort study

Objectives This study aimed to report the proportion of women with a new diagnosis of cervical cancer recommended for curative hysterectomy as well as associated factors. We also report recommended treatments by stage and patterns of treatment initiation. Design This was an observational cohort study. Inperson surveys were followed by a phone call. Setting Participants were recruited at the two public tertiary care referral hospitals in Kampala, Uganda. Participants Adult women with a new diagnosis of cervical cancer were eligible: 332 were invited to participate, 268 met the criteria and enrolled, and 255 completed both surveys. Primary and secondary outcomes measures The primary outcome of interest was surgical candidacy; a secondary outcome was treatment initiation. Descriptive and multivariate statistical analyses examined the associations between predictors and outcomes. Sensitivity analyses were performed to examine outcomes in subgroups, including stage and availability of radiation. Results Among 268 participants, 76% were diagnosed at an advanced stage (IIB–IVB). In total, 12% were recommended for hysterectomy. In adjusted analysis, living within 15 km of Kampala (OR 3.10, 95% CI 1.20 to 8.03) and prior screening (OR 2.89, 95% CI 1.22 to 6.83) were significantly associated with surgical candidacy. Radiotherapy availability was not significantly associated with treatment recommendations for early-stage disease (IA–IIA), but was associated with recommended treatment modality (chemoradiation vs primary chemotherapy) for locally advanced stage (IIB–IIIB). Most (67%) had started treatment. No demographic or health factor, treatment recommendation, or radiation availability was associated with treatment initiation. Among those recommended for hysterectomy, 55% underwent surgery. Among those who had initiated treatment, 82% started the modality that was recommended. Conclusion Women presented to public referral centres in Kampala with mostly advanced-stage cervical cancer and few were recommended for surgery. Most were able to initiate treatment. Lack of access to radiation did not significantly increase the proportion of early-stage cancers recommended for hysterectomy.

Randomised phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol

Introduction Patients relapsing within 12 months of platinum-based chemotherapy usually have a poorer response to subsequent treatments. To date, extensive research into the mechanism of resistance to platinum agents in the treatment of ovarian cancer has not resulted in improved responses or longer survival. Further experimental work and clinical trials with novel agents are therefore justified to address this unmet need. Patients with ovarian, fallopian tube or primary peritoneal cancer that has relapsed within 12 months of platinum-based chemotherapy will be randomised with stratification for BReast CAncer gene (BRCA) status, prior poly (ADP-ribose) polymerase (PARP) exposure and prior antiangiogenic therapy into weekly paclitaxel (chemotherapy), olaparib or the combination of cediranib and olaparib. They will be followed until disease progression or unacceptable toxicity develops. Our trial design permits two investigations. We will compare the efficacy and tolerability of single-agent olaparib with weekly paclitaxel. We will also compare the efficacy and tolerability of olaparib with the combination of olaparib and cediranib. The required sample size of 138 participants (46 per arm) was calculated using a 20% one-sided type I error, 80% power and 15% dropout rate. Recruitment will last 34 months with a follow-up of 18 months. Methods and analysis Ethics and dissemination This study will be conducted under a UK Medicines and Healthcare Products Regulatory Agency Clinical Trials Authorisation. Approval to conduct the study was obtained from the responsible authority before beginning the study. The sponsor will retain ownership of all data arising from the trial. We aim to publish this research in a specialist peer-reviewed scientific journal on study completion. EudraCT number: 2016-000559-28, ethics reference number: 16/LO/2150. Trial registration number ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933; Pre-results.

Effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low and middle-income countries: a systematic review protocol

Introduction Breast and cervical cancers pose a major public health burden globally, with disproportionately high incidence, morbidity and mortality in low- and middle-income countries (LMICs). The majority of women diagnosed with cancer in LMICs present with late-stage disease, the treatment of which is often costlier and less effective. While interventions to improve the timely diagnosis of these cancers are increasingly being implemented in LMICs, there is uncertainty about their role and effectiveness. The aim of this review is to systematically synthesise available evidence on the nature and effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in LMICs. Methods and analysis A comprehensive search of published and relevant grey literature will be conducted. The following electronic databases will be searched: MEDLINE (via PubMed), Cochrane Library, Scopus, CINAHL, Web of Science and the International Clinical Trials Registry Platform (ICTRP). Evidence will be synthesised in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). Two reviewers will independently screen the search outputs, select studies using predefined inclusion criteria and assess each included study for risk of bias. If sufficient data are available and studies are comparable in terms of interventions and outcomes, a meta-analysis will be conducted. Where studies are not comparable and a meta-analysis is not appropriate, a narrative synthesis of findings will be reported. Ethics and dissemination As this will be a systematic review of publicly available data, with no primary data collection, it will not require ethical approval. Findings will be disseminated widely through a peer-reviewed publication and forums such as conferences, workshops and community engagement sessions. This review will provide a user-friendly evidence summary for informing further efforts at developing and implementing interventions for addressing delays in breast and cervical cancer diagnosis in LMICs. PROSPERO registration number CRD42020177232.

Barriers to cervical cancer prevention in rural Cameroon: a qualitative study on healthcare providers’ perspective

Objective Cervical cancer in Cameroon ranks as the second most frequent cancer among women and the leading cause of cancer-related deaths, mainly due to the lack of prevention. Our principal objective was to explore potential barriers to an human papillomavirus (HPV)-based cervical cancer screening from a healthcare provider (HCP) perspective in a low-income context. Second, we aimed to explore the acceptability of a single-visit approach using HPV self-sampling. Settings The study took place in the District hospital of Dschang, Cameroon. Participants Focus groups (FGs) involved HCPs working in the area of Dschang and Mbouda. Primary and secondary outcome measures All FGs were audiorecorded, transcribed and coded independently by two researchers using the ATLAS.ti software. A qualitative methodology was used to capture insights related to the way people perceive their surroundings. Discussion topics focused on perceived barriers, suggestions to improve cervical cancer screening uptake, and acceptability. Results A total of 16 HCPs were interviewed between July and August 2019. The identified barriers were (1) lack of basic knowledge on cervical cancer among most women and men and (2) lack of awareness of the role and existence of a screening programme to prevent it. Screening for cervical cancer prevention using HPV self-sampling was considered as an acceptable approach for patients according to HCPs. Traditional chiefs were identified as key entry points to raise awareness because they were perceived as essential to reach not only women, but also their male partners. Conclusions Awareness campaigns about cervical cancer, its prevention and the availability of the screening programmes are crucial. Furthermore, involving male partners, as well as key community leaders or institutions was identified as a key strategy to encourage participation in the cervical cancer screening programme. Trial registration Ethical Cantonal Board of Geneva, Switzerland (CCER, N°2017-0110 and CER-amendment n°2) and Cameroonian National Ethics Committee for Human Health Research (N°2018/07/1083/CE/CNERSH/SP).

Residual disease after primary surgery for advanced epithelial ovarian cancer: expert elicitation exercise to explore opinions about potential impact of publication bias in a planned systematic review and meta-analysis

Objectives We consider expert opinion and its incorporation into a planned meta-analysis as a way of adjusting for anticipated publication bias. We conduct an elicitation exercise among eligible British Gynaecological Cancer Society (BGCS) members with expertise in gynaecology. Design Expert elicitation exercise. Setting BGCS. Participants Members of the BGCS with expertise in gynaecology. Methods Experts were presented with details of a planned prospective systematic review and meta-analysis, assessing overall survival for the extent of excision of residual disease (RD) after primary surgery for advanced epithelial ovarian cancer. Participants were asked views on the likelihood of different studies (varied in the size of the study population and the RD thresholds being compared) not being published. Descriptive statistics were produced and opinions on total number of missing studies by sample size and magnitude of effect size estimated. Results Eighteen expert respondents were included. Responders perceived publication bias to be a possibility for comparisons of RD <1 cm versus RD=0 cm, but more so for comparisons involving higher volume suboptimal RD thresholds. However, experts’ perceived publication bias in comparisons of RD=0 cm versus suboptimal RD thresholds did not translate into many elicited missing studies in Part B of the elicitation exercise. The median number of missing studies estimated by responders for the main comparison of RD<1 cm versus RD=0 cm was 10 (IQR: 5–20), with the number of missing studies influenced by whether the effect size was equivocal. The median number of missing studies estimated for suboptimal RD versus RD=0 cm was lower. Conclusions The results may raise awareness that a degree of scepticism is needed when reviewing studies comparing RD <1 cm versus RD=0 cm. There is also a belief among respondents that comparisons involving RD=0 cm and suboptimal thresholds (>1 cm) are likely to be impacted by publication bias, but this is unlikely to attenuate effect estimates in meta-analyses.

Prehospital care for ovarian cancer in Catalonia: could we do better in primary care? Retrospective cohort study

ObjectiveTo assess the impact of prehospital factors (diagnostic pathways, first presentation to healthcare services, intervals, participation in primary care) on 1-year and 5-year survival in people with epithelial ovarian cancer (EOC).DesignRetrospective quasi-population-based cohort study.SettingCatalan Integrated Public Healthcare System.ParticipantsPeople with EOC who underwent surgery with a curative intent in public Catalan hospitals between 1 January 2013 and 31 December 2014.Outcome measuresData from primary and secondary care clinical histories and care processes in the 18 months leading up to confirmation (signs and symptoms at presentation, diagnosis pathways, referrals, diagnosis interval) of the EOC diagnosis (stage, histology type, treatment). Diagnostic process intervals were based on the Aarhus statement. 1-year and 5-year survival analysis was undertaken.ResultsOf the 513 patients included in the cohort, 67.2% initially consulted their family physician, while 36.4% were diagnosed through emergency services. In the Cox models, survival was influenced by advanced stage at 1 year (HR 3.84, 95% CI 1.23 to 12.02) and 5 years (HR 5.36, 95% CI 3.07 to 9.36), as was the type of treatment received, although this association was attenuated over follow-up. Age became significant at 5 years of follow-up. After adjusting for age, adjusted morbidity groups, stage at diagnosis and treatment, 5-year survival was better in patients presenting with gynaecological bleeding (HR 0.35, 95% CI 0.16 to 0.79). Survival was not associated with a starting point involving primary care (HR 1.39, 95% CI 0.93 to 2.09), diagnostic pathways involving referral to elective gynaecological care from non-general practitioners (HR 0.80, 95% CI 0.51 to 1.26), or self-presentation to emergency services (HR 0.82, 95% CI 0.52 to 1.31).ConclusionsSurvival in EOC is not associated with diagnostic pathways or prehospital healthcare, but it is influenced by stage at diagnosis, administration of primary cytoreduction plus chemotherapy and patient age.

Sintilimab combined with bevacizumab in relapsed/persistent ovarian clear cell carcinoma (INOVA): an investigator-initiated, multicentre clinical trial—a study protocol of clinical trial

Background Ovarian clear cell carcinoma (OCCC) has an abysmal prognosis with a median overall survival (OS) of 25.3 months because of a low response to chemotherapy. The 5-year disease-specific survival rate after recurrence is 13.2%, with more than two-thirds of the patients dying within a year. Therefore, it is urgent to explore new therapeutic options for OCCC. Based on the characteristic immune-suppressive tumour microenvironment derived from the gene expression profile of OCCC, the combination of immunoantiangiogenesis therapy might have certain efficacy in recurrent/persistent OCCC. This trial aims to evaluate the efficacy and safety of sintilimab and bevacizumab in patients who have failed platinum-containing chemotherapy with recurrent or persistent OCCC. Method and analysis In this multicentre, single-arm, open-label, investigator-initiated clinical trial, 38 patients will be assigned to receive sintilimab 200 mg plus bevacizumab 15 mg/kg every 3 weeks. The eligibility criteria include histologically diagnosed patients with recurrent or persistent OCCC who have been previously treated with at least one-line platinum-containing chemotherapy; patients with Eastern Cooperative Oncology Group (ECOG) performance status 0–2 with an expected survival greater than 12 weeks. The exclusion criteria include patients previously treated with immune checkpoint inhibitor and patients with contraindications of bevacizumab and sintilimab. The primary endpoint is the objective response rate. The secondary endpoints are progression-free survival, time to response, duration of response, disease control rate, OS, safety and quality of life. Statistical significance was defined as p<0.05. Ethics and dissemination This trial was approved by the Research Ethics Commission of Tongji Medical College of Huazhong University of Science and Technology (2020-S337). The protocol of this study is registered at www.clinicaltrials.gov . The trial results will be published in peer-reviewed journals and at conferences. Trial registration number NCT04735861 ; Clinicaltrials. gov.

Patients’ expectations of preventive measures of medical institutions during the SARS-CoV-2 pandemic in Germany in women with an increased risk of breast and ovarian cancer: a cross-sectional, web-based survey

ObjectivesTo identify patient-approved contingency measures for protection of patients and healthcare workers (HCWs) from COVID-19 infection and to use these findings to improve staff’s preparedness to cope with the course of this pandemic or similar situations.Methods (design, setting, participants, interventions)We conducted a cross-sectional, web-based survey of women with an increased risk of breast or ovarian cancer, regardless of whether they had experienced an active malignant disease during the pandemic. A self-reported questionnaire, developed for this study, was used to assess expectations and opinions about preventive measures within medical institutions.ResultsSixty-four (71.9%) of the 89 potential participants responded to at least one question regarding contingency measures within medical institutions. Approximately 37% of the respondents preferred having information about their facility’s hygiene protocols before appointment; 57.8% of the respondents endorsed regular SARS-CoV-2 testing of patients prior to medical appointments and 95.3% endorsed regular testing of HCWs. Additionally, 84.4% of the respondents supported HCWs’ use of surgical masks and 68.8% supported HCWs’ use of masks with greater protection. Notably, 75.0% of the respondents advocated for the presence of a significant other during medical consultations; 71.9% approved the use of telemedicine and 93.8% endorsed changes in appointment practices to enable social distancing. No significant associations were found between respondents’ sociodemographic, disease-specific or pandemic-specific factors and their opinions on hygiene precautions.ConclusionsPatients at high risk of infection or severe course of COVID-19 approve strict contingency measures designed to lower the transmission of COVID-19 in medical facilities. Moreover, vulnerable groups may profit from contingency plans in healthcare facilities in order to follow preventive measures, avoid diagnostic delay or avoid worsening of pre-existing conditions. However, they also value the presence of a significant other during medical consultations and procedures.

Effectiveness and safety of weekly therapy versus 3-weekly therapy of paclitaxel plus carboplatin in women with ovarian cancer: a protocol of systematic review and meta-analysis

Introduction Network meta-analyses have confirmed that paclitaxel plus carboplatin could improve progression-free survival (PFS) and overall survival (OS) compared with platinum alone. However, detailed implementation schedule (weekly or 3-weekly therapy) was not specified in clinical practice guidelines. Evidence from studies is also inconsistent. We will conduct a systematic review and meta-analysis to evaluate the benefits and harms of weekly therapy and 3-weekly therapy of paclitaxel combined with carboplatin in women with ovarian cancer. Methods We will search PubMed, EMBASE and the Cochrane Library databases to include relevant randomised controlled trials comparing weekly therapy versus 3-weekly therapy of paclitaxel combined with carboplatin for women with ovarian cancer. Random-effects model will be used to pool data for patient-reported outcomes including survival rate, OS, PFS and adverse events. Grading of Recommendation, Assessment, Development and Evaluation approach will be used to rate the quality of evidence. Ethics and dissemination This systematic review and meta-analysis will be based on published data and does not therefore require specific ethical approval or consent for participation. The results will be published in a peer-reviewed journal. OSF registration number 10.17605/OSF.IO/GJUMA.

Randomised controlled trial testing the feasibility of an exercise and nutrition intervention for patients with ovarian cancer during and after first-line chemotherapy (BENITA-study)

Objectives Advanced ovarian cancer is a severe disease with major side effects caused by peritoneal carcinomatosis, ascites and gastrointestinal involvement as well as exhaustive treatment like debulking surgery and combination chemotherapy. Two most frequently reported side effects are muscle wasting and malnutrition, leading to frailty, decreased health-related quality of life (HRQoL) and cancer-related fatigue (CRF). As muscle wasting and malnutrition often commence during first-line chemotherapy and develop progressively into a refractory state, an early intervention is warranted. This pilot study aimed to evaluate the safety and acceptance of a combined exercise and nutrition intervention during and after first-line chemotherapy. Design The pilot study was conducted as a monocentric 1:1 randomised controlled trial (RCT) with an intervention group (IG) and a control group (CG). Participants were divided by chance into IG or CG. Information on group allocation was conveyed to the study coordinator responsible for making an appointment with the patients for the baseline assessment as well as the physiotherapist and nutritionist responsible for the intervention and outcome assessment in both groups. Participants Eligibility criteria included women ≥18 years of age, diagnosed with ovarian cancer, tubal cancer or peritoneal cancer and primary or interval debulking, scheduled but not started adjuvant or neoadjuvant chemotherapy and sufficient German-language skills. Intervention The IG received a 12-month exercise and nutrition programme, the CG continued to follow usual care. Primary and secondary outcome measures Primary outcomes were recruitment rate, adherence to intervention, completion rate and adverse events. In addition, in-person assessments (eg, HRQoL, CRF, muscle quality and function and dietary intake and quality) were conducted at baseline (T0, before chemotherapy), week 9 (T1, mid-chemotherapy), week 19 (T2, after completion of chemotherapy) and after 12 months of intervention (T3). Results Of 60 eligible patients, 15 patients signed informed consent (recruitment rate=25.0%) and were randomised into IG (n=8) and CG (n=7). Eleven participants completed the study (completion rate, 73.3%), one patient dropped out due to loss of interest, one due to poor health, one was lost to follow-up and one patient died. Conclusion The BENITA (Bewegungs- und Ernährungsintervention bei Ovarialkrebs) study demonstrated the safety and acceptance of an exercise and nutrition intervention integrated into first-line therapy and follow-up care of ovarian cancer. A large multicentre RCT is planned to investigate the effectiveness of the intervention on HRQoL, CRF and survival and to establish means of implementation into oncology guidelines and clinic routine. Trial registration number DRKS00013231.

Expanding the upper age limit for cervical cancer screening: a protocol for a nationwide non-randomised intervention study

IntroductionCervical cancer screening ceases between the ages of 60 and 65 in most countries. Yet, a relatively high proportion of cervical cancers are diagnosed in women above the screening age. This study will evaluate if screening of women aged 65–69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening. Invited women may choose between general practitioner (GP)-based screening or cervico-vaginal self-sampling. Furthermore, the study will assess if self-sampling is superior to GP-based screening in reaching long-term unscreened women.Methods and analysisThis population-based non-randomised intervention study will include 10 000 women aged 65–69 years, with no record of a cervical cytology sample or screening invitation in the 5 years before inclusion. Women who have opted-out of the screening programme or have a record of hysterectomy or cervical amputation are excluded. Women residing in the Central Denmark Region (CDR) are allocated to the intervention group, while women residing in the remaining four Danish regions are allocated to the reference group. The intervention group is invited for human papillomavirus-based screening by attending routine screening at the GP or by requesting a self-sampling kit. The reference group receives standard care which is the opportunity to have a cervical cytology sample obtained at the GP or by a gynaecologist. The study started in April 2019 and will run over the next 4.5 years. The primary outcome will be the proportion of CIN2+ detected in the intervention and reference groups. In the intervention group, the proportion of long-term unscreened women attending GP-based screening or self-sampling will be compared.Ethics and disseminationThe study has been submitted to the Ethical Committee in the CDR which deemed that the study was not notifiable to the Committee and informed consent is therefore not required. The study is approved by the Danish Data Protection Regulation and the Danish Patient Safety Authority. Results will be disseminated in peer-reviewed journals.Trial registration numberNCT04114968.

Comparison of the costs of HPV testing through community health campaigns versus home-based testing in rural Western Kenya: a microcosting study

Objectives To estimate the cost of human papillomavirus (HPV)-based screening through community health campaigns (CHCs) and home-based testing. Setting CHCs and home-based testing in six communities in rural Western Kenya. Participants CHCs and home-based screening reached 2297 and 1002 women aged 25–65 years, respectively. Outcome measures Outcome measures were overall cost per woman screened achieved through the CHCs and home-based testing and the cost per woman for each activity comprising the screening intervention. Results The mean cost per woman screened through CHCs and home-based testing were similar, at $37.7 (range $26.4–$52.0) and $37.1 (range $27.6–$54.0), respectively. For CHCs, personnel represented 49% of overall cost, supplies 25%, services 5% and capital goods 23%. For home-based testing, these were: personnel 73%, supplies 25%, services 1% and capital goods 2%. A greater number of participants was associated with a lower cost per participant. Conclusions The mean cost per woman screened is comparable for CHC and home-based testing, with differences in type of input. The CHCs generally reached more eligible women in the six communities, whereas home-based strategies more efficiently reached populations with low screening rates. Trial registration number NCT02124252 .

Factors associated with advanced stage at diagnosis of cervical cancer in Addis Ababa, Ethiopia: a population-based study

ObjectiveTo describe the patterns and factors associated with advanced stage at diagnosis of cervical cancer among Addis Ababa residents, Ethiopia.DesignA population-based cross-sectional study.SettingSeven major hospitals or diagnostic facilities in Addis Ababa, Ethiopia.ParticipantsAll histopathology-confirmed patients with incident cervical cancer diagnosed from 1 January 2017 to 30 June 2018 among Addis Ababa residents.Outcome measuresThe proportion of patients with cervical cancer diagnosed at early stage (stage I/II) and advanced stage (stage III/IV) of the disease according to International Federation of Gynaecology and Obstetrics staging criteria, and adjusted prevalence ratio (APR) for factors associated with advanced-stage diagnosis using a Poisson regression with robust variance model.ResultsThe mean age of the study participants was 52.9 (±13.3) years. Nearly two-thirds (60.4%, 95% CI: 53.8% to 66.5%) of patients with cervical cancer were diagnosed at an advanced stage. Advanced stage at diagnosis was significantly associated with paying medical bill out of pocket (APR=1.44, 95% CI: 1.08 to 1.91), diagnostic interval >90 days (APR=1.31, 95% CI: 1.04 to 1.71), practicing religion as a remedy or not taking immediate action following symptom recognition (APR=1.25, 95% CI: 1.08 to 1.91) and visiting more than three different health facilities prior to diagnostic confirmation (APR=1.24, 95% CI: 1.07 to 1.51).ConclusionsOur findings of the high proportion of advanced-stage diagnosis of cervical cancer in Addis Ababa and its strong associations with out-of-pocket medical bill, seeking care out of conventional medicine settings and multiple visits to healthcare facilities before diagnostic confirmations underscore the need for public policies to improve the affordability of cancer care and enhance community awareness about the severity of the disease and referral system, in addition to expanding cervical cancer screening.

Prevalence and genotype distribution of cervical human papilomavirus infection in the pre-vaccination era: a population-based study in the Canary Islands

ObjectiveNational Spanish studies show that prevalence of cervical human papillomavirus (HPV) infection in the female population is increasingly frequent, with an overall estimate of 14% in women aged 18–65 years. The objective of this study is to know the prevalence and distribution of HPV types in the female population of the Canary Islands prior to the introduction of HPV vaccines and to investigate the associated clinical and sociodemographic factors.MethodsBased on the Primary Health Care database, a sample of adult women (aged 18–65 years) of Gran Canaria (GC) and Tenerife (TF) stratified into nine age groups was carried out between 2002 and 2007. Women were contacted by postal letter and telephone call and were visited in their primary care centre. A clinical-epidemiological survey was completed and cervical samples were taken for cytological study and HPV detection. HPV prevalence and its 95% CI were estimated, and multivariate analyses were performed using logistic regression to identify factors associated with the infection.Results6010 women participated in the study, 3847 from GC and 2163 from TF. The overall prevalence of HPV infection was 13.6% (CI 12.8%–14.5%) and 11.1% (CI 10.3%–11.9%) for high-risk types. The most frequent HPV type was 16 followed by types 51, 53, 31, 42 and 59. HPV types included in the nonavalent vaccine were detected in 54.1% of infected women. Factors associated with an increased risk of infection were: young ages (18–29 years), the number of sexual partners throughout life, not being married, being a smoker, and having had previous cervical lesions or genital warts.ConclusionsIt is confirmed that prevalence of HPV infection in the female population of the Canary Islands is high, but similar to that of Spain, HPV 16 being the most frequent genotype. The determinants of infection are consistent with those of other populations.

Comprehensive Cervical Cancer Prevention in Tanzania (CONCEPT) study: Cohort profile

Purpose Cervical cancer is a major cause of death among women in Eastern Africa, and the distribution of human papillomavirus (HPV) according to HIV status is inadequately characterised in this region. In order to guide future cervical cancer preventive strategies that involve HPV testing, the Comprehensive Cervical Cancer Prevention in Tanzania (CONCEPT) study was established in 2015. The CONCEPT cohort aims to investigate the natural history of HPV and determine acquisition and persistence patterns of high-risk (HR) HPV among HIV-positive and HIV-negative women. Further, the influence of lifestyle and sexual/reproductive factors will be investigated. The main objective of this article is to describe how the CONCEPT cohort was established. Participants Women aged 25–60 years were enrolled from cervical cancer screening clinics in Dar-es-Salaam and Moshi, Tanzania. Data were collected at baseline, at 14 months (first follow-up) and at 28 months (second follow-up). Biological samples included two cervical swabs for care HPV DNA testing, cytology, Hybrid Capture 2, genotyping and blood samples for HIV. Visual inspection with acetic acid was performed, and sociodemographic, lifestyle and sexual/reproductive characteristics were collected through a standardised questionnaire. Findings to date 4043 women were included in the cohort from August 2015 to May 2017. At baseline, 696 (17.1%) women were HR HPV positive, and among these, 31.6% were HIV positive; 139 women (3.4%) had high-grade squamous intraepithelial lesions. 3074 women (81%) attended the first follow-up. The majority attended after receiving a phone call reminder (35%) or from home via self-samples (41%). At first follow-up, 438 (14.4%) were HR HPV positive and 30.4% of these were HIV positive. Future plans A second follow-up is underway (17 December 2018–October 2020). We plan to integrate our data with a previous cross-sectional HPV study from Tanzania to increase the power of our findings. Researchers interested in collaborating are welcomed, either by extracting data or jointly requesting further investigation from the cohort.

Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China

IntroductionRecent studies have revealed that the oncological survival outcomes of minimally invasive radical hysterectomy (MIRH) are inferior to those of abdominal radical hysterectomy (ARH) in early-stage cervical cancer, but the potential reasons are unclear.Methods and analysisEach expert from 28 study centres participating in a previously reported randomised controlled trial (NCT03739944) will provide successive eligible records of at least 100 patients who accepted radical hysterectomy for early-stage cervical cancer between 1 January 2009 and 31 December 2015. Inclusion criteria consist of a definite pathological evaluation of stages IA1 (with positive lymphovascular space invasion), IA2 and IB1 according to the International Federation of Gynecology and Obstetrics 2009 staging system and a histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. The primary endpoint is 5-year disease-free survival between the MIRH and ARH groups. The secondary endpoints include the MIRH learning curves of participating surgeons, 5-year overall survival between the MIRH and ARH groups, survival outcomes according to surgical chronology, surgical outcomes and sites of recurrence and potential risk factors that affect survival outcomes. A subgroup analysis in patients with tumour diameter less than 2 cm will follow the similar flow diagram.Ethics and disseminationThis study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (registration no. JS-1711), and is also filed on record by all other 27 centres. The results will be disseminated through community events and peer-reviewed journals.Trial registration numberNCT03738969

Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples

Introduction Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals. Methods and analysis The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention–intervention, intervention–placebo, placebo–intervention and the placebo–placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission. Ethics and dissemination The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l’Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere. Trial registration number NCT01824537 .

Women’s experiences of the renewed National Cervical Screening Program in Australia 12 months following implementation: a qualitative study

Objective To explore women’s experiences of the renewed National Cervical Screening Program in Australia from the perspective of women who have received different human papillomavirus (HPV) test results. Women aged 25 to 74 are now screened every 5 years with primary HPV screening. Design Qualitative interview study. Setting Australia. Participants Women in Australia aged 25 to 74 who reported participating in cervical screening since December 2017, purposively sampled by test result (HPV positive, HPV negative and HPV status unknown). Methods 26 interviews with women aged 25 to 74 were conducted and analysed thematically. Results Three main themes emerged: knowledge and attitudes about the programme changes, information dissemination, the meaning and responses to test results and the new cervical screening test (CST). Some women showed little awareness of the changes, but others understood that HPV is detected earlier than abnormal cells. Some expressed positive attitudes towards the CST and were not anxious about less frequent screening. Most women envisaged the changes would have minimal impact on their screening behaviour. Women mainly wanted more information about the changes and the possible results from the new CST. Overall women could recall their HPV results and understand the implications for future cervical screening. Anxiety about being at ‘increased risk’ was more apparent in women who were HPV positive without history of abnormal results. Conclusions Women show some understanding of HPV and the new CST, but more written and public communication about the changes and possible results are warranted. Efforts are needed to ensure that women who are HPV positive without history of abnormal results receive the information needed to alleviate anxiety.

Moving beyond the Cox proportional hazards model in survival data analysis: a cervical cancer study

Objectives This study explored the prognostic factors and developed a prediction model for Chinese-American (CA) cervical cancer (CC) patients. We compared two alternative models (the restricted mean survival time (RMST) model and the proportional baselines landmark supermodel (PBLS model, producing dynamic prediction)) versus the Cox proportional hazards model in the context of time-varying effects. Setting and data sources A total of 713 CA women with CC and available covariates (age at diagnosis, International Federation of Gynecology and Obstetrics (FIGO) stage, lymph node metastasis and radiation) from the Surveillance, Epidemiology and End Results database were included. Design We applied the Cox proportional hazards model to analyse the all-cause mortality with the proportional hazards assumption. Additionally, we applied two alternative models to analyse covariates with time-varying effects. The performances of the models were compared using the C-index for discrimination and the shrinkage slope for calibration. Results Older patients had a worse survival rate than younger patients. Advanced FIGO stage patients showed a relatively poor survival rate and low life expectancy. Lymph node metastasis was an unfavourable prognostic factor in our models. Age at diagnosis, FIGO stage and lymph node metastasis represented time-varying effects from the PBLS model. Additionally, radiation showed no impact on survival in any model. Dynamic prediction presented a better performance for 5-year dynamic death rates than did the Cox proportional hazards model. Conclusions With the time-varying effects, the RMST model was suggested to explore diagnosis factors, and the PBLS model was recommended to predict a patient’s w -year dynamic death rate.

Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol

Introduction Human papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicéntrico de TAMizaje y triaje de cáncer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC. Methods and analysis Women aged 30–64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50 000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre. Ethics and dissemination The study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number NCT01881659

Assessing the feasibility of a rapid, high-volume cervical cancer screening programme using HPV self-sampling and digital colposcopy in rural regions of Yunnan, China

Objective Implementation of a novel, rapid, high-volume, see-and-treat cervical cancer screening programme using self-swab human papillomavirus (HPV) testing and digital colposcopy in underserved regions of Yunnan China. Design 480–980 women per day self-swabbed for high-risk HPV (hrHPV+). Four careHPV machines (Qiagen) were run simultaneously to test the specimens. All hrHPV+ patients were contacted the same day and digital colposcopy was performed with the enhanced visual assessment system (MobileODT). Digital images were obtained, and all suspected lesions were biopsied and then treated. Setting Rural and underserved areas of the Yunnan province, Kunming municipality. Participants 3600 women, mean age 50.2 years, who had never been screened for cervical cancer. The women were of the Yi, Hui, Dai and Han ethnicities. Interventions Cryotherapy was performed on all lesions suspicious for cervical intraepithelial neoplasia (CIN) 1 and loop electrosurgical excision procedure was performed on all lesions suspicious for ≥CIN2. Endocervical curettage was performed if the transformation zone was not fully visualised. Results 216 women (6%) were hrHPV+. 168 underwent same-day colposcopy (23 CIN1, 17≥CIN2). Digital colposcopy was able to identify 15 of 16 (93.8%)≥CIN2 lesions. Conclusions This study illustrates a high-volume, rapid and practical strategy that can be used to screen and treat an ethnically diverse group of Chinese women. First, HPV self-sampling allows large numbers of women to be screened rapidly and relatively inexpensively. Only hrHPV+ women will then require further evaluation. Digital colposcopy is then performed on hrHPV+ women with a portable digital colposcope. The high-resolution images obtained can facilitate appropriate same-day treatment as they are able to accurately distinguish between CIN1 and ≥CIN2 lesions.

Use of the Aptima mRNA high-risk human papillomavirus (HR-HPV) assay compared to a DNA HR-HPV assay in the English cervical screening programme: a decision tree model based economic evaluation

Objective To estimate the impact of using the Aptima messenger RNA (mRNA) high-risk human papilloma virus (HR-HPV) assay versus a DNA HR-HPV assay in a primary HPV cervical screening programme. Design One hypothetical cohort followed for 3 years through HPV primary cervical screening. Setting England. Participants A hypothetical cohort of women aged 25–65 years tested in the National Health Service (NHS) Cervical Screening Programme (CSP) for first call or routine recall testing. Methods A decision tree parameterised with data from the CSP (2017/18) and the HORIZON study. Uncertainty analyses were conducted using data from the FOCAL and GAST studies, other DNA HPV tests in addition to one-way and probabilistic sensitivity and scenarios analyses, to test the robustness of results. Interventions Aptima mRNA HR-HPV assay and a DNA HR-HPV assay (cobas 4800 HPV assay). Main outcome measures Primary: total colposcopies and total costs for the cohort. Secondary: total HPV and cytology tests, number lost to follow-up. Results At baseline for a population of 2.25 million women, an estimated £15.4 million (95% credibility intervals (CI) £6.5 to 24.1 million) could be saved and 28 009 (95% CI 27 499 to 28 527) unnecessary colposcopies averted if Aptima mRNA assays are used instead of a DNA assay, with 90 605 fewer unnecessary HR-HPV and 253 477 cytology tests performed. These savings are due to a lower number of HPV positive samples in the mRNA arm. When data from other primary HPV screening trials were compared, results indicated that using the Aptima mRNA assay generated cost savings and reduced testing in every scenario. Conclusion Using the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the CSP.

Impact of healthcare access and HIV testing on utilisation of cervical cancer screening among US women at high risk of HIV infection: cross-sectional analysis of 2016 BRFSS data

Objective Previous studies identified several factors associated with cervical cancer screening. However, many of them used samples from the general population and limited studies focused on women with high-risk health behaviours. We aimed to disentangle the association of cervical cancer screening with healthcare access and HIV testing among women at a high risk of HIV infection. Design Nationwide cross-sectional survey in the USA. Setting 2016 Behavioral Risk Factor Surveillance System. Participants 3448 women with a history of high-risk behaviours associated with HIV infection Exposure and outcome Clinical check-up, having personal healthcare provider, health coverage and HIV testing history were treated as exposures. Appropriate cervical cancer screening, which was defined according to 2016 US Preventive Services Task Force guideline, was treated as the outcome of interest. Data analysis Multivariable logistic regression model was performed to evaluate associations of healthcare access and HIV testing with the uptake of cervical cancer screening; adjusted odds ratio (aOR) and 95% CI were reported. We further investigated if educational attainment modified associations identified in the primary multivariable model. Results A total of 2911 (84.4%) high-risk women in our sample underwent cervical cancer screening. In the multivariable model, delayed clinical check-up (≥5 years ago vs within the past year: aOR: 0.19, 95% CI: 0.14 to 0.26), having no health insurance (aOR: 0.60, 95% CI: 0.46 to 0.79) and no history of HIV testing (no testing vs testing within the past year: aOR: 0.46, 95% CI: 0.35 to 0.61) were inversely associated with cervical cancer screening utilisation. Conclusion Factors reflecting healthcare access, specifically clinical check-up and health coverage, as well as history of HIV testing were associated with cervical cancer screening in this population-based study of high-risk women. Targeted interventions are warranted to further increase cervical cancer screening among women at high risk of HIV infection.

Timeliness of diagnosis of breast and cervical cancers and associated factors in low-income and middle-income countries: a scoping review protocol

Introduction Breast and cervical cancer are leading causes of morbidity and mortality in women globally, with disproportionately high burdens in low-income and middle-income countries (LMICs). While the incidence of both cancers increases across LMICs, many cases continue to go undiagnosed or diagnosed late. The aim of this review is to comprehensively map the current evidence on the time to breast or cervical cancer diagnosis and its associated factors in LMICs. Methods and analysis This scoping review (ScR) will be informed by Arksey and O"Malley’s enhanced ScR methodology framework. It will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. We will conduct a comprehensive search of the following electronic databases: MEDLINE (via PubMed), Cochrane Library, Scopus and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). Two reviewers will independently screen all abstracts and full texts using predefined inclusion criteria. All publications describing the time to diagnosis and its associated factors in the contexts of breast or cervical cancer will be considered for inclusion. Evidence will be narratively synthesised and analysed using a predefined conceptual framework. Ethics and dissemination As this is a ScR of publicly available data, with no primary data collection, it will not require ethical approval. Findings will be disseminated widely through a peer-reviewed publication and forums such as conferences and community engagement sessions. This review will provide a user-friendly evidence summary for understanding the enormity of diagnostic delays and associated factors for breast and cervical cancers in LMICs, while helping to inform policy actions and implementation of interventions for addressing such delays.

Effectiveness of HPV vaccine by age at vaccination and number of doses: protocol for a population-based matched case–control study

Introduction In 2006, the first human papillomavirus (HPV) vaccine was approved by the Food and Drug Administration in the USA based on pre-licensure clinical trials that found it to be highly efficacious at preventing persistent infection and precancerous, high-grade cervical lesions (HGCLs) caused by viral types the vaccine protects against. However, the real-world effectiveness of HPV vaccines as used in clinical practice may be quite different from the efficacy found in pre-licensure clinical trials. More than 10 years have passed since the introduction of the vaccine programme. It is critical to determine if the full benefits of HPV are being realised in real-world settings. Methods and analysis The objectives of this study were to estimate the effectiveness of HPV vaccines as used in real-world clinical settings and to determine the degree to which the vaccine’s effectiveness varies based on age at the time of immunisation and the number of doses received. The study will be a population-based, matched case–control study. Cases will be women with newly diagnosed HGCL associated with HPV types 16 and 18. Matched controls will be women with a normal Pap test result, matched individually to cases in a 2:1 ratio by age, a practice and date of testing. Medical records will be reviewed to determine dates of receipt of the HPV vaccine for all participants. We will use multivariate conditional logistic regression to control for potential confounders. Ethics and dissemination This protocol presents minimal risk to the subjects. This protocol has received approval from the Institutional Review Board of Yale University (HIC: 1502015308), and a Health Insurance Portability and Accountability Act (HIPAA) Waiver of Authorisation has been granted to allow investigators to recruit subjects for the study. Findings will be disseminated through peer-reviewed, open-access scientific journals and conference presentations.

Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial

Background Human papillomavirus (HPV) vaccination protects against HPV, a necessary risk factor for cervical cancer. We now report results from population-based follow-up of randomised cohorts that vaccination provides HPV-type-specific protection against invasive cancer. Methods Individually and/or cluster randomised cohorts of HPV-vaccinated and non-vaccinated women were enrolled in 2002–2005. HPV vaccine cohorts comprised originally 16–17 year-old HPV 16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2465) and HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866). Altogether, 3341 vaccines were followed by the Finnish Cancer Registry in the same way as 16 526 non-HPV-vaccinated controls. The control cohort stemmed from 15 665 originally 18–19 years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial. The follow-up started 6 months after the clinical trials in 2007 and 2009 and ended in 2019. It was age aligned for the cohorts. Findings During a follow-up time of up to 11 years, we identified 17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts. HPV typing of diagnostic tumour blocks found HPV16 in nine cervical cancer cases, HPV18, HPV33 and HPV52 each in two cases and HPV45 in one cervical cancer case. The vaginal, vulvar and tongue cancer cases were, respectively, positive for HPV16, HPV52/66 and HPV213. Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05). Interpretation Vaccination is effective against invasive HPV-positive cancer. Trial registration number NCT00122681, Post-results; NCT00169494, Post-results; NCT00092534, Post-results.

Perception and knowledge of human papillomavirus (HPV) vaccine for cervical cancer prevention among fully vaccinated female university students in the era of HPV vaccination: a cross-sectional study

Objective To assess the perception and knowledge of cervical cancer prevention among fully vaccinated female university students in the era of human papillomavirus (HPV) vaccination. Design Cross-sectional using a validated questionnaire. Setting Face-to-face interview at a public university in Malaysia. Participants 384 fully vaccinated female students were included in the study. Results The total knowledge score in the questionnaire was 18 and was ranked according to score level into three groups: poor (score ≤5), moderate (score 6–10) and good (score ≥11). Mean score for knowledge of cervical cancer prevention was 8.24 (SD ±3.85), with 170 respondents (44.3%) scoring moderate knowledge level. The mean score for knowledge of HPV infection and its association with cervical cancer was 4.56±2.47, while the mean score for knowledge of HPV vaccination for cervical cancer prevention was 3.68 (SD ±1.98). A total of 186 (48.4%) respondents perceived that regular Pap smear was unnecessary after HPV vaccination. Respondents’ perceived seriousness and susceptibility of HPV infection correlated well with knowledge of cervical cancer prevention. Two main reasons for their acceptance of HPV vaccine were self-health awareness and free vaccination. Conclusion The knowledge of HPV vaccination for cervical cancer prevention was average among vaccinated university students. Many of them had poor knowledge about Pap smear and did not consider regular Pap smear as an important cervical cancer screening tool following HPV vaccination. There is still a need for continued health education to improve the perception and knowledge about HPV infection and cervical cancer prevention among young adults in the community.

Cost-effectiveness of human papillomavirus vaccine in China: a systematic review of modelling studies

Objectives China suffers from high burdens of human papillomavirus (HPV) and cervical cancer, whereas the uptake of HPV vaccine remains low. The first Chinese domestic HPV vaccine was released in 2019. However, collective evidence on cost-effectiveness of HPV vaccination in China has yet to be established. We summarised evidence on the cost-effectiveness of HPV vaccine in China. Design Systematic review and narrative synthesis Data sources PubMed, EMBASE, China National Knowledge Infrastructure and Wanfang Data were searched through 2 January 2021 Eligibility criteria for selecting studies Cost-effectiveness studies using a modelling approach focusing on HPV vaccination interventions in the setting of China were included for review. Data extraction and synthesis We extracted information from the selected studies focusing on cost-effectiveness results of various vaccination programmes, key contextual and methodological factors influencing cost-effectiveness estimates and an assessment of study quality. Results A total of 14 studies were included for review. Considerable heterogeneity was found in terms of the methodologies used, HPV vaccination strategies evaluated and study quality. The reviewed studies generally supported the cost-effectiveness of HPV vaccine in China, although some reached alternative conclusions, particularly when assessed incremental to cervical cancer screening. Cost of vaccination was consistently identified as a key determinant for the cost-effectiveness of HPV vaccination programmes. Conclusions Implementing HPV vaccination programmes should be complemented with expanded cervical cancer screening, while the release of lower-priced domestic vaccine offers more promising potential for initiating public HPV vaccination programmes. Findings of this study contributes important evidence for policies for cervical cancer prevention in China and methodological implications for future modelling efforts.

Cancer in HIV-positive and HIV-negative adolescents and young adults in South Africa: a cross-sectional study

Objective To determine the spectrum of cancers in adolescents and young adults (AYAs) living with and without HIV in South Africa. Design Cross-sectional study with cancer records provided by the National Cancer Registry (NCR) and HIV records from the National Health Laboratory Service (NHLS). Setting and participants The NHLS is the largest provider of pathology services in the South African public sector. The NCR is a division of the NHLS. We included AYAs (aged 10–24 years) diagnosed with cancer by public health sector laboratories between 2004 and 2014 (n=8479). HIV status was obtained through record linkages and text mining. Primary and secondary outcomes We determined the spectrum of cancers by HIV status in AYAs. We used multivariable logistic regression to describe the association of cancer in AYAs with HIV, adjusting for age, sex, ethnicity and calendar period. We imputed (post hoc) the HIV status for AYA with unknown HIV status. Results 8479 AYAs were diagnosed with cancer, HIV status was known for 45% (n=3812). Of those whose status was known, about half were HIV positive (n=1853). AYAs living with HIV were more likely to have Kaposi’s sarcoma (adjusted OR (aOR) 218, 95% CI 89.9 to 530), cervical cancer (aOR 2.18, 95% CI 1.23 to 3.89), non-Hodgkin’s lymphoma (aOR 2.12, 95% CI 1.69 to 2.66) and anogenital cancers other than cervix (aOR 2.73, 95% CI 1.27 to 5.86) than AYAs without HIV. About 44% (n=1062) of AYAs with HIV-related cancers had not been tested for HIV. Conclusions Targeted HIV testing for AYAs diagnosed with cancer, followed by immediate start of antiretroviral therapy, screening for cervical precancer and vaccination against human papilloma virus is needed to decrease cancer burden in AYAs living with HIV in South Africa.

Women’s acceptability of and experience with primary human papillomavirus testing for cervix screening: HPV FOCAL trial cross-sectional online survey results

Objective To study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening. Design Cross-sectional online survey of clinical trial participants. Setting Primary care, population-based Cervix Screening Program, British Columbia, Canada. Participants A total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit. Outcome measures Acceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary). Results Most respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable. Conclusions In this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening. Trial registration numbers ISRCTN79347302 and NCT00461760.

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study

Introduction Cervical cancer is the leading cause of cancer deaths among women in Malawi, but preventable through screening. Malawi primarily uses visual inspection with acetic acid (VIA) for screening, however, a follow-up for positive screening results remains a major barrier, in rural areas. We interviewed women who underwent a community-based screen-and-treat campaign that offered same-day treatment with thermocoagulation, a heat-based ablative procedure for VIA-positive lesions, to understand the barriers in accessing post-treatment follow-up and the role of male partners in contributing to, or overcoming these barriers. Methods We conducted in-depths interviews with 17 women recruited in a pilot study that evaluated the safety and acceptability of community-based screen-and-treat programme using VIA and thermocoagulation for cervical cancer prevention in rural Lilongwe, Malawi. Ten of the women interviewed presented for post-treatment follow-up at the healthcare facility and seven did not. The interviews were analysed for thematic content surrounding barriers for attending for follow-up and role of male partners in screening. Results Transportation was identified as a major barrier to post-thermocoagulation follow-up appointment, given long distances to the healthcare facility. Male partners were perceived as both a barrier for some, that is, not supportive of 6-week post-thermocoagulation abstinence recommendation, and as an important source of support for others, that is, encouraging follow-up attendance, providing emotional support to maintaining post-treatment abstinence and as a resource in overcoming transportation barriers. Regardless, the majority of women desired more male partner involvement in cervical cancer screening. Conclusion Despite access to same-day treatment, long travel distances to health facilities for post-treatment follow-up visits remained a major barrier for women in rural Lilongwe. Male partners were identified both as a barrier to, and an important source of support for accessing and completing the screen-and-treat programme. To successfully eliminate cervical cancer in Malawi, it is imperative to understand the day-to-day barriers women face in accessing preventative care.

Estimate of global human papillomavirus vaccination coverage: analysis of country-level indicators

Background Mortality rates from cervical cancer demonstrate deep inequality in health between richer and poorer populations. Over 310 000 women died of this preventable disease in 2018, mostly in low-income and middle-income countries (LMICs) where screening and treatment are beyond the capacity of health systems. Immunisation against human papillomavirus (HPV) offers a primary prevention strategy, but rates of vaccination uptake are unclear. Understanding coverage levels and factors affecting uptake can inform immunisation strategies. Objectives The aim of this study is to evaluate the status of HPV vaccination coverage from nationally reported indicators and to estimate global coverage in a single year cohort of vaccine-eligible girls. Design This study provides quantitative population-level estimates of important global health indicators. Using data from the Global Cancer Observatory and WHO/UNICEF, incidence of and mortality from cervical cancer and HPV vaccination coverage are described for countries, categorised by income group. Characteristics of LMICs achieving high coverage are explored using selected development indicators from World Bank sources. Global HPV immunisation coverage is calculated and its impact on cervical cancer mortality estimated. Results Incidence and mortality for cervical cancer correlate with poverty. Whilst all WHO member states report high infant measles vaccination rates, fewer than half report on HPV vaccination. Even amongst high-income countries, coverage varies widely. In upper-middle-income countries, there is a trend for higher coverage with increased health spending per capita. Four LMICs report good coverage levels, all associated with external funding. Global HPV immunisation coverage for 2018 is estimated at 12.2%. Of the global cohort of 61 million 15-year-old girls in 2018, 7000 are likely to die from cervical cancer, almost all in LMICs. Conclusions Countries in all income groups must devise strategies to achieve and maintain higher levels of HPV immunisation. For all but the richest, affordability remains a barrier.

Natural history of histologically confirmed high-grade cervical intraepithelial neoplasia during pregnancy: meta-analysis

Objectives This study aimed to conduct a meta-analysis of estimates of the natural history of high-grade cervical intraepithelial neoplasia (CIN) during pregnancy. Setting Studies examining the clinical courses of histologically confirmed high-grade CIN during pregnancy. Participants We searched PubMed, Web of Science and Embase for eligible studies. Studies were included if they reported the data regarding the natural history of histologically confirmed high-grade CIN during pregnancy. Final estimates were from the meta-analysis of 10 eligible studies. Primary outcome measures The regression rate, persistence rate and progression rate of histologically proven untreated high-grade CIN during pregnancy. Results A total of 10 original studies were included in this meta-analysis. During pregnancy, the regression rate, persistence rate and progression rate of high-grade CIN were 40% (95% CI 35% to 45%), 59% (95% CI 54% to 64%) and 1% (95% CI 0% to 2%), respectively. There was moderate heterogeneity among the studies. The results of the subgroup meta-analysis show that the pooled rates of regression and persistence during pregnancy were 59% (95% CI 54% to 65%) and 40% (95% CI 35% to 45%) for CIN2, and 29% (95% CI 25% to 33%) and 70% (95% CI 65% to 73%) for CIN3. Conclusions During pregnancy, the majority of histologically confirmed high-grade CIN would be persistent or regressed to lower grade CIN or normal. However, it is still worth noting that a small percentage of high-grade CIN would progress to cervical cancer during pregnancy.

Role of locoregional surgery in treating FIGO 2009 stage IVB cervical cancer patients: a population-based study

Objective We aimed to analyse the clinical value of primary site surgery in improving the cancer-specific survival (CSS) and overall survival (OS) of initial metastatic cervical cancer patients. Design A population-based retrospective study. Setting National Cancer Institute’s Surveillance, Epidemiology and End Results database. Participants We analysed 1390 patients with the International Federation of Gynecology and Obstetrics 2009 stage IVB cervical cancer with complete clinical data treated between 2010 and 2016. Interventions Primary site surgery. Measures Propensity score matching (PSM) with a ratio of 1:2 was used to balance measure covariates of comparison groups. Survival time was calculated using Kaplan-Meier methods and compared by the log-rank test. To eliminate the bias of site-specific metastasis, clinicopathological factors and subsequent therapy on survival analysis, subgroup analyses stratified by metastasis type, clinicopathological factors and subsequent therapy were employed to evaluate the effect of cervical surgery on survival. Combination of directed acyclic graph and change-in-estimate procedures was performed to indentified confounders, and Cox regression was used to assess the survival benefit of cervical surgery for primary metastatic cervical cancer patients. The consistency of our findings was evaluated through sensitivity analysis. Results Matching resulted in two comparison groups with minor differences in most variables. Pre-and-post-PSM, the median CSS and OS in the surgery group were 1.3 and 1.5, 1.1 and 1.2 times of those in the non-surgery group, respectively. Primary site surgery conferred prognosis superiority for patients with metastases to distant lymph node and other sites rather than organ metastases. After PSM and adjusting confounders, local surgery reduced the cancer related and overall mortality rates by 31% and 30%, respectively. Conclusions Surgical procedures could promote survival in patients with primary metastatic cervical cancer and should be considered a therapeutic option for carefully chosen patients.

Study protocol: Yarning about HPV Vaccination : a qualitative study of factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in Australia

Introduction Aboriginal and Torres Strait Islander women experience a higher burden of cervical cancer than non-Indigenous women in Australia. Cervical cancer is preventable partly through human papillomavirus (HPV) vaccination; in Australia, this is delivered through the national school-based immunisation programme. While HPV vaccination uptake is high among Australian adolescents, there remain gaps in uptake and completion among Aboriginal and Torres Strait Islander adolescents. This study aims to gain a comprehensive understanding of the barriers and facilitators to HPV vaccination uptake and completion among Aboriginal and Torres Strait Islander adolescents in Queensland, Australia. Methods and analysis The study will be guided by an Indigenist research approach and an ecological model for health promotion. Yarning, a qualitative Indigenous research method, will be conducted in up to 10 schools. Participants will include Year 7 (12/13 years old) Aboriginal and Torres Strait Islander adolescents; parents/caregivers; and local key informants and immunisation programme partners involved in the delivery of school-based HPV immunisation programme. Participants will be recruited through school representatives and investigator networks using purposive and snowball sampling and samples of convenience. Field notes, HPV vaccination clinic observations and sequential diagramming of the HPV vaccination process will be conducted. Thematic analysis of data will be led by Aboriginal and Torres Strait Islander researchers. Synthesised sequential diagrams of the process of HPV vaccination and qualitative themes summarising key findings will be produced. Ethics and dissemination The Aboriginal Health and Medical Research Council of New South Wales Ethics Committee (1646/20), the Australian National University Human Research Ethics Committee (HREC, 2020/478), the HREC of the Northern Territory Department of Health and Menzies School of Health Research (19-3484) and the Townsville Hospital and Health Service HREC (HREC/QTHS/73789) have approved the study. Dissemination will occur via conferences and peer-reviewed publications. Further dissemination will be determined in partnership with the Aboriginal and Torres Strait Islander Steering Committee, including Youth Representatives and Consultation Network.

Healthcare utilisation, cancer screening and potential barriers to accessing cancer care in rural South West Nigeria: a cross-sectional study

Background/aims Cancer burden is predicted to double by 2030 in sub-Saharan Africa; access to healthcare services for cancer management is a priority in the region. In Nigeria, National Cancer Control Plan aims to ensure >50% cancer screening of eligible populations by 2022 for all Nigerians. We describe healthcare utilisation, cancer screening activities and potential barriers to accessing cancer care within an understudied rural community-based adult population in South West Nigeria. Methods In April 2018, we conducted a cross-sectional study of community-based adults (>18 years) ~130 km east of Ibadan, 250 km from Lagos in Osun State, South West Nigeria. Participants completed a face-to-face survey in local dialect. We used a questionnaire to assess demographics, health status, income, medical expenditures, doctor visits and cancer screening history. Results We enrolled 346 individuals: with median age of 52 years and 75% women. Of the entire cohort, 4% had medical insurance. 46% reported a major medical cost in the last year. Cancer screening activities were infrequent in eligible participants: 1.5% reported having had cervical cancer screening, 3.3% mammogram and 5% colonoscopy screening. Cancer screening assessment was less frequent in those with less income and lower education levels. Using a multivariable logistic regression model including personal income, insurance status and education, higher personal income was associated with more cancer screening activity (OR 2.7, 95% CI 1.3 to 5.7, p<0.01). Despite this, most individuals had contact with a primary healthcare doctor (52% in the last year), and over 70% access to radio and TV suggesting the opportunity to expand community-based screening interventions and awareness exists. Conclusions Despite national increases in cancer cases, we highlight a deficiency in cancer screening and universal healthcare coverage within a community-based adult Nigerian population. Subject to availability of governmental resources, increasing financial risk protection, awareness and targeted resource allocation may help expand access in Nigeria.

Secondary analyses to test the impact on inequalities and uptake of the schools-based human papillomavirus (HPV) vaccination programme by stage of implementation of a new consent policy in the south-west of England

Objectives To test the impact on inequalities and uptake of the schools-based human papillomavirus (HPV) vaccination programme by stage of implementation of a new policy providing additional opportunities to consent. Setting Two local authorities in the south-west of England. Participants Young women (n=7129) routinely eligible for HPV vaccination aged 12–13 years during the intervention period (2017/2018 to 2018/2019 programme years). Interventions Local policy change that included additional opportunities to provide consent (parental verbal consent and adolescent self-consent). Outcomes Secondary analyses of cross-sectional intervention data were undertaken to examine uptake by: (1) receipt of parental written consent forms and; (2) percentage of unvaccinated young women by stage of implementation. Results During the intervention period, 6341 (89.0%) eligible young women initiated the HPV vaccination series. Parental written consent forms were less likely to be returned where young women attended alternative education provider settings (p<0.001), belonged to non-white British ethnic groups (p<0.01) or more deprived quintiles (p<0.001). Implementation of parental verbal consent and adolescent self-consent reduced the percentage of unvaccinated young women from 21.3% to 16.5% (risk difference: 4.8%). The effect was greater for young women belonging to the most deprived compared with the least deprived quintile (risk difference: 7.4% vs 2.3%, p<0.001), and for young women classified as Unknown ethnic category compared with white British young women (6.7% vs 4.2%, p<0.001). No difference was found for non-white British young women (5.4%, p<0.21). Conclusions Local policy change to consent procedures that allowed parents to consent verbally and adolescents to self-consent overcame some of the barriers to vaccination of young women belonging to families less likely to respond to paper-based methods of gaining consent and at greater risk of developing cervical cancer. Trial registration number 49 086 105.

Symptom appraisal, help-seeking and perceived barriers to healthcare seeking in Uganda: an exploratory study among women with potential symptoms of breast and cervical cancer

Objective We assessed the process of recognising abnormal bodily changes, interpretations and attributions, and help-seeking behaviour among community-based Ugandan women with possible symptoms of breast and cervical cancer, in order to inform health interventions aiming to promote timely detection and diagnosis of cancer. Design Qualitative in-depth interviews. Setting Rural and urban communities in Uganda. Participants Women who participated in the African Women Awareness of CANcer cross-sectional survey who disclosed potential breast and cervical cancer symptoms were eligible; recruitment was purposive. Interviews were conducted in women’s homes, lasted between 40 and 90 min, were audio-recorded, transcribed verbatim and translated to English. Thematic analysis was used to identify themes and subthemes, underpinned by the conceptual framework of the Model of Pathways to Treatment. Results 23 women were interviewed: 10 had potential symptoms of breast cancer and 13 of cervical cancer. Themes regarding symptom appraisal and help-seeking included the: (1) detection and interpretation of abnormal bodily sensations; (2) lay consultations regarding bodily changes; (3) iterative process of inferring and attributing illnesses to the bodily changes; (4) restricted disclosure of symptoms to lay people due to concerns about privacy and fear of stigmatisation; (5) help-seeking from multiple sources including both traditional and biomedical health practitioners, and (6) multiple perceived barriers to help-seeking including long waiting times, lack of medicines, absenteeism of healthcare professionals, and lack of money for transport and medical bills. Conclusion Women with potential symptoms of breast and cervical cancer undergo complex processes of symptom interpretation, attributing symptoms or inferring illness, and lay consultations before undertaking help-seeking and management. Increasing community understanding of breast and cervical cancer symptoms, and tackling perceived barriers to health-seeking, could lead to prompt and appropriate symptom appraisal and help-seeking, and contribute to improving cancer outcomes.

Prevalence of human papillomavirus in Wenzhou, China: a cross-sectional study of 127 938 outpatient women

Objectives Understanding the prevalence and genotype distribution of human papillomavirus (HPV) is critical for managing HPV vaccination programmes. Using a retrospective cross-sectional study, we examined long-term trends of HPV prevalence in Wenzhou, a coastal city in China. Setting and participants Cervical exfoliated cells were collected from 127 938 women who underwent cervical cancer screening at the gynaecology outpatient clinic of Wenzhou People’s Hospital from January 2011 to December 2020. HPV infections and genotypes were determined. The HPV genotypes were 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 6, 11, 42, 43, 44 and 81. From 2011 to 2014, we used PCR and inflow hybridisation for typing assays. In 2015–2020, HPV genotyping was performed on the collected specimens using PCR and flow fluorescence hybridisation. Results The overall prevalence of HPV infection was 17.8%. Across age groups, the prevalence fluctuated between 15.9% and 37.4%, with two peaks in the ≤20 and ≥51 year groups. The annual prevalence varied between 12.2% and 28.8%, with a significant decrease in 2011–2018 and a flat trend in 2018–2020. The five most common HPV genotypes were HPV52 (3.6%), 16 (3.0%), 58 (2.5%), 53 (1.9%) and 81 (1.3%). The prevalence of high-risk gene subtypes HPV56, 59 and the low-risk subtype HPV44 increased. Single HPV infection was the most common. Conclusion The prevalence of HPV in Wenzhou is low to mid-range; however, the high-risk genetic subtypes HPV56 and 59 have increased in recent years. We need to promote HPV vaccination and increase education regarding safer sex.

Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy

Objective To explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a ‘screen-and-treat’ strategy for HPV-positive women in low-resource settings. Design Prospective study of diagnostic accuracy. Setting The study took place in West Cameroon between September 2018 and March 2020. Participants 2014 women were recruited. Asymptomatic, non-pregnant women aged 30–49 years without history of CIN treatment, anogenital cancer or hysterectomy were eligible. Interventions Participants performed self-sampling for HPV testing with GeneXpert followed by visual inspection with acetic acid and Lugol’s iodine (VIA) triage before treatment if required. Main outcome measures Liquid-based cytology, biopsies and endocervical brushing were performed in HPV-positive women as quality control. We assessed the detection rate of CIN2+ by HPV genotyping (two pools of genotypes obtained from the Xpert system, pool_1 (HPV 16, 18, 45) and pool_2 (HPV 16, 18, 45, 31, 33, 35, 52, 58)), VIA and cytology. Results 382 (18.2%) women were HPV-positive among which 11.5% (n=44) were CIN2+. Of those 44 participants, 41 were triaged positive by extended genotyping, versus 35 by VIA and 33 by cytology. Overall, triage positivity was of 68.4% for extended genotyping, 59.3% for VIA and 14.8% for cytology, with false positive rates of 83.4%, 84.1% and 37.7%, respectively. Extended genotyping had a higher sensitivity for CIN2+ detection (93.2%, CI: 81.3 to 98.6) than VIA (79.5%, CI: 64.7 to 90.2, p=0.034) and cytology (75.0%, CI: 59.7 to 86.8, p=0.005). No significant difference was observed in the overtreatment rate in triaged women by extended genotyping or VIA (9.9%, CI: 8.6 to 11.3, and 8.8%, CI: 7.7 to 10.1), with a ratio of 6.0 and 6.3 women treated per CIN2+ diagnosed. Conclusion Triage of HPV-positive women with extended HPV genotyping improves CIN2+ detection compared with VIA with a minor loss of specificity and could be used to optimize the management of HPV-positive women. Trial registration number NCT03757299 .

Barriers and facilitators to cervical cancer screening for women from culturally and linguistically diverse backgrounds; a qualitative study of GPs

Objective To explore general practitioners’ (GPs) perspectives on the barriers and facilitators to cervical cancer screening (CCS) for women from culturally and linguistically diverse (CALD) backgrounds. Design Qualitative descriptive study involving semi-structured interviews, with interview guide informed by the Theoretical Domains Framework. Setting Adelaide, South Australia. Participants Twelve GPs with experience in providing CCS to women from CALD backgrounds participated. Results Four main themes emerged: ‘importance of clinician–patient relationship’, ‘patients’ cultural understanding regarding health care and CCS’, ‘communication and language’ and ‘health system related’. Each theme had several subthemes. GPs’ professional relationship with their patients and repeated advice from other clinicians, together with the provision of opportunistic CCS, were described as facilitators, and encompassed the theme of ‘importance of clinician–patient relationship’. This theme also raised the possibility of self-collection human papilloma virus tests. Lack of awareness and knowledge, lower priority for cancer screening and patients’ individual circumstances contributed to the theme of ‘patients’ cultural understanding regarding health care and CCS’, and often acted as barriers to CCS. ‘Communication and language’ consisted of language difficulties, interpreter use and use of appropriate resources. Language difficulties were a barrier to the provision of CCS, and GPs used interpreters and written handouts to help overcome this. The theme of ‘health system related’ involved the increased time needed for CCS consults for CALD women, access to appointments, funding, health promotion and effective use of practice management software. Conclusions This study highlights that multiple, inter-related barriers and facilitators influence CALD women’s engagement with CCS, and that GPs needed to manage all of these factors in order to encourage CCS participation. More efforts are needed to address the barriers to ensure that GPs have access to appropriate resources, and CALD patients have access to GPs they trust.

Utilisation of cervical cancer screening and factors associated with screening utilisation among women aged 30–49 years in Mertule Mariam Town, East Gojjam Zone, Ethiopia, in 2021: a cross-sectional survey

Objective To assess the practice of cervical cancer screening and its associated factors among women aged 30–49 years. Design Community-based cross-sectional survey. Setting Mertule Mariam Town, Northwest Ethiopia, 1 May–20 June 2021. Participants Women aged 30–49 years who were living in the study area were eligible for inclusion. A systematic random sampling technique was used to select study participants. A total of 488 respondents participated in the study. Data were collected by using interviewer-administered structured questionnaires. Data were entered into EpiData V.3.1 and then exported to SPSS V.25 for analysis. Bivariable and multivariable logistic regression analyses were done. Outcome measures Prevalence of cervical cancer screening and factors associated with screening utilisation. Results The prevalence of cervical cancer screening was found to be 14.1%. Age (≤16 years) at first sexual intercourse (adjusted OR 14.89, 95% CI 6.21 to 35.74), history of sexually transmitted disease (11.65, 4.56 to 29.78), having multiple sexual partners (11.65, 4.56 to 29.78), having good knowledge about cervical cancer screening (4.72, 2.33 to 9.56) and having a family history of cervical cancer (4.72, 2.33 to 9.56) were statistically significantly associated factors for utilisation of cervical cancer screening. Conclusion Utilisation of cervical cancer screening was low in Northwest Ethiopia. Educational status, age at first sexual intercourse, history of multiple sexual partners, sexually transmitted disease, family history of cervical cancer and knowledge about cervical cancer screening were significant factors for utilisation of cervical cancer screening.

Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE

IntroductionCervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is based on the detection of HPV infections. For many reasons including lower adherence to CCS, underserved women are more likely to develop CC, and die from it. We aim to demonstrate that the use of incentives could improve screening rates among this population.Methods and analysisOur cluster randomised, controlled trial will include 10 000 women aged 30–65 years eligible for CCS, living in deprived areas in four French departments, two mainlands and two overseas, and who did not perform physician-based HPV testing within the framework of the nationally organised screening programme. HPV self-sampling kit (HPVss) will be mailed to them. Two interventions are combined in a factorial analysis design ending in four arms: the possibility to receive or not a financial incentive of €20 and to send back the self-sampling by mail or to give it to a health professional, family doctor, gynaecologist, midwife or pharmacist. The main outcome is the proportion of women returning the HPVss, or doing a physician-based HPV or pap-smear test the year after receiving the HPVss. 12-month follow-up data will be collected through the French National Health Insurance database. We expect to increase the return rate of HPV self-samples by at least 10% (from 20% to 30%) compared with the postal return without economic incentive.Ethics and disseminationEthics approval was first obtained on 2 April 2020, then on July 29 2022. The ethics committee classified the study as interventional with low risk, thus no formal consent is required for inclusion. The use of health insurance data was approved by the Commission Nationale Informatique et Libertés on 14 September 2021 (ref No 920276). An independent data security and monitoring committee was established. The main trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04312178.

Performance of HPV testing, Pap smear and VIA in women attending cervical cancer screening in Kilimanjaro region, Northern Tanzania: a cross-sectional study nested in a cohort

Objective There is a concern about performance of the screening approaches, where information on the quality of novel and affordable screening approaches that will perform well in remote areas is warranted. This lack of information makes it difficult to prioritise resource use in efforts to improve cervical cancer outcomes. We aimed to compare the diagnostic value of human papillomavirus (HPV) testing on self-collected samples, Pap smear and visual inspection of the cervix with acetic acid (VIA) tests for detection of high-grade cervical intraepithelial neoplasia or worse (CIN2+). Design A combined cross-sectional and cohort study. Setting Three primary healthcare centres in Kilimanjaro region, Tanzania. Participants 1620 women undergoing cervical cancer screening from December 2018 to September 2021. Inclusion criteria were being aged 25–60 years, and no history of premalignant or cervical cancer. Exclusion criteria were overt signs of cancer and previous hysterectomy. Interventions Participants underwent HPV self-sampling with Evalyn Brush and Care HPV kit assay was used to determine prevalence of high-risk HPV infection. Women with positive HPV test were together with a random sample of HPV negative women scheduled for follow-up where VIA was performed, and Pap smear and cervical biopsies obtained. Results Of 1620 women enrolled, 229 (14.1%) were HPV positive and 222 of these attended follow-up together with 290 (20.8%) women with negative HPV test. On VIA, 17.6% were positive. On Pap smear, 8.0% were classified as high-grade squamous intraepithelial lesion. The sensitivity and specificity, respectively, of the various tests, compared with histopathology for the detection of CIN2+ were: HPV test 62.5%, 59.3%; Pap smear 82.8%, 82.1% and; VIA 48.4%, 56.8%. When combined, the sensitivity and specificity for HPV and Pap smear were 90.6%, 70.6% while HPV and VIA were 65.6% and 75.5% for the detection of CIN2+. Conclusions The performance of care HPV testing on self-collected samples opens the possibility of increasing coverage and early detection in resource-constrained settings.

Comparison of primary cytology, primary HPV testing and co-testing as cervical cancer screening for Chinese women: a population-based screening cohort

Objectives We compared clinical performance of three strategies of primary human papillomavirus (HPV) testing, primary cytology and co-testing for cervical cancer screening. Design A population-based prospective cohort study of clinical performance of screening strategy. Setting Patients recruited from community in Changzhi County, Shanxi Province, China. Patient 3209 women aged 30–64 years without gynaecological issues. Primary and secondary outcome measures The performance of different screening strategies for detecting cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). Results A total of 53 CIN2+ and 31 CIN3+ cases are detected. For CIN2+, sensitivity of primary HPV (95.9%) and co-testing (98.0%) are not statistically different, but significantly higher than primary cytology (48.0%). Specificity (86.8%), colposcopy referral rate (7.8%) and number of colposcopies required to detect one case (9.8) for primary HPV are better than co-testing (79.8%, 11.9%, 14.3%, respectively). For CIN3+, primary HPV, co-testing have 100% of sensitivity and specificity, which is significantly higher than primary cytology (56.7% and 90.2%). Number of colposcopies required to detect one case for primary HPV (15.9) is better than co-testing (23.8). Conclusions Compared with co-testing, HPV primary screening had comparable sensitivity and higher specificity for CIN2+ detection, and both of them showed better performance than cytology primary screening in cervical cancer screening.

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Objective To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe. Design Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study. Setting ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain. Participants Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021. Primary and secondary outcome measures Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS). Results A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3). Conclusions Patients had poor clinical outcomes with a median OS of <1 year and rwPFS of approximately 7 months, highlighting the significant unmet medical need in pretreated recurrent/advanced endometrial cancer patients. Novel therapies with potential to improve PFS and OS over conventional therapies could provide significant clinical benefit.

Profiling the real-world management status of high-risk human papillomavirus infection: a protocol to establish a prospective cohort of high-risk human papillomavirus-infected women in Lueyang County, China

Introduction Persistent infection with high-risk human papillomavirus (hrHPV) is the main cause of cervical cancer. Thus, the effective treatment against HPV represents an opportunity to reduce the incidence of cervical cancer. Although various treatments are effective in treating HPV infection, they still provide limited benefit in reducing the rate of cervical cancer due to the lack of implementation of a standardised protocol in many low/middle-income areas. This proposed cohort study aims to describe the status quo of treatment, attributions of the treatment decision-making process and potential factors influencing treatment decisions. Methods and analysis This is a mixed-method, 5-year prospective longitudinal study in Lueyang County, China, one of the areas with the highest cervical cancer incidence rates and lowest mean income in China. We will enrol women with hrHPV infection (at least one HPV type in the 13 high‐risk subtypes) diagnosed via a county-wide HPV infection and cervical cancer screening programme. The study procedures describe the treatment patterns and explore the potential influencing factors in treatment decision-making through questionnaires, laboratory examinations and in-depth interviews. All participants will be evaluated at baseline and at 6, 12, 24, 36, 48 and 60 months. The primary outcome is the treatment pattern, the type and duration of which will be described later. The secondary outcomes include guideline compliance and changes in the HPV infection status. The HPV impact profile, intimate relationship satisfaction, and costs within different management groups are also described and compared. Ethics and dissemination This study was reviewed, and all of the relevant approvals were obtained from the Ethics Committee of the Maternity Service Centre of Lueyang Maternal and Child Health Care Hospital (2021-001). The findings from this study will be disseminated through peer-reviewed publications, conference presentations and academic workshops. Trial registration number ChiCTR2100053757.

Acceptability of text messages and knowledge change for cervical cancer screening: a Tanzanian mixed methods study

ObjectivesTo investigate the acceptability of a text message intervention and evaluate if text messages could increase knowledge of cervical cancer and screening.DesignThis study was a substudy of a randomised controlled trial that used a mixed methods research design combining a quantitative questionnaire dataset and qualitative interview data. A before and after assessment was made of questionnaire responses. Acceptability was measured on a 6-point Likert scale and knowledge was measured through 16 binary true/false knowledge questions concerning cervical cancer and screening. Qualitative data were coded using a combined inductive–deductive approach.SettingOcean Road Cancer Institute in Dar es Salaam as well as Kilimanjaro Christian Medical Center and Mawenzi Regional hospital in the Kilimanjaro Region in Tanzania.ParticipantsHuman papillomavirus (HPV) positive women who had been randomised to the intervention group and received educative and reminder messages. Qualitative interviews were conducted with a subgroup of women in the intervention group.Interventions15 one-way educative and reminder text messages.ResultsA total of 115 women in the intervention group responded to both the baseline and follow-up questionnaire. Overall, women found it highly acceptable to receive text messages, and there was a trend towards acceptability rising between baseline and follow-up (mean: 0.22; 95% CI 0.00 to 0.44; p=0.05; t-statics=1.96). A significant increase in acceptability was found among the lowest educated and those who had not previously been screened. The qualitative interviews showed that the underlying reasons for the high acceptability rate were that the women felt someone cared for them and that the text messages were for their own benefits. The text messages did not improve the women’s knowledge on cervical cancer and screening.ConclusionsEducative and reminder text messages are highly acceptable among HPV-positive Tanzanian women; however, they do not increase the women’s knowledge of cervical cancer and screening.Trial registration numberclingov (NCT02509702).

Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I–IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study

Introduction Nowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m ( 99m Tc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over 99m Tc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of 99m Tc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging. Methods and analysis We initiated a prospective non-inferiority study with a paired comparison of both SLN methods in a single sample of 101 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA–IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with 99m Tc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures. Ethics and dissemination The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21–014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations. Trial registration number NL9011 and EudraCT 2020-005134-15.

Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol

Introduction Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear. Methods WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(−) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6–12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records. Analysis We will calculate point prevalence and prevalence of 6–12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p<0.05) using Fisher’s exact or Pearson χ2 test. Differences in geometric mean titres and seropositivity will be tested for statistical significance using the Mann-Whitney and Fisher’s exact tests, respectively. Ethics and dissemination The study was approved by the Albert Einstein College of Medicine Institutional Review Board and the Rwanda National Ethics Committee. Results will be disseminated through publication in peer-reviewed journals.

Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis

Introduction The management of women with clinical early-stage cervical cancer and lymph node involvement detected intraoperatively is heterogeneous and controversial. This paper presents the protocol of a systematic review and meta-analysis regarding the management of this specific population of patients. This proposed study aims to answer the question: does completion of radical hysterectomy improve the oncological outcomes of women with clinical early-stage cervical cancer and intraoperatively detected nodal involvement? Methods and analysis This protocol is drafted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines, and the proposed study will be conducted in accordance with the standard guidelines of ‘Preferred Reporting Items for Systematic Reviews and Meta-Analyses’ and ‘Meta-analysis of Observational Studies in Epidemiology reporting guideline’. Comprehensive literature searches will be performed in PubMed, Embase, Scopus, and Web of Science. The screening of the eligible studies, the extraction of data of interest, and the quality assessment of the included studies will all be independently performed by different members of our team. The primary outcome of this proposed study will be comparing the risk of recurrence or death from cervical cancer and the risk of all-cause death in patients with two different treatments (completion of radical hysterectomy or abandonment of radical hysterectomy); the secondary outcome of this proposed study will be comparing the risk of the grade 3/4 toxicities associated with the two types of management. Given the clinical heterogeneity among the included studies, data on outcomes will be pooled by random-effects models. Heterogeneity will be evaluated using the I2 statistic. The risk of bias for the included studies will be evaluated using the Newcastle-Ottawa Scale or the Cochrane collaboration’s tool. The grade of evidence will be evaluated by two independent members of our team using the Grading of Recommendations, Assessment, Development and Evaluations approach. Ethics and dissemination Ethical approval is not required because there will no primary data collected. The findings of this proposed study will be published in an international peer-reviewed journal. PROSPERO registration number CRD42021273527.

Global trends and age-specific incidence and mortality of cervical cancer from 1990 to 2019: an international comparative study based on the Global Burden of Disease

Objective To describe the trends of incidence and mortality of cervical cancer in different age groups and regions from 1990 to 2019. Design An international comparative study based on the Global Burden of Disease (GBD) study estimates. Participants Data were publicly available and individuals were not involved. Methods We collected detailed information on cervical cancer from the GBD study between 1990 and 2019. Average annual percentage changes (AAPCs) of age-standardised incidence and mortality rate (ASIR and ASMR) in cervical cancer, by age group and region, were calculated to quantify the temporal trends. Results Globally, the absolute numbers of incident cases and deaths were increasing, with the most cervical cancer cases and deaths being reported in China, India and Brazil. Although the ASIR and ASMR have declined overall from 1990 to 2019, an increasing or stable trend was also observed in East Asia and Southern sub-Saharan Africa. Particularly, we found that the age-specific AAPC of incidence showed an increasing trend in the age group of 15–49 years globally, and the high Sociodemographic Index region increased the most. Conclusions Cervical cancer remains a concerning disease that affects women all over the world, although the ASIR and ASMR are decreasing. Efforts to control the younger trend and to reduce the disparity between regions are imminent.

Performance of HPV E4 and p16 INK4a biomarkers in predicting regression of cervical intraepithelial neoplasia grade 2 (CIN2): protocol for a historical cohort study

Introduction Cervical intraepithelial neoplasia grade 2 (CIN2) represents a spectrum of lesions with variable progression and regression. Pathological diagnosis of CIN2 is subjective and poorly reproducible. Accurate diagnosis and identification of different patterns of CIN2 related to outcome are essential to reduce the risks of overtreatment or undertreatment. It is important to explore novel methods for risk stratification of CIN2 to enable targeted treatment of women at high risk of progression or persistent disease and follow-up of women at low risk. The combination of the novel biomarker human papillomavirus (HPV) E4 with p16 INK4a targets steps in the transition from a productive oncogenic HPV infection (CIN1) to a transformed lesion (CIN3) within CIN2. Previous cross-sectional studies suggest that HPV E4 combined with p16 INK4a may be valuable for risk assessment of CIN2. However, data on HPV E4/p16 INK4a as a predictor for CIN2 regression is lacking. Methods and analysis We will conduct a historical cohort study including 500 women aged 23–40 years with a first CIN2 diagnosis in Aarhus, Denmark during 2000–2010. Women will be eligible if they have undergone active surveillance and have no previous record of hysterectomy, cone biopsy, and CIN2 or worse. Women will be randomly selected through the Danish Pathology Databank. Tissue samples from women included will be sectioned for p16 INK4a and HPV E4 immunohistochemical staining in addition to conventional hematoxylin and eosin (H&E) staining. A positive result will be defined as HPV E4 positive. Through the Danish Pathology Databank, we will collect results on all subsequent cervical biopsies. Regression will be used as the primary outcome. Ethics and dissemination The study has been approved by the Ethical Committee in Central Denmark Region (1-10-72-60-20) and registered at the Faculty of Health, Aarhus University. Results will be published in a peer-reviewed journal and presented at scientific meetings. Trial registration number NCT05049252 .

Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol

Introduction High-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high-grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive outpatient therapy for women with HSIL. Methods and analysis Patients with biopsy-confirmed HSIL histology are invited to participate in the study planned to be conducted at 47 sites in China and 25 sites in Ukraine, Russia and the European Union. The aim is to include at least 384 patients, which will be randomised to either Cevira or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low-grade squamous intraepithelial lesion. Primary endpoint is the proportion of the responders 6 months after first treatment. Secondary efficacy and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints of the Cevira device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira group will be enrolled in an open, long-term extension study for 6 months to collect additional efficacy and safety data (study extension endpoints). Ethics and dissemination The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations. Trial registration number NCT04484415 ; clinicaltrials.gov.

Social innovations to increase health coverage: evidence from a crowdsourcing contest in Ghana

Objectives Despite progress made to expand access to health service in Ghana, inequities still exist. Social innovations have been developed as community-engaged solutions to decrease inequities. Methods In partnership with a multistakeholder group, our social innovation team organised a crowdsourcing contest to identify health innovations in Ghana. Informed by a WHO-Special Programme for Research and Training in Tropical Diseases framework, we organised a six-stage crowdsourcing challenge. Results In all, 13 innovations were received in the contest, while 2 innovations were rejected after initial screening. The 11 innovations were reviewed by a panel of four independent expert judges. Inter-rated reliability index (kappa) was 0.86. Following the review of the average score, five top innovations were recognised. These submissions can be put into three main themes: technology and strengthening (eg, mHealth for cervical cancer screening, video directly observed therapy), inclusiveness and reaching the marginalised (people with disability and infertility) and data utilisation for project improvement (seasonal calendar to reduce morbidity and mortality of children under 5 for malaria, diarrhoea and pneumonia). Conclusion In conclusion, this study shows that solutions to local problems exist. Therefore, policymakers, the government and development partners should support the scale-up of such innovations.

Acceptability of extending HPV-based cervical screening intervals from 3 to 5 years: an interview study with women in England

Objectives The introduction of primary Human Papillomavirus (HPV) testing in the National Health Service (NHS) Cervical Screening Programme in England means the screening interval for 25–49 years can be extended from 3 to 5 years. We explored women’s responses to the proposed interval extension. Methods We conducted semi-structured phone/video interviews with 22 women aged 25–49 years. Participants were selected to vary in age, socioeconomics and screening history. We explored attitudes to the current 3-year interval, then acceptability of a 5-year interval. Interviews were transcribed verbatim and analysed using framework analysis. Results Attitudes to the current 3-year interval varied; some wanted more frequent screening, believing cancer develops quickly. Some participants worried about the proposed change; others trusted it was evidence based. Frequent questions concerned the rationale and safety of longer intervals, speed of cancer development, the possibility of HPV being missed or cell changes occurring between screens. Many participants felt reassured when the interval change was explained alongside the move to HPV primary screening, of which most had previously been unaware. Conclusions Communication of the interval change should be done in the context of broader information about HPV primary screening, emphasising that people who test negative for HPV are at lower risk of cell changes so can safely be screened every 5 years. The long time needed for HPV to develop into cervical cancer provides reassurance about safety, but it is important to be transparent that no screening test is perfect.

Human papillomavirus self-sampling for cervical cancer screening among women in sub-Saharan Africa: a scoping review protocol

Introduction Evidence shows that women in sub-Saharan Africa have high rates of cervical cancer (CC) mortality compared with women in high-income countries. Effective screening programmes have significantly reduced the burden of CC in high-income countries. Self-sampling for human papillomavirus testing (HPVSS) has been reported to increase the participation and engagement of women in CC screening. Before HPVSS can be introduced for CC screening there is a need to establish its acceptability among end-users to ensure the increase in CC screening rates. Here, we outline a protocol for a scoping review aimed at mapping literature on the use and acceptability of HPVSS for screening CC in sub-Saharan Africa to reveal gaps to guide future research and practice. Method The scoping review protocol was developed according to Arksey and O’Malley and Levac et al , and guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We will search Scopus, PubMed, Medline Ovid, Cochrane and Web of Science databases for evidence on the use and acceptability of HPVSS published between January 2011 and July 2021. We will also search grey literature in the form of dissertations/theses, conference proceedings, websites of international organisations such as the WHO, and relevant government reports reporting evidence on HPVSS programmes for screening CC among women in sub-Saharan Africa. Ethics and dissemination No ethical approval is needed for the study as it will not include animals or human participants. The results of the proposed scoping review will be disseminated electronically in peer-reviewed journals, in print and through conference presentations.

Concurrent chemoradiation and brachytherapy alone or in combination with nelfinavir in locally advanced cervical cancer (NELCER): study protocol for a phase III trial

Introduction In locally advanced cervical cancer, nodal, local and distant relapse continue to be significant patterns of relapse. Therefore, strategies to improve the efficacy of chemoradiation are desirable such as biological pathway modifiers and immunomodulating agents. This trial will investigate the impact of nelfinavir, a protease inhibitor that targets the protein kinase B (AKT) pathway on disease-free survival (DFS). Methods and analysis Radiosensitising effect of nelfinavir in locally advanced carcinoma of cervix is a single-centre, open-label, parallel-group, 1:1 randomised phase-III study. Patients aged over 18 years with a diagnosis of carcinoma cervix stage III are eligible for the study. After consenting, patients will undergo randomisation to chemoradiation and brachytherapy arm or nelfinavir with chemoradiation and brachytherapy arm. The primary aim of the study is to compare the difference in 3-year DFS between the two arms. Secondary aims are locoregional control, overall survival, toxicity and quality of life between the two arms. Pharmacokinetics of nelfinavir and its impact on tumour AKT, programmed cell death ligand 1, cluster of differentiation 4, cluster of differentiation 8 and natural killer 1.1 expression will be investigated. The overall sample size of 348 with 1 planned interim analysis achieves 80% power at a 0.05 significance level to detect a HR of 0.66 when the proportion surviving in the control arm is 0.65. The planned study duration is 8 years. Ethics and dissemination The trial is approved by the Institutional Ethics Committee-I of Tata Memorial Hospital, Mumbai (reference number: IEC/0317/1543/001) and will be monitored by the data safety monitoring committee. The study results will be disseminated via peer-reviewed scientific journals, and conference presentations. Study participants will be accrued after obtaining written informed consent from them. The confidentiality and privacy of study participants will be maintained. Trial registration number The trial is registered with Clinical Trials Registry-India (CTRI/2017/08/009265) and ClinicalTrials.gov ( NCT03256916 ).

Smoking cessation strategy in the national cervical cancer screening program (SUCCESS): study protocol for a pragmatic cluster randomised trial and process evaluation in Dutch general practice

Introduction Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of a stop smoking strategy delivered by trained practice assistants after the cervical smear, and to evaluate the implementation process. Methods and analysis The study is a two-arm, pragmatic cluster randomised trial, in Dutch general practice. Randomisation takes place 1:1 at the level of the general practice. Practices either deliver the SUCCESS stop smoking strategy or the usual care condition. The strategy consists of brief stop smoking advice based on the Ask-Advise-Connect method and is conducted by trained practice assistants after routine cervical cancer screening. The primary outcome is the performance of a serious quit attempt in the 6 months after screening. Secondary outcomes are 7-day point prevalence abstinence, reduction in the number of cigarettes per day and transition in motivation to quit smoking. Follow-up for these measurements takes place after 6 months. Analysis on the primary outcome aims to detect a 10% difference between treatment arms (0.80 power, p=0.05, using a one-sided test), and will be performed according to the intention to treat principle. The process evaluation will assess feasibility, acceptability and barriers or enablers to the strategy’s implementation. For this purpose, both qualitative and quantitative data will be collected via questionnaires and in-depth interviews, respectively, in both individual study participants and involved staff. Ethics and dissemination The Dutch Ministry of Health, Welfare and Sport approved of the trial after an advisory report from the Health Council (Nr. 2018/17). A licence was provided to conduct the study under the Population Screening Act. Study results will be disseminated through publications in peer-reviewed journals and conference presentations. Trial registration number NL5052 (NTR7451).

ABCD criteria to improve visual inspection with acetic acid (VIA) triage in HPV-positive women: a prospective study of diagnostic accuracy

Objectives A simple system for visual inspection with acetic acid assessment, named ABCD criteria, has been developed to increase accuracy for triaging of high-risk human papillomavirus (HPV)-positive women. This study aimed to determine the accuracy of ABCD criteria for the detection of histologically confirmed cervical intraepithelial neoplasia grade two or worse (CIN2+) in HPV-positive women living in a low-resource setting. Design Prospective study of diagnostic accuracy. Setting Cervical cancer screening programme based on a 3T-Approach (test, triage and treat) in the Health District of Dschang, West Cameroon. Participants Asymptomatic non-pregnant women aged 30–49 years were eligible to participate. Exclusion criteria included history of CIN treatment, anogenital cancer or hysterectomy. A total of 1980 women were recruited (median age, 40 years; IQR 35–45 years), of whom 361 (18.4%) were HPV-positive and 340 (94.2%) completed the trial. Interventions HPV-positive women underwent a pelvic examination for visual assessment of the cervix according to ABCD criteria. The criteria comprised A for acetowhiteness, B for bleeding, C for colouring and D for diameter. The ABCD criteria results were codified as positive or negative and compared with histological analysis findings (reference standards). Primary outcome measure Diagnostic performance of ABCD criteria for CIN2+, defined as sensitivity, specificity, negative and positive predictive values. Results ABCD criteria had a sensitivity of 77.5% (95% CI 61.3% to 88.2%), specificity of 42.0% (95% CI 36.5% to 47.7%), positive predictive value of 15.1% (95% CI 10.8% to 20.8%), and negative predictive value of 93.3% (95% CI 87.6% to 96.5%) for detection of CIN2 +lesions. Most (86.7%) of the ABCD-positive women were treated on the same day. Conclusions ABCD criteria can be used in the context of a single-visit approach and may be the preferred triage method for management of HPV-positive women in a low-income context. Trial registration number NCT03757299 .

Histopathological profile of cervical biopsies in northern Malawi: a retrospective cross-sectional study

Objectives According to the WHO (2014), cervical cancer is the second most common cancer in women globally. More than 85% of the global cervical cancer morbidity and mortality occur in low-income and middle-income countries and the highest risk region is in Eastern and Southern Africa. Malawi has the highest age-standardised rate of cervical cancer in the world. This study was carried out to determine the histopathological profile of cervical biopsies in a public tertiary hospital in Mzuzu, northern region of Malawi. Setting A public tertiary hospital in Mzuzu, northern region of Malawi. Participants This was a retrospective study of all cervical biopsy specimen reports received in a public tertiary hospital in northern Malawi over a period of 5 years from July 2013 to June 2018. Demographic, clinical and diagnostic data were obtained from original histopathology reports. Results A total of 500 cervical biopsy reports were reviewed during the study period. The mean age of the patients was 41.99±12.5. Age ranged from 15 to 80 years. Cervicitis accounted for 46.0% (n=162) of the total non-malignant lesions seen, followed by cervical intraepithelial neoplasm, at 24.4% (n=86) and endocervical polyp, at 20.5% (n=72). Squamous cell carcinoma (SCC) accounted for 15.6% (n=78) of the total cervical biopsies studied and 85.7% of all total malignant lesions. Adenocarcinoma and undifferentiated carcinoma were 8.8% and 4.4%, respectively of the total malignant diagnosis. All patients with malignant lesions had HIV. Conclusion Our study shows that cervicitis and SCC were most common among non-malignant and malignant cervical biopsies, respectively. Since the frequency of cervical cancer is high, there is a need to have well detailed national policies to be put in place to increase detection of preinvasive lesions in order to reduce the prevalence of cervical cancer.

Phase Ib study of durvalumab (MEDI4736) in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer (DECISION study): study protocol for a prospective open-label single-arm study

Introduction Concurrent chemoradiotherapy is considered the standard treatment strategy for locally advanced cervical cancer. Most recent reports indicate that patients with bulky tumours or adenocarcinoma subtypes have poorer local control. Carbon-ion radiotherapy (CIRT) with the concurrent use of chemotherapy has shown promising results in such cases of difficult-to-treat uterine cervical cancer. Programmed death-ligand 1 (PD-L1) upregulation was observed in tumour tissue samples from patients who had undergone CIRT. Thus, a combination of CIRT and anti-PD-L1 antibody may suppress metastasis by activating antitumour immune response, in addition to exhibiting strong local effects. Objective We will assess the safety and tolerability (primary endpoint) of the concomitant use of durvalumab, an anti-PD-L1 antibody, with CIRT and weekly cisplatin for locally advanced cervical cancer. Methods and analysis This study is a non-randomised, open-label, prospective phase 1b study. Up to 10 patients with histologically proven uterine cervical cancer at stage IIB, IIIA, IIIB, IIIC1 or IVA as per International Federation of Gynecology and Obstetrics (2018) staging will be enrolled. All patients will receive CIRT of 74.4 Gy relative biological effectiveness in 20 fractions over 5 weeks (four fractions per week). Weekly cisplatin at a dose of 40 mg/m 2 will be administrated up to five times. Durvalumab at a dose of 1500 mg/body will be administrated at weeks 2 and 6. Safety and tolerability will be evaluated based on the frequency of dose-limiting toxicities until 92 days after CIRT starts. Patients will be followed-up strictly as per the scheduled protocol for 1 year after CIRT initiation. Ethics and dissemination The Human Research Ethics Committees of QST Hospital (#C21-002) and Chiba University (#2021006) have approved this study protocol. The findings will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number Japan Registry of Clinical Trials (jRCT2031210083), registered on 12 May 2021.

Understanding facilitators and barriers to follow-up after abnormal cervical cancer screening examination among women living in remote areas of Romania: a qualitative study protocol

Introduction In 2020 in Europe, Romania had the second highest incidence and mortality rates of cervical cancer, after Montenegro. To address cervical cancer in the country, the Romanian government established a national cervical cancer screening programme in 2012. The programme provides free testing as well as free treatment in the event of cervical precancer diagnosis for women 25–64 years old with health insurance who are referred from a programme-registered general practitioner. Participation in screening, retesting and follow-up for detected precancerous lesions is suboptimal, thus reducing the overall effectiveness of the programme. Aim The overall aim of the study is to examine facilitators and barriers to cervical cancer screening follow-up after an abnormal cervical cancer screening examination among underserved women living in remote areas of Romania. We have the following specific research questions: (1) what are the knowledge, perspectives and experiences of women living in remote areas of Romania with cervical cancer screening and (2) what are the knowledge, perspectives and experiences of women living in remote areas of Romania with follow-up information and services after abnormal cervical cancer screening results. Method We will conduct an exploratory qualitative study using semi-structured interviews. Data analysis will be based on the thematic analysis outlined by Braun and Clarke. We will use QSR International’s NVivo V.12 as the qualitative data analysis software for both data management and analysis. Ethics and dissemination Study findings will inform recommendations for the Romania national policy for the cervical cancer screening programme, with a particular focus on underserved women living in remote areas with limited access to healthcare services. They will also be disseminated to relevant conferences and meetings. Ethics approval was obtained from Romania (Ref. 199/1501.2021 application no. 661/15.01.2021) and Norway (Ref. 12929853).

Impact of one and two human papillomavirus (HPV) vaccine doses on community-level HPV prevalence in South African adolescent girls: study protocol and rationale for a pragmatic before–after design

Introduction Vaccines against human papillomavirus (HPV) are the key to controlling cervical cancer in low/middle-income countries (LMICs) where incidence is highest, but there have been limited data from these settings on programme impact on HPV prevalence, and none in a population with endemic HIV infection. Furthermore, for many LMICs, the currently recommended two-dose schedule is difficult to deliver at scale, so there is mounting interest in a single-dose schedule. Methods and analysis The H uman Papillomavirus O ne and Two-Dose P opulation E ffectiveness Study is a hybrid impact evaluation of the national South African HPV vaccination programme, which has targeted grade 4 girls aged at least 9 years in public schools with two doses of vaccine since 2014, and a single-dose vaccine ‘catch-up’ programme delivered in one district in 2019. Impacts of both schedules on the prevalence of type-specific HPV infection will be measured using repeat cross-sectional surveys in adolescent girls and young women aged 17–18 years recruited at primary healthcare clinics in the four provinces. A baseline survey in 2019 measured HPV prevalence in the cohort who were ineligible for vaccination because they were already above the target age or grade under either the national programme or the single-dose programme in the selected district. HPV prevalence surveys are repeated in 2021 in the selected district, and in 2023 in all four provinces. We will calculate prevalence ratios to compare the prevalence of HPV types 16 and 18 in the single-dose (2021) and two-dose (2023) cohorts, with the vaccine-ineligible (2019) cohort. Ethics and dissemination The project was approved by the University of the Witwatersrand Human Research Ethics Committee (HREC #181005), and the University of New South Wales HREC (#181-005). Findings will be disseminated through peer-reviewed journals, scientific meetings, reports and community forums.

Timeliness of diagnosis of breast and cervical cancers and associated factors in low-income and middle-income countries: a scoping review

Objectives Addressing the barriers to early breast and cervical cancer diagnosis in low and middle-income countries (LMICs) requires a sound understanding and accurate assessment of diagnostic timeliness. This review aimed to map the current evidence on the time to breast and cervical cancer diagnosis and associated factors in LMICs. Design Scoping review. Sources MEDLINE (via PubMed), Cochrane Library, Scopus and CINAHL. Eligibility criteria Studies describing the time to diagnosis and associated factors in the context of breast and cervical cancer in LMICs published from 1 January 2010 to 20 May 2021. Study selection and data synthesis Two reviewers independently screened all abstracts and full texts using predefined inclusion criteria. The review was reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Evidence was narratively synthesised using predefined themes. Results Twenty-six studies conducted across 24 LMICs were included in the review, most (24/26) of which focused on breast cancer. Studies varied considerably in their conceptualisation and assessment of diagnostic time, events, intervals and delays, with a minority of the studies reporting the use of validated methods and tools. Patient-related intervals and delays were more frequently evaluated and reported than provider-related and health system-related intervals and delays. Across studies, there were variations in the estimated lengths of the appraisal, help-seeking, patient and diagnostic intervals for both cancers and the factors associated with them. Conclusions Despite the significant burden of breast and cervical cancer in LMICs, there is limited information on the timeliness of diagnosis of these cancers. Major limitations included variations in conceptualisation and assessment of diagnostic events and intervals. These underscore the need for the use of validated and standardised tools, to improve accuracy and translation of findings to better inform interventions for addressing diagnostic delays in LMICs.

Study protocol of the ACCESS trial: a randomised trial to evaluate the effectiveness of human papillomavirus testing by self-sampling in cervical cancer screening uptake and precancer detection

IntroductionRecently, the incidence of cervical cancer has increased in Japan, probably because of an interruption in human papillomavirus (HPV) vaccination and a low cervical cancer screening rate. There is a lack of evidence for self-sampling HPV testing as a cervical cancer screening tool in Japan. The Accelerating Cervical Cancer Elimination by Self-Sampling test trial aims to compare the effectiveness of screening using the self-sampling HPV test with that of routine screening concerning screening uptake and precancer detection.Methods and analysisThis trial has a single-municipality, open-label, parallel, superiority and randomised design. Approximately 20 000 women who have not undergone cervical cancer screening for at least 3 years will be assigned randomly to the self-sampling arm and the control arm using a 1:1 ratio. Participants assigned to the control arm will undergo routine cervical cancer screening (cytology test) provided by Ichihara City, while those assigned to the self-sampling arm will choose the routine screening or self-sampling HPV test. HPV tests will be performed using the cobas 8800 system (Roche Diagnostics, Rotkreuz, Switzerland). Participants who will undergo the self-sampling HPV testing will be recommended to undergo routine screening. The results of the cytology test and further tests, such as colposcopy and biopsy, will be collected and used for this trial. The risk ratio and risk difference in the proportion of participants with cervical intraepithelial neoplasia two or worse between the two arms will be calculated. The test for the null hypothesis (the detection rates are equal between the two arms) will be performed using Pearson’s χ2 test.Ethics and disseminationThis trial was approved by the Research Ethics Committees of the Chiba Foundation for Health Promotion and Disease Prevention and the collaborating research institutes. The results will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberjRCT1030200276. Pre-results.

ACCEPTANCE: protocol for a feasibility study of a multicomponent physical activity intervention following treatment for cervical cancer

Introduction Cervical cancer treatment can have life changing sequelae and be associated with poor short-term and long-term quality of life. Physical activity (PA; that is, bodily movement) is known to improve health outcomes and quality of life for cancer survivors, both physically and psychologically. To date, no interventions to increase PA following cervical cancer have been evaluated. This study aims to (1) determine the feasibility of conducting a PA intervention after cervical cancer and (2) to explore the acceptability of the programme and evaluation measures. Methods and analysis The design is a pre study and post study design. Thirty participants aged between 18 and 60 years from the Midlands region, UK, who have completed primary treatment for cervical cancer at least 6 months previously and do not meet the national PA guidelines will be recruited. Identification of potential participants will take place through the University Hospitals of Leicester National Health Service (NHS) Trust. Participants will receive an intervention focused on increasing PA through the provision of education, action planning, goal setting, problem solving and self-monitoring of PA behaviour, particularly steps per day. Device assessed PA and questionnaires will be completed at baseline, week 6, week 12 and week 24. Feasibility will be assessed in terms of recruitment, retention, attrition, completion of measures and intervention compliance, for which specific feasibility criteria have been established. The process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures. Ethics and dissemination Ethical approval has been granted by the West of Scotland Research Ethics Committee 1 for this study. Results will inform intervention refinement for the design of a definitive pilot trial. These results will be disseminated via peer-reviewed publications and international conferences while input from a patient and public involvement (PPI) group will inform effective ways to circulate results among the wider community. Trial registration number ISRCTN16349793 , Registered 30 September 2020.

NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands

Introduction The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1). Methods and analysis We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes <1 cm) requiring neoadjuvant chemotherapy will receive DC therapy alongside standard-of-care carboplatin/paclitaxel chemotherapy and interval cytoreductive surgery. The primary endpoint is immune response, and the secondary endpoints are the safety and feasibility of the treatment as well as clinical efficacy. Ethics and dissemination Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences. Trial registration number NCT05773859 ; EUCT number 2024-512353-24-01.

Towards personalised follow-up care in ovarian cancer using online remote PROMs monitoring: a study protocol of a feasibility trial

Introduction Ovarian cancer patients often experience persistent symptoms such as fatigue and pain, impacting their quality of life. Current follow-up care, focused primarily on recurrence detection, may not adequately address these symptoms and can be burdensome. This study evaluates the feasibility of remote monitoring using patient-reported outcome measures (PROMs) and measurements of weight and abdominal circumference as an alternative to standard hospital visits. We aim to assess feasibility (ie, usability and satisfaction) of this approach and identify implementation barriers and facilitators. Methods and analysis This study is a single-centre longitudinal observational pilot that uses both qualitative and quantitative data to evaluate the feasibility of an innovative remote monitoring system for ovarian cancer follow-up care (Controle op Afstand, CopA). It is accessible to both healthcare professionals in the electronic health record and patients through the patient portal. Instead of 3-monthly in-hospital visits, patients are invited to complete regular surveys assessing PROMS about symptoms and quality of life and home measurements of weight and abdominal circumference. Feasibility will be assessed by (1) analysing patient and healthcare professional (HCP) experiences with CopA with the Measurement Instrument for Determinants of Innovations questionnaire for HCPs, and the ‘Experienced Usability and Satisfaction with Self-monitoring in the Home Setting’ questionnaire for patients, (2) investigating implementation barriers and facilitators using qualitative method and (3) performing a process evaluation of the intervention, assessing components such as reach, fidelity and compliance, time to response and number of (tele)consultations during the study period. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic analysis. Ethics and dissemination This study was reviewed by the Ethics Committee of the Amsterdam University Medical Centre (METC 2022.0256) and exempted it from further review as this study was not subject to the Dutch Medical Research Involving Human Subject Act. Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public.

Disparities in adverse event perception between patients and healthcare providers in gynaecologic anticancer therapy: results from an observational web-based study in Japan

Objective To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals. Design Observational study using a web-based questionnaire. Participants Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled. Outcome measures AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs. Results Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing. Conclusions This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes. Trial registration number jRCT1040220088, Japan Registry of Clinical Trials (jRCT).

Effect of the index of consciousness 2 on intraoperative opioid dosage in ovarian cancer patients receiving neoadjuvant chemotherapy: a study protocol for a randomised controlled trial

Introduction For ovarian cancer patients undergoing preoperative Neoadjuvant Chemotherapy (NACT), the toxicity of chemotherapeutic agents may cause hepatic and renal function impairment, altered sensitivity of the central nervous system or abnormal pain perception thresholds. These changes can further affect the metabolism and efficacy of intraoperative anaesthetics. However, the optimal intraoperative opioid dosage regimen for this specific patient population remains unclear. Currently, nociceptive stimulation monitoring technology has achieved certain progress in guiding intraoperative opioid administration. Among this technology, the index of consciousness 2 (IOC2), as a representative monitoring indicator in this field, provides important references for optimising opioid dosage regimens. This trial will investigate the opioid requirements and patient outcomes in the anaesthetic management of ovarian cancer patients undergoing preoperative NACT guided by IOC2. Methods and analysis This prospective, single-blind, single-centre randomised controlled trial will randomly recruit 90 patients undergoing open ovarian cancer cytoreductive surgery under general anaesthesia, with equal numbers assigned to the control and experimental groups. The experimental group will adjust the remifentanil plasma target concentration based on the IOC2 value, while the control group will adjust according to the patients’ mean arterial pressure. The primary outcome will be intraoperative opioid use (calculated in morphine equivalents per hour). Secondary outcomes include the average intraoperative propofol dose, post-anaesthesia care unit (PACU)-related metrics (including extubation time, time to spontaneous eye opening and morphine consumption in PACU), pain levels at 4, 24 and 48 hours postoperatively, as well as the use of analgesics and antiemetics. Postoperative recovery quality will also be assessed, including time to first flatus, time to ambulation, length of hospital stay and the 24-hour Quality of Recovery-15 (QoR-15) score. Ethics and dissemination This study involves human participants and was approved by the Ethics Committee of the Jiangsu Cancer Hospital (ethics no: XJS-2024-017). Patients gave informed consent to participate in the study before taking part. The study results will be published in peer-reviewed journals and presented at relevant academic conferences. Trial registration number ChiCTR2400091897.