Angelique Flöter Rådestad

Validation of data quality in the Swedish quality register of gynecologic cancer for cervical cancer and vulvar cancer—a Swedish gynecologic cancer group (Swe‐GCG) study

AbstractIntroductionPopulation‐based registers provide an important source of real‐world data. The growing number of large cohort studies using data from cancer registers makes validation of such registers important. The Swedish Quality Register of Gynecologic Cancer (SQRGC) is a nationwide population‐based register containing data on patient and tumor characteristics, treatment, and follow‐up. To ensure that the results from research and quality assurance reports using SQRGC data are robust and reliable, the accuracy and completeness of the register need to be validated. The aim of this study was to evaluate the quality of data on cervical cancer and vulvar cancer in the SQRGC.Material and MethodsQuality of data in the SQRGC was investigated by evaluating completeness, timeliness, comparability, and validity in accordance with recommendations from the International Agency for Research on Cancer and the national Swedish guidelines on validation of cancer registers. Completeness was evaluated by coverage relative to the Swedish National Cancer Register, and timeliness as the time from diagnosis until entry into the SQRGC. We randomly selected 276 women diagnosed with cervical cancer (n = 138) and vulvar cancer (n = 138) between 2014 and 2019 for validation. An external monitor manually re‐abstracted data on 10 core variables per sub‐register from the patients' medical records. Comparability was assessed by reviewing the adherence to international standards regarding coding. Validity was evaluated by the agreement between re‐abstracted data and original data in the SQRGC. Correlations were estimated using Pearson's correlation coefficient and Cohen's kappa coefficient.ResultsFor cervical cancer, the completeness was 99% and the timeliness was 87.1% within 12 months. The corresponding figures for vulvar cancer were 100% and 87.9%, respectively. Adherence to international coding standards was satisfactory. The median degree of agreement between re‐abstracted data and data in the SQRGC was 90.8% (range 73.2%–100%) for cervical cancer, and 85.4% (range 59.6%–98.2%) for vulvar cancer.ConclusionsThe data on cervical and vulvar cancer in the SQRGC are of adequate quality and may well be used for research and clinical purposes.

The impact of local symptoms on health‐related quality of life in vulvar cancer survivors—A nationwide prospective study

AbstractIntroductionVulvar cancer may cause serious local symptoms that may impact negatively on the woman's health‐related quality of life (HRQOL). However, knowledge about the prevalence of vulvar and lymphedema symptoms at diagnosis and during follow‐up is limited. The aim of this study was to evaluate the longitudinal development of vulvar and lymphedema symptoms as well as the trajectory of HRQOL in women with vulvar cancer. Furthermore, associations between vulvar symptoms and HRQOL were investigated.Material and MethodsIn this nationwide prospective cohort study, women completed validated patient‐reported outcome measures; the EORTC‐QLQ C30 and the EORTC‐QLQ‐VU34 at diagnosis, three, and 12 months post‐treatment. Mean scores of symptom‐ and functioning scales were calculated over time. Heatmaps were used to visualize proportional changes in the prevalence of symptoms at baseline and 12 months after treatment. Linear mixed‐effects models with patient‐specific random intercepts were specified to estimate changes in mean scores of HRQOL over time. Additionally, adjusted linear mixed‐effects models were applied to investigate the effect of the most prevalent vulvar symptom on HRQOL. The study has been registered at ClinicalTrials.gov (NCT 04152512).ResultsBetween 2019 and 2021, 153 women consented to participate in the study, and 140 (92%) completed the patient‐reported outcome measures at least once. In total, 105 (69%) completed the patient‐reported outcome measures at all three time points. The most prevalent reported symptom was itchy, irritated skin in the vulva, which decreased from 82% at diagnosis to 56% 12 months after treatment. All vulvar symptoms, except narrowing of the vaginal entrance, improved over time but persisted in large proportions of the women. Women with severe vulvar symptoms reported a significant decline in HRQOL. A deterioration of leg swelling symptoms was reported by 33% of the women. Emotional‐, role‐, social‐, and cognitive functioning, global and mental health improved significantly after treatment.ConclusionLocal vulvar symptoms were highly prevalent at diagnosis; however, as most aspects of HRQOL, they improved significantly during the first year of follow‐up. Severe vulvar symptoms were associated with impaired HRQOL. Symptoms of leg lymphedema increased after treatment. © 2025 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Anxiety and depression among women with newly diagnosed vulvar cancer – A nationwide longitudinal study

AbstractIntroductionOur objective was to investigate the trajectories of anxiety, depression, emotional and social functioning in women with newly diagnosed vulvar cancer from the time of diagnosis to 12 months after treatment. A further aim was to identify risk factors for high levels of anxiety.Material and methodsPROVE (PROspective Vulvar Cancer Evaluation) is a nationwide longitudinal cohort study investigating quality of life in women with newly diagnosed vulvar cancer by the following validated patient‐reported outcome measures at diagnosis, and 3 and 12 months after treatment: The Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Vulvar module VU34. Mean scores, changes over time and associations were analyzed by generalized estimated equations and log‐linear regression models, adjusted for possible confounders.ResultsBetween 2019 and 2021, 105 (69%) women completed the questionnaires at all three time points. At diagnosis, 42% of the women reported elevated anxiety levels, decreasing significantly to 30% during the first 12 months. Insomnia, persisting vulvar symptoms and high information needs were significantly associated with a high level of anxiety (relative risk [RR] 2.1, 95% CI 1.2–3.7 for insomnia; RR 2.8, 95% CI 1.7–4.6 for vulvar symptoms, RR 2.7, 95% CI 1.5–4.9 for information needs). We found a trend towards a higher level of anxiety in younger women (<65 years: RR 1.5, 95% CI 1.0–2.5). Participants reported a low and stable prevalence of depression (14%) and high social functioning throughout the study period.ConclusionsWomen with newly diagnosed vulvar cancer report a high level of anxiety at diagnosis. Despite a significant improvement, anxiety remains widely prevalent during the first year of follow‐up. Targeting insomnia, vulvar symptoms and unmet needs may decrease anxiety during surveillance.

Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer

The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.