Giampaolo Pompeo

Implementation of a centralized HPV-based cervical cancer screening programme in Tuscany: First round results and comparison with the foregoing Pap-based screening programme

Objective To evaluate performance of the first round of HPV-based screening in Tuscany region and compare it with the prior round of Pap-based screening Setting Tuscany region of Italy, where HPV-based cervical cancer screening started in 2013, with a strong level of centralization screening tests at the Regional Laboratory for Cancer Prevention (ISPRO). Methods The transition from Pap- to HPV-based screening was initiated for older women and at 3 out of 12 Tuscany Local Health Units (LHUs). Data from the Florence and Grosseto LHUs (about 300,000 women) were analysed and performance screening indicators estimated. Results HPV-based indicators recorded good performance, with increased compliance vs. the Pap-based programme. We registered a substantial decrease in waiting times from sampling to test reporting, probably related to the centralization strategy. Since the screening protocol was the same and conducted at a single laboratory, we could hypothesize that the difference in HPV positivity (6.8% in Florence vs. 8.4% in Grosseto) was due to a real difference in HPV prevalence among women of the two LHUs. The transition to HPV-based screening led to a significant increase both in colposcopy referral rate (4.3% vs. 1.2%) and CIN2+ detection rate (8.3‰ vs. 3.4‰). Conclusions HPV-based is more effective in detecting high-grade precancerous and cancerous lesions than Pap-based screening and is characterized by an “anticipatory effect” in the detection of CIN2+ lesions. The transition from Pap-based to HPV-based screening programme should include increased resources dedicated to colposcopy services. Centralization in a laboratory with long experience in this field promotes efficiency of the screening process.

From the Daily Peer Review of Abnormal Pap Test Slides to the Monitoring of Individual and Laboratory Performances: 5 Years of Data Collection and New Potential (Key) Performance Indicators

ABSTRACTObjectivesThe Peer Review (PR) consists of the daily examination, by all cytologists, of Pap slides that resulted abnormal/difficult, in order to reach a consensus on the final diagnosis (FD). We explore data from 5 years (2017–2021) of PR to: (i) evaluate the agreement (both inter‐observer and versus FD) over time; (ii) identify new quality indicators.Methods5673 slides were submitted to PR and examined by an average of 8 cytologists (range: 4–13). The agreement between cytologists and between the individual diagnosis with FD were evaluated by Kappa (k) and weighted Kappa (wK) and compared between ‘experts’ and ‘less experienced’ readers.ResultsThe inter‐observer agreement showed a moderate agreement among readers (whole team k = 0.44; experts k = 0.48). The highest and the lowest agreement was reported in HSIL and ASC‐H, respectively. In 2018 and 2021, a significant reduction of kappa was observed, likely attributable to team turnover. The laboratory agreement versus FD resulted in significantly higher scores in experts (wk = 0.73, 95% CI 0.73–0.74) compared to less experienced individuals (wk = 0.65, 95% CI 0.64–0.66), with a general reduction of wk recorded in 2021. The individual agreement versus FD (calculated for 16 cytologists) achieved a moderate/substantial level of agreement (wK range: 0.57–0.80), with a shift toward higher wk in experts.ConclusionThe levels of agreement are influenced by cytologist experience and team turnover. We propose new potential (key) performance indicators to strictly monitor the occurrence of systematic differences in interpretation criteria among cytologists. The proposed reference values are based on preliminary data and should be validated prospectively over a longer monitoring period.

Thin‐layer cervical sample evaluation: Conventional light microscopy versus digital whole‐slide imaging

AbstractBackgroundWhole‐slide imaging (WSI) has been adopted in many fields of pathology for education, quality assurance, and remote diagnostics. In 2021, the College of American Pathologists (CAP) updated guidelines to support pathology laboratories regarding the WSI systems validation process. However, the majority of published literature refers to histopathology rather than cytology. The aim of this study was to compare conventional light microscopy (CLM) and WSI in thin‐layer cervical samples evaluation according to CAP guideline.MethodsA sample set of 64 thin‐layer cervical specimens from women 25–64 years old who participated in cervical cancer screening programs in Tuscany was distributed among five cytologists at Institute for Cancer Research, Prevention and Clinical Network (Florence, Italy) for CLM analysis. After 2 weeks, the corresponding 64 digitally scanned slides were available at several magnifications for WSI evaluation.ResultsSubstantial/near perfect agreement between CLM and WSI evaluation (0.77 ≥ κ ≥1) was observed for the negative for intraepithelial lesion or malignancy (NILM) class with concordance rates from 83.3% to 100%.Variability in concordance was observed among all the cytologists: 50%–85.7% for low‐grade squamous intraepithelial lesion (LSIL), 47.1%–100% for high‐grade squamous intraepithelial lesion (HSIL), 50%–100% for atypical glandular cells (AGCs) favors adenocarcinoma (ADK) with moderate/near perfect agreement (0.47 ≥ κ ≥1). Concordance and agreement rates were also variable within the “borderline” cytological categories of atypical squamous cells of undetermined significance (ASC‐US), atypical squamous cells cannot exclude an HSIL (ASC‐H), and AGCs with lower or not computable kappa for some readers. The overall intralaboratory concordance between CLM and WSI was 92.9% with a near perfect agreement (κ = 0.84) for NILM. Substantial agreement (κ ≥0.65) was assessed for LSIL, HSIL/squamous cell carcinoma, AGCs, and ADK categories whereas the agreement was lower (κ ≤0.39) for ASC‐US and ASC‐H.ConclusionsThis study showed an overall substantial/near perfect agreement between CLM and WSI for all the cytological categories except the “borderline” ASC‐US and ASC‐H. Further progress in cytology WSI systems are needed before introducing it in routine diagnostics.