ArticleCancer medicine2020
Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience.
Article in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
Who cites it
10 citing papers in PubMed, 14 citations in OpenAlex.
- Beyond HPV in Eastern Europe: Genotype Distribution, Molecular Biomarkers, Vaginal Microbiome, and Implications for Cervical Cancer Prevention.Life (Basel, Switzerland) · 2026Review
- Health care policy trial of primary human papillomavirus-based cervical screening in Denmark: Comparison of three triage algorithms.International journal of cancer · 2026Article
- HPV genotype-specific p16/Ki67 expression with machine learning-assisted assessment in cervical neoplasia.Frontiers in oncology · 2026Article
- Adjunctive role of p16/Ki-67 dual-stain cytology in colposcopy referral pathways for cervical precancer and persistent high-risk HPV infection.Frontiers in oncology · 2026Article
- p16/ki-67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.International journal of cancer · 2025Review
- Enhancing Cervical Cancer Screening: Review of p16/Ki-67 Dual Staining as a Promising Triage Strategy.Diagnostics (Basel, Switzerland) · 2024Review
- Clinical utility of p16/Ki67 dual-stain cytology for detection of cervical intraepithelial neoplasia grade two or worse in women with a transformation zone type 3: A cross-sectional study.BJOG : an international journal of obstetrics and gynaecology · 2023Article
- Cervical Carcinoma: Oncobiology and Biomarkers.International journal of molecular sciences · 2021Review
- Design, Synthesis, and Anticancer Screening for Repurposed Pyrazolo[3,4-d]pyrimidine Derivatives on Four Mammalian Cancer Cell Lines.Molecules (Basel, Switzerland) · 2021Article
- Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience.Cancer medicine · 2020Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmunocytochemical staining with p16/Ki67 has been suggested as a promising triage biomarker in cervical cancer screening. As dual staining is a subjective method, proper training may be required to ensure safe implementation in routine laboratories and reduce risk of misclassification. We determined concordance between novice evaluators and an expert, stratified by number of slides reviewed at three reading points.
methodsThe study was conducted at the Department of Pathology, Randers, Denmark. Women were eligible if they were aged ≥45, had been enrolled in one of two ongoing clinical studies, and had a dual stain slide available. Dual staining was performed using the CINtec plus assay. Slides were randomly selected from three reading points at which novice evaluators had reviewed <30, ~300, and ≥500 dual stain slides respectively. Level of concordance was estimated using Cohen's Kappa, κ.
resultsOf 600 eligible slides, 50 slides were selected for review as recommended by the manufacturer. Median age was 68 years (range: 58-74). Overall concordance was good (κ = 0.68, 95% confidence interval [CI]: 0.60-0.76), with an overall agreement of 84% (95% CI: 70.9%-92.8%). Concordance improved with increasing number of slides reviewed at a given reading point, from a moderate concordance (κ = 0.47, 95% CI: 0.05-0.90) after reviewing <30 slides to a good concordance (κ = 0.66, 95% CI: 0.20-0.88) and a very good concordance (κ = 0.88, 95% CI: 0.66-1.00) after reviewing ~300 and ≥500 slides, respectively.
conclusionsWhen interpreting dual stain slides from older women, concordance increased slightly as novice evaluators received more training and experience. Although further evaluation is warranted, these findings indicate that a significant amount of training and experience of novice evaluators may be needed to ensure accurate dual stain interpretation in this age group. Future studies should accurately describe training and experience of evaluators to enable a better comparison of concordance and diagnostic accuracy across studies.
trial registrationNCT04114968 and NCT04298957.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.