Evidence map›Paper›PMID 27150161›Full record

Observational studyModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2016

p16/Ki-67 dual-stained cytology for detecting cervical (pre)cancer in a HPV-positive gynecologic outpatient population.

Roosmarijn Luttmer, Maaike G Dijkstra, Peter J F Snijders, Johannes Berkhof, Folkert J van Kemenade, Lawrence Rozendaal, Theo J M Helmerhorst, René H M Verheijen, W Abraham Ter Harmsel, W Marchien van Baal and 6 more

Abstract readComparative StudyMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Diagnostic Accuracy of p16Analytical cellular pathology (Amsterdam) · 2023
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. STMN1 and MKI67 Are Upregulated in Uterine Leiomyosarcoma and Are Potential Biomarkers for its Diagnosis.Medical science monitor : international medical journal of experimental and clinical research · 2020
    Article
  14. Article
  15. Evaluating the Performance of p16Cancer management and research · 2020
    Article
  16. Article
  17. Article
  18. Observational
  19. Article
  20. Evaluation of p16/Ki-67 dual-stained cytology as triage test for high-risk human papillomavirus-positive women.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Roosmarijn LuttmerDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Maaike G DijkstraDepartment of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, The Netherlands.
Peter J F SnijdersDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Johannes BerkhofDepartment of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
Folkert J van KemenadeDepartment of Pathology, Erasmus Medical Center, Rotterdam, The Netherlands.
Lawrence RozendaalDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Theo J M HelmerhorstDepartment of Obstetrics and Gynecology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
René H M VerheijenUMC Utrecht Cancer Center, Utrecht, The Netherlands.
W Abraham Ter HarmselRoosevelt Clinic, Leiden, The Netherlands.
W Marchien van BaalDepartment of Obstetrics and Gynecology, Flevo Hospital, Almere, The Netherlands.
Peppino G C M GraziosiDepartment of Obstetrics and Gynecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.
Wim G V QuintDDL Diagnostic Laboratory, Rijswijk, The Netherlands.
Johan W M SpruijtDepartment of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, The Netherlands.
Dorenda K E van DijkenDepartment of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Daniëlle A M HeidemanDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Chris J L M MeijerDepartment of Pathology, VU University Medical Center, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Women who test positive for a high-risk type of the human papillomavirus (HPV) require triage testing to identify those women with cervical intraepithelial neoplasia grade 3 or cancer (≥CIN3). Although Pap cytology is considered an attractive triage test, its applicability is hampered by its subjective nature. This study prospectively compared the clinical performance of p16/Ki-67 dual-stained cytology to that of Pap cytology, with or without HPV16/18 genotyping, in high-risk HPV-positive women visiting gynecologic outpatient clinics (n=446 and age 18-66 years). From all women, cervical scrapes (for Pap cytology, HPV16/18 genotyping, and p16/Ki-67 dual-stained cytology) and colposcopy-directed biopsies were obtained. The sensitivity of p16/Ki-67 dual-stained cytology for ≥CIN3 (93.8%) did neither differ significantly from that of Pap cytology (87.7%; ratio 1.07 and 95% confidence interval (CI): 0.97-1.18) nor from that of Pap cytology combined with HPV16/18 genotyping (95.1%; ratio 0.99 and 95% CI: 0.91-1.07). However, the specificity of p16/Ki-67 dual-stained cytology for ≥CIN3 (51.2%) was significantly higher than that of Pap cytology (44.9%; ratio 1.14 and 95% CI: 1.01-1.29) and Pap cytology combined with HPV16/18 genotyping (25.8%; ratio 1.99 and 95% CI: 1.68-2.35). After exclusion of women who had been referred because of abnormal Pap cytology, the specificity of p16/Ki-67 dual-stained cytology for ≥CIN3 (56.7%) remained the same, whereas that of Pap cytology (60.3%) increased substantially, resulting in a similar specificity of both assays (ratio 0.94 and 95% CI: 0.83-1.07) in this sub-cohort. In summary, p16/Ki-67 dual-stained cytology has a good clinical performance and is an interesting objective microscopy-based triage tool for high-risk HPV-positive women.

Indexed as

ImmunohistochemistryOutpatientsAdolescentAdultAgedCyclin-Dependent Kinase Inhibitor p16FemaleGenotypeHuman papillomavirus 16Human papillomavirus 18Human Papillomavirus DNA TestsHumansKi-67 AntigenMiddle AgedNetherlandsPapanicolaou TestCDKN2A protein, humanCyclin-Dependent Kinase Inhibitor p16Ki-67 Antigen

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Registered trials

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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.