Evidence map›Paper›PMID 35686564›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2023

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.

Line Winther Gustafson, Mette Tranberg, Pia Nørgaard Christensen, Rikke Brøndum, Nicolas Wentzensen, Megan A Clarke, Berit Andersen, Lone Kjeld Petersen, Pinar Bor, Anne Hammer

Open access · hybridAbstract read
In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
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

13 citing papers in PubMed, 19 citations in OpenAlex.

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  11. Validation of an on-chip p16Scientific reports · 2023
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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

10 authors at 4 institutions in 2 countries.

Line Winther GustafsonUniversity Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.ORCID 0000-0003-4149-4708
Mette TranbergUniversity Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.
Pia Nørgaard ChristensenDepartment of Pathology, Randers Regional Hospital, Randers, Denmark.
Rikke BrøndumDepartment of Pathology, Randers Regional Hospital, Randers, Denmark.
Nicolas WentzensenClinical Genetics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.
Megan A ClarkeClinical Genetics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.
Berit AndersenUniversity Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.
Lone Kjeld PetersenDepartment of Obstetrics and Gynaecology, Odense University Hospital and Open Patient Data Explorative Network, Odense, Denmark.
Pinar BorDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Anne HammerDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.ORCID 0000-0002-4616-9827
Aarhus University · DKNational Cancer Institute · USRegional Hospital Randers · DKUniversity of Southern Denmark · DK

Funding

Cervical Cancer MoonshotZIACP010230 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI SCHIFFMAN, MARK · 2018 to 2025
$33.8M
A.P. Moller Foundation 18-L-0124Dagmar Marshalls FondElse and Mogens Wedell-Wedellsborgs FoundationFabricant Einar Willumsens MindelegatHealth Research Foundation of Central Denmark Region A3234Roche Diagnostics
6 · The paper itself

Abstract

objectiveTo evaluate the clinical utility of p16/Ki67 dual-stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3).

designCross-sectional study.

settingColposcopy clinics in Central Denmark Region. POPULATION: Women aged 45 years or older referred for colposcopy because of an abnormal screening test.

methodsAll women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ).

main outcome measureSensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology.

resultsOf 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology.

conclusionsDual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.

Indexed as

Papillomavirus InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsAgedColoring AgentsColposcopyCross-Sectional StudiesCyclin-Dependent Kinase Inhibitor p16FemaleHumansKi-67 AntigenMiddle AgedPapillomaviridaeVaginal SmearsColoring AgentsCyclin-Dependent Kinase Inhibitor p16Ki-67 Antigencervical intraepithelial neoplasiacolposcopyhuman papillomaviruslarge-loop excision of the transformation zoneliquid-based cytologyp16/Ki67 dual-stain cytologypostmenopausaltransformation zone type 3

Identifiers

PMID35686564
PMCPMC10084097
OpenAlexW4281615934

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.