Evidence map›Paper›PMID 33674367›Full record

ArticleBMJ open2021

Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study.

Dorthe Ørnskov, Kirsten Jochumsen, Pernille Husted Steiner, Ivan Moulun Grunnet, Annemette Wildfang Lykkebo, Marianne Waldstrøm

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In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
–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

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

6 authors.

Dorthe ØrnskovClinical Pathology, Sygehus Lillebalt Vejle Sygehus, Vejle, Denmark dorthe.oernskov@rsyd.dk.ORCID http://orcid.org/0000-0003-0218-7211
Kirsten JochumsenDepartment of Gynecology, Odense University Hospital, Odense, Denmark.
Pernille Husted SteinerDepartment of Gynecology, Sygehus Lillebalt Kolding Sygehus, Kolding, Denmark.
Ivan Moulun GrunnetDepartment of Gynecology, Odense University Hospital, Odense, Denmark.
Annemette Wildfang LykkeboDepartment of Gynecology, Sygehus Lillebalt Kolding Sygehus, Kolding, Denmark.
Marianne WaldstrømClinical Pathology, Sygehus Lillebalt Vejle Sygehus, Vejle, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS).

designCross-sectional study.

settingColposcopy clinic.

participantsWomen (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding.

interventionAll women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination. PRIMARY OUTCOME: Absolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS. SECONDARY OUTCOME: The acceptability by women of self-sampling.

resultsBoth the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI).The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar's test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar's test >0.05).The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample.

conclusionSelf-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

Indexed as

Papillomavirus InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsColposcopyCross-Sectional StudiesDNA, ViralEarly Detection of CancerFemaleHumansPapillomaviridaePregnancySensitivity and SpecificityVaginal SmearsDNA, Viralgynaecological oncologymolecular diagnosticspathologypublic health

Identifiers

PMID33674367
PMCPMC7939007

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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.