Evidence map›Paper›PMID 29678360›Full record

Trial reportGynecologic oncology2018

Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study.

Mariam El-Zein, Sheila Bouten, Karolina Louvanto, Lucy Gilbert, Walter Gotlieb, Robert Hemmings, Marcel A Behr, Eduardo L Franco, CASSIS Study Group

Abstract readRandomized Controlled TrialValidation Study
PubMed Publisher
In one paragraph

Trial report in Gynecologic oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Guideline
  2. Comparison of Human Papillomavirus Genotyping by Research vs. Clinical Assay for Two Self-Collection Devices.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
    Trial
  3. A DNA methylation assay (MPap) using self-collected tampon versus cytology collection swab for endometrial cancer detection.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Article
  4. Observational
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. The IARC Perspective on Cervical Cancer Screening.The New England journal of medicine · 2021
    Article
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Mariam El-ZeinDivision of Cancer Epidemiology, McGill University, Montreal, Canada.
Sheila BoutenDivision of Cancer Epidemiology, McGill University, Montreal, Canada.
Karolina LouvantoDivision of Cancer Epidemiology, McGill University, Montreal, Canada.
Lucy GilbertGynecologic Cancer Service, McGill University Health Centre - Glen Site Cedars Cancer Centre, Montreal, Canada.
Walter GotliebDivision of Gynecologic Oncology and Colposcopy, McGill University - Jewish General Hospital, Montreal, Canada.
Robert HemmingsDepartment of Obstetrics and Gynecology, McGill University Health Centre - St Mary's Hospital Centre, Montreal, Canada.
Marcel A BehrDepartment of Microbiology, McGill University Health Centre, Montreal, Canada.
Eduardo L FrancoDivision of Cancer Epidemiology, McGill University, Montreal, Canada. Electronic address: eduardo.franco@mcgill.ca.
CASSIS Study Group
McGill University Health Centre · CAMcGill University · CAJewish General Hospital · CA

Funding

CIHR FDN-143347
6 · The paper itself

Abstract

objectiveWe compared the self-sampling performance of the newly designed HerSwab™ device with a physician-collected cervical sample and another self-sample using the cobas® PCR Female swab for the detection of cervical intraepithelial neoplasia (CIN) and cancer.

methodsWomen referred for colposcopy at McGill University affiliated hospital clinics collected two consecutive self-samples, one with HerSwab™ and one with cobas® swab, after receiving instructions. The order of sampling was randomized. The colposcopist then collected a cervical sample and conducted a colposcopic examination. Samples were tested for human papillomavirus (HPV) DNA. Sensitivity and specificity to detect CIN2+ and respective 95% confidence intervals (CI) were calculated to compare sampling approaches. The HPV testing agreement between samples was measured using the Kappa statistic.

resultsOf 1217 women enrolled, 1076 had complete results for HPV and cytology; 148 (13.8%) had CIN1, 147 (13.7%) had CIN2/3, and 5 (0.5%) had cancer. There was very good agreement between methods for HPV detection (HerSwab™ versus physician: kappa=0.84; cobas® swabs versus physician: kappa=0.81; HerSwab™ versus cobas® swabs: kappa=0.87). The sensitivity of HPV detection for CIN2+ was 87.6% (95%CI: 79.8-93.2) with self-sampling using HerSwab™, 88.6% (95%CI: 80.9-94.0) with self-sampling using the cobas® swab, and 92.4% (95%CI: 85.5-96.7) with physician sampling. Corresponding estimates of specificity were 58.1% (95%CI: 54.1-62.1), 55.0% (95%CI: 50.9-59.0) and 58.7% (95%CI: 54.6-62.6). Cytology (ASC-US or more severe) done on the physician-collected specimen was 80.2% (95%CI: 70.8-87.6) sensitive and 61.4% (95%CI: 57.2-65.5) specific for CIN2+.

conclusionsThe HerSwab™ had good agreement with physician sampling in detecting HPV, and adequate performance in detecting high-grade lesions among women referred to colposcopy for abnormal cytology.

Indexed as

AdultAgedFemaleHumansMiddle AgedPapillomaviridaePapillomavirus InfectionsSelf CareSpecimen HandlingUterine Cervical DysplasiaUterine Cervical NeoplasmsVaginal SmearsYoung AdultCervical cancerCervical intraepithelial neoplasiaCervical screeningHPV DNA testingSelf-sampling

Identifiers

PMID29678360
OpenAlexW2803094090

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.