Evidence map›Paper›PMID 35115348›Full record

ArticleBMJ open2022

Study protocol of the ACCESS trial: a randomised trial to evaluate the effectiveness of human papillomavirus testing by self-sampling in cervical cancer screening uptake and precancer detection.

Misuzu Fujita, Minobu Shimazu, Kengo Nagashima, Misae Suzuki, Ichiro Tauchi, Miwa Sakuma, Setsuko Yamamoto, Makio Shozu, Hideki Hanaoka, Nobuhide Tsuruoka and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
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

12 authors at 3 institutions in 1 country.

Misuzu FujitaDepartment of Public Health, Chiba University Graduate School of Medicine, Chiba, Japan.ORCID 0000-0001-5308-4744
Minobu ShimazuClinical Research Center, Chiba University Hospital, Chiba, Japan.
Kengo NagashimaResearch Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Tachikawa, Tokyo, Japan.ORCID 0000-0003-4529-9045
Misae SuzukiMunicipal Health Center, Department of Health and Welfare, Ichihara City, Ichihara, Japan.
Ichiro TauchiMunicipal Health Center, Department of Health and Welfare, Ichihara City, Ichihara, Japan.
Miwa SakumaMunicipal Health Center, Department of Health and Welfare, Ichihara City, Ichihara, Japan.
Setsuko YamamotoMunicipal Health Center, Department of Health and Welfare, Ichihara City, Ichihara, Japan.
Makio ShozuDepartment of Reproductive Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Hideki HanaokaClinical Research Center, Chiba University Hospital, Chiba, Japan.
Nobuhide TsuruokaYushudai Clinic, Ichihara, Chiba, Japan.
Tokuzo KasaiDepartment of Public Health, Chiba University Graduate School of Medicine, Chiba, Japan.
Akira HataDepartment of Public Health, Chiba University Graduate School of Medicine, Chiba, Japan ahata@faculty.chiba-u.jp.
Chiba University · JPChiba University Hospital · JPThe Institute of Statistical Mathematics · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecently, the incidence of cervical cancer has increased in Japan, probably because of an interruption in human papillomavirus (HPV) vaccination and a low cervical cancer screening rate. There is a lack of evidence for self-sampling HPV testing as a cervical cancer screening tool in Japan. The Accelerating Cervical Cancer Elimination by Self-Sampling test trial aims to compare the effectiveness of screening using the self-sampling HPV test with that of routine screening concerning screening uptake and precancer detection. METHODS AND ANALYSIS: This trial has a single-municipality, open-label, parallel, superiority and randomised design. Approximately 20 000 women who have not undergone cervical cancer screening for at least 3 years will be assigned randomly to the self-sampling arm and the control arm using a 1:1 ratio. Participants assigned to the control arm will undergo routine cervical cancer screening (cytology test) provided by Ichihara City, while those assigned to the self-sampling arm will choose the routine screening or self-sampling HPV test. HPV tests will be performed using the cobas 8800 system (Roche Diagnostics, Rotkreuz, Switzerland). Participants who will undergo the self-sampling HPV testing will be recommended to undergo routine screening. The results of the cytology test and further tests, such as colposcopy and biopsy, will be collected and used for this trial. The risk ratio and risk difference in the proportion of participants with cervical intraepithelial neoplasia two or worse between the two arms will be calculated. The test for the null hypothesis (the detection rates are equal between the two arms) will be performed using Pearson's χ ETHICS AND DISSEMINATION: This trial was approved by the Research Ethics Committees of the Chiba Foundation for Health Promotion and Disease Prevention and the collaborating research institutes. The results will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: jRCT1030200276. Pre-results.

Indexed as

AlphapapillomavirusPapillomavirus InfectionsUterine Cervical NeoplasmsEarly Detection of CancerEquivalence Trials as TopicFemaleHumansMass ScreeningPapillomaviridaeRandomized Controlled Trials as TopicVaginal Smearsepidemiologygynaecological oncologyinfectious diseasespreventive medicineprotocols & guidelinespublic health

Identifiers

PMID35115348
PMCPMC8814812
OpenAlexW4210430577

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.