Evidence map›Paper›PMID 38471680›Full record

ArticleBMJ open2024

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Jack Wilkinson, Calvin Heal, George A Antoniou, Ella Flemyng, Zarko Alfirevic, Alison Avenell, Ginny Barbour, Nicholas J L Brown, John Carlisle, Mike Clarke and 28 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors.

Jack WilkinsonCentre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK jack.wilkinson@manchester.ac.uk.ORCID 0000-0003-3513-4677
Calvin HealCentre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
George A AntoniouManchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Ella FlemyngEvidence Production and Methods Directorate, Cochrane, London, UK.
Zarko AlfirevicDepartment of Women's and Children's Health, University of Liverpool, Liverpool, UK.
Alison AvenellHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0003-4813-5628
Ginny BarbourMedical Journal of Australia, Sydney, New South Wales, Australia.
Nicholas J L BrownDepartment of Psychology, Linnaeus University, Växjö, Sweden.
John CarlisleAnaesthesia and Critical Care, Torbay Hospital, Torquay, UK.
Mike ClarkeNorthern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.ORCID 0000-0002-2926-7257
Patrick DickerDepartment of Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, Ireland.
Jo C DumvilleDivision of Nursing, Midwifery and Social Work, School of Health Sciences, The University of Manchester, Manchester, UK.
Andrew GreyDepartment of Medicine, University of Auckland, Auckland, New Zealand.ORCID 0000-0002-7803-0096
Steph GrohmannEvidence Production and Methods Directorate, Cochrane, London, UK.
Lyle GurrinSchool of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
Jill Alison HaydenCommunity Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada.ORCID 0000-0001-7026-144X
James HeathersSafeBeat Rx Inc, St Louis, Missouri, USA.
Kylie Elizabeth HunterEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-2796-9220
Toby LassersonEvidence Production and Methods Directorate, Cochrane, London, UK.
Emily LamIndependent Lay Member, Cheshire, UK.
Sarah LensenDepartment of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0002-1694-1142
Tianjing LiDepartment of Ophthalmology, University of Colorado, Denver, Colorado, USA.
Wentao LiDepartment of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.ORCID 0000-0001-8980-0909
Elizabeth LoderBMJ Publishing, London, UK.
Andreas LundhCentre of Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Gideon Meyerowitz-KatzSchool of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.
Ben W MolDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.ORCID 0000-0001-8337-550X
Neil E O'ConnellDepartment of Clinical Science, Brunel University, Uxbridge, UK.
Lisa ParkerSchool of Pharmacy, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-8635-6953
Barbara K RedmanDivision of Medical Ethics, New York University Grossman School of Medicine, New York, New York, USA.
Lene SeidlerEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Kyle A SheldrickFaculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Emma SydenhamCochrane Central Production Service, Cochrane, London, UK.ORCID 0000-0002-1471-4237
David TorgersonYork Trials Unit, Dept of Health Sciences, University of York, York, UK.
Madelon van WelyCochrane Gynaecology and Fertility Satellite and Cochrane Sexually Transmitted Infection Group, Cochrane, Duivendrecht, The Netherlands.
Rui WangDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.ORCID 0000-0002-6622-8134
Lisa BeroCenter for Bioethics and Humanities, University of Colorado-Anschutz Medical Campus, Denver, Colorado, USA.ORCID 0000-0003-1893-6651
Jamie J KirkhamCentre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.ORCID 0000-0003-2579-9325

Funding

Maximizing Use of High-Quality Evidence in Eye Care: Cochrane Eyes and Vision US ProjectUG1EY020522 · NEI · UNIVERSITY OF COLORADO DENVER · PI Tianjing Li · 2017 to 2026
$10.1M
NEI NIH HHS UG1 EY020522
6 · The paper itself

Abstract

introductionRandomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Indexed as

Evidence-Based MedicineResearch DesignConsensusHumansInformed ConsentRandomized Controlled Trials as TopicSystematic Reviews as TopicRandomized Controlled TrialSTATISTICS & RESEARCH METHODSSystematic Review

Identifiers

PMID38471680
PMCPMC10936473

What OpenQuestion holds

Textmetadata
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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.