Evidence map›Paper›PMID 37873409›Full record

ArticlemedRxiv : the preprint server for health sciences2023

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, Virginia Barbour, Nicholas J L Brown, John Carlisle, Mike Clarke and 28 more

Abstract readPreprint
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors.

Jack WilkinsonCentre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0003-3513-4677
Calvin HealCentre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
George A AntoniouManchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Ella FlemyngEvidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
Zarko AlfirevicEmeritus Professor, University of Liverpool, UK.
Alison AvenellHealth Services Research Unit, University of Aberdeen, UK.
Virginia BarbourMedical Journal of Australia, Sydney, Australia.
Nicholas J L BrownDepartment of Psychology, Linnaeus University, Växjö, Sweden.
John CarlislePerioperative Medicine, Torbay hospital, UK.
Mike ClarkeDepartment of Epidemiology and Public Health, Royal College of Surgeons in Ireland.
Patrick DickerNorthern Ireland Methodology Hub, Queen's University Belfast, Northern Ireland.
Jo DumvilleDivision of Nursing, Midwifery & Social Work, School of Health Sciences, The University of Manchester, Manchester, UK.
Andrew GreyDepartment of Medicine, University of Auckland, Auckland, New Zealand.
Steph GrohmannEvidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
Lyle C GurrinSchool of Population and Global Health, The University of Melbourne, Australia.
Jill A HaydenDepartment of Community Health & Epidemiology, Faculty of Medicine, Dalhousie University, Canada.
James HeathersSafeBeat Rx Inc, USA.
Kylie E HunterEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Toby LassersonEvidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
Emily LamIndependent lay member, unaffiliated, Cheshire, UK.
Sarah LensenDepartment of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Tianjing LiDepartment of Ophthalmology, University of Colorado Anschutz Medical Campus.
Wentao LiDepartment of Obstetrics and Gynaecology, Monash University, VIC, Australia.
Elizabeth LoderThe BMJ, London, UK.
Andreas LundhCochrane Denmark & Centre for Evidence-Based Medicine Odense, Department of Clinical Research, University of Southern Denmark, Denmark.
Gideon Meyerowitz-KatzSchool of Health and Society, University of Wollongong, Wollongong, Australia.
Ben W MolMonash University, Clayton, Victoria, Australia.
Neil E O' ConnellCentre for Health and Wellbeing across the Lifecourse, Dept of Health Sciences, Brunel University London, UK.
Lisa ParkerSchool of Pharmacy, Charles Perkins Centre, The University of Sydney, Australia.
Barbara K RedmanDivision of Medical Ethics, New York University Grossman School of Medicine, New York, NY.
Anna Lene SeidlerEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Kyle A SheldrickFaculty of Medicine, University of New South Wales, Australia.
Emma SydenhamCochrane Central Production Service, UK.
David J TorgersonYork Trials Unit, Dept of Health Sciences, University of York, UK.
Madelon van WelyCochrane Gynaecology and Fertility Satellite and Cochrane Sexually Transmitted Infection Group, Amsterdam.
Rui WangDepartment of Obstetrics and Gynaecology, Monash University, VIC, Australia.
Lisa BeroUniversity of Colorado Anschutz Medical Campus, Colorado, USA.
Jamie J KirkhamCentre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, 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

Introduction: Randomised 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 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, 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.

Identifiers

PMID37873409
PMCPMC10593010

What OpenQuestion holds

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Registered trials

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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.