A survey of experts to identify methods to detect problematic studies: stage 1 of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews project

被引：2

作者：

Wilkinson, Jack ^{[1
]}

Heal, Calvin ^{[1
]}

Antoniou, George A. ^{[2
,3
]}

Flemyng, Ella ^{[4
]}

Avenell, Alison ^{[5
]}

Barbour, Virginia ^{[6
]}

Bordewijk, Esmee M. ^{[7
]}

Brown, Nicholas J. L. ^{[8
]}

Clarke, Mike ^{[9
]}

Dumville, Jo ^{[10
,11
]}

Grohmann, Steph ^{[4
]}

Gurrin, Lyle C. ^{[12
]}

Hayden, Jill A. ^{[13
]}

Hunter, Kylie E. ^{[14
]}

Lam, Emily ^{[15
]}

Lasserson, Toby ^{[4
]}

Li, Tianjing ^{[15
]}

Lensen, Sarah ^{[16
]}

Liu, Jianping ^{[17
]}

Lundh, Andreas ^{[18
,19
,20
]}

Meyerowitz-Katz, Gideon ^{[21
]}

Mol, Ben W. ^{[22
]}

O'Connell, Neil E. ^{[23
]}

Parker, Lisa ^{[24
]}

Redman, Barbara ^{[25
]}

Seidler, Anna Lene ^{[14
]}

Sheldrick, Kyle ^{[26
]}

Sydenham, Emma ^{[27
]}

Dahly, Darren L. ^{[28
]}

van Wely, Madelon ^{[7
]}

Bero, Lisa ^{[29
]}

Kirkham, Jamie J. ^{[1
]}

机构：

[1] Univ Manchester, Ctr Biostat, Manchester Acad Hlth Sci Ctr, Manchester, England

[2] Manchester Univ NHS Fdn Trust, Manchester Vasc Ctr, Manchester, England

[3] Univ Manchester, Manchester Acad Hlth Sci Ctr, Sch Med Sci, Div Cardiovasc Sci, Manchester, England

[4] Cochrane Cent Execut, Evidence Prod & Methods Directorate, London, England

[5] Univ Aberdeen, Hlth Serv Res Unit, Aberdeen, Scotland

[6] Med Journal Australia, Sydney, Australia

[7] Univ Amsterdam, Ctr Reprod Med, Dept Obstet & Gynaecol, Med Ctr, Amsterdam, Netherlands

[8] Linnaeus Univ, Dept Psychol, Vaxjo, Sweden

[9] Queens Univ Belfast, Northern Ireland Methodol Hub, Belfast, North Ireland

[10] Univ Manchester, Sch Hlth Sci, Div Nursing Midwifery & Social Work, Manchester, England

[11] Manchester Univ NHS Fdn Trust, NIHR Manchester Biomed Res Ctr, Manchester Acad Hlth Sci Ctr, Manchester, England

[12] Univ Melbourne, Sch Populat & Global Hlth, Melbourne, Australia

[13] Dalhousie Univ, Dept Community Hlth & Epidemiol, Halifax, NS, Canada

[14] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, Australia

[15] Univ Colorado, Dept Ophthalmol, Anschutz Med Campus, Aurora, CO USA

[16] Univ Melbourne, Royal Womens Hosp, Dept Obstet Gynaecol & Newborth Hlth, Melbourne, Australia

[17] Beijing Univ Chinese Med, Ctr Evidence Based Chinese Med, Beijing, Peoples R China

[18] Univ Southern Denmark, Cochrane Denmark, Odense, Denmark

[19] Univ Southern Denmark, Ctr Evidence Based Med Odense, Dept Clin Res, Odense, Denmark

[20] Copenhagen Univ Hosp Bispebjerg & Frederiksberg, Dept Resp Med & Infect Dis, Copenhagen, Denmark

[21] Univ Wollongong, Sch Hlth & Soc, Wollongong, Australia

[22] Monash Univ, Dept Obstet & Gynaecol, Melbourne, Australia

[23] Brunel Univ London, Ctr Wellbeing Lifecourse, Dept Hlth Sci, London, England

[24] Univ Sydney, Charles Perkins Ctr, Sydney Med Sch, Sydney, Australia

[25] NYU, New York, NY USA

[26] Univ New South Wales, Fac Med, Sydney, Australia

[27] Cochrane Cent Editorial Serv, London, England

[28] Univ Coll Cork, HRB Clin Res Facil, Cork, Ireland

[29] Univ Colorado, Anschutz Med Campus, Aurora, CO USA

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2024年 / 175卷

基金：

美国国家卫生研究院;

关键词：

Research integrity; Fraud; Fabrication; Misconduct; Trustworthiness; Randomised controlled trials; Systematic reviews; Forensic analysis; Evidence synthesis; Critical appraisal; RANDOMIZED CONTROLLED-TRIALS; DATA FABRICATION; RESEARCH MISCONDUCT; INTEGRITY; MANUSCRIPTS; JOURNALS; FRAUD;

D O I：

10.1016/j.jclinepi.2024.111512

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Background and Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is developing a tool to identify problematic RCTs in systematic reviews of health care-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorized these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusion: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

引用

页数：10

共 45 条

[1] Are these data real? Statistical methods for the detection of data fabrication in clinical trials [J].

Al-Marzouki, S ;

Evans, S ;

Marshall, T ;

Roberts, I .

BMJ-BRITISH MEDICAL JOURNAL, 2005, 331 (7511) :267-270

[2]

Anaya JJPP, 2016, PeerJ Preprints, V4

[3]

[Anonymous], 2012, NATURE, V481, P21

[4]

Barnett Adrian, 2022, F1000Res, V11, P783, DOI 10.12688/f1000research.123002.2

[5] Properties of sufficiency and statistical tests [J].

Bartlett, MS .

PROCEEDINGS OF THE ROYAL SOCIETY OF LONDON SERIES A-MATHEMATICAL AND PHYSICAL SCIENCES, 1937, 160 (A901) :0268-0282

[6]

BARTON DE, 1957, BIOMETRIKA, V44, P168, DOI 10.2307/2333249

[7]

Blanco David, 2019, F1000Res, V8, P1682, DOI 10.12688/f1000research.20556.3

[8] Hoax-detecting software spots fake papers [J].

Bohannon, John .

SCIENCE, 2015, 348 (6230) :18-19

[9] Participant withdrawals were unusually distributed in randomized trials with integrity concerns: a statistical investigation [J].

Bolland, Mark J. ;

Gamble, Greg D. ;

Avenell, Alison ;

Cooper, David J. ;

Grey, Andrew .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2021, 131 :22-29

[10] Methods to assess research misconduct in health-related research: A scoping review [J].

Bordewijk, Esmee M. ;

Li, Wentao ;

van Eekelen, Rik ;

Wang, Rui ;

Showell, Marian ;

Mol, Ben W. ;

van Wely, Madelon .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2021, 136 :189-202

← 1 2 3 4 5 →