TY - JOUR
T1 - Indicators of questionable research practices were identified in 163,129 randomized controlled trials
AU - Damen, Johanna A.
AU - Heus, Pauline
AU - Lamberink, Herm J.
AU - Tijdink, Joeri K.
AU - Bouter, Lex
AU - Glasziou, Paul
AU - Moher, David
AU - Otte, Willem M.
AU - Vinkers, Christiaan H.
AU - Hooft, Lotty
N1 - Funding Information:
Funding: This work was supported by The Netherlands Organization for Health Research and Development (ZonMw) grant “ Fostering Responsible Research Practices ” ( 445001002 ) (C.V., J.T., and W.O.). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2022 The Authors
PY - 2023/2/1
Y1 - 2023/2/1
N2 - Objectives: To explore indicators of the following questionable research practices (QRPs) in randomized controlled trials (RCTs): (1) risk of bias in four domains (random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment); (2) modifications in primary outcomes that were registered in trial registration records (proxy for selective reporting bias); (3) ratio of the achieved to planned sample sizes; and (4) statistical discrepancy. Study Design and Setting: Full texts of all human RCTs published in PubMed in 1996–2017 were automatically identified and information was collected automatically. Potential indicators of QRPs included author-specific, publication-specific, and journal-specific characteristics. Beta, logistic, and linear regression models were used to identify associations between these potential indicators and QRPs. Results: We included 163,129 RCT publications. The median probability of bias assessed using Robot Reviewer software ranged between 43% and 63% for the four risk of bias domains. A more recent publication year, trial registration, mentioning of CONsolidated Standards Of Reporting Trials-checklist, and a higher journal impact factor were consistently associated with a lower risk of QRPs. Conclusion: This comprehensive analysis provides an insight into indicators of QRPs. Researchers should be aware that certain characteristics of the author team and publication are associated with a higher risk of QRPs.
AB - Objectives: To explore indicators of the following questionable research practices (QRPs) in randomized controlled trials (RCTs): (1) risk of bias in four domains (random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment); (2) modifications in primary outcomes that were registered in trial registration records (proxy for selective reporting bias); (3) ratio of the achieved to planned sample sizes; and (4) statistical discrepancy. Study Design and Setting: Full texts of all human RCTs published in PubMed in 1996–2017 were automatically identified and information was collected automatically. Potential indicators of QRPs included author-specific, publication-specific, and journal-specific characteristics. Beta, logistic, and linear regression models were used to identify associations between these potential indicators and QRPs. Results: We included 163,129 RCT publications. The median probability of bias assessed using Robot Reviewer software ranged between 43% and 63% for the four risk of bias domains. A more recent publication year, trial registration, mentioning of CONsolidated Standards Of Reporting Trials-checklist, and a higher journal impact factor were consistently associated with a lower risk of QRPs. Conclusion: This comprehensive analysis provides an insight into indicators of QRPs. Researchers should be aware that certain characteristics of the author team and publication are associated with a higher risk of QRPs.
KW - Bias
KW - Meta-research
KW - Questionable research
KW - RCT
KW - Responsible research
KW - Selective reporting
UR - https://www.scopus.com/pages/publications/85144993448
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85144993448&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/36470577
U2 - 10.1016/j.jclinepi.2022.11.020
DO - 10.1016/j.jclinepi.2022.11.020
M3 - Article
C2 - 36470577
SN - 0895-4356
VL - 154
SP - 23
EP - 32
JO - Journal of clinical epidemiology
JF - Journal of clinical epidemiology
ER -