https://doi.org/10.1016/j.jclinepi.2022.11.020

Abstract

Objective

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 RobotReviewer software ranged between 43% and 63% for the four risk of bias domains. A more recent publication year, trial registration, mentioning of CONSORT-checklist, and a higher journal impact factor were consistently associated with a lower risk of QRPs.

Conclusion

This comprehensive analysis provides 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.

This comprehensive analysis provides 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.