International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials...

The number of retractions of randomized clinical trials (RCTs) following post-publication allegations of misconduct is increasing. To address this issue, we aimed to establish an international multistakeholder consensus on post-publication integrity concerns related to RCTs. After prospective registration (https://osf.io/njksm), we assembled a multidisciplinary stakeholder group comprising 48 participants from 18 countries across six continents, recruited using a curated list of journal editors and snowballing. An underpinning evidence synthesis collated 89 articles related to post-publication integrity concerns. Integrity statements related to RCTs created were subjected to anonymized two-round Delphi survey. A hybrid face-to-face-online consensus development meeting was convened to consolidate the consensus. The response rates of the two Delphi survey rounds were 65% (31/48) and 67% (32/ 48), respectively. There were 101 and 41 statements in the first and second Delphi rounds, respectively. After the two Delphi rounds and the consensus development meeting, consensus was achieved on 104 statements consolidated to 84 after merging, editing, and removing duplicates. This set of statements included general aspects (n = 9), journal instructions (n = 14), editorial and peer review (n = 7), correspondence and complaints (n = 4), investigations for integrity concerns (n = 16), decisions and sanctions (n = 9), critical appraisal guidance (n = 1), systematic reviews of RCTs (n = 8), and research recommendations (n = 16). In conclusion, this international multistakeholder consensus statement aimed to underpin policies for preventing post-publication integrity concerns in RCT publications and assist in improving investigations of misconduct allegations.