Background: Randomised clinical trials (RCTs) hold the highest validity level in effectiveness
research. However, there is a growing concern regarding their trustworthiness. We
aimed to appraise the quality and reporting of recommendation documents regarding
research integrity to describe their contribution towards fostering RCT integrity.
Methods: Following prospective registration (https://doi.org/10.17605/OSF.IO/DN93K),
searches of electronic databases (Scopus, PubMed, Google Scholar) and relevant websites
were performed from inception to 30 July 2023 without language limitations. Data extraction
and document appraisal using adapted versions of AGREE II, RIGHT and ACCORD checklists
were carried out in duplicate. Appraisal data were synthesised as % of the maximum
score and documents were classified as: good >= 70%, average 50-69%, and poor < 50%.
Results: From 1310 citations 14 recommendation documents were selected. Of these,
11 documents (78%) were of poor quality according to all three appraisal checklists.
Reviewer agreement was 86-100% regarding the checklist items. The top three documents
were: " International multi-stakeholder consensus statement on clinical trial integrity"(score
70% on AGREE II, 96% on RIGHT and 88% on ACCORD); " Development of consensus on essential
virtues for ethics and research integrity"(score 51% on AGREE II, 71% on RIGHT and
77% on ACCORD); and " Hong Kong principles for assessing researchers"(score 19% on
AGREE II, 57% on RIGHT and 10% on ACCORD). Conclusion There is a room from improvement
in the quality and reporting of recommendation documents to help fostering RCT integrity.
All stakeholders in the RCT lifecycle making concerted efforts to improve trust in
evidence-based medicine need robust guidance to underpin research integrity policies
and guidelines.
