Randomised clinical trials integrity and patient, carer and public involvement: A scoping umbrella review

Patient, carer and public involvement (PCPI), an approach being endorsed in research, may also improve research integrity. After prospective registration (https://osf.io/nfgxp), we conducted a scoping umbrella review to collate evidence on the contribution of PCPI toward the integrity of randomized clinical trials (RCTs). Three databases were searched on 17 July 2024 with a double-blind selection process. We included systematic reviews that addressed PCPI issues related to clinical research integrity. Quality was appraised with a modified AMSTAR-2 instrument. We identified 27 reviews. The overlap between primary studies was low. The quality of the reviews was rated as high-moderate for two, low for four, and critically low for 21. Findings on adherence to ethical and professional standards emphasized the importance of early citizen engagement in RCTs, the role of PCPI in the ethical approval process, and the need for research integrity training. There was a lack of research on the role of PCPI relating to post-publication issues. Our findings supported the need for developing a consensus approach to ascertain the role of PCPI in responsible RCT design, conduct, and reporting, to enhance the credibility and trustworthiness of clinical research.