Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a systematic review.

ABSTRACT:

Background

Patient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are relevant to patients. The minimal clinically important difference (MCID) in the primary outcome influences trial design and feasibility and should be predicated on PPI. We aimed to determine current practice of reporting PPI and the MCID in phase III/IV randomised controlled trials (RCTs).

Methods

Following a search of Medline, Embase, and the Cochrane Central Register of Controlled Trials, we included primary publications of phase III/IV RCTs, in English, inclusive of any medical specialty or type of intervention, that reported a health-related outcome. We excluded protocols and secondary publications of RCTs. We extracted RCT cha

SUBMITTER: Brennan J 

PROVIDER: S-EPMC10233858 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature