The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence.

ABSTRACT:

Background

Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT.

Methods

We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool.

Results

We included 45 qualitative studies that involved 1732 RCT participants. Impor

SUBMITTER: Naidoo N 

PROVIDER: S-EPMC6970283 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature