The Role of Qualitative Research in Progression Decision-Making in Mixed-Methods Pilot and Feasibility Randomized Controlled Trials: A Scoping Review.

Pilot and feasibility randomized controlled trials (RCTs) help determine whether to proceed to a full-scale trial and identify necessary modifications. Qualitative research embedded in these trials can offer insight into feasibility, acceptability, and implementation of interventions, which is not always evident through quantitative data alone. It remains unclear how qualitative findings have influenced decisions to progress to full-scale RCTs. A scoping review was conducted, guided by Joanna Briggs Institute methodology. MEDLINE was searched for pilot and feasibility RCTs of health intervention published between 2017 and 2022 in four target journals, focusing on those using qualitative research to inform progression decision-making. Eligible studies were published in English with freely available full-text results. Titles and abstracts were screened independently by two reviewers, with full texts screened by one reviewer and a random 20% sample double-screened by a second reviewer. Data were extracted on trial characteristics, progression criteria, qualitative methods, and decision-making processes. Of the 932 records screened, 69 trials (across 94 publications) met inclusion criteria. Two approaches to using qualitative research in progression decision-making were identified: the application of prespecified progression criteria and the integration of qualitative and quantitative data. Of 18 trials which reported prespecified progression criteria, five included qualitative progression criteria. Eight trials employed mixed-methods integration techniques. Three used both integration techniques and qualitative progression criteria. The findings highlight limited but promising examples of meaningful integration. Clearer guidance is needed to support the consistent and transparent use of qualitative research in informing progression decisions in pilot and feasibility RCTs.