Using qualitative methods in pilot and feasibility trials to inform recruitment and retention processes in full-scale randomised trials: a qualitative evidence synthesis

Objectives To systematically review published pre-trial qualitative research studies and explore how their findings were used to inform recruitment and retention processes in full-scale randomised trials. Design Qualitative evidence synthesis using thematic analysis. Data sources and eligibility criteria We conducted a comprehensive search of databases; Dissertation Abstracts International, CINAHL, Embase, MEDLINE, Sociological Abstracts and Psycinfo. We included all reports of pre-trial qualitative data on recruitment and retention in clinical trials up to March, 2018. Data extraction and synthesis Two authors independently extracted data using a predefined data extraction form that captured study aims, design, methodological approach, adopted and main findings, including barriers and facilitators to recruitment and or retention. The synthesis was undertaken using Thomas and Harden’s three stage thematic synthesis method and reported following the ENTREQ guidelines. Confidence was assessed using GRADE-CERQual approach. Results Thirty-five papers (connected to 31 feasibility studies) from three different countries, published between 2010 and 2017 were included. All studies were embedded in pilot or feasibility studies to inform design aspects in preparation for a subsequent full-scale trial. Twelve themes were identified as recruitment barriers and three as recruitment facilitators. Two themes were identified as barriers for retention and none as retention facilitators. The findings from qualitative research in feasibility or pilot trials are often not explicitly linked to proposed changes to the recruitment and retention strategies to be used in the future or planned full-scale trial. Conclusions Many trial teams do pre-trial qualitative work with the aim of improving, among other things, recruitment and retention in future full-scale trials. Just over half of all reports of such work do not clearly show how their findings will change the recruitment and retention strategy of the future trial. The scope of pre-trial work needs to expand beyond looking for problems and also look for what might help and spend more time on retention.

Publication year:2022

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