Pragmatic Approaches to Team-Based Qualitative Analysis of Study Participants’ Exit Interview Data in a Pragmatic Clinical Trial

Abstract

The OPTIMUM trial is a multisite pragmatic randomized clinical trial of an adapted Mindfulness Based Stress Reduction (MBSR) program for people with chronic low back pain in primary care settings provided via telehealth group medical visits. Researchers conducted fifty-nine exit interviews at the end of the intervention to inform the ongoing conduct of the trial and to better understand patients’ experiences. This manuscript describes a pragmatic approach to the qualitative analysis of exit interviews within a pragmatic clinical trial. The analysis included three important pivots. First, researchers conducted a process evaluation using a rapid approach called the Lightning Report method. Second, team-based approaches to qualitative analysis were utilized to pair experienced and inexperienced qualitative researchers. Third, based upon principles from Big Qual methodology, a codebook was developed and applied to provide an aerial overview of the data in preparation for more in-depth exploration. Based upon these pivots, the process evaluation provided actionable results in a timely fashion, team members increased analytical skills, and multiple analyses are being applied to the data set. By describing the pragmatic decisions to pivot approaches to qualitative analysis, this manuscript contributes to existing literature regarding rapid qualitative analysis methods for process evaluation in pragmatic clinical trials, team-based mentorship in large trials, and applications from Big Qual for large data sets.