A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric IBD

Background Process evaluations conducted alongside clinical trials can improve understanding of treatment fidelity and provide contextual knowledge to aide interpretations of trial outcomes. We adopted a multiple-goals perspective to investigate treatment fidelity in two related pilot clinical trials of an adjuvant treatment for pediatric-onset Inflammatory Bowel Disease. This included a focus on barriers and enablers of performing trial-specific activities and of integrating those activities into daily life. Methods We interviewed a sub-sample of participants of the Resistant Starch in Pediatric Inflammatory Bowel Disease ( NCT04522271 ) and Optimized Resistant Starch in Inflammatory Bowel Disease pilot trials ( NCT04520594 ) and their caregivers ( N =42). The trials examined the effects of personalized food-derived resistant starches as an adjuvant therapy on intestinal microbiome functioning. Codes were identified inductively though conventional content analysis and then mapped to personal projects units of analysis, to explore how participants navigated between activities. Results Three themes were identified. The first described the potential impact of living with inflammatory bowel disease and taking prescribed medications. The second described characteristics of trial-specific activities that might impact on their enactment, including perceived difficulty, and challenges following procedures or using trial materials. The third described the integration of trial-specific activities with school, work, household demands, and social, and extracurricular activities. Conclusions Adjusting to living with inflammatory bowel disease and managing its treatment can impact trial participation. Integrating trial-related activities into daily life can be challenging, which could heighten perceptions of goal conflict. Findings can inform interpretations of trial outcomes and development of strategies for trial optimization and implementation of the adjuvant therapy into clinical practice.