Patient Perceptions of Their Own Data in mHealth Technology–Enabled N-of-1 Trials for Chronic Pain: Qualitative Study

BACKGROUND: N-of-1 (individual comparison) trials are a promising approach for comparing the effectiveness of 2 or more treatments for individual patients; yet, few studies have qualitatively examined how patients use and make sense of their own patient-generated health data (PGHD) in the context of N-of-1 trials. OBJECTIVE: The objective of our study was to explore chronic pain patients’ perceptions about the PGHD they compiled while comparing 2 chronic pain treatments and tracking their symptoms using a smartphone N-of-1 app in collaboration with their clinicians. METHODS: Semistructured interviews were recorded with 33 patients, a consecutive subset of the intervention group in a primary study testing the feasibility and effectiveness of the Trialist N-of-1 app. Interviews were transcribed verbatim, and a descriptive thematic analysis was completed. RESULTS: Patients were enthusiastic about recording and accessing their own data. They valued sharing data with clinicians but also used their data independently. CONCLUSIONS: N-of-1 trials remain a promising approach to evidence-based decision making. Patients appear to value their roles as trial participants but place as much or more importance on the independent use of trial data as on comparative effectiveness results. Future efforts to design patient-centered N-of-1 trials might consider adaptable designs that maximize patient flexibility and autonomy while preserving a collaborative role with clinicians and researchers.