Patients’ Perspectives and Experiences of Participating in Anesthesia Research: A Qualitative Study

BACKGROUND: Exploring participants' experiences in comparative effectiveness anesthesia clinical trials offers valuable insights for improving trial design, conduct, and outcome measures while identifying factors that may hinder trial success. The challenges and opportunities of conducting comparative effectiveness trials are distinct from classic explanatory trials. To optimize and conduct a full-scale comparative effectiveness trial, we interviewed patients to identify barriers and facilitators to study participation and offer strategies to improve the recruitment and retention of participants in anesthesia comparative effectiveness clinical trials. METHODS: We conducted qualitative semi-structured interviews using constructs from the Consolidated Framework for Implementation Research. Interviews assessed barriers and facilitators to study participation in an anesthesia clinical trial comparing outcomes after receiving either total intravenous anesthesia (TIVA) or inhaled volatile anesthesia (INVA). Interview guides were co-developed with a multidisciplinary team, including patient partners, and addressed study participation, acceptability of the study procedures, and prior experiences with anesthesia. Participants were recruited at two large academic medical centers. Two coders used a standardized codebook to code each interview, achieving > 95% agreement. Interview transcripts were analyzed using thematic analysis. RESULTS: Ninety-one patients were approached, 43 agreed to participate, and 35 interviews were conducted until we reached thematic saturation. Patients found participation in the anesthesia research study to be positive, straightforward, and non-intrusive. Study-related barriers to enrollment and participation included survey language, blinding, randomization, and concerns for breach of confidentiality. Patient-related barriers included fear and mistrust of research and discomfort with technology. Study-related facilitators included the safety and non-experimental nature of both general anesthesia techniques, use of digital technology, minimal time burden, trust and clear communication by the study staff, and compensation. Patients were motivated to participate by altruistic values. Adaptable barriers were addressed, and solutions were implemented to improve study procedures and staff responsibilities, aimed at enhancing participation and ensuring positive experiences for patients in future anesthesia comparative effectiveness clinical trials. CONCLUSIONS: Key elements to consider when designing and conducting a comparative effectiveness anesthesia trial include promoting participant comfort and trust, ensuring clear communication, highlighting the safety and clinical equipoise of the trial comparators, supportive behaviors from the clinical team, minimizing time burden, and using simple-to-learn digital technology. Findings of this study were used to refine the full-scale pragmatic, comparative effectiveness, randomized controlled trial evaluating patient experiences with TIVA and INVA.