Eliciting Patient Preferences for Pragmatic Critical Care Trials: A Qualitative Study.

Rationale: Conducting pragmatic comparative effectiveness trials in critically ill populations poses distinct challenges. Knowledge gaps exist in how to best conduct pragmatic research while demonstrating respect for critically ill patients and their families. Objectives: To engage patients with lived critical care experience to elicit their perspectives on 1) decisions related to the design and conduct of pragmatic comparative effectiveness trials in acute and critical care settings and 2) subsequent notification of pragmatic trial participation. Methods: We conducted a qualitative research study using the principles of reflexive thematic analysis. An interview guide was developed by investigators with expertise in qualitative methodology, critical care, emergency medicine, and pragmatic comparative effectiveness trials; this guide used two research study examples to elicit feedback from participants. Using a purposive sampling technique to ensure the inclusion of diverse perspectives, we recruited a convenience sample of patients from two hospitals during a hospitalization for a critical illness or injury. Interviews with participants were conducted via telephone after discharge, audio recorded, and transcribed verbatim. A codebook was developed inductively, and coding was performed in duplicate. Emerging themes were reviewed and validated with the larger research team. Results: A total of 20 interviews were completed, and saturation was achieved. Findings were organized into four themes: 1) trust and past care experiences influence patient receptivity to pragmatic comparative effectiveness research, 2) familiarity with research influences patient comfort and willingness to participate, 3) altruism and a desire to contribute to research knowledge motivate patient participation in research, and 4) the experience of critical illness influences patient receptivity to the research process. Conclusions: Patients with a lived experience of critical illness are generally supportive of pragmatic comparativeness effectiveness trials in the emergency or critical care setting. The factors influencing patient receptivity identified in this study highlight opportunities for investigators, healthcare leaders, and regulators to better align with patients in the future design and conduct of pragmatic comparative effectiveness trials.