Interviewing
MH
We used a purposive sampling approach. We first identified 5 REGAIN sites with relatively high numbers of enrolled patients and site lead investigators who were willing to assist us with recruiting participants. Carrying out this interview study at sites that enrolled relatively high numbers was deemed necessary to provide sufficient cases to discuss with each interviewee during the interview. For each of these sites, we compiled the cases in which patients were either successfully randomized or excluded due to anesthesiologist refusal. We sent this list to the site PI, who identified the anesthesiologist associated with each case. We then sent an email to each identified anesthesiologist informing them of the interview study and inviting them to participate. Participants provided verbal consent and were compensated $75 for participating.Interviews were one-on-one encounters conducted via video chat or phone call. The interviewers were CD (an anthropology graduate student and REGAIN clinical research coordinator), MH (a medical student with an anthropology background), and JC (a PhD anthropologist with experience conducting qualitative studies in perioperative settings). Prior to the interview, the participant was sent the list of REGAIN cases that would be discussed and asked to review them. The interview consisted of two sections (the interview guide can be found in the During the chart-stimulated portion of our interviews, we questioned anesthesiologists about 2–4 cases on which they were the anesthesiologist of record and in which either (a) the patient was successfully randomized or (b) the patient, though meeting REGAIN’s eligibility criteria, was excluded from the study by the clinical team. The number of cases we reviewed per interviewee and the specific mix of randomized versus excluded cases varied depending on the frequency with which participants had encountered REGAIN cases and the determinations they had made about patient enrollment. For each patient case, we asked the interviewee to open the record, then elicited an open-ended narrative about how the interviewee determined this patient was suitable or unsuitable for randomization. As this account developed, we posed scripted and spontaneous follow-up probes about how specific factors played into their reasoning: e.g., the patient’s medical history, the interviewee’s stance toward regional and general approaches, patient and family input, institutional standards, and the interviewee’s views toward the REGAIN trial. Once all patient cases had been discussed and the chart-stimulated portion was complete, we carried out a conventional semi-structured interview. In this section, we asked participants about their general views on clinical research, the role of physicians in facilitating clinical research, and any barriers that they felt hindered their participation in clinical studies.