Discussion
fracture, ’
INTRAOPERATIVE COMPLICATIONS, RECRUITMENT, COMPLICATIONS
In this study, we sought to get a detailed sense of how practicing clinicians reason about whether to proceed with or refuse randomization of patients eligible for pragmatic trials. We interviewed anesthesiologists participating in REGAIN, a pragmatic trial on anesthesia in hip fracture. We found that, in line with their perceived role as preventors of any peri- and intraoperative complications, anesthesiologists approached the cases of eligible patients by focusing intently on contraindications to the delivery of one or the other anesthetic being tested. Interviewees sometimes reasoned about eligible patients using a prototype-based approach in which their concern was whether a patient was representative of a class of problematic patients. In other cases, their reasoning was probabilistic, focused on whether a given type of patient would experience complications from a particular anesthetic. In contrast to the feelings of discomfort they expressed when they excluded patients from randomization, when anesthesiologists allowed randomization to proceed, they felt confident that either of the approaches being tested would be safe. Anesthesiologists saw themselves as having a fiduciary duty to patients and did not hesitate to provide recommendations, even when they recognized that doing so would complicate trial recruitment. Nevertheless, they voiced strong support for clinical research and participation in it, stating that their involvement was mainly hindered by production pressure and workflow disruptions.The main strength of this study is its use of chart-stimulated interviewing to elicit detailed accounts of specific trial-eligible patients from the physicians who treated them. Prior studies that have examined why particular patients have or have not been enrolled in trials have examined informed consent conversations [Our findings have several implications for attempts to evaluate and intervene in physicians’ tendency to exclude patients from clinical trials. First, though equipoise remains the most prominent conceptual tool for examining the ethical basis for physician determinations about study enrollment, it has questionable utility for addressing the reasoning of the anesthesiologists who participated in REGAIN. The traditional definition of equipoise grounds it in a particular metacognitive state, namely a feeling of “genuine uncertainty regarding the comparative merits of treatments A and B for population P” [Our results also complicate arguments made to spur on the development of the “learning health system.” [Finally, the differing modes of clinical reasoning involve different types of uncertainty. Uncertainty is not a monolithic phenomenon; it has varying sources and manifestations [