Limitations
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RECRUITMENT
This study has important limitations. We carried out interviews, not direct observations of clinical practice. These interviews are retrospective, rationalized accounts; missing are the aspects of real-time practice that are not so easy to reflect on and articulate. Relatedly, it is possible that interviewees’ recall was sometimes faulty. We tried to mitigate both these effects by drawing on the concreteness of real cases explored through chart stimulation and careful probing. The rich, multidimensional nature of the accounts we obtained suggests that this was to some degree successful. Interviewees’ accounts might also reflect social desirability bias. We tried to blunt this tendency by having non-clinicians who did not have leading roles in REGAIN and had not previously corresponded with participants conduct all interviews and all recruitment communications. The study also has characteristics that likely limit its generalizability. Our sample of interviewees was derived mainly from two high-enrolling sites that presented abundant cases to discuss. It is possible that physicians at sites with lower enrollment dealt with different circumstances when reasoning about patient cases, reflecting differences in clinical and research infrastructures across sites. Our findings are also specific to one pragmatic trial in one medical specialty with its own norms and practice patterns. However, we believe the findings of this study stress the importance of examining the specifics of a given trial’s clinical setting for evaluating and effectively intervening in clinicians’ tendency to refuse enrollment of eligible patients.