Clinical reasoning in pragmatic trial randomization: a qualitative interview study

Area of Science:

• Anesthesiology
• Clinical Trial Design
• Qualitative Research

Background:

• Pragmatic trials require clinician enrollment, creating potential conflicts between patient care and research participation.
• Clinician refusal to enroll patients can impede trial completion and limit generalizability.
• The REGAIN trial (NCT02507505) investigated spinal vs. general anesthesia for hip fracture patients.

Purpose of the Study:

• To explore anesthesiologists' reasoning processes when deciding whether to randomize eligible patients in a pragmatic trial.
• To identify factors influencing clinician decisions regarding patient enrollment in clinical research.
• To inform strategies for mitigating clinician refusal and enhancing trial recruitment.

Main Methods:

• Qualitative study involving interviews with 29 anesthesiologists participating in the REGAIN trial.
• Employed a constructivist grounded theory approach with chart-stimulated and semi-structured interviews.
• Data analysis included coding, focused coding for thematic synthesis, and abductive reasoning.

Main Results:

• Anesthesiologists prioritize preventing perioperative complications, using prototype- and probability-based reasoning with varying uncertainty.
• Clinicians expressed confidence in anesthetic options when accepting patients for randomization.
• Despite supporting research, clinicians cited production pressure and workflow disruptions as major barriers to participation.

Conclusions:

• Current assessments of clinician randomization decisions may overlook the nuances of clinical reasoning.
• Understanding clinicians' specific reasoning patterns is crucial for evaluating enrollment decisions and anticipating future participation.
• Tailored approaches considering clinical reasoning are needed to improve pragmatic trial recruitment and generalizability.