| Summary: | Objective: To determine General Practitioners' reasons for not entering patients into a clinical trial comparing the safety and effectiveness of outpatient anti-coagulation management by community pharmacists and physicians. Methods: A prospective, randomized comparison of community pharmacy and physician-based warfarin management was developed. All General Practitioners practicing on the North Shore were invited to participate. After eighteen months of physician recruitment, only eight had agreed to participate. To determine reasons for
physicians' non-participation in this research, a comprehensive survey was developed. Surveys were mailed to all General Practitioners (n=l 18) who had been invited to participate in the original clinical trial: 8 who had agreed to participate and 110 who had not. Physicians were asked the extent to which they agreed to specific statements describing potential concerns with the study and to rank the most important reasons why they did or did not participate in the clinical trial. A $50 cheque was included with all surveys, and reminders were sent at one and four weeks. Responses were anonymous. Results: The response rate from physicians who had not participated in the clinical trial
was 78 out of 110 (73%). Sixty-four of 78 respondents (83%) had five or more warfarin
patients in their practice, and only one had no eligible patients. Thirty-nine (51%) had
participated in 1 to 5 clinical trials in the past, while twenty-nine (38%) had no previous trail participation. The three most important reasons for not entering patients were "concern about the issue of legal liability" (40%), "concern about healthcare
professionals taking over physician responsibilities" (33%), and "desire to remain responsible for patients" (29%). The response rate for the eight physicians who agreed to enter patients was 100%. The most important reason for agreeing to participate was the belief that "research advances the profession" (87%). Conclusion: General practitioners were reluctant to enter patients in a clinical trial that
involved pharmacists taking on additional responsibility for patient care. Issues of
responsibility and legal liability, as well as concern about other health care professionals taking over physicians' duties need to be clearly addressed.
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