Article Figures & Data
Tables
Physician Affiliation System A n (%) System B n (%) System C n (%) System D n (%) P Value Approached 73 55 58 25 Consented 33 (45.2) 24 (43.6) 29 (50.0) 19 (76.0) .040 Completed 27 (37.0) 20 (36.4) 23 (39.7) 14 (56.0) .355 Mean (SD) Mean (SD) Mean (SD) P Value Time from first contact to consent, days 31.24 (44.58) 49.75 (89.75) 32.24 (29.60) .667 Number of contacts before consent 2.45 (1.72) 1.71 (1.04) 2.97 (0.73) <.001* -
SD, standard deviation.
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System A: The Research Coordinator (RC) was responsible for contacting and consenting physicians as well as ensuring completion of study materials. System B: A system physician champion helped the RC make first contact with physician subjects. The RC was then responsible for contacting and consenting physicians and ensuring completion of study materials. System C: The system physician champion selected a lead physician at each clinic. This person worked with the RC for contacting and consenting physicians as well as ensuring completion of study materials. System D: The system physician champion was responsible for all contact with the physician participants. The RC was not permitted to contact physician participants directly. Data for time from first contact to consent and number of contacts before consent were not available for System D.
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↵* Significant differences were observed between all three groups for number of contacts before consent.
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Physician Affiliation System A System B System C System D Date of initial IRB submission 04/24/08 07/09/08 06/09/08 06/09/08 Date of initial IRB approval 05/23/08 09/10/08 10/28/08 06/27/08 Date of final IRB approval* 08/13/08 09/16/08 11/13/08 07/13/08 Total time for final approval, days 111 69 157 34 -
IRB, institutional review board.
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System A: The Research Coordinator (RC) was responsible for contacting and consenting physicians as well as ensuring completion of study materials. System B: A system physician champion helped the RC make first contact with physician subjects. The RC was then responsible for contacting and consenting physicians and ensuring completion of study materials. System C: The system physician champion selected a lead physician at each clinic. This person worked with the RC for contacting and consenting physicians as well as ensuring completion of study materials. System D: The system physician champion was responsible for all contact with the physician participants. The RC was not permitted to contact physician participants directly. Data for time from first contact to consent and number of contacts before consent were not available for System D.
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↵* Difference between date of initial and final IRB approval reflects the need for amendment(s).
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Ensure adequate time for IRB approval.
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Take advantage of the established organizational structure within each site.
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Make friends with the office personnel. They control access to the physicians.
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Distinguish the research team from pharmaceutical representatives.
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Establish a preferred method of contact with each physician.
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Set deadlines for study completion.
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Provide information and materials in multiple technological formats to account for individual preferences.
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PBRN, practice-based research network; IRB, institutional review board.
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