Communication during the recruitment phase of a multicenter trial: the recruitment hotline.
The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized trial that compares the safety and efficacy of angioplasty and bypass surgery in selected patients with multivessel coronary disease. During recruitment, the Clinical Coordinating Center (CC) required an organized manner of responding to the many questions expected from the 18 clinical sites. Thus a dedicated telephone line was established to provide the clinical sites with information quickly and ensure consistent dissemination of information. In addition, the hotline functioned as a backup mechanism for patient randomization in the event of a computer failure at one of the sites. During the first 13 months of recruitment, 1332 calls were received. The average number of daily calls peaked at 7.3 with 14 calls being the highest in any one day. Calls gradually declined as the clinical sites became more familiar with the protocol, data collection forms, and computer systems. Most questions were answered by the data management staff; however a substantial number (37%) required faculty level input. For questions that could not be answered immediately, the median time for a return call was 25 min. The BARI hotline was an efficient way to provide accurate and consistent feedback to all sites and to identify areas that required protocol clarification. It allowed rapid identification of differences in protocol interpretation across sites so that these variations could be addressed. Review of specific questions by the Operations Committee resulted in decisions on how to apply the protocol to particularly difficult or exceptional cases. While the system was labor-intensive, its benefits outweighed this disadvantage. Recommended modifications to lower costs would result in a system that could be easily adapted for use in other clinical trials.
Sutton-Tyrrell
K
K
BARI Clinical Coordinating Center, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, PA, USA.
Crow
S
S
Hankin
B
B
Trudel
J
J
Faille
C
C
D015277:Hotlines / Q000458:organization & administration*; D006801:Humans; D007255:Information Services / Q000458:organization & administration*; D008331:Management Information Systems; D015337:Multicenter Studies as Topic / Q000379:methods*; D009204:Myocardial Revascularization; D018579:Patient Selection; D010559:Personnel Management; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014584:User-Computer Interface