COMMUNICATION DURING THE RECRUITMENT PHASE OF A MULTICENTER TRIAL - THE RECRUITMENT HOTLINE

The Bypass Angioplasty Revascularization Investigation (BARI) is a ran domized 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 a n organized manner of responding to the many questions expected from t he 18 clinical sites. Thus a dedicated telephone line was established to provide the clinical sites with information quickly and ensure cons istent dissemination of information. In addition, the hotline function ed as a backup mechanism for patient randomization in the event of a c omputer failure at one of the sites. During the first 13 months of rec ruitment, 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 gr adually declined as the clinical sites became more familiar with the p rotocol, data collection forms, and computer systems. Most questions w ere answered by the data management staff; however a substantial numbe r (37%) required faculty level input. For questions that could not be answered immediately, the median time for a return call was 25 min. Th e BARI hotline was an efficient way to provide accurate and consistent feedback to all sites and to identify areas that required protocol cl arification. It allowed rapid identification of differences in protoco l interpretation across sites so that these variations could be addres sed. Review of specific questions by the Operations Committee resulted in decisions on how to apply the protocol to particularly difficult o r exceptional cases. While the system was labor-intensive, its benefit s outweighed this disadvantage. Recommended modifications to lower cos ts would result in a system that could be easily adapted for use in ot her clinical trials. (C) Elsevier Science Inc.