Sutton-Tyrrell K, Crow S, Hankin B, Trudel J, Faille C
BARI Clinical Coordinating Center, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, PA, USA.
Control Clin Trials. 1996 Oct;17(5):415-22. doi: 10.1016/s0197-2456(95)00153-0.
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.
旁路血管成形术血运重建研究（BARI）是一项随机试验，比较血管成形术和搭桥手术在选定的多支冠状动脉疾病患者中的安全性和有效性。在招募期间，临床协调中心（CC）需要一种有组织的方式来回应来自18个临床站点的众多问题。因此，设立了一条专用电话线，以便迅速向临床站点提供信息，并确保信息的一致传播。此外，该热线在某个站点出现计算机故障时作为患者随机分组的备用机制。在招募的前13个月里，共接到1332个电话。每日平均电话数量峰值为7.3个，其中一天最多接到14个电话。随着临床站点对方案、数据收集表和计算机系统越来越熟悉，电话数量逐渐减少。大多数问题由数据管理人员回答；然而，相当数量（37%）的问题需要教员层面的投入。对于无法立即回答的问题，回电的中位时间为25分钟。BARI热线是一种向所有站点提供准确一致反馈并确定需要方案澄清的领域的有效方式。它能够快速识别各站点在方案解释上的差异，以便解决这些差异。运营委员会对具体问题的审查导致了关于如何将方案应用于特别困难或特殊情况的决策。虽然该系统劳动强度大，但其好处超过了这一缺点。为降低成本而建议的修改将产生一个可轻松适用于其他临床试验的系统。
