Kingry Connie, Bastien Arnaud, Booth Gillian, Geraci Therese S, Kirpach Brenda R, Lovato Laura C, Margolis Karen L, Rosenberg Yves, Sperl-Hillen JoAnne M, Vargo Laura, Williamson Jeff D, Probstfield Jeffrey L
Division of Cardiology, Department of Medicine, University of Washington Medical Center, Seattle, Washington 98103, USA.
Am J Cardiol. 2007 Jun 18;99(12A):68i-79i. doi: 10.1016/j.amjcard.2007.03.025. Epub 2007 Apr 12.
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter clinical trial using a double 2 x 2 factorial design in 10,251 participants with type 2 diabetes mellitus at high risk for cardiovascular disease (CVD) events. ACCORD is testing 3 complementary medical treatment strategies that may reduce high rates of major CVD morbidity and mortality in patients with type 2 diabetes. The ACCORD vanguard phase, conducted at 59 clinics in the United States and Canada, recruited 1,174 participants in 20 weeks from January through June 1, 2001, with a recruitment efficiency (R-factor) of 0.65. The recruitment strategies used in this vanguard phase were almost exclusively chart and database review within clinical practices and institutions. Recruitment for the main trial began in February 2003, involved 77 clinics, and resulted in an additional 9,077 participants by October 29, 2005 (total, 10,251). The R-factor during main trial recruitment was 0.96. Although new and refined recruitment strategies were formulated from the vanguard experience, the most powerful determinant of improved recruitment efficiency was the immediate start of enrollment by most clinics at the beginning of the main trial. Recruitment in the main trial required only a brief extension of 3 months and facilitated the nearly complete capture of the expected number of person-years of observation. Described herein are vanguard and main trial recruitment activities, including strategy implementation, screening procedures, randomization results, problems encountered, and lessons learned.
糖尿病心血管风险控制行动（ACCORD）试验是一项随机、多中心临床试验，采用双2×2析因设计，纳入了10251名患有2型糖尿病且心血管疾病（CVD）事件高危的参与者。ACCORD正在测试3种互补的医学治疗策略，这些策略可能降低2型糖尿病患者主要CVD发病率和死亡率的高发生率。ACCORD先锋阶段在美国和加拿大的59个诊所进行，在2001年1月至6月1日的20周内招募了1174名参与者，招募效率（R因子）为0.65。该先锋阶段使用的招募策略几乎完全是在临床实践和机构内进行图表和数据库审查。主要试验的招募于2003年2月开始，涉及77个诊所，到2005年10月29日又招募了9077名参与者（总计10251名）。主要试验招募期间的R因子为0.96。尽管根据先锋阶段的经验制定了新的和改进的招募策略，但招募效率提高的最有力决定因素是大多数诊所在主要试验开始时立即开始入组。主要试验的招募仅需短暂延长3个月，并有助于几乎完全获取预期的观察人年数。本文描述了先锋阶段和主要试验的招募活动，包括策略实施、筛查程序、随机化结果、遇到的问题和吸取的经验教训。
