Gagnon J, Province M A, Bouchard C, Leon A S, Skinner J S, Wilmore J H, Rao D C
Physical Activity Sciences Laboratory, Laval University, Quebec, P.Q., Canada.
Ann Epidemiol. 1996 Nov;6(6):520-9. doi: 10.1016/s1047-2797(96)00068-3.
The HERITAGE (HEalth, RIsk factors, exercise Training And GEnetics) Family Study is the first multicenter family clinical trial of its kind. Conducted by a consortium of five universities in the United States and Canada, the study has as its primary goal to document the role of the genotype in the cardiovascular, metabolic, and hormonal responses to aerobic exercise training. A comprehensive protocol was implemented at four Clinical Centers (CC) for the generation of data on sedentary subjects. This group included 450 caucasians from 90 nuclear families (father, mother, three children) and 200 black subjects from 40 to 100 family units over a 5-year period. The entire family was tested before and after a 20-week exercise training program. The fifth participating center, the Data Coordinating Center (DCC), is responsible for data management and data analysis. A Consortium Coordinating Center (CCC) responsible for the overall coordination and direction of the study was established at the Quebec CC. Quality assurance and quality control are jointly coordinated by the CCC and the DCC. A multicenter study of this magnitude requires careful standardization of all procedures and constant monitoring of quality control at all levels of operation. This report describes the quality assurance and quality control measures implemented in the HERITAGE Family Study, including some examples with real data.
HERITAGE（健康、风险因素、运动训练与遗传学）家族研究是同类研究中的首个多中心家族临床试验。该研究由美国和加拿大五所大学组成的联盟开展，其主要目标是记录基因型在有氧运动训练的心血管、代谢和激素反应中的作用。在四个临床中心（CC）实施了一项全面方案，以生成久坐不动受试者的数据。在5年期间，该组包括来自90个核心家庭（父亲、母亲、三个孩子）的450名白种人和来自40至100个家庭单位的200名黑人受试者。整个家族在为期20周的运动训练计划前后均接受了测试。第五个参与中心，即数据协调中心（DCC），负责数据管理和数据分析。在魁北克临床中心设立了一个负责该研究总体协调和指导的联盟协调中心（CCC）。质量保证和质量控制由CCC和DCC共同协调。如此规模的多中心研究需要对所有程序进行仔细标准化，并在各级操作中持续监测质量控制。本报告描述了HERITAGE家族研究中实施的质量保证和质量控制措施，包括一些实际数据示例。
