Leventhal H, Nerenz D R, Leventhal E A, Love R R, Bendena L M
Institute for Health, Health Care Policy, and Aging Research, Division on Health, Rutgers University, New Brunswick, New Jersey 08903.
Prev Med. 1991 Jan;20(1):132-46. doi: 10.1016/0091-7435(91)90014-u.
Two ways of approaching the design of long-term clinical trials are presented and contrasted. The first, termed the "static" view, emphasizes close adherence to formal rules of study design. The second, termed the "dynamic" view, emphasizes the behavioral aspects of patient participation in trials of long duration. The dynamic view is discussed in detail, with discussion of how recruitment of participants, random assignment to conditions, compliance with protocol, and measurement of outcomes are affected by behavioral dynamics. Data from a recently completed tamoxifen toxicity trial are used to illustrate the points and to focus the discussion of behavioral dynamics on the design of a chemoprevention trial for breast cancer using tamoxifen.
本文介绍并对比了两种进行长期临床试验设计的方法。第一种方法被称为“静态”观点，强调严格遵循研究设计的正式规则。第二种方法被称为“动态”观点，强调患者在长期试验中参与的行为方面。本文详细讨论了动态观点，并探讨了行为动态如何影响参与者的招募、条件的随机分配、方案的依从性以及结果的测量。最近完成的一项他莫昔芬毒性试验的数据被用于阐述这些要点，并将行为动态的讨论聚焦于使用他莫昔芬进行乳腺癌化学预防试验的设计上。
