Wisniewski Stephen R, Stegman Diane, Trivedi Madhukar, Husain Mustafa M, Eng Heather, Shores-Wilson Kathy, Luther James, Biggs Melanie M, Burroughs Diane, Ritz A Louise, Fava Maurizio, Quitkin Frederic, Rush A John
Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA 15261, USA.
J Psychiatr Res. 2004 May-Jun;38(3):241-8. doi: 10.1016/j.jpsychires.2003.06.001.
In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STARD) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STARD Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.
在大型多中心试验中，可行性研究或预试验对于在正式研究启动之前测试开展该研究各方面的功能可能至关重要。针对“缓解抑郁的序贯治疗方案”（STARD）项目开展了一项可行性试验，这是一项针对非精神病性重度抑郁症门诊患者的多中心、前瞻性、序贯随机临床试验。从2000年12月14日至2001年6月8日，对42名患者进行了入选STARD可行性试验的筛查。24名符合条件并同意参与的患者接受了西酞普兰治疗，为期长达12周。在该试验过程中，出现了一些问题，导致研究程序有所修改。因该试验而做出的修改影响了四个方面：（1）沟通；（2）患者和医疗服务提供者的负担；（3）数据收集表格；（4）受试者的招募和留存。本文描述了在STAR*D可行性试验中所学到的内容，以便计划开展类似试验的研究人员能够了解开展此类研究项目的实际问题。虽然所收集的信息很有用，但它确实推迟了正式试验的启动。我们认为这笔成本是对整体研究程序开发的一种投资，这应该会带来更完善的研究。
