Treatment research at the crossroads: The scientific interface of clinical trials and effectiveness research
Treatment research at the crossroads: The scientific interface of clinical trials and effectiveness research
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DOI：
10.1176/ajp.156.1.5
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发表时间：
1999-01-01
影响因子：
17.7
通讯作者：
Wells, KB
中科院分区：
文献类型：
--
作者：
Wells, KB
目的：政策和临床管理决策取决于常规护理下精神病治疗对健康和成本影响的数据，即，有效性然而，临床试验提供了在最佳实践条件下治疗效果的信息。对疗效和有效性研究的设计、分析和惯例的理解可以使研究更好地为临床和社会问题提供信息。方法：本文对比了临床试验和有效性研究的优势和局限性，以解决政策和临床决策。这些研究方法进行评估的结果，治疗，服务提供的背景下，实施公约和有效性。结果如下：临床试验和有效性研究共享内部和外部效度的问题，尽管在临床试验中更关注内部效度（例如，随机化、盲法、标准化方案）和有效性研究中的外部有效性（例如，以社区为基础的治疗，代表性样品）。结论：为了在临床试验和有效性研究的界面上开展研究，必须重新定义研究目标，必须共享和发展成本效用和计量经济学分析等方法。开发联合收割机，结合功效和有效性研究的特点，将需要分离的公约，如频率的后续行动，强度的测量，样本量的中心科学问题的目的和有效性。
Objective: Policy and clinical management decisions depend on data on the health and cost impacts of psychiatric treatments under usual care, i.e., effectiveness. Clinical trials, however, provide information on treatment efficacy under best-practice conditions. An understanding of the design, analysis, and conventions of both efficacy and effectiveness studies can lead to research that better informs clinical and societal questions. Method: This paper contrasts the strengths and limitations of clinical trials and effectiveness studies for addressing policy and clinical decisions. These research approaches are assessed in terms of outcomes, treatments, service delivery context, implementation conventions, and validity. Results: Clinical trials and effectiveness research share problems of internal and external validity despite more attention to internal validity in clinical trials (e.g., randomization, blinding, standardized protocols) and to external validity in effectiveness studies (e.g., community-based treatments, representative samples). Conclusions: To develop research at the interface of clinical trials and effectiveness studies, research goals must be redefined, and methods, such as cost-utility and econometric analyses, must be shared and developed. Development of hybrid designs that combine features of efficacy and effectiveness research will require separation of conventions such as frequency of follow-up, intensity of measurement, and sample size from the central scientific issues of aims and validity.