ESTIMATING EFFICACY OF A MEDICAL INTERVENTION

估计医疗干预的效果

• 批准号: 6138851
• 负责人: JAMES TRUSSELL
• 金额: $ 17.19万
• 依托单位: PRINCETON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-01-01 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6138851
• 关键词: Europe; United States; computer data analysis; drug screening /evaluation; human data; induced abortion; pharmacology

In France, where medical abortion has been available longest, the majority of eligible women elect medical rather than surgical abortion when given a choice. Although not yet widely available in the United States, American women will soon also have a choice of several methods of medical abortion and may be expected to opt for medical methods. The goal of this project is to devise a standard method for analyzing the efficacy of medical abortion and to use the method to resolve several pressing clinical questions about the regimens. To date, research on the efficacy of medical abortion has followed the conceptual model used for analysis of surgical abortion; the failure rate is computed by simple division and expressed as a proportion. The problem, however, is that while surgical abortion is a discrete event occurring in the space of a few minutes or less, medical abortion is a process typically lasting from several days to several weeks. In this process, two events may occur that are not encountered with surgical abortion. A woman can opt out of the process before a determination of efficacy is possible by electing to have a surgical termination or a clinician can perform a surgical intervention that is not medically necessary. Protocols specify different maximum waiting periods. Probabilities of failure, therefore, should explicitly account for differences in observation periods. For these reasons, we propose and defend a conceptual scheme for analyzing efficacy with appropriate life-table procedures. We further propose to reanalyze data on more than 10,000 subjects in large multi-center clinical trials that have already been (or are currently being conducted) in the United States, Europe, and several developing countries. Following the scheme that we outline, we will produce new and consistent estimates of the efficacy of the main regimens and thereby help to resolve eight important unanswered clinical questions that will affect protocols for the regimens that will be adopted in the United States.

在药物流产历史最悠久的法国， 大多数符合条件的女性选择药物治疗而不是手术治疗 当有选择时堕胎。 虽然尚未广泛普及 在美国，美国女性很快也将有选择 几种药物流产方法，可能会选择 用于医疗方法。 该项目的目标是设计一个 药物流产疗效分析标准方法 并用该方法解决了临床上的一些紧迫问题 有关治疗方案的问题。 迄今为止，功效研究 药物流产的概念模型遵循 手术流产分析；故障率的计算公式为 简单除法并以比例表示。 问题， 然而，虽然手术流产是一个离散事件 药物流产发生在几分钟或更短的时间内 是一个通常持续几天到几天的过程 几周。 在这个过程中，可能会发生两个不存在的事件： 遇到过手术流产。 女性可以选择退出 确定功效之前的过程是可能的 选择手术终止妊娠或临床医生可以 进行非医学上必要的外科手术。 协议规定了不同的最长等待期。 因此，失败的概率应该明确考虑 观察期间的差异。 由于这些原因，我们 提出并捍卫分析功效的概念方案 具有适当的生命表程序。 我们进一步建议 重新分析大型多中心超过 10,000 名受试者的数据 已经（或正在进行）的临床试验 进行）在美国、欧洲和一些发展中国家 国家。 按照我们概述的计划，我们将生产 对主要治疗方案疗效的新且一致的估计 从而帮助解决八个重要的悬而未决的临床问题 会影响治疗方案的问题 被美国采用。