{"title":"临床试验和意向治疗分析的未来方向:通过正确的问题实现令人钦佩的意图。","authors":"Wendy K Silverman, Jeremy W Pettit, James Jaccard","doi":"10.1080/15374416.2024.2384035","DOIUrl":null,"url":null,"abstract":"<p><p>We call for clinical trials researchers to carefully consider questions about use of intention-to-treat (ITT) analysis and per protocol analysis. We discuss how questions about <i>efficacy and mechanisms of efficacy</i> are appropriately answered through the application of per protocol analysis. ITT analysis is well-suited and appropriate for addressing questions related to treatment <i>effectiveness</i>, typically adherence to the treatment with respect to an outcome. While guided by admirable intentions, ITT analysis is often not guided by the right questions, leading to ITT misapplication. We address additional misconceptions that often lead to ITT misapplication, including issues relating to treatment noncompletion and violation of random assignment. We further highlight future directions and implications, particularly that future clinical child and adolescent research trial designs will be increasingly characterized by hybrid trials that combine elements of efficacy, effectiveness, and implementation research, where ITT and per protocol analysis will be appropriately applied to answer the right questions.</p>","PeriodicalId":48350,"journal":{"name":"Journal of Clinical Child and Adolescent Psychology","volume":null,"pages":null},"PeriodicalIF":4.2000,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Future Directions in Clinical Trials and Intention-To-Treat Analysis: Fulfilling Admirable Intentions Through the Right Questions.\",\"authors\":\"Wendy K Silverman, Jeremy W Pettit, James Jaccard\",\"doi\":\"10.1080/15374416.2024.2384035\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>We call for clinical trials researchers to carefully consider questions about use of intention-to-treat (ITT) analysis and per protocol analysis. We discuss how questions about <i>efficacy and mechanisms of efficacy</i> are appropriately answered through the application of per protocol analysis. ITT analysis is well-suited and appropriate for addressing questions related to treatment <i>effectiveness</i>, typically adherence to the treatment with respect to an outcome. While guided by admirable intentions, ITT analysis is often not guided by the right questions, leading to ITT misapplication. We address additional misconceptions that often lead to ITT misapplication, including issues relating to treatment noncompletion and violation of random assignment. We further highlight future directions and implications, particularly that future clinical child and adolescent research trial designs will be increasingly characterized by hybrid trials that combine elements of efficacy, effectiveness, and implementation research, where ITT and per protocol analysis will be appropriately applied to answer the right questions.</p>\",\"PeriodicalId\":48350,\"journal\":{\"name\":\"Journal of Clinical Child and Adolescent Psychology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2024-08-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Child and Adolescent Psychology\",\"FirstCategoryId\":\"102\",\"ListUrlMain\":\"https://doi.org/10.1080/15374416.2024.2384035\",\"RegionNum\":1,\"RegionCategory\":\"心理学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHOLOGY, CLINICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Child and Adolescent Psychology","FirstCategoryId":"102","ListUrlMain":"https://doi.org/10.1080/15374416.2024.2384035","RegionNum":1,"RegionCategory":"心理学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHOLOGY, CLINICAL","Score":null,"Total":0}
引用次数: 0
摘要
我们呼吁临床试验研究人员仔细考虑有关使用意向治疗(ITT)分析和按方案分析的问题。我们将讨论如何通过应用按方案分析来恰当地回答疗效和疗效机制方面的问题。ITT 分析非常适合解决与治疗效果有关的问题,通常是与治疗结果有关的治疗依从性问题。虽然 ITT 分析的出发点令人钦佩,但它往往没有以正确的问题为导向,从而导致 ITT 应用的失误。我们讨论了经常导致 ITT 应用错误的其他误解,包括与治疗未完成和违反随机分配有关的问题。我们进一步强调了未来的发展方向和意义,特别是未来的儿童和青少年临床研究试验设计将越来越多地以混合试验为特征,这些试验结合了疗效、有效性和实施研究的要素,在这些试验中,ITT 分析和按方案分析将被恰当地应用于回答正确的问题。
Future Directions in Clinical Trials and Intention-To-Treat Analysis: Fulfilling Admirable Intentions Through the Right Questions.
We call for clinical trials researchers to carefully consider questions about use of intention-to-treat (ITT) analysis and per protocol analysis. We discuss how questions about efficacy and mechanisms of efficacy are appropriately answered through the application of per protocol analysis. ITT analysis is well-suited and appropriate for addressing questions related to treatment effectiveness, typically adherence to the treatment with respect to an outcome. While guided by admirable intentions, ITT analysis is often not guided by the right questions, leading to ITT misapplication. We address additional misconceptions that often lead to ITT misapplication, including issues relating to treatment noncompletion and violation of random assignment. We further highlight future directions and implications, particularly that future clinical child and adolescent research trial designs will be increasingly characterized by hybrid trials that combine elements of efficacy, effectiveness, and implementation research, where ITT and per protocol analysis will be appropriately applied to answer the right questions.
期刊介绍:
The Journal of Clinical Child and Adolescent Psychology (JCCAP) is the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association. It publishes original contributions on the following topics: (a) the development and evaluation of assessment and intervention techniques for use with clinical child and adolescent populations; (b) the development and maintenance of clinical child and adolescent problems; (c) cross-cultural and sociodemographic issues that have a clear bearing on clinical child and adolescent psychology in terms of theory, research, or practice; and (d) training and professional practice in clinical child and adolescent psychology, as well as child advocacy.