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接受或不接受 iAdhere 的原因:潜伏性结核感染治疗试验。

Reasons for acceptance or nonparticipation in iAdhere: a trial of latent TB infection treatment.

机构信息

Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Public Health Institute at Denver Health, Denver, CO, USA.

出版信息

Int J Tuberc Lung Dis. 2024 Nov 1;28(11):521-526. doi: 10.5588/ijtld.23.0599.

Abstract

BACKGROUNDUnderstanding the motivations behind clinical trial participation can help enhance recruitment strategies and determine the generalizability of trial results. This study focuses on the reasons for participating in or declining the Tuberculosis Trials Consortium Study 33 (iAdhere), a clinical trial on the treatment of latent tuberculosis infection (LTBI).METHODSA quantitative evaluation was conducted among screened patients to ascertain their reasons for participating or not in the iAdhere trial. The study gathered data from enrolled participants and those who chose not to enroll.RESULTSAmong 1,002 enrolled individuals, 290 participants provided 749 reasons for enrolling. The most common reasons included access to shorter treatment regimens (56%), avoiding progression to TB disease (45%), and improving health (21%). Of the 670 eligible persons who chose not to enroll, 551 individuals provided 800 reasons, with the most common being a preference for standard therapy (17%), disinterest in study medication or TB therapy (both 13%), and the inconvenience of daily observed treatment (12%).CONCLUSIONThe desire for shorter treatment options and preventing active disease motivates participation in LTBI trials. The diverse reasons for declining enrolment suggest the importance of developing targeted recruitment strategies. These findings support exploring shorter treatment regimens and can guide future recruitment efforts..

摘要

背景了解参与临床试验的动机有助于加强招募策略,并确定试验结果的普遍性。本研究专注于参与或拒绝结核病临床试验联盟研究 33 号(iAdhere)的原因,该试验是一项关于潜伏性结核感染(LTBI)治疗的临床试验。方法在筛选出的患者中进行了定量评估,以确定他们参与或不参与 iAdhere 试验的原因。该研究从入组参与者和未入组的参与者中收集数据。结果在 1002 名入组的个体中,有 290 名参与者提供了 749 个入组原因。最常见的原因包括获得更短的治疗方案(56%)、避免进展为结核病(45%)和改善健康(21%)。在 670 名符合条件但选择不入组的人中,有 551 人提供了 800 个原因,最常见的原因是偏爱标准治疗(17%)、对研究药物或结核病治疗不感兴趣(均为 13%)以及日常观察治疗的不便(12%)。结论对更短治疗方案的需求和预防活动性疾病是参与 LTBI 试验的动机。拒绝入组的原因多种多样,这表明制定有针对性的招募策略非常重要。这些发现支持探索更短的治疗方案,并可以指导未来的招募工作。.

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