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青少年及青年癌症临床试验中远程同意书的使用,儿童肿瘤学组报告

Utilization of Teleconsent for Adolescent and Young Adult Cancer Clinical Trials, a Report from the Children's Oncology Group.

作者信息

Terao Michael, Mittal Nupur, Roth Michael, Saha Aniket, Super Leanne, Reichek Jennifer

机构信息

Office of Student Learning and Academic Advising, Georgetown University School of Medicine, Washington, District of Columbia, USA.

Department of Pediatrics, Rush University Medical Center, Chicago, Chicago, USA.

出版信息

J Adolesc Young Adult Oncol. 2024 Feb;13(1):132-137. doi: 10.1089/jayao.2023.0085. Epub 2023 Aug 4.

Abstract

Adolescents and young adults (AYAs, ages 15-39 years) are underrepresented in oncology clinical trials. Reasons for this include accessibility of the trial and whether the trial is presented to AYAs. The coronavirus disease 2019 (COVID-19) pandemic not only amplified these enrollment challenges but also presented opportunities for improving the enrollment process through virtual methods such as electronic informed consent and teleconsent. While AYAs are well positioned to take advantage of these opportunities, the extent to which institutions utilize remote enrollment processes is unclear. The goal of this study was to identify the utilization of and barriers to using teleconsent for AYA oncology clinical trials. The Children's Oncology Group (COG) AYA Responsible Investigator (RI) Network Teleconsent Working Group sought to understand teleconsent utilization both before and during the pandemic. The working group developed an online survey distributed via email to COG AYA RI Network members ( = 197). The survey received 49 responses (25%) from 40 different institutions. Before the pandemic, 13% of respondents reported that their institution allowed study enrollment via teleconsent. After the pandemic, 23% reported using teleconsent for clinical trial enrollment and 38% reported changes in institutional Review Board policies and procedures allowing teleconsent. Respondents reported that the greatest benefit of teleconsent was patient convenience and the greatest barrier was institutional restrictions on teleconsent utilization. Respondents reported that sharing institutional guidelines would be the most helpful intervention to improve teleconsent adoption. Teleconsent is a promising but underutilized approach. Institutions should work together to address common challenges to accessibility and acceptance of clinical trials by AYA cancer patients.

摘要

青少年和青年(年龄在15至39岁之间的AYA)在肿瘤学临床试验中的代表性不足。原因包括试验的可及性以及试验是否向AYA进行了介绍。2019冠状病毒病(COVID-19)大流行不仅加剧了这些入组挑战,还提供了通过电子知情同意和电话同意等虚拟方法改进入组流程的机会。虽然AYA有很好的条件利用这些机会,但各机构利用远程入组流程的程度尚不清楚。本研究的目的是确定在AYA肿瘤学临床试验中使用电话同意的情况及障碍。儿童肿瘤学组(COG)AYA责任研究者(RI)网络电话同意工作组试图了解大流行之前和期间电话同意的使用情况。该工作组开展了一项在线调查,通过电子邮件分发给COG AYA RI网络成员(n = 197)。该调查收到了来自40个不同机构的49份回复(25%)。在大流行之前,13%的受访者报告称他们的机构允许通过电话同意进行研究入组。在大流行之后,23%的受访者报告在临床试验入组中使用了电话同意,38%的受访者报告机构审查委员会的政策和程序发生了变化,允许电话同意。受访者表示电话同意的最大好处是患者便利,最大障碍是机构对电话同意使用的限制。受访者表示分享机构指南将是提高电话同意采用率最有帮助的干预措施。电话同意是一种有前景但未得到充分利用的方法。各机构应共同努力,应对AYA癌症患者参与临床试验在可及性和接受度方面的共同挑战。

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