开发和评估多媒体信息资源以提高儿童、青少年及其父母参与试验的程度（TRECA研究）：一系列关联随机对照试验的研究方案
Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials.
作者信息
Martin-Kerry Jacqueline, Bower Peter, Young Bridget, Graffy Jonathan, Sheridan Rebecca, Watt Ian, Baines Paul, Stones Catherine, Preston Jennifer, Higgins Steven, Gamble Carrol, Knapp Peter
机构信息
Department of Health Sciences, University of York, Heslington, YO10 5DD, York, UK.
MRC North West Hub for Trials Methodology Research, NIHR School for Primary Care Research, University of Manchester, M13 9PL, Manchester, UK.
出版信息
Trials. 2017 Jun 8;18(1):265. doi: 10.1186/s13063-017-1962-z.
BACKGROUND
Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.
METHODS
The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members' decision-making processes, when compared to standard participant information sheets alone.
DISCUSSION
This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.
TRIAL REGISTRATION
ISRCTN registry: ISRCTN73136092 (doi: 10.1186/ISRCTN73136092 ). Registered on 24 August 2016.
背景
随机对照试验已被广泛确立为测试健康干预措施同时尽量减少偏倚的最佳方法。然而，在医疗保健试验中招募儿童和青少年并使其随后继续参与试验具有挑战性。参与者信息表往往冗长，难以阅读和理解。使用多媒体呈现关键信息可能有助于克服这些限制，并更好地支持年轻人及其父母决定是否参与临床试验。
方法
TRECA（儿童和青少年试验参与）研究有两个阶段。第一阶段涉及对儿童、青少年及其父母进行定性研究，以为多媒体信息资源的开发提供参考，并进行迭代用户测试以完善这些资源。第二阶段将把多媒体信息资源的使用纳入英国的六项主要试验中。被邀请参与主要试验的患者和父母将被随机分配，要么将多媒体信息资源与标准参与者信息表结合使用，要么单独使用多媒体信息资源，要么仅使用标准参与者信息表。主要结果将是多媒体信息资源对试验招募的影响。与仅使用标准参与者信息表相比，测量的其他结果包括多媒体信息资源对参与者继续参与主要试验的影响以及对家庭成员决策过程的影响。
讨论
本研究将确定使用参与式设计原则开发的多媒体信息资源是否能够增加儿童和青少年参与试验的招募率和留存率。患者还有可能通过使用多媒体信息资源做出更明智的决定。多媒体信息资源还有助于提供临床试验之外其他医疗保健决策的信息。
试验注册
ISRCTN注册库：ISRCTN73136092（doi: 10.1186/ISRCTN73136092）。于2016年8月24日注册。
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