PDF(Pubmed)
Abstract：
BACKGROUND: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies.
METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items.
RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%).
CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.
METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items.
RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%).
CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.
摘要：
背景：招募临床试验参与者是一个持续的挑战，对于什么样的招聘策略会导致更好的招聘，人们知之甚少。招聘干预可以被认为是复杂的干预措施，通常涉及多个组件，针对不同的群体，适应不同的群体。我们使用干预描述和复制模板（TIDieR）报告清单（包括12项建议报告复杂干预措施）来指导评估如何描述招募干预措施。我们的目标是(1)检查在多大程度上我们可以识别招聘干预研究中每个TIDieR项目的信息，(2)观察每个项目的额外细节，以描述这些研究之间的有用差异。
方法：我们确定了随机，嵌套招募干预研究从两个来源提供招募或参与率的意愿：Cochrane对试验的审查，评估改善招募的策略，以随机试验，和临床研究数据库的在线资源。首先,我们评估了作者报告每个TIDieR项目信息的程度.第二,我们为7个TIDieR项目开发了描述性分类变量，并提取了其他5个项目的相关报价。
结果：我们评估了122项招募干预研究。我们能够提取与大多数TIDieR项目相关的信息(例如，简短的基本原理，材料,程序)，但少数很少报告的项目除外(例如，剪裁,修改,计划/实际保真度)。描述性变量提供了对研究特征的有用概述，大多数研究使用各种形式的信息干预（55％）在一个时间点（90％），通常由研究团队的一名成员(59%)在临床护理环境中(41%)。
结论：我们基于TIDieR的变量为复杂试验招募干预措施的核心要素提供了有用的描述。招聘干预研究可变地报告复杂干预的核心要素；一些过程要素(例如，交货方式,位置)几乎总是被描述，而其他人(例如，持续时间,保真度)很少报告，几乎没有迹象表明他们缺席的原因。未来的研究应探讨这些基于TIDieR的变量是否可以构成更好地报告成功招募干预措施要素的方法的基础。
方法：我们确定了随机，嵌套招募干预研究从两个来源提供招募或参与率的意愿：Cochrane对试验的审查，评估改善招募的策略，以随机试验，和临床研究数据库的在线资源。首先,我们评估了作者报告每个TIDieR项目信息的程度.第二,我们为7个TIDieR项目开发了描述性分类变量，并提取了其他5个项目的相关报价。
结果：我们评估了122项招募干预研究。我们能够提取与大多数TIDieR项目相关的信息(例如，简短的基本原理，材料,程序)，但少数很少报告的项目除外(例如，剪裁,修改,计划/实际保真度)。描述性变量提供了对研究特征的有用概述，大多数研究使用各种形式的信息干预（55％）在一个时间点（90％），通常由研究团队的一名成员(59%)在临床护理环境中(41%)。
结论：我们基于TIDieR的变量为复杂试验招募干预措施的核心要素提供了有用的描述。招聘干预研究可变地报告复杂干预的核心要素；一些过程要素(例如，交货方式,位置)几乎总是被描述，而其他人(例如，持续时间,保真度)很少报告，几乎没有迹象表明他们缺席的原因。未来的研究应探讨这些基于TIDieR的变量是否可以构成更好地报告成功招募干预措施要素的方法的基础。
