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.
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。