Centre for Ageing Population Studies, Primary Care and Population Health, University College London, London, UK.
Department of Clinical and Movement Neurosciences, Institute of Neurology, University College London, London, UK.
Clin Trials. 2022 Dec;19(6):665-672. doi: 10.1177/17407745221118555. Epub 2022 Aug 26.
BACKGROUND/AIMS: Self-management interventions are increasingly being developed and researched to improve long-term condition outcomes. To understand and interpret findings, it is essential that fidelity of intervention delivery and participant engagement are measured and reported. Before developing fidelity checklists to assess treatment fidelity of interventions, current recommendations suggest that a synthesis of fidelity measures reported in the literature is completed. Therefore, here we aim to identify what the current measures of fidelity of intervention delivery and engagement for self-management interventions for long-term conditions are and whether there is treatment fidelity.
Four databases (MEDLINE, PubMed, CINAHL Plus and ScienceDirect) and the journal implementation science were systematically searched to identify published reports from inception to December 2020 for experimental studies measuring fidelity of intervention delivery and/or participant engagement in self-management interventions for long-term conditions. Data on fidelity of delivery and engagement measures and the findings were extracted and synthesised.
Thirty-nine articles were identified as eligible, with 25 studies measuring fidelity of delivery, 19 reporting engagement and 5 measuring both. For fidelity of delivery, measures included structured checklists, participant completed measures and researcher observations/notes. These were completed by researchers, participants and intervention leaders. Often there was little information around the development of these measures, particularly when the measure had been developed by the researchers, rather than building on others work. Eighteen of 25 studies reported there was fidelity of intervention delivery. For engagement, measures included data analytics, participant completed measures and researcher observations. Ten out of 19 studies reported participants were engaged with the intervention.
In complex self-management interventions, it is essential to assess whether treatment fidelity of each core component of interventions is delivered, as outlined in the protocol, to understand which components are having an effect. Treatment fidelity checklists comparing what was planned to be delivered, with what was delivered should be developed with pre-defined cut-offs for when fidelity has been achieved. Similarly, when measuring engagement, while data analytics continue to rise with the increase in digital interventions, clear cut-offs for participant use and content engaged with to be considered an engagement participant need to be pre-determined.
背景/目的:自我管理干预措施正日益被开发和研究,以改善长期病情的结果。为了理解和解释研究结果,必须测量和报告干预措施的实施保真度和参与者的参与度。在开发评估干预措施治疗保真度的保真度检查表之前,目前的建议是完成文献中报告的保真度措施的综合分析。因此,在这里,我们旨在确定当前用于长期疾病自我管理干预措施的干预措施交付和参与的保真度的衡量标准是什么,以及是否存在治疗保真度。
系统地检索了四个数据库(MEDLINE、PubMed、CINAHL Plus 和 ScienceDirect)和期刊实施科学,以确定从开始到 2020 年 12 月发表的实验研究报告,这些研究报告测量了长期疾病自我管理干预措施的干预措施交付和/或参与者参与的保真度。提取并综合了交付和参与措施的保真度数据和研究结果。
确定了 39 篇符合条件的文章,其中 25 项研究测量了交付的保真度,19 项报告了参与度,5 项测量了两者。对于交付的保真度,措施包括结构化检查表、参与者完成的措施和研究人员观察/笔记。这些由研究人员、参与者和干预负责人完成。这些措施的开发通常缺乏信息,特别是当这些措施是由研究人员开发的,而不是在他人工作的基础上开发的。25 项研究中有 18 项报告了干预措施的交付保真度。对于参与度,措施包括数据分析、参与者完成的措施和研究人员观察。19 项研究中有 10 项报告了参与者对干预措施的参与。
在复杂的自我管理干预措施中,必须评估是否按照方案交付了干预措施的每个核心组成部分的治疗保真度,以了解哪些组成部分产生了效果。应该开发治疗保真度检查表,将计划交付的内容与实际交付的内容进行比较,并为达到保真度设定预设的截止值。同样,在测量参与度时,虽然随着数字干预措施的增加,数据分析不断增加,但需要预先确定用于考虑参与的参与者的明确截止值,以及用于考虑参与的参与者的用户使用和参与内容。