School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.
Centre for Brain and Mental Health Research, University of Newcastle, Callaghan, New South Wales, Australia.
BMJ Open. 2019 Jul 30;9(7):e028417. doi: 10.1136/bmjopen-2018-028417.
Treatment fidelity is an important and often neglected component of complex behaviour change research. It is central to understanding treatment effects, especially for evaluations conducted outside of highly controlled research settings. Ensuring that promising interventions can be delivered adequately (ie, with fidelity) by real-world clinicians within real-world settings is an essential step in developing interventions that are both effective and 'implementable'. Whether this is the case for behaviour change counselling, a complex intervention developed specifically for maximising the effectiveness of real-world consultations about health behaviour change, remains unclear. To improve our understanding of treatment effects, best practice guidelines recommend the use of strategies to enhance, monitor and evaluate what clinicians deliver during patient consultations. There has yet to be a systematic evaluation of whether and how these recommendations have been employed within evaluations of behaviour change counselling, nor the impact on patient health behaviour and/or outcome. We seek to address this gap.
Methods are informed by published guidelines. Ten electronic databases (Medline, PubMed, EMBASE, PsycINFO, CINAHL Complete, ScienceDirect, Taylor and Francis; Wiley, ProQuest and Open Grey) will be searched for published and unpublished articles that evaluate behaviour change counselling within real-world clinical settings (randomised and non-randomised). Eligible papers will be rated against the National Institute of Health fidelity framework. A synthesis, evaluation and critical overview of fidelity practices will be reported and linear regression used to explore change across time. Random-effect meta-regression is planned to explore whether fidelity (outcomes reported and methods used) is associated with the impact of behaviour change counselling. Standardised effect sizes will be calculated using Hedges' g (continuous outcomes) and ORs (binary/dichotomous outcomes).
No ethical issues are foreseen. Findings will be disseminated via journal publication and conference presentation(s).
CRD42019131169.
治疗保真度是复杂行为改变研究中一个重要但经常被忽视的组成部分。它是理解治疗效果的核心，特别是对于在高度受控的研究环境之外进行的评估。确保有前途的干预措施能够在现实环境中由现实世界的临床医生充分（即具有保真度）实施，是开发既有效又“可实施”的干预措施的关键步骤。行为改变咨询这种复杂干预措施是否如此，该干预措施专门用于最大限度地提高关于健康行为改变的实际咨询的效果，目前尚不清楚。为了提高我们对治疗效果的理解，最佳实践指南建议使用策略来增强、监测和评估临床医生在患者咨询期间提供的内容。尚未对这些建议在行为改变咨询评估中是否以及如何被采用进行系统评估，也没有对患者的健康行为和/或结果产生影响。我们旨在解决这一差距。
方法依据已发表的指南。将从十个电子数据库（Medline、PubMed、EMBASE、PsycINFO、CINAHL Complete、ScienceDirect、Taylor and Francis；Wiley、ProQuest 和 Open Grey）中搜索评估现实临床环境中行为改变咨询的已发表和未发表文章（随机和非随机）。符合条件的论文将根据国家卫生研究院保真度框架进行评分。将报告对保真度实践的综合、评估和批判性概述，并使用线性回归探索随时间的变化。计划进行随机效应荟萃回归，以探讨行为改变咨询的影响是否与保真度（报告的结果和使用的方法）相关。使用 Hedges' g（连续结果）和 ORs（二项/分类结果）计算标准化效应量。
预计不会出现伦理问题。研究结果将通过期刊发表和会议报告进行传播。
PROSPERO 注册号：CRD42019131169。
