Lowers V, Kirby R, Young B, Harris R V
Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Whelan Building, Liverpool, L69 3GL, UK.
Trials. 2024 Dec 18;25(1):824. doi: 10.1186/s13063-024-08659-9.
Primary dental care settings are strategically important locations where randomised controlled trials (RCTs) of behaviour change interventions (BCIs) can be tested to tackle oral diseases. Findings have so far produced equivocal results. Improving treatment fidelity is posed as a mechanism to improve scientific rigour, consistency and implementation of BCIs. The National Institutes of Health Behaviour Change Consortium (NIH BCC) developed a tool to assess and evaluate treatment fidelity in health behaviour change interventions, which has yet to be applied to the primary dental care BCI literature.
We conducted a scoping review of RCTs delivered in primary dental care by dental team members (in real-world settings) between 1980 and 2023. Eligible studies were coded using the NIH BCC checklist to determine the presence of reported fidelity strategies across domains: design, training, delivery, receipt and enactment.
We included 34 eligible articles, reporting 21 RCTs. Fidelity reporting variations were found both between and within NIH BCC domains: strategy reporting ranged from 9.5 to 85.7% in design, 9.5 to 57.1% in training, 0 to 66.7% in delivery, 14.3 to 36.8% in receipt and 13.3 to 33.3% in enactment. The most reported domain was design (M = 0.45), and the least reported domain was delivery (M = 0.21). Only one study reported over 50% of the recommended strategies in every domain.
This review revealed inconsistencies in fidelity reporting with no evidence that fidelity guidelines or frameworks were being used within primary dental care trials. This has highlighted issues with interpretability, reliability and reproducibility of research findings. Recommendations are proposed to assist primary dental care trialists with embedding fidelity strategies into future research.
基层牙科护理机构是行为改变干预措施（BCIs）随机对照试验（RCTs）的重要战略地点，可在此测试这些干预措施以应对口腔疾病。迄今为止，研究结果不一。提高治疗保真度被视为提高BCIs科学严谨性、一致性和实施效果的一种机制。美国国立卫生研究院行为改变联盟（NIH BCC）开发了一种工具，用于评估和评价健康行为改变干预措施中的治疗保真度，但该工具尚未应用于基层牙科护理BCIs文献。
我们对1980年至2023年间牙科团队成员在基层牙科护理机构（在实际环境中）开展的RCTs进行了范围综述。使用NIH BCC清单对符合条件的研究进行编码，以确定各领域（设计、培训、实施、接受和执行）报告的保真度策略。
我们纳入了34篇符合条件的文章，报告了21项RCTs。在NIH BCC各领域之间以及领域内均发现了保真度报告的差异：设计领域的策略报告率为9.5%至85.7%，培训领域为9.5%至57.1%，实施领域为0至66.7%，接受领域为14.3%至36.8%，执行领域为13.3%至33.3%。报告最多的领域是设计（M = 0.45），报告最少的领域是实施（M = 0.21）。只有一项研究在每个领域报告了超过50%的推荐策略。
本综述揭示了保真度报告的不一致性，没有证据表明基层牙科护理试验中使用了保真度指南或框架。这凸显了研究结果的可解释性、可靠性和可重复性问题。提出了相关建议，以协助基层牙科护理试验人员将保真度策略纳入未来研究。
