Lowers V, Christiansen P, Young B, Hennessy J, Harris R V
Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, L69 3GL, UK.
Department of Psychology, Institute of Population Health, University of Liverpool, Liverpool, UK.
Trials. 2025 May 13;26(1):156. doi: 10.1186/s13063-025-08856-0.
Behaviour change interventions delivered in dental settings could be useful in reducing oral health inequalities. Pragmatic randomised controlled trials testing interventions, however, are vulnerable to problems with internal and external validity. Intervention fidelity strategies are helpful to address methodological problems and to provide scientific assurances about trial results. This paper sets out the intervention fidelity assessment of the RETURN intervention which was delivered in dental settings to promote planned dental visits.
The assessment was guided by the National Institutes of Health Behaviour Change Consortium intervention fidelity framework domains of training and delivery. A mixed-methods design was selected, using quantitative data collected during intervention delivery training, together with qualitative observations (n = 58), interviews (n = 13) and audio-recordings of intervention delivery sessions (n = 472). Data were analysed separately using descriptive statistics and multiple logistic regression for the quantitative data and reflexive thematic analysis for the qualitative data. Data were integrated to provide a comprehensive fidelity assessment.
Dental nurses were successfully trained to deliver the RETURN intervention; training was successfully standardised, and skills drift minimised. Training presented challenges, and not all nurses achieved competency sign-off to deliver the intervention independently. Nurse characteristics such as dental nursing experience, wider trial procedures and confidence were all found to impact training success. The RETURN intervention was judged to have been delivered with high levels of fidelity, despite few interventions reaching the pre-determined fidelity threshold. Fidelity levels of between 75% and 85% were achieved across intervention domains. Interventionist, intervention dose and intervention topic (dental visiting barrier) were all found to have a relationship with fidelity levels.
Dental nurses can be trained to deliver a brief behaviour change intervention alongside their usual clinical roles, and this can be delivered with a high degree of intervention fidelity. The results from this fidelity assessment provide assurances about the scientific validity of the RETURN trial results. Recommendations about the suitability of dental nurse interventionists within future dental trials are discussed.
ISRCTN 84666712. Registered on 12/04/2021.
在牙科环境中实施的行为改变干预措施可能有助于减少口腔健康不平等现象。然而，测试干预措施的实用随机对照试验容易出现内部和外部效度问题。干预保真策略有助于解决方法学问题，并为试验结果提供科学保证。本文阐述了在牙科环境中实施的RETURN干预措施的干预保真度评估，该干预旨在促进有计划的牙科就诊。
评估以美国国立卫生研究院行为改变联盟干预保真度框架的培训和实施领域为指导。采用混合方法设计，使用干预实施培训期间收集的定量数据，以及定性观察（n = 58）、访谈（n = 13）和干预实施环节的录音（n = 472）。定量数据分别使用描述性统计和多元逻辑回归进行分析，定性数据使用反思性主题分析进行分析。整合数据以提供全面的保真度评估。
牙科护士成功接受了实施RETURN干预措施的培训；培训成功实现了标准化，技能偏差最小化。培训存在挑战，并非所有护士都达到了独立实施干预措施的能力验收标准。发现牙科护理经验、更广泛的试验程序和信心等护士特征都会影响培训的成功。尽管很少有干预措施达到预定的保真度阈值，但RETURN干预措施被判定具有较高的保真度。各干预领域的保真度水平在75%至85%之间。发现干预者、干预剂量和干预主题（牙科就诊障碍）均与保真度水平有关。
牙科护士可以在其日常临床工作中接受培训，实施简短的行为改变干预措施，并且可以在高度干预保真的情况下进行。此次保真度评估的结果为RETURN试验结果的科学有效性提供了保证。讨论了关于牙科护士干预者在未来牙科试验中的适用性的建议。
ISRCTN 84666712。于2021年4月12日注册。
