Lowers Victoria, 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.
BMC Prim Care. 2025 Feb 17;26(1):43. doi: 10.1186/s12875-025-02732-1.
Behaviour change interventions delivered in real-world settings could be vulnerable to threats to internal and external validity if methodological considerations are overlooked. The primary dental care setting is a difficult environment within which to deliver research protocols presenting unique challenges for robust scientific research delivery. Intervention fidelity strategies are an important mechanism to improve the scientific rigor of such studies. Feasibility studies provide a vital opportunity to refine and optimise research processes and implementation strategies before embarking on larger scale projects. This paper sets out the development of a comprehensive intervention fidelity strategy guided by The National Institutes of Health Behavior Change Consortium.(BCC) recommendations.
Using observations (53 h) and qualitative interviews (17 patient interviews and 2 staff interviews) conducted during the delivery of the RETURN feasibility study (InteRventions to rEduce inequaliTies in the Uptake of Routine deNtal care), an intervention fidelity strategy was developed for use in the RETURN main trial.
A comprehensive intervention fidelity strategy was developed, structured around the five domains of the BCC's recommendations (design, training, delivery, receipt, enactment) and attending to the goals pertaining to each of those domains. This paper sets out the fidelity strategy implemented in the RETURN main trial.
The RETURN fidelity strategy was influenced by the unique research environment the primary dental care setting presents. The strategy could serve as a blueprint to other researchers conducting research in similar settings. It is also intended that this strategy is read alongside the RETURN results upon their publication.
ISRCTN10853330, registered: 07/10/2019.
如果忽视方法学方面的考虑,在现实环境中实施的行为改变干预措施可能容易受到内部和外部效度威胁。初级牙科保健环境是一个难以实施研究方案的环境,对于进行有力的科学研究带来了独特的挑战。干预保真策略是提高此类研究科学严谨性的重要机制。可行性研究为在开展更大规模项目之前完善和优化研究流程及实施策略提供了重要契机。本文阐述了一项在国立卫生研究院行为改变联盟(BCC)建议指导下制定的全面干预保真策略。
通过在“RETURN可行性研究”(旨在减少常规牙科保健利用方面不平等的干预措施)实施过程中进行的观察(53小时)和定性访谈(17次患者访谈和2次工作人员访谈),制定了一项用于RETURN主要试验的干预保真策略。
制定了一项全面的干预保真策略,围绕BCC建议的五个领域(设计、培训、实施、接受、执行)构建,并关注与每个领域相关的目标。本文阐述了RETURN主要试验中实施的保真策略。
RETURN保真策略受到初级牙科保健环境所呈现的独特研究环境的影响。该策略可为其他在类似环境中开展研究的人员提供蓝图。同时,预计在RETURN结果发表时,可结合本文阅读该策略。
ISRCTN10853330,注册时间:2019年10月7日。