Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia.
Institute of Bone and Joint Research, The University of Sydney, St Leonards, New South Wales, Australia.
BMJ Open. 2024 Oct 7;14(10):e090360. doi: 10.1136/bmjopen-2024-090360.
First steps for knee osteoarthritis (OA) is a cluster randomised implementation trial examining the effect of an educational reminder message included in knee X-ray reports on the proportion of people subsequently referred to exercise professionals for their knee OA. Evaluating the processes supporting the completion of the study and the efficacy of the reminder message is essential to interpreting the outcomes of the study and aiding translation into practice.
We will conduct a concurrent process evaluation throughout the current study using a previously published framework for examining cluster randomised trials. This framework divides processes into those occurring at the cluster level and those at the target population level. For the current study, the cluster level is within radiology clinics. The target population is people with newly diagnosed radiologically evident, structural knee OA. A mixed methods design, incorporating survey data, administrative records, field notes and semi-structured interviews with representatives from radiology clinics and people with knee OA, will evaluate these processes. The focus of the evaluation will be recruitment and response processes of the radiology clinics and delivery and response processes for the people with knee OA. We will also describe the context and explore how the nudge theory of behavioural change influences the outcome of the study.
The study protocol, inclusive of the process evaluation, was approved by Macquarie University Human Research Ethics Committee (#520221190343842). Findings will be disseminated through national and international conferences, national industry stakeholders and patient advocacy groups to reach all levels of healthcare. Staff at radiology clinics and people with knee OA involved in interviews provide written, informed consent to participate in the process evaluation. Specific findings will be incorporated into training modules aimed at radiology clinics and will be developed by our industry partners.
Prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001414707p). Registration occurred in December 2022.
膝骨关节炎（OA）的初步治疗是一项集群随机实施试验，旨在研究在膝关节 X 光报告中包含教育提醒信息对随后将患者转诊给运动专业人员治疗膝 OA 的比例的影响。评估支持研究完成的过程和提醒信息的效果对于解释研究结果和促进实践转化至关重要。
我们将使用先前发表的用于检查集群随机试验的框架，在当前研究中进行同时进行的过程评估。该框架将过程分为发生在集群层面和目标人群层面的过程。对于当前的研究，集群层面在放射科诊所内。目标人群是新诊断出放射学上明显、结构上的膝 OA 的人群。混合方法设计，包括调查数据、行政记录、现场笔记和对放射科诊所代表和膝 OA 患者的半结构化访谈，将评估这些过程。评估的重点将是放射科诊所的招募和反应过程以及膝 OA 患者的交付和反应过程。我们还将描述背景，并探讨行为改变的推动理论如何影响研究结果。
该研究方案，包括过程评估，已获得麦考瑞大学人类研究伦理委员会的批准（编号：520221190343842）。研究结果将通过国家和国际会议、国家产业利益相关者和患者倡导团体进行传播，以覆盖所有级别的医疗保健。参与访谈的放射科诊所工作人员和膝 OA 患者提供书面知情同意书，同意参与过程评估。具体发现将纳入针对放射科诊所的培训模块，并由我们的行业合作伙伴开发。
前瞻性注册于澳大利亚新西兰临床试验注册中心（ACTRN12622001414707p）。注册于 2022 年 12 月进行。
