Harvey Kathryn, Ralph Penelope, Spencer Llinos Haf, Doungsong Kodchawan, Morrison Val, Lemmey Andrew, Golding-Day Miriam, Dodd Susanna, Hardwick Ben, Dorkenoo Shanaz, Hennessey Sophie, Williams Nefyn
Department of Primary Care and Mental Health, University of Liverpool, Liverpool, UK.
Faculty of Life Sciences and Education, University of South Wales, Newport, UK.
Trials. 2024 Dec 18;25(1):826. doi: 10.1186/s13063-024-08655-z.
Randomised controlled trials (RCTs) often struggle with recruitment and many need extensions which leads to delayed implementation of effective interventions. Recruitment to complex intervention trials have similar difficulties. Alongside this, the COVID-19 pandemic had a major impact upon trial recruitment. Research has shown that many other recruitment issues can be anticipated, for example overestimating target population prevalence; however, a range of factors may play a role. The aim of this study is to investigate facilitators and barriers to recruitment from the perspective of the recruiter.
Fracture in the Elderly Multidisciplinary Rehabilitation - phase III (FEMuR III) was a RCT of a complex intervention post-surgery for hip fracture in patients over 60 years old. A process evaluation was undertaken, and semi-structured interviews were conducted with seven recruiters between November 2022 and March 2023 to identify barriers and facilitators to recruitment. A thematic analysis was undertaken in NVIVO (Version 12) using a critical realist perspective.
The trial took place mostly during the COVID-19 pandemic, and the unique impact of this on reported barriers is considered. A key finding included recruiter reluctance to approach patients that they felt would not benefit from the trial due to other factors (e.g. comorbidities or complex living situations). A possible barrier to recruiting carers appeared to be that family members did not relate to the label of 'carer' and so did not take part. Facilitators included recruiters approaching patients with other clinical or research staff. This approach, which included tailored initial information on the trial, reduced participant stress by increasing patient familiarity with recruiting staff and allowing staff time to develop relationships with patients.
This paper identifies barriers and facilitators of recruitment to FEMuR III with six broad themes for both barriers and facilitators identified in the qualitative data synthesis. The impact of the COVID-19 pandemic was the main, but not sole, barrier to recruitment. Key findings concern reluctance to approach some eligible patients, the label of 'carer', the involvement of clinical staff and patient preference for trial group. Strategies to identify and overcome recruitment problems are highlighted and should be implemented and evaluated in further RCTs of complex interventions.
ISRCTN28376407. November 23, 2018.
随机对照试验(RCT)常常在招募参与者方面面临困难,许多试验需要延长时间,这导致有效干预措施的实施延迟。复杂干预试验的招募也有类似的困难。与此同时,新冠疫情对试验招募产生了重大影响。研究表明,许多其他招募问题是可以预见的,例如高估目标人群的患病率;然而,一系列因素可能都在起作用。本研究的目的是从招募者的角度调查招募的促进因素和障碍。
老年骨折多学科康复——三期试验(FEMuR III)是一项针对60岁以上髋部骨折患者术后复杂干预措施的随机对照试验。进行了一项过程评估,并在2022年11月至2023年3月期间与7名招募者进行了半结构化访谈,以确定招募的障碍和促进因素。在NVIVO(第12版)中采用批判实在论的视角进行了主题分析。
该试验主要在新冠疫情期间进行,并考虑了疫情对所报告障碍的独特影响。一个关键发现是,招募者不愿接触那些他们认为由于其他因素(如合并症或复杂的生活状况)无法从试验中受益的患者。招募照顾者的一个可能障碍似乎是家庭成员不认同“照顾者”这个标签,因此没有参与。促进因素包括招募者与其他临床或研究人员一起接触患者。这种方法包括提供关于试验的量身定制的初始信息,通过增加患者对招募人员的熟悉程度以及让工作人员有时间与患者建立关系,减轻了参与者的压力。
本文确定了FEMuR III试验招募的障碍和促进因素,在定性数据综合分析中确定了障碍和促进因素各有六个广泛的主题。新冠疫情的影响是招募的主要但并非唯一的障碍。关键发现涉及不愿接触一些符合条件的患者、“照顾者”这个标签、临床工作人员的参与以及患者对试验组的偏好。文中强调了识别和克服招募问题的策略,应在进一步的复杂干预随机对照试验中实施和评估。
ISRCTN28376407。2018年11月23日。