Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study.
Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study.
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DOI：
10.1302/2633-1462.28.bjo-2021-0074.r1
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发表时间：
2021-08
期刊：
影响因子：
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通讯作者：
Goldberg A
中科院分区：
文献类型：
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作者：
Realpe AX;Blackstone J;Griffin DR;Bing AJF;Karski M;Milner SA;Siddique M;Goldberg A
建立了一项多中心、随机、临床医生主导、实用、平行组的两种外科手术的骨科试验，以获得高质量的有效性证据。然而，该试验面临招募挑战，并努力保持30%以上的招募率，尽管这在外科试验中并不罕见。我们进行了一项定性研究，目的是收集有关招募实践的信息，以确定患者同意和参与骨科试验的障碍。我们收集了5家参与骨科试验招募的医院的招募预约和研究团队成员（主要研究者和研究护士）访谈的11段录音。我们对定性数据集进行了主题分析，目的是确定知情同意和信息提供的不明确、中断或阻碍试验招募的方面。招聘人员在招募骨科外科试验人员时面临四个常见障碍：患者对干预措施的偏好；复杂的招聘途径；各种后勤问题；以及关于平衡的不同观点。临床医生表示担心，该试验可能不会显示出两种治疗方法的显著差异，从而证实它们的平衡。然而，由于他们自己的偏好和感知到的患者对干预臂的偏好，他们经历了角色冲突。本研究提供了骨科随机对照试验招募障碍的初步信息。我们在一次全站点研究者会议上分享了这些发现，并鼓励研究者找到解决已确定障碍的方法；这使征聘工作顺利完成。复杂的试验可能受益于使用混合方法的方法，以减轻招募失败，并改善患者参与和知情同意。本文引用本文：骨化学学报；2021;2(8):631-637。
A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637.