Academic Orthopaedics, Trauma & Sports Medicine, University of Nottingham School of Medical and Surgical Sciences, Nottingham, UK
Division of Primary Care, University of Nottingham, Nottingham, UK.
BMJ Open. 2021 Jun 29;11(6):e046913. doi: 10.1136/bmjopen-2020-046913.
Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults.
This is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods.
This study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public.
ISRCTN13922779.
掌骨干骨折（MSF）是常见的手部创伤性骨折，通常影响处于工作年龄段的年轻人。它们给医疗保健资源和社会带来了巨大负担；然而，目前缺乏指导其治疗的证据。确定最有益和最具成本效益的治疗方法将确保优化护理，并为国民保健制度提供经济价值。本研究旨在评估一项比较成人 MSF 手术和非手术治疗的随机对照试验的可行性。
这是一项多中心前瞻性队列研究，包含一项嵌套的定性研究，包括患者访谈和焦点小组，以及一项嵌入式因子随机亚研究，评估使用短信最大限度地收集数据和保留参与者。感兴趣的结果包括合格性、招募和保留率、随访完成情况、主要结局测量评估、选择结局测量的最小临床重要差异（MCID）的计算以及确定数据收集方法的可行性和在未来试验中使用的适当时间点。数据将使用安全的在线数据管理系统进行捕获。数据分析将是描述性的，定性数据将使用主题归纳分析。每个患者报告结局测量的最小临床重要效应将使用基于锚的反应性统计和基于分布的方法进行估计。
本研究已获得研究伦理委员会和健康研究管理局的伦理批准（REC 参考 20/EE/0124）。结果将通过同行评议的出版物和会议演讲提供给患者、临床医生、研究人员和资助者。将利用社交媒体平台、当地媒体和患者咨询小组的反馈，最大限度地将研究结果传播给患者和公众。
ISRCTN83542644。
