Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
BMJ Open. 2022 Jun 9;12(6):e060436. doi: 10.1136/bmjopen-2021-060436.
INTRODUCTION: Progress in degenerative cervical myelopathy (DCM) is hindered by inconsistent measurement and reporting. This impedes data aggregation and outcome comparison across studies. This limitation can be reversed by developing a core measurement set (CMS) for DCM research. Previously, the AO Spine Research Objectives and Common Data Elements for DCM (AO Spine RECODE-DCM) defined 'what' should be measured in DCM: the next step of this initiative is to determine 'how' to measure these features. This protocol outlines the steps necessary for the development of a CMS for DCM research and audit. METHODS AND ANALYSIS: The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials and the Consensus-based Standards for the selection of health Measurement Instruments. The process involves five phases. In phase 1, the steering committee agreed on the constructs to be measured by sourcing consensus definitions from patients, professionals and the literature. In phases 2 and 3, systematic reviews were conducted to identify tools for each construct and aggregate their evidence. Constructs with and without tools were identified, and scoping reviews were conducted for constructs without tools. Evidence on measurement properties, as well as on timing of assessments, are currently being aggregated. These will be presented in phase 4: a consensus meeting where a multi-disciplinary panel of experts will select the instruments that will form the CMS. Following selection, guidance on the implementation of the CMS will be developed and disseminated (phase 5). A preliminary CMS review scheduled at 4 years from release. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Cambridge (HBREC2019.14). Dissemination strategies will include peer-reviewed scientific publications; conference presentations; podcasts; the identification of AO Spine RECODE-DCM ambassadors; and engagement with relevant journals, funders and the DCM community.
简介:退行性颈脊髓病(DCM)的研究进展受到测量和报告方法不一致的阻碍。这阻碍了研究间的数据汇总和结果比较。通过开发 DCM 研究的核心测量集(CMS)可以克服这一局限性。此前,AO 脊柱研究目标和 DCM 常见数据元素(AO Spine RECODE-DCM)定义了 DCM 中“应该”测量的内容:该倡议的下一步是确定“如何”测量这些特征。本方案概述了开发 DCM 研究和审核 CMS 所需的步骤。
方法与分析:CMS 将根据有效性试验的核心结局测量和健康测量仪器选择的共识标准制定的指南进行开发。该过程包括五个阶段。在第 1 阶段,指导委员会通过从患者、专业人员和文献中获取共识定义,就应测量的结构达成一致意见。在第 2 期和第 3 期,进行了系统综述,以确定每个结构的工具,并汇总其证据。确定了有工具和无工具的结构,并对无工具的结构进行了范围综述。目前正在汇总关于测量特性以及评估时间的证据。这些将在第 4 阶段展示:一个多学科专家小组将在共识会议上选择构成 CMS 的工具。选择后,将制定并发布有关 CMS 实施的指南(第 5 阶段)。发布后 4 年计划进行初步 CMS 审查。
伦理与传播:已获得剑桥大学的伦理批准(HBREC2019.14)。传播策略将包括同行评议的科学出版物;会议演讲;播客;AO 脊柱 RECODE-DCM 大使的确定;以及与相关期刊、资助者和 DCM 社区的合作。
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