A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study.

IF 15.8 1区 医学 Q1 Medicine PLoS Medicine Pub Date : 2024-08-22 eCollection Date: 2024-08-01 DOI:10.1371/journal.pmed.1004447
Benjamin M Davies, Xiaoyu Yang, Danyal Z Khan, Oliver D Mowforth, Alvaro Y Touzet, Aria Nouri, James S Harrop, Bizhan Aarabi, Vafa Rahimi-Movaghar, Shekar N Kurpad, James D Guest, Lindsay Tetreault, Brian K Kwon, Timothy F Boerger, Ricardo Rodrigues-Pinto, Julio C Furlan, Robert Chen, Carl M Zipser, Armin Curt, James Milligan, Sukhivinder Kalsi-Rayn, Ellen Sarewitz, Iwan Sadler, Tammy Blizzard, Caroline Treanor, David Anderson, Nader Fallah, Olesja Hazenbiller, Carla Salzman, Zachary Zimmerman, Anne M Wandycz, Shirley Widdop, Margaret Reeves, Rye Raine, Sukvinder K Ryan, Ailish Malone, Ali Gharooni, Jefferson R Wilson, Allan R Martin, Michael G Fehlings, Angus G K McNair, Mark R N Kotter
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Abstract

Background: Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research.

Methods and findings: A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery.

Conclusions: The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.

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最小数据集--核心结果集、核心数据元素和核心测量集--用于颈椎脊髓退行性病变研究(AO Spine RECODE DCM):一项共识研究。
背景:退行性颈椎脊髓病(DCM)是一种进行性慢性脊髓损伤,估计每 50 个成年人中就有 1 人患病。由于没有标准化的指导,临床研究都是自行选择结果,往往不能充分反映疾病的情况,也限制了研究之间的可比性。利用通过多方利益相关者共识形成的标准最低数据集可以解决这些问题。这就需要将定义核心结果集(COS)(关键结果列表)和核心数据元素(CDEs)(解释结果所需的关键抽样特征列表)的过程结合起来。然后,在核心测量集(CMS)中进一步确定 "如何 "测量和/或报告这些结果。这可能包括对报告结果数据的标准化时间点的建议。本研究为 DCM 研究定义了 COS、CDE 和 CMS:通过一系列修改后的德尔菲流程,开发了最小数据集。第一阶段包括成立一个国际 DCM 利益相关者小组。第 2 阶段包括编制一份成果、数据元素和领域的长清单。第 3 阶段采用两阶段德尔菲流程,对结果和 CDE 进行优先排序。第 4 阶段通过共识会议确定最终的 DCM 最小数据集。第 5 阶段利用 COS 最终确定了每个结果的测量结构定义。在第 6 阶段,对文献进行了系统回顾,以确定测量工具的范围和心理测量特性。第 7 阶段采用修改后的德尔菲程序,为候选测量工具的短名单提供信息。然后,通过一次共识会议(第 8 阶段)形成了最终的测量工具集。为支持实施工作,数据集被整合到临床研究表(CRF)模板中,供未来临床试验使用(第 9 阶段)。共有 28 项结果和 6 个领域(疼痛、神经功能、生活影响、放射学、经济影响和不良事件)被纳入最终的 COS。32 项结果和 4 个领域(个人、疾病、调查和干预)被录入最终 CDE。最后,为 CMS 确定了 4 种结果工具(mJOA、NDI、SF-36v2 和 SAVES2),并建议对术后结果进行评估的试验应包括基线测量和术后 6 个月的测量:结论:AO脊柱RECODE-DCM为目前的DCM临床试验提供了最低限度的数据集。这些数据可在 https://myelopathy.org/minimum-dataset/ 上获得。虽然预计 CDE 和 COS 具有很强的持久相关性,但我们也认识到,随着新测量工具的出现,以及越来越多的患者转而接受非手术治疗,可能有必要对其进行更新和调整,尤其是 CMS 方面。
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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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