Bateman Marcus, Evans Jonathan P, Vuvan Viana, Jones Val, Watts Adam C, Phadnis Joideep, Bisset Leanne, Vicenzino Bill
Derby Shoulder Unit, Royal Derby Hospital, University Hospitals of Derby & Burton NHS Foundation Trust, Uttoxeter Road, Derby, UK.
Health Services and Policy Research, Smeall Building, JS03, St Lukes Campus, Exeter, UK.
Trials. 2021 May 10;22(1):339. doi: 10.1186/s13063-021-05291-9.
Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development.
This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus.
There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences.
Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497 .
外侧肘肌腱病（LET）是一种常见病症，可导致严重残疾并产生相关社会经济成本。尽管对此进行了广泛研究，但结果测量方法差异很大，这限制了跨研究的证据综合。2019年，肌腱病领域的一个由国际专家、医疗保健专业人员和患者组成的工作组（国际肌腱病科学研讨会共识（ICON）小组）公布了一项共识工作的结果，确定了肌腱病研究中应测量的九个核心领域。本研究的目的是为LET制定一个映射到这些核心领域的核心结局集（COS）。主要成果将为LET未来的结局评估提供一个模板。在本方案中，我们详细阐述了COS-LET制定的方法。
本研究将采用三阶段方法。（1）对调查LET的研究进行系统综述，将生成目前用于量化治疗效果或结局的所有工具的综合列表。（2）临床医生和对LET有专门兴趣的研究人员组成的指导委员会将工具与九个核心肌腱病结局领域的列表进行匹配，从而产生一组候选工具。（3）将开展一项国际三阶段德尔菲研究，参与人员包括经验丰富的临床医生、研究人员和患者。在这项德尔菲研究中，将根据使用风湿病结局测量（OMERACT）真实性、可行性和区分度筛选标准进行筛选来选择候选工具，设定70%的一致性阈值作为共识标准。
目前在试验或临床实践中尚无用于测量或监测LET的COS。本项目的成果将是一个推荐在所有未来与LET相关的英文研究中使用的最小COS。研究结果将发表在高质量期刊上，并通过专业网络、社交媒体以及在国际会议上进行展示广泛传播。
于2019年11月在有效性试验核心结局测量（COMET）数据库注册。https://www.comet-initiative.org/Studies/Details/1497 。
