The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis
The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis
复制标题
DOI：
10.3899/jrheum.181194
复制
发表时间：
2019-08-01
影响因子：
3.9
通讯作者：
Conaghan, Philip G.
中科院分区：
文献类型：
--
作者：
Smith, Toby O.;Hawker, Gillian A.;Conaghan, Philip G.
客观的。更新 1997 年 OMERACT-OARSI（国际风湿病学-骨关节炎研究协会结果测量）核心领域集，用于髋关节和/或膝关节骨关节炎 (OA) 的临床试验。方法。对 COMET 核心结果集 (COS) 数据库进行了初步审查，以确定之前 COS 中报告的所有领域，包括患有髋关节和/或膝关节 OA 的个体。这些成果是在三大洲（欧洲、澳大利亚、北美）举行的 5 场患者和卫生专业人员/研究人员会议上提出的。随后在患者、医疗保健专业人员、研究人员和行业代表中进行了三轮国际德尔菲调查，以就髋关节和/或膝关节 OA 核心领域集中的关键领域达成共识。结果在 OMERACT 2018 上以小组形式提出和讨论，并在最终全体会议上达成了共识。结果。之前已识别出四个 COS。利用这些信息以及患者和健康专业人员/研究人员会议，德尔福调查形成了 50 个潜在领域。来自 25 个不同国家的 426 人参与了德尔菲演习。 OMERACT 2018 代表 (n = 129) 对候选域进行投票。除了包括死亡率在内的不良事件的强制核心领域外，六个领域已达成一致，要求在所有髋关节和/或膝关节 OA 临床试验中强制测量和报告：疼痛、身体功能、生活质量和患者对目标关节的整体评估。联合结构被认为在特定情况下是强制性的，即取决于干预措施。结论。针对髋部和/或膝部 OA 的更新核心域集已达成一致。将开始确定应推荐哪种结果衡量工具来涵盖每个核心领域。
Objective. To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).Methods. An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.Results. Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient's global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.Conclusion. The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.