The outcomes of Perthes' disease DEVELOPMENT OF A CORE OUTCOMES SET FOR CLINICAL TRIALS IN PERTHES' DISEASE
The outcomes of Perthes' disease DEVELOPMENT OF A CORE OUTCOMES SET FOR CLINICAL TRIALS IN PERTHES' DISEASE
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DOI：
10.1302/0301-620x.102b5.bjj-2020-0072
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发表时间：
2020-05-01
影响因子：
4.6
通讯作者：
Perry, D. C.
中科院分区：
文献类型：
--
作者：
Leo, D. G.;Jones, H.;Perry, D. C.
AimsTo确定一套关键的身体，情感和社会的结果，在临床实践和研究Perthes病在children.MethodsThe研究遵循的指南COMET倡议（核心成果措施的有效性试验）。对文献进行了系统回顾，以确定先前研究中报告的结局列表，并通过定性研究进行补充，探讨Perthes病患者家庭的经历。总之，这些结果构成了德尔菲调查（两轮）的基础，其中18例Perthes病患者、46例父母和36名骨科医生对每个结果的重要性进行了评级。国际Perthes研究小组（IPSG）（达拉斯，得克萨斯州，美国（2018年10月））讨论的结果，未能达成任何共识（无论是“在”或“出”）之前，最终的共识会议与外科医生，患者和parents.ResultsIn的代表，共确定了23个不同的结果域的系统性审查，并从定性访谈进一步十。经过第一轮的德尔菲调查，与会者建议五个进一步的成果领域。在德尔菲的第二轮中，总共有38个结果。其中，16个结局的评分超过预先规定的70%重要性阈值（分为6个主要类别：不良事件;生活影响;资源使用;病理生理学表现;死亡;和技术考虑）。最后的共识会议后，14个成果被列入最终的核心成果集（COS）。ConclusionCore Outcome Sets（COSs）是重要的，以提高标准化的临床研究成果，并帮助患者，临床医生和资助机构之间的沟通。这项研究的结果应该是一个催化剂，以发展高质量的临床研究，以确定最佳的治疗儿童与Perthes病。
AimsTo identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children.MethodsThe study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes' disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes' disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either 'in' or 'out') before a final consensus meeting with representatives of surgeons, patients, and parents.ResultsIn total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS).ConclusionCore Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes' disease.