Edge Hill University, Ormskirk, UK.
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK.
Bone Joint J. 2024 Nov 1;106-B(11):1306-1311. doi: 10.1302/0301-620X.106B11.BJJ-2024-0352.R1.
A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement.
A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings.
A total of 45 respondents completed the survey. Nine core mandatory domains were identified: 'return to work or normal daily role'; delivery of care was measured in the domains 'patient satisfaction with the outcome of surgery' and 'would the patient have the same operation again'; 'pain'; 'revision'; 'elbow function'; 'independence in activities of daily living'; 'health-related quality of life'; and 'adverse events'. 'Elbow range of motion' was identified as important by consensus but was felt to be less relevant by the PPIE panel. The PPIE panel unanimously stated that pain should be used as the primary outcome domain.
This study defined core domains for the clinical outcomes of elbow replacement obtained by consensus from patients, carers, and healthcare professionals. Pain may be used as the primary outcome in future studies, where appropriate. Further work is required to define the instruments that should be used.
对肘部置换的文献进行回顾后发现，目前用于评估干预措施有效性的临床结果测量指标并不一致。本研究旨在确定肘部置换的核心结局领域。
使用对 1990 年 1 月至 2021 年 2 月期间发表的 362 项肘部置换研究的范围综述中的结果，开展了为期四周的实时德尔菲调查。将总共 583 个结果描述项合理化后得到 139 个独特的结果。调查由 139 个结果分为 18 个领域组成。该调查的可读性和清晰度由一个顾问小组确定，该小组包括一名患者代表。参与者可以实时查看其他参与者的汇总回复，并在研究期间随时多次重新查看回复。参与者可以提出纳入其他项目的建议。患者和公众参与和参与（PPIE）小组审议了共识结果。
共有 45 名受访者完成了调查。确定了 9 个核心强制性领域：“重返工作或正常日常生活角色”；“对手术结果的患者满意度”和“患者是否会再次接受相同的手术”这两个领域测量的是护理的提供；“疼痛”；“翻修”；“肘部功能”；“日常生活活动的独立性”；“健康相关生活质量”；以及“不良事件”。“肘部活动范围”虽然通过共识确定为重要，但患者参与和参与小组认为其相关性较低。患者参与和参与小组一致表示，疼痛应作为主要的结局领域。
本研究通过患者、护理人员和医疗保健专业人员的共识确定了肘部置换的核心领域。在适当的情况下，疼痛可能被用作未来研究的主要结局。还需要进一步的工作来定义应使用的工具。
