Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.
Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.
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DOI：
10.1080/17453674.2016.1181816
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发表时间：
2016-07
影响因子：
3.7
通讯作者：
Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries
中科院分区：
文献类型：
--
作者：
Rolfson O;Bohm E;Franklin P;Lyman S;Denissen G;Dawson J;Dunn J;Eresian Chenok K;Dunbar M;Overgaard S;Garellick G;Lübbeke A;Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries
摘要-国际关节置换术登记学会（ISAR）患者报告结局指标（PROM）工作组已评估并推荐了髋关节和膝关节置换术登记研究PROM选择、管理和解释的最佳实践。常用的2种通用PROM是健康调查简表（SF-36或SF-12）和EuroQol五维（EQ-5D）。工作组建议，登记研究应选择已适当开发的特定PROM，这些PROM具有良好的关节置换术患者测量特性。工作组建议使用1项疼痛问题（“在过去4周内，您如何描述您[右/左] [髋/膝]的疼痛？”）;回复：无、非常轻度、轻度、中度或重度）和单项满意度结局（“您对[右/左] [髋/膝]置换术的满意度如何？"）;响应：非常不满意、不满意、中性、满意或非常满意）。调查后勤包括患者说明、基于纸质和电子的数据收集、随访提醒、集中式随访（而非基于医院的随访）、样本量、患者或关节特异性评价、收集间隔、应答频率、缺失值和建立PROM登记项目的因素。工作组建议在病例组合调整模型中纳入年龄、性别、关节诊断、术前一般健康状况以及关节疼痛和功能评分。解释和统计分析应考虑疼痛、功能和一般健康状况的绝对水平以及改善、缺失数据、分析方法和病例组合调整、最小临床重要差异和最小可检测变化。工作组建议在术前和术后1年立即收集数据，可接受的应答频率阈值为60%，记录无应答者，记录不完整或缺失的数据。
Abstract — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.