胫骨骨干骨折患者报告结局测量量表的测量性能;与多中心 TRAVEL 研究同时进行的验证研究。

Measurement properties of Patient-Reported Outcome Measures in patients with a tibial shaft fracture; validation study alongside the multicenter TRAVEL study.

机构信息

Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 Rotterdam, the Netherlands.

Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 Rotterdam, the Netherlands.

出版信息

Injury. 2021 Apr;52(4):1002-1010. doi: 10.1016/j.injury.2020.12.030. Epub 2020 Dec 31.

Abstract

The aim of this study was to evaluate the measurement properties of the Short Musculoskeletal Function Assessment (SMFA) and Lower Extremity Functional Scale (LEFS) in patients who sustained a tibial shaft fracture, by comparing them with the scores of a general health-related quality of life instrument scale (i.e., EuroQoL-5D). Data of 136 patients participating in a multicenter randomized controlled trial comparing incisions for intramedullary nail entry in adults with a tibial shaft fracture were used. Patients completed the SMFA, LEFS, EQ-5D and an anchor question at 2 and 6 weeks, and at 3, 6 and 12 months. Reliability (internal consistency), construct validity, responsiveness (longitudinal validity), floor and ceiling effects, minimal important change (MIC), and smallest detectable change (SDC) were determined. The SMFA and LEFS (sub)scales showed adequate internal consistency (0.84<α<0.94). Construct and longitudinal validity were also adequate (correctly predicted hypotheses between 83%-100%). Floor effects were not present. Ceiling effects were present at 12 months for the SMFA lower extremity dysfunction and bother subscales (22% and 19%, respectively) and the LEFS (19%). MICs could not be determined with the available data. The SDC was 13.84 points for the SMFA and 38.74 points for the LEFS. This study confirms that the SMFA and LEFS are reliable, valid, and responsive instruments for monitoring functional limitation in patients after sustaining a tibia shaft fracture during at least the first six months post-injury. An anchor-based MIC for the SMFA remains to be determined.

摘要

本研究旨在通过与一般健康相关的生活质量工具量表(即 EuroQoL-5D)的评分进行比较,评估短肌肉骨骼功能评估(SMFA)和下肢功能量表(LEFS)在胫骨骨干骨折患者中的测量性能。使用参加比较成人胫骨骨干骨折髓内钉入路切口的多中心随机对照试验的 136 名患者的数据。患者在 2 周和 6 周以及 3 个月、6 个月和 12 个月时完成 SMFA、LEFS、EQ-5D 和一个锚定问题。确定了可靠性(内部一致性)、结构有效性、反应性(纵向有效性)、地板和天花板效应、最小重要变化(MIC)和最小可检测变化(SDC)。SMFA 和 LEFS(子)量表表现出足够的内部一致性(0.84<α<0.94)。结构和纵向有效性也足够(正确预测了 83%-100%的假设)。地板效应不存在。在 12 个月时,SMFA 下肢功能障碍和困扰子量表(分别为 22%和 19%)和 LEFS 出现天花板效应(19%)。无法用现有数据确定 MIC。SMFA 的 SDC 为 13.84 分,LEFS 的 SDC 为 38.74 分。本研究证实,SMFA 和 LEFS 是可靠、有效且敏感的工具,可用于监测胫骨骨干骨折后至少前 6 个月内患者的功能受限。SMFA 的基于锚定的 MIC 仍有待确定。

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