Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden.
Advanced Reconstruction of Extremities and Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden.
Disabil Rehabil. 2022 Dec;44(26):8471-8479. doi: 10.1080/09638288.2021.2015628. Epub 2021 Dec 21.
PURPOSE: To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS: This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. RESULTS: The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. CONCLUSION: The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities.
目的：评估 EQ-5D-3L 和 EQ-5D-5L 在下肢大截肢（LLA）患者中的测量特性。
方法：这是一项回顾性基于登记的研究，使用瑞典截肢和假肢登记处（SwedeAmp）的数据。纳入在单侧 LLA 后 6 个月随访（包括 EQ-5D-3L 或 EQ-5D-5L）的患者。比较 EQ-5D-3L 和 EQ-5D-5L 的可行性、反应模式、信息性以及收敛性和已知组有效性。
结果：样本包括 700 名接受膝下截肢（76%）、膝上截肢（18%）或膝关节离断（7%）的患者。EQ-5D-3L 和 -5L 的可行性（完成率 98%）和报告无问题的比例（7%和 6%）相似。与 EQ-5D-3L 相比，EQ-5D-5L 在所有维度上的绝对和相对信息性均更高，移动性维度的改善最大。在收敛有效性分析中，EQ-5D-5L 通常与疾病特异性测量指标的相关性更强。只有 EQ-5D-5L 能够区分不同截肢水平的亚组。
结论：研究结果支持在 LLA 患者中使用 EQ-5D-5L 而非 EQ-5D-3L，主要原因是信息性提高以及与已知组和收敛性有效性的相关性提高。
对康复的意义：两种 EQ-5D 版本（EQ-5D-3L 和 EQ-5D-5L）的测量特性尚未在下肢截肢（LLA）患者中进行评估。结果支持在 LLA 患者中使用 EQ-5D-5L 而非 EQ-5D-3L，主要原因是信息性提高以及与疾病特异性患者报告结局测量指标的相关性提高。在未来的 EQ-5D 临床结局研究、健康经济评估以及 LLA 患者的常规随访中，建议使用 EQ-5D-5L 的五水平版本。在 LLA 后的早期康复过程中，6 个月后，大多数患者报告在移动性、疼痛/不适和日常活动方面存在问题。
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