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哪些人能从髋关节置换术或膝关节置换术中获益?术前患者报告的结局阈值可预测有意义的改善。

Who Benefits From Hip Arthroplasty or Knee Arthroplasty? Preoperative Patient-reported Outcome Thresholds Predict Meaningful Improvement.

作者信息

Langenberger Benedikt, Steinbeck Viktoria, Busse Reinhard

机构信息

Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany.

出版信息

Clin Orthop Relat Res. 2024 May 1;482(5):867-881. doi: 10.1097/CORR.0000000000002994. Epub 2024 Feb 21.

Abstract

BACKGROUND

Hip arthroplasty (HA) and knee arthroplasty (KA) are high-volume procedures. However, there is a debate about the quality of indication; that is, whether surgery is truly indicated in all patients. Patient-reported outcome measures (PROMs) may be used to determine preoperative thresholds to differentiate patients who will likely benefit from surgery from those who will not.

QUESTIONS/PURPOSES: (1) What were the minimum clinically important differences (MCIDs) for three commonly used PROMs in a large population of patients undergoing HA or KA treated in a general orthopaedic practice? (2) Do patients who reach the MCID differ in important ways from those who do not? (3) What preoperative PROM score thresholds best distinguish patients who achieve a meaningful improvement 12 months postsurgery from those who do not? (4) Do patients with preoperative PROM scores below thresholds still experience gains after surgery?

METHODS

Between October 1, 2019, and December 31, 2020, 4182 patients undergoing HA and 3645 patients undergoing KA agreed to be part of the PROMoting Quality study and were hence included by study nurses in one of nine participating German hospitals. From a selected group of 1843 patients with HA and 1546 with KA, we derived MCIDs using the anchor-based change difference method to determine meaningful improvements. Second, we estimated which preoperative PROM score thresholds best distinguish patients who achieve an MCID from those who do not, using the preoperative PROM scores that maximized the Youden index. PROMs were Hip Disability and Osteoarthritis Outcome Score-Physical Function short form (HOOS-PS) (scored 0 to 100 points; lower indicates better health), Knee Injury and Osteoarthritis Outcome Score-Physical Function short form (KOOS-PS) (scored 0 to 100 points; lower indicates better health), EuroQol 5-Dimension 5-level (EQ-5D-5L) (scored -0.661 to 1 points; higher indicates better health), and a 10-point VAS for pain (perceived pain in the joint under consideration for surgery within the past 7 days) (scored 0 to 10 points; lower indicates better health). The performance of derived thresholds is reported using the Youden index, sensitivity, specificity, F1 score, geometric mean as a measure of central tendency, and area under the receiver operating characteristic curve.

RESULTS

MCIDs for the EQ-5D-5L were 0.2 for HA and 0.2 for KA, with a maximum of 1 point, where higher values represented better health-related quality of life. For the pain scale, they were -0.9 for HA and -0.7 for KA, of 10 points (maximum), where lower scores represent lower pain. For the HOOS-PS, the MCID was -10, and for the KOOS-PS it was -5 of 100 points, where lower scores represent better functioning. Patients who reached the MCID differed from patients who did not reach the MCID with respect to baseline PROM scores across the evaluated PROMs and for both HA and KA. Patients who reached an MCID versus those who did not also differed regarding other aspects including education and comorbidities, but this was not consistent across PROMs and arthroplasty type. Preoperative PROM score thresholds for HA were 0.7 for EQ-5D-5L (Youden index: 0.55), 42 for HOOS-PS (Youden index: 0.27), and 3.5 for the pain scale (Youden index: 0.47). For KA, the thresholds were 0.6 for EQ-5D-5L (Youden index: 0.57), 39 for KOOS-PS (Youden index: 0.25), and 6.5 for the pain scale (Youden index: 0.40). A higher Youden index for EQ-5D-5L than for the other PROMs indicates that the thresholds for EQ-5D-5L were better for distinguishing patients who reached a meaningful improvement from those who did not. Patients who did not reach the thresholds could still achieve MCIDs, especially for functionality and the pain scale.

CONCLUSION

We found that patients who experienced meaningful improvements (MCIDs) mainly differed from those who did not regarding their preoperative PROM scores. We further identified that patients undergoing HA or KA with a score above 0.7 or 0.6, respectively, on the EQ-5D-5L, below 42 or 39 on the HOOS-PS or KOOS-PS, or below 3.5 or 6.5 on a 10-point joint-specific pain scale presurgery had no meaningful benefit from surgery. The thresholds can support clinical decision-making. For example, when thresholds indicate that a meaningful improvement is not likely to be achieved after surgery, other treatment options may be prioritized. Although the thresholds can be used as support, patient preferences and medical expertise must supplement the decision. Future studies might evaluate the utility of using these thresholds in practice, examine how different thresholds can be combined as a multidimensional decision tool, and derive presurgery thresholds based on additional PROMs used in practice.

CLINICAL RELEVANCE

Preoperative PROM score thresholds in this study will support clinicians in decision-making through objective measures that can improve the quality of the recommendation for surgery.

摘要

背景

髋关节置换术(HA)和膝关节置换术(KA)是常见的手术。然而,对于手术指征的质量存在争议,即是否所有患者都真正需要手术。患者报告的结局指标(PROMs)可用于确定术前阈值,以区分可能从手术中获益的患者和不会获益的患者。

问题/目的:(1)在普通骨科实践中接受HA或KA治疗的大量患者中,三种常用PROMs的最小临床重要差异(MCIDs)是多少?(2)达到MCID的患者与未达到的患者在重要方面有何不同?(3)术前PROM评分阈值如何最好地区分术后12个月有显著改善的患者和没有改善的患者?(4)术前PROM评分低于阈值的患者术后仍会有改善吗?

方法

在2019年10月1日至2020年12月31日期间,4182例接受HA的患者和3645例接受KA的患者同意参与PROMoting Quality研究,因此被纳入德国九家参与研究的医院之一的研究护士的研究中。从1843例HA患者和1546例KA患者的选定组中,我们使用基于锚定的变化差异方法得出MCIDs,以确定有意义的改善。其次,我们使用使约登指数最大化的术前PROM评分,估计哪个术前PROM评分阈值能最好地区分达到MCID的患者和未达到的患者。PROMs包括髋关节残疾和骨关节炎结局评分-身体功能简表(HOOS-PS)(评分0至100分;分数越低表示健康状况越好)、膝关节损伤和骨关节炎结局评分-身体功能简表(KOOS-PS)(评分0至100分;分数越低表示健康状况越好)、欧洲五维健康量表5级(EQ-5D-5L)(评分-0.661至1分;分数越高表示健康状况越好),以及用于疼痛的10分视觉模拟量表(过去7天内在考虑手术的关节中感受到的疼痛)(评分0至10分;分数越低表示健康状况越好)。使用约登指数、敏感性、特异性、F1评分、作为集中趋势度量的几何平均数以及受试者工作特征曲线下面积来报告得出的阈值的性能。

结果

EQ-5D-5L的HA和KA的MCIDs均为0.2,最高为1分,分数越高表示与健康相关的生活质量越好。对于疼痛量表,HA为-0.9,KA为-0.7,满分10分(最高),分数越低表示疼痛越低。对于HOOS-PS,MCID为-10,对于KOOS-PS为-5,满分100分,分数越低表示功能越好。在评估的PROMs中,以及对于HA和KA,达到MCID的患者与未达到MCID的患者在基线PROM评分方面存在差异。达到MCID的患者与未达到的患者在包括教育和合并症等其他方面也存在差异,但在PROMs和关节置换类型中并不一致。HA的术前PROM评分阈值,EQ-5D-5L为0.7(约登指数:0.55),HOOS-PS为42(约登指数:0.27),疼痛量表为3.5(约登指数:0.47)。对于KA,阈值分别为EQ-5D-5L为0.6(约登指数:0.57),KOOS-PS为39(约登指数:0.25),疼痛量表为(约登指数:0.40)。EQ-5D-5L的约登指数高于其他PROMs,表明EQ-5D-5L的阈值在区分有显著改善的患者和没有改善的患者方面更好。未达到阈值的患者仍可实现MCIDs,尤其是在功能和疼痛量表方面。

结论

我们发现,经历有意义改善(MCIDs)的患者与未经历的患者主要在术前PROM评分方面存在差异。我们进一步确定,术前EQ-5D-5L评分分别高于0.7或0.6、HOOS-PS或KOOS-PS低于42或39、或术前10分关节特异性疼痛量表低于3.5或6.5的接受HA或KA的患者,手术没有显著益处。这些阈值可支持临床决策。例如,当阈值表明手术后不太可能实现有意义的改善时,可以优先考虑其他治疗选择。尽管这些阈值可作为支持,但患者的偏好和医学专业知识必须补充决策。未来的研究可能会评估在实践中使用这些阈值的效用,研究如何将不同的阈值组合为多维决策工具,并根据实践中使用的其他PROMs得出术前阈值。

临床意义

本研究中的术前PROM评分阈值将通过客观测量支持临床医生进行决策,从而提高手术推荐的质量。

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