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关节置换术后两年患者报告结局测量几乎没有额外价值:一项系统评价和荟萃分析。

Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis.

作者信息

Spece Hannah, Kurtz Michael A, Piuzzi Nicolas S, Kurtz Steven M

机构信息

Drexel University School of Biomedical Engineering, Science, and Health Systems, Philadelphia, Pennsylvania, USA.

Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

出版信息

Bone Joint J. 2025 Mar 1;107-B(3):296-307. doi: 10.1302/0301-620X.107B3.BJJ-2024-0910.R1.

Abstract

AIMS

The use of patient-reported outcome measures (PROMs) to assess the outcome after total knee (TKA) and total hip arthroplasty (THA) is increasing, with associated regulatory mandates. However, the robustness and clinical relevance of long-term data are often questionable. It is important to determine whether using long-term PROMs data justify the resources, costs, and difficulties associated with their collection. The aim of this study was to assess studies involving TKA and THA to determine which PROMs are most commonly reported, how complete PROMs data are at ≥ five years postoperatively, and the extent to which the scores change between early and long-term follow-up.

METHODS

We conducted a systematic review of the literature. Randomized controlled trials (RCTs) with sufficient reporting of PROMs were included. The mean difference in scores from the preoperative condition to early follow-up times (between one and two years), and from early to final follow-up, were calculated. The mean rates of change in the scores were calculated from representative studies. Meta-analyses were also performed on the most frequently reported PROMs.

RESULTS

A total of 24 studies were assessed. The most frequently reported PROMs were the Oxford Knee Score (OKS) for TKA and the University of California, Los Angeles activity scale for THA. The mean rate of follow-up based on the number of patients available at final follow-up was 70.5% (39.2% to 91.0%) for knees and 82.1% (63.2% to 92.3%) for hips. The actual rates of collection of PROM scores were lower. For TKA, the mean OKS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and transformed WOMAC changes were -16.3 (95% CI -17.5 to -15.2), 23.2 (95% CI 17.2 to 29.2), and -29.7 (95% CI -32.4 to -27.0) points for short-term follow-up. These decreased to 1.3 (95% CI -0.8 to 3.3), -3.4 (95% CI -7.0 to 0.3), and 4.7 (95% CI -1.5 to 10.9) points for the remaining follow-up. A similar meta-analysis was not possible for studies involving THA. We commonly observed that the scores plateaued after between one and two years, and that there was little or no change beyond this time.

CONCLUSION

The long-term PROMs for TKA and THA beyond one or two years are often incomplete and lose sensitivity at this time. Given the considerable resources, costs, and challenges associated with the collection of these scores, their clinical value is questionable. Therefore, consideration should be given to abandoning the requirement for the collection of long-term PROMs in favour of more robust and reliable measures of success that offer more clinical relevance and use.

摘要

目的

使用患者报告结局测量指标(PROMs)来评估全膝关节置换术(TKA)和全髋关节置换术(THA)后的结局的情况正在增加,同时伴有相关的监管要求。然而,长期数据的稳健性和临床相关性常常受到质疑。确定使用长期PROMs数据是否合理,包括其相关资源、成本以及收集过程中的困难,这一点很重要。本研究的目的是评估涉及TKA和THA的研究,以确定最常报告的PROMs指标是什么,术后≥5年时PROMs数据的完整程度如何,以及早期和长期随访之间评分变化的程度。

方法

我们对文献进行了系统综述。纳入了充分报告PROMs的随机对照试验(RCTs)。计算了从术前状态到早期随访时间(1至2年之间)以及从早期到最终随访的评分平均差异。从代表性研究中计算评分的平均变化率。还对最常报告的PROMs进行了荟萃分析。

结果

共评估了24项研究。TKA中最常报告的PROMs是牛津膝关节评分(OKS),THA中是加利福尼亚大学洛杉矶分校活动量表。基于最终随访时可获得的患者数量,膝关节的平均随访率为70.5%(39.2%至91.0%),髋关节为82.1%(63.2%至92.3%)。PROM评分的实际收集率较低。对于TKA,短期随访时OKS、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)以及转换后的WOMAC变化的平均得分分别为-16.3(95%CI -17.5至-15.2)、23.2(95%CI 17.2至29.2)和-29.7(95%CI -32.4至-27.0)分。在剩余随访中,这些得分降至1.3(95%CI -0.8至3.3)、-3.4(95%CI -7.0至0.3)和4.7(95%CI -1.5至10.9)分。对于涉及THA的研究,无法进行类似的荟萃分析。我们通常观察到,评分在1至2年后趋于平稳,此后几乎没有变化。

结论

TKA和THA术后一年或两年以上的长期PROMs数据通常不完整,且此时会失去敏感性。鉴于收集这些评分涉及大量资源、成本和挑战,其临床价值值得怀疑。因此,应考虑放弃收集长期PROMs的要求,转而采用更稳健、可靠且具有更强临床相关性和实用性的成功评估指标。

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