替代临床路径在原发性髋关节和膝关节置换患者中的比较效果：一项实用随机对照试验。

Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial.

机构信息

School of Public Health, Curtin University, Western Australia, Australia; Alberta Bone & Joint Health Institute, University of Calgary, Canada.

出版信息

Osteoarthritis Cartilage. 2012 Oct;20(10):1086-94. doi: 10.1016/j.joca.2012.06.017. Epub 2012 Jul 11.

DOI:10.1016/j.joca.2012.06.017

PMID:22796513

Abstract

OBJECTIVE

Total hip replacement (THR) and total knee replacement (TKR) (arthroplasty) surgery for end-stage osteoarthritis (OA) are ideal candidates for optimization through an algorithmic care pathway. Using a comparative effectiveness study design, we compared the effectiveness of a new clinical pathway (NCP) featuring central intake clinics, dedicated inpatient resources, care guidelines and efficiency benchmarks vs. the standard of care (SOC) for THR or TKR.

METHODS

We compared patients undergoing primary THR and TKR who received surgery in NCP vs. SOC in a randomised controlled trial within the trial timeframe. 1,570 patients (1,066 SOC and 504 NCP patients) that underwent surgery within the study timeframe from urban and rural practice settings were included. The primary endpoint was improvement in Western Ontario and McMaster University osteoarthritis index (WOMAC) overall score over 12 months post-surgery. Secondary endpoints were improvements in the physical function (PF) and bodily pain (BP) domains of the Short Form 36 (SF-36).

RESULTS

NCP patients had significantly greater improvements from baseline WOMAC scores compared to SOC patients after adjusting for covariates (treatment effect=2.56; 95% confidence interval (CI) [1.10-4.01]). SF-36 BP scores were significantly improved for both hip and knee patients in the NCP (treatment effect=3.01, 95% CI [0.70-5.32]), but SF-36 PF scores were not. Effects of the NCP were more pronounced in knee patients.

CONCLUSION

While effect sizes were small compared with major effects of the surgery itself, an evidence-informed clinical pathway can improve health related quality of life (HRQoL) of hip and knee arthroplasty patients with degenerative joint disorder in routine clinical practice for up to 12 months post-operatively. CLINICALTRIALS.GOV IDENTIFIER: NCT00277186.

摘要

目的

针对终末期骨关节炎（OA），全髋关节置换术（THR）和全膝关节置换术（TKR）（关节置换术）是通过算法护理途径进行优化的理想选择。采用比较效果研究设计，我们比较了一种新的临床途径（NCP），其特点是中央接诊诊所、专用住院资源、护理指南和效率基准，与 THR 或 TKR 的标准护理（SOC）相比。

方法

我们比较了在试验时间范围内接受 NCP 与 SOC 手术的初次 THR 和 TKR 患者。在城乡实践环境中，有 1570 名患者（SOC 患者 1066 名，NCP 患者 504 名）在研究时间范围内接受了手术。主要终点是手术后 12 个月时 Western Ontario 和 McMaster 大学骨关节炎指数（WOMAC）总体评分的改善。次要终点是 Short Form 36（SF-36）身体功能（PF）和身体疼痛（BP）领域的改善。

结果

在调整协变量后，与 SOC 患者相比，NCP 患者的 WOMAC 基线评分有显著改善（治疗效果=2.56；95%置信区间（CI）[1.10-4.01]）。NCP 中的髋膝关节患者的 SF-36 BP 评分均显著提高（治疗效果=3.01，95%CI[0.70-5.32]），但 SF-36 PF 评分没有。NCP 的效果在膝关节患者中更为明显。