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

机译:替代性临床途径对原发性髋和膝关节置换患者的比较有效性:一项实用的随机对照试验

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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.
机译:目的:用于终末期骨关节炎(OA)的全髋关节置换术(THR)和全膝关节置换术(TKR)(关节成形术)是通过算法护理路径进行优化的理想候选者。使用比较有效性研究设计,我们比较了具有中央入口诊所,专用住院资源,护理指南和效率基准的新临床途径(NCP)与THR或TKR的护理标准(SOC)的有效性。方法:我们在随机对照试验中比较了接受原发性THR和TKR的NCP与SOC手术患者。在城市和农村实践背景下的研究时间内,纳入了1,570例患者(1,066例SOC和504例NCP患者)。主要终点是手术后12个月内西安大略省和麦克马斯特大学骨关节炎指数(WOMAC)总体得分的改善。次要终点是简短表格36(SF-36)的身体功能(PF)和身体疼痛(BP)域的改善。结果:校正协变量后,与SOC患者相比,NCP患者的基线WOMAC评分有明显改善(治疗效果= 2.56; 95%置信区间(CI)[1.10-4.01])。 NCP的髋关节和膝关节患者的SF-36 BP评分均得到显着改善(治疗效果= 3.01,95%CI [0.70-5.32]),但SF-36 PF评分没有改善。 NCP的作用在膝关节患者中更为明显。结论:与手术本身的主要疗效相比,虽然疗效较小,但循证知情的临床途径可在常规临床实践中改善髋关节和膝关节置换术后退行性关节疾病患者的健康相关生活质量(HRQoL),最高可达12术后几个月。 Clinicaltrials.gov标识符:NCT00277186。

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