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全髋关节置换术后康复的有效性:一项比较荷兰与德国常规护理的观察性研究方案。

Effectiveness of rehabilitation after a total hip arthroplasty: a protocol for an observational study for the comparison of usual care in the Netherlands versus Germany.

作者信息

Seeber Gesine H, Wijnen Annet, Lazovic Djordje, Bulstra Sjoerd K, Dietz Günter, van Lingen Christiaan P, Stevens Martin

机构信息

Universitätsklinik für Orthopädie und Unfallchirurgie Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Oldenburg, Germany.

Department of Orthopedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

BMJ Open. 2017 Aug 11;7(8):e016020. doi: 10.1136/bmjopen-2017-016020.

Abstract

INTRODUCTION

Osteoarthritis is the most common joint disorder worldwide. Total hip arthroplasty (THA) is considered one of the most effective treatments for end-stage hip osteoarthritis. The number of THAs is expected to increase dramatically in the coming decades. Usual postoperative rehabilitation after primary THA differs between the German and the Dutch system. In the Netherlands, patients undergo fast-track surgery and are discharged into their home environment within a few days without receiving any aftercare. In Germany, patients stay in the hospital for about 12 days before being transferred to a rehabilitation centre for a period of 3 weeks. The superficially more cost-effective Dutch system of usual care after THA is judged critically in both countries due to suboptimal rehabilitation outcomes. The aim of this study is therefore to compare the Dutch with the German usual care rehabilitation after primary THA. It is hypothesised that the German procedure is more effective in terms of functional outcomes and patient satisfaction than the Dutch procedure and that in the long run the German approach is more cost-effective than the Dutch system.

METHODS AND ANALYSIS

Medical effectiveness will be assessed at four different time points by means of patient self-reported questionnaires and functional tests. Assessments include the Hip disability and Osteoarthritis Outcome Score, Patient Acceptable Symptom State, Short Form 36, EuroQol 5 Dimensions 3 Level Questionnaire, Timed Up & Go Test and Five Times Sit-to-Stand Test. Additionally, long-term economic aspects in both countries will be assessed from a societal perspective, to get a first impression on whether cutting costs for rehabilitation, as practised in the Netherlands, really disburdens the healthcare system efficiently.

ETHICS AND DISSEMINATION

The study is approved by the Institutional Review Boards of both University Medical Center Groningen (METc2015/483) and Hannover Medical School (no 2874-2015) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013). The results of the study will be published in international peer-reviewed scientific journals. Patient data will be presented anonymously in any publication or scientific journal.

TRIAL REGISTRATION NUMBER

DRKS00011345; Pre-results.

摘要

引言

骨关节炎是全球最常见的关节疾病。全髋关节置换术(THA)被认为是终末期髋关节骨关节炎最有效的治疗方法之一。预计在未来几十年,全髋关节置换术的数量将急剧增加。初次全髋关节置换术后的常规康复在德国和荷兰体系中有所不同。在荷兰,患者接受快速康复手术,术后几天内即可出院回家,无需任何后续护理。在德国,患者先在医院住院约12天,然后转至康复中心进行为期3周的康复治疗。由于康复效果欠佳,荷兰这种表面上更具成本效益的全髋关节置换术后常规护理体系在两国都受到了批评。因此,本研究的目的是比较初次全髋关节置换术后荷兰与德国的常规护理康复情况。研究假设德国的治疗方法在功能结局和患者满意度方面比荷兰的方法更有效,并且从长远来看,德国的方法比荷兰体系更具成本效益。

方法与分析

通过患者自我报告问卷和功能测试在四个不同时间点评估医疗效果。评估内容包括髋关节残疾和骨关节炎结果评分、患者可接受症状状态、简明健康调查问卷36项、欧洲五维健康量表3级问卷、计时起立行走测试和五次坐立测试。此外,将从社会角度评估两国的长期经济状况,以初步了解荷兰所采用的削减康复成本做法是否真的能有效减轻医疗系统负担。

伦理与传播

本研究已获得格罗宁根大学医学中心(METc2015/483)和汉诺威医学院(编号2874 - 2015)的机构审查委员会批准,并将按照《赫尔辛基宣言》(2013年第64版)的原则进行。研究结果将发表在国际同行评审的科学期刊上。在任何出版物或科学期刊中,患者数据将匿名呈现。

试验注册号

DRKS00011345;预结果。

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