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一项基于观察登记的髋膝关节骨关节炎患者健康与风险因素研究的研究方案。

Study protocol for an observational register-based study on health and risk factors in patients with hip and knee osteoarthritis.

作者信息

Gustafsson Kristin, Rolfson Ola, Eriksson Marit, Dahlberg Leif, Kvist Joanna

机构信息

Department of Physiotherapy, Rehabilitation Centre, Ryhov County Hospital Jönköping, Jönköping, Sweden.

Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.

出版信息

BMJ Open. 2018 Oct 3;8(10):e022812. doi: 10.1136/bmjopen-2018-022812.

Abstract

INTRODUCTION

Hip and knee osteoarthritis is a leading cause of disability worldwide. Currently, the course of deterioration in pain and physical functioning in individuals with osteoarthritis is difficult to predict. Factors such as socioeconomic status and comorbidity contribute to progression of osteoarthritis, but clear associations have not been established. There is a need for early identification of individuals with slow disease development and a good prognosis, and those that should be recommended for future joint replacement surgery.

METHODS AND ANALYSIS

This nationwide register-based study will use data for approximately 75 000 patients who sought and received core treatment for osteoarthritis in primary healthcare, and were registered in the Swedish population-based National Quality Register for Better Management of Patients with Osteoarthritis. These data will be merged with data for replacement surgery, socioeconomic factors, healthcare consumption and comorbidity from the Swedish Hip Arthroplasty Register, the Swedish Knee Arthroplasty Register, Statistics Sweden and the National Board of Health and Welfare, Sweden. The linkage will be performed using personal identity numbers that are unique to all citizens in Sweden.

ETHICS AND DISSEMINATION

The study was approved by the Regional Ethical Review Board in Gothenburg, Sweden (dnr 1059-16). The results from this study will be submitted to peer-reviewed journals and reported at suitable national and international meetings.

TRIAL REGISTRATION NUMBER

NCT03438630.

摘要

引言

髋膝关节骨关节炎是全球致残的主要原因。目前,骨关节炎患者疼痛和身体功能的恶化过程难以预测。社会经济地位和合并症等因素会促使骨关节炎病情进展,但尚未明确其关联。有必要尽早识别疾病发展缓慢且预后良好的个体,以及那些适合推荐进行未来关节置换手术的个体。

方法与分析

这项基于全国登记册的研究将使用约75000名在初级医疗保健机构寻求并接受骨关节炎核心治疗、且登记在瑞典基于人群的骨关节炎患者更好管理国家质量登记册中的患者数据。这些数据将与来自瑞典髋关节置换登记册、瑞典膝关节置换登记册、瑞典统计局以及瑞典卫生和福利委员会的置换手术、社会经济因素、医疗消费和合并症数据合并。将使用瑞典所有公民唯一的个人身份号码进行数据链接。

伦理与传播

该研究已获得瑞典哥德堡地区伦理审查委员会批准(编号1059 - 16)。本研究结果将提交给同行评审期刊,并在合适的国家和国际会议上报告。

试验注册号

NCT03438630。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7a7/6194475/ed8d771d957b/bmjopen-2018-022812f01.jpg

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