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解析膝骨关节炎的治疗途径:包括一项前瞻性队列研究、一项定性研究和一项成本效益研究的 TREATright 研究方案。

Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study.

机构信息

Clinical Orthopaedic Research Hvidovre (CORH), Department of Orthopaedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark

Clinical Orthopaedic Research Hvidovre (CORH), Department of Orthopaedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark.

出版信息

BMJ Open. 2021 Jul 7;11(7):e048411. doi: 10.1136/bmjopen-2020-048411.

Abstract

INTRODUCTION

Knee osteoarthritis (OA) is associated with chronic knee pain and functional disability that negatively affect the ability to carry out normal daily activities. Patients are offered a large variety of non-surgical treatments, often not in accordance with clinical guidelines. This observational study will provide a comprehensive overview of treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon, including timing and order of treatment modalities, predictors of treatment outcomes, cost-effectiveness of treatment pathways and patients' views on different treatment pathways.

METHODS AND ANALYSIS

Patients with primary referrals to an orthopaedic surgeon due to knee OA are consecutively invited to participate and fill out a questionnaire prior to their consultation with an orthopaedic surgeon. Follow-up questionnaires will be obtained at 6 and 24 months after inclusion. Based on a prospective cohort study design, including questionnaires and register data, we will (1) describe treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon; (2) describe the characteristics of patients choosing different treatment pathways; (3) develop predictive models for patient-self-determined classifications of good and poor treatment outcomes; (4) evaluate the cost-effectiveness of treatment pathways that live up to clinical guidelines versus pathways that do not; based on a qualitative study design using semistructured individual interviews, we will (5) describe the patients' perspectives on treatment pathways for knee OA.

ETHICS AND DISSEMINATION

The study is approved by the Danish regional ethical committee (journal number H-17017295) and the Danish Data Protection Agency (journal number AHH-2017-072). Data will be anonymised and handled in line with the General Data Protection Regulation and the Danish Data Protection Act. The study results will be submitted to international open-access peer-reviewed journals and disseminated at conferences.

TRIAL REGISTRATION NUMBER

NCT03746184, pre-results.

摘要

简介

膝关节骨关节炎(OA)与慢性膝关节疼痛和功能障碍有关,这些问题会降低患者进行日常活动的能力。患者通常会接受多种非手术治疗,但这些治疗往往不符合临床指南。本观察性研究将全面概述膝关节 OA 患者在咨询骨科医生后的 2 年内的治疗途径,包括治疗方式的时间和顺序、治疗效果的预测因素、治疗途径的成本效益以及患者对不同治疗途径的看法。

方法和分析

连续邀请因膝关节 OA 初次就诊的骨科医生的患者参与,并在咨询骨科医生之前填写一份问卷。将在纳入后 6 个月和 24 个月时获得随访问卷。基于前瞻性队列研究设计,包括问卷调查和登记数据,我们将:(1)描述在咨询骨科医生后的 2 年内膝关节 OA 的治疗途径;(2)描述选择不同治疗途径的患者的特征;(3)为患者自定的良好和不良治疗效果分类开发预测模型;(4)根据使用半结构化个体访谈的定性研究设计,评估符合临床指南与不符合临床指南的治疗途径的成本效益;(5)描述患者对膝关节 OA 治疗途径的看法。

伦理和传播

该研究已获得丹麦区域伦理委员会(期刊编号 H-17017295)和丹麦数据保护局(期刊编号 AHH-2017-072)的批准。数据将被匿名化,并按照《通用数据保护条例》和《丹麦数据保护法》进行处理。研究结果将提交给国际开放获取同行评审期刊,并在会议上进行传播。

试验注册号

NCT03746184,预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cca6/8264876/fdb6ed6ef92f/bmjopen-2020-048411f01.jpg

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