随机对照试验方案，评估促进髋和膝关节骨关节炎共同决策策略的比较效果（DECIDE-OA 研究）。

Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

机构信息

Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2019 Feb 24;9(2):e024906. doi: 10.1136/bmjopen-2018-024906.

DOI:10.1136/bmjopen-2018-024906

PMID:30804032

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6443066/

Abstract

INTRODUCTION

There are several different interventions available to promote shared decision making (SDM); however, little is known about the comparative effectiveness of different approaches.

OBJECTIVE

To examine the impact of patient-directed and physician-directed decision support strategies on the quality of treatment decisions for hip and knee osteoarthritis (OA).

TRIAL DESIGN

A 2×2 factorial randomised controlled trial.

SETTING

One academic medical centre, one community hospital and one orthopaedic specialty hospital.

PARTICIPANTS AND INTERVENTIONS

The enrolment targets were 8 surgeons and 1120 patients diagnosed with hip or knee OA. Patients were randomly assigned to receive one of two different decision aids (DAs) stratified by site. The DAs varied in length, content and the level of detail regarding treatment options. Both DAs were available by paper or online.Surgeons were randomly assigned to receive a report detailing patients' goals and treatment preferences at the time of the visit or not. Eligible patients received their assigned DA before their visit and completed three surveys: before the visit (timepoint (T)1), 1-week postvisit (T2) and 6 months from either the visit date or surgery date for patients who underwent surgery (T3). Study staff and participating surgeons were not blinded, but the statistician conducting the analyses was blinded to the arms.

MAIN OUTCOME MEASURE AND ANALYSIS

The primary study outcome was decision quality, the percentage of patients who were well informed and received their preferred treatment. Secondary outcomes included involvement in decision making, surgical rates, health outcomes, decision regret and satisfaction. A logistic regression model with the generalised estimating equations approach was used to compare rates of decision quality between the groups and account for the clustering of patients within providers.

ETHICS AND DISSEMINATION

Ethics approval was obtained through the institutional review board at the main site. The findings will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT02729831; Pre-results.

摘要

简介

有几种不同的干预措施可用于促进共同决策（SDM）；然而，对于不同方法的比较效果知之甚少。

目的

研究以患者为导向和以医生为导向的决策支持策略对髋膝关节骨关节炎（OA）治疗决策质量的影响。

试验设计

一项 2×2 析因随机对照试验。

设置

一家学术医疗中心、一家社区医院和一家骨科专科医院。

参与者和干预措施

目标入组人数为 8 名外科医生和 1120 名被诊断为髋或膝关节 OA 的患者。患者随机分配接受两种不同的决策辅助工具（DA）之一，按地点分层。这些 DA 在长度、内容和治疗方案的详细程度上有所不同。两种 DA 均可通过纸质或在线形式提供。外科医生随机分配到在就诊时收到一份详细说明患者目标和治疗偏好的报告或不收到。符合条件的患者在就诊前收到他们指定的 DA，并在就诊前（T1）、就诊后 1 周（T2）和就诊或手术日期后 6 个月（T3）完成了三项调查。研究工作人员和参与的外科医生没有被蒙蔽，但进行分析的统计人员对臂部情况不知情。