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选择预期寿命有限的体弱老年人的髋部骨折进行非手术治疗与手术治疗的共享决策:一项全国实施研究方案。

Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study.

机构信息

Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.

Department of Trauma Surgery, Sint Antonius Ziekenhuis, Utrecht, the Netherlands.

出版信息

BMJ Open. 2024 Apr 17;14(4):e083429. doi: 10.1136/bmjopen-2023-083429.

Abstract

BACKGROUND AND PURPOSE

Recent research has highlighted non-operative management (NOM) as a viable alternative for frail older adults with hip fractures in the final phase of life. This study aims to guide Dutch physicians and hospitals nationwide in a standardised implementation of shared decision-making regarding surgery or NOM in selected frail older adults with a hip fracture.

METHODS AND ANALYSIS

The patient population for implementation includes frail older adults aged ≥70 years with an acute proximal femoral fracture, nursing home care or a similar level of care elsewhere and at least one additional criterion (ie, malnutrition, severe mobility impairment or ASA≥4). The 2-year implementation study will be conducted in four phases. In phases 1 and 2, barriers and facilitators for implementation will be identified and an implementation protocol, educational materials and patient information will be developed. Phase 3 will involve an implementation pilot in 14 hospitals across the Netherlands. The protocol and educational material will be improved based on healthcare provider and patient experiences gathered through interviews. Phase 4 will focus on upscaling to nationwide implementation and the effect of the implementation on NOM rate will be measured using data from the Dutch Hip Fracture Audit.

ETHICS AND DISSEMINATION

The study was exempted by the local Medical Research Ethics Committee (MEC-2023-0270, 10 May 2023) and Medical Ethics Committee United (W23.083, 26 April 2023). The study's results will be submitted to an open access international peer-reviewed journal. Its protocols, tools and results will be presented at several national and international academic conferences of relevant orthogeriatric (scientific) associations.

TRIAL REGISTRATION NUMBER

NCT06079905 .

摘要

背景与目的

最近的研究强调,对于生命终末期体弱的髋部骨折老年患者,非手术治疗(NOM)是一种可行的替代选择。本研究旨在为荷兰全国的医生和医院提供指导,以便在选定的体弱髋部骨折老年患者中,就手术或 NOM 进行标准化的共享决策。

方法与分析

实施对象包括年龄≥70 岁、有急性股骨近端骨折、居住在养老院或类似护理场所、且至少符合以下一项附加标准(即营养不良、严重活动障碍或 ASA≥4)的体弱老年人。为期 2 年的实施研究将分为 4 个阶段进行。在第 1 阶段和第 2 阶段,将确定实施的障碍和促进因素,并制定实施方案、教育材料和患者信息。第 3 阶段将在荷兰的 14 家医院进行实施试点。将根据通过访谈收集的医疗保健提供者和患者的经验来改进方案和教育材料。第 4 阶段将侧重于在全国范围内推广实施,并通过荷兰髋部骨折审计的数据来衡量实施对 NOM 率的影响。

伦理与传播

该研究已被当地医学研究伦理委员会(MEC-2023-0270,2023 年 5 月 10 日)和联合医学伦理委员会(W23.083,2023 年 4 月 26 日)豁免。该研究的结果将提交给一个开放获取的国际同行评议期刊。其方案、工具和结果将在相关老年骨科(科学)协会的几次全国和国际学术会议上展示。

临床试验注册号

NCT06079905。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c3f/11029367/0e98d8ff347f/bmjopen-2023-083429f01.jpg

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