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股骨近端骨折后医疗服务提供、功能能力和生活质量 - 'ProFem':一项基于个体链接调查和法定健康保险数据的基于人群、前瞻性研究的研究方案。

Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data.

机构信息

Institute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.

Institute for Health Services Research and Health Economics, German Diabetes Center, Leibniz Center for Diabetes Research at the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.

出版信息

BMJ Open. 2019 Jun 25;9(6):e028144. doi: 10.1136/bmjopen-2018-028144.

DOI:10.1136/bmjopen-2018-028144
PMID:31243034
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6597653/
Abstract

INTRODUCTION

Proximal femoral fractures (PFF) are among the most frequent fractures in older people. However, the situation of people with a PFF after hospital discharge is poorly understood. Our aim is to (1) analyse healthcare provision, (2) examine clinical and patient-reported outcomes (PROs), (3) describe clinical and sociodemographic predictors of these and (4) develop an algorithm to identify subgroups with poor outcomes and a potential need for more intensive healthcare.

METHODS AND ANALYSIS

This is a population-based prospective study based on individually linked survey and statutory health insurance (SHI) data. All people aged minimum 60 years who have been continuously insured with the AOK Rheinland/Hamburg and experience a PFF within 1 year will be consecutively included (SHI data analysis). Additionally, 700 people selected randomly from the study population will be consecutively invited to participate in the survey. Questionnaire data will be collected in the participants' private surroundings at 3, 6 and 12 months after hospital discharge. If the insured person considers themselves to be only partially or not at all able to take part in the survey, a proxy person will be interviewed where possible. SHI variables include healthcare provision, healthcare costs and clinical outcomes. Questionnaire variables include information on PROs, lifestyle characteristics and socioeconomic status. We will use multiple regression models to estimate healthcare processes and outcomes including mortality and cost, investigate predictors, perform non-responder analysis and develop an algorithm to identify vulnerable subgroups.

ETHICS AND DISSEMINATION

The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (approval reference 6128R). All participants including proxies providing written and informed consent can withdraw from the study at any time. The study findings will be disseminated through scientific journals and public information.

TRIAL REGISTRATION NUMBER

DRKS00012554.

摘要

简介

股骨近端骨折(PFF)是老年人中最常见的骨折之一。然而,人们对出院后的 PFF 情况知之甚少。我们的目的是:(1)分析医疗服务提供情况,(2)检查临床和患者报告的结果(PROs),(3)描述这些结果的临床和社会人口统计学预测因素,以及(4)开发一种算法来识别预后不良和可能需要更密集医疗保健的亚组。

方法和分析

这是一项基于个体链接调查和法定健康保险(SHI)数据的基于人群的前瞻性研究。所有连续受 AOK Rheinland/Hamburg 保险且在 1 年内经历 PFF 的年龄至少 60 岁的人将被连续纳入(SHI 数据分析)。此外,将从研究人群中随机选择 700 人连续邀请参加调查。问卷调查数据将在出院后 3、6 和 12 个月在参与者的私人环境中收集。如果被保险人认为自己只能部分或根本无法参与调查,则在可能的情况下将采访代理人。SHI 变量包括医疗服务提供情况、医疗保健费用和临床结果。问卷变量包括 PROs、生活方式特征和社会经济地位的信息。我们将使用多元回归模型来估计包括死亡率和成本在内的医疗服务流程和结果,调查预测因素,进行非应答者分析,并开发一种算法来识别脆弱亚组。

伦理和传播

该研究已获得 Heinrich-Heine-University Düsseldorf 医学院伦理委员会的批准(批准参考号 6128R)。所有参与者(包括提供书面和知情同意的代理人)都可以随时退出研究。研究结果将通过科学期刊和公共信息进行传播。

试验注册编号

DRKS00012554。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51cb/6597653/9def14c75d0f/bmjopen-2018-028144f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51cb/6597653/9def14c75d0f/bmjopen-2018-028144f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51cb/6597653/9def14c75d0f/bmjopen-2018-028144f01.jpg

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