Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union.

IF 4.6 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Quality of Care and Clinical Outcomes Pub Date : 2025-03-06 DOI:10.1093/ehjqcco/qcaf007

J J Coughlan, R A Byrne, G C M Siontis, L McGovern, R Durand, A Lübbeke, A Bano, A G Fraser

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Abstract

Introduction: Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes and cardiovascular) approved in the European Union (EU).

Methods: This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high risk orthopaedic, diabetes and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex and ethnicity of participants, and the performance of stratified analyses based on these factors.

Results: The majority (>90%) of studies in all three device categories (orthopaedics, diabetes and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of patients in the included orthopaedic and diabetes device studies, but less than 40% of patients in the included cardiovascular device studies (p < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.

Conclusions: Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed if these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies. Study registration Cardiovascular device systematic review: PROSPERO (CRD42022308593, Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).

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在欧盟批准的高风险医疗器械临床研究中按年龄、性别和种族纳入和报告。

在临床研究中充分纳入和代表患者对研究结果的普遍性至关重要。本分析的目的是确定在欧洲联盟（EU）批准的高风险医疗器械（骨科、糖尿病和心血管）临床研究中按年龄、性别和种族纳入和报告情况。方法：这是对高风险医疗器械临床证据的三个协调系统评价数据的分析。该分析包括641项研究，报告了190多万接受高风险骨科、糖尿病和心血管医疗设备治疗的患者。主要结果是提供参与者年龄、性别和种族数据的研究的比例，以及基于这些因素的分层分析的表现。结果：所有三种器械类别（骨科、糖尿病和心血管）的大多数研究（>90%）提供了参与者的年龄和性别数据，但只有少数研究(结论：本分析中几乎所有研究都提供了年龄和性别的人口统计数据，但只有少数研究分析了这些因素是否对器械性能有任何影响。很少有研究提供了研究参与者的种族信息。与骨科和糖尿病器械研究相比，心血管器械研究纳入的女性患者比例较低。心血管设备系统评价：PROSPERO (CRD42022308593)，糖尿病设备系统评价：PROSPERO （CRD42022366871）。骨科器械系统评价：开放科学框架（https://osf.io/6gmyx）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Heart Journal - Quality of Care and Clinical Outcomes CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

9.40

自引率

3.80%

发文量

期刊介绍： European Heart Journal - Quality of Care & Clinical Outcomes is an English language, peer-reviewed journal dedicated to publishing cardiovascular outcomes research. It serves as an official journal of the European Society of Cardiology and maintains a close alliance with the European Heart Health Institute. The journal disseminates original research and topical reviews contributed by health scientists globally, with a focus on the quality of care and its impact on cardiovascular outcomes at the hospital, national, and international levels. It provides a platform for presenting the most outstanding cardiovascular outcomes research to influence cardiovascular public health policy on a global scale. Additionally, the journal aims to motivate young investigators and foster the growth of the outcomes research community.