ArticleEuropean heart journal. Quality of care & clinical outcomes2025
Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union.
Article in European heart journal. Quality of care & clinical outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The trial behind it
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Who cites it
2 citing papers in PubMed.
- The problem with one-size-fits-all medicine: Biological sex and the aging immune system.PLoS biology · 2026Article
- Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.The Lancet regional health. Europe · 2025Review
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
introductionAdequate 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.
methodsThis 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.
resultsThe 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 the patients in the included orthopaedic and diabetes device studies, but <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.
conclusionsAlmost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed whether 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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