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

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).