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- Farid H Mahmud, Antoine B M Clarke, Yesmino Elia, Jacqueline Curtis, Paul Benitez-Aguirre, Fergus J Cameron, Scott T Chiesa, Cheril Clarson, Jennifer J Couper, Maria E Craig, R Neil Dalton, Denis Daneman, Elizabeth A Davis, John E Deanfield, Kim C Donaghue, Timothy W Jones, Sally M Marshall, Andrew Neil, and M Loredana Marcovecchio.
- Division of Endocrinology, Department of Paediatrics, The Hospital for Sick Children and University of Toronto, 555 University Avenue, RM 5446 Black Wing, Toronto, ON, M5G 1X8, Canada. farid.mahmud@sickkids.ca.
- Bmc Med. 2023 Dec 20; 21 (1): 506506.
BackgroundGiven limited data regarding the involvement of disadvantaged groups in paediatric diabetes clinical trials, this study aimed to evaluate the socioeconomic representativeness of participants recruited into a multinational clinical trial in relation to regional and national type 1 diabetes reference populations.MethodsRetrospective, cross-sectional evaluation of a subset of adolescent type 1 diabetes cardiorenal intervention trial (AdDIT) participants from Australia (n = 144), Canada (n = 312) and the UK (n = 173). Validated national measures of deprivation were used: the Index of Relative Socioeconomic Disadvantage (IRSD) 2016 (Australia), the Material Resources (MR) dimension of the Canadian Marginalisation index 2016 (Canada) and the Index of Multiple Deprivation (IMD) 2015 (UK). Representativeness was assessed by comparing the AdDIT cohort's distribution of deprivation quintiles with that of the local paediatric type 1 diabetes population (regional), and the broader type 1 diabetes population for which the trial's intervention was targeted (national).ResultsRecruited study cohorts from each country had higher proportions of participants with higher SES, and significant underrepresentation of lower SES, in relation to their national references. The socioeconomic make-up in Australia mirrored that of the regional population (p = 0.99). For Canada, the 2nd least deprived (p = 0.001) and the most deprived quintiles (p < 0.001) were over- and under-represented relative to the regional reference, while the UK featured higher regional and national SES bias with over-representation and under-representation from the least-deprived and most-deprived quintiles (p < 0.0001).ConclusionsSignificant national differences in trial participation of low SES participants were observed, highlighting limitations in access to clinical research and the importance of reporting sociodemographic representation in diabetes clinical trials.Trial RegistrationNCT01581476. Registered on 20 April 2012.© 2023. The Author(s).
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