Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2026
Reporting of geriatric participant characteristics and inclusion of older adults in infectious diseases clinical trials: a secondary analysis of a systematic review.
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Blagojevic Christina, Bryce Aliya, Ovadia Aaron, Slater Matthew, Pryal Daire, Careaga Rodrigo Escobar, Moffroid Hadrien, Yerramilli Arvind, Charani Esmita, Daneman Nick, Tong Steven Y C, Ong Sean W X
Аннотация
OBJECTIVES: As we care for a globally ageing patient population, it is important that infectious diseases randomized controlled trials (RCTs) reflect these demographic changes with adequate representation of older adults. Using a dataset of published infectious disease RCTs, we aimed to evaluate the inclusion of older adults based on trial eligibility criteria and reporting of relevant geriatric characteristics.
METHODS: We conducted a secondary analysis of a previously published systematic review of infectious disease RCTs published between January 2014 and August 2023 in ten high-impact journals. We assessed the overall proportion of RCTs that included older adults (defined as ≥65 years), stratified by country income and subject area, and evaluated predictors of whether a study excluded older adults using logistic regression. We also assessed whether studies reported key geriatric characteristics including frailty, functional status, cognition, and place of residence.
RESULTS: There were 1093 RCTs that included adults ≥18 years; 207 (18.9%) excluded older adults by design. The weighted mean age by trial size across all included studies that reported a mean age (n = 1029) was 53.5 years, which differed across trial subject area and country income. Participants in trials conducted in high-income countries (n = 581 studies; weighted mean age 63.7 years) were older than those conducted in mixed income (n = 168 studies; 49.8 years) and low-income countries (n = 272 studies, 27.8 years). Studies conducted exclusively in older adults (n = 19, 1.7%) were more likely to report at least one geriatric characteristic of interest (n = 8/19 studies, 42.1%) compared with all studies that included older adults (n = 55/886 studies, 6.2%, χ2 = 37.0, p <0.0001).
CONCLUSIONS: Older adults remain underrepresented in infectious disease RCTs. Their inclusion is essential in ensuring generalisability of results to the population encountered in clinical practice. Geriatric characteristics remain underreported even in geriatric-focused RCTs despite the heterogeneity of older adults.
METHODS: We conducted a secondary analysis of a previously published systematic review of infectious disease RCTs published between January 2014 and August 2023 in ten high-impact journals. We assessed the overall proportion of RCTs that included older adults (defined as ≥65 years), stratified by country income and subject area, and evaluated predictors of whether a study excluded older adults using logistic regression. We also assessed whether studies reported key geriatric characteristics including frailty, functional status, cognition, and place of residence.
RESULTS: There were 1093 RCTs that included adults ≥18 years; 207 (18.9%) excluded older adults by design. The weighted mean age by trial size across all included studies that reported a mean age (n = 1029) was 53.5 years, which differed across trial subject area and country income. Participants in trials conducted in high-income countries (n = 581 studies; weighted mean age 63.7 years) were older than those conducted in mixed income (n = 168 studies; 49.8 years) and low-income countries (n = 272 studies, 27.8 years). Studies conducted exclusively in older adults (n = 19, 1.7%) were more likely to report at least one geriatric characteristic of interest (n = 8/19 studies, 42.1%) compared with all studies that included older adults (n = 55/886 studies, 6.2%, χ2 = 37.0, p <0.0001).
CONCLUSIONS: Older adults remain underrepresented in infectious disease RCTs. Their inclusion is essential in ensuring generalisability of results to the population encountered in clinical practice. Geriatric characteristics remain underreported even in geriatric-focused RCTs despite the heterogeneity of older adults.