Reporting of geriatric participant characteristics and inclusion of older adults in infectious diseases clinical trials: a secondary analysis of a systematic review

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: = 37.0, p