The Sex-Specific Impact of the FORTA (Fit-fOR-The-Aged) List on Medication Quality and Clinical Endpoints in Older Hospitalized Patients: Secondary Analysis of a Randomized Controlled Trial

Abstract

Background Little is known about the sex-specific impact of drug optimization tools such as the Fit fOR The Aged (FORTA) list on drug use and relevant clinical endpoints in older people. Objective We aimed to detect gender differences of interventional effects on medication quality and related clinical effects in the VALFORTA trial. Patients and methods A sex-specific analysis of data from 409 patients (147 men and 262 women, mean age 79.4 and 82.7 years, respectively) in acute geriatric care comparing the control and FORTA intervention groups was performed. Changes of the FORTA score (sum of over-and undertreatment errors per patient), the incidence of adverse drug events (ADEs) during hospitalization, and several clinically relevant endpoints [e.g., the Barthel index (BI)] were tested for equivalence at a 20% margin. "Success" or "failure" for the development of these clinical endpoints was defined and their frequencies compared by a risk reduction analysis. Results Sex differences were insignificant for the reduction of the FORTA score, the improvement of BI, or over-and undertreatment errors (p > 0.05). In women only, the FORTA intervention significantly increased the number of patients without an ADE (p = 0.010). Statistical sex equivalence was found for the improvement of the FORTA scores, BI, and the number of prevented events (e.g., falls, confusion, or renal failure) (p < 0.05), but not for the improvement of specific mistreatments or over-and undertreatment scores under altered inclusion criteria (p > 0.05). Conclusions Both sexes benefit equally from the FORTA intervention regarding the amelioration of the quality of drug treatment as well as several clinically relevant outcomes. In addition, the positive impact of the FORTA intervention on the number of adverse drug events appears to be greater in women. Trial Registration Number DRKS00000531.