Are people with aphasia included in stroke trials? A systematic review and narrative synthesis

Objective: To examine the proportion of people with aphasia (PwA) included and retained in randomised controlled trials (RCTs) of stroke interventions published in the previous 6 years, as well as aphasia-relevant eligibility criteria and inclusion/retention strategies. Data sources: Comprehensive searching of Embase, PubMed and Medline (Ovid) for the period January 2016 – November 2022. Review methods: RCTs examining stroke interventions targeting cognition, psychological wellbeing/ health-related quality of life (HRQL), multidisciplinary rehabilitation, and self-management were included. Methodological quality was assessed using the Critical Appraisal Skills Programme (CASP) Randomised Controlled Trial checklist. Descriptive statistics were applied to extracted data, and results were reported narratively. Results: Fifty-seven RCTs were included. These examined self-management (32%), physical (26%) psychological wellbeing/HRQL (18%), cognitive (14%), and multidisciplinary (11%) interventions. Of 7313 participants, 107 (1.5%) had aphasia and were included in three trials. About one-third did not report on aphasia (32%); over one quarter required functional communication (28%); one quarter excluded all aphasia (25%); and 14% excluded severe aphasia. No aphasia-specific inclusion/retention strategies were available. Conclusion: The findings highlight ongoing under-representation. However, due to shortcomings in aphasia reporting, the findings may underestimate actual inclusion rate. Excluding PwA has implications for the external validity, effectiveness, and implementation of stroke research findings. Triallists may require support in aphasia research strategies and methodological reporting