Introduction
In stroke research, people with aphasia are generally under-represented, and frequently excluded from intervention trials for which language status is highly salient, including post-stroke information, self-management, and depression screening. The exclusion of people with aphasia impacts the representativeness of stroke trial findings, which has significance for the quality and equity of clinical management. Preparing a stroke trialist to include people with aphasia is significant for the efficient use of trial resources and to more validly inform clinical treatment and care decisions.
Objective
The objective of this study was to investigate the proportion of people with aphasia (PwA) included and retained in randomized controlled trials (RCTs) of stroke interventions and the use of aphasia-friendly inclusion and retention methods.
Methods
- The protocol for this systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO).
- The searches were conducted using electronic databases: PubMed, Embase, and Medline.
- RCTs examining stroke interventions targeting cognition, psychological well-being/health-related quality of life (HRQL), self-management, and rehabilitation were included.
- Methodological quality was evaluated using the Critical Appraisal Skills Program (CASP).
Results
- Fifty-seven RCTs were included.
- These examined self-management (32%), physical (26%) psychological well-being/HRQL (18%), cognitive (14%), and multidisciplinary (11%) interventions.
- Of 7313 participants, 107 (1.5%) had aphasia and were included in three trials.
- Approximately one-third did not report on aphasia (32%), over one-quarter needed functional communication (28%), one quarter excluded all aphasia (25%), and 14% excluded severe aphasia.
- No aphasia-specific inclusion/retention methods were available.
Conclusion
The results of this systematic review suggest that the findings highlight ongoing under-representation. However, due to shortcomings in aphasia reporting, the findings may underestimate the substantial inclusion rate. Excluding PwA has implications for the effectiveness, external validity, and implementation of stroke research findings. Trialists could need assistance with reporting methodologies and aphasia research methods.