Aphasia treatment research: a decision-making tool to guide the design of phased trials from the Collaboration of Aphasia Trialists (CATs) trials for aphasia panel

Abstract

Background Systematic reviews of randomised controlled trials with meta-analyses indicate that speech and language therapy for aphasia after stroke is effective in improving communication. However, high-quality evidence to identify an intervention’s target population (who), regimen (what), timing (when), and dose (how much) is lacking. The predominance of underpowered aphasia trials and comparative studies with design limitations may be attributed to: 1) the perceived complexity of designing trials of interventions for a complex behaviour such as human communication, 2) the lack of funded research in the field and 3) a lack of training and understanding in the field of aphasiology regarding the importance of formalised clinical trials and the role they play in advancing clinical practice. Clinical trial phasing is designed to make sure an intervention is safe and shows proof of concept, with well-defined key components before evaluating for efficacy (and subsequently effectiveness) at scale. The field of aphasiology needs a systematic approach to trial phasing for people in different stages of their recovery.Scope and Aim To examine the utility of an adapted decision-making tool to guide the design of aphasia intervention trials. The tool will assist researchers to evaluate key components within existing evidence and address evidence gaps in aphasia treatment research.Procedures The expert interdisciplinary group in aphasia treatment research methodology adapted the Stroke Recovery and Rehabilitation Roundtable Trial Development Framework (SRRR-TDF) for use in aphasia research. The Stroke Recovery and Rehabilitation Roundtable-Trials Development Framework-Aphasia (SRRR-TDF-A) was applied to two key treatment components (“how much” and “what” type). Detailed working examples and the processes of applying the framework to the evidence are provided. The SRRR-TDF-A was completed to support each example, with the essential elements addressing: i) developing the research question, ii) designing the study, iii) conducting the research, and iv) evaluating and interpreting the research.Outcomes The expert interdisciplinary group adapted the SRRR-TDF, into the Stroke Recovery and Rehabilitation Roundtable Development Framework-Aphasia (SRRR-TDF-A), a decision-making tool appropriate for aphasia trials. The expert group reported that using the SRRR-TDF-A tool enabled a “step-by-step” process to distill and synthesise the evidence. This led to an easy-to-follow process to identify the “next steps” required to address the research question. The expert group provided aphasia researchers with a tangible guide to developing clinical trials using the existing evidence base.Conclusions/Recommendations We recommend aphasia researchers apply SRRR-TDF-A decision making tool to guide development of the next trial phase for a targeted aphasia intervention.