Grant: Project Grant

Stroke is a leading cause of death and long-term disability in Canada and globally. In addition to the loss of physical function, stroke severely impacts multiple dimensions of a patients' quality of life (QOL). Randomized controlled trials remain the gold standard for generating high-level evidence about the effectiveness of stroke interventions. However, outcomes assessment in acute stroke trials remains a significant challenge for patients and trial investigators. Acute stroke trials typically adopt measures of functional disability, such as the modified Rankin scale (mRS), as primary outcome, but do not assess a broad range of QOL dimensions (e.g., fatigue, cognitive function, mood, mental health, etc.) which are known to be important to stroke patients. In addition, the assessment of outcomes in acute stroke trials is still predominantly done by trained personnel during routine in-person follow-up visits or via telephone and is often limited to 90-day assessments. This poses several challenges, such as proxy bias and inability to collect multiple outcomes at higher frequency and for longer time periods. Recent limitations imposed by the COVID-19 pandemic have only amplified these inefficiencies. Consequently, outcome assessment in acute stroke trials remains investigator-centered, prone to proxy-bias, inefficient, and limited to short-term assessments, resulting in missed opportunities to capture patients' perspectives about treatment interventions. This project aims to co-develop the strokePRO, a user-centered electronic platform for outcome assessment, with stroke survivors and trialists. This system will facilitate flexible and remote collection of outcomes (in acute stroke trials) directly from the patient, a need that became clear during the COVID-19 pandemic. strokePRO is a promising intervention that can enhance patient recruitment and retention in stroke trials, improve robustness and quality of outcomes data, and trial operations while reducing costs.