Michelle Nelson, PhD is a Research Scientist within the Lunenfeld-Tanenbaum Research Institute in Toronto, Canada. She is an Assistant Professor (status) in the Institute of Health Policy, Management and Evaluation at the University of Toronto. Her research is concentrated on the organization and delivery of health care services for patients with multiple intersecting health and social concerns, examining topics related to clinical management of uncertainty, collaborative practice, integrated care, health profession education, within the context of rehabilitation and community reintegration.
Aligning stroke rehabilitation with the needs of real world patients: the mismatch of research participants and older stroke patients with comorbidities
The prevalence of stroke increases with age, with two thirds of strokes occurring among people over 65. Rehabilitation plays an important role in recovery for stroke patients, with care provided in alignment with clinical practice guidelines (CPGs). One challenge however, is the potential mismatch of research participants and real world patients. CPGs prioritize randomized control trials as evidence-based best practices. However, a recent review of stroke rehabilitation randomized control trials (RCTs) found that the RCTS tended to include younger participants; often excluded participants based on age related criteria, and often excluded individuals with comorbidities.
The objective of this study was to determine the proportion of real world stroke patients that would meet the enrolment criteria of stroke rehabilitation randomized controlled trials. A retrospective chart audit was conducted for all patients admitted and discharged from a high intensity stroke rehabilitation unit for a one-year period from 2012-2013 (n=110). Stroke rehabilitation RCT exclusion criteria were extracted from a recent systematic scoping review that analyzed the study inclusion and exclusions of 428 RCTs (including age, cognitive impairment, previous stroke, and comorbidities). These study exclusions were applied to the 110 patients to determine how many patients would have been eligible to participate in the RCTs. Results showed that 60.1% of these patients would have been excluded from participating in stroke RCTs by one or more exclusion criteria. Specifically, 5.5% of patients would have been excluded from stroke RCTs based on age, 84.5% of patients would have been ineligible for 54% of RCTs based on cognitive impairment, 28% of patients would have been ineligible for 36% of RCTs based on a previous stroke, and 4.2% of patients would have been excluded based on the presence of a Charlson Comorbidity Index condition or stroke risk factor.
Results highlight the difference between clinical trials subjects and ‘real world’ stroke patients. Based on our understanding of how people accumulate chronic conditions with increased age, it can be inferred that this high quality evidence may not reflect the clinical reality of stroke rehabilitation. Given the high prevalence of increased age and comorbidities among ‘real world’ stroke rehabilitation patients, this study emphasizes the importance of including ‘typical stroke patients’ in research studies or supporting the use of alternative methodologies that addresses application of study results to older patients with comorbidities.