This is a major problem, cherry picking patients for clinical trials. So until they start actually using real world data, IT IS YOUR RESPONSIBILITY TO HAVE PERFECT STROKES AND PERFECT HEALTH.
Assessing the Concordance Between Stroke Rehabilitation Research Participants & 'Real World'Stoke Patients
Abstract
Stroke
rehabilitation programs have been transformed to better align with
stroke Clinical Practice Guidelines (CPGs), which 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, excluded
participants based on age related criteria, and often excluded
individuals with comorbidities. The objective of this study was to
determine the proportion of stroke patients that would meet the
enrolment criteria of stroke rehabilitation randomized controlled
trials. A retrospective chart audit was conducted for all patients
discharged from a high intensity stroke rehabilitation unit for a
one-year period (n=110). RCT exclusion criteria were extracted from a
recent review that analyzed the study inclusion and exclusions of 428
RCTs (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.
Patients admitted to the stroke rehab unit had a mean age of 67.4 years
and an average of 6.2 co-morbidities. 60.1% of these patients would have
been excluded from participating in the RCTs by one or more exclusion
criteria. 5.5% of patients would have been excluded 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 CCI condition or stroke risk
factor. Results highlight the difference between trial subjects and
‘real world’ patients. Based on our understanding of how people
accumulate chronic conditions with age, it can be inferred that the high
quality evidence may not reflect the clinical reality of stroke
rehabilitation. Given the high prevalence of increased age and
comorbidities among 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.
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