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Background and Purpose: The modified Rankin Scale (mRS) is the most widely used primary outcome measure in acute stroke trials. However, substantial interobserver variability impairs outcome assessment as well as reduces power of clinical trials. Guided by the International Classification of Functioning, Disability and Health, we developed a comprehensive, hierarchical assessment tool (miFUNCTION) to address the shortcomings of the modified Rankin Scale and deliver a more thorough understanding of disability following stroke., Methods: The initial construct validity of miFUNCTION was established in a pilot study of patients at an outpatient stroke prevention clinic that had been diagnosed with stroke within 60 days. To further assess criterion validity, miFUNCTION was compared against the modified Rankin Scale and other outcome measures within the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial. Logistic regression analysis with miFUNCTION as an outcome was used to demonstrate the beneficial effect of endovascular treatment., Results: The pilot study showed moderate inter-observer agreement (k = 0.585, p < 0.005) but near perfect correlation between miFUNCTION and modified Rankin Scale (ρ = 0.821, p < 0.05). The correlation of miFUNCTION and modified Rankin Scale was near perfect again in the ESCAPE trial (ρ = 0.944). Effect size of the multivariable models using modified Rankin Scale (adjusted odds ratio: 3.45, 95% confidence interval: 2.05-5.78) and miFUNCTION (adjusted odds ratio: 3.32, 95% confidence interval: 1.99-5.55) as an outcome measure for the ESCAPE trial patients was similar., Conclusions: miFUNCTION is strongly associated with the degree of disability following stroke both in an outpatient setting and a clinical trial. Further work remains to assess sensitivity to change and to improve the inter-observer reliability of the scale.

Objective: Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data., Design: Multi-site mixed method randomized controlled trial., Setting: Acute and community care in three Canadian cities., Subjects: Caregivers were family members or friends providing care to individuals who experienced their first stroke., Intervention: The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care., Main Measures: Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver., Results: Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction., Conclusions: Preliminary findings suggest the research design is feasible, caregivers' needs are complex, and the support intervention may enhance caregivers' perceived support and mastery. The intervention will be tested further in a large scale trial., (© The Author(s) 2014.)