Comprehensive assessment of disability post-stroke using the newly developed miFUNCTION scale.

Area of Science:

• Neurology
• Rehabilitation Medicine
• Clinical Trials

Background:

• The modified Rankin Scale (mRS) is standard for acute stroke trials but suffers from interobserver variability, limiting outcome assessment.
• This variability can reduce the statistical power of clinical trials evaluating stroke interventions.

Purpose of the Study:

• To develop and validate miFUNCTION, a comprehensive, hierarchical assessment tool based on the International Classification of Functioning, Disability and Health.
• To address the limitations of the mRS and provide a more thorough understanding of post-stroke disability.

Main Methods:

• Construct validity of miFUNCTION was assessed in a pilot study of recent stroke patients.
• Criterion validity was evaluated by comparing miFUNCTION against the mRS and other measures in the ESCAPE clinical trial.
• Logistic regression analyzed miFUNCTION as an outcome to demonstrate treatment effects.

Main Results:

• The pilot study showed moderate inter-observer agreement for miFUNCTION (k=0.585) and near-perfect correlation with mRS (ρ=0.821).
• The ESCAPE trial confirmed a near-perfect correlation between miFUNCTION and mRS (ρ=0.944).
• Both scales demonstrated similar effect sizes in multivariable models for treatment efficacy.

Conclusions:

• miFUNCTION strongly correlates with stroke-related disability in both outpatient and clinical trial settings.
• Further research is needed to assess miFUNCTION's sensitivity to change and enhance its inter-observer reliability.