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Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies
Jessica S Cranston1, Brett D Kaplan2, Jeffrey L Saver2
1From the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles (J.S.C., B.D.K., J.L.S.); Department of Neuroscience, Duke University, Durham, NC (J.S.C.); and Department of Kinesiology, University of Maryland, College Park (B.D.K.). jessicascranston@gmail.com.
Stroke
|September 22, 2017
Summary
Determining the minimal clinically important difference (MCID) for acute ischemic stroke treatments is crucial. This study found the MCID to be 1.1%-1.5%, aligning with actual clinical practice and guiding future trial design.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- Establishing the minimal clinically important difference (MCID) is vital for assessing new therapies, particularly for acute ischemic stroke.
- Previous expert surveys yielded higher MCIDs than observed in clinical practice, potentially due to anchoring bias.
Purpose of the Study:
- To determine the MCID for acute ischemic stroke treatments using a survey designed to mitigate bias.
- To establish a clinically relevant MCID that aligns with expert behavior in guideline writing and practice.
Main Methods:
- An internet-based survey was administered to 122 academic stroke neurologists in the US.
- A base-1000 patient framework was used to minimize anchoring bias in expert judgment of MCID.
- Survey responses assessed demographic data, clinical experience, and expert opinion on the MCID for functional independence.
Main Results:
- The median MCID reported by neurologists was 1.3% (IQR, 0.8% to >2%).
- Responder analysis confirmed the survey participants were representative of the broader expert population.
- The revised MCID range of 1.1%-1.5% aligns with expert behavior in practice and guideline development.
Conclusions:
- Survey design significantly impacts MCID estimates for acute ischemic stroke treatments.
- A bias-mitigated MCID of 1.1%-1.5% provides a more accurate benchmark for evaluating neuroprotective agents.
- This revised MCID can inform clinical trial design, funding decisions, and regulatory evaluations.