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Determining the minimum clinically important differences for outcomes in the DOMINO trial.

Robert Howard¹, Patrick Phillips, Tony Johnson

¹King's College London, Institute of Psychiatry, Department of Old Age Psychiatry, London, UK. robert.j.howard@kcl.ac.uk

International Journal of Geriatric Psychiatry

|September 18, 2010

Summary

Determining the minimum clinically important difference (MCID) is crucial for interpreting dementia trial results. The DOMINO trial established MCIDs for sMMSE, BADLS, and NPI, providing valuable benchmarks for future research.

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Area of Science:

Clinical Trials
Dementia Research
Statistical Analysis

Background:

Minimum clinically important difference (MCID) is vital for patient-relevant outcomes in dementia treatment trials.
Many dementia randomized controlled trials (RCTs) do not report MCIDs, or their observed differences fail to reach established thresholds.

Purpose of the Study:

To determine appropriate Minimum Clinically Important Difference (MCID) values for key outcome measures in the DOMINO dementia trial.
To provide a transparent methodology for MCID determination in dementia research.

Main Methods:

Investigated expert opinion- and distribution-based values for MCID.
Triangulated data to establish MCIDs for Standardised Mini-mental State Examination (sMMSE), Bristol Activities of Daily Living Scale (BADLS), and Neuropsychiatric Inventory (NPI).
Used standard deviations (SD) of change scores from baseline, with investigators blinded to treatment allocation.

Main Results:

Established MCIDs of 1.4 points for sMMSE, 3.5 for BADLS, and 8.0 for NPI.
These values were derived from 0.4 of the SD of the change in score in the first 127 DOMINO participants.

Conclusions:

MCID values are essential for a comprehensive interpretation of dementia trial results.
Researchers should clearly report their methods for determining MCID values in dementia studies.