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Multiple sclerosis functional composite: impact of reference population and interpretation of changes
B M J Uitdehaag1, H J Adèr, T J A Roosma
1Department of Neurology, VU Medical Centre, Amsterdam, The Netherlands. bmj.uitdehaag@vumc.nl
Multiple Sclerosis (Houndmills, Basingstoke, England)
|October 3, 2002
Summary
Choosing different reference populations for the Multiple Sclerosis Functional Composite (MSFC) impacts score comparability. While trial statistics remain unaffected, clinical interpretation of MSFC changes becomes more complex.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- The Multiple Sclerosis Functional Composite (MSFC) is a recommended clinical outcome measure for multiple sclerosis (MS) trials.
- MSFC is defined relative to a reference population, and different populations can affect scores.
Purpose of the Study:
- To investigate the effect of selecting different reference populations on MSFC outcomes in simulated clinical trials.
- To assess the impact of reference population choice on the sensitivity to change and comparability of MSFC scores.
Main Methods:
- Simulated 343 intervention trials using the MSFC.
- Compared results using three distinct reference populations: two MS patient groups and one healthy control group.
- Analyzed the influence of sex, age, and education on MSFC scores in healthy controls.
Main Results:
- The selection of reference populations did not alter trial statistics or statistical significance.
- However, different reference populations significantly affected the comparability of results between trials.
- Clinical interpretation of observed changes in MSFC scores was complicated by the choice of reference population.
Conclusions:
- While MSFC trial statistics are robust to reference population choice, inter-trial comparability is compromised.
- Standardizing reference populations is crucial for accurate clinical interpretation and comparison of MSFC data across multiple sclerosis studies.