Inaccurate Use of the Upper Extremity Fugl-Meyer Negatively Affects Upper Extremity Rehabilitation Trial Design: Findings From the ICARE Randomized Controlled Trial.
Shashwati Geed, Christianne J Lane, Monica A Nelsen and 3 others
PMID 32991872WHAT IT FOUND
Rescaling the Fugl-Meyer score with a statistical model cut the sample size needed for a stroke trial by 32 percent.
Raw scores overstated recovery in mildly impaired patients and understated it in severely impaired ones, with errors exceeding the clinically meaningful threshold in half the observations.
Key findings
01Using a Rasch-rescaled version of the Upper Extremity Fugl-Meyer instead of the raw summed score reduced the required sample size for a hypothetical trial by 32 percent.
02Raw Fugl-Meyer scores were inaccurate in half of all observations, overstating function for mildly impaired patients and understating it for severely impaired patients.
03Removing the four easiest items from the rescaled scale further reduced the required sample size by 34 percent compared to the raw scale.
STILL TO COME
How it was doneWhat they found
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What it does not show
The study only analyzed data from patients with mild-to-moderate impairment (UEFM scores 19-58), so the findings may not apply to patients with severe or very mild impairment. The sample size and effect size calculations were based on a hypothetical trial model, not an actual trial conducted with the new scale. The authors note that these findings need to be validated in a second independent randomized controlled trial. The study collapsed the three different treatment arms of the original ICARE trial into one group for most analyses, focusing on measurement rather than treatment effects.
Declared interests
The ICARE study was supported by the National Institutes of Health (N.I.H.). The authors declared no other conflicts of interest in the provided text.
The easy way to misread this
Do not assume this paper proves a new clinical treatment works. It is a methodological study about how to score the Fugl-Meyer test more accurately for research purposes, not a report of patient outcomes from an intervention.