Sensory-motor assessment in clinical research trials.
The assessment of changes in sensory-motor function in clinical research presents a unique set of difficulties. Clinimetrics is the science of measurement as related to the identification of a clinical disorder, the tracing of the progression of the condition under study, and calculation of its impact. The selection of appropriate measures for clinical studies of sensory-motor function must consider validity, sensitivity, specificity, responsiveness, reliability, and feasibility. Reasonable measures of motor function in clinical research include manual examination of muscle strength, electrophysiology, functional scales, patient-reported outcomes (e.g., quality of life), and for severe conditions such as ALS, survival. The assessment of sensory function includes targeted electrophysiology and QOL, as well as more focused measures such as quantitative sensory testing and the scoring of positive symptoms. Each individual measure and each combination of endpoints has its strengths and limitations.
Department of Neuroscience, Albert Einstein College of Medicine, New York, USA; Department of Neurology, Albert Einstein College of Medicine, New York, USA. Electronic address: joseph.arezzo@einstein.yu.edu.
Joseph C
JC
Arezzo
Shirley
S
Seto
Herbert H
HH
Schaumburg
D035843:Biomedical Research; D006801:Humans; D009068:Movement; D017063:Outcome Assessment, Health Care; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis* / Q000503:physiopathology; D015203:Reproducibility of Results; D012677:Sensation; D012680:Sensitivity and Specificity
ALS functional rating scale; Clinical trials of neuropathy; assessment of sensory-motor function; clinimetrics; electrophysiology; patient-reported outcome measures; quantitative sensory testing