Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations.
Have state-of-the-art clinical trials failed to deliver treatments for neurodegenerative diseases because of shortcomings in the rating scales used? This Review assesses two methodological limitations of rating scales that might help to answer this question. First, the numbers generated by most rating scales do not satisfy the criteria for rigorous measurements. Second, we do not really know which variables most rating scales measure. We use clinical examples to highlight concerns about the limitations of rating scales, examine their underlying rationales, clarify their implications, explore potential solutions, and make some recommendations for future research. We show that improvements in the scientific rigour of rating scales can improve the chances of reaching the correct conclusions about the effectiveness of treatments.
Hobart
Jeremy C
JC
Neurological Outcome Measures Unit, Peninsula College of Medicine and Dentistry, Plymouth, Devon, UK. jeremy.hobart@pms.ac.uk
Cano
Stefan J
SJ
Zajicek
John P
JP
Thompson
Alan J
AJ
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D019636:Neurodegenerative Diseases / Q000628:therapy; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards*; D016896:Treatment Outcome