Training examiners to administer a quantitative neurological examination for a multicenter clinical trial.
A battery of quantitative neurological tests was used in a multicenter clinical trial to compare ACTH with placebo for the treatment of patients with multiple sclerosis in acute exacerbation. Since the battery of tests was administered in ten centers by physical therapists, it was critical that the examiners were well trained and remained so. Results of experiments showed that physical therapists could be successfully trained to administer the tests in a uniform fashion and remained trained for three years, the duration of the clinical trial. The fact that physical therapists are not taught tell-tale side effects of a treatment, and hence do not perceive these as do the physician examiners, introduces another level of objectivity into neurological clinical trials.
D000203:Activities of Daily Living; D000324:Adrenocorticotropic Hormone / Q000627:therapeutic use; D004521:Educational Measurement; D006804:Ergonomics; D006801:Humans; D007858:Learning; D008297:Male; D009069:Movement Disorders / Q000175:diagnosis; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000503:physiopathology; D009460:Neurologic Examination; D026741:Physical Therapy Modalities / Q000193:education*; D010919:Placebos
D010919:Placebos; D000324:Adrenocorticotropic Hormone