Information from patients who are unable to continue their visits to a study centre may be of major importance for the interpretation of results in multiple sclerosis (MS) clinical trials. To validate a questionnaire based on the Expanded Disability Status Scale (EDSS), patients in five different European centres were assessed independently by pairs of trained EDSS raters, first by telephone interview and a few days later by standardized neurological examination. Seventy women and 40 men with an average age of 43.7 years (range 19-74 years) were included in the study. Mean EDSS score at the last visit was 4.5 (0-9). EDSS assessment by telephone was highly correlated with the EDSS determined by physical examination (Pearson's correlation coefficient = 0.95). An intraclass correlation coefficient (ICC) of 94.8% was found for the total sample; 77.6% and 86%, respectively, for patients with EDSS < 4.5 (n = 46) and > 4.5 (n = 64). Kappa values for full agreement were 0.48; for variation by +0.5 steps and +1.0 steps, 0.79 and 0.90, respectively. Best agreement could be found in higher EDSS scores, where assessment by telephone interview might be needed most. The telephone questionnaire is a valid tool to assess EDSS score in cases where the patient is unable to continue visiting a study centre or in long-term follow-up of trial participants.
Objective: To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).Methods: In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-b-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.Results: Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). Conclusions: Early BCG may benefit CIS and affect its long-term course.Classification of evidence: BCG, as compared to placebo, was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy (Class I evidence). Neurology ® 2014;82:41-48 GLOSSARY BCG 5 Bacille Calmette-Guérin; CDMS 5 clinically definite multiple sclerosis; CI 5 confidence interval; CIS 5 clinically isolated syndrome; CSE 5 conventional spin-echo; DMT 5 disease-modifying therapy; EDSS 5 Expanded Disability Status Scale; Gd 5 gadolinium; IFN 5 interferon; MS 5 multiple sclerosis; RR 5 relative risk; T1W 5 T1-weighted; T2W 5 T2-weighted; TE 5 echo time; TR 5 repetition time.The majority of multiple sclerosis (MS) cases start with a first demyelinating episode (usually referred to as clinically isolated syndrome [CIS]) that is generally reversible. Approximately half of these cases convert to clinically definite MS (CDMS) within 2 years of the diagnosis and have substantial risk of disability, while about 10% of people with CIS remain free of further neurologic events, even in the presence of MRI compatible with MS.
Our observation that in many patients with MS-related TN a pontine demyelinating plaque and neurovascular compression coexist should prompt neurologists to seek possible neurovascular compression in patients with MS-related TN.
Background and Purpose: The etiology of stroke in the young is different from that in older patients and remains unknown in almost one third of the cases. To gain further insight into both pathogenic and etiologic determinants, we prospectively studied a large number of consecutive young adults with focal cerebral ischemia.
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