title: Can the Expanded Disability Status Scale be assessed by telephone?
abstract: 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.
authors.affiliation: Department of Neurology, Kantonspital Basel, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Lechner-Scott
authors.forename: L
authors.initials: L
authors.lastname: Kappos
authors.forename: M
authors.initials: M
authors.lastname: Hofman
authors.forename: C H
authors.initials: CH
authors.lastname: Polman
authors.forename: H
authors.initials: H
authors.lastname: Ronner
authors.forename: X
authors.initials: X
authors.lastname: Montalban
authors.forename: M
authors.initials: M
authors.lastname: Tintore
authors.forename: M
authors.initials: M
authors.lastname: Frontoni
authors.forename: C
authors.initials: C
authors.lastname: Buttinelli
authors.forename: M P
authors.initials: MP
authors.lastname: Amato
authors.forename: M L
authors.initials: ML
authors.lastname: Bartolozzi
authors.forename: M
authors.initials: M
authors.lastname: Versavel
authors.forename: F
authors.initials: F
authors.lastname: Dahlke
authors.forename: J-F
authors.initials: JF
authors.lastname: Kapp
authors.forename: R
authors.initials: R
authors.lastname: Gibberd
mesh_terms: D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D005060:Europe; D005260:Female; D006801:Humans; D007407:Interviews as Topic / Q000379:methods* / Q000592:standards; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis*; D015203:Reproducibility of Results; D016138:Walking