title: Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial.
abstract: We wished to determine whether the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) is reliable when used as primary outcome measure in a multicenter clinical trial. To establish inter-rater reliability, we randomly assigned 19 primary raters and 11 back-up raters to score nine amyotrophic lateral sclerosis (ALS) patients using the ALSFRS-R. To assess intra-rater reliability and reliability of telephone administration, we randomly assigned consecutive participants of the Clinical Trial of High Dose Coenzyme Q10 in ALS (QALS) to have in-person ALSFRS-R interviews at both screening and baseline visits (n=41 patients) or to have the ALSFRS-R interview by telephone at screening and in person at the baseline visit (n=27). An intraclass correlation coefficient (ICC) of reliability was calculated using a one-way random effects analysis of variance model. In the inter-rater reliability assessment, the primary raters performed 54 ratings on nine patients with ICC=0.93 (95% CI 0.84-0.98). For back-up raters, 32 ratings on nine patients resulted in ICC=0.93 (95% CI 0.82-0.98). The intra-rater reliability for in-person interviews was ICC = 0.95 (95% CI 0.92-0.98). The reliability of telephone administration compared to in-person interviews was ICC=0.97 (95% CI 0.93-0.98). We conclude that the ALSFRS-R shows excellent inter- and intra-rater reliability, and reliability of telephone administration when used as primary outcome measure in a multicenter ALS trial.
authors.affiliation: Department of Neurology, The Eleanor and Lou Gehrig MDA/ALS Research Center, College of Physicians and Surgeons, New York, NY, USA. pk88@columbia.edu
authors.forename: Petra
authors.initials: P
authors.lastname: Kaufmann
authors.forename: Gilbero
authors.initials: G
authors.lastname: Levy
authors.forename: Jacquelina
authors.initials: J
authors.lastname: Montes
authors.forename: Richard
authors.initials: R
authors.lastname: Buchsbaum
authors.forename: Alexandra I
authors.initials: AI
authors.lastname: Barsdorf
authors.forename: Vanessa
authors.initials: V
authors.lastname: Battista
authors.forename: Rachel
authors.initials: R
authors.lastname: Arbing
authors.forename: Paul H
authors.initials: PH
authors.lastname: Gordon
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mitsumoto
authors.forename: Bruce
authors.initials: B
authors.lastname: Levin
authors.forename: John L P
authors.initials: JL
authors.lastname: Thompson
mesh_terms: D000203:Activities of Daily Living; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy / Q000503:physiopathology*; D017028:Caregivers / Q000523:psychology*; D003067:Coenzymes; D004311:Double-Blind Method; D006801:Humans; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D013689:Telephone / Q000295:instrumentation; D014451:Ubiquinone / Q000031:analogs & derivatives / Q000627:therapeutic use; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D003067:Coenzymes; D014815:Vitamins; D014451:Ubiquinone; C024989:coenzyme Q10