Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial.
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.
Kaufmann
Petra
P
Department of Neurology, The Eleanor and Lou Gehrig MDA/ALS Research Center, College of Physicians and Surgeons, New York, NY, USA. pk88@columbia.edu
Levy
Gilbero
G
Montes
Jacquelina
J
Buchsbaum
Richard
R
Barsdorf
Alexandra I
AI
Battista
Vanessa
V
Arbing
Rachel
R
Gordon
Paul H
PH
Mitsumoto
Hiroshi
H
Levin
Bruce
B
Thompson
John L P
JL
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
D003067:Coenzymes; D014815:Vitamins; D014451:Ubiquinone; C024989:coenzyme Q10