Measurement of Health-Related Quality of Life in Patients With Amyotrophic Lateral Sclerosis in Clinical Trials of New Therapies

Bibliographic Data

ID9104118
AuthorsAnne M Damiano (Covance (United States), corresponding author), Donald L Patrick (0000-0003-0756-0492, University of Washington), Gladys I Guzman (Covance (United States), corresponding author), Marek J Gawel, Marek Gawel (Sunnybrook Health Science Centre), Deborah F Gelinas, Deborah Gelinas (California Pacific Medical Center), Howard M Natter (Allegheny College), Kathleen K Ingalls (West Chester University)
Year1999
Volume37
Issue1
Pages15-26
Publication date1999-01-01
Peer ReviewedYes
Open AccessNo
TypeARTICLE
VenueMedical Care (JOURNAL)
Journal identifiersISSN: 0025-7079 • E-ISSN: 1537-1948
PublisherOvid Technologies (Wolters Kluwer Health) (PUBLISHER)
DOI10.1097/00005650-199901000-00004
PMID10413388
OpenAlexW2323336256
LanguageEN
Citations received5
References cited16

OBJECTIVES: Recent trials of amyotrophic lateral sclerosis (ALS) therapies have included the Sickness Impact Profile (SIP) to evaluate health-related quality of life (HQL). The purpose of this study was to assess the feasibility, psychometric properties, and interpretation of the Sickness Impact Profile in this setting. METHODS: The Sickness Impact Profile was administered at baseline, 3, 6, and 9 months during a double-blind, placebo-controlled study of recombinant human insulin-like growth factor I. The frequency of missing Sickness Impact Profile data and administration time were recorded. Patients' scores on the Appel ALS (AALS) Rating Scale were used to identify a stable subgroup for reliability testing and clinically distinct groups for validity testing. Internal consistency reliability and reproducibility were evaluated using Cronbach's alpha and intraclass correlation coefficients, respectively. Analysis of variance (ANOVA) models and t tests were used to assess validity. Effect sizes and the responsiveness index were used to assess responsiveness. RESULTS: At baseline, 259 (97%) patients completed a 30-minute Sickness Impact Profile interview. At subsequent assessments, response rates ranged from 92% to 97% and mean administration times ranged from 25 to 27 minutes. The overall Sickness Impact Profile score demonstrated alpha reliability and 3-month stability coefficients of 0.94 and 0.80, respectively. Baseline overall Sickness Impact Profile scores discriminated between patients in the two AALS-defined groups with a mean of 13.0+/-7.8 and 24.0+/-11.7 in the better and worse AALS groups, respectively. Similarly, mean overall SIP change scores discriminated patients progressing at different rates (slow to moderate = 4.00+/-7.97; rapid = 10.74+/-8.76). With few exceptions, dimension and category scores met similar criteria. Responsiveness statistics for the physical and overall Sickness Impact Profile scores were lower at 3 months and higher at 6 and 9 months. CONCLUSIONS: The feasibility, psychometric, and interpretive findings support the validity of the Sickness Impact Profile for assessing outcomes of amyotrophic lateral sclerosis and its treatment. Based on these findings, we recommend including the Sickness Impact Profile in future amyotrophic lateral sclerosis clinical trials

Amyotrophic lateral sclerosis · Clinical trial · Cronbach's alpha · Disease · Intraclass correlation · Physical therapy · Placebo · Psychometrics · Quality of life (healthcare) · Amyotrophic Lateral Sclerosis Research · Clinical Psychology · Internal Medicine · Medicine · Neurogenetic and Muscular Disorders Research · Parkinson's Disease and Spinal Disorders

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