INTERPRETING SCORES ON THREE COPD PATIENT-REPORTED OUTCOME MEASURES
Author(s)
Stephen P McKenna, PhD, Director of Research1, James Twiss, BSc, Research Assistant1, David M Meads, MSc, Research Associate1, Dennis Revicki, PhD, Director2, Robin Pokrzywinski, MHA, Project Manager3, Rupert Gale, MSc, Manager41Galen Research, Manchester, United Kingdom; 2 United BioSource Corporation, Bethesda, MD, USA; 3 United Biosource Corporation, Pittsburgh, PA, USA; 4 Novartis AG, Horsham, United Kingdom
OBJECTIVES: To aid interpretation of scores on the Living with COPD scale (LCOPD; scored 0-22), COPD and Asthma Sleep Impact Scale (CASIS; scored 0-100) and COPD and Asthma Fatigue Scale (CAFS, scored 0-100). These new patient reported outcome measures, designed for use in clinical trials, have previously been shown to be reliable and valid. METHODS: Questionnaire data from UK (n=162; 46% male; mean age=69.3 years) and US (n=145; 51% male; mean age=71.7 years) surveys were analysed. Mean questionnaire scores were evaluated against clinician severity rating and by exacerbation status (US only). Effect sizes (ES) and standard errors of measurement (SEM) were used to provide a preliminary estimate of the minimal important difference (MID). RESULTS: Scores on the LCOPD and CAFS were significantly related to clinician rating of COPD severity (p<0.001). A similar trend for the CASIS was not statistically significant. Scores on all measures were also significantly higher (p<0.05), indicating greater impairment if the patient had had an exacerbation in the previous week. For the LCOPD the values for 0.3 ES, 0.5 ES and SEM were 2.0, 3.3 and 1.4 respectively. For the CASIS the figures were 7.4, 12.3 and 7.4 and for the CAFS; 7.3, 12.2 and 5.5. Therefore, these distribution-based analyses suggest that the MID is in the region of 2 for the LCOPD and 7 for the CASIS and CAFS. CONCLUSIONS: The analyses provide preliminary information on how to interpret scores on the scales. Further analyses of longitudinal data are required to confirm these findings, to assess anchor-based estimates and to allow greater precision in powering studies using these questionnaires.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
QL7
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Respiratory-Related Disorders