ASSESSING THE EQUIVALENCE OF ELECTRONIC AND PAPER DATA COLLECTION OF EQ-5D DATA IN RHEUMATOID ARTHRITIS

Author(s)

Tiplady B1, Goodman K2, Cummings G3, Lyle D3, Carrington R4, Battersby C5, Ralston S61invivodata Ltd, Twickenham, England, United Kingdom, 2Institute of Genetics and Molecular Medicine, Edinburgh, Scotland, United Kingdom, 3Wellcome Trust Clinical Research Facility, Edinburgh, Scotland, United Kingdom, 4AstraZeneca R&D Charnwood, Loughborough, England, United Kingdom, 5AstraZeneca R&D Alderley Park, Macclesfield, England, United Kingdom, 6Molecular Medicine Centre, Edinburgh, Scotland, United Kingdom

OBJECTIVES: Electronic methods (ePRO, E) are increasingly being used for patient diaries and questionnaires. Where paper (P) instruments are migrated to E it is necessary to compare to the original to to determine if the different modalities are equivalent. We have carried out an equivalence study of a number of instruments including the EQ-5D in rheumatoid arthritis. METHODS: A total of 43 patients (31 female) aged 32 - 83 years took part in a single session during which they completed P and E (Palm TX handheld) assessments in randomised order, with a 45 minute interval between the two modes. Assessments included measures of pain, fatigue, disability and health status. RESULTS: Mean scores were similar between the two modes. Utility P: 0.612; E: 0.608; Effect size of P-E difference: -0.017. ICC=0.79. VAS P: 64.2; E: 64.5; Effect size: 0.013; ICC = 0.75. All patients found both P and E either very easy or quite easy to use. CONCLUSIONS: The low magnitude of the effect sizes does not suggest that any significant differences are occurring between modes. ICC values met the a priori threshold of 0.75 for "excellent" agreement, and were in general agreement with paper retest reliability for this scale.This study supports the equivalence of an electronic method of completing the EQ-5D instrument compared to the original paper version.

Conference/Value in Health Info

2010-05, ISPOR 2010, Atlanta, GA, USA

Value in Health, Vol. 13, No. 3 (May 2010)

Code

PMS35

Disease

Musculoskeletal Disorders

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