CROSS-CULTURAL PSYCHOMETRIC EVALUATION OF THE ENSEMBLE MDS

Author(s)

Bushnell DM1, McCarrier KP2, Martin ML2, Paczkowski R3, Shen W3, Buesching D31Health Research Associates, Inc., Mountlake Terrace, WA, USA, 2Health Research Associates, Inc., Seattle, WA, USA, 3Eli Lilly and Company, Inc., Indianapolis, IN, USA

OBJECTIVES: The ENSEMBLE MDS is a battery of phenotypic patient-reported instruments administered at baseline in clinical studies.  The component measures assess potential predictors (Self-Reported Health Status (SRH), Total Illness Burden Index (TIBI), Patient Health Questionnaire-4, Depression Diagnosis, Perceived Stress Scale) or effect modifying factors of clinical outcomes and/or treatment response (MacArthur Perceived Status Ladder, MacArthur Income, Barratt Simplified Measure of Social Status, Perceived Social Support Scale (SS-5).  This report furthers the initial validation conducted in the United States by evaluating the reproducibility and construct validity outside the United States. METHODS: The ENSEMBLE MDS and other assessments (MOS SF-36, EQ-5D, Life Orientation Test-Revised (LOT-R), items on illness/bed days and doctor visits) were administered to a sample of adults with depression, type 2 diabetes, or rheumatoid arthritis in Germany (n=61), Spain (n=61) and Singapore (n=56, Simplified Chinese). Participants completed the battery on paper and returned one-week later to complete a retest. Test-retest reproducibility was assessed using the intraclass correlation coefficient (ICC); convergent validity by Pearson correlations between MDS instruments and components of the SF-36 and EQ-5D, with hypothesized relationships significant at r>0.30; and known-groups tested using tertiles of the LOT-R, doctor visits and illness days. RESULTS: The mean age of the participants was 55±13 years, 63% were female, 66% were married/living with partner.  Between 85% and 100% completed MDS instruments at the retest (mean 6.7±0.6 days).  The ICCs for the retest of different components ranged from 0.81 to 0.99.  All hypothesized correlations with convergent measures were significant (r>0.40; p<0.01), and the MDS SS-5 discriminated between LOT-R tertiles (F=24.6, p<0.001), SRH between doctor visits (F=8.0 p<0.01) and TIBI between illness days (F=14.9, p<0.001). CONCLUSIONS: Consistent with the results found in the United States, the ENSEMBLE MDS was observed to have adequate reproducibility, appropriate convergent validity and to significantly discriminate between known groups outside the United States.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

QU2

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Diabetes/Endocrine/Metabolic Disorders, Mental Health, Musculoskeletal Disorders

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