PAPER AND WEB EQUIVALENCE OF THE ENSEMBLE MDS - A TOOL USED TO COLLECT PHENOTYPIC INFORMATION PRIOR TO TREATMENT

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 generic patient-reported instruments designed for use in clinical studies or comparative effectiveness research. The component instruments assess baseline patient characteristics that are believed to be either predictors (health status, illness burden, depression, anxiety, and perceived stress) or effect-modifying factors (perceived social status, objective social status, perceived social support, income) of clinical outcomes and/or treatment response.  We sought to evaluate the equivalence of the MDS across two different modes of administration – paper and web. METHODS: This study was a data collection effort that used a randomized cross-over design in the United States (English) and Singapore (Simplified Chinese).  Participants were outpatients with a clinical diagnosis of one of five targeted health conditions: depression, type 2 diabetes, psoriasis, rheumatoid arthritis and chronic kidney disease. Those enrolled were randomized to initially complete the MDS on paper or web format, and returned 24 hours later to complete the alternate format.  Equivalence was evaluated by the intraclass correlation coefficient (ICC) with equivalency defined at or above the minimal acceptable level of 0.70.  These analyses were performed individually for each of the nine MDS component measures. RESULTS: A total of 314 participants (258 in US, 56 in Singapore) were analyzed. In the US, mean age was 49±13 years, 61% were female; in Singapore mean age was 57±12, 59% female.  The ICCs between paper and web administration of the different components of the ENSEMBLE MDS ranged between 0.74 and 0.98 in the US, and between 0.75 and 0.97 in Singapore. CONCLUSIONS: Equivalence between paper and web-based administration of the ENSEMBLE MDS was demonstrated statistically for the US-English Version and the Chinese version for Singapore, indicating stability of subject comprehension and response patterns across two modes of administration in two different languages and cultures.

Conference/Value in Health Info

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

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

Code

PMS93

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

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

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