CLINICAL HISTORY, RESOURCE UTILIZATION, AND OTHER PATIENT-REPORTED OUTCOMES (PROS) IN MIGRAINEURS- AN ADAPTABLE WEB-BASED METHODOLOGY FOR THE DESIGN, IMPLEMENTATION AND CONDUCT OF A MULTI-NATIONAL SURVEY OF PATIENTS

Author(s)

Payne KA1, Wilcox TK2, Yeomans K1, Kawata AK2, Varon SF3, Burk CT4, Lipton RB5, Blumenfeld A61United BioSource Corporation, Montreal, QC, Canada, 2United BioSource Corporation, Bethesda, MD, USA, 3Allergan Inc., Irvine, CA, USA, 4Caroline Burk Inc., Laguna Beach, CA, USA, 5Albert Einstein College of Medicine, Bronx, NY, USA, 6The Headache Center of Southern California, Del Mar, CA, USA

OBJECTIVES: Migraine is a common and disabling condition.  Real-world health care resource utilization and patient reported outcomes data are important for documenting the burden of illness and are necessary inputs for economic models.  An efficient and adaptable methodology for the conduct of international health economic and PRO data gathering is described. METHODS: An IRB approved, web-based, cross-sectional survey of headache sufferers was conducted in 9 countries (US, Canada, Australia, UK, Germany, France, Spain, Italy, Taiwan).  Registered panelists received email invitations in their country’s language and provided consent from a web link option; non-migraineurs were excluded on the basis of reported symptoms, and eligible subjects were classified as either chronic (≥15 headache days per month), episodic (1-14), or potential migraineurs (migraine-like symptoms).  Survey enrollment was rolled out in waves and completed when targeted sample of chronic migraineurs was obtained. Survey outcomes included sociodemographic, headache symptoms, resource utilization, disability and productivity from HIT-6, MIDAS, MSQ v2.1.  Validation rules were pre-programmed to enhance data quality. RESULTS: Of 63,001 survey invitees, 20,987 responded. A total of 9118 completers (14.5%) comprised the final cohort (n= 516 ( Australia) - 1597 (US)); 83.6% female; mean age 41 (± 12) years; 499 (5.5 %) chronic migraineurs. Mean study period across countries was 12.6 days; results were available within 3-5 days after study completion. The core survey required minimal adaptation for international use beyond translation, permitting both country-specific and pooled analyses.  Main challenges included adapting questionnaires to a web-based format and predicting eligibility rates for countries without pre-screened headache survey candidates.  Despite inherent limitations of on-line studies, particularly generalizability, the observed proportion of chronic to episodic migraineurs within a headache population was consistent with other published reports using mailed questionnaires.  CONCLUSIONS: International, web-based, patient-reported surveys are a method of collecting clinical, resource utilization and PRO data, while minimizing time and cost.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PMC25

Topic

Economic Evaluation, Methodological & Statistical Research

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies, Modeling and simulation

Disease

Multiple Diseases, Neurological Disorders, Respiratory-Related Disorders

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