THE ELECTRONIC SCHIZOPHRENIA TREATMENT ADHERENCE REGISTRY - E-STAR - AN ELECTRONIC REGISTRY TO EVALUATE OUTCOMES DATA IN PATIENTS WITH SCHIZOPHRENIA/SCHIZOAFFECTIVE DISORDER

Author(s)

Farmer D1, Claerhout B2, Mehnert A3, Ingham M4, Jacobs A on behalf of the e-STAR study group .4, 1 IES, Surrey, UK; 2 Custodix NV, Merelbeke, Belgium; 3 Janssen Cilag, Neuss, Germany; 4 Janssen Pharmaceutica, Beerse, Belgium

OBJECTIVES: Health Technology Assessment groups suggest that registries designed for the purpose of collecting patient data on resource use and outcomes are a relevant supplement to data collected in randomized controlled clinical trials because they reflect a routine clinical care setting and enable considered treatment decisions and healthcare resource allocation to be made (www.nice.org). The Electronic Schizophrenia Treatment Adherence Registry (e–STAR) is a non-interventional, international registry designed to evaluate medication usage and long-term clinical outcomes in patients with schizophrenia or schizoaffective disorder undergoing a change in antipsychotic medication in a naturalistic setting. METHODS: In- or out-patients who start a new antipsychotic medication during the course of their routine clinical management are eligible for enrolment in the e–STAR project. Data are collected through an innovative Electronic Data Capture system and transmitted to the registry at baseline — the time of switch to the new medication — and every 3 months for the following 24 months. Data are also collected retrospectively for the 12 months preceding baseline. A secure website is used, which anonymises data and conducts automated data quality checks before being transmitted to the registry. Patient data on demographics, treatment and hospitalisation history, and clinical outcomes are collected. RESULTS: Changes in clinical and other outcome measures following a switch to the new medication will enable clinicians — and other decision makers — to evaluate the effectiveness and utility of the treatment switch in a routine clinical care setting by identifying optimal outcome patterns in defined cohorts of patients. CONCLUSION: To date, 6 countries are participating in the e–STAR project, which aims to enroll at least 5000 patients. This paper decribes the logistics of the project.

Conference/Value in Health Info

2004-10, ISPOR Europe 2004, Hamburg, Germany

Value in Health, Vol. 7, No. 6 (November/December 2004)

Code

PMH7

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Mental Health

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×