ARE QALYS SUITABLE FOR SCHIZOPHRENIA TRIALS?

Author(s)

Mangalore R1, Knapp M1, McKendrick J21London School of Economics, London, United Kingdom; 2 Eli Lilly and Company Ltd, Basingstoke, Hampshire, United Kingdom

OBJECTIVES:The utility of quality adjusted life years (QALYs) as an evaluative tool in clinical psychiatric research and drug trials relating to schizophrenia has rarely been tested due to the many limitations surrounding its use. The limitations include lack of comprehensive models of quality of life specific to schizophrenia, unavailability of appropriate measures sensitive enough to pick up small changes that are expected in the course of the illness, and lack of adequate information about the performance of available instruments. METHODS: This paper reviews currently available evidence on the use of QALYs in studies of people with schizophrenia examining the relationship between QALY scores and scores on instruments regularly used in schizophrenia studies such as the PANSS or the CGI, in order to see if it is possible to construct reliable ‘crosswalks' between such clinical measures and the QALY-generating scores. RESULTS: The limited evidence in the field suggests that the calculation of QALYs to quantify the adverse effects of schizophrenia is difficult. Nevertheless, usefulness of such calculation for a proper estimation of the true burden of schizophrenia cannot be ignored. Data from a large observational study, following 600 people with schizophrenia over three years, are used to analyse the correlation between utility-generating scores from EQ-5D and schizophrenia specific measures of clinical circumstances such as the PANSS, the MADRS, the AIMS measure of side effects, the Simpson-Angus measure of side effects and the Barnes Akathisia Rating Scale to see how generic instruments such as EQ-5D perform in evaluating different health states in Schizophrenia. CONCLUSIONS Although the EQ-5D index does not capture the changes in quality of life associated with symptoms changes, it may be reasonably valid for calculating QALYs for patients with schizophrenia.

Conference/Value in Health Info

2005-11, ISPOR Europe 2005, Florence, Italy

Value in Health, Vol. 8, No.6 (November/December 2005)

Code

PMH39

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Mental Health

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