QUALITY OF LIFE MEASUREMENT IN CURRENT CLINICAL TRIALS- FOCUS ON CHRONIC DISEASES

Author(s)

Mayank Bhanderi, MPharm, Senior Associate, Nitesh Singh, MPharm, Senior Associate, Rajeev Kumar, MPharm, Associate, Abhineet Chawla, MPharm, Associate, Manu Sehgal, MPharm, Assistant Vice President Heron Health Private Ltd, Chandigarh, India

OBJECTIVES: The objective of this study was to measure the prevalence and to identify the factors governing the selection of quality of life (QoL) as an outcome measure in current randomised controlled trials (RCT’s) in chronic disease conditions. METHODS: A clinical trial registry (clinicaltrials.gov) was searched for ongoing/planned RCT’s under the relevant disease conditions (Asthma, Diabetes, Rheumatoid arthritis, Parkinson’s disease and Alzheimer’s disease) for the reporting of QoL outcomes. Each study was reviewed independently by two reviewers to meet inclusion. RESULTS: Out of 1597 potential studies, 1016 met inclusion criteria. Of the included studies, only 13.2% (134/1016) studies assessed QoL as one of the outcome measures (5 as primary outcome, 129 as secondary outcome). Use of QoL was frequently observed in rheumatoid arthritis (26.7%) followed by asthma (23.1%), Parkinson’s disease (22.5%), Alzheimer’s disease (10.2%) and diabetes (4.7%), (Χ2 = 74.627, p<0.0001). A statistically significant difference was observed in the QoL assessment between the studies when analysed by the phase of development (Χ2 13.382, p=0.001) with a total of 17.6% of phase III and 16.1% of phase IV trials assessing QoL. Out of 134 trials assessing QoL, 78 (58%) were sponsored by the industry, 13 (10%) by government agencies, 18 (13%) by universities, 17 (13%) by combined bodies, and 8 (6%) were sponsored by other sources. Out of 134 only 63 studies reported tool used for the measurement of QoL (generic tool in 28, disease specific tool in 30 and both in 5 studies). CONCLUSIONS: The reviewed data depicts low prevalence of QoL as an outcome measure in chronic disease conditions, low prevalence of generic instrument usage and poor reporting of instrument used for the assessment of QoL. The determinants for these observations could be evaluated further.

Conference/Value in Health Info

2008-09, ISPOR Asia Pacific 2008, Seoul, South Korea

Value in Health, Vol. 11, No. 6 (November 2008)

Code

PMC5

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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