Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.
Therapeutic interventions in health care require the use of resources. Since these resources
are limited, it is important for clinical decision-makers to have economic information in
addition to safety and efficacy data. In the economic environment of health care today, the
incremental costs for a new therapeutic intervention must be offset by the value associated
with better outcomes such as improved health and health-related quality of life and/or lower
health care utilization costs over time.
Questions about the cost and effectiveness of medical care have generated considerable
attention in medical outcomes research. In 1993, the Department of Health and Human Services
appointed a multi-disciplinary group to recommend standards for the evaluation of health
care. The panel's report suggested that standardized outcomes analyses be conducted to
evaluate the cost-effectiveness of medical care. These analyses require preference-weighted
measures of health-related quality of life. Such measures are needed in order to adjust
survival time for health-related quality of life.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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