Measuring Exacerbations Of COPD: A Novel Approach

Main Category: COPD
Also Included In: Respiratory / Asthma
Article Date: 28 Jul 2010 - 3:00 PDT

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Exacerbations are a major cause of morbidity and mortality in chronic obstructive pulmonary disease (COPD), leading to dramatic reductions in quality of life and expensive emergency room visits and hospitalizations. To date, there has been no standard, validated method for defining or evaluating these events in clinical trials, limiting scientific understanding of these events and the effect of treatment.

Since detection of exacerbations is dependent on a patient's decision to contact their health care provider in response to worsening symptoms, and the decision to alter treatment is largely based on patient report, it is logical and desirable to standardize these assessments through a patient-reported outcome (PRO) instrument. The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) was developed as a daily diary based on COPD patients' descriptions of their exacerbations with input from experts in pulmonary medicine.

The instrument development process has been led by Drs. Nancy Kline Leidy with the assistance of Dr. Teresa Wilcox and a scientific team from the United BioSource Corporation. Drs. Paul Jones of St. George's Hospital Medical School, London UK, and Dr. Sanjay Sethi of the University at Buffalo, New York, provided important clinical and scientific input throughout.

The project has been supported through unrestricted funds from multiple pharmaceutical sponsors interested in improving treatment of COPD. "The EXACT is unique because it systematically assesses exacerbations of COPD. It also provides a standardized method for evaluating the treatment benefit of COPD therapies and provides important, quantitative information about patients' day-to-day experience with COPD," says Dr. Leidy.

The EXACT has undergone initial testing for reliability and validity and has been translated into 28 languages. The diary is currently being used in several multinational clinical trials. The development of the EXACT is described in the most recent issue of Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 5,000 clinicians, decision-makers, and researchers worldwide.

Source:
ISPOR

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