Exacerbations are events characterized by an acute, sustained worsening in the patient’s COPD beyond normal day-to-day variability, including an increase in respiratory symptoms such as dyspnea, cough, and sputum production that may require a change in treatment.
- The EXACT total score, computed daily over time, is designed to standardize the assessment of the patient’s condition in order to capture this dynamic process.
EXACT scores complement and extend information provided by traditional health care resource utilization (HCRU) data by:
- Standardizing the magnitude of symptomatic change around HCRU events (those seen in the clinic, emergency room, or hospital); and,
- Quantifying frequency, severity, and duration of reported and unreported, symptom-defined events.
The EXACT may be used in longitudinal, natural history studies, or clinical trials, including:
- Maintenance/prevention trials testing the efficacy of therapies to modify or prevent COPD exacerbations; and,
- Acute treatment trials evaluating therapies to treat exacerbations of COPD.
The EXACT was developed under the EXACT-PRO Initiative, a multi-year, multi-sponsor project involving experts in pulmonary medicine, instrument development, and drug development regulatory issues, dedicated to the development of a single, standardized instrument for evaluating the effects of treatment on acute exacerbations of COPD. See the summary of development methods here.
The EXACT has been translated into more than 55 languages. A full list of translations is available here.
To facilitate standardized use, an EXACT User Manual describing the instrument’s development, intended use, administration procedures, and scoring is provided to all licensed users.