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URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM380961.pdf
Proper Citation: Exacerbations of Chronic Pulmonary Disease Tool (RRID:SCR_003718)
Description: An electronically administered patient-reported outcome (PRO) measure that is a qualified measure of symptoms of acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), for use in phase 2 trials. Refer to the proposed context of use, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM399682.pdf. Its intent to quantify frequency, severity, and duration of acute exacerbations in clinical trials of COPD including those with chronic bronchitis. It is designed as an electronic diary made up of fourteen items to be completed by the patient each evening just prior to bedtime. (An item-reduction statistical analysis narrowed the questions from 23 to 14.) For more information see, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM386248.pdf
Abbreviations: EXACT
Synonyms: Exacerbation of Chronic Pulmonary Disease Tool Patient Reported Outcome Instrument, EXACT-PRO, Exacerbation of Chronic Pulmonary Disease Tool Patient Reported Outcome (EXACT-PRO) Instrument, Exacerbations of Chronic Pulmonary Disease Tool (EXACT)
Resource Type: assessment test provider, material resource
Keywords: patient-reported outcome measure, clinical outcome assessment, drug development, clinical, drug, patient-reported outcome, clinical trial, antibacterial drug, instrument, antibacterial, questionnaire, gold standard
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