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CareFusion’s AM3 home spirometer and eDiary received EXACT-PRO Initiative certification last month.
The AM3 reads and saves relevant expiratory flow-volume parameters, such as PEF, FEV1, FVC and FEF, as well as recording symptoms, events, and medication, including severity and dose.
The eDiary guides patients through the process with instructions. Visual indicators, which the company refers to as a traffic light feature, allow immediate assessment of the measurement. The eDiary consists of flexible, programmable questionnaires embedded into a workflow: diary sessions can be controlled by independent time windows (e.g., morning/evening questions), audible and visual alerts, branching logic, and automated score calculation with immediate feedback to the patient.
Since it is intended for specific use in clinical studies, questions and instructions have been made available in many languages, including Kanji and Cyrillic character sets, making it appropriate for international trials.
The EXACT-PRO Initiative
A multi-sponsor initiative led to the introduction of a new patient reported outcome tool, EXACT-EXAcerbations of Chronic Pulmonary Disease Tool-because it was designed to standardize the method for evaluating acute exacerbations of COPD and chronic bronchitis (AECB).
Leading the project is Dr. Nancy Kline Leidy, Senior Vice President of Scientific Affairs for United BioSource Corporation, along with Dr. Terry Wilcox, Senior Research Scientist, and Senior Clinical Consultants, Drs. Paul Jones and Sanjay Sethi.
Patients use the 14-item per day diary on a personal digital assistant (PDA) that is meant to take less than three minutes to complete. This instrument has already been translated into 25 languages and there are presently other translations in progress.