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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.