iCardiac Technologies, a centralized core laboratory specializing in respiratory and cardiac safety studies, has launched a Direct-to-Subject Pre-Coaching video tool to help minimize the variability in respiratory test data caused by differences in subject technique and technician coaching. The training videos will be embedded in equipment iCardiac sends to all trial sites and are brief enough to be shown to subjects at the beginning of each testing visit.
The videos will not replace but rather augment the coaching efforts of the site-based pulmonary technicians. By providing guidance and a clear demonstration to each subject shortly before he or she performs a spirometry test, the videos ensure that each subject hears critical information—explained in a clear and consistent way—about how to successfully complete a test. Further, the videos serve to assist and provide a timely refresher to less experienced site technicians on how to effectively coach subjects.
This video-based training standardization platform, now available in 20 languages, has already been deployed by iCardiac on a major global study.
Spirometry measures lung function, which is the amount of air inhaled and the rate at which it is expelled from the lungs. The accuracy and consistency of spirometry test results rely heavily on the patient’s understanding of how to optimally perform the test, and the knowledge and consistency of the medical professional at the site that is coaching that subject through the test.
While performing this test, subjects often make common errors such as a poor breathing effort, incomplete exhalation, or improper use of the equipment. Consistent and effective spirometry testing are critical to the overall outcome and reliability of a clinical trial.
“From the over 250 respiratory clinical trials that we have performed, it is clear that a leading source of test data variability is the variation of coaching styles and knowledge among medical technicians at different clinical sites,” said John Sage, senior vice president of Respiratory & eCOA at iCardiac Technologies. “This tool directly and effectively addresses this common issue.”
“We drew upon principles from the fields of cognitive learning, technology-enhanced instruction and psychology to develop this simple but powerful solution,” said Alex Zapesochny, president & CEO of iCardiac Technologies. “And it is being embraced not only by sponsors but also by many site technicians and study subjects for simplifying and improving the overall clinical trial experience.”