Activity monitors have a place in COPD. Researchers reviewed the existing literature and suggest standards regarding these devices for use with COPD patients participating in drug development programs.
Researchers reviewed the existing literature and suggest standards regarding activity monitors for measuring the activity of COPD patients participating in drug development programs.
The review was published in Contemporary Clinical Trials recently, and was conducted by Bill Byrom of Product Innovation, ICON Clinical REsearch in Buckinghamshire, UK, and David A. Rowe of the School of Psychological Sciences and Health, at the University of Strathclyde, in Glasgow, UK.
“In clinical trials of COPD treatment, improvements in physical activity and mobility are important secondary outcomes and these are routinely estimated using in-clinic controlled assessments of exercise capacity such as treadmill tests and the six minute walking test (6MWT),” the reviewers say.
However, they add, there is some reason to believe that allowing patients to use an activity monitor would provide a better understanding of how much activity and mobility the patient has.
The authors list three reasons activity monitors are not used often: regulatory acceptance, a lack of scientific understanding about to apply the data from such devices, and a lack of standards regarding the collection and implementation of the data. After reviewing 76 studies published between 1999 and 2014 and noting such factors as the model of the activity monitor, the placement location, how long patients wore the devices, how many hours made up a valid day, how many valid days were required, what a non-wear episode was, how missing data was handled, the researchers reached some conclusions and made some recommendations.
“Large scale implementation of activity monitors in regulatory clinical trials requires accepted and consistent methodology for how these wearables are used and how the data they generate is interpreted,” say the reviewers. They add that the standards may vary depending on the patient population and that “this review of activity monitor use with COPD patients has shown little consensus and much variability.”
The researchers conclude that the devices used in clinical trials should be limited to those that have been validated through a body of evidence.
They also say that “the research community have yet to converge on a set of standard methodologies, despite their value in measuring important health outcomes for pharmaceutical clinical trials.”
The standards proposed in this review could help “drive the use of activity monitors in measurement of free-living activity in COPD clinical drug development programs, and may have an application beyond COPD and apply equally to other disease indications characterized by low intensity of physical activity and high degrees of sedentary behavior,” the authors conclude.