Medidata tracking anxiety, pain levels via new ‘Patient Burden Index’
The Patient Burden Index (PBI) is a new feature of Medidata's Edge Design Optimizer, which visualizes the data to help improve study operations planning by providing insights into downstream effects, a company spokesperson explained.
According to Medidata, the index enables sponsors and contract research organizations (CROs) to develop “a lean study design that achieves essential clinical and statistical outcomes, with a focus on minimizing the site and patient burden.”
The company identified eight risk components for researchers to address directly, including the level of anxiety and pain caused by a procedure, as well as its level of physical invasiveness.
Other components include the potential for harmful exposure and hospitalization, as well as time, items, and type, as it pertains to completing surveys or interviews.
“Each component was assessed and placed on a scale of severity, and then further developed and validated internally,” the spokesperson told us.
“The subjective measures of pain and anxiety were validated through unbiased independent surveys with clinical site staff and patients.”
