Researchers Using ePROs to Evaluate Statin-Related Adverse Events

Dec. 9, 2019
Study is intended to prospectively monitor participant response to statin medications via an app

Oncologists and other clinical researchers are increasingly taking advantage of electronic patient-reported outcomes (ePROs).  For instance, the University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare are using a cloud-based clinical trial platform using ePROs to evaluate statin-related adverse events.

The collaborative digital study, to be conducted with vendor Medable Inc., is intended to prospectively monitor participant response to statin medications via an app, and notify clinicians and patients when the patient should stop or start their medication based on presenting symptoms collected via ePROs. The app seeks to use this methodology to identify statin-intolerant individuals in the study, by assessing the pattern, location and timing of their muscle symptoms.

 Statins, such as Lipitor and Crestor are some of the most widely used drugs in the world, due to their effectiveness for reducing cholesterol and resultantly, cardiovascular disease (CVD) mortality and events. Although statins are widely available, cost-effective drugs, data suggests that over three years, patient compliance may be as low as 50 percent, due to side effects such as muscle pain. Improving statin adherence will thus have a powerful impact on mitigating the burden of preventable CV disease.

 The statin-associated muscle symptom clinical index (SAMS-CI) is a method for assessing the likelihood that a patient’s muscle symptoms (e.g., pain, aching, cramping and weakness) are caused or worsened by statin use. This is important because the diagnosis and treatment of SAMS relies on patient self-reports of symptoms, which can be biased by a number of non-statin-related factors such as medications and health conditions.

 “The problem with SAMS is that there are no diagnostic tests for this condition and clinicians have to rely on patient-reported perceptions of pain that may have occurred months or even years ago,” said Beth Taylor, Ph.D., lead study investigator and associate professor of Kinesiology at UConn, in a prepared statement. “We wanted to digitize the paper questionnaire into a clinical index onto an app, where patients could take their statin medication at home, and rank their pain levels in real-time. Medable was able to help us conceptualize the initial research idea into a patient-friendly app, and we wouldn’t have been able to do this without their guidance.”

In October 2017 I had the chance to speak to Claire Snyder, M.H.S., Ph.D., a professor at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health about her work with colleagues on a “User’s Guide for Integrating Patient Reported Outcomes in Electronic Health Records: Design and Implementation Considerations,” which received support from the Patient-Centered Outcomes Research Institute (PCORI).

Snyder’s research focuses the quality of life for cancer patients and the coordination of care between cancer specialists and primary care providers. She is investigating the use of patient-reported outcome questionnaires in routine oncology practice.

I asked her why patient-reported outcomes are becoming more important to clinicians. She responded that there are a number of factors increasing the emphasis on integrating PROs into EHRs. “First, there is more focus on patient-centered care. One way to assess patient-centered care and outcomes is through patient reports,” she said. “Simultaneously, technological advances have made it easier to collect and use PROs in routine clinical care. The third thing is that the PROs can promote patient-centered care on their own but are even better positioned to promote patient-centered care when they are integrated into the EHR with the other clinical information.”

The Users’ Guide provides options and scenarios around many issues, including whether the PRO data should be fully integrated into the EHR or collected outside of it; how to deal with data from multiple EHRs in a health system; how data should be displayed; consent issues for secondary usage of the data; whether the data might signal an alert or some other clinical decision support. “The Users’ Guide is laid out with different options and relative advantages and disadvantages with no need to select just one option,” she explained. “In some cases you have to pick just chocolate or vanilla, but in other cases you can do a swirl.”