- Both Stage 2 and Stage 3 Meaningful Use requirements under the Medicare and Medicaid EHR Incentive Programs emphasize the need for patient engagement. With the widespread use of certified EHR technology, should patients have the ability to record or provide patient-reported outcomes within these systems?
Whether patients should have this ability or not depends upon healthcare service providers. According to a survey from Cutting Edge Information, 68 percent of clinical trials at top companies now utilize patient-reported outcomes while 90 percent of small pharmaceuticals developing clinical trials incorporate patient-reported data in their health IT systems.
“Although PROs (patient-reported outcomes) are increasingly embraced in the pharmaceutical industry, life science organizations must not rely solely on these measures to support regulatory approval,” Victoria Cavicchi, research analyst at Cutting Edge Information, said in a public statement. “Teams should play a balancing act and incorporate the right mix of traditional clinical evidence with patient responses to build the strongest case for emerging products.”
As the healthcare industry continues to push forward patient engagement and the inclusion of patient portals, clinical teams conducting drug trials may benefit from patient-reported outcomes when it comes to all effects of a drug including its overall success rates.
More life science companies have been including this type of data in their clinical trials to ensure all drug side effects are accounted for. However, one barrier standing in the way of patient-reported outcomes is the approval of the Food and Drug Administration (FDA).
Biomarkers and other biological endpoints are more likely to be approved for trial inclusion by the FDA than patient-reported outcomes. Nonetheless, the survey indicates that it is beneficial for pharmaceuticals to include both biological endpoints as well as patient-reported data within clinical studies.
There are several other barriers to incorporating patient-reported data in EHR and health IT systems. A case report published in the Journal of the American Medical Informatics Association (JAMIA) shows a variety of different challenges that healthcare providers will need to overcome in order to incorporate patient-generated information within electronic medical systems.
The researchers of the case study considered clinical observations among staff, providers, and patients as well as written feedback from end-users and system development meetings. Some of the barriers uncovered include clinical benefit uncertainties and issues with time, workflow, and practice efforts.
However, there were several key aspects that facilitated patient-reported outcomes such as usable system interfaces, process automation, and collecting relevant patient-generated data at the right time.
When it comes to using EHR technology to gather patient-reported outcomes, it is vital to ensure there is clinical relevancy as well as to minimize provider and patient burdens. As the healthcare industry continues to push forward patient engagement and develop new uses for complex medical technologies, it is likely that patient-reported outcomes will gain more clinical benefits throughout the healthcare spectrum.