Taken together, the papers presented at the June 2012 meeting of the Electronic Data Methods (EDM) Forum demonstrated the great potential of using data gathered for patient care for patient-centered outcomes research (PCOR). This is important because these data are increasingly in electronic form, and, in electronic systems, many more patients are now available for study than are available in the typical clinical trial. The large number of patients in these systems is, in turn, critical to generate the large samples that are needed to study rare diseases and adverse medication effects. As Paul Wallace noted on the closing panel, such large numbers are critical in order to move from evidence-based medicine based on RCTs, “n of many” studies of efficacy in the average patient, to “patient effectiveness,” which calls for “many n-of-1” studies.
Despite this potential, however, numerous barriers to data sharing were discussed, ranging from proprietary concerns deriving from a competitive business environment to patient privacy and confidentiality. In particular, HIPAA Privacy Rule and Common rule requirements often lead to de-identification approaches that makes data less useful. In some cases, however, hospital lawyers and IRBs that are unsure of alternative approaches and what is permissible may be acting more conservative than the regulations actually demand…Read the rest of this post by Georgetown University Professor of Health Systems Administration and Population Dr. Michael Stoto on the EDM Forum website.
The EDM Forum site has additional publications and training resources on the use of clinical data for PCOR and CER, including ”Electronic Data Methods (EDM) Forum: Building the Infrastructure to Conduct Comparative Effectiveness Research and Patient-Centered Outcomes Research using Electronic Clinical Data,” a special supplement through Medical Care that features 14 papers on innovative strategies to building the infrastructure for CER, PCOR, and QI using electronic clinical data. Learn more through the EDM Forum’s upcoming webinar series. The first event of the series— “Protecting Human Subjects and Their Data in Multi-Site Research”—is scheduled for August 16.