It happened again. Someone asked me if it was possible to use real world data for a comparative effectiveness study in wound care. There was a fantastic presentation on this topic given in 2016 at ISPOR (the International Society for Pharmacoeconomics and Outcomes Research):
HARNESSING BIG DATA FOR WOUND HEALING RESEARCH: WHICH IS MORE RELEVANT IN THE QUEST FOR EVIDENCE: REAL WORLD PATIENT CENTERED OUTCOMES OR RANDOMIZED TRIALS?
–Marcia Nusgart R.Ph. Elise Berliner, Ph.D. Caroline E. Fife, M.D. Marissa Carter Ph.D. Presented at ISPOR May 25, 2016
If you or your company is interested in using real world data, I think that presentation (linked above) is one of the best overviews of the topic.
The US Wound Registry (USWR) has set the standard for harnessing real world data from electronic health records (EHRs) to create data registries. The Analysis of Bias Criteria (ABC method) is summarized in this excellent standards document from the USWR.