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.
–Caroline
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
Dr. Fife:
Kudos on your 2016 slide presentation regarding the deficiency of RCT’s in wound care research.
IMHO, the power of the studies is not the problem. The problem is using a frequentist prospective in RCTs where the variables being studied are not well defined. CONSISTENT Bayesian methodology must be employed. Additionally, Fischer’s century old method of smoothing out data by solely relying on RCT randomization is too limited and outmoded.
As in all of medicine, robust wound care ontologies must be developed, refined, and continually updated to form a CONSISTENT backbone for all study assumptions. Refining of robust ontologies should only require minor tweaking as new information is acquired. Your wound healing index is a step (no pun intended) in the right direction in developing these ontologies.
Please contact me if you would like to discuss this further.
Respectfully,
Allan S. Goldberg, DP.M., FAPWCA, FABQAURP