There are some big threads to tie together. Let’s start with this paper by Dr. Marissa Carter that just became available today via eprint in Wound Repair and Regeneration. It establishes guidelines for the analysis of data from patient registries. It’s specifically focused on wound care registries.
That topic sounds boring, but the problem is that there is almost no independent funding in wound care research that helps us understand which wound care products work best. If we are going to figure this out, the only way will be via the analysis of Real World Evidence (RWE) obtained from patient electronic health records (EHRs).
http://onlinelibrary.wiley.com/doi/10.1111/wrr.12565/abstract;jsessionid=46AC623B2787433A776B6830FC7769C8.f02t02
I will tie this to a thread from a previous blog. We published a paper last month in WWR which set standards for the way that data went INTO patient registries from EHRs. We called it the ABC’s of patient registries for wound care. It explained more than a decade of work by the US Wound Registry (USWR) to identify sources of bias that can impact the use of real world data and how those sources of bias can be controlled so that data from patients can be turned into EVIDENCE about what works best for patients.
https://carolinefifemd.com/2017/06/29/uswr-intellicureehr-learning-healthcare-system/
We’ve been pulling on these threads for more than a decade to bring them together. However, I had a really painful conversation with a friend last month who is a well known cardiologist. Cardiology runs several registries that have really set the standard for the use of real world data. He told me that they have $48 million in funding from industry for their registry work. He said they were trying to divest themselves of industry support, but that funding has allowed them to do incredible work. Quite frankly, the USWR could determine the most effective cellular product for really compromised wound patients, but right now, the manufacturer of the “winning” product(s) couldn’t get the FDA to use registry data for expanded indications, and the rest of the industry partners would hate us for doing the work. So, we could save millions of dollars for the Medicare trust fund, Medicare patients and the American taxpayer, but still have no funding for our work AND no friends. And that takes me to my next story . . .
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.
