I’m tying threads together about real world evidence, cellular products and the US Wound Registry (USWR). These are threads that the USWR has been weaving for more than a decade. I was reluctant to do this interview with the Kaiser Health reporter (Tayor) whose article on cellular products is on the front page of the Philadelphia Inquirer.
I stopped doing randomized, controlled trials in wound care about a decade ago when I realized that we were enrolling subjects in wound care trials who did not look anything like the actual patients we were taking care of. Tom Serena said this in his interview with Taylor, but he and I proved it in the attached tables, the first one to do with venous leg ulcers and the second one to do with diabetic foot ulcers. The tables show the actual subjects enrolled in trials of cellular products performed in those clinics vs. the actual patients being seen in those clinics. The wounds are larger, deeper, and the patients have more than one of them, and the patients are older and sicker.
The result is that we actually have no idea how the cellular products will work in real patients. On the other hand, in some ways it doesn’t matter, because if you read the coverage policies of the Medicare Administrative Carriers (MACs) carefully, you will note that the cellular products are not actually covered for patients if the wounds or the patients are not like the ones enrolled in the trials. Let’s hope no one ever audits the use of CTPs in wound centers and finds out that’s not who we treat with them, since the patients enrolled in the trials are not the patients who need them. Is this Kafkaesque, or what?
And now you understand why we need Real World Evidence from the USWR so much.