Two months ago (Jan 2016), Diabetes Care published an article by Fedorko and colleagues entitled, “Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Non healing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial.” (http://care.diabetesjournals.org/content/early/2016/01/05/dc15-2001.abstract).
Surprisingly, digital photographs were used to determine the primary endpoint of “amputation,” even though photographic assessment has never been validated as a surrogate for actual amputation, particularly after only 12 weeks of care. The percentage of patients requiring major amputation as determined by photographic assessment was five times greater than that reported in other studies which used actual amputations as the definition of “amputation”. This should have raised concern among the reviewers that photographic assessment might be a misleading surrogate for actual outcome. The results of the trial were largely irrelevant to clinical practice since a significant percentage of the wounds in both groups were Wagner Grade 2 ulcers. The use of HBOT for Wagner grade 2 DFUs is not supported by current evidence and is not recommended by the Clinical Practice Guidelines produced by the Undersea and Hyperbaric Medical Society. Many letters to the editor of Diabetes Care were submitted by physicians deeply concerned about validity of the study, but Diabetes Care rejected all of them outright so these concerns cannot be aired in the journal and responded to by the authors.
There is a nearly continuous cry for patient reported outcome measures as part of value based payment reform, and to support wound healing research. However, the US Wound Registry is the only organization that currently has ANY patient reported measures for patients with wounds approved by CMS (specifically, wound related quality of life and nutritional screening for patients with wounds generously sponsored by Nestle). There is a lot of talk, talk, talk about the need for a wound outcome measure and meetings organized to discuss the topic with CMS- but it’s all hot air. This is not rocket science. The USWR has 2 patient reported wound measures already. As soon as someone funds the work, the USWR can have a patient reported wound outcome ready to go as an eCQM that can be installed into ANY certified electronic health record, which providers can then report for PQRS credit and which can also be used as an outcome measure for clinical research.
Why do we need patient reported wound outcomes? Dr. Linden was a principal investigator on the Fedorko trial but was not allowed to participate in the writing of the manuscript because has irrefutable evidence that many patients in the study who were allocated to the outcome of “amputated” on the basis of a photograph actually healed. I have posted one of Dr. Linden’s video clips of an “amputated” Fedorko patient here: https://videopress.com/v/MFLcTIBV It’s only a few seconds long. I encourage you to watch it and forward the link to your colleagues. Check out my editorial in the March issue of Today’s Wound Clinic for additional information about this trial that will shock you.
I propose that asking the patient what their wound outcome is should be included as an endpoint for all prospective, randomized, controlled trials in wound healing. This endpoint needs to be mandatory if our love affair with the “highest form of evidence” (sic) is going to continue, and if payers intend to use the results of trials like the deeply flawed Fedorko study to justify removing coverage of limb-saving treatments from the largest province in Canada. Because, apparently, as in the case of the Fedorko trial, a picture is not worth a thousand words, and it is certainly not worth a manuscript in Diabetes Care. (And if anyone is ready to stop TALKING about patient reported outcomes and actually create one, contact me.)
Now, go and Do the Right Thing™
Caroline Fife, MD
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