Wound Care Clinical Trials: Setting the Record Straight
By Thomas E. Serena MD, FACS, FACHM, FAPWCA
A recent article by Kaiser Health News misquoted me as saying that we enroll only "healthy" patients in our clinical trials. At moments like this, one feels that something has been overlooked. One of my research coordinators, recalling the serious adverse events (SAEs) of the previous week said, "The only patients sicker than ours are underground."
Anyone who has ever spent more than ten minutes in a wound clinic knows that our patients are anything but healthy. Our acuity levels mirror the dialysis and transplant units. We check the obituaries when our patients miss appointments.
The Chronic Wound Epidemic
Although it should be, this is not just a minor annoyance. A procession of anecdotal observations on the failing health of the wound care space—in a time of flux and disarray—is neither enlightening nor supportive. The article itself focuses on the use of expensive products in wound care. In comparison to other medical specialties, such as oncology or cardiology, our products are inexpensive and cost effective. Chronic wounds are an unacknowledged epidemic. The huge increase in spending has less to do with the cost of wound care products than it does to the staggering number of patients who need them. Why is wound care research so poorly funded? The National Institutes of Health (NIH) does not even have a wound care division.
I personally funded the only cooperative research group in the wound-healing sector.* Our underfunded investigators work tirelessly to advance the science, while oncology cooperative groups and registries receive hundreds of millions of dollars annually. There have been some victories, however, and it is unfair to criticize our burgeoning specialty for lack of evidence.
Clearly, my attempt to describe the realities of "seat of the pants" scientific research was DOA, and the author of the article preferred to accept the opinion that enrolling healthy patients leads to misleading results. This is true, but we do not have healthy patients. What is misleading, then, is a lack of understanding about the difference between efficacy and effectiveness in clinical research. Efficacy comes from clinical trial data where multiple variables are controlled. Effectiveness is from real world studies in larger populations with more diversity.
What Goes Into a Randomized Clinical Trial in Wound Care
In order to conduct a randomized controlled clinical trial (RCT), we must study a homogenous population: for example, patients with diabetes with Wagner I or II ulcers, without renal failure and under adequate glucose control. On average, only about 10% of the wound clinic population qualifies for an RCT. It does not mean that we wantonly select healthy patients to skew the results. It is an absolute necessity to control as many variables as possible. A homogenous population allows an accurate comparison of an active treatment with standard of care (SOC). If the active agent heals more patients than SOC, the product is said to be efficacious.
What about the other 90% of the patients we see in the clinic? Will this new product work for them? Upon completion of a RCT, we conduct a registry that follows patients treated with the product. If it works in the "real world," it is said to be effective. The data from RCTs and registries comprise the basis of decision making for product use in the wound clinic, and should guide payers in their reimbursement strategy.
Look, I have neither the time nor the inclination to validate our standing in the wound care community with the press. The world we inhabit is a Dickensian charnel house, and the majority of our patients present with comorbidities that complicate and compromise their wounds - to the extent that if we can preserve their limbs from the surgeon's saw, we consider it a major victory. Sadly, these patients are not candidates for clinical research. Where would we start?
In my judgment, the article referred to above is little more than a hit piece quite wide of the mark. The truth—in case you're interested—can be found in the basement of the hospital, where we struggle with an epidemic problem deadlier then most cancers. Perhaps someone other than the dedicated wound nurses and physicians will read the article and join the fight...
* The wound healing cooperative group welcomes investigators interested in clinical research. Please feel free to contact me at email@example.com.
About The Author
Dr. Thomas Serena has published more than 75 peer-reviewed papers and has made in excess of 200 presentations worldwide. He has been elected to the Board of Directors of both The Wound Healing Society and the American College of Hyperbaric Medicine (ACHM), the leading academic society in the field of Hyperbaric Medicine. In 2013 Dr. Serena was elected vice president of the American Professional Wound Care Association (APWCA) is currently the president-elect of the Association for the Advancement of Wound Care (AAWC). Dr. Serena has opened and operates Wound Care and hyperbaric oxygen treatment clinics across the United States.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.