From the Editor

Come October, our industry should have early access to a study that I hope will change the national conversation about wound care. Published by Value in Health, the journal of the ISPOR (International Society for Pharmacoeconomics and Outcomes Research), and carried out by the Alliance of Wound Care Stakeholders, the open-source article “An Economic Evaluation of the Impact, Cost and Medicare Policy Implications of Chronic Nonhealing Wounds” will be accessible for free and can be shared with others. Please do so! To enable the analysis conducted in the study, the U.S. Wound Registry (USWR) identified all the diagnosis and procedure codes used by more than 130 wound centers and 500 wound care practitioners in 2014. These codes were then run against the Medicare 5% dataset for the same calendar year. Using such an inclusive set of codes allowed us to capture the most comprehensive picture of wound care costs to date. We were then able to demonstrate that nearly 15% of Medicare beneficiaries have at least one type of wound or related infection, the most prevalent of which were surgical infections (4%). A fact that will surprise healthcare policy experts (but not wound care practitioners) is that the majority of wound care costs occur in the outpatient setting. However, even the wound care experts involved in this study, including yours truly, were surprised by the fact that the most expensive category is surgical wounds. We knew the costs would be huge, but the results were nonetheless staggering. The estimated total Medicare spending for all wound types in 2014 ranged from $28.1 billion-$96.8 billion, depending on how the cost of infection is allocated. For reasons explained in this paper, the higher figure is likely closer to the mark. Perhaps the most powerful message is the price tag. 

Why did the Alliance carry out a study of wound care costs? The reason is, with so many competing priorities, it is not possible to get attention directed at wound care unless people can be convinced that the magnitude of the problem constitutes a healthcare crisis. Even when a crisis exists, it is still necessary to make people aware of it in order to get resources directed at it. Here’s a tragic example: As I write this editorial, the city of Houston, TX, has thus far been inundated with 36 inches of rain from Hurricane Harvey. And rain is still pouring down. The total area covered with water is approximately the size of Lake Michigan, and some of that water is 10 feet deep. The magnitude of this disaster within the nation’s fourth-largest city is impossible to comprehend or describe. The devastation is unlike anything we have seen in the United States from a natural disaster. However, in 2001, Tropical Storm Allison dumped 36 inches of rain in 24 hours on downtown Houston, breaking the world record at that time. The entire Houston Medical Center system had to be evacuated. That’s nine massive hospitals, including two major trauma centers, Texas Children’s Hospital, and MD Anderson Cancer Center. This was carried out in the dark of night, in chest-high water, without electricity, and without cellphone or landline communication to the outside world. It was the largest evacuation in U.S. history, and it wasn’t on the news because the Oklahoma City bomber was executed that weekend and the nation’s media were entirely focused elsewhere. The fact that a city of Houston’s magnitude could go “off the grid” without anyone seeming to notice or care certainly made the situation more frustrating. However, this time around things are different! While the images of Houston and the entire south Texas coast are heartbreaking, awareness of tragedy is what spurs people into action and gets attention focused on where it is needed. 

Thanks to the aforementioned Alliance study, we will be able to make the case that chronic wounds are a huge healthcare crisis. They are more prevalent than heart failure, and more costly. Yet, because cardiologists have done a spectacular job of publicizing the impact of heart failure with maps of prevalence¹ and information about cost and mortality, they have obtained huge sums of federal funding for research, as well as the support of Medicare for many healthcare initiatives. Cardiologists have another advantage, and that is they are a recognized medical specialty and have a specific disease they can tackle. Our problem is that wounds are a symptom of a disease (or even several diseases). This has profound implications for research. 

In 1998, I participated in my first clinical research study, the Becaplermin trial. I was excited about the concept of harnessing growth factors, a novel idea nearly 20 years ago. The inclusion criteria for the study were relatively small, superficial, uninfected, diabetic foot ulcers (DFUs) in patients without peripheral arterial disease or any other major illnesses. These exclusions were to ensure that the product (later called REGRANEX, Smith and Nephew) did not appear to be ineffective due to the presence of some significant patient factor. All the subsequent wound care trials in which I participated were designed the same way. By 2008, I decided that I no longer could be part of this system. The fault was not with the trial sponsors. The U.S. Food & Drug Administration required trials like this in order to demonstrate efficacy — that a product works under ideal conditions. Unfortunately, afterwards, Medicare, usually through the various Medicare Administrative Contractors, would craft policy that limited coverage of the product to patients who matched the inclusion criteria of the randomized controlled trial (RCT). So, when physicians subsequently used the product in real-world patients, they and the hospitals risked monetary recoupment, if audited, because the majority of patients who need an advanced therapeutic, such as a cellular product, do not resemble the inclusion criteria of an RCT. Marissa Carter, PhD, and I demonstrated this when we reviewed more than 1,100 wound care trials and found that the majority of real-world patients would have been ineligible to participate in any of the RCTs that brought wound care products to market.² A reporter with Kaiser Health News recently wrote an article stating that the U.S. spends a lot of money on products that don’t have much evidence.³ She is partly correct. Here are some facts:

• Many advanced therapeutics do have excellent RCT data. So, it is not correct to say that we don’t have good data.
• Unfortunately, almost none of the RCTs performed on advanced therapeutics for wound care are “generalizable” to real-world patients.
• In other words, there may be excellent data, but not in the patients who need the products. 
• The reason we can’t enroll real-world patients in clinical trials is there hasn’t been a way to statistically control for their relative level of “sickness” within the study.

If you don’t believe me that real-world patients are different from subjects in RCTs, take a look at the tables from a paper recently published in Wound Repair and Regeneration, which I have shared on my personal blog.⁴ Within virtually the same group of clinics, the real-world venous ulcers were five times larger than those enrolled in cellular product RCTs for venous ulcers. Real-world patients also lived with multiple ulcers, were more likely to be older than age 65, and were more likely to have concomitant arterial disease. Real-world DFUs were more likely to be Wagner Grade III, whereas cellular product trials enroll Wagner Grade I ulcers, and the patients are more likely to live with renal failure or other serious medical problems that are excluded in DFU trials. That is one reason we created the Wound Healing Index, which allows the creation of matched cohorts of real-world patients for clinical trials.⁵ When I decided to stop participating in nongeneralizable RCTs, I decided to focus on finding a way forward for real-world research. One option may be to use data from the USWR. We’ve worked a decade to control the sources of bias in the USWR to make this possible.⁶ For now, it’s important to make sure we disseminate the Value in Health paper as widely as possible. Chronic wound care is a healthcare crisis in this country, and we need to make sure everyone knows that. If you want to help with Hurricane Harvey recovery efforts, I recommend donations to the Salvation Army and the Red Cross, but please go directly to their websites to donate (to avoid fraudulent sites). Additionally, HMP Communications has posted “HMP Help for Harvey” on GoFundMe and Facebook to help connect first responders and other healthcare professionals from across different specialties while providing an outlet where information and stories can be shared during disaster relief efforts. On behalf of my fellow Texans, thank you for your kind calls, emails, and text messages. 

Caroline E. Fife is chief medical officer at Intellicure Inc.; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands, TX; and co-chair of the Alliance of Wound Care Stakeholders.

References

1. Heart Failure Fact Sheet. CDC. 2016. Accessed online: www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm

2. Carter MJ, Fife CE, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009;22(7):316-24.

3. Taylor M. Patients With Open Wounds Get Unproven Treatments. Kaiser Health News. 2017. Accessed online: www.houstonchronicle.com/news/article/patients-with-open-wounds-get-unproven-treatments-11735697.php

4. Fife CE. Front page of the Philadelphia Inquirer … My Interview With Kaiser Health. Caroline Fife MD.com. 2017. Accessed online: https://carolinefifemd.com/2017/08/02/front-page-of-the-philadelphia-inquirer-my-interview-with-kaiser-health

5. Fife CE, Horn SD, Smout RJ, Barrett RS, Thomson B. A predictive model for diabetic foot ulcer outcome: the wound healing index. Adv Wound Care (New Rochelle). 2016;5(7):279-87. 

6. Fife CE, Eckert KA. Harnessing electronic healthcare data for wound care research: standards for reporting observational registry data obtained directly from electronic health records. Wound Repair Regen. 2017;25(2)192-209.