…and how truthful reporting of healing rates could save the field of wound care

In 2016, the quality data of all the physicians participating in the Physician Quality Reporting System (PQRS) became publicly available for the first time on the CMS Physician Compare website. (Note, the public data lag 2 years behind the calendar year.) The majority of physicians are now subject to the Merit Based Incentive Payment System (MIPS) in which quality reporting comprises 60% of the total performance score this first year. Practitioners hoping to realize a bonus payment must successfully report 6 quality measures, at least 1 of which is supposed to be a practice-relevant outcome measure. That means that MIPS success for wound care practitioners is largely dependent on the reporting of quality measures which CMS did not create. Fortunately, the US Wound Registry (USWR) did.
Wound care–relevant quality measures are available through the USWR, a Qualified Clinical Data Registry (QCDR) recognized by CMS to develop quality measures and report quality data under MIPS. Federal law requires that the outcome measure(s) reported by a QCDR be risk adjusted. Risk adjustment “levels the playing field” for outcomes reporting, making it possible to compare provider performance fairly. That means if wound healing rates are reported as measure of quality to CMS, they have to be reported in relation to how difficult the wounds were to heal in the first place. Otherwise, the doctors caring for the sickest patients and/or patients with the most difficult wounds will appear to have worse healing rates that the doctors caring for the healthiest patients.
Until recently, no risk stratification system existed for wound care, so for many years, a different method has been used to facilitate the reporting of wound healing rates. The method for reporting healing rates is called “making stuff up.” That is the subject of a paper just out in Advances in Wound Care:
I want to thank the editor, Dr. Chandan Sen, for allowing us to keep the “Alice in Wonderland” theme of the paper. We can no longer continue to just make up healing rates.

Publicly reported wound healing rates – a work of total fiction

When Alice said she could believe “six impossible things before breakfast,” she might have been talking about the healing rates posted on wound center websites. We performed a systematic analysis of wound center websites. We found no data on-line in South Dakota, North Dakota, Utah, Oregon, Hawaii, or Alaska. Of the remaining 44 U.S. states, the mean publicly reported wound healing rate was 92%, and the mean time to heal was 4.3 weeks. How do we know that can’t be true?

Randomized Controlled Trials in wound healing – the Mad Hatter’s Tea Party

We then systematically reviewed the randomized controlled trial (RCT) data from many venous leg ulcer (VLU) and diabetic foot ulcer (DFU) trials. Among controls in 20 VLU prospective trials, the mean healing rate reported was 42.7%. The mean healing rate for controls enrolled in 26 DFU prospective trials was a mere 37.9%. These low healing rates are even more shocking when you consider that the wounds enrolled in RCTs are much less severe than those found in real world patients (see previous blog post). Real world VLUs are 5 times larger than those enrolled in RCTs, and real world DFUs are 3 times larger than those enrolled in RCTs. Furthermore, 43.6% of real world DFUs are grade Wagner 3 or higher, when only Wagner 1 and 2 ulcers were eligible for the RCTs, and all of these trials exclude patients with significant arterial disease or serious co-morbid conditions. That’s why wound healing research as it is currently performed makes as much sense as the Mad Hatter’s Tea Party. If relatively healthy patients with small, uncomplicated ulcers, receiving protocolized care heal, at best, only 42% of the time, then it is quite simply impossible for a 92% healing rate to be anything other than a fantasy.

Time for a Reality Check – the role of real world data

We next evaluated real-world data from the USWR, analyzing 62,964 DFUs, 97,420 VLUs and 66,577 pressure ulcers. At 12 weeks, nearly 45% of VLUs were healed, but only about 30% of DFUs and PUs. If you do not apply any time constraints and count wounds that heal in any time frame, substantially more wounds will be reported as healed (remember, they are big). VLUs still have the highest percentage of wound closure by wound type at 56.9% healed. This means, in the real world, the best you can do is to heal about half your patients.

I want to be the first wound care practitioner to brag about a 50% healing rate – why?

Without a standardized risk stratification method, there has been considerable pressure to inflate healing rates on websites and on social media accessed by consumers, because not to do so makes practitioners look bad. A few years ago, I published a smaller subset of real world data demonstrating that healing rates were optimistically about 66%. A few months later, I was shocked to read the comments of a physician who, in a non-peer reviewed article, touted his 92% healing rate and disparaged the physicians contributing to the USWR for their poor quality of care. Now I say, “OK then, bring it.” Let’s risk stratify our patients and see who has the better healing rate in the sick ones.
I can brag that I have a 50% healing rate, among wounds that were only 30% likely to heal. That’s the purpose of the Wound Healing Index (WHI). There are some wounds that will get well with benign neglect. There are some wounds that cannot be healed by anyone. Between those extremes are wounds for which optimal care will make the difference between healing and not healing. If you wanted to find a wound care practitioner for your Mother, you would look for a clinician who had (for example), a 50% healing rate in wounds that were less than 50% likely to heal.
There’s another reason for us to start telling the truth about healing. By reporting that all wounds heal, we are unable to demonstrate the impact of advanced therapeutics like hyperbaric oxygen therapy or cellular products.
The Alliance of Wound Care Stakeholders’ article in Value in Health is now available. We now know that chronic wounds cost Medicare between $30 Billion and $90 Billion per year. It is simply not possible to justify that expenditure if >95% of patients heal. The fact is, the majority of patients may NOT heal. And that is why wound care costs so much. For some patients, chronic wounds may be like any other chronic disease. We need to figure out which advanced therapeutics are really able to take a wound from the “not likely to heal” category and put it in the “likely to heal” category. And the only way we will be able to do that, is with risk stratification.
Fife CE, Eckert KA. Harnessing electronic healthcare data for wound care research: standards for reporting observational data obtained directly from electronic health records. Wound Repair Regen 2017; doi:10.1111/wrr.12523.
Fife CE, Carter MJ. Wound care outcomes and associated cost among patients treated in US outpatient wound centers: data from the US Wound Registry. Wounds 2012;24:10–17.