Guest Editorial: Maintaining Our Objections to the NPUAP Changes

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Greg Bohn, MD, FACS, President, Association for the Advancement of Wound Care

In my 30 years as a surgeon, new research and better science have resulted in great advancements in medicine. Technology has changed how surgery is performed and improved outcomes. In wound care research, we are developing a body of science that guides evidence-based care to promote healing. 

The AAWC has championed evidence-based medicine, leading this effort globally with the consolidated, consensus-built guidelines initiative. In addition, the AAWC and the Wound Healing Society initiated the Clinical Endpoints Study (WEP-CEP) to improve and foster meaningful wound research, further exemplifying the AAWC’s leadership efforts to improve wound care as a discipline. The 2 organizations were recognized at the 2016 World Union of Wound Healing Societies meeting in Florence, Italy as being the top progressive global societies in wound healing.

The AAWC and its members know the importance of practicing from the evidence and the value an educated wound care clinician brings to patients by providing the best care possible. Although new research and science are usually followed by change, not all change is evidence-based. At SAWC Fall, the National Pressure Ulcer Advisory Panel changes in terminology to the Pressure Ulcer Staging System were the focus of much discussion. The AAWC participated in the NPUAP process and has been an active participant (attending every panel meeting in the last 2 years and contributing to the use of evidence-based practice), but our voice and contributions have been ignored in this latest NPUAP initiative. During the Panel meeting leading up to the Consensus Conference where the changes in terminology were unveiled, our AAWC representative spoke about the substantial contributions and the direction the research and evidence on pressure ulcer development and understanding were taking us, noting the most recent changes in terminology do not seem to be evidence-based. When we believed our comments were not acknowledged at the Panel meeting, the AAWC Board of Directors wrote a detailed and well-referenced response to the NPUAP to bring better evidence and science to the staging system used in the United States. This evidence-based response was delivered to the NPUAP according to their specifications, but without explanation it was not given Panel consideration. As a Consensus Conference attendee, I repeatedly witnessed the Panel and moderator dismiss AAWC attempts to comment. The changes in terminology to the present broken staging system were presented and subsequently published despite thorough and timely AAWC input and participation. 

You as a wound care provider need to consider the important implications of these changes. The AAWC hosted an open mic forum at SAWC Fall this past October. Attendees expressed great concern over the legal implications of the terms used in the revised staging system — in particular, that the term injury will bias juries in the US court system. Inherent in the Merriam-Webster definition of injury is the concept of “an act that damages or hurts … for which the law allows an action to recover damages.” In his presentation at SAWC Fall, noted health law attorney Norris Cunningham of the firm Hall, Render, Killian, Heath and Lyman pointed out specific legal ramifications. The term injury gives a direct path to causation and fault attributable to the provider. When combined with the fact pressure ulcers are considered “never events,” provider liability and institutional exposure are compounded. In addition, the term may be used to imply elder abuse, which has led to prosecution for criminal charges brought against providers. 

The term intense and prolonged was added to some staging definitions. The AAWC had specifically challenged this addition at the Consensus Conference and were led to believe the terms would be removed; instead, the terms were included. The terms are not scientifically validated, nor do they fit with known pathophysiologic description of the process. How much time is too much? How much is prolonged? There is no measure of this concept with regard to ulcer pathophysiology to explain what this means. These loaded terms may well bias perceptions of fault in assessing blame for pressure-related ulcers.

The removal of certain terminology in the staging document is just as concerning. Previously, the phrase “Evolution may be rapid, exposing additional layers of tissue even with optimal treatment” was included in the definition of deep tissue injury. This qualifying phrase was helpful in many cases because it noted that despite best efforts, pressure-related wounding can occur. However, the term has been removed; no reason was given for the removal. 

The creation of a medical device-related pressure ulcer designation also was met with much disagreement. When first presented, the Panel indicated pressure-related ulceration of the head and face would always be Stage 4 because of the lack of subcutaneous tissue. One audience member 

came to the microphone to correct the anatomic error (no literature had been cited or discussed), and many in attendance saw little reason for the creation of this category. 

One final question on the Consensus Conference: where was the disclosure? The Consensus Conference was conducted as an educational event with CME/CEU credits granted through Creighton University (Omaha, NE). Although the process is similar to many conferences we attend for education, the work and material produced and presented resulted in a staging document that has clinical, legal, regulatory, and reimbursement ramifications. Our legal system will base decisions regarding guilt or innocence largely on the document. Our government Medicare program will make coverage decisions (including denial of payment) based on this document; regulatory and governmental agencies underscore the importance of disclosure. Some NPUAP members work in this area in our legal system (some more extensively than others), but Panel members’ involvement in pressure ulcer-related legal work was not disclosed, which is particularly concerning given the proposed terminology changes may have more influence on the legal ramifications of pressure-related conditions than on the science of this category of ulcers. 

No reimbursement codes currently apply to these proposed changes in terminology, directly impacting our patients who require adequate and accurate coding to obtain offloading cushions, bed overlays, dressings, and other medical devices needed to treat them effectively. Thus, reimbursement will be provided or denied without appropriate coding. 

Adopting these changes in terminology seems premature and may have a negative impact on patient care. Following the open forum at SAWC Fall, the AAWC drafted a detailed response to the changes in terminology. This response was published in the AAWC newsletter and is available on the AAWC website. Please read it carefully. The changes in terminology can have both predicted and unanticipated effects for you, your patients, and your institution. Although evidence and science suggest the need to amend the current staging system, more time is needed to make better sense of pressure ulcer development and characterization. We encourage you to “Stop and Not Adopt.”

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This article was not subject to the Ostomy Wound Management peer-review process.