In March 2019, an article was published in Advances in Skin & Wound Care entitled “Reexamining the Literature on Terminal Ulcers, SCALE, Skin Failure, and Unavoidable Pressure Injuries.”1 It summarized and proposed relationships among terminal ulcers, skin failure, Skin Changes At Life’s End (SCALE), and unavoidable pressure injuries (PIs) based in part on sessions hosted at the 2017 National Pressure Ulcer Advisory Panel conference.1 This article presents the results of a survey that was partially based on that article and designed to assess healthcare professionals’ opinions about relevant terminology to determine their levels of agreement and consensus.
Evidence-based medicine is a combination of the scientific evidence, expert opinion/knowledge, and patient preference.2 This survey was designed to solicit expert knowledge/opinion on this terminology. The survey was created by the study authors in January and February 2019 and implemented with the SurveyMonkey platform (San Mateo, California). It contained seven demographic questions about respondents’ clinical experience and background, as well as one question on whether the respondent had read the original CE/CME article.1 The instructions stated that it was not necessary to have read the article to complete the survey, and the questions were designed to stand alone from it.
In the second section of the survey, participants were asked to indicate their level of agreement with 10 consensus statements. The options were strongly agree, somewhat agree, somewhat disagree, and strongly disagree. Participants could also elaborate by appending narrative comments to any of the survey questions. The consensus statements included four questions concerning skin failure, two questions on Kennedy terminal lesions (now known as Kennedy terminal ulcers [KTUs]), and a single question for each of the following: SCALE, Trombley-Brennan terminal tissue injury, avoidability of terminal ulceration, and the CMS definition of PI. A final open-ended question asked participants to comment on what they believe is needed to provide a better conceptual framework for end-of-life skin changes.
Respondents were informed at the start of the survey that results were anonymous and completion implied permission to participate. As an incentive, participants could enter their name and email at the end of the survey for a chance to win one of five $100 American Express gift cards or a print copy of a wound care textbook. This information was stored separately from survey results, and only deidentified results were shared with these authors.
The survey was open from March 1 to June 30, 2019. To publicize the survey, notices were placed in the March through June issues of Advances in Skin & Wound Care, as well as in one issue of Nursing2019. In addition, emails were sent to members of relevant organizations that agreed to disseminate notification about the survey, including the American Professional Wound Care Association, the World Union of Wound Healing Societies, the World Council of Enterostomal Therapists, the International Interprofessional Wound Care Group, and attendees of the International Interprofessional Wound Care Course. Notices were also displayed on the journal website (www.woundcarejournal.com) and social media platforms, as well as in professional presentations by the survey coauthors.
A total of 505 responses were received, but not all respondents answered every question. Most completed surveys were from North America, with global respondents from Europe, South America, the Middle East, Asia, and Australia. Fewer than half of the participants (n = 208, 42.89%) stated they had read the article the survey was based on; 20 respondents did not answer this question. Table 1 summarizes the participant demographics. Table 2 reports on their responses by level of agreement or disagreement. Each statement required 80% of respondents to agree (either strongly agree or somewhat agree) to reach consensus; 9 of the 10 statements reached consensus. A total of 119 comments T3 were received, and the open-ended responses are grouped by theme in Table 3 Some of the responses are listed more than once if they fit more than one theme.
Survey respondents were experienced in skin and wound care, with the largest group (n = 181, 37.55%) having more than 20 years of experience and 125 (25.93%) stating they had 10 to 20 years’ experience (Table 1). Of the 505 respondents, 483 identified their profession. Most were nurses (n = 347, 71.84%) who, primarily identified as direct care providers, NPs, or nurse educators. Responding physicians (n = 45, 8.91%) were primarily specialists with identified specialties including plastic or general surgery, emergency medicine, and dermatology. Almost half of the respondents (n = 237, 49.17%) estimated that wound care comprised greater than 60% of their clinical practice. Pressure injuries were a part of clinical care for 90.2% of respondents (n = 437). Two-thirds of the respondents (n = 320, 66.12%) took care of patients with all three of the following: leg ulcers, foot ulcers, and PIs. The majority worked in acute hospital care (n = 191, 39.79%), followed by outpatient wound care clinics (n = 128, 26.67%).
One question in the demographic section of the survey asked about participant certifications. Seven common certifications and an “other” category were provided as responses, and respondents could check all that applied. In total, the respondents held 342 individual certifications, but some individuals held more than one. Most of the “other” responses (n = 172) were advanced degrees and not formal wound care certifications.
The following section details each consensus statement and the reported results. To help contextualize the responses, a summary of some of the concepts is included. For a more in-depth overview, refer to the summary article and/or the primary sources of related terms.
All of the statements reached consensus except for the proposed association of PIs as part of skin failure. High-quality research is needed to validate the clinical observations and proposed mechanisms of these injuries.
Statements 1 and 2: Kennedy Terminal Ulcers
Statement 1, “Kennedy terminal lesions are attributable to local ischemia and are less likely to be a primary pressure injury,” reached 84.29% agreement. In Statement 2, “Kennedy terminal lesions are prognostic of impending death,” there was 93.82% agreement.
The KTU was one of the first terminal ulcers reported in modern literature.3 Therefore, it is possible that respondents were familiar with this lesion. Similar to Charcot’s ulcer ominous, it is most common over the sacrum or coccyx. It is described as a red, yellow, and/or black pear-shaped lesion that appears suddenly. It may be on intact skin or form an erosion (ie, loss of epidermis with an epidermal base) or an ulcer (ie, loss of epidermis with a dermal or deeper base).3
The majority of respondents agreed that ischemia probably played a greater role than pressure in KTUs (84.29%; Statement 1). The sacrum does not have good collateral circulation and is prone to injury. When the heart or brain is compromised, circulation from the skin, kidneys, liver, lungs, or gastrointestinal tract is often shunted to preserve vital functions. Blood is shifted—literally squeezed—by vasoconstriction, first from skin and soft tissues toward the heart and brain, and then from visceral organs because of the ingenious adrenergic distribution that makes the brain the most protected organ.4 It is hypothesized that when the capillaries become leaky, local hemorrhage can cause a red color on the surface of the skin. As a bruise resolves, it can evolve to a yellow-brown color. If local ischemia is complete and the blood supply shuts down, a black color can result. The color changes can vary in the KTU depending on the relative amount of ischemia.
Knight and colleagues5 measured sacral local tensions of oxygen and carbon dioxide, along with sweat lactate and urea, for indirect measures of ischemia in 14 healthy volunteers. With varying external applied pressures, they concluded that oxygen levels were lowered in soft tissues subjected to higher pressures and that this decrease is generally associated with an increase in carbon dioxide levels “well above the normal basal levels (with) considerable increases, in some cases up to twofold, in the concentrations of both sweat lactate and urea at the loaded site compared with the unloaded control.”5 The investigators also stated “…it is well established that prolonged-pressure ischemia will affect the viability of soft tissues, leading to their eventual breakdown.” Therefore, the KTU may represent local ischemia partly from shunted cutaneous circulation subject to a much lower-than-usual pressure, contributing to the local lesion.
Although more than 90% of the respondents agreed that KTUs are prognostic of impending death, one of the comments noted that according to Kennedy’s data 44.3% of patients did not die in the 6-week period following the lesion’s appearance. There is only one published data-based article about KTUs.3 Future research should include prospective databases, case series, and cohort-based studies. These lesions are most likely unavoidable and should not be included in PI incidence and prevalence studies.6
According to the CMS’s State Operations Manual: Guidance to Surveyors (F686), KTUs need to be differentiated from other ulcers/injuries:6
- The facility is responsible for accurately assessing and classifying an ulcer as a KTU or other type of PU /PI and demonstrate that appropriate preventative measures were in place to prevent non-KTU pressure ulcers. KTUs have certain characteristics which differentiate them from pressure ulcers such as the following:
- KTUs appear suddenly and within hours;
- Usually appear on the sacrum and coccyx but can appear on the heels, posterior calf muscles, arms and elbows;
- Edges are usually irregular and are red, yellow, and black as the ulcer progresses, often described as pear, butterfly or horseshoe shaped; and
- Often appear as an abrasion, blister, or darkened area and may develop rapidly to a Stage 2, Stage 3, or Stage 4 injury.
However, there is no statement regarding KTUs in the Resident Assessment Instrument User’s Manual for long-term care.7
Statement 3: Trombley-Brennan Terminal Tissue Injuries
The third survey statement reached 80.74% agreement. In examining the etiology of these injuries, the pink color would again come from hemorrhage of the superficial vessels, and the purple-maroon color could arise from deeper vessels and mature into a bruise type of evolution. Vertical striations on the legs and horizontal areas on the abdomen may follow skin folds, edema patterns, or the vascular plexus structure of the skin.8
In the original report, none of the lesions lost their skin integrity or broke down to form an ulcer. However, the survey authors received seven respondent comments about these injuries breaking down with ulcer formation.
Statements 4 to 7: Skin Failure
Of all the concepts in the survey, skin failure has the most related articles in the literature.9–13 Skin failure may be acute or chronic and occur at the end of life or with acute and chronic illnesses.9–13 All but one of the statements on skin failure achieved consensus. In Statement 7, “The definition of skin failure at the end of life should include a description of the degree of skin injury and the area involved,” there was 93.4% agreement. Statement 6, “Skin failure is an event in which the skin and underlying tissue die because of hypoperfusion and occurs concurrently with severe failure of other organ systems (two or more),” achieved 95.62% agreement. Similarly, statement 5, “Skin failure can occur with acute illness, chronic illness, and at end of life,” achieved an even greater 98.1% agreement. However, consensus was not reached for Statement 4, “The concept of skin failure does not include pressure injuries;” 60.38% of respondents disagreed with this statement.
In defining skin failure, Langemo and Brown9 state: “Skin failure is an event in which the skin and underlying tissue die due to hypoperfusion that occurs concurrent with severe dysfunction or failure of other organ systems.” Levine has also published commentaries on skin failure10,11 that include proposed definitions such as “the state in which tissue tolerance is so compromised that cells can no longer survive in zones of physiologic impairment such as hypoxia, local mechanical stresses, impaired delivery of nutrients, and buildup of toxic metabolic byproducts. In this schema, skin failure can occur over bony prominences where skin and underlying tissues, including muscle, are stretched and subjected to external pressure.”11 These criteria for skin failure with hypoperfusion and compromise of two or more other organs can occur with an acute illness, chronic illness, or at the end of life.
What continues to need clarity is whether skin failure involves one or more organs. The survey featured a number of written comments concerning the desire for more evidence to clarify whether one severe organ failure is enough (eg, cardiac arrest) or if two internal organs must fail.
It is important to distinguish skin failure from other dermatologic disease processes that cause skin compromise from mechanisms other than hypoperfusion (eg, erythroderma with hyperperfusion compromise of the skin where >90% of the skin is red). The extent of skin compromise is an important component in describing ischemic injury associated with skin failure. Specific descriptions of skin changes should also be documented. Some written comments from the survey suggest that the severity of skin injury (erythema, erosion, ulcer, necrosis, bruising) and extent of the injury (percent of body surface area) may be a better documentation base to define treatment than the degree of skin injury.
The respondents agreed that skin failure can occur at the end of life and also with acute and chronic illnesses. There are two data-based articles on skin failure associated with acute illnesses from Delmore and colleagues.12,13 In 2015, they defined acute skin failure as “hypoperfusion of the skin resulting in tissue death in the setting of critical illness”12 and later revised the definition as “the hypoperfusion state that leads to tissue death that occurs simultaneously to a critical illness.”13
There is evidence that, with ischemia, the threshold pressure for a PI is lower and may occur even with an acceptable standard of care.6 There were 15 open-ended comments stating that PIs occur more readily with skin failure or are part of the concept of skin failure.
Statement 9: SCALE
For the statement “The changes outlined in the SCALE statements can occur in the absence of skin failure,” there was 81.42% agreement and thus consensus. Skin Changes At Life’s End14,15 can occur as patients are dying without two internal organs failing, although many of the SCALE criteria may be present within the definition of skin failure. Further, SCALE includes changes in skin color, turgor, or integrity (involving factors such as medical devices, incontinence, chemical irritants, chronic exposure to body fluids, skin tears, shear, friction, and infection). Suboptimal nutrition can result in weight loss, wasting, and skin changes with dehydration. Diminished tissue perfusion may cause a local decrease in skin temperature, mottled vasculature, and skin necrosis or gangrene. Pressure injuries are also a component of SCALE. Most of these changes may be unavoidable.
Statements 8 and 10: Unavoidable Skin Changes
For Statement 8, “Kennedy terminal ulcer (KTU), Trombley-Brennan terminal tissue injury (TB-TII), Skin Changes At Life’s End (SCALE), and skin failure at the end of life are unavoidable and not attributable to substandard care,” there was 86.59% agreement and thus consensus. Similarly, in Statement 10, “How much do you agree with the Centers for Medicare and Medicaid Services’ definition of avoidable/unavoidable pressure injury?” there was 90.91% agreement and consensus.
The most current CMS definitions (effective November 28, 2017) provided to distinguish avoidable and unavoidable PIs are as follows:6
“Avoidable” means that the resident developed a pressure ulcer/injury and that the facility did not do one or more of the following: evaluate the resident’s clinical condition and risk factors; define and implement interventions that are consistent with resident needs, resident goals, and professional standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate.
“Unavoidable” means that the resident developed a pressure ulcer/injury even though the facility has evaluated the resident’s clinical condition and risk factors; defined and implemented interventions that are consistent with resident needs, goals, and professional standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate.
The CMS also provides some clarification regarding PIs at the end of life. Even if a resident has an advance directive, the facility still needs to provide the resident with supportive and pertinent care as long as it is not prohibited by the directive.6 Further, statements about whether a PI is avoidable or unavoidable are also provided:6
It is important for surveyors to understand that when a facility has implemented individualized approaches for end-of-life care in accordance with the resident’s wishes, the development, continuation, or worsening of a PU/PI may be considered unavoidable. If the facility has implemented appropriate efforts to stabilize the resident’s condition (or indicated why the condition cannot or should not be stabilized) and has provided care to prevent or treat existing PU/PIs (including pertinent, routine, lesser aggressive approaches, such as cleaning, turning, repositioning), the PU/PI may be considered unavoidable and consistent with regulatory requirements.
Some of the written responses expressed concern about how to define “substandard care.” Perhaps the elements of the process that CMS describes in the “avoidable” definition could be used to define what survey respondents called “substandard care.”
At the end of the survey, survey authors asked for write-in comments; some of these have been organized by theme in Table 3. Many survey participants stated they would like a more definitive statement on skin failure/end-of-life skin changes (eg, from a task force or consensus group). They also requested definitions that are more closely aligned with evidence. Clearly, there is a need for more scientific evidence through research using an improved conceptual framework for end-of-life skin failure. Specific ideas about diagnostic criteria need to be validated, and enhanced definitions require further research. Clinicians want to know more about how to describe these wounds, how they impact funding, and how to relate these issues to patients and families. The need for more focused education for clinicians is a future opportunity.
This study represents a first step in exploring the global skin and wound care community’s opinions about terminal ulcers/injuries, skin failure, and SCALE in a structured way. It was clear respondents want clarified terminology and hope for a global consensus. Importantly, there was a lack of consensus as to whether skin failure includes PIs. The need for more research in this area, including clear diagnostic criteria, was repeatedly expressed by survey participants. The next steps could include a knowledge translation task force or a global consensus conference to explore terminology and propose scientific validation studies. This research may be facilitated by the development of databases through sponsoring national or international professional organizations.
- KTU and TB-TTI are believed to be terminal ulcers observed in patients at end of life.
- Survey results reveal that there is no current consensus as to whether the concept of skin failure includes pressure injuries.
- Skin failure (acute, chronic, and/or end of life) criteria must be further defined and the validated.
- Although definitions for unavoidable and avoidable pressure injuries exist from the CMS and other regulatory bodies, global criteria for determining when a pressure injury is avoidable or unavoidable should be validated and agreed upon.
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6. Centers for Medicare & Medicaid Services. State Operations Manual: Guidance to Surveyors F686. 2017. www.amtwoundcare.com/uploads/2/0/3/7/20373073/som-guidance-to-surveyors-f686-only.pdf
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7. Centers for Medicare & Medicaid Services. Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual. Version 1.17.1. October 2019. https://downloads.cms.gov/files/mds-3.0-rai-manual-v1.17.1_october_2019.pdf
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