In 2016, the National Pressure Ulcer Advisory Panel (NPUAP) changed the taxonomy and nomenclature of the pressure ulcer staging system to the pressure injury staging system.1 On January 14, 2017, the NPUAP posted clarifications to those revisions.2 This striking amendment to the staging system, like any other change, brings out early adopters, supporters, nonsupporters, and those who wait and see, all looking at a complex issue through different prisms. In this case, it attracted commentaries from many circles.
It is not the intent of this editorial to take a position on any 1 group. However, I have become curious about the development and establishment of guidelines in general. Therefore, for this editorial I have followed the practices of evidence-based medicine.
I reviewed the literature, searching for any guidance in the medical journalism space or from government agencies regarding the changing the name, definition, or classification of diseases and related ramifications. It was no surprise that there is a paucity of literature on the subject. I did, however, find a recent "landmark paper" in the Journal of the American Medical Association Internal Medicine3 titled "Guidance for Modifying the Definition of Diseases: Checklist." The authors, a team from the Guidelines International Network's Overdiagnosis Working Group, expressed concern that "no guidelines exist currently for health policy panels and others considering changes to disease definitions."3 They further state "that groups frequently widen disease definitions that may increase the proportion of the population labeled as unwell and potentially causing harm to patients."3 A ramification of changing the name or taxonomy of a diagnostic category, such as going from diabetes to include "prediabetes" as a diagnostic subcategory or "prehypertension," for example, affects the epidemiology of the disease through increases in incidence and prevalence. "Seemingly minor changes in disease definitions can result in substantial changes in prevalence."3 Given the change in nomenclatures of an illness or condition such as pressure injuries and the extensive heterogeneity of definitions and types of lesions and patients, there should be corresponding studies of incidence and prevalence that "cross-classify," showing where the "definitions agree or are discordant."3
In looking to the foreground knowledge about the frequency and prevalence of deep tissue injuries (DTIs), only a few studies exist. One such study by Kottner et al4 investigated the point prevalence of DTIs in hospitals and skilled nursing facilities throughout Germany. The group conducted 2 cross-sectional studies over 2 years in hospital patients and skilled nursing facility residents. The participants included 6919 patients from 56 institutions in 2008 and 8451 patients from 91 institutions in 2009 with DTIs ranging from 4.3% prevalence (95% confidence interval [CI], 3.8-4.9) in nursing homes to 7.1% prevalence (95% CI, 6.2-8.0) in hospitals. Point prevalence rates of DTIs were 0.4% (95% CI, 0.2-0.5) in hospitals and less than 0.1% in nursing homes.4 Interestingly, VanGilder et al5 reported a DTI prevalence at approximately 3% in US facilities. The higher prevalence in the hospital setting compared with skilled nursing facilities suggests the possibility of prolonged surgeries, spinal anesthesia, and intensive care unit stays with concordant intrinsic and extrinsic DTI risk factors.
Because of the recent change in the taxonomy of the NPUAP staging system and education, we can anticipate a corresponding rise in the reported prevalence of suspected DTI and DTI diagnosis. Considering this eventuality, we do have an obligation to use scientific rigor in the reporting of these newly classified descriptions and taxonomies of DTI. The FDA6 and its roadmap to patient-focused outcome measurements and clinical trials put forth the concept that we must understand the disease or condition primarily. We should know the natural history of the disease or the condition of interest, including the diagnosis and the pathophysiology, and range of disease manifestations. We must also conceptualize the treatment benefit for the patients we serve by identifying meaningful concepts, treatments, and benefits and by selecting the right clinical outcome assessments. The methodologies must include appropriate content validity (qualitative or mixed methods research) with valid cross-sectional measurement properties that include reliability and construct validity.
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