A European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel Collaboration to Produce Clinical Practice Guidelines for the Prevention and Treatment of Pressure Ulcers

Katrien Vanderwee: written on behalf of the Guideline Development Group:

  • EPUAP

    • M. Clark
    • C. Dealey
    • T. Defloor
    • L. Schoonhoven
    • A. Witherow

  • NPUAP

    • M. Baharestani
    • D. Langemock M
    • J. Bla.E. Posthauer
    • J. Cuddigan
    • C. Ratliff
    • L. Edsberg
    • G. Taler
    • S. Garber

Introduction

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances (www.nice.org.uk). Guidelines have become increasingly popular in response to concerns regarding wide variation in health care as well as the fact that much of this care is of poor quality.

There is a pressing need for guidelines in pressure ulcer prevention and care. Considerable uncertainty exists among practitioners regarding best practices and a thorough literature review for guidelines has not been done over a decade. Additionally, there have been considerable advances in pressure ulcer prevention and care over the past decade. These include new technologies such as pressure mapping, new techniques for reducing pressure and new dressings. These new therapies lead to further uncertainty among clinicians regarding best practices.

Current guidelines do not fill this need. The only guidelines of national stature in the USA were published by the then Agency for Healthcare Policy and Research in 1992 and 1994 and later used as a basis for organisational specialty guidelines by the Paralyzed Veterans of America (PVA), American Medical Directors Association, Wound, Ostomy and Continence Nurses and the Wound Healing Society. The European guidelines were published by the European Pressure Ulcer Advisory Panel in 1998 and 1999. All these guidelines, in part, are now clearly outdated. Despite the fact that the management of pressure ulcers is clearly an international issue and much relevant research appears in the non-English literature, an international guideline does not exist.

The National Pressure Ulcer Advisory Panel (NPUAP) and the European Pressure Ulcer Advisory Panel (EPUAP) are proposing to fill this need and are developing guidelines that systematically analyze the world literature on pressure ulcer prevention and treatment and comment on the current evidence regarding prevention and treatment strategies. The EPUAP are leading on the pressure ulcer prevention guideline in collaboration with the American NPUAP. The NPUAP are leading the pressure ulcer treatment guideline in collaboration with the EPUAP.

Purpose of the Guidelines

A scope document was developed to define exactly what the guideline will and will not examine and what the guideline developers will consider.

Prevention Guideline

The aim of the guideline is to prevent the development of pressure ulcers. The guideline recommendations will apply to all patients and vulnerable people of all age groups. The guideline is intended for the use of health care professionals who are involved in the care of patients and vulnerable people that are at risk of developing pressure ulcers, whether they are in hospital, long-term care, assisted living at home or any other setting, and regardless of their diagnosis or health care needs. It will also help to guide patients and carers on the range of prevention strategies that are available.

Treatment Guideline

The aim of this guideline is to recommend evidence-based care for patients with existing pressure ulcers. The guideline recommendations will apply to all patients and vulnerable people of all age groups, whether they are in hospital, longterm care, assisted living at home or any other setting. The guideline is intended for the use of health care professionals who are involved in the care of patients with existing pressure ulcers. Patients with pressure ulcers are usually at risk for additional pressure ulcers, therefore the prevention guideline should be followed for these individuals. Based on the results of a gap analysis of existing pressure ulcer treatment guidelines, recommendations regarding the unique needs of several special populations will be addressed where evidence exists. These include spinal cord injured individuals, infants and children, critically ill patients, patients requesting palliative care and bariatric patients.

Methods

The EPUAP and NPUAP nominated six representatives each to form the Guideline Development Group (GDG). This GDG determines and controls the guideline development process. In order to have broader multidisciplinary representation to address the wider scope of the treatment guideline, three additional members have been added to the NPUAP core group. In addition the guidelines have been broken down into topics and Small Working Groups (SWGs) formed to review each topic. All GDG and SWG members have been screened for conflicts of interest. Representatives of industry were excluded from these groups, but are invited to participate as stakeholders.

Identify evidence

To identify the scientific literature on pressure ulcer prevention and treatment, several electronic databases were consulted such as PubMed, Cinahl, EMBASE, The Cochrane Database of Systematic Reviews, The Cochrane Central Register of Controlled Trials, Health Technology Assessment, and AMED databases.

A sensitive search strategy was developed by the GDG. All the references retrieved by the electronic literature search were screened by the GDG based on the following inclusion criteria. The articles must be primarily focused on pressure ulcer prevention, risk assessment and treatment. The articles must be published in a peer reviewed journal. An abstract must be available. The studies have to use one of the following designs: randomised controlled trials, controlled clinical trials, cohort studies, case-control studies and case series. At least ten subjects should be included in the case series. Systematic Reviews or meta-analysis are included if they use the Cochrane methodology. There is no restriction on the basis of language of study. Economic evaluations were excluded because there are relatively few in the literature and differences in health care systems across countries.

To gain an appreciation for the entire body of evidence on each topic, evidence tables developed by the Agency for Healthcare Policy and Research (now Agency for Healthcare research and Quality), the Paralyzed Veterans of America and the Registered Nurses of Ontario have been used to provide an overview of pre-2000 research. The NPUAP gratefully acknowledges the support of these organisations, particularly as the initial searches yielded over 5000 abstracts. Work continues on reviewing the evidence prior to developing draft statements.

Evaluating the Evidence

The full papers of selected references were obtained and divided according to topic and then sent to the relevant SWGs. The SWGs consist of trustees and members of the EPUAP and NPUAP. The members of the SWGs create evidence tables and score a methodology checklist developed by the GDG for each study. The template of the evidence table consisted of reference of the study, type of study, sample, intervention, outcome measures and length of follow-up, results, limitation and the question including or excluding the study. The methodology checklists, based on the Scottish Intercollegiate Guidelines Network, helped the reviewers to judge the quality of the study. All papers were evaluated by two members of the SWGs. The GDG are undertaking a quality check of a random sample of 10% of the completed evidence tables.

Each SWG have formulated conclusions about the body of available evidence based on the evidence tables using the strength of evidence developed by the PVA:

  1. Large randomised trials with clear-cut results (and low risk of error)
  2. Small randomised trials with uncertain results (and moderate to high risk of error)
  3. Non-randomised trials with concurrent or contemporaneous controls
  4. Non-randomised trials with historical controls
  5. Case series with no controls

Based on these conclusions, a first draft of recommendations is being developed. Each statement will be given a strength of evidence rating, using a modified PVA rating:

  1. Recommendation supported by primary scientific evidence from properly designed and implemented controlled trials on pressure ulcers in humans providing statistical results that consistently support the guideline statement (Level I studies)
  2. Recommendation supported by primary scientific evidence from properly designed and implemented clinical series on pressure ulcers in humans providing statistical results that consistently support the guideline statement (Level II, III, IV, V studies)
  3. The recommendation is supported by expert opinion

In addition: Informed Clinical Consensus: Expert opinion supported by secondary or indirect scientific evidence from properly designed and implemented studies using surrogate outcomes; animal, in vivo, in vitro studies; studies of other chronic wounds. This additional category was added when it was realised that there was insufficient direct evidence for some treatments in the pressure ulcer literature. Rather than ‘remain silent’ on clinical issues lacking such evidence (or resorting to expert opinion alone), a plan for cautious examination of research from other types of chronic wounds or surrogate was agreed. In particular, this has allowed SWGs considering treatment strategies to consider evidence from treatments of other types of chronic wounds to inform their expert opinion. Care has been taken to avoid bias and avoid overgeneralization of findings to patients with pressure ulcers.

The GDG will review the draft recommendations and then they will be posted on the guideline website for stakeholders to review.

Stakeholder involvement

The entire process of developing the guideline can be followed by stakeholders on a website (www.pressureulcerguideline.org). A stakeholder is someone who has interest in pressure ulcers and wishes to contribute to the guideline by reading the draft guideline, ensuring that all relevant evidence has been included and commenting on the draft guideline within the timeframe allowed. Anyone can become a stakeholder, either as an individual or as a representative for a society / organization. The list of existing stakeholders is available on the website. All members of EPUAP and NPUAP are encouraged to sign up as stakeholders and participate in this process.

Conclusion

We believe that this is an exciting development and we hope that many will want to participate in the process by becoming stakeholders. The aim is to complete the guidelines development process by late 2008 and our progress will be reported at the World Union of Wound Healing Societies conference in Toronto.

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