Since the early 1990s, clinical practice guidelines have become an increasingly integral part of clinical practice. Health care professionals possess an intrinsic desire to provide the best care possible. As such, guidelines influence patients, providers, and payers. Practice guidelines based on the best scientific evidence available have the potential to enhance consistency of care, reduce morbidity and mortality, and improve quality of life, at least for some conditions.1,2
Much of the seminal work in guideline development methodology occurred in the 1990s. Since that time, a number of pressure ulcer guidelines have been developed by the industry, governmental agencies, and professional organizations. The methodological rigor involved in developing these guidelines varies, as does the currency of evidence supporting guideline recommendations. An analysis of existing pressure ulcer guidelines was undertaken by a task force of the National Pressure Ulcer Advisory Panel (NPUAP) in preparation for its collaborative venture with the European Pressure Ulcer Advisory Panel (EPUAP) to develop evidence-based international guidelines on pressure ulcer prevention and treatment. The results of this gap analysis are described below.
What Are Clinical Practice Guidelines?
Guidelines are developed to provide up-to-date scientific clinical evidence on specific areas of clinical practice, with the goal of providing consistent and appropriate clinical practice. The Institute of Medicine defined clinical guidelines as "systematically developed statements for practitioner and patient decisions about appropriate health care for specific clinical situations."3 The guideline is, in essence, a concise instruction for practice based on the best scientific evidence available. The World Health Organization also recognized the importance of ensuring that health care recommendations are informed by the best available research evidence, which is obtained through a rigorous literature identification process.4
Benefits of Clinical Practice Guidelines
Clinical guidelines improve the quality of clinical decisions by providing explicit, scientifically supported recommendations on the appropriateness of treatments.1 They call attention to practices that have been deemed harmful and unsupported by scientific evidence. Guidelines assist in ensuring the consistency and efficiency of care delivered and help close the gap between what a clinician does and what the scientific evidence supports. Guidelines serve as a common point of reference for both prospective and retrospective clinical practice audits.1 Gaps identified in scientific evidence alert researchers to areas of practice in need of additional research. Guidelines also assist health care agencies in providing consistency of care and optimizing value for the dollar in delivery of care.1
Guidelines accompanied by a consumer version and/or disseminated widely to the public serve to inform patients and the public about what clinicians should be doing.5 Guidelines also serve to influence public policy by drawing attention to underrecognized health problems, underserved populations, clinical services, and preventive interventions.1
Potential Limitations of Clinical Practice Guidelines
A guideline is based on the best clinical evidence available at the time the recommendation for practice is made. Unfortunately, with time, new scientific evidence may inform practitioners that the recommendation was not the best for all patients.1 Research methodology may be flawed, and much needed research on humans cannot be conducted because of the limitations of federal government human subject research regulations. Guidelines need to be flexible for individualized implementation based on the status of the patient and the clinical environment in which the care is delivered.6 Recommendations may affect payers' decisions to cover or not cover a service. Conflicting guidelines from a variety of sources can confuse practitioners.7 Outdated recommendations have the potential of promoting outdated care. Lastly, guidelines that conclude a treatment or procedure may not be beneficial can be dangerous and may limit approval and/or funding for future research on the topic.1
Updating Guidelines
In 2001, Shekelle et al8 reviewed 17 guidelines published by the Agency for Healthcare Research and Quality and estimated that 90% remained valid after 3.6 years and that nearly half were outdated in 5.8 years. Based on this work, they recommended guidelines be reassessed on a 3-year cycle. Given that most pressure ulcer guidelines are older than 3 years, it was determined that existing guidelines needed to be examined for gaps to identify areas in current guidelines that are deficient. This was done in preparation for the development of collaborative international guidelines.
Methodology
Search Strategy
A search was conducted for guidelines related to pressure ulcer prevention and treatment. Seven sets of guidelines containing recommendations for both prevention and treatment were identified. Two guidelines contained all or some aspects of prevention, but not treatment. Two guidelines addressed treatment only. The Web site-http://www.guideline.gov-yielded the majority of guidelines. Other strategies included searches of electronic databases, bibliographies of published articles, and contacts with international colleagues. This review was restricted to guidelines written in or translated into English. The authors would welcome English translations of other guidelines as they undertake international guideline development work. Only nonindustry-sponsored guidelines were included. Pressure ulcer prevention and treatment guidelines selected for critique included the following: Agency for Healthcare Research and Quality (AHRQ [formerly the Agency for Healthcare Policy and Research]) 9,10; EPUAP11-13; Wound, Ostomy and Continence Nurses Society14; Registered Nurses' Association of Ontario15,16; Singapore Ministryof Health17; Paralyzed Veterans of America18; National Institute for Clinical Excellence19; The University of Iowa Gerontological Nursing Interventions Research Center20; the American Medical Directors Association21,22; the Wound Healing Society23; and the Australian Wound Management Association.24
Data Extraction
Descriptive information extracted for each guideline included the year of development and year of last review, the type of developing group, if the guidelines were adapted from another source, source of funding for the development process, financial disclosures/conflict of interest disclosures by panel, disciplines represented by panel members, target patient population(s), target setting(s), target clinical specialty, and intended users. Guideline objectives and major outcomes considered were also reviewed. Whether a cost analysis was performed was also considered.
The authors developed guideline analysis criteria that synthesized the following: the National Guideline Clearinghouse criteria used to compare and contrast guidelines on its Web site (http://www.guideline.gov), criteria for methodological rigor from the Appraisal of Guidelines Research and Evaluation Instrument that were not already included in the Clearinghouse criteria (http://www.agreecollaboration.org), and recommendations from NPUAP board members identifying additional guideline characteristics and critical content necessary for comprehensive, evidence-based, international guidelines for the prevention and treatment of pressure ulcers.
Tables were developed using the guideline appraisal criteria itemized in Figure 1. Through a series of phone conferences, the authors reached a common understanding of each criterion. Each author was then assigned guidelines to review, extracting data to complete the table for his or her respective guidelines. Data extraction for each guideline was then reviewed for accuracy by one of the other authors. Authors also identified whether critical content for prevention and treatment was included in each guideline (Figures 2 and 3).
The completed table allowed the group to quickly compare and contrast the methodological rigor involved in guideline development, the currency and comprehensiveness of supporting evidence, and inclusion of critical content. Using a modified Delphi technique, gaps in pressure ulcer prevention and treatment guidelines were identified.
Results
Pressure ulcer guidelines meeting inclusion criteria for this analysis were appraised by the authors. Some of the guidelines had been revised since their inception, whereas others had not. A comprehensive body of knowledge existed in the current guidelines but was determined to be timely only to the date each guideline was published and the extent of the review of literature completed. Overall, the pressure ulcer guidelines were well conceptualized, organized, and clinically grounded. This group of reviewers determined that the processes for selecting material to be included in the guidelines could have been more stringent in some cases. Many of the guidelines referred to the AHRQ prevention and treatment guidelines, refining and extending recommendations based on current literature and the needs of special populations.
Numerous gaps were identified in some or all sets of guidelines. More specifically, the group identified the following areas as weaknesses in some or all of the guidelines:
* Guidelines need to be based on a thorough, comprehensive review and synthesis of the literature up to the time of publication. The science of pressure ulcer treatment has moved forward since some guidelines were developed, and multiple new products and technologies now exist that need to be addressed in the guidelines. The Wound, Ostomy and Continence Nurses Society guidelines14 and the Wound Healing Society guidelines22 contain the most up-to-date information; however, neither was based on a completely thorough review of the literature.
* It would be most helpful for clinicians if treatment guidelines were organized according to a framework or set of principles (eg, principles of wound bed preparation, incorporation of some discussion of newer research to support these principles).
* Not all care guidelines were multidisciplinary-focused, nor were they developed by a multidisciplinary team of care providers.
* The target population for most guidelines was adults and/or older adults. Special populations were included in the Paralyzed Veterans of America guideline,18 focusing on persons with spinal cord injury, and the American Medical Directors Association guideline,21,22 focusing on older adults and residents of long-term-care facilities. Although most guidelines provide broad recommendations that could be applied to multiple populations, there are some unique aspects of pressure ulcer prevention and treatment that should be investigated and developed for specialty populations, such as neonatal, pediatric, bariatric, geriatric, palliative care, and critical care patients. Future guidelines should address the unique needs of these specialty populations.
* Few guidelines contained a cost-benefit analysis.
* The EPUAP guidelines were the first multinational collaborative effort to produce pressure ulcer guidelines; however, a broader international perspective is still needed.
* Methodological rigor varied among guidelines. Some guidelines identified explicit search strategies, inclusion-exclusion criteria, methods for data extraction into evidence tables, and quality ratings of individual studies to inform guideline developers. Others merely used a committee consensus process.
* Published meta-analyses and comprehensive literature reviews are an increasingly common source of supporting evidence for guidelines. Many of these reviews are excellent (eg, the Cochrane Reviews). However, a careful examination of the methodologies used to create these reviews is essential before using them to make recommendations for patient care. Was the review comprehensive? Is there any bias in the selection and review of studies? What statistical methods were used for meta-analysis?
* Rating schemas varied among guidelines. The "strength of evidence" supporting a given guideline recommendation was often based on a "design hierarchy" that placed the randomized controlled clinical trial at the top. The quality of the study, regardless of design, was considered by some, but not all, guideline developers. "Strength of recommendation" rating schemes tend to address the quality and design of supporting studies while explicitly identifying and acknowledging the role of clinical expertise in providing patient care. The "strength of recommendation" rating often brings the science to the bedside by asking: "After a careful and comprehensive analysis of current science and clinical expertise, what are the best recommendations we can offer our patients?"
* Both internal and external, as well as legal, reviews are needed. Comments from all internal and external reviewers need to be compiled and acted upon.
* Not all guidelines contained a clinical algorithm that the group of reviewers believed would be beneficial to include.
* Guidance for implementation of guidelines was lacking in some instances. Guidelines tend to provide broad recommendations that can be applied to multiple patient populations in diverse settings. Translating guideline recommendations into the specific protocols, educational strategies, and practices that will work in specific settings and populations is often challenging. The companion implementation guidelines developed by the American Medical Directors Association are an excellent example of ways to bridge this translational gap. Individual facilities and agencies are ultimately responsible for implementation, education, and continuous quality improvement.
* Patient education information was included in only a few sets of guidelines.
* Seamless care between care settings is an important concept and was not addressed in guidelines reviewed.
* Characteristics and properties of support surfaces were included but could be better delineated, particularly in terms of selection of the appropriate surface for a patient with a particular type of pressure ulcer. The NPUAP has standardized terms and definitions related to support surfaces, and these need to be incorporated and updated as new technologies emerge (http://www.npuap.org/NPUAP_S3I_TD.pdf).
* Mention of nutrition was lacking in most guidelines. Recommendations from those guidelines addressing nutrition could be more specific and updated based on newer scientific evidence.
* Implementation of all recommendations should be based on patient goals and preferences.
* Several ethical issues are inherent within the guidelines: truth telling and respect for individual wishes (palliative and supportive versus healing and restorative treatment focus), distributive justice (availability of more expensive and technologically advanced products in poor and underserved populations), distributive justice and beneficence (the responsibility of all health care providers to provide the most cost-effective and efficacious treatment for their patients, wisely utilizing resources to achieve the "most good for the greatest number" of patients).
The Future
The EPUAP and the NPUAP have been working on a collaborative international project to develop international pressure ulcer prevention and treatment guidelines. Literature searches will be performed, evidence tables will be prepared, guidelines will be drafted, and the draft guideline recommendations will be distributed to wound care providers and researchers and other stakeholders throughout the world for input.
A Web site has been developed for communication among international guideline developers as they review and analyze the scientific evidence on pressure ulcer prevention and treatment. As literature reviews and guidelines are drafted, they will be available on the Web site for stakeholder review and recommendations. The EPUAP and NPUAP Web sites have links to the guideline Web site (http://www.EPUAP.org, http://www.NPUAP.org). It is anticipated that these new international pressure ulcer prevention and treatment guidelines will be completed by late 2008.
Evidence supporting the international guidelines will be presented at the World Union of Wound Healing Societies conference in Toronto, Canada, in June 2008. Members of the international wound care community will be invited to comment on various aspects of the guidelines during this conference.
References