Pressure Ulcer Guidelines: ''Minding the Gaps' - Lippincott Williams ...

From the NPUAPPressure Ulcer Guidelines: ‘‘Minding the Gaps’’When Developing New GuidelinesDiane Langemo, PhD, RN, FAAN; Janet Cuddigan, PhD, RN, CWCN, CCRN;Mona Baharestani, PhD, ANP, CWOCN, CWS, FAPWCA, FCCWS;Catherine R. Ratliff, PhD, APRN,BC, CWOCN; Mary Ellen Posthauer, RD, CD, LD;Joyce Black, PhD, RN, CWCN, CPSN; and Susan Garber, MA, OTR, FAOTA, FACRMSince the early 1990s, clinical practice guidelines have becomean increasingly integral part of clinical practice. Healthcare professionals possess an intrinsic desire to providethe best care possible. As such, guidelines influence patients,providers, and payers. Practice guidelines based on the bestscientific evidence available have the potential to enhanceconsistency of care, reduce morbidity and mortality, and improvequality of life, at least for some conditions. 1,2Much of the seminal work in guideline development methodologyoccurred in the 1990s. Since that time, a number ofpressure ulcer guidelines have been developed by the industry,governmental agencies, and professional organizations.The methodological rigor involved in developing these guidelinesvaries, as does the currency of evidence supportingguideline recommendations. An analysis of existing pressureulcer guidelines was undertaken by a task force of the NationalPressure Ulcer Advisory Panel (NPUAP) in preparation for itscollaborative venture with the European Pressure Ulcer AdvisoryPanel (EPUAP) to develop evidence-based internationalguidelines on pressure ulcer prevention and treatment. Theresults of this gap analysis are described below.What Are Clinical Practice Guidelines?Guidelines are developed to provide up-to-date scientificclinical evidence on specific areas of clinical practice, with thegoal of providing consistent and appropriate clinical practice.The Institute of Medicine defined clinical guidelines as ‘‘systematicallydeveloped statements for practitioner and patientdecisions about appropriate health care for specific clinicalsituations.’’ 3 The guideline is, in essence, a concise instructionfor practice based on the best scientific evidence available.The World Health Organization also recognized the importanceof ensuring that health care recommendations areinformed by the best available research evidence, which isobtained through a rigorous literature identification process. 4Benefits of Clinical Practice GuidelinesClinical guidelines improve the quality of clinical decisionsby providing explicit, scientifically supported recommendationson the appropriateness of treatments. 1 They callattention to practices that have been deemed harmful andunsupported by scientific evidence. Guidelines assist in ensuringthe consistency and efficiency of care delivered andhelp close the gap between what a clinician does and whatthe scientific evidence supports. Guidelines serve as a commonpoint of reference for both prospective and retrospectiveclinical practice audits. 1 Gaps identified in scientificevidence alert researchers to areas of practice in need of additionalresearch. Guidelines also assist health care agenciesin providing consistency of care and optimizing value for thedollar in delivery of care. 1Guidelines accompanied by a consumer version and/ordisseminated widely to the public serve to inform patientsand the public about what clinicians should be doing. 5Guidelines also serve to influence public policy by drawingattention to underrecognized health problems, underservedpopulations, clinical services, and preventive interventions. 1Potential Limitations of Clinical Practice GuidelinesA guideline is based on the best clinical evidence availableat the time the recommendation for practice is made. Unfortunately,with time, new scientific evidence may informpractitioners that the recommendation was not the best for allpatients. 1 Research methodology may be flawed, and muchneeded research on humans cannot be conducted becauseof the limitations of federal government human subject researchregulations. Guidelines need to be flexible for individualizedimplementation based on the status of the patientand the clinical environment in which the care is delivered. 6Recommendations may affect payers’ decisions to cover ornot cover a service. Conflicting guidelines from a variety ofDiane Langemo, PhD, RN, FAAN, is the Chester Fritz Distinguished Professor Emeritus at the University of North Dakota, Grand Forks, ND; Janet Cuddigan, PhD, RN, CWCN, CCCN, isAssistant Professor and Acting Department Chairperson at the University of Nebraska Medical Center School of Nursing, Omaha, NE; Mona Baharestani, PhD, ANP, CWOCN, CWS,FAPWCA, FCCWS, is Associate Professor, East Tennessee State University Center for Nursing Research, Johnson City, TN; Catherine R. Ratliff, PhD, APRN,BC, CWOCN, is an AssociateProfessor, University of Virginia Health System, Charlottesville, VA; Mary Ellen Posthauer, RD, CD, LD, is Registered and Licensed Dietitian and Consultant for SupremeCare West, Inc,Evansville, IN; Joyce Black, PhD, RN, CWCN, CPSN, is Associate Professor, University of Nebraska Medical Center, School of Nursing, Omaha, NE; and Susan Garber, MA, OTR, FAOTA,FACRM, is a retired Professor from the Baylor College of Medicine, Houston, TX. Correspondence may be sent to Diane Langemo, PhD, RN, FAAN, 430 Oxford St, Stop Box 9025, GrandForks, ND 58202-9205, or National Pressure Ulcer Advisory Panel, 1255 23rd St NW, Washington, DC 20037.WWW.WOUNDCAREJOURNAL.COM 213 ADVANCES IN SKIN & WOUND CARE & MAY 2008Copyright @ 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

From the NPUAPsources can confuse practitioners. 7 Outdated recommendationshave the potential of promoting outdated care. Lastly,guidelines that conclude a treatment or procedure maynot be beneficial can be dangerous and may limit approvaland/or funding for future research on the topic. 1Updating GuidelinesIn 2001, Shekelle et al 8 reviewed 17 guidelines publishedby the Agency for Healthcare Research and Quality andestimated that 90% remained valid after 3.6 years and thatnearly 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 than3 years, it was determined that existing guidelines needed tobe examined for gaps to identify areas in current guidelinesthat are deficient. This was done in preparation for the developmentof collaborative international guidelines.MethodologySearch StrategyA search was conducted for guidelines related to pressureulcer prevention and treatment. Seven sets of guidelines containingrecommendations for both prevention and treatmentwere identified. Two guidelines contained all or some aspectsof prevention, but not treatment. Two guidelines addressedtreatment only. The Web siteVhttp://www.guideline.govVyielded the majority of guidelines. Other strategies includedsearches of electronic databases, bibliographies of publishedarticles, and contacts with international colleagues. This reviewwas restricted to guidelines written in or translated intoEnglish. The authors would welcome English translationsof other guidelines as they undertake international guidelinedevelopment work. Only nonindustry–sponsored guidelineswere included. Pressure ulcer prevention and treatmentguidelines selected for critique included the following: Agencyfor Healthcare Research and Quality (AHRQ [formerly theAgency for Healthcare Policy and Research]) 9,10 ; EPUAP 11–13 ;Wound, Ostomy and Continence Nurses Society 14 ; RegisteredNurses’ Association of Ontario 15,16 ; Singapore Ministryof Health 17 ; Paralyzed Veterans of America 18 ; NationalInstitute for Clinical Excellence 19 ; The University of IowaGerontological Nursing Interventions Research Center 20 ;the American Medical Directors Association 21,22 ; the WoundHealing Society 23 ; and the Australian Wound ManagementAssociation. 24Data ExtractionDescriptive information extracted for each guideline includedthe year of development and year of last review, thetype of developing group, if the guidelines were adaptedfrom another source, source of funding for the developmentprocess, financial disclosures/conflict of interest disclosuresby panel, disciplines represented by panel members, targetpatient population(s), target setting(s), target clinical specialty,and intended users. Guideline objectives and majoroutcomes considered were also reviewed. Whether a costanalysis was performed was also considered.The authors developed guideline analysis criteria thatsynthesized the following: the National Guideline Clearinghousecriteria used to compare and contrast guidelines on itsWeb site (http://www.guideline.gov), criteria for methodologicalrigor from the Appraisal of Guidelines Research andEvaluation Instrument that were not already included in theClearinghouse criteria (http://www.agreecollaboration.org),and recommendations from NPUAP board members identifyingadditional guideline characteristics and critical contentnecessary for comprehensive, evidence-based, internationalguidelines for the prevention and treatment of pressureulcers.Tables were developed using the guideline appraisal criteriaitemized 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 respectiveguidelines. Data extraction for each guideline was then reviewedfor accuracy by one of the other authors. Authors alsoidentified whether critical content for prevention and treatmentwas included in each guideline (Figures 2 and 3).The completed table allowed the group to quickly compareand contrast the methodological rigor involved in guidelinedevelopment, the currency and comprehensiveness of supportingevidence, and inclusion of critical content. Using amodified Delphi technique, gaps in pressure ulcer preventionand treatment guidelines were identified.ResultsPressure ulcer guidelines meeting inclusion criteria for thisanalysis were appraised by the authors. Some of the guidelineshad been revised since their inception, whereas othershad not. A comprehensive body of knowledge existed inthe current guidelines but was determined to be timely onlyto the date each guideline was published and the extentof the review of literature completed. Overall, the pressureulcer guidelines were well conceptualized, organized, andclinically grounded. This group of reviewers determinedthat the processes for selecting material to be included inthe guidelines could have been more stringent in somecases. Many of the guidelines referred to the AHRQ preventionand treatment guidelines, refining and extendingrecommendations based on current literature and the needsof special populations.ADVANCES IN SKIN & WOUND CARE & VOL. 21 NO. 5 214 WWW.WOUNDCAREJOURNAL.COMCopyright @ 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

From the NPUAPFigure 1.SUMMARY OF GUIDELINE APPRAISAL CRITERIA& Not all care guidelines were multidisciplinary-focused, nor werethey developed by a multidisciplinary team of care providers.& The target population for most guidelines was adults and/orolder adults. Special populations were included in the ParalyzedVeterans of America guideline, 18 focusing on personswith spinal cord injury, and the American Medical DirectorsAssociation guideline, 21,22 focusing on older adults andresidents of long-term-care facilities. Although most guidelinesprovide broad recommendations that could be appliedto multiple populations, there are some unique aspects ofpressure ulcer prevention and treatment that should beinvestigated and developed for specialty populations, suchas neonatal, pediatric, bariatric, geriatric, palliative care, andcritical care patients. Future guidelines should address theunique needs of these specialty populations.& Few guidelines contained a cost-benefit analysis.& The EPUAP guidelines were the first multinational collaborativeeffort to produce pressure ulcer guidelines; however,a broader international perspective is still needed.& Methodological rigor varied among guidelines. Some guidelinesidentified explicit search strategies, inclusion-exclusioncriteria, methods for data extraction into evidence tables, andREDEFINING THEBOUNDARIES OF MEDICINENumerous gaps were identified in some or all sets ofguidelines. More specifically, the group identified the followingareas as weaknesses in some or all of the guidelines:& Guidelines need to be based on a thorough, comprehensivereview and synthesis of the literature up to the time of publication.The science of pressure ulcer treatment has movedforward since some guidelines were developed, and multiplenew products and technologies now exist that need tobe addressed in the guidelines. The Wound, Ostomy andContinence Nurses Society guidelines 14 and the WoundHealing Society guidelines 22 contain the most up-to-dateinformation; however, neither was based on a completelythorough review of the literature.& It would be most helpful for clinicians if treatmentguidelines were organized according to a framework or setof principles (eg, principles of wound bed preparation,incorporation of some discussion of newer research to supportthese principles).Geisinger Medical Center, Danville, PA, seeks a Director of theWound Clinic. The qualified physician will be board certified inDermatology, Internal Medicine, or Family Medicine with an interestin wound care.About this position:• The Director will be responsible for patient care and oversightof the Wound Clinic, located within the Departmentof Dermatology• The clinic currently includes 5 Dermatology nurses,1 dermatologist and 1 podiatrist• Research opportunities are available in cooperation with theGeisinger Center for Health Research• Nine dermatology residents rotate through the clinicFor more information, please contact Lori Surak,Physician Recruiter, at 1-800-845-7112, email ljsurak@geisinger.eduor visit www.geisinger.org/docjobsWWW.WOUNDCAREJOURNAL.COM 215 ADVANCES IN SKIN & WOUND CARE & MAY 2008Copyright @ 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

From the NPUAPFigure 2.CONTENT INVENTORY FOR PRESSUREULCER PREVENTION GUIDELINES& Both internal and external, as well as legal, reviews areneeded. Comments from all internal and external reviewersneed to be compiled and acted upon.& Not all guidelines contained a clinical algorithm that thegroup of reviewers believed would be beneficial to include.& Guidance for implementation of guidelines was lackingin some instances. Guidelines tend to provide broad recommendationsthat can be applied to multiple patientpopulations in diverse settings. Translating guideline recommendationsinto the specific protocols, educational strategies,and practices that will work in specific settings andpopulations is often challenging. The companion implementationguidelines developed by the American MedicalFigure 3.CONTENT INVENTORY FOR PRESSUREULCER TREATMENT GUIDELINESquality ratings of individual studies to inform guideline developers.Others merely used a committee consensus process.& Published meta-analyses and comprehensive literature reviewsare an increasingly common source of supporting evidencefor guidelines. Many of these reviews are excellent(eg, the Cochrane Reviews). However, a careful examinationof the methodologies used to create these reviews is essentialbefore using them to make recommendations for patientcare. Was the review comprehensive? Is there any bias in theselection and review of studies? What statistical methodswere used for meta-analysis?& Rating schemas varied among guidelines. The ‘‘strengthof evidence’’ supporting a given guideline recommendationwas often based on a ‘‘design hierarchy’’ that placed therandomized controlled clinical trial at the top. The quality ofthe study, regardless of design, was considered by some,but not all, guideline developers. ‘‘Strength of recommendation’’rating schemes tend to address the quality and designof supporting studies while explicitly identifying and acknowledgingthe role of clinical expertise in providing patient care.The ‘‘strength of recommendation’’ rating often brings thescience to the bedside by asking: ‘‘After a careful and comprehensiveanalysis of current science and clinical expertise, whatare the best recommendations we can offer our patients?’’ADVANCES IN SKIN & WOUND CARE & VOL. 21 NO. 5 216 WWW.WOUNDCAREJOURNAL.COMCopyright @ 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

From the NPUAPDirectors Association are an excellent example of waysto bridge this translational gap. Individual facilities andagencies are ultimately responsible for implementation,education, and continuous quality improvement.& Patient education information was included in only a fewsets of guidelines.& Seamless care between care settings is an importantconcept and was not addressed in guidelines reviewed.& Characteristics and properties of support surfaces wereincluded but could be better delineated, particularly in termsof selection of the appropriate surface for a patient with aparticular type of pressure ulcer. The NPUAP has standardizedterms and definitions related to support surfaces, andthese need to be incorporated and updated as new technologiesemerge (http://www.npuap.org/NPUAP_S3I_TD.pdf).& Mention of nutrition was lacking in most guidelines.Recommendations from those guidelines addressing nutritioncould be more specific and updated based on newerscientific evidence.& Implementation of all recommendations should be basedon patient goals and preferences.& Several ethical issues are inherent within the guidelines:truth telling and respect for individual wishes (palliative andsupportive versus healing and restorative treatment focus),distributive justice (availability of more expensive and technologicallyadvanced products in poor and underservedpopulations), distributive justice and beneficence (the responsibilityof all health care providers to provide the mostcost-effective and efficacious treatment for their patients,wisely utilizing resources to achieve the ‘‘most good for thegreatest number’’ of patients).The FutureThe EPUAP and the NPUAP have been working on a collaborativeinternational project to develop internationalpressure ulcer prevention and treatment guidelines. Literaturesearches will be performed, evidence tables will beprepared, guidelines will be drafted, and the draft guidelinerecommendations will be distributed to wound care providersand researchers and other stakeholders throughoutthe world for input.A Web site has been developed for communication amonginternational guideline developers as they review and analyzethe scientific evidence on pressure ulcer prevention andtreatment. As literature reviews and guidelines are drafted,they will be available on the Web site for stakeholder reviewand recommendations. The EPUAP and NPUAP Web siteshave links to the guideline Web site (http://www.EPUAP.org, http://www.NPUAP.org). It is anticipated that thesenew international pressure ulcer prevention and treatmentguidelines will be completed by late 2008.Evidence supporting the international guidelines will bepresented at the World Union of Wound Healing Societies conferencein Toronto, Canada, in June 2008. 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Guidelines for the treatment of pressure ulcers.Wound Repair Regen 2006;14:663.24. Australian Wound Management Pressure Ulcer Interest Subcommittee. Clinical PracticeGuidelines for the Prediction and Prevention of Pressure Ulcers. West Leederville, WA:Cambridge Publications; 2001. Available at: http://www.awma.com.au/publications/publications.php#clinical. Last accessed March 10, 2008.WWW.WOUNDCAREJOURNAL.COM 217 ADVANCES IN SKIN & WOUND CARE & MAY 2008Copyright @ 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.