Treatment of Pressure Ulcers: A Clinical Practice Guideline From the American College of PhysiciansFREE
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Abstract
Description:
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations based on the comparative effectiveness of treatments of pressure ulcers.
Methods:
This guideline is based on published literature on this topic that was identified by using MEDLINE, EMBASE, CINAHL, EBM Reviews, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the Health Technology Assessment database through February 2014. Searches were limited to English-language publications. The outcomes evaluated for this guideline include complete wound healing, wound size (surface area, volume, and depth) reduction, pain, prevention of sepsis, prevention of osteomyelitis, recurrence rate, and harms of treatment (including but not limited to pain, dermatologic complications, bleeding, and infection). This guideline grades the quality of evidence and strength of recommendations by using ACP's clinical practice guidelines grading system. The target audience for this guideline includes all clinicians, and the target patient population is patients with pressure ulcers.
Recommendation 1:
ACP recommends that clinicians use protein or amino acid supplementation in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)
Recommendation 2:
ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)
Recommendation 3:
ACP recommends that clinicians use electrical stimulation as adjunctive therapy in patients with pressure ulcers to accelerate wound healing. (Grade: weak recommendation, moderate-quality evidence)
Pressure ulcers affect 3 million adults in the United States across health care settings. They have a major impact on health status, quality of life, and health care costs. Treatment of pressure ulcers is critical to promote healing and minimize the risk for complications. Treatment interventions include management of conditions that give rise to pressure ulcers (support surfaces and nutritional support), protection and promotion of wound healing (wound dressings; topical applications; and various adjunctive therapies that are used in addition to standard pressure ulcer care, such as vacuum-assisted closure, ultrasound therapy, electrical stimulation, and hyperbaric oxygen therapy), and surgical repair of the wound (1) (Table 1). Treatment of pressure ulcers often requires a multidisciplinary approach involving nurses, physicians, and other members of a care team.
The purpose of this American College of Physicians (ACP) guideline is to present the available evidence on the comparative effectiveness of treatments for pressure ulcers. The target audience for this guideline includes all clinicians, including physicians, nurses, dietitians, and physical therapists. The target patient population comprises adults with pressure ulcers. For recommendations on the risk assessment and prevention of pressure ulcers, please refer to the accompanying ACP guideline (2).
Methods
This guideline is based on a systematic evidence review (3), an updated evidence review (Supplement), and an evidence report sponsored by the Agency for Healthcare Research and Quality (AHRQ) (1) that addressed the following key questions:
1. In adults with pressure ulcers, what is the comparative effectiveness of treatment strategies for improved health outcomes, including but not limited to complete wound healing, healing time, reduced wound surface area, pain, and prevention of serious complications of infection? Does the comparative effectiveness of treatment strategies differ on the basis of features (anatomical site or severity) of the pressure ulcers, patient characteristics, and health care settings?
2. What are the harms of treatments for pressure ulcers? Do the harms differ on the basis of features (anatomical site or severity) of the pressure ulcers, patient characteristics, and health care settings?
We searched MEDLINE, EMBASE, CINAHL, EBM Reviews, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the Health Technology Assessment database through February 2014 for studies in English. The primary outcomes of interest for this guideline include complete wound healing and wound size (surface area, volume, and depth) reduction. Additional outcomes include pain, prevention of sepsis, prevention of osteomyelitis, recurrence rate, and harms of treatment (including but not limited to pain, dermatologic complications, bleeding, and infection). Although most studies reported statistical significance of various outcomes, the guideline panel assessed clinically significant changes when evaluating the evidence.
Further details about the methods and inclusion and exclusion criteria applied in the evidence review are available in the full AHRQ report (1) and the Supplement. This guideline rates the quality of evidence and strength of recommendations by using ACP's guideline grading system (Table 2). Details of the ACP guideline development process can be found in ACP's methods paper (4).
Benefits and Comparative Effectiveness of Pressure Ulcer Treatment Strategies
Most studies reported on only 1 outcome each (such as reduction of pressure ulcer size, improved wound healing, or rate of wound healing). Complete wound healing was reported in few studies; intermediate outcomes, such as reduction of wound size and rate of wound healing, were used to assess efficacy of the interventions. Some improvements were seen only in patients with large ulcers (>7 cm). Table 1 provides descriptions of the various treatment strategies, and Table 3 summarizes the evidence. Moderate-quality evidence showed that air-fluidized beds reduced pressure ulcer size compared with other surfaces (6–10), but pressure ulcer outcomes did not differ in comparisons of other support surfaces (low- to moderate-quality evidence) (11–14, 21–25). Moderate-quality evidence showed that protein-containing supplements improved wound healing (27–40), although vitamin C supplementation did not (low-quality evidence) (26). Low-quality evidence showed that hydrocolloid dressings reduced ulcer size compared with gauze dressings (42–51) and that platelet-derived growth factor (PDGF) improved wound healing (69–73). Findings were mixed or did not differ for hydrocolloid compared with foam dressings (moderate-quality evidence) (52–59), radiant heat (moderate-quality evidence) (60–63), topical collagen (low-quality evidence) (42, 66–68), and oxandrolone (41). Low-quality evidence showed that dextranomer paste was inferior to other wound dressings for reducing ulcer area (64, 65). Moderate-quality evidence showed that electrical stimulation accelerated wound healing as an adjunctive therapy (74–83), and low-quality evidence showed no difference or mixed findings for the other adjunctive therapies assessed, including electromagnetic therapy (84–87), therapeutic ultrasound (88–90), negative-pressure wound therapy (91–93), light therapy (94–96), and laser therapy (100–103).
Effectiveness of Pressure Ulcer Treatment Strategies Based on Pressure Ulcer Features, Patient Characteristics, and Health Care Settings
Low-quality evidence from 3 fair-quality retrospective studies showed that patients with sacral pressure ulcers had a lower recurrence rate after surgery than those with ischial pressure ulcers (104–106).
Low-quality evidence from 1 fair-quality study showed that patients with spinal cord injury had a higher rate of recurrent pressure ulcers after surgical flap closure than other patients with pressure ulcers (104).
Low-quality evidence from 1 good-quality and 3 fair-quality studies showed that electrical stimulation was similarly effective in patients with spinal cord injuries compared with other patients (74, 78, 80, 81).
Low-quality evidence from 1 good-quality and 8 fair-quality studies showed that electrical stimulation produced similar results in a hospital and a rehabilitation center (74–83).
Harms of Pressure Ulcer Treatment Strategies
Reporting of harms was sparse, and comparison among trials was difficult because of heterogeneity of treatments or populations.
Support Surfaces
Evidence was insufficient to conclude about harms for various support surfaces because few studies reported adverse events and those that reported them mostly found no statistically significant difference compared with controls.
Nutrition
Evidence was insufficient to conclude about harms for nutritional supplementation because adverse event reporting was poor for these studies.
Medications
More patients had elevated liver enzyme levels (32.4% vs. 2.9%; P < 0.001) with oxandrolone than with placebo, but there was no difference in withdrawals due to adverse events (19% vs. 18%) (41).
Local Wound Applications
Skin irritation, inflammation, and tissue damage and maceration were the most commonly reported harms for various dressings and topical therapies (moderate-quality evidence). Evidence was insufficient to determine whether specific dressings or topical therapies resulted in less harm than others. Evidence was also insufficient to conclude about harms for biological agents because few harms were reported and the studies lacked precision.
Surgery
The most commonly reported harm from surgery was dehiscence. Reoperation due to recurrence or flap (tissue placed over the open wound) failure ranged from 12% to 24% among patients treated with surgery (low-quality evidence) (105, 107). Low-quality evidence from 1 intervention series showed a 21% complication rate for all skin flap surgeries and showed that tensor fascia lata flaps were associated with higher complication rates (49%), whereas rotation flaps were associated with the lowest complication rates (12%) compared with other surgical flap procedures (108).
Adjunctive Therapies
The most common adverse effect reported with electrical stimulation was skin irritation (low-quality evidence) (75, 79, 81). No substantial adverse effects were reported for light therapy (94, 95, 97, 98) or laser therapy (100–103) (low-quality evidence).
Harms of Pressure Ulcer Treatments Based on Pressure Ulcer Features, Patient Characteristics, and Health Care Settings
Dehiscence was more common if bone was removed during the surgery (low-quality evidence) (105), and patients with ischial ulcers had higher complication rates than those with sacral or trochanteric ulcers (low-quality evidence) (107, 109).
Low-quality evidence showed that frail elderly patients had more adverse events associated with electrical stimulation than younger patients (75, 79, 81).
Summary
Treatment of pressure ulcers involves multiple methods intended to alleviate the conditions contributing to ulcer development (support surfaces, repositioning, and nutritional support), protection of the wound from contamination and creation of a clean wound environment, promotion of tissue healing (local wound applications, debridement, and wound cleansing), adjunctive therapies, and consideration for surgical repair. Evidence showed that many interventions were similar to controls for alleviation of pressure ulcers. Air-fluidized beds were superior to other support surfaces (primarily standard hospital beds) for reducing pressure ulcer size. Alternating-air beds and low–air-loss mattresses did not differ substantially from other surfaces for reducing wound size. Overall, few harms were reported for support surfaces.
Nutritional supplementation with protein or amino acids improved the rate of wound healing.
Hydrocolloid dressings were superior to gauze dressings for reducing wound size and were equivalent to foam dressings for complete wound healing. Although radiant heat dressings accelerated wound healing, there was no evidence that they improved complete wound healing compared with other dressings. Dextranomer paste was inferior to other dressings for reducing wound size. Platelet-derived growth factor improved ulcer healing compared with placebo for more severe ulcers, and evidence was insufficient to determine the effect of other biological agents. The most commonly reported harms for local wound applications included skin irritation, inflammation, and tissue damage and maceration.
Adjunctive therapies, including electromagnetic therapy, negative-pressure wound therapy, therapeutic ultrasound, and laser therapy, were similar to controls for ulcer alleviation. Electrical stimulation accelerated wound healing compared with control, but there was no evidence that it was superior for complete wound healing. The most common adverse effect for this treatment was skin irritation, and frail elderly patients were more susceptible to adverse events associated with electrical stimulation. Light therapy resulted in reduced ulcer size compared with control and was not associated with any substantial adverse events; however, it was equivalent to sham treatment for complete wound healing.
Although surgery is considered an option for advanced-stage pressure ulcers, evidence was insufficient to determine the superiority of one surgical technique over another for wound closure. Dehiscence, a commonly reported adverse event, was more common when bone was removed and in patients with ischial ulcers.
Recommendations
Recommendation 1: ACP recommends that clinicians use protein or amino acid supplementation in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)
Evidence showed that nutritional supplementation with protein or amino acids reduced pressure ulcer wound size, but evidence for the optimal dose or form of protein was insufficient. Protein supplementation was assessed in conjunction with standard therapies, such as dressings or support surfaces. Also, the trials generally included patients with nutritional deficiencies, and the evidence may not be generalizable to all patients with pressure ulcers because they may not benefit from nutritional supplementation. Evidence also did not show any benefit of vitamin C supplementation compared with placebo. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined.
Recommendation 2: ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)
Low-quality evidence showed that hydrocolloid dressings are better than gauze dressings for reducing wound size. In addition, moderate-quality evidence showed that hydrocolloid dressings resulted in complete wound healing similar to that of foam dressings (hydrocellular or polyurethane). Evidence was insufficient to determine whether specific dressings resulted in fewer harms than others. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined.
Recommendation 3: ACP recommends that clinicians use electrical stimulation as adjunctive therapy in patients with pressure ulcers to accelerate wound healing. (Grade: weak recommendation, moderate-quality evidence)
Moderate-quality evidence supports the use of electrical stimulation in addition to standard treatment because it has been shown to accelerate the healing rate of stage 2 to 4 ulcers. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined.
The Figure summarizes the recommendations and clinical considerations.
Figure. Summary of the American College of Physicians guideline on treatment of pressure ulcers.
PDGF = platelet-derived growth factor.
Inconclusive Areas of Evidence
Evidence was insufficient to determine the effectiveness or comparative effectiveness of alternating-air chair cushions, 3-dimensional polyester overlays versus gel overlays, zinc supplementation, l-carnosine supplementation, comparisons of different wound dressings other than those addressed earlier, debriding enzymes compared with dressings or other topical therapies, topical application of phenytoin to promote healing, maggot therapy, biological agents other than PDGF (fibroblast, nerve, and macrophage suspension), surgical techniques, or hydrotherapy (wound cleansing using whirlpool or pulsed lavage) for treatment of pressure ulcers (1) (Supplement). Evidence was also insufficient to balance the benefits and harms of various support surfaces to treat pressure ulcers. Many studies assessed reduction in wound size or rate of healing rather than complete wound healing, and more evidence is needed on intermediate outcomes as predictors of complete healing, the most important outcome. Although hyperbaric oxygen therapy is often used to treat pressure ulcers in hospitals, we found insufficient evidence to assess its safety and efficacy.
High-Value Care
ACP does not recommend the use of various advanced support surfaces, including alternating-air and low–air-loss beds, because the quality of evidence for these surfaces was limited and the harms were poorly reported and could be significant given the immobility of the patient. Furthermore, due to their expense, the use of advanced support surfaces adds unnecessary costs to health care systems. In addition, although low-quality evidence showed that dressings containing PDGF promoted healing, ACP supports the use of other dressings, such as hydrocolloid and foam dressings, which are effective at promoting healing and cost less than PDGF dressings.
Supplemental Material
Supplement. Pressure Ulcer Treatment Strategies: Update to a Comparative Effectiveness Review
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Published In
Annals of Internal Medicine
Volume 162 • Number 5 • 3 March 2015
Pages: 370 - 379
History
Published online: 3 March 2015
Published in issue: 3 March 2015
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© 2015 American College of Physicians.
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Treatment of Pressure Ulcers: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med.2015;162:370-379. [Epub 3 March 2015]. doi:10.7326/M14-1568
Treatment of Pressure Ulcers: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med.2015;162:370-379. [Epub 3 March 2015]. doi:10.7326/M14-1568
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Comment
Of the 14 cited studies, 5 focus on arginine supplementation, and one each on a proprietary formulation, a collagen protein hydrolysate, and ornithine alpha-keto glutarate, presumably the recommended amino acid supplementations. Of the 5 studies of arginine, Reference 28 (N=16, 3 groups, duration 2 weeks)2 provides no statistics. Reference 30 (N = 35)2 uses historical controls. Reference 33 (N=16, 3 groups, duration 3 weeks)4 finds worse outcomes with protein supplementation unless it is enriched with arginine. Reference 35 (N=23, duration 3 weeks)5 compares 2 doses of arginine and concludes that they are equally effective. Reference 396 and the title of the journal in which it was published were not found in PubMed or Google Scholar.
Also noted is that reduction in wound size is of uncertain clinical significance.
The Recommendation, supporting a protean and undefined intervention to achieve an outcome of uncertain importance based on evidence categorized as “moderate quality”, supports and lends credence to a multibillion dollar industry that is based largely on credulity. Is this really Choosing Wisely?
Thomas E. Finucane
1. Qaseem A, Humphrey L, Forciea MA et al. Treatment of pressure ulcers: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2015;162(5):370-379. doi:10.7326/M14-1568.
2. Benati G, Delvecchio S, Cilla D et al. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7.
3. Brewer S, Desneves K, Pearce L et al. Effect of an arginine-containing nutritional supplement on pressure ulcer healing in community spinal patients. J Wound Care. 2010 Jul;19(7):311-6.
4. Desneves KJ1, Todorovic BE, Cassar A et al. Treatment with supplementary arginine, vitamin C and zinc in patients with pressure ulcers: a randomised controlled trial. Clin Nutr. 2005 Dec;24(6):979-87. Epub 2005 Nov 15.
5. Meaume S, Kerihuel JC, Constans T et al. Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial. J Nutr Health Aging. 2009 Aug;13(7):623-30.
6. van Anholt RD, Sobotka L, Meijer EP et al. An arginine-and micronutrient-enriched nutritional supplement accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. European Wound Management Association Journal 2010; 10:45.
Comment
In respect to nutritional care, they recommended the use of protein or amino acid supplementation to reduce wound size. However, as often happens, guidelines cover a defined review time and evidence from most recent trials is lost. Specifically, a high-quality trial (the Oligoelement Sore Trial [OEST]) [4] published in a recent issue of Annals of Internal Medicine has demonstrated that malnourished PU patients receiving a high-calorie, high-protein nutritional support (approximately 30-30 kcal/kg/day and 1.5 grams of protein/kg/day) achieve improved healing when a mix of micronutrients (arginine, zinc, and antioxidants) involved in tissue regeneration [5] is additionally provided.
Despite covering a similar review time, compared to ACP’ guidelines, those released by NPUAP, EPUAP and PPPIA [3] include also a moderate-strength recommendation on the use arginine and micronutrients-enriched nutritional support. On account of the results of the OEST study [4], the expectation now is that this is going to become a high-strength recommendation.
Although this trial does not provide any specific indication on the amount of calorie and proteins to be supplied, it clearly emphasizes the importance of nutritional care and of delivering a more tailored nutritional support which should include but not be limited to high amounts of calories and proteins (suggested intake, 30-30 kcal/kg/day and 1.5 grams of protein/kg/day) [3,7]. This applies at least to patients malnourished or at nutritional risk, an aspect pointed out many times in NPUAP-EPUAP-PPPIA guidelines [3]. This type of patients are more likely to be compromised, depleted and unable to meet energy needs [6]. On the other hand, it is worth mentioning that most PU patients are at nutritional risk [4,7]. Therefore, it is reasonable to state that PU care without attention for nutrition is incomplete PU care. Nutritional screening and support should systematically considered in the management of every PU patients.
References
1. Smith ME, Totten A, Hickam DH, Fu R, Wasson N, Rahman B, Motu'apuaka M, Saha S. Pressure ulcer treatment strategies: a systematic comparative effectiveness review. Ann Intern Med 2013;159:39-50.
2. Qaseem A, Humphrey LL, Forciea MA, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Treatment of pressure ulcers: a clinical practice guideline from the american college of physicians. Ann Intern Med 2015;162:370-9.
3. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014.
4. Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med 2015;162:167-74.
5. Schols JMGA, Heyman H, Meijer EP. Nutritional support in the treatment and prevention of pressure ulcers: an overview of studies with an arginine enriched oral nutritional supplement. J Tissue Viability 2009;18:72-79.
6. Cereda E, Klersy C, Rondanelli M, Caccialanza R. Energy balance in patients with pressure ulcers: a systematic review and meta-analysis of observational studies. J Am Diet Assoc 2011;111:1868-1876
7. Posthauer ME, Banks M, Dorner B, Schols JM. The role of nutrition for pressure ulcer management: national pressure ulcer advisory panel, European pressure ulcer advisory panel, and pan pacific pressure injury alliance white paper. Adv Skin Wound Care 2015;28:175-188.
Dressing Choice
Recommendation 2: ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence).
This has got to be the most peculiar recommendation that I have seen. Without reference to the stage of the wound, the level of exudate, the location of the pressure ulcer, making recommendations about any dressing is challenging enough. But reviewers, how are you going to place hydrocolloid or foam on a deep tissue, heavily exudating ulceration?
In Reply
Many research advances about PrU treatment have recently occurred. Searching the literature from the inception of databases may overshadow the more significant and recent studies. We agree that all literature should be reviewed, but significant and recent research should take precedence over those published decades ago.
Qaseem et al. found no difference (albeit low quality evidence) with vitamin C supplementation but recommended protein supplementation. (1) In addition to Cereda’s comment about their recent trial about supplementation, we would also like to point out a systemic review by Choo et al. (2) The majority of reviewed articles found that protein supplements alone did not promote pressure ulcer healing. However, protein supplements enriched with arginine, zinc, vitamin C, or other antioxidants showed significant wound healing. Therefore, we agree with Cereda’s comment that protein or vitamin supplementation alone may be necessary but not sufficient to heal PrU.
Finally, we are disappointed that Qaseem et al. omitted donut cushions. (1) The National Pressure Ulcer Advisory Panel (NPUAP) has repeatedly recommended against donut cushions, because they increase tissue pressure at the wound edge, thereby decreasing circulation and increasing edema. (3) However, many physicians and patients are unaware of the harm. A survey found that over half of critical care physicians thought that donut cushions are recommended. (4) Anecdotally, we continue seeing providers of various levels of experience from medical and surgical specialties make this mistake, and it is likely due to a lack of education during residency. (4) Also, patients can readily purchase these cushions (just search on any internet engine to see the number of vendors and customer reviews). Are we as providers routinely and specifically asking patients what they are using? It is essential to address explicitly the harm of donut cushions.
We are pleased that ACP is trying to improve physician awareness, and we agree that further PrU research is needed to inform practice. We urge the readership to review the comprehensive 2014 Prevention and Treatment of Pressure Ulcers Clinical Practice Guideline that was collaboratively published by the NPUAP, European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA). (5)
REFERENCES
1. Qaseem A, Humphrey LL, Forciea MA, Starkey M, Denberg TD. Treatment of Pressure Ulcers: A Clinical Practice Guideline From the American College of PhysiciansTreatment of Pressure Ulcers. Annals of Internal Medicine. 2015;162(5):370-9.
2. Choo TS, Hayter M, Watson R. The effectiveness of nutritional intervention(s) and the treatment of pressure ulcers--a systematic literature review. Int J Nurs Pract. 2013;19 Suppl 1:19-27.
3. National Pressure Ulcer Advisory Panel. Pressure Ulcer Prevention Points. 2007.
4. Cox J, Roche S, Gandhi N. Critical care physicians: attitudes, beliefs, and knowledge about pressure ulcers. Adv Skin Wound Care. 2013;26(4):168-76.
5. European Pressure Ulcer Advisory Panel NPUAP, Pan Pacific Pressure Injury Alliance, 2014;Pages. Accessed at Cambridge Media at http://www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-16Oct2014.pdf.
The International Pressure Ulcer Guideline Development Group
The international GDG released a comprehensive evidence-based guideline on pressure ulcer prevention and treatment in 2014 (3), updating the 2009 NPUAP/EPUAP guideline (4). The ACP and GDG both used rigorous methodologies to examine direct evidence on pressure ulcer prevention and treatment. The ACP recommendations are consistent with those of the GDG.
The GDG identified limitations in direct evidence, yet were driven by their purpose to provide evidence-based guidance for clinicians who are faced with very real pressure ulcer prevention and treatment decisions. Rather than “remain silent” on important aspects of pressure ulcer care not addressed by pressure ulcer research, the GDG developed a methodology for evaluating indirect evidence (e.g., healthy humans in biomechanical studies, bench research from animal and cell culture models and studies of chronic wounds).
Expert opinion was used when direct or indirect evidence was unavailable. Many “expert opinion” recommendations provide guidance on how to implement evidence-based recommendations. All recommendations were made available for review by members of the sponsoring organizations, guideline working groups and approximately 1,000 stakeholders in 63 countries. All comments were carefully considered before finalizing the guideline. Recommendations were then formally evaluated by the development team using the GRADE methodology.
The editorial accompanying publication of the ACP pressure ulcer guidelines (5), highlighted situations where “research alone” fails to provide adequate clinical guidance. However, it may have created the impression that the majority of recommendations in the 2014 international guideline were based solely on expert opinion. In fact, many of the recommendations were based on indirect evidence.
We agree that more quality research is needed. Given the substantial lack of evidence addressing pressure ulcer management today it is unlikely that these gaps will be closed in the near future. Concurrently, there is the need to provide best evidence-based practices at the bedside. Guidelines that leave unanswered questions might be of limited help. The GDG believes that consideration of indirect evidence and expert opinion using a transparent and unbiased process is necessary and appropriate in the development of clinically-relevant recommendations when direct research evidence is lacking.
References
1. Qaseem A, Mir TP, Starkey M, Denberg TD. Risk assessment and prevention of pressure ulcers: a clinical practice guideline from the american college of physicians. Annals Of Internal Medicine. 2015;162(5):359-69.
2. Qaseem A, Humphrey LL, Forciea MA, Starkey M, Denberg TD. Treatment of pressure ulcers: a clinical practice guideline from the american college of physicians. Ann Intern Med. 2015;162(5):370-9.
3. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.). Osborne Park, Western Australia: Cambridge Media; 2014.
4. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Janet Cuddigan (Ed.). Washington, DC: National Pressure Ulcer Advisory Panel; 2009.
5. Black J. Pressure ulcer prevention and management: a dire need for good science. Annals Of Internal Medicine. 2015;162(5):387-8.
* The International Pressure Ulcer Guideline Development Group (GDG) is comprised of representatives from the National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA). The primary purposes of the GDG are to conduct comprehensive reviews and appraisals of available research and develop evidence-based guidelines with the input of international pressure ulcer experts and stakeholders.
Additional Guideline Development Group Members (in alphabetical order):
Keryln Carville, PhD, RN; Perth, Australia. Michael Clark, PhD; Wales, UK. Diane Langemo, PhD, RN, FAAN; Grand Forks, ND, USA. Siu Ming Susan Law, BScN, MScN, RN, RM-ET; Hong Kong. Laurie McNichol, MSN, RN, GNP, CWOCN, CWON-AP; Greensboro, NC, USA. Pamela Mitchell, MN, RN, PGDipWHTR; Christchurch, New Zealand. Cees Oomens, PhD, Ir; Eindhoven, The Netherlands. Lisette Schoonhoven, PhD; Southampton, UK. Joyce Stechmiller, PhD, ACNP-BD, FAAN; Gainesville, FL, USA. Ai Choo Tay, BN, CWS; Singapore, Republic of Singapore.
Cost versus Benefit of Air-Fluidized Beds
Author's Response
To address Drs. Monfre and Endo’s concerns about the evidence review, we reiterate that the guideline is based on a systematic evidence review conducted by an experienced evidence based practice center commissioned by AHRQ. The reviewers used well-established methodology for acquiring, summarizing, and grading the evidence, and included experts in the field during the review’s development, as well as during public comment and peer review periods. This guideline follows the recently published standards from the Guidelines International Network and Institute of Medicine (1, 2). As to the issue of donut cushions, no studies on donut cushions met the inclusion criteria in the evidence review, thus we do not discuss this intervention in the guideline. Further, it is beyond the scope of the guideline to identify every available device which has or has not been studied for harm or benefit.
Dr. Cuddigan and colleagues seek advice beyond what is available from direct evidence. However, a guideline, by definition, should be based on a systematic literature review and not expert opinion (1, 2) and the American College of Physicians’s guidelines are always based on evidence from systematic literature reviews. While we agree that clinicians need guidance even in the absence of direct evidence, resources such as point of care tools are better suited to provide such advice rather than guidelines.
Mary Ann Forciea, MD, FACP
University of Pennsylvania Health System, Philadelphia, PA
Linda L. Humphrey, MD, MPH, MACP
Oregon Health and Science University, Portland, OR
Amir Qaseem, MD, PhD, MHA, FACP
American College of Physicians, Philadelphia, PA
References
1. Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Pr; 2011.
2. Qaseem A, Forland F, Macbeth F, Ollenschlager G, Phillips S, van der Wees P. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156(7):525-31.