Amir Qaseem, MD, PhD, MHA; Linda L. Humphrey, MD, MPH; Mary Ann Forciea, MD; Melissa Starkey, PhD; Thomas D. Denberg, MD, PhD; for the Clinical Guidelines Committee of the American College of Physicians *
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations.
Acknowledgment: The authors thank M.E. Beth Smith, DO, for updating the literature from the evidence review for the development of this guideline.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Dr. Barry reports grants and salaries from the Informed Medical Decisions Foundation and Healthwise outside the submitted work. Dr. Cooke reports support for travel to meetings for the study or other purposes from the American College of Physicians; board membership with the National Board of Medical Examiners; a consultancy for the University of Texas; employment with the University of California, San Francisco; and travel, accommodation, or meeting expenses from the American Board of Internal Medicine and the Accreditation Council for Graduate Medical Education outside the submitted work. Dr. Dallas reports support for travel to meetings for the study or other purposes from the American College of Physicians and stock ownership in Pfizer, Ortho Pharmaceutical, Sanofi-Aventis, GlaxoSmithKline, and Merck. Dr. Schwartz reports services from the National Heart, Lung, and Blood Institute during the conduct of the study; personal fees from
Allergan, Bayer, Blue Cross Blue Shield Association, General Electric, UBC, and Genentech outside the submitted work; and a grant from Pfizer outside the submitted work. Dr. Shekelle reports personal fees from the ECRI Institute during the conduct of the study and royalties from UpToDate. Authors not named here have disclosed no conflicts of interest. Authors followed the policy regarding conflicts of interest described at www.annals.org/article.aspx?articleid=745942. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1568. A record of conflicts of interest is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, email@example.com.
Current Author Addresses: Drs. Qaseem and Starkey: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Humphrey: Oregon Health & Science University, 3710 SW U.S. Veterans Hospital, Portland, OR 97201.
Dr. Forciea: University of Pennsylvania Health System, 3615 Chestnut Street, Philadelphia, PA 19104.
Dr. Denberg: Carilion Clinic, PO Box 13727, Roanoke, VA 24036.
Author Contributions: Conception and design: A. Qaseem.
Analysis and interpretation of the data: A. Qaseem, L.L. Humphrey, M.A. Forciea, M. Starkey, T.D. Denberg.
Drafting of the article: A. Qaseem, M.A. Forciea, M. Starkey, T.D. Denberg.
Critical revision of the article for important intellectual content: A. Qaseem, L.L. Humphrey, M.A. Forciea, M. Starkey, T.D. Denberg.
Final approval of the article: A. Qaseem, L.L. Humphrey, M.A. Forciea, T.D. Denberg.
Statistical expertise: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem, M. Starkey, T.D. Denberg.
Collection and assembly of data: A. Qaseem, M. Starkey.
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.
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
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)
ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)
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)
Table 1. Selected Pressure Ulcer Treatment Interventions
Table 2. The American College of Physicians' Guideline Grading System
Table 3. Evidence for Pressure Ulcer Treatment Strategies
Summary of the American College of Physicians guideline on treatment of pressure ulcers.
PDGF = platelet-derived growth factor.
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Thomas E. Finucane, MD
Johns hopkins School of Medicine
March 18, 2015
Recommendation 1 of the American College of Physicians Practice Guideline on Treatment of Pressure Ulcers is “that clinicians use protein or amino acid supplementation in patients with pressure ulcers to reduce wound size”. They note that “Evidence for the optimal dose or form of protein was insufficient.”1 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. Finucane1. 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.
Emanuele Cereda MD, PhD
Servizio di Dietetica Nutrizione Clinica
March 20, 2015
Pressure ulcers (PUs) are a tough problem to manage and a horrible one for patients, having a negative impact on mortality, morbidity, quality of life, and health care costs. Different treatment strategies could be and should be integrated to achieve healing . However, recent evidence-based guidelines by the American College of Physicians (ACP)  have highlighted that most interventions are supported by low-quality evidence and could be recommended according to experts’ opinion. This synthesis of literature is consistent with the one recently released (September 2014) by the National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA) . 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])  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  is additionally provided. Despite covering a similar review time, compared to ACP’ guidelines, those released by NPUAP, EPUAP and PPPIA  include also a moderate-strength recommendation on the use arginine and micronutrients-enriched nutritional support. On account of the results of the OEST study , 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 . This type of patients are more likely to be compromised, depleted and unable to meet energy needs . 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. References1. 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;111:1868-18767. 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.
Scott Matthew Bolhack, MD, MBA, CWS, CMD, FACP, FAAP
TLC HealthCare Wound Specialists
March 29, 2015
The authors state in Recommendation 2:
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?
Jill Monfre PhD RN CWOCN, Justin Endo MD
Dr. Endo: Assistant Professor, Department of Dermatology, University of Wisconsin; Dr. Monfre: Clinical Nurse Specialist, University of Wisconsin Hospital and Clinics
April 2, 2015
We appreciate Qaseem et al. creating the Clinical Practice Guidelines for the Treatment of Pressure Ulcers (PrU), based on best available evidence. (1) However, we would like to comment on their literature search methodology, caveats about nutrition supplementations, and their omission of the use of donut cushions.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) REFERENCES1. 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.
David L. Keller, MD
April 17, 2015
Cost versus Benefit of Air-Fluidized Beds
Table 3 states that air-fluidized beds have moderate quality evidence of reducing pressure ulcer size, compared with other surfaces, leading to an improved overall treatment effect. In trying to understand why air-fluidized beds were not included in the recommended treatments for pressure ulcers, I noted that the section on "High Value Care" states that "the use of advanced support surfaces adds unnecessary costs to the health care systems". However, the evidence demonstrating improvement due to electrical stimulation was of similar quality ("moderate") as air-fluidized beds. Electrical stimulation was included in the recommended treatments for pressure ulcers. Is electrical stimulation really less expensive than an air-fluidized bed, after accounting for the professional fees charged by the clinician providing that service? How many communities have such a clinician? The cost of air-fluidized beds, like any other commodity, is flexible and based on the volume of orders received. A recommendation by ACP for air-fluidized beds would increase the number of orders and decrease the cost of such beds, due to economies of scale. Economic considerations should not bias clinical recommendations. We are physicians, not economists.
Janet E. Cuddigan, PhD, RN, CWCN, FAAN, Jan Kottner, PhD, Emily Haesler, BN
University of Nebraska Medical Center, Charité-Universitätsmedizin Berlin, Canberra, Australia
April 21, 2015
The International Pressure Ulcer Guideline Development Group
The International Pressure Ulcer Guideline Development Group (GDG) congratulates the American College of Physicians (ACP) on the recent publication of their pressure ulcer prevention (1) and treatment (2) guidelines. The ACP guidelines make an important contribution to the field by fulfilling their purpose of presenting available evidence on the comparative effectiveness of risk assessment, prevention and treatment of pressure ulcers. 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.
Amir Qaseem MD, PhD, Mary Ann Forciea, MD, Linda Humphrey, MD, MPH
ACP, University of Pennsylvania, Oregon Health Science Universtiy
August 12, 2015
We agree with Dr. Cereda that nutrition is an important component of pressure ulcer treatment, and found moderate-quality evidence that protein-containing nutritional supplements resulted in wound improvement. We are aware of the recent Annals article on arginine supplementation and although it was not included in our evidence review because it was published after our literature search dates, it would likely be included in an update of the guideline. In response to Dr. Finucane’s comments about the nutritional data, although the protein supplementation studies used a wide variety of formulations, these supplements overall showed benefits for pressure ulcer outcomes and are therefore a suitable treatment option in conjunction with other therapies.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, FACPUniversity of Pennsylvania Health System, Philadelphia, PALinda L. Humphrey, MD, MPH, MACPOregon Health and Science University, Portland, ORAmir Qaseem, MD, PhD, MHA, FACPAmerican College of Physicians, Philadelphia, PAReferences1. 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.
Qaseem A, Humphrey LL, Forciea MA, et al, for the 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;162:370–379. doi: https://doi.org/10.7326/M14-1568
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