Roger Chou, MD; Tracy Dana, MLS; Christina Bougatsos, MPH; Ian Blazina, MPH; Amy J. Starmer, MD, MPH; Katie Reitel, MSW, MPH; David I. Buckley, MD, MPH
Financial Support: By AHRQ (contract 290-2007-10057-I).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-2540.
Requests for Single Reprints: Roger Chou, MD, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Chou, Starmer, and Buckley; Ms. Dana; Ms. Bougatsos; Mr. Blazina; and Ms. Reitel: Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239.
Author Contributions: Conception and design: R. Chou, C. Bougatsos, D.I. Buckley.
Analysis and interpretation of the data: R. Chou, T. Dana, C. Bougatsos, I. Blazina, A.J. Starmer, K. Reitel, D.I. Buckley.
Drafting of the article: R. Chou, C. Bougatsos, A.J. Starmer, K. Reitel, D.I. Buckley.
Critical revision of the article for important intellectual content: R. Chou, A.J. Starmer, D.I. Buckley.
Final approval of the article: R. Chou, A.J. Starmer, D.I. Buckley.
Statistical expertise: R. Chou.
Obtaining of funding: R. Chou.
Administrative, technical, or logistic support: T. Dana, C. Bougatsos, I. Blazina, A.J. Starmer, K. Reitel.
Collection and assembly of data: R. Chou, T. Dana, C. Bougatsos, I. Blazina, A.J. Starmer, K. Reitel, D.I. Buckley.
Pressure ulcers are associated with substantial health burdens but may be preventable.
To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk.
MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists.
Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes.
Multiple investigators abstracted and checked study details and quality using predefined criteria.
One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses’ clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low–air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions.
Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings.
More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.
Agency for Healthcare Research and Quality.
Summary of evidence search and selection.
* Includes the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews.
† Includes reference lists, grant databases, clinical trial registries, and suggestions from peer reviewers.
‡ A key question on the diagnostic accuracy of risk assessment instruments; outcomes related to resource utilization; studies of low-risk surgical populations; and studies of drugs, intraoperative warming therapy, and polarized light are included in the full Agency for Healthcare Research and Quality report (15).
§ Some studies are included for >1 key question.
Table. Summary of Findings
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William V. Padula , Heidi M. Wald, Mary Beth F. Makic
William V. Padula, PhD, MS: Postdoctoral Fellow, Section of Hospital Medicine, University of Chicago, Chicago, IL; Heidi M. Wald, MD, MSPH: Assistant Professor, School of Medicine, University of Color
July 18, 2013
IN RESPONSE: Pressure Ulcer Risk Assessment and Prevention
To the Editor: The comparative effectiveness review of pressure ulcer prevention by Chou et al. is important to U.S. hospitals with wound teams established for investigating implementation of a bundled evidence-based protocol for pressure ulcer prevention (1). Hospitals are addressing pressure ulcer prevention since CMS enacted nonpayment policy for hospital-acquired conditions in 2008 (2). The financial constraints of this policy directly affect clinicians who implement a pressure ulcer prevention protocol to protect patients from harm. Clinicians reference the 5-point evidence-based guideline developed by the National Pressure Ulcer Advisory Panel (NPUAP): risk assessment; skin care; nutrition; mechanical loading and support surfaces; and clinical education (3). This bundled protocol must be implemented consistently in its entirety in order to effectively prevent pressure ulcers.
Because of the importance of pressure ulcer prevention since 2008, the field would benefit from studies developed since then rather than reviewing outdated literature. Studies reviewed by Chou et al. developed prior to the announcement of CMS policy did not incorporate the same incentives that exist today for clinicians to prevent avoidable pressure ulcers. This discrepancy may account for low quality studies on pressure ulcer prevention as well as inconsistent bundling of prevention protocols before 2008 compared to current studies. Chou et al. assumed the challenging initiative to classify the effectiveness of individual components of the prevention protocol from a scarce literature base with few high-quality studies. Many trials and cohort studies that the investigators reviewed failed to incorporate all components of the prevention protocol with standard consistency, but rather compared the significance of individual preventive interventions relative to each other. By including such studies in their review, Chou et al.’s results are biased towards ineffective preventive interventions since they are reviewed separately instead of bundled.
The NPUAP guidelines are clear that pressure ulcer prevention is only effective through consistent implementation of a bundled protocol, instead of selectively implementing individual components. This concept is analogous to the classic Gestalt Principle of the whole being greater than the sum of its parts. The best practices framework for quality improvement in health care by Nelson et al. supports this principle of practicing bundled evidence-based protocols that incorporate all domains of health services: leadership; staff; information technology; and performance and improvement (4). The NPUAP guideline as a whole is stronger because it engages each practice domain to achieve cost-effective patient outcomes (5). Reviews segregating or isolating components of the evidence-based protocol fall short of comparative effectiveness for pressure ulcers prevention.
1. Chou R, Dana T, Bougatsos C, Blazina I, Starmer AJ, Reitel K, Buckley DI. Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):28-38. [PMID: 23817702]
2. Kurtzman E, Buerhaus PI. New Medicare Payment Rules: Danger or Opportunity for Nursing? Am J Nursing 2008;108(6):30-5. [PMID: 18535440]
3. National Pressure Ulcer Advisory Panel. Pressure Ulcer Prevention Points. Washington, DC: National Pressure Ulcer Advisory Panel, 2007. Accessed at www.npuap.org on 05 July 2013.
4. Nelson EC, Batalden PB, Huber TP, Johnson JK, Godfrey MM, Headrick LA, Wasson JH. Success Characteristics of High-performing Microsystems. In: Nelson EC, Batalden PB, Godfrey MM, ed. Quality By Design. San Francisco: Jossey-Bass; 2007:3-33.
5. Padula WV, Mishra MK, Makic MBF, Sullivan PW. Improving the Quality of Pressure Ulcer Care with Prevention: a cost-effectiveness analysis. Med Care. 2011 Apr;49(4):385-92. [PMID: 21368685]
Roger Chou, MD
Oregon Health & Science University
August 19, 2013
To clarify, we did not exclude studies that evaluated bundled protocols for pressure ulcer prevention. Any controlled clinical trial or cohort study that compared alternative interventions for pressure ulcer prevention—including bundled protocols—was included. In fact, studies of pressure ulcer interventions did not evaluate single component therapies in isolation, but as part of multicomponent prevention strategies, though details about these strategies were often limited, representing a shortcoming of the available literature. As noted in our review, it is important for future studies of pressure ulcer preventive interventions to better describe the other components of care that were provided.In addition, in order to understand what should be included in bundled pressure ulcer prevention protocols, it is first necessary to understand the effectiveness of the individual components. Therefore, studies that evaluate the effects of adding a specific component to standard or usual care, such as a number of the studies included in our review, are critical for understanding comparative effectiveness. We found no evidence to support the hypothesis by Padula and colleagues that recent studies were more likely to report positive results than older studies due to more consistent use of standardized bundled prevention protocols. Indeed, the only good-quality trial to compare the effects of using a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, was published in 2011 (1). It found no effect of using a pressure ulcer risk assessment instrument on incidence of pressure ulcers compared with less standardized risk assessment based on nurses’ clinical judgment.
1. Webster J, Coleman K, Mudge A, Marquart L, Gardner G, Stankiewicz M, et al. Pressure ulcers: effectiveness of risk-assessment tools. A randomized controlled trial (the ULCER trial). BMJ Qual SAf. 2011;20:297-306.
Chou R, Dana T, Bougatsos C, Blazina I, Starmer AJ, Reitel K, et al. Pressure Ulcer Risk Assessment and Prevention: A Systematic Comparative Effectiveness Review. Ann Intern Med. 2013;159:28-38. doi: 10.7326/0003-4819-159-1-201307020-00006
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Published: Ann Intern Med. 2013;159(1):28-38.
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