CLINICAL INVESTIGATIONS

Hospital-Acquired Pressure Ulcers: Results from the National Medicare Patient Safety Monitoring System Study
Courtney H. Lyder, ND,* Yun Wang, PhD,k Mark Metersky, MD,# Maureen Curry, MHA, Rebecca Kliman, MPH,** Nancy R. Verzier, MSN, and David R. Hunt, MD

OBJECTIVES: To determine the national and state incidence levels of newly hospital-acquired pressure ulcers (PUs) in Medicare beneciaries and to describe the clinical and demographic characteristics and outcomes of these individuals. DESIGN: Retrospective secondary analysis of the national Medicare Patient Safety Monitoring System (MPSMS) database. SETTING: Medicare-eligible hospitals across the United States and select territories. PARTICIPANTS: Fifty-one thousand eight hundred fortytwo randomly selected hospitalized fee-for-service Medicare beneciaries discharged from the hospital between January 1, 2006, and December 31, 2007. MEASUREMENTS: Data were abstracted from the MPSMS, which collects information on multiple hospital adverse events. RESULTS: Of the 51,842 individuals in the MPSMS 2006/07 sample, 2,313 (4.5%) developed at least one new PU during their hospitalization. The mortality risk adjusted odds ratios were 2.81 (95% condence interval (CI) = 2.443.23) for in-hospital mortality, 1.69 (95% CI = 1.611.77) for mortality within 30 days after discharge, and 1.33 (95% CI = 1.231.45) for readmission within 30 days. The hospital riskadjusted main length of stay was 4.8 days (95% CI = 4.75.0 days) for individuals who did not develop PUs and 11.2 days (95% CI = 10.19 11.4) for those with hospital-acquired PUs (P < .001).
From the *School of Nursing, University of California at Los Angeles, Los Angeles, California; Health System Patient Safety Institute, University of California at Los Angeles, Los Angeles, California; Qualidigm, Middletown, Connecticut; Centers for Outcomes Research and Evaluation, Yale University, New Haven, Connecticut; kYale-New Haven Health, New Haven, Connecticut; #Division of Pulmonary and Critical Care Medicine, School of Medicine, University of Connecticut, Farmington, Connecticut; **Ofce of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, Maryland; and Ofce of Health Information Technology Adoption, Ofce of the National Coordinator for Health IT, Washington, District of Columbia. Address correspondence to Courtney H. Lyder, Los Angeles School of Nursing, University of California, 700 Tiverton Avenue, Factor Building, 2256, Los Angeles, CA 90095. E-mail: clyder@sonnet.ucla.edu DOI: 10.1111/j.1532-5415.2012.04106.x

The Northeast region and Missouri had the highest incidence rates (4.6% and 5.9%, respectively). CONCLUSION: Individuals who developed PUs were more likely to die during the hospital stay, have generally longer hospital lengths of stay, and be readmitted within 30 days after discharge. J Am Geriatr Soc 60:16031608, 2012.

Key words: pressure ulcer; adverse events; hospitalacquired pressure ulcer; patient safety; medical events

he development of pressure ulcers (PUs) has been associated with the quality of health care.1,2 Hence, higher rates of PU development (PUD) may signal overall poor care by the healthcare system. The National Quality Forum (NQF) created hospital Never Events in 2003 events that should never occur during hospitalization.1 The NQF believes that development of Stage III or IV PUs are such events. In the 13 states that have incorporated Never Events, hospitals can be nancially penalized for not reporting individuals who develop Stage III or IV PUs in a timely manner. The federal government has also identied PUD as a public heath concern.2 Most recently, the Centers for Medicare and Medicaid Services (CMS) made a signicant policy decision not to pay for hospital-acquired Stage III and IV PUs.3 A major limitation of existing PU studies has been their small sample size (<200 participants). Thus, the ability to compare an individual hospitals incidence rate with national or state level data has been lacking. Clinicians and policy makers abilities to determine the effect of specic individual clinical characteristics on the risk of developing hospital-acquired PUs (HAPUs) and the effect of PUs on outcomes (e.g., hospital length of stay and mortality) has also been challenging. Without a good understanding of national and state incidence rates and an understanding of specic clinical characteristics, effective PU prevention in the Medicare population is difcult. There is no large database to help determine incidence of

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PUs among hospitalized Medicare beneciaries as a basis for measuring improvement. Neither are there known published Medicare studies that have reported on HAPUs against which hospitals can benchmark at the national or state level. Given the increasing number of Medicare beneciaries being admitted to hospitals and the concomitant potential for increases in PU incidence, a Medicare Patient Safety Monitoring System (MPSMS) study capitalized on abstracted data from a large sample of medical records of fee-for-service Medicare beneciaries discharged in 2006/07 to address these gaps in knowledge.4 The data for this study came from three national databases: the CMS National Claim History database, the CMS Claims History database, and the MPSMS. The purpose was to explore the overall incidence, prevalence, and clinical characteristics associated with Medicare beneciaries who developed HAPUs and to determine rates in states and geographic regions.

STUDY SAMPLE
The MPSMS is a nationwide surveillance system designed to identify rates of specic adverse events within the hospitalized fee-for-service Medicare population. An adverse event is an unintended harm, injury, or loss that is more likely associated with an individuals interaction with the healthcare delivery system than with diseases the individual may have. The MPSMS determines the national rates for Medicare beneciaries in the following adverse event categories: central venous catheter (CVC)-associated blood stream infections; CVC-associated mechanical adverse events; CVC-associated blood stream infection (BSI) adverse drug events; HAPU- and ventilator-associated pneumonia; hip and knee replacements; and postoperative rates of venous thrombolic event, cardiac events, and pneumonia.4 The MPSMS PU study uses secondary analyses of the Hospital Payment Monitoring Program (HPMP) sample.5 The HPMP medical record sample is an existing database, selected randomly each month from the Medicare National Claims History File by CMS from a pool of approximately 1 million fee-for-service Medicare beneciary hospital discharges. For this study, the records of hospital discharges between January 1, 2006, and December 31, 2007, totaling 51,842 Medicare fee-for-service inpatient discharges across the 50 states, Washington, DC, Puerto Rico, and the U.S. Virgin Islands, were selected for use. Trained medical record abstractors collected documentation describing individuals with HAPUs that developed during their index hospitalizations. The medical record abstractors were trained on model charts. Interrater reliability (between principal investigator and medical abstractors) was established at 90% before the medical abstractors were allowed to abstract the medical records. Charts of individuals with PUs present on admission (prevalence) were reviewed to determine whether new ulcers (incidence) developed during the hospital stay. The National PU Advisory Panels Stage I (2001) and Stage II to IV (1989) denitions of PUs were used to distinguish a PU from another potential skin injury.6,7 The comorbidities for PUs were dened as congestive heart failure (CHF), chronic obstructive pulmonary disease

(COPD), cerebrovascular disease (CVD), diabetes mellitus, usage of corticosteroids, obesity, and smoking. These were selected because of their association with PUs in the literature. The PU diagnosis was determined based on physician and nurse documentation in the medical record during admission (prevalence) or at any time during hospitalization. Newly developed PUs (incidence) were also monitored during hospitalization. The abstractors determined whether an individual developed a HAPU based on documentation of a HAPU in the medical record or on the description of ulceration. The locations of PUs, newly acquired and those documented on admission, were also recorded. To further distinguish HAPUs from PUs already present on admission, new PUs found in the same body region as PUs present on admission were not counted as HAPUs. Any individual who developed at least one new PU during the hospitalization was included in the analyses. Participant demographic information (e.g., age, sex, race), International Classication of Diseases, Ninth Revision (ICD-9) diagnoses (707), and other characteristics (e.g., obesity, CHF, COPD as determined by ICD coding) were obtained from the Medicare Enrollment Database. The outcomes of interest were in-hospital mortality rates, readmission or mortality during the 30 days after discharge, and hospital length of stay. The CMS National Claim History database was the source of in-hospital mortality and readmission information. The Medicare Enrollment Database was the source of 30-day mortality information.

STATISTICAL ANALYSIS
Descriptive and bivariate analyses were conducted to identify participants baseline demographics and medical diagnoses and to compare the observed differences in characteristics and outcomes (mortality, readmission, and length of stay) of participants who developed HAPUs and those who did not. The chi-square test was used to compare dichotomous and categorical variables, and the t-test was used to compare continuous variables. The hierarchal generalized linear modeling (HGLM) approach8 10 was applied to assess the association between participant characteristics and development of HAPUs by modeling the log-odds of HAPUs as a function of participant demographic and clinical variables. This approach was used to determine whether there was a relationship between the outcomes and development of HAPUs after adjustment for participant characteristics. Two modeling steps were constructed for each outcome. The rst step was tted to a model without adjusting for participant characteristics, and the second step was tted to a model with adjustments for participant demographics and medical conditions.11 To examine differences in HAPU rates across states and regions, all HGLMs were tted with a random state-specic effect to account for within-state correlation of the observed adverse events and outcomes to distinguish between within-state variations from between-state variation. The CMS regions were used to cluster states. A 95% condence interval (CI) was calculated for each estimate for the models. To take into account differences in

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Medicare fee-for-service volume between states, all HGLMs were weighted by a total number of discharges from each state. All statistical analyses were conducted using Stata version 8.0 (StataCorp., College Station, TX) and SAS version 8.12 (SAS Institute, Inc., Cary, NC). Hierarchical models were estimated using the GLIMMIX macro in SAS.

Table 2. Hierarchical Generalized Linear Model Association Between Participant Characteristics and Pressure Ulcer Development
Characteristic Odds Ratio (95% Condence Interval) PValue

RESULTS Participant Characteristics

Fifty-one thousand eight hundred forty-two discharges were included in the nal study sample for the combined years 2006 and 2007 (Table 1). The HAPU incidence rate was determined to be 4.5% (2,313/51,842), and PU prevalence on admission was 5.8% (2,999/51,842). Of the 2,999 individuals who entered the hospital with a PU, 16.7% (502/2,999) developed at least one new PU at a different location during their hospitalization. The majority of participants who developed at least one PU were nonwhite and aged 75 to 84. These participants had signicantly higher rates of CHF, COPD, CVD, diabetes mellitus, and use of corticosteroids during hospitalization. Obesity was signicantly associated with HAPUs (Table 1). The majority of HAPUs were located on the coccyx or sacrum (41%), followed by the hip and buttock region (23%) and the heels (23%). The stages of HAPUs could not be determined because of the wide variability in documentation of description and staging by clinicians. Participant characteristic such as age, diagnosis (cancer, CHF, COPD, CVD, diabetes mellitus), and presence of obesity were all signicantly associated with HAPUs (P < .001; Table 2). Overall, the nationwide HAPU incidence rate was 4.5% (95% CI = 4.14.7%). Variance across the nation was statistically signicant (Figure 1). The between-state

Age (reference  85) <65 6574 7584 Female White Cancer Congestive heart failure Chronic obstructive pulmonary disease Cerebrovascular disease Diabetes mellitus Corticosteroids Obese Smoking

0.82 (0.790.84) 0.82 (0.80.84) 0.89 (0.870.91) 0.99 (0.971.01) 1.01 (0.981.03) 1.07 (1.051.09) 1.11 (1.091.13) 1.05 (1.021.07) 1.11 1.07 1.03 1.04 1.00 (1.091.13) (1.051.09) (1.001.07) (1.011.07) (0.981.03)

<.001 <.001 <.001 .37 .56 <.001 <.001 <.001 <.001 <.001 .04 .002 .80

variance was 3.2% (standard error 1.2%), the weighted rates drawn from HGLM ranged from 3.1% (95% CI = 2.54.1%) to 5.9% (95% CI = 5.17.0%). The odds of developing PUs if treated in a state 1 standard deviation (SD) above the national average relative to the odds of developing PUs if treated at a state 1 SD below the national average were 1.43. Higher incidence rates were noted in the Northeast and Missouri. The ve states with the lowest HAPU rates were Wisconsin (3.1%), Alabama (3.3%), Tennessee (3.7%), Puerto Rico (3.7%), and North Carolina (3.8%), and the ve states with the highest HAPU rates were New York (5.2%), Missouri (5.3%), New Jersey (5.3%), Massachusetts (5.5%) and Pennsylvania (5.9%). Rates in Wisconsin and Alabama were statistically signicantly lower than the national average.

Table 1. Participant Characteristics

Total (N = 51,842) Participants with Pressure Ulcers (n = 2,313) Participants without Pressure Ulcers (n = 49,529)

Characteristic

P-Value

Age, mean standard deviation Age, n (%) <65 6574 7584 >84 Nonwhite, n (%) Female, n (%) Congestive heart failure, n (%) Chronic obstructive pulmonary disease, n (%) Cerebrovascular disease, n (%) Diabetes mellitus, n (%) Corticosteroids, n (%) Obese, n (%) Smoking, n (%)

73.3 13.0 8,878 15,824 17,621 9,519 43,639 29,088 15,071 (17.1) (30.5) (34.0) (18.4) (84.2) (56.1) (29.1)

78.0 11.2 236 494 879 704 1,980 1,307 1,013 (10.2) (21.4) (38.0) (30.4) (85.6) (56.5) (43.8)

73.2 13.0 8,642 15,330 16,742 8,815 41,659 27,781 14,058 (17.4) (31.0) (33.8) (17.8) (84.1) (56.1) (28.4)

<.001 <.001

.05 .69 <.001 <.001 <.001 <.001 .003 .02 <.001

14,716 (28.4)

810 (35.0)

13,906 (28.1)

11,862 (22.9) 17,512 4,154 6,822 8,324 (33.8) (8.0) (13.2) (16.1)

785 (33.9) 971 223 343 306 (42.0) (9.6) (14.8) (13.2)

11,077 (22.4) 16,541 3,931 6,479 8,018 (33.4) (7.9) (13.1) (16.2)

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Figure 1. Pressure ulcer incidence rates according to Centers for Medicare and Medicaid Services Regional Map.

Mortality, Readmission, and Length of Stay

The mortality data revealed that the development of HAPUs was signicantly associated with higher in-hospital mortality (11.2%) and mortality within 30 days after discharge (15.3%). HGLMs were tted to further understand the association between the development of new HAPUs and hospital outcomes (Table 3), mortality and hospital length of stay (Table 4). Participants with HAPUs were signicantly more likely to be readmitted within 30 days after discharge (odds ratio (OR) = 1.33, 95% CI = 1.231.45), and were more likely to have died in the hospital. The riskadjusted ORs were 2.81 (95% CI = 2.443.23) for in-hospital mortality and 1.69 (95% CI = 1.611.77) for mortality within 30 days after discharge. Participants who developed HAPUs had signicantly longer hospital lengths of stay (11.6 10.1 days) than those without (4.9 5.2 days).

Table 4. Hierarchical Generalized Linear Models Association of Participant Outcomes with Pressure Ulcer (PU) Development
Outcome Estimatea (95% Condence Interval) PValue

Mortality 30 days from discharge In-hospital Readmission within 30 days after discharge Length of stay With PUs Without PUs
a

1.69 (1.611.77) 2.81 (2.443.23) 1.33 (1.231.45) 2.11 (2.072.15) 1.25 (1.231.28)

<.001 <.001 <.001 <.001

DISCUSSION
The data from this study revealed that HAPUs remain a signicant problem for hospitalized individuals. Although a 4.5% HAPU incidence rate and 5.8% prevalence rate on admission were found, no other large Medicare studies were located to place these ndings into context of the current literature. The between-state incidence rate variance

For mortality and readmission, the estimate is odds ratio. For length of stay, the estimate is mean length of stay at the log scale. All estimates were adjusted for participant characteristics (age, sex, congestive heart failure, chronic obstructive pulmonary disease, cerebrovascular disease, diabetes mellitus, obesity, corticosteroids, smoking status, coronary artery disease, and renal failure).

was 3.2% (P < .001). Thus, to benchmark appropriately, it is imperative for hospitals to be cognizant not only of the national incidence rate, but also of their own states rates. Several states mandate that hospitals track and

Table 3. Association Between Hospital Outcomes and Pressure Ulcer (PU) Development
Outcome Total With PUs Without PUs P-Value

Mortality, n (%) Within 30-days after discharge In hospital Readmission within 30 days after discharge, n (%) Length of stay, days, mean standard deviation

2,551 (4.0) 1,892 (3.6) 9,235 (17.8) 5.2 5.7

353 (15.3) 258 (11.1) 523 (22.6) 11.6 10.0

2,198 (4.4) 1,634 (3.3) 8,712 (17.6) 4.9 5.3

<.001 <.001 <.001 <.001

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report their PU rates to their state departments of health, but it is often difcult for hospital staff to obtain access to relevant benchmarks for comparison between like minded hospitals within the state. Thus, this study provides a glimpse of PU incidence and presence at the state and national level for Medicare beneciaries. Most prevalence studies use a 1-day period to determine community-acquired PU rates for the hospital, with some studies reporting hospital PU prevalence rates of as high as 15%.1214 The large difference between the 15% reported in the research literature and the 5.8% found in the current study may be because, when a 1-day prevalence is used, individuals with longer hospital lengths of stay are more likely to be counted. Another explanation for this difference is that the majority of prevalence studies reported are completed during hospitalization, versus the current study, which counted on PUs on admission and HAPUs. The ndings from the MPSMS have also demonstrated that individuals with HAPUs have much longer hospital lengths of stay. Thus, a 1-day prevalence study (often used by hospitals to determine prevalence rates) may not be an accurate reection of individuals who developed HAPUs during their stay. The ndings of the current study support current literature that suggests that specic chronic diseases such as CHF, COPD, CVD, diabetes mellitus, obesity, and use of corticosteroids may increase vulnerability to the development of HAPUs.15,16 Thus, individuals entering the hospital with a constellation of these conditions should be identied as being at higher risk for developing HAPUs. The majority of participants developed HAPUs over the coccyx and sacrum, hips and buttocks, and heels. These ndings support the analyses by the National Pressure Ulcer Advisory Panel (NPUAP).14 Obesity was associated with HAPUs. Chronic impairment of systematic perfusion that occurs in individuals who are obese frequently results in chronic skin and wound problems.17 Blood supply to fatty tissue may not be adequate to provide appropriate oxygen and nutrition. This could be further compounded if the individuals dietary input does not include essential vitamins and nutrients. HAPUs also have been shown to be an important risk factor associated with mortality. The MPSMS PU ndings strengthen the body of research that suggests that individuals with HAPUs have higher mortality in the hospital and within 30 days of discharge. Therefore, hospitals should identify individuals at high risk for HAPUs and implement preventative interventions on admissions accordingly. It could be argued that, because of the good PU prevention programs being implemented in hospitals throughout the United States, rates of 4.5% might be acceptable.18,19 These ndings also suggest that HAPUs may develop independent of good care being provided.20,21 Thus, some HAPUs may be unavoidable, as suggested by the NPUAP22 and other national associations.23,24 There were several limitations inherent in the MPSMS PU study. Retrospective abstraction of medical records is a limitation in data collection because it is possible that HAPUs could have been present and simply not recorded or adequately described. In several cases, the clinician did not document PUs, yet based on clinical characteristics and the location and description of the ulcer, the research team

decided to count these as HAPUs. There is a slight possibility (highly unlikely) that these were not HAPUs. Care was taken to exclude all other chronic ulcers based on medical diagnoses in the medical records and using ICD-9 coding (e.g., diabetic ulcers, venous stasis ulcers, arterial ulcers). To distinguish individuals with HAPUs from those with PUs already present on admission, no PUs, new or old, found in the same body region as a PU already present on admission were counted as HAPUs. This approach may have led to undercounting the number of individuals who developed new HAPUs during the hospital stay. The inability to capture the staging of HAPUs was another limitation. The variability of documented staging of HAPUs in the medical record made this variable unreliable. Staging of PUs using the NPUAP staging system is not required. Given the new CMS Hospital-Acquired Conditions, under which hospitals will no longer be reimbursed for Stage 3 and 4 PUs unless they were identied upon admission, accuracy in staging of these ulcers may improve. That is, clinicians may need to be reeducated on staging of PUs using the 2007 NPUAP staging system because correct staging of PUs is necessary to make appropriate choices in their management of the PUs. Although several undesirable outcomes were associated with the development of HAPUs, no assertion is made that there was a causal relationship between the development of HAPUs and these outcomes. Nonetheless, describing these associations is important to help identify high-risk individuals. For example, even though it cannot be stated that HAPUs directly contributed to the longer hospital length of stay, these ndings suggest that an individual with a prolonged hospital length of stay is at greater risk of developing HAPUs and that both add nancial burden to the hospital. Hospitals should use the MSPMS PU data as one point of comparison, but hospitals may have different rates because of differences in patient acuity, so the data from the current study may or may not indicate that institutional improvement in PU prevention is warranted. The data support that multiple chronic conditions or any combination of these conditions may contribute to the development of HAPUs. Perhaps these conditions lead to readmission and HAPUs are merely a surrogate for identifying very sick people rather than being a causative factor for readmission. Thus, data on the incidence and prevalence of PUs must not simply be collected; understanding of the underlying diseases that may lead to HAPUs must be gained. Regardless of the limitations, the MPSMS PU study has major strengths. To the best of the knowledge of the authors, this is the rst study to use data abstracted directly from medical records to assess HAPUs in hospitalized Medicare beneciaries at the national and state levels. With the use of an evidence-based algorithm developed by nationally recognized experts, the MPSMS is the largest database of its kind. The PU ndings have important clinical and public health implications. MPSMS PU ndings clearly guide clinicians to anatomical sites where PUs are most likely to develop and identify critical characteristics and conditions that increase the risk of HAPUs in Medicare beneciaries. The ndings suggest that these individuals are more likely to die or be readmitted within 30 days. It was surprising that the Northeast region had higher rates of HAPUs. The aggressive prevention and recognition

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programs occurring in the Northeast region may lead to higher rates being reported than in other regions, which may explain this in part.2527 Regardless, with these data, it is now possible for hospitals to benchmark their Medicare beneciaries HAPU rates at the national and state levels.

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ACKNOWLEDGMENTS
The analyses upon which this publication is based were performed under Contract 5002006-CToo2C, entitled Utilization Quality Control: Quality Improvement Organization for the State of Connecticut, sponsored by CMS, Department of Health and Human Services. The authors assume full responsibility for the accuracy and completeness of the ideas presented. This article is a direct result of the Health Care Quality Improvement Program initiated by CMS, which has encouraged identication of quality improvement projects derived from analyses of patterns of care and therefore required no special funding on the part of the contractor. Ideas and contributions to the authors concerning experience and engaging with issues presented are welcomed. The authors would like to thank the MPSMS team at Qualidigm for its support and contributions. We specically thank Nancy Verzier, RN, MSN, CPHQ, and Michael Pineau, RN, MS, for their excellent management of the project and Nancy Morse for manuscript preparation. Conict of Interest: There are no nancial, personal, potential conicts of interest in the conduct of the study or in the manuscript development. Dr. Lyder had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of data analysis. M. Meterskys employer is remunerated for his quality insurance and safety work with Qualidigm. Author Contributions: Study concept and design: Courtney Lyder, Mark Metersky, Nancy Verzier, David Hunt. Acquisition of subjects and/or data: Courtney Lyder, Maureen Curry, Nancy Verzier. Analysis and interpretation of data: Courtney Lyder, Yun Wang, Mark Metersky, Maureen Curry. Preparation of manuscript: Courtney Lyder, Yun Wang, Mark Metersky, Maureen Curry, Rebecca Kliman, Nancy Verzier, David Hunt. Sponsors Role: The content of the publication does not necessarily reect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.

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