IMPROVING PATIENT CARE
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.
Chou R., Dana T., Bougatsos C., Blazina I., Starmer A., Reitel K., Buckley D.; 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.
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.
Pressure ulcers are defined as “localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear” (1). Risk factors include older age, cognitive impairment, physical impairments, and comorbid conditions that affect soft tissue integrity and healing (such as urinary incontinence, edema, impaired microcirculation, hypoalbuminemia, and malnutrition) (2, 3). Pressure ulcers affect 1.3 million to 3 million adults in the United States and are associated with decreased quality of life; impaired function; complications, such as infection; poorer prognosis; and increased costs of care (3–6).
Interventions to prevent the occurrence or reduce the severity of pressure ulcers could have important health effects and may be more efficient than treating ulcers after they have developed (7). Recommended prevention strategies generally involve the use of risk assessment tools to identify persons at higher risk for ulcers in conjunction with preventive interventions, with higher-risk patients receiving more intensive interventions (1, 8, 9). Commonly used risk assessment instruments include the Braden, Norton, and Waterlow scales (3, 10–12).
Various preventive interventions are available, including various support surfaces, repositioning, skin care (including creams, dressings, and management of incontinence), and nutritional supplementation (8, 9). Each of these categories encompasses various interventions. The use of preventive interventions may vary according to patient characteristics or the care setting. For example, nutritional supplementation may be of greater benefit in patients who are undernourished, and skin care needs may be greater for persons with incontinence. Some interventions that require substantial nursing resources or specialized equipment may be less feasible for community settings.
The purpose of this report is to review the comparative clinical utility of pressure ulcer risk assessment instruments and the benefits and harms of preventive interventions. This topic was nominated to the Agency for Healthcare Research and Quality (AHRQ) by the American College of Physicians, which intends to develop a guideline on prevention and management of pressure ulcers. Treatment of established pressure ulcers is addressed in a separate report (13).
We followed a standardized protocol and developed an analytic framework (Figure 1) that included the following key questions:
Is the use of risk assessment tools effective in reducing the incidence or severity of pressure ulcers, and how does effectiveness vary according to setting and patient characteristics?
In patients at increased risk for pressure ulcers, what is the effectiveness and comparative effectiveness of preventive interventions in reducing the incidence or severity of pressure ulcers and how does effectiveness vary according to assessed risk level, setting, or patient characteristics?
What are the harms of interventions for preventing pressure ulcers?
The protocol was developed using a standardized process (14), with input from experts and the public. Detailed methods and data for the review, including search strategies, detailed inclusion criteria, data abstraction tables, and tables with quality ratings of individual studies, are available in the full report (15). The first key question focused on direct evidence of effects of using a risk assessment instrument on pressure ulcer incidence or severity. An underlying assumption was that the risk assessment instrument will inform the use of preventive interventions. The other key questions evaluated the benefits and harms of various preventive interventions. Settings of interest included acute care hospitals, long-term care facilities, rehabilitation facilities, operative and postoperative settings, and community settings (for example, home care and wheelchair users in the community). Patient characteristics of interest included age; race or skin tone; physical impairment; body weight; and medical comorbid conditions, such as urinary incontinence, diabetes, and peripheral vascular disease. A key question on the diagnostic accuracy of risk assessment instruments; outcomes related to resource utilization (such as duration of hospital stay); studies of low-risk surgical populations; and other treatments, including drugs, intraoperative warming therapy, and polarized light, are included in the full report (15).
We searched Ovid MEDLINE from 1946 to November 2012, CINAHL (EBSCOhost) from 1988 through November 2012, the Cochrane Library through the fourth quarter of 2012, grant databases, clinical trial registries, and reference lists.
At least 2 reviewers independently evaluated each study to determine inclusion eligibility. English-language articles were selected for full review if they were relevant to a key question and met predefined inclusion criteria.
We included controlled clinical trials and cohort studies that compared pressure ulcer incidence or severity after use of a risk assessment instrument versus clinical judgment or another risk assessment instrument, as well as randomized trials of preventive interventions that reported pressure ulcer incidence or severity or harms. We excluded trials in which more than 20% of patients had stage 2 or higher ulcers at baseline. Figure 2 shows the results of the search and study selection process.
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.
One investigator abstracted details about the study design, population, setting, interventions, analysis, follow-up, and results. A second investigator reviewed data for accuracy. Two investigators independently applied predefined criteria (16–18) to assess the quality of each study as good, fair, or poor. Discrepancies were resolved through consensus.
For studies of interventions, we abstracted relative risks (RRs) and associated 95% CIs or calculated them on the basis of the pressure ulcer incidence in each intervention group.
We did not conduct meta-analysis because of methodological limitations in the studies and clinical heterogeneity. We assessed the overall strength of each body of evidence as high, moderate, low, or insufficient in accordance with the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews (14, 19), on the basis of the quality of studies, consistency among studies, precision of estimates, and directness of evidence.
This research was funded by AHRQ's Effective Health Care Program. Investigators worked with AHRQ staff to develop and refine the scope, analytic framework, and key questions. AHRQ staff had no role in study selection, quality assessment, synthesis, or development of conclusions. AHRQ staff provided project oversight, distributed the draft report for peer review, and reviewed the draft report and manuscript. The investigators are solely responsible for the content of the manuscript and the decision to submit it for publication.
One good-quality trial (n = 1231) randomly assigned patients newly admitted to internal medicine or oncology wards to the Waterlow scale, the Ramstadius tool, or nurses’ judgment and followed patients through discharge (20). Six percent of patients had ulcers at baseline, and the mean discharge period was 9 days. The Ramstadius tool is a combination risk assessment and intervention protocol that specifies the use of an alternating-air mattress and frequent repositioning in patients assessed as being at high risk. In the other 2 groups, nurses used the Waterlow scale or clinical judgment to assess risk, but subsequent interventions were not specified. Incidence of pressure ulcers did not differ among the groups (8%, 5%, and 7%, respectively), and no patients were lost to follow-up. Similar proportions of patients received more intensive preventive interventions (for example, more advanced support surfaces, documented pressure ulcer care plan, skin integrity referral, or dietitian referral) in the 3 groups.
Two other trials reported conflicting results of the effects of using risk assessment instruments on the likelihood of subsequent ulcers, but both were rated poor-quality (21, 22). One trial (21) used a nonrandomized design with nonconcurrent controls and did not adjust for confounders, and the other (22) used unclear methods of randomization, reported important baseline differences between groups, and did not blind outcome assessors to risk assessment scores.
Support surfaces are various devices designed to redistribute pressure (23) and include mattresses and related equipment (such as mattress overlays or bed systems), heel supports, and wheelchair or chair cushions. Criteria for classifying support surfaces have historically included the material used (for example, foam, air, gel, beads, or water), whether the support surface is static or dynamic (for example, alternating-air or low–air-loss systems), and whether it requires power (24). More recent proposals recommend classification of support surfaces as “reactive” (one with the capacity to change load distribution in response to applied loads) or “active” (one that can alter load distribution independent of applied loads) (24, 25). However, most published trials used older and often poorly standardized classification methods. In this report, we broadly classified mattresses and related support surfaces as static, alternating-air, or low–air-loss. These are reviewed separately from heel supports and wheelchair cushions.
Forty-one randomized trials (in 42 publications) evaluated support surfaces in patients at increased risk for pressure ulcers (26–67) (Table 1 of the Supplement). Sample sizes ranged from 32 to 1972 patients, and follow-up ranged from 6 days to 6 months or until time of discharge. When reported, mean Braden scores ranged from 9.4 to 16 (27, 28, 35, 36, 38, 47–49, 53, 58, 64, 66, 67), Norton scores ranged from 12 to 13 (30–32, 34, 40, 52, 60), and Waterlow scores ranged from 13 to 19 (33, 41, 42, 44, 57, 62). Trial settings included acute care hospitals and long-term care nursing facilities.
Three trials were rated as good-quality (56, 57, 66), 20 fair-quality (27, 30–32, 35–38, 41, 42, 46, 48–50, 52, 54, 62, 63, 65, 67), and 18 poor-quality (26–29, 33, 34, 39, 40, 43–45, 47, 51, 53, 58–61, 64). Methodological shortcomings included unclear methods of randomization and allocation concealment and failure to report blinding of outcomes assessors. In some studies, patients who developed pressure ulcers received additional preventive interventions, but no trial reported results adjusted for such differences. “Standard hospital mattress” comparators varied and were frequently not well-described in the studies but have changed over time from spring to foam mattresses. No study directly evaluated how effectiveness of preventive interventions varied according to care setting or in subgroups defined by patient characteristics.
One good-quality (n = 1166) (57) and 4 fair-quality (n = 83 to 543) trials (41, 48, 54, 65) found that a more advanced static mattress or overlay was associated with lower risk for incident pressure ulcers than a standard hospital mattress (RR range, 0.16 to 0.82). The difference was not statistically significant in 2 trials (57, 65), including the largest good-quality trial, which found no difference between a viscoelastic and polyurethane foam mattress versus a standard mattress in risk for pressure ulcers after 11 to 12 days (15% vs. 22%; RR, 0.78 [95% CI, 0.55 to 1.1]) (57). The static support surfaces evaluated in the fair-quality trials were the Softform (Medical Support Systems, Cardiff, United Kingdom) mattress (41), a sheepskin overlay (48, 54), and an air overlay (65). Six poor-quality trials reported results generally consistent with these findings (26, 40, 43, 45, 53, 61). The variability across trials in the support surfaces evaluated made it difficult to reach conclusions about the effectiveness of specific static support surfaces versus standard hospital mattresses, although 3 trials found that an Australian medical sheepskin overlay was associated with lower risk for incident ulcers than a standard mattress (RRs, 0.30, 0.58, and 0.58) (48, 53, 54).
Three fair-quality (n = 52 to 100) (42, 49, 52) and 6 poor-quality (n = 37 to 407) trials (29, 33, 44, 51, 59, 60) found no differences among different advanced static support mattresses or overlays in incidence of pressure ulcers. One fair-quality trial (n = 40) of nursing home residents found that a foam replaceable-parts mattress was associated with lower risk for incident ulcers than a 10.2-cm (4-in)–thick dimpled foam overlay (25% vs. 60%; RR, 0.42 [CI, 0.18 to 0.96]) (67).
Low–air-loss support surfaces provide a flow of air to assist in managing the skin microclimate (23). One fair-quality trial of intensive care unit patients (n = 98) found that a low–air-loss bed was associated with a lower likelihood of 1 or more pressure ulcers than a standard hospital bed (12% vs. 51%; RR, 0.23 [CI, 0.10 to 0.51]) (46), but a small, poor-quality trial (n = 36) found no difference between a low–air-loss mattress and a standard hospital bed after cardiovascular surgery (47).
One fair-quality trial (n = 62) found that a low–air-loss mattress was associated with a lower incidence of pressure ulcers than the Hill-Rom Duo mattress (Hill-Rom, Auburn, Australia), which has options for constant low pressure and alternating air, but the difference was not statistically significant (10% vs. 19%; RR, 0.53 [CI, 0.15 to 1.9]) (63).
Alternating-air support surfaces inflate and deflate sequentially, resulting in pressure at different parts of the surface for short periods (23). One good-quality, 1 fair-quality, and 4 poor-quality trials (n = 32 to 487) found no difference among various alternating-air mattresses or overlays versus various advanced static mattresses or overlays in pressure ulcer incidence or severity (26, 28, 30, 34, 59, 66). The good-quality trial (n = 447) (66) found no difference between an alternating-air mattress and a viscoelastic foam mattress plus repositioning every 4 hours in incidence of stage 2 to 4 pressure ulcers after 20 weeks in patients with a high prevalence (33%) of baseline stage 1 pressure ulcers (15% vs. 16%; RR, 0.98 [CI, 0.64 to 1.5]). The fair-quality trial (n = 148) found no difference between an alternating-air overlay and a silicone overlay in risk for incident ulcers after 3 months in patients without pressure ulcers at baseline (54% vs. 59%; RR, 0.91 [CI, 0.69 to 1.2]) (30). A fair-quality trial (n = 43) of intensive care patients found that stepped care (defined as initial use of less advanced and less expensive support surfaces followed by more advanced and more expensive support surfaces if ulcers developed, according to a predefined algorithm) starting with alternating-air mattresses was associated with decreased risk for incident pressure ulcers after 11 to 12 days versus stepped care starting primarily with static support surfaces (0% vs. 35% for stage 2 or higher ulcers; RR, 0.06 [CI, 0.00 to 0.96]) (37). Three poor-quality trials (n = 108 to 487) found that various alternating-air mattresses or overlays were associated with lower risk for incident pressure ulcers than standard hospital mattresses (26, 28, 58).
Four trials (1 good-quality, 2 fair-quality, and 1 poor-quality) (n = 44 to 1972) found no clear differences among different alternating-air mattresses or overlays (35, 55, 56, 58, 62).
One fair-quality trial of patients with fracture (n = 239) found that the Heelift Suspension Boot (DM Systems, Evanston, Illinois) was associated with lower risk for heel, foot, or ankle ulcers than usual care without leg elevation (3.3% vs. 13% for stage 2 ulcers; RR, 0.25 [CI, 0.09 to 0.72]) (36). Two poor-quality trials (n = 52 and 240) found no clear differences between a boot and usual care (64) or among types of boots (39) in risk for ulcers.
Four fair-quality trials of older nursing home residents (n = 32 to 248) compared sophisticated and standard wheelchair cushions (27, 31, 32, 38). None focused on patients with spinal cord injuries. Results were inconsistent and are difficult to interpret because of differences across trials in the types of cushions evaluated. One trial (n = 248) found no difference in ulcer risk between a contoured, individually customized foam cushion and a slab cushion (31), and another trial (n = 32) found no difference between a specialized wheelchair cushion with an incontinence cover versus a generic foam cushion (38). A third trial (n = 141) found that the JAY cushion (contoured urethane foam with a gel pad topper) (Sunrise Medical, Fresno, California) was associated with decreased risk for incident pressure ulcers versus a standard foam cushion (8.8% vs. 26% for stage 2 or 3 ulcers; RR, 0.36 [CI, 0.15 to 0.85]) (32). Another trial (n = 232) found that various skin-protection wheelchair cushions were associated with lower risk for ischial tuberosity ulcers than a standard segmented foam cushion when used with a fitted wheelchair (9.9% vs. 6.7%; RR, 0.13 [CI, 0.02 to 1.0]) (27).
Six trials evaluated nutritional interventions to prevent pressure ulcers, but 5 were rated as poor quality (68–73). Methodological limitations in all trials included inadequate description of randomization and allocation concealment methods and failure to blind outcome assessors. Some trials also reported baseline differences in pressure ulcer risk (68), high attrition (69, 70), or failure to blind patients and caregivers (68–70, 72, 73). One trial reported that 28% of patients were malnourished at baseline (70). Although the other trials enrolled patients at higher risk for pressure ulcers, baseline nutritional status was not specifically reported.
The trials found little evidence to support the effectiveness of enteral or oral nutritional supplementation for preventing pressure ulcers. The only fair-quality trial (n = 95) compared high-fat, low-carbohydrate enteral nutrition with and without additional vitamins and antioxidants and found no difference in risk for any incident ulcer in critically ill patients with acute lung injury (33% vs. 49%; RR, 0.67 [CI, 0.40 to 1.10]) (73). One poor-quality trial (n = 129) of enteral supplementation (72) and 3 poor-quality trials (n = 59 to 495) of oral supplementation (69–71) found no statistically significant effects on risk for subsequent ulcers versus placebo or a standard hospital diet, although trends favored supplementation. One poor-quality trial (n = 672) found that high-calorie liquid nutritional supplements plus standard hospital diet were associated with lower risk for pressure ulcers at 15 days than standard hospital diet alone in critically ill older patients (68).
The goal of repositioning is to decrease risk for pressure ulcers by reducing periods of sustained pressure. The frequency of repositioning and the positions used vary (1). One fair-quality cluster randomized trial (n = 213) found that repositioning at a 30-degree tilt every 3 hours was associated with lower risk for incident pressure ulcers than usual care (90-degree lateral repositioning every 6 hours during the night) after 28 days (3.0% vs. 11%; RR, 0.27 [CI, 0.08 to 0.93]) (74). Another fair-quality trial (n = 235) found no difference in risk for incident pressure ulcers between different repositioning intervals (alternating between the semi-Fowler 30-degree and lateral positions) (75). Two other repositioning trials (n = 46 and 838) followed patients for only 1 night (76) or were susceptible to confounding due to differential use of support surfaces (77).
Two small, poor-quality trials (n = 15 and 19) found that the addition of small, unscheduled shifts in body position to standard repositioning every 2 hours had no effect on ulcer risk, but each reported only 1 or 2 ulcers (78, 79).
Dressings and pads may prevent pressure ulcers by reducing the risk for skin surface breakdown. A fair-quality trial of cardiac surgery patients (n = 85) found that a silicone border foam sacral dressing applied at admission to the intensive care unit was associated with a lower likelihood of pressure ulcers than standard care (including use of a low–air-loss bed), but the difference was not statistically significant (2.0% vs. 12%; RR, 0.18 [CI, 0.02 to 1.5]) (80). A poor-quality trial of patients in long-term care (n = 37) found that use of the REMOIS Pad (consisting of a hydrocolloid skin adhesive layer, a support layer of urethane film, and an outer layer of multifilament nylon) (ALCARE, Tokyo, Japan) on the greater trochanter was associated with decreased risk for stage 1 ulcers versus no pad after 4 weeks (81). A fair-quality crossover trial of incontinent female nursing home residents (n = 81) found no statistically significant difference between changing incontinence pads 3 versus 2 times each night in risk for incident stage 2 pressure ulcers after 4 weeks (82).
As with dressings and pads, various creams, lotions, and cleansers may be useful for preventing skin breakdown. One fair-quality trial (n = 331) (83) found that fatty acid creams were associated with decreased risk for incident pressure ulcers versus placebo (RR, 0.42 [CI, 0.22 to 0.80]). A poor-quality trial (n = 86) reported consistent results (84). Evidence from 3 poor-quality trials (n = 79 to 258) was insufficient to determine effectiveness of other creams or lotions (85–87). Methodological shortcomings included failure to report adequate methods for randomization or allocation concealment, failure to blind care providers or patients, and unclear attrition.
One fair-quality trial (n = 93) found that the Clinisan cleanser (Synergy Health, Swindon, United Kingdom) was associated with lower risk for incident ulcers (three quarters of which were stage 1) than standard soap and water in patients with incontinence (18% vs. 42%; RR, 0.43 [CI, 0.19 to 0.98]) (88).
The trials of nutritional supplementation, repositioning, and skin care are summarized in Table 2 of the Supplement.
Harms were reported in 16 trials (32, 35, 36, 48, 53, 54, 56, 72, 76, 77, 81, 86–90) of preventive interventions. Of the trials reporting harms, few provided detailed information on specific harms, although none reported serious treatment-related harms. The only harms reported in trials of creams and dressings were single cases of rashes or blisters (81, 87, 88).
Three trials reported cases of heat-related discomfort with a sheepskin overlay, leading to some withdrawals (48, 53, 54). One trial found that a urethane and gel wheelchair pad (JAY cushion) was associated with increased risk for withdrawal due to discomfort versus a standard foam wheelchair pad (8% vs. 1%; RR, 6.2 [CI, 0.77 to 51]) (32).
One trial of nutritional supplementation with tube feeding found that 54% (29 of 54) of patients removed the tube within 1 week and 67% (32 of 48) removed it within 2 weeks (72). One trial found that a 30-degree tilt repositioning was more difficult to tolerate than a standard 90-degree position (87% vs. 24%; RR, 0.17 [CI, 0.06 to 0.51]) (76).
The Table summarizes the findings of this review. 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 (20). As detailed in our full report (15), commonly used instruments (such as the Braden, Norton, and Waterlow scales) seem to be relatively weak predictors of which patients are more likely to develop ulcers (91–96). However, data on predictive accuracy are difficult to interpret because higher-risk patients may have preferentially received more intensive interventions. In addition, the usefulness of risk assessment instruments depends on the availability of effective subsequent interventions. We found that more advanced static support surfaces are more effective than standard hospital mattresses for preventing pressure ulcers in higher-risk patients (41, 48, 54, 57, 65). Evidence was inadequate to reliably determine the effectiveness of other preventive interventions, such as repositioning, nutritional supplementation, creams, and dressings or pads, versus usual care. Although evidence on harms of preventive interventions was sparse, serious harms seemed to be rare. As detailed in our full report (15), data on resource utilization were primarily limited to a small number of trials that found no effects of various support surfaces on length of hospital stay (45, 48, 57). The applicability of trial findings to clinical practice could be limited by delays in use of preventive interventions or differences in the quality of care between research and typical clinical settings.
Table. Summary of Findings
Our findings on the effectiveness of preventive interventions are generally consistent with those of other systematic reviews that found some evidence that more advanced static support surfaces are associated with decreased risk for pressure ulcers compared with standard hospital mattresses (97, 98), limited evidence on the effectiveness and comparative effectiveness of dynamic support surfaces (97, 98), and limited evidence on other preventive interventions (98, 99). These reviews differed from ours in that they included trials that enrolled patients with higher-stage, preexisting ulcers and trials published only as abstracts. Although 1 other prior review found that nutritional supplementation was associated with decreased risk for incident pressure ulcers (odds ratio, 0.74 [CI, 0.62 to 0.88]), conclusions were based on pooling of poor-quality trials, none of which individually found a statistically significant effect (100).
Our review has limitations. We excluded non–English-language articles; however, some studies have found no evidence of bias due to language restrictions in systematic reviews of noncomplementary medicine interventions (101, 102). In addition, we did not exclude poor-quality studies a priori. Rather, we described the limitations of the studies, emphasized higher-quality studies, and performed sensitivity analyses that excluded poor-quality studies. We also found that results of poor-quality and higher-quality trials were generally consistent. We did not formally assess publication bias due to small numbers of studies and clinical heterogeneity of the available studies (103). Most included studies had important methodological shortcomings, with nearly half of the studies of preventive interventions rated as poor-quality. Some preventive interventions evaluated in older trials may no longer be available, and many trials of support surfaces evaluated specific brand-name products that have since changed, both of which could affect generalizability to currently available interventions. Smaller trials with negative findings may have been underpowered to detect clinically relevant effects.
Prevention of pressure ulcers is an important health priority. Given the limitations of the evidence, current decisions about whether to use pressure ulcer risk assessment instruments may depend, in part, on such considerations as preferences for standardized assessments, ease of use, and nursing preferences. Limited evidence indicates no clear differences between alternating-air and low–air-loss mattresses and overlays versus advanced static support surfaces, yet such interventions are commonly used and can be more costly. One trial found that a stepped care approach that used less expensive dynamic support surfaces before switching to more expensive alternatives in patients with early ulcers was effective and may be more efficient than using more expensive support surfaces initially in all patients (37). More research is needed to determine whether more intensive repositioning, nutritional, or skin care interventions are more effective than usual preventive care (including standard repositioning, nutrition, and skin care). It is critical that future studies of preventive interventions adhere to methodological standards, including appropriate use of blinding (such as blinding of outcome assessors even when blinding of patients and caregivers is not feasible), and clearly describe usual care and other comparison treatments. Studies should routinely report baseline risk for pressure ulcers in enrolled patients and consider predefined subgroup analyses to help better understand how preventive interventions might be optimally targeted.
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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.
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