Table 17Summary of evidence

Key Question and SubcategoriesStrength of EvidenceConclusion
Key Question 1. For adults in various settings, is the use of any risk-assessment tool effective in reducing the incidence or severity of pressure ulcers compared with other risk-assessment tools, clinical judgment alone, and/or usual care?
 Pressure ulcer incidence or severity: Waterlow scale vs. clinical judgmentLowOne good-quality randomized trial (n = 1,231) found no difference in pressure ulcer incidence between patients assessed with either the Waterlow scale or Ramstadius tool compared with clinical judgment alone (RR, 1.4; 95% CI, 0.82 to 2.4; and RR, 0.77; 95% CI, 0.44 to 1.4, respectively).
 Pressure ulcer incidence or severity: Norton scale vs. clinical judgmentInsufficientOne poor-quality nonrandomized study (n = 240) found that use of a modified version of the Norton scale to guide use of preventive interventions was associated with lower risk of pressure ulcers compared with nurses’ clinical judgment alone (RR, 0.11; 95% CI, 0.03 to 0.46).
 Pressure ulcer incidence or severity: Braden scale vs. clinical judgmentInsufficientOne poor-quality cluster randomized trial (n = 521) found no difference between training in and use of the Braden score vs. nurses’ clinical judgment in risk of incident pressure ulcers but included patients with prevalent ulcers.
Key Question 1a. Do the effectiveness and comparative effectiveness of risk-assessment tools differ according to setting?InsufficientNo study evaluated how effectiveness of risk-assessment tools varies according to care setting.
Key Question 1b. Do the effectiveness and comparative effectiveness of risk-assessment tools differ according to patient characteristics and other known risk factors for pressure ulcers, such as nutritional status or incontinence?InsufficientNo study evaluated how effectiveness of risk-assessment tools varies in subgroups defined by patient characteristics.
Key Question 2. How do various risk-assessment tools compare with one another in their ability to predict the incidence of pressure ulcers?
 Diagnostic accuracy: Braden scaleModerateIn 2 good- and 5 fair-quality studies, the median AUROC for the Braden scale was 0.77 (range, 0.55 to 0.88). In 16 studies, based on a cutoff of ≤18, the median sensitivity was 0.74 (range, 0.33 to 1.0) and median specificity 0.68 (range, 0.34 to 0.86), for a positive likelihood ratio of 2.31 and negative likelihood ratio of 0.38.
 Diagnostic accuracy: Norton scaleModerateIn 3 studies (1 good and 2 fair quality), the median AUROC for the Norton scale was 0.74 (range, 0.56 to 0.75). In 5 studies, using a cutoff of ≤14, median sensitivity was 0.75 (range, 0.0 to 0.89) and median specificity 0.68 (range, 0.59 to 0.95), for a positive likelihood ratio of 1.83 and negative likelihood ratio of 0.42.
 Diagnostic accuracy: Waterlow scaleModerateIn 4 studies (1 good and 3 fair quality), the median AUROC for the Waterlow scale was 0.61 (range, 0.54 to 0.66). In 2 studies, based on a cutoff of ≥10, sensitivities were 0.88 and 1.0, and specificities 0.13 and 0.29, for positive likelihood ratios of 1.15 and 1.24 and negative likelihood ratios of 0.0 and 0.41.
 Diagnostic accuracy: Cubbin and Jackson scaleModerateIn 3 studies (1 good and 2 fair quality), the median AUROC for the Cubbin and Jackson scale was 0.83 (range, 0.72 to 0.90). In 3 studies, based on a cutoff of ≤24 to 29, median sensitivity was 0.89 (range, 0.83 to 0.95) and median specificity was 0.61 (0.42 to 0.82), for positive likelihood ratios that ranged from 1.43 to 5.28 and negative likelihood ratios that ranged from 0.06 to 0.40.
 Diagnostic accuracy: direct comparisons between risk-assessment scalesModerateIn 2 good- and 4 fair-quality studies that directly compared risk-assessment tools, there were no clear differences between scales based on the AUROC.
Key Question 2a. Does the predictive validity of various risk-assessment tools differ according to setting?
 Diagnostic accuracy: Braden scale, across settingsLowOne fair-quality study found that a Braden scale score of ≤18 was associated with similar sensitivities and specificities in acute care and skilled nursing settings. Twenty-eight studies (10 good, 16 fair, and 2 poor quality) that evaluated the Braden scale in different settings found no clear differences in the AUROC or in sensitivities and specificities at standard (≤15 to 18) cutoffs.
 Diagnostic accuracy: Cubbin and Jackson scale, ICU settingLowTwo studies (1 good and 1 fair quality) found that the Cubbin and Jackson scale was associated with similar diagnostic accuracy compared with the Braden or Waterlow scales in intensive care patients.
 Diagnostic accuracy: Braden scale, optimal cutoff in different settingsLowOne good-quality study reported a lower optimal cutoff on the Braden scale in an acute care setting (sensitivity 0.55 and specificity 0.94 at a cutoff of ≤15) than a long-term care setting (sensitivity 0.57 and specificity 0.61 at a cutoff of ≤18), but the statistical significance of differences in diagnostic accuracy was not reported. Two studies of surgical patients (1 good and 1 fair quality) found lower optimal cutoff scores than observed in studies of patients in other settings.
Key Question 2b. Does the predictive validity of various risk-assessment tools differ according to patient characteristics?
 Diagnostic accuracy: Braden scale, differences according to raceLowOne fair-quality study reported similar AUROCs for the Braden scale in black and white patients in acute care and skilled nursing settings.
 Diagnostic accuracy: Braden scale, differences according to baseline pressure ulcer riskModerateThree studies (1 good and 2 fair quality) found no clear difference in AUROC estimates based on the presence of higher or lower mean baseline pressure ulcer risk scores.
Key Question 3. In patients at increased risk of developing pressure ulcers, what are the effectiveness and comparative effectiveness of preventive interventions in reducing the incidence or severity of pressure ulcers?
 Pressure ulcer incidence or severity: advanced static mattresses or overlays vs. standard hospital mattressModerateOne good-quality trial (n = 1,166) and 4 fair-quality trials (n = 83 to 543) found that a more advanced static mattress or overlay was associated with lower risk of incident pressure ulcers than a standard mattress (RR range, 0.16 to 0.82), although the difference was not statistically significant in 2 trials. Six poor-quality trials reported results that were generally consistent with these findings. Three trials found no difference in length of stay. The static support surfaces evaluated in the trials varied, although a subgroup of 3 trials each found that an Australian medical sheepskin overlay was associated with lower risk of ulcers than a standard mattress (RR, 0.30, 0.58, and 0.58).
 Pressure ulcer incidence or severity: advanced static mattress or overlay vs. advanced static mattress or overlayModerateThree fair-quality trials (n = 52 to 100) found no differences between different advanced static support mattresses or overlays in risk of pressure ulcers. One fair-quality trial (n = 40) of nursing home patients found that a foam replaceable-parts mattress was associated with lower risk of ulcers compared with a 4-inch thick, dimpled foam overlay (25% vs. 60%; RR, 0.42; 95% CI, 0.18 to 0.96). Six poor-quality trials (n = 37 to 407) also found no differences between different advanced static mattresses or overlays.
 Pressure ulcer incidence or severity: low-air-loss bed vs. standard hospital mattressLowOne fair-quality trial (n = 98) found that a low-air-loss bed was associated with lower likelihood of 1 or more pressure ulcers in ICU patients (12% vs. 51%; RR, 0.23; 95% CI, 0.10 to 0.51), but a small (n = 36) poor-quality trial found no difference between a low-air-loss mattress compared with a standard hospital bed following cardiovascular surgery.
 Pressure ulcer incidence or severity: low-air-loss mattress compared with dual option (constant low pressure/alternating air) mattressLowOne fair-quality trial (n = 62) found no clear difference between a low-air-loss mattress compared with the Hill-Rom Duo® mattress (options for constant low pressure or alternating air) in risk of ulcers.
 Pressure ulcer incidence or severity: alternating air pressure overlay or mattress vs. standard hospital mattressLowThree poor-quality trials (n = 108 to 487) found lower incidence of pressure ulcers with use of an alternating air pressure mattress or overlay compared with a standard hospital mattress.
 Pressure ulcer incidence or severity: alternating air pressure overlay or mattress vs. advanced static overlay or mattressModerateSix trials (n = 32 to 487; 1 good quality, 1 fair quality, and 4 poor quality) found no difference between an alternating air pressure overlay or mattress compared with various advanced static mattresses or overlays in pressure ulcer incidence or severity.
 Pressure ulcer incidence or severity: alternating air pressure overlay or mattress vs. alternating air pressure overlay or mattressModerateFour trials (n = 44 to 1,972; 1 good quality, 2 fair quality, and 1 poor quality) found no clear differences between different alternating air mattresses or overlays. The good-quality (n = 1,972) trial found no difference in risk of stage 2 ulcers between an alternating air pressure overlay and an alternating air pressure mattress (RR, 1.0, 95% CI, 0.81 to 1.3; adjusted OR, 0.94, 95% CI, 0.68 to 1.3).
 Pressure ulcer incidence or severity: heel supports or boots vs. usual careLowOne fair-quality trial (n = 239) of fracture patients found that the Heelift® Suspension Boot was associated with decreased risk of heel, foot, or ankle ulcers compared with usual care without leg elevation (7% vs. 26% for any ulcer, RR, 0.26, 95% CI, 0.12 to 0.53; 3.3% vs. 13.4% for stage 2 ulcers, RR, 0.25, 95% CI, 0.09 to 0.72). One poor-quality trial (n = 52) of hospitalized patients found no difference in risk of ulcers between a boot (Foot Waffle®) and usual care (hospital pillow to prop up legs).
 Pressure ulcer incidence or severity: heel ulcer preventive intervention vs. heel ulcer preventive interventionInsufficientOne poor-quality trial (n = 240) of hospitalized patients found no differences between three different types of boots (bunny boot, egg-crate heel lift positioner, and Foot Waffle®) in risk of ulcers, although the overall incidence of ulcers was low (5% over 3 years) and results could have been confounded by differential use of cointerventions.
 Pressure ulcer incidence or severity: more sophisticated wheelchair cushions vs. standard wheelchair cushionsLowFour fair-quality trials (n = 32 to 248) of older nursing home patients found inconsistent evidence on effects of more sophisticated wheelchair cushions compared with standard wheelchair cushions on risk of pressure ulcers, with the largest trial finding no difference between a contoured, individually customized foam cushion compared with a slab cushion. Results are difficult to interpret because the trials evaluated different cushions.
 Pressure ulcer incidence or severity: nutritional supplementation vs. standard hospital dietLowFive of 6 trials (1 fair quality and 5 poor quality; n = 59 to 672) found no difference between nutritional supplementation compared with standard hospital diet in risk of pressure ulcers. Four trials evaluated supplementation by mouth and 2 evaluated enteral supplementation.
 Pressure ulcer incidence or severity: repositioning intervention vs. usual careLowOne fair-quality cluster trial (n = 213) found that repositioning at a 30-degree tilt every 3 hours was associated with lower risk of pressure ulcers compared with usual care (90-degree lateral repositioning every 6 hours during the night) after 28 days (3.0% vs. 11%; RR, 0.27; 95% CI, 0.08 to 0.93), and 1 fair-quality trial (n = 235) found no difference in risk of pressure ulcers between different repositioning intervals. Two other trials (n = 46 and 838) evaluated repositioning interventions but followed patients for only 1 night or were susceptible to confounding due to differential use of support surfaces.
 Pressure ulcer incidence or severity: small unscheduled shifts in body position vs. usual careLowTwo small (n = 15 and 19) poor-quality trials found that the addition of small unscheduled shifts in body position (using a small rolled towel to designated areas during nurse-patient interactions) to standard repositioning every 2 hours had no effect on risk on pressure ulcers, but the studies reported only 1 or 2 ulcers in each trial.
 Pressure ulcer incidence or severity: silicone border foam sacral dressing vs. no silicone border foam dressingLowOne fair-quality (n = 85) trial of patients undergoing cardiac surgery found that a silicone border foam sacral dressing applied at ICU admission (the Mepilex® Border sacrum) was associated with lower likelihood of pressure ulcers compared with standard care (including preoperative placement of a silicone border foam dressing for surgery and use of a low-air-loss bed), but the difference was not statistically significant (2.0% vs. 12%; RR, 0.18; 95% CI, 0.02 to 1.5).
 Pressure ulcer incidence or severity: REMOIS pad vs. no padInsufficientOne poor-quality randomized trial (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) on the greater trochanter was associated with decreased risk of stage 1 ulcers compared with no pad on the contralateral trochanter after 4 weeks (5.4% vs. 30%; RR, 0.18; 95% CI, 0.05 to 0.73).
 Pressure ulcer incidence or severity: changing incontinence pad 3 vs. 2 times per dayLowOne fair-quality crossover trial (n = 81) found no statistically significant difference in risk of pressure ulcers between changing incontinence pads 3 times vs. twice after 4 weeks.
 Pressure ulcer incidence or severity: intraoperative warming vs. usual careLowOne fair-quality randomized trial (n = 324) of patients undergoing major surgery found no statistically significant difference in risk of pressure ulcers between patients who received an intraoperative warming intervention (forced-air warming and warming of all intravenous fluids) compared with usual care.
 Pressure ulcer incidence or severity: corticotropin vs. shamInsufficientOne poor-quality randomized trial (n = 85) of patients undergoing femur or hip surgery found no difference in risk of pressure ulcers between those who received 80 IU of corticotropin intramuscularly compared with a sham injection.
 Pressure ulcer incidence or severity: polarized lightInsufficientOne small poor-quality randomized trial (n = 23) found no statistically significant difference between polarized light compared with standard care in risk of pressure ulcers.
 Pressure ulcer incidence or severity: fatty acid cream vs. placeboLowOne fair-quality trial (n = 331) and 1 poor-quality trial (n = 86) found that creams with fatty acids were associated with decreased risk of new pressure ulcers compared with placebo (RR, 0.42, 95% CI, 0.22 to 0.80; RR, 0.17, 95% CI, 0.04 to 0.70).
 Pressure ulcer incidence or severity: other cream or lotion vs. placeboInsufficientEvidence from 3 poor-quality trials (n = 79 to 258) was insufficient to determine effectiveness of other creams or lotions for preventing pressure ulcers.
 Pressure ulcer incidence or severity: skin cleanser vs. standard soap and waterLowOne fair-quality randomized trial (n = 93) found that the Clinisan cleanser was associated with lower risk of ulcer compared with standard soap and water in patients with incontinence at baseline (18% vs. 42%; RR, 0.43; 95% CI, 0.19 to 0.98).
Key Question 3a. Do the effectiveness and comparative effectiveness of preventive interventions differ according to risk level as determined by different risk-assessment methods and/or by particular risk factors?
Pressure ulcer incidence or severity: static foam overlay vs. standard care, lower risk surgical populationModerateTwo trials (1 good and 1 fair quality; n = 175 and 413) found that use of a static foam overlay was associated with increased risk of pressure ulcers compared with standard care in lower risk surgical patients, although the difference was not statistically significant in 1 trial (OR, 1.9, 95% CI, 1.0 to 3.7; RR, 1.6, 95% CI, 0.76 to 3.3).
Pressure ulcer incidence or severity: static dry polymer overlay vs. standard care, lower risk surgical populationLowTwo trials (1 good and 1 poor quality) found that a dry polymer overlay was associated with decreased risk of pressure ulcers compared with standard care in lower risk surgical patients.
Pressure ulcer incidence or severity: static foam block mattress vs. standard care, lower risk surgical populationInsufficientOne poor-quality trial found no significant difference between a static foam block mattress and a standard hospital mattress in pressure ulcer incidence.
Pressure ulcer incidence or severity: alternating air vs. static mattress or overlay, lower risk surgical populationLowTwo trials (1 good and 1 poor quality; n = 198 and 217) found no differences between alternating compared with static support surfaces in risk of pressure ulcer incidence or severity.
Key Question 3b. Do the effectiveness and comparative effectiveness of preventive interventions differ according to setting?InsufficientNo study evaluated how effectiveness of preventive interventions varies according to care setting.
Key Question 3c. Do the effectiveness and comparative effectiveness of preventive interventions differ according to patient characteristics?InsufficientNo study evaluated how effectiveness of preventive interventions varies in subgroups defined by patient characteristics.
Key Question 4. What are the harms of interventions for the prevention of pressure ulcers?
 Harms: support surfacesLowNine of 48 trials of support surfaces reported harms.
  • Three trials (n = 297 to 588) reported cases of heat-related discomfort with sheepskin overlays, with 1 trial reporting increased risk of withdrawal due to heat discomfort compared with a standard mattress (5% vs. 0%; RR, 0.95; 95% CI, 0.93 to 0.98).
  • One trial (n = 39) that compared different dynamic mattresses reported some differences in pain and sleep disturbance, and 2 trials (n = 610 and 1,972) found no differences in risk of withdrawal due to discomfort.
  • One trial (n =198) reported no differences in risk of adverse events between a multicell pulsating dynamic mattress compared with a static gel pad overlay.
  • One trial (n = 239) of heel ulcer preventive interventions reported no difference in risk of adverse events between the Heelift® Suspension Boot and standard care in hip fracture patients.
  • One trial (n = 141) reported that a urethane and gel wheelchair pad (Jay® cushion) was associated with increased risk of withdrawal due to discomfort compared with a standard foam wheelchair pad (8% vs. 1%; RR, 6.2; 95% CI, 0.77 to 51).
 Harms: nutritional supplementationLowOne trial of nutritional supplementation found that tube feeds were tolerated poorly, with 54% having the tube removed within 1 week and 67% prior to completing the planned 2-week intervention. Four trials of nutritional supplementation by mouth did not report harms.
 Harms: repositioningLowTwo (n = 46 and 838) of 6 trials of repositioning interventions reported harms. Both trials reported more nonadherence due to intolerability of a 30-degree tilt position compared with standard positioning.
 Harms: lotions and creamsLowThree (n = 93 to 203) of 6 trials of lotions or creams reported harms. One trial found no differences in rash between different creams, and 2 trials each reported 1 case of a wet sore or rash.
 Harms: dressingsLowOne (n = 37) of 3 trials of dressings reported harms. It reported that application of the REMOIS pad resulted in pruritus in 1 patient.
Key Question 4a. Do the harms of preventive interventions differ according to the type of intervention?InsufficientNo study evaluated how harms of preventive interventions vary according to the type of intervention.
Key Question 4b. Do the harms of preventive interventions differ according to setting?InsufficientNo study evaluated how harms of preventive interventions vary according to care setting.
Key Question 4c. Do the harms of preventive interventions differ according to patient characteristics?InsufficientNo study evaluated how harms of preventive interventions vary in subgroups defined by patient characteristics

Note: AUROC=area under the receiver operating characteristic, CI=confidence interval, ICU=intensive care unit, OR=odds ratio, RR=risk ratio.

From: Discussion

Cover of Pressure Ulcer Risk Assessment and Prevention: Comparative Effectiveness
Pressure Ulcer Risk Assessment and Prevention: Comparative Effectiveness [Internet].
Comparative Effectiveness Reviews, No. 87.
Chou R, Dana T, Bougatsos C, et al.

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