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National Clinical Guideline Centre (UK). The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. London: National Institute for Health and Care Excellence (NICE); 2014 Apr. (NICE Clinical Guidelines, No. 179.)
Pressure relieving and redistributing devices are widely accepted methods of trying to prevent the development of pressure ulcers for people considered as being at risk. The devices used include different types of mattresses, overlays, cushions and seating. These devices work by reducing or redistributing pressure, friction or shearing forces.
Selection of a device may depend on factors such as mobility of the individual, the results of skin assessment, the level of and site at risk, weight, staff availability and skill plus the general health and condition of the individual. It is also important that any device is able to be cleaned and decontaminated effectively. It is accepted that these devices should be used in conjunction with other preventative strategies such as repositioning.
Specific devices are available for certain at risk sites, for example, the heel. Pressure redistributing devices for heels are considered in Chapter 13.
The GDG were therefore interested in identifying whether the use of pressure redistributing devices, including both static and dynamic surfaces, are effective in the prevention of pressure ulcers.
12.1. Review question: What are the most clinically and cost-effective pressure re-distributing devices for the prevention of pressure ulcers?
For full details see review protocol in Appendix C.
12.1.1. Clinical evidence (adults)
A Cochrane review by McInnes et al (2011)127 was identified from the search and was adapted for this review. The Cochrane review was quality assured and, as it was of very high quality and matched the majority of the protocol (see Appendix C), the information was used to populate this review for the summary of studies, forest plots and for the quality assessment of studies (see Appendix G-I). Fifty-three studies were included in the Cochrane review. Three studies were removed but used in the review on the use of pressure redistributing devices for the prevention of heel pressure ulcers28,71,207 as they included devices which are specific to only heel ulcers (see Chapter 13). One study60 was at high risk of bias and did not report outcomes clearly and was excluded (from our review and the Cochrane review). One other study (Economides, 1995)58 was excluded as it looked at wound breakdown rather than incidence of pressure ulcers. Two other studies (Gentilello, 198869 and Summer, 1989195) were excluded from this review as they were more relevant to the repositioning review (see Chapter 9). Eight other studies27,30,54,82,125,163,209,217 which were not included in the Cochrane review, were identified and included in this review (see Appendix G).
In total, 54 studies were included in this review 3,6,15,31,33,35,38-40,42,48,61,62,70,72,76,77,83,87,90,94,101,103,104,113,114,117,126,130,148,14927,30,54,68,82,125,161,163-165,172,174,180,185,192,198-200,209,214,217,218,223. Evidence from these studies is summarised in the clinical GRADE evidence profiles below.
See also the study selection flow chart in Appendix D, forest plots in Appendix I, study evidence tables in Appendix G and exclusion list in Appendix J.
In the studies, various types of devices were used to redistribute pressure to prevent pressure ulcers. The Cochrane review categorised them as low-tech (non-powered) constant low pressure support surfaces, high-tech support surfaces and other support surfaces. The types of devices included are listed below;
- ‘Low-tech’ continuous low pressure (CLP) support surfaces:
- Standard foam mattresses.
- Alternative foam mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Gel-filled mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Fibre-filled mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Air-filled mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Water-filled mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Bead-filled mattresses/overlays: conformable and aim to redistribute pressure over a larger contact area.
- Sheepskins
- ‘High-tech’ support surfaces:
- Alternating-pressure mattresses/overlays: air-filled sacs that inflate and deflate sequentially to relieve pressure at different anatomical sites for short periods; these may incorporate a pressure sensor
- Air-fluidised beds: warmed air circulates through fine ceramic beads covered by a permeable sheet; allowing support over a larger contact area (CLP)
- Low-air-loss beds: support provided by a series of air sacs through which warmed air passes (CLP)
- Other support surfaces:
- Turning beds/frames: aides manual repositioning of the patient, or by motor driven turning and tilting.
- Operating table overlays: conformable and aim to redistribute pressure over a larger contact area.
- Wheelchair cushions: either conforming cushions that reduce contact pressures by increasing surface area in contact, or mechanical cushions which alternate pressure.
- Limb protectors: pads and cushions of different forms to protect bony prominences.
The Cochrane review considered all studies, regardless of whether grade 1 pressure ulcers were described separately, although the authors state that studies comparing the incidence of pressure ulcers of grade 2 or greater are more likely to be reliable. For the purposes of the current review, the GDG therefore chose to include pressure ulcers of grade 2 and above were.
Although the included studies used a range of grading systems, those which reported pressure ulcers of grade 2 and above separately, used the EPUAP or NPUAP classification system (see Table 50). For studies that did not use the EPUAP/NPUAP and reported grade of ulcer separately, the distinction was usually a break in the skin or blister.
The Cochrane review reported that methods of measuring secondary outcomes such as comfort, durability, reliability and acceptability were not well developed. Where data were presented details were provided, but this was not incorporated into the analysis. As some of these outcomes were considered by the GDG to be critical for decision making, for the purposes of this review these outcomes have been included in the GRADE evidence tables (see Table 52).
The Cochrane review meta-analysed studies where there was more than 1 trial for an outcome which compared similar devices. The results were pooled using a fixed effect model, but if heterogeneity (I2 = 50% or above and the p value was less than 0.10) was found, a random-effects model was used. The review states that it was assumed that the risk ratio remained constant for different lengths of follow-up and so results were pooled if participants were followed-up for different lengths of time.
No studies were found for standard or pressure-relieving chairs, tilt-in-space wheelchairs, postural support or limb protectors.
Summary of included studies
12.1.2. ‘Low-tech’ constant low-pressure (CLP) supports
The Cochrane review compared standard foam hospital mattresses with other low specification (‘low-tech’), constant low-pressure (CLP) supports. Sheepskin, static air-filled supports; water-filled supports; contoured or textured foam supports; gel-filled supports; bead-filled supports; fibre-filled supports, and alternative foam mattresses or overlays were considered to be low-tech CLP. However it is noted that there is not an international definition of what a standard foam mattress is. In addition the definition can change over time, within countries, and even within hospitals. If a description of the standard mattress was given it was included in the review, which is outlined in Table 51. The Cochrane review assumes that standard mattresses are likely to vary less within countries than between countries, and undertook subgroup analysis by country, although this intention was not pre-specified.
12.1.2.1. Standard foam hospital mattress compared with other “low-tech” CLP
12.1.3. Comparisons between alternative foam mattresses
12.1.4. Comparisons between ‘low-tech’ constant low-pressure supports
12.1.5. ‘High-tech’ pressure supports
This section outlines 3 main groups of supportsL alternating pressure devices (AP), low-air loss beds and air-fluidised low beds.
12.1.5.1. Alternating-pressure compared with constant low pressure
12.1.5.2. Alternating-pressure compared with constant low pressure
12.1.6. Comparisons between different alternating-pressure devices
12.1.7. Low-air-loss (LAL) beds
Three studies evaluated the use of low-air-loss beds. Such devices provide a flow of air that assists in controlling the microclimate of the person's skin (NPUAP 2007).20 Two studies (Inman 1993 and Cobb 1997) were pooled as they included people in ICU.33,93 A further study (Bennett) considered a low-air-loss hydrotherapy bed compared to a variety of mattresses which was not in people in ICU, and therefore was not pooled.14
12.1.7.1. Comparisons between LAL and other devices
12.1.8. Other devices
12.1.8.1. Operating room mattress
12.1.8.2. Operating table overlay
12.1.8.3. Face pillows in the operating theatre
12.1.9. Profiling beds
12.1.9.1. Comparison between profiling bed and flat-based bed
12.1.10. Seat cushions
12.1.10.1. Comparison between different cushions
12.1.11. Economic evidence (adults)
Published literature
Nine studies were included with relevant comparisons.65,96,115,131,149,159,160,167,217 These are summarised in the economic evidence profiles below (Table 76 - Table 80). See also the study selection flow chart in Appendix D and study evidence tables in Appendix G.
Four studies that met the inclusion criteria were selectively excluded due to methodological limitations and availability of more applicable evidence.13,92,93,206 These are summarised in Appendix K, with reasons for exclusion given.
Six further studies were found which included devices for the prevention of pressure ulcers as part of more complex prevention strategies.121,124,153,202,226,227 These studies were not included as they evaluated the cost-effectiveness of the prevention strategies as a whole, and did not provide information on the cost-effectiveness of the devices alone.
It is clear from Table 77 that 2 of the included studies65,149 demonstrate conflicting results, despite both being conducted from the perspective of the UK NHS, with costs based on 2003 UK prices. Nixon and colleagues found that alternating pressure replacement mattresses (AR) dominate alternating pressure overlays (AO), whilst Fleurence found that AOs are cost effective. Both studies indicate that ARs have a greater effectiveness, with Nixon reporting greater time to pressure ulcer development and Fleurence a small increase in QALYs associated with an increase in pressure ulcer free days. However, the incremental pressure ulcer free days in Nixon are 10 times greater than those reported in Fleurence. This is most likely due to the different methods of collecting effectiveness data (Nixon is based on a within trial analysis whilst Fleurence is based on an estimation validated by experts) and the 2 different approaches to modelling (a regression analysis to calculate additional costs and pressure ulcer free days in Nixon, and a decision tree in Fleurence). Unit costs of devices presented in these 2 papers are almost identical, both obtained from Huntleigh Healthcare and reported in 2003 prices, yet Fleurence assumes a 2 year time horizon for overlays and an 8 year horizon for mattresses, whilst Nixon and colleagues assume a 2 year time horizon for both devices. Of note, a zero cost of pressure ulcer management is assumed in Nixon, whilst a value of £1,133 is used to represent this cost in Fleurence. There are also differences in assumptions surrounding the proportion of mattresses that were rented or purchased.
Unit costs
The following unit costs were presented to aid consideration of cost effectiveness (Table 81).
Note - these prices have been obtained directly from manufacturers, and represent the list price for the NHS. It is acknowledged that prices vary locally, therefore these prices are illustrative only. The devices included in the table are those identified by GDG members as being commonly used, and should not be interpreted as recommended devices.
12.1.12. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
12.1.13. Economic evidence (neonates, infants, children and young people)
Published literature
No relevant economic evaluations were identified.
Economic considerations
In the absence of economic evidence, the GDG considered relevant UK NHS unit costs of various mattresses and overlays (Table 82) These were considered alongside clinical evidence obtained from the Delphi consensus panel to inform qualitative judgement about cost-effectiveness.
12.1.14. Evidence statements
12.1.14.1. Clinical (adults)
12.1.14.1.1. Cubed foam mattress (COMFORTEX DECUBE) versus standard hospital mattress (standard polypropylene SG40)
- One study (n=44) showed a cubed foam mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2-4) when compared to a standard hospital mattress (very low quality).
- One study (n=44) showed a cubed foam mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard hospital mattress (very low quality).
- One study (n=44) reported medians for a cubed foam mattress and standard hospital mattress for length of stay in hospital. The median for a cubed foam mattress was 21 days (range 5-64) and 23 days (range 4-120) for the standard hospital mattress. No estimate for effect or precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Health-related quality of life
12.1.14.1.2. Bead filled mattress (BEAUFORT) versus standard hospital mattress
- One study (n=75) showed a bead filled mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard foam mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.3. Softform mattress versus standard 130mm NHS foam mattress
- One study (n=170) showed a softform mattress is more clinically effective at reducing the incidence of pressure ulcers (grade 2-4) when compared to a standard 130mm NHS foam mattress (low quality).
- One study (n=170) showed there is no clinical difference between a softform mattress and a standard 130mm NHS foam mattress for perception of comfort being very uncomfortable (low quality).
- One study (n=170) showed there may be no clinical difference between a softform mattress and a standard 130mm NHS foam mattress for perception of comfort being uncomfortable, but the direction of the estimate of effect favoured the softform mattress (very low quality).
- One study (n=170) showed a softform mattress is more clinically effective for perception of comfort being adequate when compared to a standard 130mm NHS foam mattress (low quality).
- One study (n=170) showed a softform mattress is more clinically effective for perception of comfort being comfortable when compared to a standard 130mm NHS foam mattress (low quality).
- One study (n=170) showed a softform mattress is more clinically effective for perception of comfort being very comfortable when compared to a standard 130mm NHS foam mattress (low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.4. Water-filled mattress versus standard hospital mattress
- One study (n=316) showed a water-filled mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard hospital mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.5. Alternative foam pressure-reducing mattress (CLINIFLOAT, OMNIFORM, SOFTFORM, STM5, THERAREST, TRANSFOAM, VAPOURLUX) versus standard hospital mattress
- Two studies (n=696) showed an alternative foam pressure-reducing mattress is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard hospital mattress (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.6. High-specification foam mattress (visco-polymer energy absorbing foam mattress (CONFORM-ED) versus standard mattress (KING's FUND, LINKNURSE, SOFTFOAM, TRANSFOAM, KING's FUND MATTRESS with a SPENCO or PROPAD overlay)
- One study (n=1166) showed there is potentially no clinical difference between a high-specification foam mattress and a standard mattress for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the high-spec foam mattress (very low quality).
- One study (n=706) showed there is no clinical difference between a high-specification foam mattress and a standard mattress for perception of comfort , the direction of the estimate of effect favoured the standard mattress (low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.7. Inflated static overlay versus microfluid static overlay and low-air-loss dynamic mattress
- One study (n=110) showed there may be a clinical benefit for a constant low-pressure support (inflated static overlay) compared to a constant low-pressure support (microfluid static overlay) and alternating-pressure support (low-air-loss dynamic mattress) for reducing the incidence of pressure ulcers (all grades) (very low quality).
- One study (n=64) showed there is no clinical benefit of a constant low-pressure support (inflated static overlay) for patient acceptability (comfort) when compared with a constant low-pressure support (microfluid static overlay) and alternating-pressure support (low-air-loss dynamic mattress) (moderate quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.8. Alternative foam mattress versus standard foam mattress
- Five studies (n=2016) showed an alternative foam mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard foam mattress (very low quality).
- Four UK studies (n=1980) showed an alternative foam mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard foam mattress (very low quality).
- Two studies (n=206) showed an alternative foam mattress is more clinically effective at reducing the incidence of pressure ulcers (grade 2-4) when compared to a standard foam mattress (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.9. Pressure redistributing mattress (CLINIFLOAT, OMNIFOAM, THERAREST, TRANSFOAM, VAPERM) versus standard NHS foam mattress (REYLON 150mm)
- One study (n=505) showed a pressure redistributing mattress is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to standard NHS foam mattress (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.10. Foam mattress replacement (MAXIFLOAT) versus foam mattress overlay (IRIS 3000)
- One study (n=40) showed a foam mattress replacement (Maxifloat) is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a foam mattress overlay (very low quality).
- One study (n=40) showed a foam mattress replacement (Maxifloat) is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to a foam mattress overlay (very low quality).
- One study (n=40) reported means for a foam mattress replacement (Maxifloat) and foam mattress overlay for time to develop new pressure ulcers. The median for a foam mattress replacement (Maxifloat) was 9.2 days and 6.5 days (range 4-120) for the foam mattress overlay. No estimate for effect or precision could be derived. (very low quality)
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.11. Solid foam overlay versus convoluted foam overlay
- One study (n=84) showed a solid foam overlay is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a convoluted foam overlay (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.12. Pressure-reducing foam mattress (TRANSFOAM) versus pressure-reducing foam mattress (TRANSFOAMWAVE)
- One study (n=100) showed there may be no clinical difference between a pressure-reducing TRANSFOAM foam mattress and a pressure-reducing TRANSFOAMWAVE foam mattress for reducing the incidence of pressure ulcers (all grades), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.13. Constant low-pressure mattress (CARITAL OPTIMA) versus standard foam mattress (10cm thick foam density 35kg/m3)
- One study (n=40) showed a constant low-pressure mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard foam mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.14. Dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)
- One study (n=84) showed there may be a clinical benefit for a SOFFLEX dry flotation mattress compared to a ROHO dry flotation mattress for reducing the incidence of pressure ulcers (all grades) (very low quality).
- One study (n=84) showed that there may not be a clinical benefit of a ROHO dry flotation mattress compared to a SOFFLEX dry flotation mattress for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- One study (n=84) showed there is no clinical difference between a SOFFLEX dry flotation mattress and a ROHO dry flotation mattress for patient acceptability (perception of comfort being very uncomfortable) (moderate quality).
- One study (n=84) showed a SOFFLEX dry flotation mattress is potentially more clinically effective for patient acceptability (perception of comfort being uncomfortable) when compared to a ROHO dry flotation mattress (low quality).
- One study (n=84) showed there may be no clinical difference between a SOFFLEX dry flotation mattress and a ROHO dry flotation mattress for patient acceptability (perception of comfort being adequate), but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=84) showed there may be no clinical difference between a SOFFLEX dry flotation mattress and a ROHO dry flotation mattress for patient acceptability (perception of comfort being comfortable), but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=84) showed there may be no clinical difference between a SOFFLEX dry flotation mattress and a ROHO dry flotation mattress for patient acceptability (perception of comfort being very comfortable), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.15. Gel mattress versus air-filled overlay (SOFCARE)
- One study (n=66) showed there may be a clinical benefit for a gel mattress compared to an air-filled overlay for reducing the incidence of pressure ulcers (all grades) (very low quality).
- One study (n=66) showed there may be a clinical benefit for a gel mattress compared to an air-filled overlay for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.16. Static air mattress (GAY MAR SOFCARE) versus water mattress (LOTUS PXM 3666)
- One study (n=37) showed there may be a clinical benefit for a water mattress compared to a static air mattress for reducing the incidence of pressure ulcers (all grades) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.17. Inflated static overlay (RIK or THERAKAIR) versus microfluid static overlay
- One study (n=105) showed there may be a clinical benefit for an inflated static overlay compared to a microfluid static overlay for reducing the incidence of pressure ulcers (all grades) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.18. Foam overlay versus Silicore overlay (SPENCO)
- One study (n=68) showed there may be a clinical benefit of a Silicore overlay compared to a foam overlay for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.19. Australian medical sheepskin versus no sheepskin
- Three studies (n=1281) showed Australian medical sheepskin is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to no sheepskin (very low quality).
- Three studies (n=1281) showed there is potentially no clinical difference between an Australian medical sheepskin and no sheepskin for reducing the incidence of pressure ulcers (grade 2 and above), the direction of the estimate of effect favoured the Australian medical sheepskin (very low quality).
- One study (n=539) reported 10 participants in the sheepskin group complained about its comfort. The clinical importance is unknown (very low quality).
- One study (n=297) reported 6 participants in the sheepskin group withdrew before study completion due to the sheepskin causing irritation, was too hot or uncomfortable. The clinical importance is unknown (very low quality).
- One study (n=539) reported a clinical benefit of Australian medical sheepskin when compared to no sheepskin for delaying the time to develop new pressure. The hazard ratio was 0.39 (95% CI 0.22 -0.69; p<0.001) (very low quality).
- One study (n=543) reported a clinical benefit for Australian medical sheepskin when compared to no sheepskin for delaying the time to develop new pressure ulcers. The mean for Australian medical sheepskin was 12 days and 9 days for no sheepskin. No estimate of clinical effect or precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.20. Static air overlay and cold foam mattress versus cold foam mattress alone
- One study (n=74) showed a static air overlay and cold foam mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to a cold foam mattress alone (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.21. 3D macroporous polyester overlay versus visco-elastic overlay
- Two studies (n=122) showed there is potentially no clinical difference between a macroporous polyester overlay and a visco-elastic overlay for reducing the incidence of pressure ulcers, the direction of the estimate of effect favoured the macroporous polyester overlay (low quality).
12.1.14.1.22. Alternating-pressure versus standard foam mattress
- Two studies (n=409) showed an alternating-pressure air mattress is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard foam mattress (low quality).
- One study (n=82) showed an alternating-pressure air mattress is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to a standard foam mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.23. Alternating-pressure versus constant low-pressure for pressure ulcer prevention
- Eleven studies (n=1622) showed alternating-pressure is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to constant low-pressure (very low quality).
- Six studies (n=826) showed alternating-pressure is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to constant low-pressure (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.24. Alternating pressure (various devices) versus constant low pressure (various devices)
- One study (n=230) showed an alternating-pressure mattress is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a constant low-pressure mattress (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.25. Alternating-pressure versus Silicore or foam overlay
- Four studies (n=331) showed there is potentially no clinical difference between alternating-pressure and a Silicore or foam overlay for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the alternating-pressure mattress (very low quality).
- Two studies (n=180) showed that, for people with chronic neurological conditions, there is potentially no clinical difference between an alternating-pressure overlay and a silicore overlay for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the alternating-pressure mattress (very low quality).
- Two studies (n=151) showed that, for people without chronic neurological conditions, there may be no clinical difference between an alternating-pressure mattress and silicore or foam overlay for reducing the incidence of pressure ulcers (all grades) but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=187) showed that there may not be a clinical difference between a silicore overlay when compared to an alternating-pressure overlay for patient acceptability (drop out due to discomfort), but the direction of the estimate of effect could favour the silicore overlay (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.26. Alternating-pressure versus water or static air mattress
- Three studies (n=458) showed there may be no clinical difference between alternating-pressure and water or static air mattress for reducing the incidence of pressure ulcers (all grades) but the direction of the estimate of effect could favour the water or static air mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.27. Alternating-pressure setting on mattress (DUO2) versus continuous low-pressure setting on mattress (DUO2)
- One study (n=140) showed there may be no clinical difference between a continuous low-pressure setting on mattress and an alternating-pressure setting on mattress for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured continuous low-pressure setting on mattress (very low quality).
- One study (n=170) reported that there was no difference in length of stay related to pressure ulcer development among people at high-risk placed on the intervention or control mattresses. The clinical importance is unknown. (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.28. Alternating-pressure air mattress (ALPHA-X-CELL) versus visco-elastic foam mattress (TEMPUR)
- One study (n=447) showed there may be no clinical difference between alternating-pressure air mattress and visco-elastic foam mattress for the incidence of pressure ulcers (all grades) but the direction of the estimate of effect could favour the visco-elastic foam mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.29. Alternating-pressure mattress (NIMBUS 3) versus dry flotation mattress overlay (ROHO)
- One study (n=16) showed there may be no clinical difference between an alternating-pressure mattress and a dry flotation mattress overlay for reducing the incidence of pressure ulcers (all grades), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.30. Dynamic flotation mattress (NIMBUS2) and alternating-pressure cushion versus low-pressure inflatable mattress (REPOSE SYSTEM) and cushion (polyurethane)
- One study (n=50) showed there may be no clinical difference between dynamic flotation mattress with alternating-pressure cushion and low-pressure inflatable mattress and cushion for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.31. Standard foam mattress in ICU/Standard foam mattress post-ICU versus Alternating-pressure mattress (NIMBUS) in ICU/Standard foam mattress post-ICU
- One study (n=160) showed no clinical difference between a standard foam mattress in ICU followed by a standard foam mattress post-ICU and an alternating-pressure mattress in ICU followed by a standard foam mattress post-ICU for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the standard foam mattress in ICU followed by a standard foam mattress post-ICU (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.32. Standard mattress in ICU/Standard foam mattress post-ICU versus Standard foam mattress ICU/constant low-pressure mattress (TEMPUR) post-ICU
- One study (n=155) showed there may be no clinical difference between a standard foam mattress in ICU followed by a constant low-pressure mattress post-ICU and a standard foam mattress in ICU followed by a standard foam mattress post-ICU for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured standard foam mattress in ICU followed by a constant low-pressure mattress post-ICU (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.33. Alternating-pressure mattress (NIMBUS) in ICU/Standard foam mattress post-ICU versus Standard foam mattress ICU/constant low-pressure mattress (TEMPUR) post-ICU
- One study (n=155) showed there may be no clinical difference between an alternating-pressure mattress in ICU followed by a standard foam mattress post-ICU and a standard foam mattress in ICU followed by a constant low-pressure mattress post-ICU for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the alternating-pressure mattress in ICU (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.34. Standard foam mattress in ICU/Standard foam mattress post-ICU versus Alternating-pressure mattress (NIMBUS) in ICU/ constant low-pressure mattress (TEMPUR) post-ICU
- One study (n=157) showed there may be no clinical difference for a standard foam mattress in ICU followed by a standard foam mattress post-ICU and an alternating-pressure mattress in ICU followed by a constant low-pressure mattress post-ICU for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the standard foam mattress in ICU followed by a standard foam mattress post-ICU (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.35. Alternating-pressure mattress (NIMBUS) in ICU/Standard foam mattress post-ICU versus alternating-pressure mattress (NIMBUS) in ICU/constant low-pressure mattress (TEMPUR) post-ICU
- One study (n=157) showed there may be no difference for an alternating-pressure mattress in ICU followed by a standard foam mattress post-ICU compared to an alternating-pressure mattress in ICU followed by a constant low-pressure mattress post-ICU for reducing the incidence of pressure ulcers (all grades) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.36. Standard foam mattress ICU/constant low-pressure mattress (TEMPUR) post-ICU versus alternating-pressure mattress (NIMBUS) in ICU/ constant low-pressure mattress (TEMPUR) post-ICU
- One study (n=142) showed there may be no clinical difference for a standard foam mattress in ICU followed by a constant low-pressure mattress post-ICU compared to an alternating-pressure mattress in ICU followed by a constant low-pressure mattress post-ICU for reducing the incidence of pressure ulcers (all grades) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.37. Alternating-pressure mattress with 2 layers of air cells (PEGASUS AIRWAVE SYSTEM) versus alternating-pressure large cell ripple mattress
- One study (n=62) showed an alternating-pressure mattress with 2 layers of air cells is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to an alternating-pressure large cell ripple mattress (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.38. Alternating-pressure mattress (PEGASUS AIRWAVE SYSTEM) versus alternating-pressure mattress (PEGASUS CAREWAVE SYSTEM)
- One study (n=75) showed there is no clinical difference between a Pegasus airwaves alternating-pressure mattress system and a Pegasus care wave alternating-pressure mattress system for reducing the incidence of pressure ulcers (grade 2 and above) (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.39. Alternating-pressure mattress (TRINOVA) versus control
- One study (n=44) showed there may be a clinical benefit for a Trinova alternating-pressure mattress compared to a control for reducing the incidence of pressure ulcers (all grades) (very low or moderate quality).
- One study (n=44) showed there may be a clinical benefit for a Trinova alternating-pressure mattress compared to a control for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- One study (n=44) reported data for the Trinova alternating-pressure mattress for patient acceptability (comfort). 11/18 participant thought the mattress was comfortable, 10/18 participants thought that the mattress was acceptable and 5/18 found the mattress comfort unacceptable. No estimate of effect or precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.40. Alternating-pressure overlay versus alternating-pressure mattress
- One study (n=1971) showed there is potentially no difference for an alternating-pressure mattress alternating-pressure overlay compared to for reducing the incidence of pressure ulcers (grade 2 and above) (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.41. Alternating-pressure bed (THERAPULSE) versus alternating-pressure mattress (HILL-ROM DUO)
- One study (n=62) showed there may be a clinical benefit for an alternating-pressure THERAPULSE bed compared to an alternating-pressure (HILL-ROM DUO) mattress for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- One study (n=62) reported means for an alternating-pressure THERAPULSE bed and an alternating-pressure (HILL-ROM DUO) mattress for length of stay in hospital for people who developed a pressure ulcer. The mean for an alternating-pressure (HILL-ROM DUO) mattress was 26 days (range 23-37.3) and 24 days (range 13-59) for an alternating-pressure (HILL-ROM DUO) mattress. No estimate for effect or precision could be derived (very low quality).
- One study (n=62) reported means for an alternating-pressure THERAPULSE bed and an alternating-pressure (HILL-ROM DUO) mattress for length of stay in hospital for people who did not develop a pressure ulcer. The mean for an alternating-pressure (HILL-ROM DUO) mattress was 18 days (range 5-127) and 20 days (range 5-49) for an alternating-pressure (HILL-ROM DUO) mattress. No estimate for effect or precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Health related quality of life
12.1.14.1.42. Alternating low-pressure air mattress with multi-stage inflation and deflation of air cells versus standard (CLINACTIV, HILLROM) alternating low-pressure air mattress with single-stage inflation and deflation of air cells
- One study (n=610) showed there is potentially no clinical difference between an alternating low-pressure air mattress with single-stage inflation and deflation of air cells compared to an alternating low-pressure air mattress with multi-stage inflation and deflation of air cells for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the low-pressure air mattress with single-stage inflation and deflation of air cells (very low quality).
- One study (n=610) showed there may be no clinical difference between an alternating low-pressure air mattress with multi-stage inflation and deflation of air cells and an alternating low-pressure air mattress with single-stage inflation and deflation of air cells for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of the estimate of effect could favour either intervention (very low quality).
- One study (n=610) showed there may be a clinical benefit for an alternating low-pressure air mattress with multi-stage inflation and deflation of air cells compared to an alternating low-pressure air mattress with single-stage inflation and deflation of air cells for patient acceptability (withdrawal due to discomfort) (very low quality).
- One study (n=610) reported a benefit for an alternating low-pressure air mattress with multi-stage inflation and deflation of air cells compared to an alternating low-pressure air mattress with single-stage inflation and deflation of air cells for time to develop a new pressure ulcer. The medians for an alternating low-pressure air mattress with multi-stage inflation and deflation of air cells was 5.0 days (Interquartile range 3.0-8.5) and 8 days (interquartile range 3.0 8.5) for an alternating low-pressure air mattress with single-stage inflation and deflation of air cells. No estimate of clinical effect or precision could be derived (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.43. Low-air-loss bed (KINAIR/THERAKAIR) versus static air mattress overlay/inflated static overlay (EHOB WAFFLE) or standard ICU bed
- One study (n=123) showed a low-air-loss bed is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a static air mattress overlay (very low quality).
- Two studies (n=183) showed there may be a clinical benefit for a low-air-loss bed compared to static air mattress overlay/inflated static overlay for reducing the incidence of pressure ulcers (all grades) (very low quality).
- Two studies (n=221) showed a low-air-loss bed is more clinically effective at reducing the incidence of pressure ulcers (grade 2and above)when compared to a static air mattress overlay or standard ICU bed (low quality).
- One study (n=98) showed a low air loss hydrotherapy bed is more clinically effective at reducing the incidence of people developing multiple ulcers when compared to a standard care (standard bed or foam, air or alternating-pressure mattress) (low quality).
- Three studies (n=319) showed a low-air-loss bed is more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to static air mattress overlay/standard ICU bed or standard care (standard bed or foam, air or alternating-pressure mattress) (low quality).
- One study (n=98) reported some information about patient acceptability (comfort) for the low air loss hydrotherapy mattress. 10/42 provided information about comfort, of these 5/10 participants though it was comfortable and 4/10 participants thought it was uncomfortable. The clinical importance is unknown (very low quality).
- One study (n=98) reported some information about patient acceptability (withdrawal from the study) for the low air loss hydrotherapy mattress compared with standard care (standard bed or foam, air or alternating-pressure mattress). In the low air loss hydrotherapy mattress group, 24/48 participantstients withdrew from the study, 6 on the first day of the study because a participant or family member complained about the bed (wet, cold or uncomfortable). In the standard care group 2/58 participants withdrew from the study. The clinical importance is unknown (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.44. Indentation load deflection (IDL) (25%) operating room foam mattress (density 1.3 cubic feet, IDL 30lb) versus operating room usual care (padding as required, including gel pads, foam mattresses, ring cushions (donuts))
- One study (n=413) showed an indentation load deflection operating room foam mattress has a potential for clinical harm at reducing the incidence of pressure ulcers (all grades) when compared to operating room usual care (low quality).
- One study (n=413) showed that there was potentially no clinical difference of an indentation load deflection operating room foam mattress compared to operating room usual care for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of the estimate of effect favoured usual care (very low quality).
- One study (n=413) reported that participants on the indentation load deflection operating room foam mattress were significantly more likely to have skin changes than those on the usual care operating room table. The clinical importance is unknown (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.45. Viscoelastic polymer pad versus no overlay
- One study (n=416) showed a viscoelastic polymer pad is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades of pressure ulcers) when compared to no overlay (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.46. Viscoelastic foam overlay versus no overlay
- One study (n=175) showed there may be no clinical difference for a viscoelastic foam overlay compared to no overlay for reducing the incidence of pressure ulcers (all grades), the direction of the estimate of effect favoured the viscoelastic foam overlay (very low quality).
- One study (n=175) showed there may be no clinical difference between viscoelastic foam overlay and no overlay for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of the estimate of effect could favour either intervention (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.47. Neoprene air filled bladder (dry flotation) device compared to a disposable polyurethane foam prone head positioner
- One study (n=44) showed there is potentially a clinical benefit for a neoprene air filled bladder (dry flotation) device compared to a disposable polyurethane foam prone head positioner for reducing the incidence of pressure ulcers (all grades) (very low quality).
- One study (n=44) showed there may be a clinical benefit for a neoprene air filled bladder (dry flotation) device compared to a disposable polyurethane foam prone head positioner for reducing the incidence of pressure ulcers (grade 2and above) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.48. A prone view protective helmet system with a disposable polyurethane foam prone head positioner versus a disposable polyurethane foam prone head positioner
- One study (n=44) showed a prone view protective helmet system with a disposable polyurethane foam prone head positioner has a potential for clinical benefit for reducing the incidence of pressure ulcers (all grades) when compared to a disposable polyurethane foam prone head positioner (very low quality).
- One study (n=44) showed there may be a clinical benefit for a prone view protective helmet system with a disposable polyurethane foam prone head positioner compared to a disposable polyurethane foam prone head positioner for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.49. A neoprene air filled bladder (dry flotation) device versus a prone view protective helmet system with a disposable polyurethane foam prone head positioner
- One study (n=44) showed there is no clinical difference between a neoprene air filled bladder (dry flotation) device and a prone view protective helmet system with a disposable polyurethane foam prone head positioner for reducing the incidence of pressure ulcers (all grades) (low quality).
- One study (n=44) showed there is no clinical difference between a neoprene air filled bladder (dry flotation) device and a prone view protective helmet system with a disposable polyurethane foam prone head positioner for reducing the incidence of pressure ulcers (grade 2 and above) (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.1.50. A multi-cell pulsating dynamic mattress versus a standard mattress
- Two studies (n=368) showed that for people undergoing surgery, a multi-cell pulsating dynamic mattress system is more clinically effective at reducing the incidence of pressure ulcers (all grades) when compared to a standard mattress (low quality).
- One study (n=170) showed that for people undergoing surgery, a multi-cell pulsating dynamic mattress system is potentially more clinically effective at reducing the incidence of pressure ulcers (grade 2 and above) when compared to a standard mattress (very low quality).
- One study (n=170) reported information about the length of stay in hospital for people who developed pressure ulcers. The average length of stay for those developing pressure ulcers was 14 days. Six of the 8 people who developed ulcers had a length of stay longer than average for the specific diagnosis. The clinical importance is unknown (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Health related quality of life
12.1.14.1.51. A visco-elastic foam accident and emergency (A&E) overlay and ward mattress versus standard A&E overlay and ward mattress
- One study (n=101) showed there may be a clinical benefit for visco-elastic foam A&E overlay and ward mattress compared to a standard A&E overlay and ward mattress for reducing the incidence of pressure ulcers (grade 2 and above) (very low quality).
- One study (n=101) showed there may be a clinical benefit for visco-elastic foam A&E overlay and ward mattress compared to standard A&E overlay and ward mattress for reducing the incidence of pressure ulcers (all grades) (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.2. Wheelchair cushions
12.1.14.2.1. Slab foam cushion versus bespoke contoured foam cushion
- Two studies (n=300) showed there is no clinical difference between a slab foam cushion when compared with a bespoke contoured foam cushion for reducing the incidence of pressure ulcers (all grades) (low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.2.2. Gel cushion with foam base (JAY) versus foam cushion
- One study (n=141) showed a gel cushion with foam base is potentially more clinically effective at reducing the incidence of pressure ulcers (all grades of pressure ulcers) when compared to a foam cushion (low quality).
- One study (n=163) showed there may be a clinical benefit for a gel cushion with foam base compared to a foam cushion for patient acceptability (withdrawal due to discomfort) (very low quality).
- No evidence was found for the following outcomes:
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.2.3. Pressure reducing cushion (not specified – chosen by nurse based on the individual) versus standard 3 inch convoluted foam cushion (EGGRATE)
- One study (n=32) showed there may be a clinical benefit for a pressure reducing cushion compared to a standard 3 inch convoluted foam cushion for reducing the incidence of pressure ulcers (all grades), (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.2.4. Skin protection cushion versus segmented foam cushion
- One study (n=232) showed a skin protection cushion is potentially more clinically effective at reducing the incidence of sitting related ischial tuberosities when compared to a segmented foam cushion (very low quality).
- One study (n=232) showed a skin protection cushion is potentially more clinically effective at reducing the incidence of pressure ulcers of the combined ischial tuberosities and sacral/coccyx areas when compared to a segmented foam cushion (very low quality).
- No evidence was found for the following outcomes:
- Patient acceptability
- Rates of development of pressure ulcers
- Time to develop new pressure ulcers
- Time in hospital or NHS care
- Health related quality of life
12.1.14.3. Economic (adults)
12.1.14.3.1. Alternating pressure verses alternative foam
- One cost–utility analysis found that alternating pressure overlays and alternating pressure mattress replacements dominate (less costly and more effective) high specification foam mattresses in the prevention of pressure ulcers. This analysis was assessed as partially applicable with potentially serious limitations.
12.1.14.3.2. Comparisons between alternating pressure devices
- One cost–utility analysis found that alternating pressure mattress replacements were not cost effective compared to alternating pressure overlays for the prevention of pressure ulcers (ICER: £253,000 per QALY gained). This analysis was assessed as partially applicable with potentially serious limitations.
- Conversely, 1 cost-effectiveness analysis found alternating pressure mattress replacements dominate alternating overlays, with a longer time to pressure ulcer development and reduced costs. This analysis was assessed as partially applicable with potentially serious limitations.
12.1.14.3.3. High specification foam verses standard practice
- One cost–effectiveness analysis found that high specification foam mattresses dominate standard mattresses in the prevention of pressure ulcers, with a reduced incidence of pressure ulcers at a lower cost. This analysis was assessed as partially applicable with minor limitations.
- One cost–utility analysis found that use of pressure redistribution foam mattresses (for all residents) dominates standard practice in the prevention of pressure ulcers, with an increase in QALYs at a lower cost. This analysis was assessed as partially applicable with potentially serious limitations
- One cost-effectiveness analysis found that visco-polymer energy absorbing foam mattresses dominate standard mattresses, with reduced costs and reduced incidence of pressure ulcer. This analysis was assessed as partially applicable with minor limitations.
12.1.14.3.4. Constant low pressure supports compared to standard care
- One cost–effectiveness analysis found that usual care plus Australian medical sheepskin was more costly and more effective than usual care alone (ICER: £2,298 per sacral pressure ulcer avoided). This analysis was assessed as partially applicable with potentially serious limitations.
- One cost–effectiveness analysis found that a preventative treatment protocol and use of a Clinitron Rite-Hite Air Fluidised Therapy bed dominates standard care on an ICU bed (reduction in pressure ulcer incidence and reduced costs). This analysis was assessed as partially applicable with potentially serious limitations.
- One cost–effectiveness analysis found that use of an inflated static overlay dominated (reduction in pressure ulcer incidence and reduced costs) standard care in the prevention of pressure ulcers. This analysis was assessed as partially applicable with potentially serious limitations.
12.1.14.3.5. Constant low pressure supports compared to standard care in operating theatre
- One cost–utility analysis found that use of viscoelastic polymer overlays on operating tables (for people undergoing surgery expected to last ≥90 minutes) dominates current practice, yielding higher QALYs at a lower cost. This analysis was assessed as partially applicable with minor limitations.
12.1.14.4. Clinical (neonates, infants, children and young people)
No evidence was identified
12.1.14.5. Economic (neonates, infants, children and young people)
No evidence was identified
12.2. Recommendations and link to evidence
12.2.1. Adults
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new pressure ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | There was low to very low quality evidence to suggest that high specification foam mattresses were better than standard foam mattress for preventing pressure ulcers. All studies showed a clinical benefit of higher specification foam mattresses (cubed foam mattress, soft foam mattress, pressure redistributing foam mattress), in reducing the incidence of pressure ulcers when compared to standard hospital mattresses (standard polypropylene SG40, standard 130mm NHS foam mattress, standard 150mm NHS foam mattress). A study published in 2003 which included a visco-polymer energy absorbing foam mattress compared to a standard mattress or cushion (which was a variety of foam mattresses or overlays), showed no clinical difference for the prevention of pressure ulcers or comfort of surface. The softfoam mattress was judged to be adequate to very comfortable in comparison to the standard 130mm NHS foam mattress. The GDG recognised that the standard hospital mattress used in the studies was likely to have varied yearly and by hospital. Current standard hospital mattresses are likely to be higher specification foam mattresses than those included in the studies (as the majority of the studies were undertaken greater than 10 years ago). The GDG further acknowledged that the type of mattress used in community settings will vary. Both a bead-filled mattress and a water-filled mattress showed a clinical benefit for reducing the incidence of pressure ulcers when compared to standard hospital mattresses (type not specified). However these studies were published in 1982 and the type of standard hospital mattress used in the study is unlikely to be representative of the mattress used in current clinical practice. One small study found a foam mattress to be of clinical benefit in reducing the incidence of pressure ulcers compared to a foam overlay. Another small study found solid foam to be clinically beneficial for reducing the incidence of pressure ulcers compared to convoluted foam. Sheepskin overlay was found to be of clinical benefit compared to no sheepskin overlay for preventing all grades of pressure ulcers (using the AHCPR classification) but this did not follow for pressure ulcers of grade 2 and above. The sheepskin overlay had comfort issues that were specific to the nature of the sheepskin, such as irritation and being too hot. The following were clinically beneficial for reducing the incidence of pressure ulcers; a constant low pressure mattress compared to a standard foam mattress, an alternating pressure mattress compared to a standard foam mattress, various types of alternating pressure mattresses compared to various constant low pressure mattresses, and a variety of alternating-pressure devices compared to other alternating-pressure devices. A mattress with a single-stage inflation system delayed the onset until the development of pressure ulcers compared to a multi-stage inflation system. In 3 studies low air loss beds were found to be of clinical benefit for reducing the incidence of pressure ulcers when compared to a standard bed. In addition, a static air overlay on a cold foam (a form of polyurethane) mattress was of clinical benefit compared to no overlay on a cold foam mattress, a gel mattress was found to be more clinically beneficial than an air-filled overlay, an inflated static overlay was more clinically beneficial than a microfluid static overlay and a silicore overlay was more beneficial than a foam overlay, for reducing incidence of pressure ulcers. No clinical benefit was found for an alternating-pressure compared to silicore or foam overlay. Operating theatre A viscoelastic polymer pad was clinically beneficial for reducing the incidence of pressure ulcers compared to no overlay. A pressure redistributing (indentation load deflection) operating room foam mattress was not beneficial in comparison to operating room usual care (using padding, gel pads, foam mattresses and ring cushions) for reducing the incidence of all grades of pressure ulcers (grade 1 and above). However grade 2 and above pressure ulcers demonstrated no clinical difference. A multi-cell pulsating dynamic mattress system was more beneficial than the standard mattress (gel pad or standard pad in operating room or a replacement mattress postoperatively or a standard hospital mattress with a 6 inch or 4 inch overlay) for reducing the incidence of all grades of pressure ulcer and, in particular, grade 2 and above. The GDG considered that for people in the operating theatre, a high specification foam theatre mattress should be given as a minimum, as people undergoing surgery were likely to be at risk of developing a pressure ulcer. The group also recognised that in some operating theatres, equivalent pressure redistributing surfaces may be used and that these may provide similar benefits. Therefore a separate recommendation for people undergoing surgery (in the operating theatre) was developed. Accident and Emergency A visco-elastic overlay was more beneficial than the standard Accident and Emergency overlay for reducing the incidence of pressure ulcers. The GDG wished to highlight that individuals awaiting admission in Accident and Emergency, particularly those on trolleys, should be provided with high specification foam mattresses as a minimum, in line with those who have been admitted to secondary care, as these individuals may be at risk of developing pressure ulcers. Intensive care There was no clinical benefit of alternating pressure or constant low pressure mattresses for the prevention of pressure ulcers in people in intensive care. The GDG considered that for these individuals, a high specification foam mattress, provided on admission to intensive care, should be given as a minimum. Wheelchair cushions Two studies suggest no clinical difference between a high specification foam cushion and a slab foam cushion. A gel filled pad and a pressure-reducing cushion (designed to improve tissue tolerance in sitting by providing more surface area and reducing peak pressure) were clinically beneficial compared to foam cushions for reducing the incidence of pressure ulcers in people who use a wheelchair. A skin protection cushion was clinically beneficial compared to a segmented foam cushion for reducing the incidence of pressure ulcers. Fewer people in the pre-contoured foam plus gel filled pad group withdrew due to discomfort than in the foam cushion group. The GDG highlighted that people who use wheelchairs were likely to be at risk of developing pressure ulcers and that pressure redistribution was likely to be needed. The GDG noted that the evidence suggested a benefit of high specification foam cushions. The GDG therefore developed a recommendation for this population to emphasise the need to provide high specification foam cushions to prevent pressure ulcers. The following comparisons were not thought to inform the recommendation: alternative foam mattress versus standard foam mattress, pressure-reducing foam mattress compared to a pressure-reducing foam mattress or a dry flotation mattress compared to dry flotation mattress The GDG discussed the needs of individuals who are likely to be sitting for long periods of time. Although limited evidence was identified specifically in this population, the GDG felt that these individuals were likely to have similar pressure redistributing requirements as adults who use a wheelchair. The GDG therefore chose to develop a recommendation highlight that the needs of these individuals should be considered and to further recommend that these people are provided with a pressure redistributing cushion. Primary and community care settings The GDG noted that there was limited evidence available focusing on people in primary and community care settings such as nursing homes. The GDG considered that this group of people were likely to be at risk of developing pressure ulcers and would benefit from specific preventative care. Despite the lack of evidence, the GDG considered that the benefits of high specification foam mattresses were likely to be applicable to this population, in line with those being admitted to secondary care. People in primary and community care settings were therefore included in the recommendation to highlight that this population should be provided with a high specification foam mattress to prevent the development of pressure ulcers. Summary Given the available evidence, the GDG noted that the provision of a high-specification foam mattress was likely to significantly reduce the risk of pressure ulcer development. No potential harms for the provision of high-specification foam mattresses were identified. As such, the GDG agreed that all individuals considered at risk of developing pressure ulcers should be considered for a high-specification foam mattress, including the specific populations outlined above. The GDG noted that this was likely to include all individuals admitted to secondary care, dependent upon individual characteristics (for example, their clinical condition), as well as people requiring ongoing care in primary care settings, people with significant limited mobility and all other individuals considered at risk of developing pressure ulcers. The GDG considered the use of overlays as an alternative to the provision of a high specification mattress. Although there was evidence to suggest that there was some benefit of using an overlay such as sheepskin in some scenarios, the provision of high specification foam mattresses was considered to be adequate as a minimum. Any further benefit from the use of an overlay in addition to a high specification mattress was unclear. |
| Economic considerations | The GDG considered evidence from 9 economic evaluations, alongside relevant UK unit costs of devices. Three economic evaluations found high specification foam to dominate standard practice, as they reduce the incidence of pressure ulcers and reduces costs. The GDG therefore agreed that the use of high specification foam would be cost-effective and potentially cost saving, compared to standard mattresses, for the population outlined in the recommendation above. The GDG did not consider the evidence (either clinical or economic) to be clear enough to make a recommendation in favour of other types of support surface, over the use of high specification foam, for the prevention of pressure ulcers in these people. Note that at present high specification foam is generally considered to be standard care in the UK NHS, thus this recommendation is not expected to have a large impact on resources. One cost-utility analysis found that the use of viscoelastic polymer overlays on operating tables led to an increase in QALYs and a reduction in costs. The clinical evidence also showed that the use of support surfaces reduces the incidence of pressure ulcers in theatre, which implies an increase in quality of life and a reduction in treatment costs. The GDG therefore felt that the use of high specification foam theatre mattresses or equivalent pressure redistributing surfaces would be cost effective, and may even be cost-saving, for people who are undergoing surgery. No economic evidence was identified specifically relating to pressure redistributing cushions for people who use a wheelchair. The GDG noted that the clinical evidence showed clinical benefit (reduction in incidence of pressure ulcers) when pre-contoured foam plus a gel filled pad and a pressure -reducing cushion were used in this population, compared to foam cushions. The clinical benefit of these cushions indicates that they prevent pressure ulcer related reductions in quality of life, and that they reduce treatment costs. The GDG agreed that the use of high specification foam, or other pressure redistributing cushions, would be highly likely to be cost-effective, and may even be cost saving, for people who use a wheelchair. |
| Quality of evidence | There was low to very low quality evidence for high specification foam mattresses compared to standard foam mattresses for the prevention of pressure ulcers. The type of mattresses included in the studies (both as intervention and comparison) were highly variable. Studies of other types of mattresses, overlays, beds and cushions had low to very low quality evidence. Most of the studies had serious to very serious imprecision and risk of bias. Only limited evidence was identified for people who were in primary care or community care settings such as nursing homes. |
| Other considerations | The GDG highlighted that all people in secondary care are considered to be at risk of developing a pressure ulcer and should therefore receive a high specification foam mattress. |
12.2.2. Neonates, infants, children and young people
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 2 statements from the Delphi consensus survey to inform the recommendations on the use of pressure redistributing devices for the prevention of pressure ulcers. The statement was ‘Healthcare professionals should use a high specification cot mattress for all neonates and infants, or a high specification foam mattress for all children and young people’. In developing the recommendation, the GDG also considered evidence from the statement ‘Healthcare professionals should use a high specification pressure redistributing overlay for all neonates, infants, children and young people at risk of developing a pressure ulcer’. Both statements were accepted by the Delphi consensus panel. Further detail on the Delphi consensus survey can be found in Appendix N. The statement on mattresses was included in Round 1 of the Delphi consensus survey. A number of comments from panel members suggested that the provision of pressure redistributing mattresses would be dependent upon the risk of the individual, following risk assessment. Further responses suggested that there may be potential harms when providing a high specification mattress, notably that these mattresses can limit the child's ability to move which may affect rehabilitation. A large proportion of comments highlighted the need to ensure that care is tailored to the individual. For example, 1 panel member emphasised that the need for a pressure redistributing mattress would be dependent upon the child's clinical condition, the length of stay, risk level and mobility. The statement on overlays was included in Round 1 of the Delphi consensus survey. A number of comments from panel members suggested that the use of mattresses was generally preferable to overlays, however there were specific situations in which overlays could provide a benefit. Panel members iilustrated this with the example of a delay in the provision of a high specification mattress which could result in potential harm (namely, the development of a pressure ulcer), or in community or home settings. However, some panel members also highlighted specific harms of using an overlay in place of a mattress. For example, panel members emphasised that some overlays could raise a child above the bed rails resulting in a falling hazard. Other comments noted that the weight of a child (particularly for neonates) should be considered when using specific pressure redistributing devices. Another comment noted that there were issues relating to cleaning and decontamination with regards to overlays. The GDG discussed the statement on mattresses and agreed that a recommendation should be developed. On further reflection and consideration of the qualitative comments received, the group agreed that pressure redistributing mattresses should be provided to all neonates, infants, children and young people who would be considered to be at significant risk of developing a pressure ulcer in a hospital setting. The GDG felt that those in community settings who required a pressure redistributing mattress were likely to be neonates, infants, children and young people at significant risk of developing a pressure ulcer. Further discussion on the statement on overlays from the GDG took into account the potential harms raised by the consensus panel. The GDG however, felt that the use of overlays for neonates and infants was common place and agreed that for these populations, the use of a high specification cot overlay might be an option in place of a high specification cot mattress. The GDG felt that the benefits of recommending pressure redistribution in the form of a high specification mattress were likely to be substantial in the subsequent prevention of pressure ulcer development, particularly in such a large population. Although potential harms were identified by the consensus panel in the use of cot and bed mattresses (for example, by limiting movement and potentially preventing rehabilitation) and cot overlays the GDG considered that these were likely to be outweighed by a significant benefit in pressure ulcer prevention. |
| Economic considerations | There are costs associated with high specification foam cot and bed mattresses, and overlays. The estimated purchase costs are £50-£199 (typical products identified by GDG members), and the devices can be used over a number of years, therefore the expected cost per patient is low. The GDG considered these costs likely to be offset by the benefits of the intervention in terms of improvement in the person's quality of life, and reduction in future treatment costs through reduction in pressure ulcer incidence. The GDG felt there was insufficient evidence to recommend the use of more expensive dynamic support surfaces for prevention of pressure ulcers in this population. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 2 statements which were included in Round 1 of the Delphi consensus survey and both reached 83% consensus agreement. Further details can be found in Appendix N. |
| Other considerations | There were no other considerations. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new pressure ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus panel to develop the recommendation. The statement was ‘Healthcare professionals should offer infants, children and young people who are long term wheel chair users appropriate wheelchair assessments.’ The statement was accepted by the GDG in Round 1 of the survey. Further detail on the Delphi consensus survey can be found in Appendix N. The statement was included in Round 1 of the Delphi consensus. Qualitative responses gathered from panel members suggested that there were a variety of methods for assessing the pressure ulcer development in people who use wheelchairs (for example, pressure mapping) and that it was important to ensure that infants, children and young people who use wheelchairs received education in the importance of pressure ulcer prevention. A number of panel members highlighted the importance of ensuring that the assessments took place regularly because the growth of children may affect the appropriateness of their wheelchair size and the need to consider wheel chair cushions. There is also the potential for rapid change in clinical condition in these children. One comment identified that assessment should be carried out by a healthcare professional who is appropriately trained in carrying out assessment. A second comment suggested that this would be in co-ordination with paediatric occupational therapists/physiotherapists. One panel member noted that there is a lack of paediatric occupational therapists available in their area. There were also comments from panel members regarding difficulty in providing timely wheel chair assessments in their area. One panel member noted that this was often due to wheel chair users travelling from outside of their local area to access services, whilst a second stated that this would be because of the lack of paediatric occupational therapists available. The GDG discussed the statement and agreed that a recommendation should be developed. The GDG felt that there were likely to be a range of benefits, including but not limited to the prevention of pressure ulcer development, from providing infants, children and young people with regular wheelchair assessments and that doing so represented good practice. The group felt that this was supported by qualitative comments received identifying that these individuals often changed physical and clinical state rapidly (for example, they were likely to grow or their clinical condition may change quickly) meaning that regular assessment was important. The GDG acknowledged that there may be some areas in which the lack of paediatric occupational therapists, or occupational therapists with experience of working with children may be limited. The GDG therefore did not wish to recommend who should be carrying out the assessment, as it was acknowledged that this was likely to vary across the UK. |
| Economic considerations | There are costs associated with wheelchair assessments and provision of pressure redistribution. The GDG noted that this is a very high risk population, and provision of pressure redistribution is crucial. The GDG considered the likely cost implications (for example the cost of a paediatric pressure relieving cushion, £185), and concluded that the benefits of the intervention in terms of improvement in quality of life and reduction in future treatment costs (through reduction in incidence of pressure ulcers) are likely to far outweigh the costs. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey and reached 97% consensus agreement. Further details can be found in Appendix N. |
| Other considerations | There were no other considerations. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus panel to develop the recommendation. The statement was ‘Pressure redistributing surfaces should be used to prevent occipital pressure ulcers in neonates / infants / children / young people at risk of developing pressure ulcers.’ During Round 1 of the Delphi consensus panel, qualitative feedback to a number of statements on the prevention of pressure ulcers highlighted that the sites at risk from pressure damage were different in neonates, infants, children and young people, those in adults. For these populations members of the panel considered the occiput to be a site at great risk of pressure ulcer development. As such, the GDG felt that a statement should be developed for the use of specific pressure redistributing devices for the prevention of occipital pressure ulcers for inclusion in Round 2 of the survey. The statement ‘Pressure redistributing surfaces should be used to prevent occipital pressure ulcers in neonates / infants / children / young people at risk of developing pressure ulcers’ was therefore developed. The statement was accepted by the Delphi panel in Round 2 of the survey. Further detail on the Delphi consensus survey can be found in Appendix N. During Round 2 of the Delphi consensus survey, qualitative responses gathered highlighted that the clinical condition of the child may prevent the use of pressure redistributing devices for the prevention of occipital pressure ulcers (for example, those with a cervical spine injury may have their head mobilised in skull traction). Other comments suggested that the method of pressure redistribution may come from the use of repositioning strategies, or devices such as gel pads or cushions. The GDG discussed the statement and the qualitative responses received and agreed that a recommendation should be developed. The GDG felt that responses received from the panel were helpful and agreed that the recommendation should reflect that the exact pressure redistributing strategy employed would need to be tailored to the individual, accounting for factors such as clinical condition. The GDG therefore developed a recommendation to reflect that any neonates, infants, children and young people considered at risk of developing an occipital pressure ulcer should be provided with a pressure redistributing surface. The GDG agreed that the benefits of preventing occipital ulcers, that were to come from the provision of a pressure redistributing surface, were likely to outweigh any possible harms (for example, the possibility of increasing pressure on other sites). |
| Economic considerations | The GDG acknowledged that there would be cost implications of providing occipital pressure redistributing surface. The GDG considered the example of a gel pillow which costs £6.83. This device could be used by a number of patients; therefore the cost per patient would be small. Prevention of pressure ulcers prevents detrainments to quality of life, and future treatment costs. The GDG therefore agreed that provision of an appropriate pressure redistribution surface was highly likely to be cost-effective for people at risk of developing occipital pressure ulcers. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 2 of the Delphi consensus survey and reached 76% consensus agreement. Further details can be found in Appendix N. |
Tables
Table 50Glossary of terms (NPUAP 2007)20
| Term | Definition |
|---|---|
| Physical concepts related to support surfaces | |
| Static | Not active or moving; stationary. However with regards to support surfaces the description has now changed to mean ‘non-powered’. |
| Dynamic | Relating to energy or to objects in motion. However with regards to support surfaces the description has now changed to mean ‘powered’. |
| Friction (frictional force) | The resistance to motion in a parallel direction relative to the common boundary of 2 surfaces. |
| Coefficient of friction | A measurement of the amount of friction existing between 2 surfaces. |
| Envelopment | The ability of a support surface to conform, so to fit or mold around irregularities in the body. |
| Fatigue | The reduced capacity of a surface or its components to perform as specified. This change may be the result of intended or unintended use and/or prolonged exposure to chemical, thermal, or physical forces. |
| Force | A push-pull vector with magnitude (quantity) and direction (pressure, shear) that is capable of maintaining or altering the position of a body. |
| Immersion | Depth of penetration (sinking) into a support surface. |
| Life expectancy | The defined period of time during which a product is able to effectively fulfil its designated purpose. |
| Mechanical load | Force distribution acting on a surface. |
| Pressure | The force per unit area exerted perpendicular to the plane of interest. |
| Pressure redistribution | The ability of a support surface to distribute load over the contact areas of the human body. This term replaces prior terminology of pressure reduction and pressure relief surfaces |
| Pressure reduction | This term is no longer used to describe classes of support surfaces. The term is pressure redistribution; see above. |
| Pressure relief | This term is no longer used to describe classes of support surfaces. The term is pressure redistribution; see above |
| Shear (shear stress) | The force per unit area exerted parallel to the plane of interest. |
| Shear strain | Distortion or deformation of tissue as a result of shear stress. |
| Components of support surfaces | |
| Air | A low density fluid with minimal resistance to flow. |
| Cell/bladder | A means of encapsulating a support medium. |
| Viscoelastic foam | A type of porous polymer material that conforms in proportion to the applied weight. The air exists and enters the foam cells slowly which allows the material to respond slower than a standard elastic foam (memory foam). |
| Elastic foam | A type of porous polymer material that conforms in proportion to the applied weight. Air enters and exits the foam cells more rapidly, due to greater density (non memory). |
| Closed cell foam | A non-permeable structure in which there is a barrier between cells, preventing gases or liquids from passing through the foam. |
| Open cell foam | A permeable structure in which there is no barrier between cells and gases or liquids can pass through the foam. |
| Gel | A semisolid system consisting of a network of solid aggregates, colloidal dispersions or polymers which may exhibit elastic properties (can range from a hard gel to a soft gel). |
| Pad | A cushion-like mass of soft material used for comfort, protection or positioning. |
| Viscous fluid | A fluid with a relatively high resistance to flow of the fluid. |
| Elastomer | Any material that can be repeatedly stretched to at least twice its original length; upon release the stretch will return to approximately its original length. |
| Solid | A substance that does not flow perceptibly under stress. Under ordinary conditions retains its size and shape. |
| Water | A moderate density fluid with moderate resistance to flow. |
| Features of support surfaces | |
| Air fluidised | A feature of a support surface that provides pressure redistribution via a fluid-like medium created by forcing air through beads as characterised by immersion and envelopment. |
| Alternating pressure | A feature of a support surface that provides pressure redistribution via cyclic changes in loading and unloading as characterised by frequency, duration , amplitude, and rate of change parameters. |
| Lateral rotation | A feature of a support surface that provides rotation about a longitudinal axis as characterised by degree of patient turn, duration and frequency. |
| Low air loss | A feature of a support surface that provides a flow of air to assist in managing the heat and humidity (microclimate) of the skin. |
| Zone | A segment with a single pressure redistribution capability. |
| Multi-zoned surface | A surface in which different segments can have different pressure redistribution capabilities. |
| Categories of support surfaces | |
| Reactive support surface | A powered and non-powered support surface with the capability to change its load distribution properties only in response to applied load. |
| Active support surface | A powered support surface, with the capability to change its load distribution properties, with or without applied load. |
| Integrated bed system | A bed frame and support surface that are combined into a single unit whereby the surface is unable to function separately. |
| Non-powered | Any support surface not requiring or using external sources of energy for operation (Energy = D/C or A/C). |
| Powered | Any support surface requiring or using external sources of energy to operate (Energy = D/C or A/C). |
| Overlay | An additional support surface designed to be placed directly on top of an existing surface. |
| Mattress | A support surface designed to be placed directly on the existing bed frame. |
Table 51Summary of included studies
| Study | Intervention/comparator | Population | Outcomes | Study length |
|---|---|---|---|---|
| Andersen 19823 | Standard hospital mattress versus alternating air mattress versus water-filled mattress (air mattress for camping filled with water). | Peoplein acute setting at high risk of pressure ulcer development (Anderson scale) and without pressure ulcers. |
| 10-day follow-up |
| Aronovitch 19996 | Alternating pressure system intra and postoperatively (MICROPULSE) versus conventional management (gel pad (ACTION PAD) or standard pad in operating room and a replacement mattress (PRESSURE GUARD II) postoperatively). | People undergoing elective surgery under general anaesthetic. |
| 7-day follow-up |
| Bennett 199815 | Low air loss hydrotherapy (Permeable fast drying filter sheet over low-air-loss cushions (circulating air)(clensicair) versus standard care (standard bed or foam, air, alternating-pressure mattresses, skin care not standardised). | People in acute and long-term care incontinent of urine or faeces with pressure ulcers grade 2 or below. |
| 60-day follow-up |
| Brienza 201027 | Skin protection cushion (SPC) versus segmented foam cushion (SFC) The skin protection cushion was a commercially available cushion with an incontinence cover. Cushions were selected from 3 which were designed to improve tissue tolerance by reducing peak pressures near bony prominences, accommodating orthopaedic deformities through immersion, enveloping small irregularities at the seating interface without causing height pressure gradients, and dissipating heat and moisture. Solid seat inserts were provided. The segmented foam cushion was a cross-cut, 7.6cm thick, segmented foam cushion with fitted incontinence cover and solid seat insert. | Elderly, nursing home population who used wheelchairs as primary means of seating and mobility and were at-risk for developing pressure ulcers. |
| 6 months |
| Cassino 201330 | Three-dimensional overlay (AIARTEX), made of 3-D macro-porous material, 9mm thick, made completely of polyester and weighing 800grams, consisting of 2 parallel layers, 1 on top of the other, linked by transverse monofilaments versus dry viscoelastic polyurethane polymer overlay (AKTON) 15.9mm thick, made of vulcanised rubber with a strong memory for shape, weighing 35kg | People in long term care. |
| 12 weeks |
| Cavicchioli 200731 | High-tech (HILL-ROM, DUO 2) mattress on alternating low-pressure setting versus high-tech (HILL-ROM DUO 2), mattress on continuous low-pressure setting. | People in acute and long-term care deemed at risk of pressure ulceration (Braden score of less than 17 activity or mobility sub-scales less than 3). |
| 2-week follow-up |
| Cobb 199733 | Low air loss bed (KINAIR) versus static air mattress overlay (EHOB WAFFLE). | People in hospital and intensive care units considered high risk on Braden score. |
| 40-day follow-up |
| Collier 199635 | Comparison of 8 foam mattresses: new standard hospital mattress versus pressure redistributing foam mattresses (CLINIFLOAT, OMNIFOAM, SOFTFORM, STM5, THERAREST, TRANSFOAM, VAPOURLUX). | People on a general medical ward, no further details. |
| Not clear but assessed weekly |
| Conine 199039 | Alternating-pressure overlay versus silicore overlay over standard hospital mattress (spring or foam) All participants received usual care including 2-3 hourly turning; daily bed baths; weekly bath or shower; use of heel, ankle and other protectors. | People with chronic neurological diseases. |
| 3-month follow-up |
| Conine 199338 | Slab cushion bevelled at base to prevent seat sling versus contoured foam cushion with a posterior cut out in the area of ischial tuberosities and an anterior ischial bar. | People in extended care at high risk of pressure ulcers. |
| 3-month follow-up |
| Conine 199440 | Gelcushion with foam base (JAY) versus foam cushion. | Elderly adults in an extended care hospital deemed at high risk of pressure ulcers |
| 3-month follow-up |
| Cooper 199842 | Dry flotation mattress (ROHO) versus dry flotation mattress (SOFFLEX). | People in a mixed emergency orthopaedic trauma ward with Waterlow risk scores of 15 or above. |
| 7-day follow-up |
| Daechsel 198548 | Alternating-pressure mattress versus silicore overlay. | People with neurological conditions in a long-term care hospital at high risk. |
| 3-month follow-up |
| Demarre 201254 | Alternating low pressure air mattress with multi-stage inflation and deflation of the air cells (CLINACTIV, HILL-ROM) versus standard Alternating low pressure air mattress with single stage, steep inflation and deflation of air cells (HILL-ROM). | People In hospital. The wards were neurology, rehabilitation, cardiology, dermatology, pneumology oncology and chronic care or a combination of different types of medical conditions. |
| 14 days |
| Exton-Smith 198261 | Alternating-pressure mattress with 2 layers of air cells (PEGASUS AIRWAVE SYSTEM) versus alternating-pressure large cell ripple mattress | Geriatric adults, with fractured neck of femur and long-stay patients without pressure ulcers of grade 2 or greater, Norton score less than 14. |
| 2-week follow-up |
| Feuchtinger 200662 | Operating table with water-filled warming mattress and a 4-cm thermo active viscoelastic foam overlay versus standard operating room table configuration (operating room table with water-filled warming mattress) | People scheduled for cardiac surgery with extracorporeal circulation, not required to be free of pressure ulcers. |
| 5-day follow-up |
| Gebhardt 199668 | Alternating-pressure air mattresses (shallow small cell overlays, medium depth large cell overlays, deep mattresses and deep pulsating low air loss bed) versus constant low-pressure supports (fibre overlays, foam mattresses/overlays, static air overlays, gel overlay, water overlay, bead overlay, low air loss mattresses, static air overlay, low-air-loss beds and air-fluidised bead beds) | People in ICU with a Norton score less than 13 with no pressure ulcers. |
| unclear |
| Geyer 200170 | Pressure-reducing wheelchair cushions (a commercial cushion, chosen by nurse based on the individual, from a group of cushions designed specifically to improve tissue tolerance in sitting by providing more surface area and/or reducing peak pressure near the ischial tuberosities, sacrum and coccygeal areas. A fitted incontinence cover was also included versus standard 3-inch convoluted foam (EGGRATE) cushion | Elderly adults in nursing homes; wheelchair users with Braden score of 18 or less. |
| 12-month follow-up |
| Goldstone 198272 | Bead bed system (BEAUFORT)(includes bead-filled mattress on A&E trolley; bead-filled operating table overlay; bead-filled sacral cushion for operating table; bead-filled boots to protect heels on operating table | People over 60 years with femur fracture. |
| Follow-up not clear |
| Gray 199477 | Pressure redistributing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress. | People with orthopaedic trauma, vascular and medical oncology units without breaks in the skin. |
| 10-day follow-up |
| Gray 199876 | Pressure redistributing foam mattress (TRANSFOAM) versus pressure redistributing foam mattress (TRANSFOAMWAVE). | People in hospital admitted for bed-rest or surgery with intact skin, no terminal illness. |
| 10-day follow-up |
| Grisell 200882 | A neoprene air filled bladder (dry flotation) device (ROHO) versus a disposable polyurethane foam prone head positioner (OSI) versus a prone view protective helmet system with a disposable polyurethane foam head positioner). | People undergoing elective surgery – thoracic, lumbar or thora-columbar spinal surgery that required prone positioning. |
| No details |
| Gunningberg 200083 | 10cm visco-elastic foam mattress (TEMPUR-PEDIC) on arrival in A&E, and visco-elastic foam overlay on standard ward mattress versus standard A&E trolley mattress (5cm) and ward mattress (10cm foam). | People admitted with a suspected hip fracture via an A&E department; over 65 years; who did not have pressure ulcers. |
| Follow-up until discharge or 14 days postoperatively |
| Hampton 199787 | Alternating-pressure mattress (CAIRWAVE SYSTEM) versus alternating pressure mattress (AIRWAVE SYSTEM). | People with average age 77 years; number of people at high-very high risk. |
| 20 days maximum follow-up |
| Hofman 199490 | Cubed foam mattress (COMFORTEX DECUBE) versus standard hospital foam mattress (standard polypropylene SG40) | People with a femoral-neck fracture and risk score over 8 (Dutch consensus scale). |
| 2-week follow-up |
| Inman 199394 | Low-air-loss air-suspension beds (KINAIR) versus standard Intensive care unit bed (people rotated every 2 hours) | People over 17 years with APACHE II score over 15. |
| Average 17 days follow-up |
| Jolley 2004101 | Australian medical sheepskin mattress overlay (leather-backed with a dense uniform 25 mm wool pile versus usual care determined by staff (repositioning and any other pressure redistributing device or prevention strategy with/without low-tech constant pressure relieving devices | People at low to moderate risk of developing a pressure ulcer; aged over 18 years. |
| Unclear follow-up period; average 7 days. |
| Kemp 1993103 | Convoluted foam overlay (either 3 inch overlay with density of 1.42lb per cubic foot (acute settings) or a 4 inch overlay with unknown density (long-term settings)) versus solid foam overlay (4 inches solid sculptured overlay with density to 1.33lb per cubic foot) | People aged over 65 years, inpatients with Braden Score of 16 or less from general medicine, acute geriatric medicine and long term care. Free from pressure ulcers. |
| 1-month follow-up |
| Keogh 2001104 | Profiling bed with a pressure reducing foam mattress/cushion versus. Flat-based bed with a pressure relieving/redistributing mattress/cushion. | People from 2 surgical and 2 medical wards; aged over 18 years; Waterlow score of 15-25; tissue damage no greater than grade 1 |
| 5-10 days follow-up |
| Laurent 1998113 | Standard mattress in ICU; standard mattress postoperatively versus alternating pressure mattress (NIMBUS) in ICU; standard mattress postoperatively versus standard mattress in ICU; Constant low pressure mattress (TEMPUR) postoperatively versus alternating pressure mattress (NIMBUS) in ICU; constant low pressure mattress (TEMPUR) postoperatively. | Adults over 15 years of age, admitted for major cardiovascular surgery |
| unclear |
| Lazzara 1991114 | Air-filled (SOFCARE) overlay versus gel mattress. | People in a nursing home at risk of pressure ulcers (Norton score over15) |
| 6-month follow-up |
| Lim 1988117 | Foam slab cushion (2.5cm medium density foam glued to 5cm firm chipped foam) versus contoured foam cushion (same foam as above; cut into a customised shape to relieve pressure on ischial tuberosities). | Residents of an extended care facility; aged at least 60; free of pressure ulcers but at high risk of developing 1 (Norton score of less than 4); using a wheelchair for at least 4 hours per day; without progressive disease or confined to bed |
| 5-month follow-up |
| Malbrain 2010125 | Reactive dry floatation mattress overlay (ROHO) versus the active alternating pressure mattress (NIMBUS 3). | People in ICU at high risk of pressure ulcers (Norton score of less than 8) and requiring mechanical ventilation for at least 5 days with intact skin or with Pus on admission. |
| No details but mean study duration reported for patients was 15 (s.d 14) in the NIMBUS group and 12.2 (s.d 5.5) in the ROHO group |
| McGowan 2000126 | Standard hospital mattress, sheet and an Australian Medical Sheepskin overlay; sheepskin heel and elbow protectors as required versus standard hospital mattress, sheet with or without other low tech constant pressure devices as required. | Orthopaedic patients aged 60 years and over; low or moderate risk (Braden scale) |
| Discharge from hospital, transfer to a rehabilitation ward. |
| Mistiaen 2009; Mistiaen 2010132 | Australian medical sheepskin versus usual care. Co-interventions: usual intervention for prevention of pressure ulcers in study settings. | People from an aged care facility (predominantly rehabilitation department) and rehabilitation centre. Grade 1 pressure ulcers included in sample |
| 30-day follow-up |
| Nixon 1998148 | Dry visco-elastic polymer pad on operating table versus standard operating theatre table mattress plus aheel support (GAMGEE). | People 55 years and over; admitted for elective major general, gynaecological or vascular surgery in supine or lithotomy position and free of preoperative pressure damage greater than grade 1. |
| 8-day follow-up |
| Nixon 2006149 | Alternating-pressure overlay (alternating cell height minimum 8.5cm, max 12.25 cm) versus alternating-pressure mattress (alternating cell height min 19.6cms, max 29.4cms). | People in acute or elective hospital aged 55 years or over with limited Braden activity and mobility score (1 or 2) . |
| 30-day follow-up and a further 30-day follow-up |
| Price 1999161 | Low-pressure inflatable mattress (REPOSE SYSTEM) and cushion in polyurethane material) versus dynamic flotation Nimbus II plus alternating-pressure cushion for a chair (ALPHA TRANSCELL): all other care standard best practice, including regular repositioning. | People with fractured neck of femur and Medley score of over 25 (very high risk) aged over 60 years. |
| 14-day follow-up |
| Ricci 2013163 | 3-D mattress overlay (AIARTEX) (a macro-porous 3-D material (9mm thick)) made in polyester flame retardant versusvisco-elastic mattress overlay (AKTON)(15.9mm thick). Made of vulcanised cross-linked rubber material which keeps its shape. | People in a long-term unit at moderate or high risk of pressure ulcer development (according to Braden scale). |
| 4 weeks |
| Russell 2000165 | Multi-cell pulsating dynamic mattress system (MICROPULSE SYSTEM)in the operating room and postoperatively versus Conventional care (gel pad (ACTION PAD) in operating room, standard mattress (HILL_ROM CENTRA with 6 inch foam overlay or HILL-ROM CENTRA with 4 inch foam overlay) postoperatively). | People over 18 years; undergoing scheduled cardiothoracic surgery under general anaesthetic; surgery of at least 4 hours duration; free of pressure ulcers. |
| 7-day follow-up |
| Russell 2003166 | Visco-polymer energy absorbing foam mattress (CONFOR-MED 3 inch layer viscoelastic foam and a 3 inch layer of standard polyurethane foam))/cushion combination versus standard mattress/cushion combination (KING'S FUND, LINKNURSE, SOFTFOAM, TRANSFOAM, KING'S FUND MATTRESS with a SPENCO or PROPAD mattress overlay). | People in elderly acute, orthopaedic and rehabilitation wards; over 65 years; Waterlow score of 15-20. |
| Median 8-14 (experimental) and 9-17 (control) |
| Sanada 2003172 | Double-layer cell overlay (TRICELL) - 2 layers consisting of 24 narrow cylinder air cells, 10cm) versus single-layer air cell overlay (AIR DOCTOR single layer consisting of 20 round air cells, 7.5cm) versus standard hospital mattress (PARACARE 8.5cm polyester). | People in an acute care unit; Braden score of 16 or less; bed bound; free of pressure ulcers. |
| Follow-up duration not reported |
| Santy 1994174 | Pressure redistributing mattresses (CLINIFLOAT, OMNIFOAM, THERAREST, TRANSFOAM, VAPERM) versus NHS contract surface – standard foam (REYLON 150mm). | People aged over 55 years with hip fracture, with or without pressure ulcers. |
| 14-day follow-up |
| Schultz 1999179 | Experimental mattress overlay in operating room made of foam with a 25% indentation load deflection of 30lb and density of 1.3 cubic feet versus usual care (padding as required, including gel pads, foam mattresses, ring cushions). | People admitted for surgery; aged over 18 years; admitted with intact skin. |
| 6-day follow-up |
| Sideranko 1992185 | Alternating air mattress (LAPIDUS AIRFLOAT SYSTEM 1.5 inch thick) versus static air mattress (GAY MARSOFCARE, 4-inch thick) versus Water mattress (LOTUSs PXM 3666,4 inch thick). | Adults in surgical ICU ; without existing skin breakdown |
| Mean 9.4 days follow-up |
| Stapleton 1986192 | Large cell ripple bed pad (TALLEY) versus polyether foam pad 2 feet × 2 feet × 3 inch thickness versus silicore bed pad (SPENCO). | Female elderly adults with fractured neck of femur; without existing pressure ulcers; Norton score 14 or less. |
| Duration of follow-up unclear |
| Takala 1996198 | Constant low pressure mattress (CARITAL OPTIMA) (21 double air bags on a base) versus standard hospital foam mattress (10cm thick foam density 35kg/m3). | People admitted to ICU with non-trauma conditions. |
| 14-day follow-up |
| Taylor 1999199 | Alternating-pressure mattress with pressure redistributing cushion (PEGASUS TRINOVA) versus alternative alternating-pressure system (unnamed) with pressure redistributing cushion. | People in hospital aged 16 or over; intact skin, requiring a pressure-relieving support. |
| Discharge from hospital or death |
| Theaker 2005200 | Alternating pressure mattress (KCI THERAPULSE) versus alternating pressure mattress(HILL-ROM DUO). | People in ICU at high risk. |
| 2 weeks follow-up after discharge from ICU |
| Vanderwee 2005214 | Alternating pressure air mattress (ALPHA-X-CELL) versus visco-elastic foam mattress (TEMPUR). | People in surgical, internal medicine or geriatric hospital; at risk of developing pressure ulcer (Braden score of less than 17) |
| unclear |
| Van Leen 2011209 | Combination of a standard 15cm cold foam mattress with a static air overlay versus a standard 15cm cold foam mattress. | People in a nursing home. |
| 6 months follow-up |
| Vermette 2012217 | Air-inflated static overlay (RIK and THERAKAIR) versus microfluid static overlay or a low-air-loss dynamic mattress with pulsation for people at moderate to very high risk. | People on a medical, surgical, active geriatric, or an intensive care unit ward of an acute care hospital. Considered to be at moderate to high risk (Braden score of 14 or less) |
| 2 weeks follow-up |
| Vyhlidal 1997218 | Foam mattress overlay (IRIS 3000, 4-inch thick 1.8lb density with dimpled surface) versus foam mattress replacement (MAXIFLOAT). | People newly admitted to a skilled nursing facility; free of pressure ulcers but at risk (Braden score of less than 18). |
| 10-21 day follow-up |
| Whitney 1984223 | Alternating-pressure mattress (134 3-inch diameter air cells, 3 minute cycle) versus. convoluted foam pad (eggcrate) People in both groups were turned every 2 hours. | People on medical – surgical units; relatively little skin breakdown; aged 19-91 years. |
| 8-day follow-up |
Table 52Clinical evidence profile: constant low-pressure supports (CLP) versus standard foam mattresses (SFM) for pressure ulcer prevention
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Constant low-pressure supports (CLP) | Standard foam mattresses (SFM) | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - cubed foam mattress (COMFORTEX DECUBE) versus standard hospital mattress (standard polypropylene SG40) – grade 2-4 pressure ulcers (Dutch consensusj)90 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 4/17 (23.5%) | 13/19 (68.4%) | RR 0.34 (0.14 to 0.85) | 452 fewer per 1000 (from 103 fewer to 588 fewer) | Very low | Critical |
| - | 68.4% | 451 fewer per 1000 (from 103 fewer to 588 fewer) | ||||||||||
| Incidence of pressure ulcers - softfoam mattress versus standard 130mm NHS foam mattress – grade 2-4 pressure ulcers (no details of grading system)77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious imprecision | None | 6/90 (6.7%) | 27/80 (33.8%) | RR 0.2 (0.09 to 0.45) | 270 fewer per 1000 (from 186 fewer to 307 fewer) | Low | Critical |
| - | 33.8% | 270 fewer per 1000 (from 186 fewer to 308 fewer) | ||||||||||
| Incidence of pressure ulcers - cubed foam mattress (COMFORTEX DECUBE) versus standard hospital mattress (standard polypropylene SG40) – all grades of pressure ulcers (Dutch consensusj)90 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 6/17 (35.3%) | 14/19 (73.7%) | RR 0.48 (0.24 to 0.96) | 383 fewer per 1000 (from 29 fewer to 560 fewer) | Very low | Critical |
| - | 73.7% | 383 fewer per 1000 (from 29 fewer to 560 fewer) | ||||||||||
| Incidence of pressure ulcers - bead-filled mattress (BEAUFORT) versus standard hospital mattress – all grades of pressure ulcers72 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | Seriousb | None | 5/32 (15.6%) | 21/43 (48.8%) | RR 0.32 (0.14 to 0.76) | 332 fewer per 1000 (from 117 fewer to 420 fewer) | Very low | Critical |
| - | 48.8% | 332 fewer per 1000 (from 117 fewer to 420 fewer) | ||||||||||
| Incidence of pressure ulcers - water-filled mattress versus standard hospital mattress –all grades of pressure ulcersk3 | ||||||||||||
| 1 | Randomised trial | Very seriouse | No serious inconsistency | No serious indirectness | Seriousb | None | 7/155 (4.5%) | 21/161 (13%) | RR 0.35 (0.15 to 0.79) | 85 fewer per 1000 (from 27 fewer to 111 fewer) | Very low | Critical |
| - | 13% | 84 fewer per 1000 (from 27 fewer to 110 fewer) | ||||||||||
| Incidence of pressure ulcers - alternative foam pressure-reducing mattresses (CLINIFLOAT, OMNIFOAM, SOFTFORM, STM5, THERAREST, TRANSFOAM, VAPOURLUX) versus standard hospital mattress – all grades of pressure ulcers (RCN and NPUAP grading system)l35; Santy (1994)174 | ||||||||||||
| 2 | Randomised trials | Very seriousf | No serious inconsistency | No serious indirectness | No serious imprecision | None | 42/571 (7.4%) | 17/73 (23.3%) | Not pooled as Collier (1996) had 0 events but 0.36 (0.22 to 0.59) for Santy (1994) | 149 fewer per 1000 (from 95 fewer to 182 fewer) | Low | Critical |
| - | 13.3% | 85 fewer per 1000 (from 55 fewer to 104 fewer) | ||||||||||
| Incidence of pressure ulcers – high specification foam mattress/cushion - visco-polymer energy absorbing foam mattress (CONFORM-ED) versus standard mattress or cushion(KING's FUND, LINKNURSE, SOFTFOAM, TRANSFOAM, KING'S FUND MATTRESS with a SPENCO or PROPAD mattress overlay – all grades of pressure ulcers (Torrance scale)m167 | ||||||||||||
| 1 | Randomised trial | Very seriousg | No serious inconsistency | No serious indirectness | Seriousb | None | 48/562 (8.5%) | 66/604 (10.9%) | RR 0.78 (0.55 to 1.11) | 24 fewer per 1000 (from 49 fewer to 12 more) | Very low | Critical |
| - | 10.9% | 24 fewer per 1000 (from 49 fewer to 12 more) | ||||||||||
| Comfort scores – very uncomfortable – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious imprecision | None | 0/90 (0%) | 0/80 (0%) | Not pooled | Not pooled | Low | Critical |
| Comfort scores - uncomfortable – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | Very serious imprecisioni | None | 0/90 (0%) | 2/80 (2.5%) | OR 0.12 (0.01 to 1.91) | 22 fewer per 1000 (from 25 fewer to 22 more) | Very low | Critical |
| - | 2.50% | 22 fewer per 1000 (from 25 fewer to 22 more) | ||||||||||
| Comfort scores – adequate – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious imprecision | None | 6/90 (6.7%) | 44/80 (55%) | RR 0.12 (0.05 to 0.27) | 484 fewer per 1000 (from 402 fewer to 523 fewer) | Low | Critical |
| -- | 55% | 484 fewer per 1000 (from 402 fewer to 523 fewer) | ||||||||||
| Comfort scores - comfortable – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious imprecision | None | 62/90 (68.9%) | 26/80 (32.5%) | RR 2.12 (1.5 to 2.99) | 364 more per 1000 (from 162 more to 647 more) | Low | Critical |
| - | 32.50% | 364 more per 1000 (from 162 more to 647 more) | ||||||||||
| Comfort scores – very comfortable – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress77 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious imprecision | None | 11/90 (12.2%) | 0/80 (0%) | OR 7.45 (2.2 to 25.24) | 120 more from 50 more to 190 more) | Low | Critical |
| Comfort – high specification foam mattress or cushion - visco-polymer energy absorbing foam mattress (CONFORM-ED) versus standard mattress or cushion (KING's FUND, LINKNURSE, SOFTFOAM, TRANSFOAM, KING'S FUND MATTRESS with a SPENCO or PROPAD mattress overlay167 | ||||||||||||
| 1 | Randomised trial | Very seriousg | No serious inconsistency | No serious indirectness | No serious imprecision | None | 2.33 +/-0.98 n=323 | 2.46 +/-1.01 n=383 | - | MD 0.13 lower (0.28 lower to 0.02 higher) | Low | Critical |
| Length of stay in hospital (days) – cubed foam mattress (COMFORTEX DECUBE) versus standard hospital mattress (standard polypropylene SG40) 90 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious | Very serioush | Median 21 days (range 5-64) | Median 23 days (range 4-120) | - | See footnoteh | Very low | Important |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation and allocation concealment reported. No blinding was reported. It was unclear if incomplete outcome data was addressed. There was a higher drop-out than event rate in CLP arm for grade 2-4 ulcer outcome.
- b
The confidence interval crossed 1 MID point.
- c
There was inadequate sequence generation. There was unclear allocation concealment and blinding. Incomplete outcome data was not addressed(Goldstone (1982)).
- d
There was unclear sequence generation, allocation concealment, blinding, addressing of incomplete outcome data and if groups similar at baseline (Gray 1994).
- e
There was unclear sequence generation, allocation concealment, blinding and addressing of incomplete outcome data (Andersen (1982)).
- f
There was unclear sequence generation, allocation concealment and addressing of incomplete outcome data. No blinding was reported. It was unclear if groups were similar at baseline (Collier (1996)). There was unclear sequence generation, blinding and addressing of incomplete outcome data. The differential drop-out with higher drop-out in standard hospital mattress group (Santy (1994)).
- g
There was unclear allocation concealment. No blinding was reported (Russell (2003)).
- h
The datawere given as median and range so it was not possible to analyse data in Revman.
- i
The confidence interval crossed both MID points.
- j
Dutch consensus grading system (1985): 0= normal skin; 1= persistent erythema of the skin; 2= blister formation; 3= superficial (sub-cutaneous necrosis); 4= deep sub-cutaneous necrosis.
- k
Bullae, black necrosis and skin defects were evidence of pressure ulcers.
- l
Collier (1996) used RCN grading and Santy (1994) used NPUAP 1989.
- m
Torrance scale, where blanching erythema represents a Torrance grade I ulcer and non-blanching erythema represents a Torrance grade II ulcer.
- n
There were a limited number of events.
Table 53Clinical evidence profile: constant low pressure support (inflated static overlay (ISO)) versus constant low pressure support (microfluid static overlay (MSO)) and alternating pressure support (low-air-loss dynamic mattress (LALDM))
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | CLP | CLP and AP | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - all grades of pressure ulcers (NPUAP)217 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 2/55 (3.6%) | 6/55 (10.9%) | RR 0.33 (0.07 to 1.58) | 73 fewer per 1000 (from 101 fewer to 63 more) | Very low | Critical |
| - | 10.9% | 73 fewer per 1000 (from 101 fewer to 63 more) | ||||||||||
| Comfort – all grades of pressure ulcers (NPUAP)217 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 29/34 (85.3%) | 27/30 (90%) | RR 0.95 (0.79 to 1.14) | 45 fewer per 1000 (from 189 fewer to 126 more) | Moderate | Important |
| - | 90% | 45 fewer per 1000 (from 189 fewer to 126 more) | ||||||||||
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
No details of sequence generation were reported by the authors. There was no blinding for participants, clinical staff or research evaluators.
- b
The confidence interval crossed both MID points.
Table 54Clinical evidence profile: alternative foam mattress versus standard foam mattress
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Alternative foam mattress | Standard foam mattress | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - various alternatives (pooled) – all grades of pressure ulcerse35;90;167,174; 77 | ||||||||||||
| 5 | Randomised trials | Very seriousa | Very seriousb | No serious indirectness | Seriousd | None | 102/1240 (8.2%) | 124/776 (16%) | RR 0.43 (0.24 to 0.76) | 91 fewer per 1000 (from 38 fewer to 121 fewer) | Very low | Critical |
| - | 26.6% | 152 fewer per 1000 (from 64 fewer to 202 fewer | ||||||||||
| Incidence of pressure ulcers (UK studies only) – all grades of pressure ulcerse35 ;167 ;174 ;77 | ||||||||||||
| 4 | Randomised trials | Very seriousa | Very seriousc | No serious indirectness | Seriousd | None | 96/1223 (7.8%) | 110/757 (14.5%) | RR 0.41 (0.19 to 0.87) | 86 fewer per 1000 (from 19 fewer to 118 fewer) | Very low | Critical |
| - | 18.7% | 110 fewer per 1000 (from 24 fewer to 151 fewer) | ||||||||||
| Incidence of pressure ulcers (pooled) – pressure-reducing foam mattress (SOFTFOAM) versus standard 130mm NHS foam mattress - grade 2 and above pressure ulcerse90;77 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious | No serious indirectness | No serious imprecision | None | 10/107 (9.3%) | 40/99 (40.4%) | RR 0.24 (0.13 to 0.45) | 307 fewer per 1000 (from 222 fewer to 352 fewer) | Low | Critical |
| - | 51.1% | 388 fewer per 1000 (from 281 fewer to 445 fewer) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation for 3 studies (Collier 1996, Gray 1994, Hofman 2003 and Santy 1994). There was unclear allocation concealment in 4 studies (Collier 1996, Gray 1994, Hofman 2003 and Santy, 1994). There was no blinding in 3 studies (Collier 1996, Hofman 1994, Russell 2003) and unclear blinding in 2 studies (Gray 1994 and Santy 1994) It was unclear if incomplete outcome data was addressed in 4 studies (Collier 1996, Gray 1994, Hofman 1994 and Santy 1994) It was unclear if similar at baseline in 2 studies (Collier 1996 and Gray 1994) There was different timing of outcome assessment in 2 studies (Collier 1996 and Gray 1994). Higher differential drop-out with higher rate in the standard hospital mattress group (Santy 1994). There was a higher drop-out than event rate for incidence of pressure ulcers, all grades and grade 2 and above (Hofman 1994).
- b
I2 = 77%, p=0.004
- c
I2 =84%, p=0.002
- d
The confidence interval crossed 1 MID point.
- e
Collier (1996) used RCN grading system, Gray (1994) had no details of grading system, Hofman (1994) used Dutch consensus, Russell (2003) used the Torrance scale, Santy (1994) used NPUAP 1989 grading system.
Table 55Clinical evidence profile: comparisons between alternative foam supports
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Comparisons between alternative foam supports | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – pressure redistributing mattresses (CLINIFLOAT, OMNIFOAM, THERAREST, TRANSFOAM, VAPERM) versus standard NHS foam mattress (REYLON 150mm) – all grades of pressure ulcers (NPUAP)h174 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 42/441 (9.5%) | 17/64 (26.6%) | RR 0.36 (0.22 to 0.59) | 170 fewer per 1000 (from 109 fewer to 207 fewer) | Low | Critical |
| - | 26.6% | 170 fewer per 1000 (from 109 fewer to 207 fewer) | ||||||||||
| Incidence of pressure ulcers - foam mattress replacement (MAXIFLOAT) versus foam mattress overlay (IRIS 3000)– all grades of pressure ulcersi218 | ||||||||||||
| 1 | Randomised trial | Seriousb | No serious inconsistency | No serious indirectness | Seriousc | None | 5/20 (25%) | 12/20 (60%) | RR 0.42 (0.18 to 0.96) | 348 fewer per 1000 (from 24 fewer to 492 fewer) | Very low | Critical |
| - | 60% | 348 fewer per 1000 (from 24 fewer to 492 fewer) | ||||||||||
| Incidence of pressure ulcers - solid foam overlay versus convoluted foam overlay – all grades of pressure ulcers (NPUAP)j103 | ||||||||||||
| 1 | Randomised trial | Very seriousg | No serious inconsistency | No serious indirectness | Seriousc | None | 12/39 (30.8%) | 21/45 (46.7%) | RR 0.66 (0.37 to 1.16) | 159 fewer per 1000 (from 294 fewer to 75 more) | Low | Critical |
| - | 46.7% | 159 fewer per 1000 (from 294 fewer to 75 more) | ||||||||||
| Incidence of pressure ulcers - pressure-reducing foam mattress (TRANSFOAM) versus pressure-reducing foam mattress (TRANSFOAMWAVE) – all grades of pressure ulcersk76 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | Very seriouse | None | 1/50 (2%) | 1/50 (2%) | RR 1 (0.06 to 15.55) | 0 fewer per 1000 (from 19 fewer to 291 more) | Very low | Critical |
| - | 2% | 0 fewer per 1000 (from 19 fewer to 291 more) | ||||||||||
| Incidence of pressure ulcers - foam mattress replacement (MAXIFLOAT) versus foam mattress overlay (IRIS 3000)– – grade 2 and above pressure ulcers9218 | ||||||||||||
| 1 | Randomised trial | Seriousb | No serious inconsistency | No serious indirectness | Seriousc | None | 3/20 (15%) | 8/20 (40%) | RR 0.38 (0.12 to 1.21) | 248 fewer per 1000 (from 352 fewer to 84 more) | Very low | Critical |
| - | 40% | 248 fewer per 1000 (from 352 fewer to 84 more) | ||||||||||
| Time to pressure ulcer development (mean days) - foam mattress replacement (MAXIFLOAT) versus foam mattress overlay (IRIS 3000)– all grades of pressure ulcers218 | ||||||||||||
| 1 | Randomised trial | Seriousb | No serious inconsistency | No serious indirectness | No serious | Very seriousf | 9.2 days | 6.5 days | p=0.3288 | - | Very low | Important |
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment, blinding and addressing of incomplete outcome data reported by the authors. Differential drop-out with higher drop-out in standard hospital mattress group.
- b
There was unclear allocation concealment and blinding. There were baseline differences. Vyhlidal (1997).
- c
The confidence interval crossed 1 MID.
- d
There were unclear sequence generation and addressing of incomplete outcome data. Baseline data were provided for the treatment arm only (Gray (1998)).
- e
The confidence interval crossed both MIDs and there were a limited number of events.
- f
There was not enough data to analyse in Revman.
- g
There was unclear allocation concealment, blinding and baseline differences reported by the authors and the authors did not address incomplete outcome data (Kemp (1993)).
- h
NPUAP 1989 grading system.
- i
There was an unclear grading system used, stage 0= no redness or breakdown; stage 1= erythema only, redness does not disappear for 24 hours after pressure is relieved; stage 2= break in skin such as blisters, or abrasions; stage 3= break in skin exposing subcutaneous tissue; stage 4= break in skin extending through tissue and subcutaneous layers, exposing muscle or bone.
- j
NPUAP1989.
- k
No details of grading system were provided by the authors.
Table 56Clinical evidence profile: comparisons between CLP supports
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | CLP supports | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – constant low pressure mattress (CARITAL OPTIMA) versus standard foam mattress (10cm thick foam density 35kg/m3)– all grades of pressure ulcers (Shea)p198 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 0/21 (0%) | 7/19 (36.8%) | RR 0.06 (0 to 0.99) | 346 fewer per 1000 (from 4 fewer to 368 fewer) | Very low | Critical |
| - | 36.8% | 346 fewer per 1000 (from 4 fewer to 368 fewer) | ||||||||||
| Incidence of pressure ulcers – dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO) – all grades of pressure ulcers (Stirling grade)p42 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 3/41 (7.3%) | 5/43 (11.6%) | RR 0.63 (0.16 to 2.47) | 43 fewer per 1000 (from 98 fewer to 171 more) | Very low | Critical |
| - | 11.6% | 43 fewer per 1000 (from 97 fewer to 171 more) | ||||||||||
| Incidence of pressure ulcers - dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO) – grade 2 and above pressure ulcers(Stirling grade)p42 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 1/41 (2.4%) | 0/43 (0%) | Peto OR 7.76 (0.15 to 391.44) | 20 more (from 40 more to 90 more | Very low | Critical |
| - | 0% | 20 more (from 40 more to 90 more | ||||||||||
| Incidence of pressure ulcers - gel mattress versus air-filled overlay (SOFCARE) – all grades of pressure ulcers (NPUAP)p114 | ||||||||||||
| 1 | Randomised trial | Very seriouse | No serious inconsistency | No serious indirectness | Very seriousd | None | 8/33 (24.2%) | 10/33 (30.3%) | RR 0.8 (0.36 to 1.77) | 61 fewer per 1000 (from 194 fewer to 233 more) | Very low | Critical |
| - | 15.2% | 30 fewer per 1000 (from 97 fewer to 117 more) | ||||||||||
| Incidence of pressure ulcers - gel mattress versus air-filled overlay (SOFCARE) – grade 2 and above pressure ulcers (NPUAP)p114 | ||||||||||||
| 1 | Randomised trial | Very seriouse | No serious inconsistency | No serious indirectness | Very seriousd | None | 4/33 (12.1%) | 5/33 (15.2%) | RR 0.8 (0.24 to 2.72) | 23 fewer per 1000 (from 2 fewer to 35 fewer) | Very low | Critical |
| - | 15.2% | 30 fewer per 1000 (from 116 fewer to 261 more) | ||||||||||
| Incidence of pressure ulcers -static air mattress (GAY MAR SOFCARE) versus water mattress (LOTUS PXM 3666)– all grades of pressure ulcers (grading system not reported)16185 | ||||||||||||
| 1 | Randomised trial | Very seriousf | No serious inconsistency | No serious indirectness | Very seriousd | None | 1/20 (5%) | 2/17 (11.8%) | RR 0.43 (0.04 to 4.29) | 67 fewer per 1000 (from 113 fewer to 387 more) | Very low | Critical |
| - | 11.8% | 67 fewer per 1000 (from 113 fewer to 388 more) | ||||||||||
| Incidence of pressure ulcers – inflated static overlay (RIK or THERAKAIR) versus microfluid static overlay – all grades of pressure ulcers (NPUAP)217 | ||||||||||||
| 1 | Randomised trial | Seriousq | No serious inconsistency | No serious indirectness | Very seriousd | None | 2/55 (3.6%) | 6/50 (12%) | RR 0.3 (0.06 TO 1.43) | 84 fewer per 1000 (from 13 fewer to 52 more) | Very low | Critical |
| - | 12% | 84 fewer per 1000 (from 13 fewer to 52 more) | ||||||||||
| Incidence of pressure ulcers -foam overlay versus Silicore overlay (SPENCO) – grade 2and above pressure ulcersp192 | ||||||||||||
| 1 | Randomised trial | Very seriousg | No serious inconsistency | No serious indirectness | Very seriousd | None | 14/34 (41.2%) | 12/34 (35.3%) | RR 1.17 (0.64 to 2.14) | 60 more per 1000 (from 127 fewer to 402 more) | Very low | Critical |
| - | 29.4% | 60 more per 1000 (from 127 fewer to 402 more) | ||||||||||
| Incidence of pressure ulcers – Australian medical sheepskin versus no sheepskin (all grades of pressure ulcers)p130; 126; 101 | ||||||||||||
| 3 | Randomised trials | Very serioush | Seriousi | No serious indirectness | No serious | None | 59/644 (9.2%) | 120/637 (18.8%) | RR 0.48 (0.31 to 0.74) | 98 fewer per 1000 (from 49 fewer to 130 fewer) | Very low | Critical |
| - | 16.6% | 86 fewer per 1000 (from 43 fewer to 115 fewer) | ||||||||||
| Incidence of pressure ulcers - Australian medical sheepskin versus no sheepskin (grade 2 and above pressure ulcers )p130; 126; 101 | ||||||||||||
| 3 | Randomised trials | Very serioush | No serious inconsistency | No serious indirectness | Seriousb | None | 18/644 (2.8%) | 33/637 (5.2%) | RR 0.56 (0.32 to 0.97) | 23 fewer per 1000 (from 2 fewer to 35 fewer) | Very low | Critical |
| - | 3.5% | 15 fewer per 1000 (from 1 fewer to 24 fewer) | ||||||||||
| Incidence of pressure ulcers -static air overlay (and cold foam mattress) versus cold foam mattress– grade 2 and above pressure ulcers16209 | ||||||||||||
| 1 | Randomised trial | Very seriousk | No serious inconsistency | No serious indirectness | Seriousb | None | 2/38 (5.3%) | 7/36 (19.4%) | RR 0.27 (0.06 to 1.22) | 142 fewer per 1000 (from 183 fewer to 43 more) | Very low | Critical |
| - | 19.4% | 142 fewer per 1000 (from 182 fewer to 43 more) | ||||||||||
| Incidence of pressure ulcers – 3D macroporous polyester overlay versus visco-elastic overlay (all grades of pressure ulcers)30,163 | ||||||||||||
| 2 | Randomised trial | Seriousr | No serious inconsistency | No serious indirectness | Seriousb | None | 0/60 (0%) | 1/62 (1.6%) | Peto OR 0.14 (0.00 to 7.21) | 20 fewer per 1000 (from 70 fewer to 40 more) | Low | Critical |
| Comfort - Australian medical sheepskin versus no sheepskin101 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | No serious | Very seriousl | - | - | - | See footnotel | Very low | Critical |
| Withdrawal due to discomfort – Australian medical sheepskin versus no sheepskin126 | ||||||||||||
| 1 | Randomised trial | Serioush | No serious inconsistency | No serious indirectness | No serious | Very seriousm | - | - | - | See footnotem | Very low | Critical |
| Patient acceptability – very uncomfortable -dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)42 | ||||||||||||
| 1 | Randomised trial | Seriousc | No serious inconsistency | No serious indirectness | No serious | None | 0/41 (0%) | 0/43 (0%) | Not pooled | Not pooled | Moderate | Critical |
| Patient acceptability – uncomfortable - dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)42 | ||||||||||||
| 1 | Randomised trial | Seriousc | No serious inconsistency | No serious indirectness | Seriousb | None | 0/41 (0%) | 5/43 (11.6%) | OR 0.13 (0.02 to 0.77) | 99 fewer per 1000 (from 24 fewer to 114 fewer) | Low | Critical |
| - | 11.6% | 99 fewer per 1000 (from 24 fewer to 113 fewer) | ||||||||||
| Patient acceptability – adequate - dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)42 | ||||||||||||
| 1 | Randomised trial | Seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 4/41 (9.8%) | 4/43 (9.3%) | RR 1.05 (0.28 to 3.92) | 5 more per 1000 (from 67 fewer to 272 more) | Very low | Critical |
| - | 9.3% | 5 more per 1000 (from 67 fewer to 272 more) | ||||||||||
| Patient acceptability – comfortable - dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)42 | ||||||||||||
| 1 | Randomised trial | Seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 24/41 (58.5%) | 24/43 (55.8%) | RR 1.05 (0.72 to 1.52) | 28 more per 1000 (from 156 fewer to 290 more) | Very low | Critical |
| - | 55.8% | 28 more per 1000 (from 156 fewer to 290 more) | ||||||||||
| Patient acceptability – very comfortable - dry flotation mattress (SOFFLEX) versus dry flotation mattress (ROHO)42 | ||||||||||||
| 1 | Randomised trial | Seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 13/41 (31.7%) | 10/43 (23.3%) | RR 1.36 (0.67 to 2.76) | 84 more per 1000 (from 77 fewer to 409 more) | Very low | Critical |
| - | 23.3% | 84 more per 1000 (from 77 fewer to 410 more) | ||||||||||
| Time to onset of first pressure ulcer - Australian medical sheepskin versus no sheepskin101 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | No serious | Seriousn | - | - | HR 0.39 (95% CI 0.22 to 0.69) | p<0.001 | Very low | Important |
| Time to onset of first pressure ulcer - Australian medical sheepskin versus no sheepskin130 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | No serious | Very seriousp | 12 days | 9 days | - | - | Very low | Important |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation reported by the authors but block randomisation may have been used. Some outcome assessors may have been blinded but it was unclear. No allocation concealment was reported. There was a higher drop-out than event rate for incidence of pressure ulcers(Takala (1996)).
- b
The confidence interval crossed 1 MID.
- c
There was unclear blinding reported by the authors. There was a higher drop-out than event rate for incidence of all grades of pressure ulcers and grade 2 and above pressure ulcers(Cooper (1998)).
- d
The confidence interval crossed both MIDs.
- e
There was unclear allocation concealment and blinding reported by the authors and methods used foraddressing incomplete outcome data were unclear (Lazzara (1991)).
- f
There was unclear sequence generation, allocation concealment and blinding reported by the authors and methods for addressing incomplete outcome data. Similarity at baseline was unclear(Sideranko (1992)).
- g
There was unclear sequence generation, allocation concealment and blinding reported by the authors. (Stapleton (1986)).
- h
There was unclear sequence generation (Jolley 2004), unclear allocation concealment (McGowan 2000) and no blinding (Jolley 2004, McGowan 2000 and Mistiaen 2009, 2010). Methods for addressing incomplete outcome data were unclear (Mistiaen 2009, 2010) and not addressed (Jolley 2004).It was unclear if there were baseline differences (Jolley 2004). There was a higher drop-out than event rate (Jolley 2004, Mistiaen 2009, 2010) for incidence of pressure ulcers, all grades and grade 2 and above.
- i
I2 = 52%, p=0.12.
- j
The confidence interval crossed 1 MID.
- k
There were ethical issues of not using repositioning. Limited details of sequence generation and allocation concealment were reported by the authors. No details of blinding of outcome assessors were reported. There was a higher drop-out than event rate for incidence of pressure ulcers(Van Leen (2011))
- l
Comfort data was not given for both groups. Ten participants in the sheepskin group complained about its comfort (too hot= 6; sensitive to the wool surface= 2; uncomfortable= 2) and requested its removal.
- m
The study did not report details of comfort in both groups. Six participants in the experimental group withdrew before completion of data collection because the sheepskin caused an irritation, was too hot or uncomfortable.
- n
No data was given for each arm but HR presented. Kaplan-Meier survival curves used (p<0.001, log-rank test).
- o
There was not enough data to analyse in Revman.
- p
Takala (1996) used Shea 1975 grading system; Cooper (1998) used the Stirling grading system; Lazzara (1991) used NPUAP 1989 system; Sideranko (1992)did not report the grading system; Stapleton (1986) adapted the grading system from Kenedi et al (1976) bed sore biomechanics study, where category A= superficial/blister, category B = a break in skin (no crater) and category C= a break in skin (with crater) and category D= blackened tissue; Jolley (2004) and McGowan (2000) used the US Agency for Health Care and Policy Research grading system; Mistiaen (2009, 2010) and Van Leen 2011 used the EPUAP grading system.
- q
No details of sequence generation were reported. There was no blinding for patient, clinical staff or research evaluator.
- r
Ricci (2013) reported unclear allocation concealment and there were baseline differences in Norton scores. Cassino (2013) found baseline differences for grade of pressure ulcers.
Table 57Clinical evidence profile: alternating-pressure versus standard foam mattress
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Alternating-pressure | Standard foam mattress | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – alternating air mattress or overlay versus standard foam mattress - all grades of pressure ulcersc3;172 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 13/221 (5.9%) | 31/188 (16.5%) | RR 0.31 (0.17 to 0.58) | 114 fewer per 1000 (from 69 fewer to 137 fewer) | Low | Critical |
| - | 25% | 172 fewer per 1000 (from 105 fewer to 207 fewer) | ||||||||||
| Incidence of pressure ulcers – alternating air mattress versus standard foam mattress - grade 2 and above pressure ulcersc172 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 5/55 (9.1%) | 6/27 (22.2%) | RR 0.41 (0.14 to 1.22) | 131 fewer per 1000 (from 191 fewer to 49 more) | Very low | Critical |
| - | 22.2% | 131 fewer per 1000 (from 191 fewer to 49 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment, blinding and addressing incomplete outcome data reported by the authors (Andersen 1982). There was unclear blinding and no addressing of incomplete outcome data. There was a higher drop-out than event rate for incidence of pressure ulcers for all grades and grade 2 and above (Sanada 2003).
- b
The confidence interval crossed 1 MID point.
- c
Andersen 1982 used the classification of Bullae, black necrosis, and skin defects as evidence of pressure sores. Sanada (2003) used NPUAP 1989 grading system.
Table 58Clinical evidence profile: alternating-pressure versus constant low-pressure
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Alternating-pressure (AP) | Constant low-pressure | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – alternating pressure (all studies meta-analysed all had various types of alternating pressure) versus constant low pressure (various types of constant low-pressure) - all grades of pressure ulcersl39; 48; 192; 223;68; 3; 161; 185; 214 | ||||||||||||
| 11 | Randomised trials | Very seriousa,b,c,d,e | No serious inconsistency | No serious indirectness | Seriousf | None | 125/785 (15.9%) | 170/837 (20.3%) | RR 0.85 (0.65 to 1.11) | 30 fewer per 1000 (from 71 fewer to 22 more) | Very low | Critical |
| - | 23.1% | 35 fewer per 1000 (from 81 fewer to 25 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure (various) versus constant low pressure (various) – all grades of pressure ulcers68 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 15/115 (13%) | 39/115 (33.9%) | RR 0.38 (0.22 to 0.66) | 210 fewer per 1000 (from 115 fewer to 265 fewer) | Low | Critical |
| - | 33.9% | 210 fewer per 1000 (from 115 fewer to 264 fewer) | ||||||||||
| Incidence of pressure ulcers – alternating pressure versus Silicore or foam overlayk – all grades of pressure ulcers and all populationsl39; 48; 192; 223 | ||||||||||||
| 4 | Randomised trials | Very seriousb | No serious inconsistency | No serious indirectness | Seriousf | None | 59/145 (40.7%) | 81/186 (43.5%) | RR 0.91 (0.72 to 1.16) | 39 fewer per 1000 (from 122 fewer to 70 more) | Very low | Critical |
| - | 31.6% | 28 fewer per 1000 (from 88 fewer to 51 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure versus water or static air mattress – all grades of pressure ulcersl3;161;185 | ||||||||||||
| 3 | Randomised trials | Very seriousc | No serious inconsistency | No serious indirectness | Very serioush | None | 13/226 (5.8%) | 12/232 (5.2%) | RR 1.31 (0.51 to 3.35) | 16 more per 1000 (from 25 fewer to 122 more) | Very low | Critical |
| - | 5% | 15 more per 1000 (from 25 fewer to 117 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure setting on mattress (DUO 2) versus continuous low pressure setting on mattress (DUO 2) – all grades of pressure ulcersl31 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | Very serioush | None | 2/69 (2.9%) | 1/71 (1.4%) | RR 2.06 (0.19 to 22.18) | 15 more per 1000 (from 11 fewer to 298 more) | Very low | Critical |
| - | 1.4% | 15 more per 1000 (from 11 fewer to 297 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure air mattress (ALPHA-X-CELL) versus viscoelastic foam mattress (TEMPUR) – all grades of pressure ulcersl214 | ||||||||||||
| 1 | Randomised trial | Seriouse | No serious inconsistency | No serious indirectness | Very seriousg | None | 34/222 (15.3%) | 35/225 (15.6%) | RR 0.98 (0.64 to 1.52) | 3 fewer per 1000 (from 56 fewer to 81 more) | Very low | Critical |
| - | 15.6% | 3 fewer per 1000 (from 56 fewer to 81 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure mattress (NIMBUS 3) versus dry flotation mattress overlay (ROHO) – all grades of pressure ulcersl125 | ||||||||||||
| 1 | Randomised trial | Very seriousi | No serious inconsistency | No serious indirectness | Very seriousg | None | 2/8 (25%) | 2/8 (25%) | RR 1 (0.18 to 5.46) | 0 fewer per 1000 (from 205 fewer to 1000 more) | Very low | Critical |
| - | 0% | - | ||||||||||
| Incidence of pressure ulcers – alternating pressure mattress versus Silicore – participants not singularly with chronic neurological conditions – all grades of pressure ulcers12192 ;223 | ||||||||||||
| 2 | Randomised trials | Very seriousb | No serious inconsistency | No serious indirectness | Very seriousg | None | 16/57 (28.1%) | 32/94 (34%) | RR 0.89 (0.54 to 1.47) | 37 fewer per 1000 (from 157 fewer to 160 more) | Very low | Critical |
| - | 30.7% | 34 fewer per 1000 (from 141 fewer to 144 more) | ||||||||||
| Incidence of pressure ulcers –alternating pressure overlay versus silicore overlay – participants with chronic neurological conditions – all grades of pressure ulcers1239; 48 | ||||||||||||
| 2 | Randomised trials | Very seriousb | No serious inconsistency | No serious indirectness | Seriousf | None | 43/88 (48.9%) | 49/92 (53.3%) | RR 0.92 (0.7 to 1.22) | 43 fewer per 1000 (from 160 fewer to 117 more) | Very low | Critical |
| 42.1% | - | 34 fewer per 1000 (from 126 fewer to 93 more) | ||||||||||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersl68;161,192,214;125 | ||||||||||||
| 6 | Randomised trials | Very seriousb | No serious inconsistency | No serious indirectness | Seriousf | None | 45/394 (11.4%) | 70/432 (16.9%) | RR 0.80 (0.58 to 1.11) | 34 fewer per 1000 (from 71 fewer to 19 more) | Very low | Critical |
| - | 14% | 28 fewer per 1000 (from 59 fewer to 15 more) | ||||||||||
| Drop out due to discomfort – alternating pressure overlay versus silicore overlay 39 | ||||||||||||
| 1 | Randomised trial | Very seriousb | No serious inconsistency | No serious indirectness | Very seriousg | None | 19/93 (20.4%) | 17/94 (18.1%) | RR 1.13 (0.63 to 2.03) | 24 more per 1000 (from 67 fewer to 186 more) | Very low | Critical |
| 0% | - | |||||||||||
| Comfort rating at 14 days dynamic flotation mattress (NIMBUS 2) and alternating pressure cushion versus low pressure inflatable mattress (REPOSE SYSTEM) and cushion (polyurethane) 161 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | Very seriousg | None | 60 (s.d 25) n= 26 | 67 (s.d 18) n= 24 | - | MD 7 lower (19.01 lower to 5.01 higher) | Very low | Critical |
| Length of stay in hospital - alternating pressure setting on mattress (DUO 2) versus continuous low pressure setting on mattress (DUO 2) 31 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | No serious | Very seriousj | - | - | - | See footnote10 | Very low | Important |
| Rate of development of pressures ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was not adequate sequence generation, allocation concealment and unclear blinding was reported by the authors. There was a higher drop-out than the event rate for incidence of pressure ulcers (Gebhardt 1996).
- b
There was unclear sequence generation reported by the authors (Conine 1990, Daeschel 1985, Stapleton 1986, Whitney 1984). There was unclear allocation concealment reported by the authors (Conine 1990, Daeschel 1985, Stapleton 1986). There was unclear blinding reported by the authors(Daeschel 1985, Stapleton 1986, Whitney 1984). There was unclear addressing of incomplete outcome data (Daeschel 1985).There were unclear baseline differences ( Whitney 1984).
- c
There was unclear sequence generation reported by the authors (Anderson 1982, Sideranko 1992). There was unclear allocation concealment reported by the authors(Anderson 1982, Price 1999, Sideranko 1992). There was unclear blinding reported by the authors (Anderson 1982, Sideranko 1992) and no blinding (Price 1999). There was unclear addressing of incomplete outcome data (Anderson 1982, Price 1999, Sideranko 1992). There was a higher drop-out rate than event rate for incidence of all grades of pressure ulcers and comfort rating at 14 days (Price 1999).
- d
There was unclear sequence generation and allocation concealment reported by the authors. There were differences between groups at baseline. There was a higher drop-out rate than event rate(Cavicchioli (2007)).
- e
There was unclear blinding and addressing of incomplete outcome data(Vanderwee (2005)).
- f
The confidence interval crossed 1 MID.
- g
The confidence interval crossed both MIDs.
- h
The confidence interval crossed both MIDs and limited number of events.
- i
There were baseline differences; the allocation concealment unclear and only single blinding (Malbrain, 2010).
- j
There were no data presented, but the authors state that there was no difference in length of stay related to pressure ulcer development among high-risk participantsplaced on the intervention or control mattresses.
- k
Conine (1990) and Daeschel (1985) included participants with chronic neurological conditions, which we identified as a group to be stratified. However the Cochrane review included these studies together and in a subgroup test, no subgroup differences were found so the results are presented together. The results of those with and without chronic neurological conditions are also presented separately.
- l
Conine (1990) and Daechsel (1985) used Exton-Smith scale; Stapleton (1986) adapted the grading system from Kenedi et al (1976) bed sore biomechanics study, where category A= superficial/blister, category B = a break in skin (no crater) and category C= a break in skin (with crater) and category D= blackened tissue; Whitney (1984) used a system where stage 0 = no redness or skin breakdown; stage 1= skin redness, fades in 15 minutes or less; stage II inflammation of the skin, fading time exceeds 15 minutes, less than 1 hour; stage III= inflammation of the skin fading time exceeds 1 hour; stage IV= skin break with redness of surrounding skin, redness fades longer than 1 hour; Gebhardt (1996) used a grading system by Bliss (1966) grade 1= persistent erythema; grade 2= epidermal loss; grade 3= blue-black discoloration or cavity extending to dermis ; grade 4=cavity to subcutaneous tissue or deeper; Andersen (1982) used bullae, black necrosis and skin defects as evidence of pressure sores; Price (1999) used the Hofman 1994 scale where 0=normal skin, 1= persistent erythema of the skin; 2= blister formation; 3= superficial subcutaneous necrosis; 4= deep subcutaneous necrosis; Sideranko (1992) did not report grading system; Vanderwee (2005) did not report grading system but grade 1 was non-blanchable erythema or NBE; Malbrain (2010) used EPUAP and Cavicchioli (2007) used EPUAP 2007.
Table 59Clinical evidence profile: alternating pressure and constant low pressure in ICU/post ICU (factorial design)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – standard mattress in ICU/standard foam mattress post-ICU versus alternating pressure mattress (NIMBUS) in ICU/standard foam mattress post-ICU – grade 2 and above pressure ulcers113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 14/80 (17.5%) | 10/80 (12.5%) | RR 1.40 (0.66 to 2.96) | 50 more per 1000 (from 60 fewer to 160 more) | Very low | Critical |
| - | 12.5% | 50 more per 1000 (from 60 fewer to 160 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment and no blinding(Laurent (1998)).
- b
The confidence interval crossed 1 MID.
Table 60Clinical evidence profile: standard mattress in ICU/standard foam mattress post-ICU versus standard ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – standard mattress in ICU/standard foam mattress post-ICU versus standard ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers 113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 14/80 (17.5%) | 11/75 (14.7%) | RR 1.19 (0.58 to 2.46) | 28 more per 1000 (from 62 fewer to 214 more) | Very low | Critical |
| - | 14.7% | 28 more per 1000 (from 62 fewer to 215 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There were unclear sequence generation, allocation concealment and no blinding. Laurent (1998).
- b
The confidence interval crossed both MIDs.
Table 61Clinical evidence profile: alternating pressure (NIMBUS) ICU/SFM post-ICU versus standard ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - alternating pressure (NIMBUS) ICU/SFM post-ICU versus standard ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 10/80 (12.5%) | 11/75 (14.7%) | RR 0.85 (0.38 to 1.89) | 22 fewer per 1000 (from 91 fewer to 131 more) | Very low | Critical |
| - | 14.7% | 22 fewer per 1000 (from 91 fewer to 131 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment and no blinding reported by the authors (Laurent (1998)).
- b
The confidence interval crossed both MIDs.
Table 62Clinical evidence profile: standard ICU/standard foam mattress post-ICU versus slternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR)CLP post-ICU – grade 2 and above pressure ulcers
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - standard ICU/standard foam mattress post-ICU versus alternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR)CLP post-ICU – grade 2 and above pressure ulcers113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 14/80 (17.5%) | 10/77 (13%) | RR 1.35 (0.64 to 2.85) | 45 more per 1000 (from 47 fewer to 240 more) | Very low | Critical |
| - | 13% | 46 more per 1000 (from 47 fewer to 240 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment and no blinding. Laurent (1998).
- b
The confidence interval crossed both MIDs.
Table 63Clinical evidence profile: alternating pressure mattress (NIMBUS) ICU/standard foam mattress post-ICU versus alternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – alternating pressure mattress (NIMBUS) ICU/SFM post-ICU versus alternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 10/80 (12.5%) | 10/77 (13%) | RR 0.96 (0.42 to 2.18) | 5 fewer per 1000 (from 75 fewer to 153 more) | Very low | Critical |
| - | 13% | 5 fewer per 1000 (from 75 fewer to 153 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment and no blinding reported by the authors(Laurent (1998)).
- b
The confidence interval crossed both MIDs.
Table 64Clinical evidence profile: standard ICU/constant low pressure mattress (TEMPUR) post-ICU versus alternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | AP and CLP in ICU/post ICU (factorial design) | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - standard ICU/constant low pressure mattress (TEMPUR) post-ICU versus alternating pressure mattress (NIMBUS) ICU/constant low pressure mattress (TEMPUR) post-ICU – grade 2 and above pressure ulcers113 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb | None | 11/75 (14.7%) | 10/77 (13%) | RR 1.13 (0.51 to 2.5) | 17 more per 1000 (from 64 fewer to 195 more) | Very low | Critical |
| - | 13% | 17 more per 1000 (from 64 fewer to 195 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There were unclear sequence generation, allocation concealment and no blinding. Laurent (1998).
- b
The confidence interval crossed both MIDs.
Table 65Clinical evidence profile: comparisons between alternating-pressure devices
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Comparisons between alternating-pressure devices | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – alternating-pressure mattress (TRINOVA) versus control – all grades of pressure ulcers199 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | Very seriouse | None | 0/22 (0%) | 2/22 (9.1%) | RR 0.2 (0.01 to 3.94) | 73 fewer per 1000 (from 90 fewer to 267 more) | Very low | Critical |
| - | 9.1% | 73 fewer per 1000 (from 90 fewer to 268 more) | ||||||||||
| Incidence of pressure ulcers – alternating low pressure air mattress with multi-stage inflation and deflation of air cells versus standard (CLINACTIV, HILLROM) alternating low pressure air mattress with single-stage inflation and deflation of air cells – all grades of pressure ulcers54 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | Seriousb | None | 68/298 (22.8%) | 56/312 (17.9%) | RR 1.27 (0.93 to 1.74) | 48 more per 1000 (from 13 fewer to 133 more) | Very low | Critical |
| - | 18% | 49 more per 1000 (from 13 fewer to 133 more) | ||||||||||
| Incidence of pressure ulcers – alternating-pressure mattress with 2 layers of air cells (PEGASUS AIRWAVE SYSTEM) versus alternating-pressure large cell ripple mattress – grade 2 and above pressure ulcers61 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 5/31 (16.1%) | 12/31 (38.7%) | RR 0.42 (0.17 to 1.04) | 225 fewer per 1000 (from 321 fewer to 15 more) | Very low | Critical |
| - | 38.7% | 224 fewer per 1000 (from 321 fewer to 15 more) | ||||||||||
| Incidence of pressure ulcers – alternating-pressure mattress (PEGASUS AIRWAVE SYSTEM) versus alternating-pressure mattress (PEGASUS CAREWAVE SYSTEM) – grade 2 and above pressure ulcers87 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | No serious imprecision | None | 0/36 (0%) | 0/39 (0%) | Not pooled | Not pooled | Low | Critical |
| 0% | - | |||||||||||
| Incidence of pressure ulcers - alternating-pressure mattress (TRINOVA) versus control – grade 2 and above pressure ulcers199 | ||||||||||||
| 1 | Randomised trial | Very seriousd | No serious inconsistency | No serious indirectness | Very seriouse | None | 0/22 (0%) | 2/22 (9.1%) | RR 0.2 (0.01 to 3.94) | 73 fewer per 1000 (from 90 fewer to 267 more) | Very low | Critical |
| - | 9.1% | 73 fewer per 1000 (from 90 fewer to 268 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure overlay versus alternating pressure mattress – grade 2 and above pressure ulcers147 | ||||||||||||
| 1 | Randomised trial | Very seriousf | No serious inconsistency | No serious indirectness | Seriousb | None | 106/989(10.7%) | 101/982(10.3%) | RR 1.04(0.81 to 1.35) | 4 more per 1000 (from 20 fewer to 36 more) | Very low | Critical |
| - | 10.3% | 4 more per 1000 (from 20 fewer to 36 more) | ||||||||||
| Incidence of pressure ulcers – alternating pressure bed (THERAPULSE) versus alternating pressure mattress (HILL-ROM DUO) – grade 2 and above pressure ulcers200 | ||||||||||||
| 1 | Randomised trial | Very seriousg | No serious inconsistency | No serious indirectness | Very seriouse | None | 3/30 (10%) | 6/32 (18.8%) | RR 0.53 (0.15 to 1.94) | 88 fewer per 1000 (from 159 fewer to 176 more) | Very low | Critical |
| - | 18.8% | 88 fewer per 1000 (from 160 fewer to 177 more) | ||||||||||
| Incidence of pressure ulcers - alternating low pressure air mattress with multi-stage inflation and deflation of air cells versus standard (CLINACTIV, HILLROM) alternating low pressure air mattress with single-stage inflation and deflation of air cells – grade 2 and above pressure ulcers54 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | Very seriouse | None | 17/298 (5.7%) | 18/312 (5.8%) | RR 0.99 (0.52 to 1.88) | 1 fewer per 1000 (from 28 fewer to 51 more) | Very low | Critical |
| - | 0% | - | ||||||||||
| Withdrawal due to discomfort - alternating low pressure air mattress with multi-stage inflation and deflation of air cells versus standard (CLINACTIV, HILLROM) alternating low pressure air mattress with single-stage inflation and deflation of air cells54 | ||||||||||||
| 1 | Randomised trial | Very serioush | No serious inconsistency | No serious indirectness | Very seriouse | None | 11/298 (3.7%) | 17/312 (5.4%) | RR 0.68 (0.32 to 1.42) | 17 fewer per 1000 (from 37 fewer to 23 more) | Very low | Critical |
| - | 0% | - | ||||||||||
| Comfort alternating-pressure mattress (TRINOVA) versus control199 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | No serious imprecision | Very seriousi | n=18 | - | - | - | Very low | Critical |
| Length of stay in hospital (mean days) for people who did develop a pressure ulcer - alternating pressure bed (THERAPULSE) versus alternating pressure mattress (DUP) 200 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | No serious imprecision | Very seriousj | 26 (range 23-37.3) | 24 (range 13-59) | - | - | Very low | Important |
| Length of stay in hospital (days) for people who did develop a pressure ulcer- alternating pressure bed (THERAPULSE) versus alternating pressure mattress (DUP) 200 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | No serious imprecision | Very seriousj | 18 (range 5-127) | 20 (range 5-49) | - | - | Very low | Important |
| Time to develop new pressure ulcer (days) - alternating low pressure air mattress with multi-stage inflation and deflation of air cells versus standard (CLINACTIV, HILLROM) alternating low pressure air mattress with single-stage inflation and deflation of air cells54 | ||||||||||||
| 1 | Randomised trial | Serioush | No serious inconsistency | No serious indirectness | No serious imprecision | Very seriousj | 5.0 (IQR 3.0-8.5) | 8.0 days (IQR 3.0-8.5) | p=0.182 11 | - | Very low | Important |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | |
- a
There was inadequate sequence generation reported by the authors. There was unclear allocation concealment, blinding and addressing of incomplete outcome data (Exton-Smith 1982).
- b
The confidence interval crossed 1 MID.
- c
There was unclear sequence generation, allocation concealment, blinding and addressing of incomplete outcome data reported by the authors. There were baseline differences (Hampton 1997).
- d
There was unclear sequence generation, blinding and addressing incomplete outcome data reported by the authors. There was selective reporting (Taylor 1999).
- e
The confidence interval crossed both MIDs.
- f
There was no blinding reported by the authors. There was a high drop-out in both groups (Nixon 2006).
- g
There was unclear sequence generation and addressing of incomplete outcome data reported by the authors (Theaker 2005).
- h
There was no blinding of outcome assessors reported by the authors. There was a high drop-out in both groups (Demarre 2012).
- i
Only comfort data for the intervention studied was reported. 18/22 participants completed the comfort questionnaire, 11/18 (61.1%) described the mattress as being comfortable. Most 10/18 (55.5%) found the mattress to be acceptable; overall opinion was that the mattress was unacceptable 5/18.
- j
There was not enough data provided to analyse in Revman.
- k
Mann-Whitney U-test=113, p=0.182.
- l
Taylor (1999) did not report the grading system used but both pressure ulcers were superficial 1 was non-blanching erythema and 1 was a superficial break in the skin. Demarre (2012) used EPUAP 1999 grading system; Exton-Smith (1982) unclear grading system but included grade 3 and 4 which were superficial or deep sores; Hampton (1997) did not report the grading system; Nixon (2006) used EPUAP 2004 and NPUAP 1999; Theaker (2005) used the Lowthian scale.
Table 66Clinical evidence profile: low air loss versus standard bed
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Low air loss | Standard bed | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – low-air-loss bed (KINAIR) versus static air mattress overlay (EHOB WAFFLE) or standard ICU bed - people in ICU - all grades of pressure ulcerse33,94 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious inconsistency | No serious indirectness | No serious | None | 12/111 (10.8%) | 37/110 (33.6%) | RR 0.32 (0.18 to 0.58) | 229 fewer per 1000 (from 141 fewer to 276 fewer) | Low | Critical |
| - | 35.4% | 241 fewer per 1000 (from 149 fewer to 290 fewer) | ||||||||||
| Incidence of pressure ulcers – low-air-loss hydrotherapy bed (CLENSICAIR) versus standard care (standard bed or foam, air, alternating-pressure mattresses) - grade 2 and above pressure ulcerse15 | ||||||||||||
| 1 | Randomised trial | Very seriousa,d | No serious inconsistency | No serious indirectness | Serious imprecisionb | None | 8/42 (19%) | 4/56 (7.1%) | RR 2.67 (0.86 to 8.27) | 119 more per 1000 (from 10 fewer to 519 more) | Low | Critical |
| - | 119 more per 1000 (from 10 fewer to 516 more) | |||||||||||
| Incidence of pressure ulcers – low-air-loss bed (KINAIR) versus static air mattress overlay (EHOB WAFFLE) or standard ICU bed – people in ICU - grade 2 and above pressure ulcerse33;93 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 9/111 (8.1%) | 36/110 (32.7%) | RR 0.25 (0.13 to 0.49) | 245 fewer per 1000 (from 167 fewer to 285 fewer) | Low | Critical |
| - | 34.5% | 259 fewer per 1000 (from 176 fewer to 300 fewer) | ||||||||||
| Comfort – low air loss hydrotherapy (CLENSICAIR) versus standard care (standard bed or foam, air , alternating-pressure mattresses) 15 | ||||||||||||
| 1 | Randomised trial | Very seriousa,d | No serious inconsistency | No serious indirectness | No serious imprecision | Very lowc | n=10 | - | - | See footnote4 | Very low | Critical |
| Patient acceptability– low air loss hydrotherapy (CLENSICAIR) versus standard care (standard bed or foam, air , alternating-pressure mattresses)15 | ||||||||||||
| 1 | Randomised trial | Very seriousa,d | No serious inconsistency | No serious indirectness | No serious imprecision | Very lowc | - | - | - | See footnote5 | Very low | Critical |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
Unclear sequence generation (Cobb 1997, Inman 1993) and allocation concealment (Bennett 1998, Inman 1993) was reported by the authors. Unclear blinding was reported (Cobb 1997, Inman 1993, Bennett 1998). No addressing of incomplete outcome data was reported (Inman 1993). There were differences at baseline (Cobb 1997).
- b
Confidence interval crossed 1 MID point.
- c
Data on comfort was only from the intervention group and only 10/42 participants completed the questionnaire. 5/10 thought it was comfortable, 4/10 thought it was uncomfortable.
- d
It should be noted that there were more drop-outs overall from the treatment than the control group 24/48 (35%) versus 2/58 (3%) (p=0.0001). Six participants receiving low airloss hydrotherapy exited the study on the first day because either a participant or family member complained about the bed. This was due to being wet, cold or uncomfortable on the specialty bed. Two participants were removed by the research investigators or nurses as a result of hypothermia within the first 24 hours of enrolment.
- e
Bennett (1998) used NPUAP 1989; Cobb (1997) used NPUAP 1989 and Shea 1975; Inman (1993) used Shea 1975.
Table 67Clinical evidence profile: indentation load deflection (IDL) (25%) operating room foam mattress (density 1.3 cubic feet, IDL 30lb) versus operating room usual care (padding as required, including gel pads, foam mattresses, ring cushions)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | ILD operating room mattress | Usual care | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - all grades of pressure ulcers180 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 55/206 (26.7%) | 34/207 (16.4%) | RR 1.63 (1.11 to 2.38) | 103 more per 1000 (from 18 more to 227 more) | Low | Critical |
| - | 16.4% | 103 more per 1000 (from 18 more to 226 more) | ||||||||||
| Incidence of pressure ulcers - grade 2 and above pressure ulcers180 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | Very seriousc | None | 6/206 (2.9%) | 3/207 (1.4%) | RR 2.01 (0.51 to 7.93) | 15 more per 1000 (from 7 fewer to 100 more) | Very low | Critical |
| - | 1.5% | 15 more per 1000 (from 7 fewer to 104 more) | ||||||||||
| Patient acceptability – postoperative skin changes180 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | No serious | Very seriousd | - | - | p=0.0111 | See footnotee | Very low | Critical |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was no allocation concealment reported by the authors.
- b
The confidence interval crossed 1 MID point.
- c
The confidence interval crossed both MID points.
- d
No details given for number of participants in each arm for postoperative skin changes.
- e
People on the experimental mattress (IDL) were significantly more likely to have skin changes than those on the usual care operating room table, no further details were given.
Table 68Clinical evidence profile: operating table overlay versus no overlay
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | ILD operating room mattress | Usual care | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - viscoelastic polymer pad versus no overlay- all grades of pressure ulcers148 | ||||||||||||
| 1 | Randomised trial | Seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 22/205 (10.7%) | 43/211 (20.4%) | RR 0.53 (0.33 to 0.85) | 96 fewer per 1000 (from 31 fewer to 137 fewer) | Low | Critical |
| - | 20.4% | 96 fewer per 1000 (from 31 fewer to 137 fewer) | ||||||||||
| Incidence of pressure ulcers - viscoelastic foam overlay versus no overlayf – all grades of pressure ulcers62 | ||||||||||||
| 1 | Randomised trial | Very seriousc | No serious inconsistency | No serious indirectness | Very seriousd | None | 13/85 (15.3%) | 9/90 (10%) | RR 1.53 (0.69 to 3.39) | 53 more per 1000 (from 31 fewer to 239 more) | Very low | Critical |
| - | 10% | 53 more per 1000 (from 31 fewer to 239 more) | ||||||||||
| Incidence of pressure ulcers – viscoelastic foam overlay versus no overlay – grade 2 and above pressure ulcersf62 | ||||||||||||
| 1 | Randomised trials | Very seriousc | No serious inconsistency | No serious indirectness | Very seriouse | None | 13/85 (15.3%) | 9/90 (10%) | RR 2.12 (0.2 to 22.93) | 12 more per 1000 (from 9 fewer to 244 more) | Very low | Critical |
| - | 10% | 12 more per 1000 (from 9 fewer to 241 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There were differences at baseline. The standard mattress group had a longer length of operation, longer pre-operative stay and more time in hypotensive state than the dry polymer pad group (Nixon 1998).
- b
The confidence interval crossed 1 MID.
- c
There was unclear sequence generation, allocation concealment and addressing of incomplete outcome data (Feuchtinger 2006).
- d
The confidence interval crossed both MIDs.
- e
The confidence interval crossed both MID points and limited number of events.
- f
Nixon (1998) used the Torrance 1983 grading system; Feuchtinger (2006)used EPUAP 2005 grading system.
Table 69Clinical evidence profile: disposable polyurethane foam prone head positioner (OSI) versus neoprene air filled bladder (dry flotation) device (ROHO)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | OSI face pillow | ROHO face pillow | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – all grades of pressure ulcersd82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 10/22 (45.5%) | 0/22 (0%) | Peto OR 12.55 (3.11 to 50.57) | 450 more (from 240 more to 670 more) | Very low | Critical |
| - | 0% | 450 more (from 240 more to 670 more) | ||||||||||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersd82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb,c | None | 2/22 (9.1%) | 0/22 (0%) | Peto OR 7.75 (0.47 to 128.03) | 90 more from 50 fewer to 230 more) | Very low | Critical |
| - | 0% | 90 more from 50 fewer to 230 more | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
Grisell (2008): did not provide details of baseline data. No blinding was reported by the authors. There was a higher drop-out than event rate.
- b
There were a limited number of events.
- c
The confidence interval crossed both MID points.
- d
NPUAP grading system.
Table 70Clinical evidence profile: disposable polyurethane foam prone head positioner (OSI) versus prone view protective helmet system with a disposable polyurethane foam prone head positioner (DUPACO)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | OSI face pillow | Dupaco face pillow | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – all grades of pressure ulcersd82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousb | None | 10/22 (45.5%) | 0/22 (0%) | Peto OR 12.55 (3.11 to 50.57) | 450 more (from 240 more to 670 more) | Very low | Critical |
| - | 0% | 450 more (from 240 more to 670 more) | ||||||||||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersd82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very seriousb,c | None | 2/22 (9.1%) | 0/22 (0%) | Peto OR 7.75 (0.47 to 128.03) | 90 more from 50 fewer to 230 more | Very low | Critical |
| - | 0% | 90 more from 50 fewer to 230 more | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
Grisell (2008) did not provide details of baseline data. No blinding was reported by the authors. There was a higher drop-out than event rate.
- b
There were a limited number of events.
- c
The confidence interval crossed both MID points.
- d
NPUAP grading system.
Table 71Clinical evidence profile: neoprene air filled bladder (dry flotation) device (ROHO) versus prone view protective helmet system with a disposable polyurethane foam prone head positioner (DUPACO)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | ROHO face pillow | Dupaco face pillow | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – all grades of pressure ulcersb82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 0/22 (0%) | 0/22 (0%) | Not pooled | Not pooled | Low | Critical |
| - | 0% | Not pooled | ||||||||||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersb82 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 0/22 (0%) | 0/22 (0%) | Not pooled | Not pooled | Low | Critical |
| - | 0% | Not pooled | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
Grisell (2008): No details of baseline data were reported or blinding was reported by the authors. There was a higher drop-out than event rate.
- b
NPUAP grading system.
Table 72Clinical evidence profile: multi-cell pulsating dynamic mattress system (MICROPULSE) versus standard mattress for people undergoing surgery
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Micropulse System for surgical patients | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – all grades of pressure ulcersd6;164 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 3/188 (1.6%) | 14/180 (7.8%) | RR 0.21 (0.06 to 0.7) | 61 fewer per 1000 (from 23 fewer to 73 fewer) | Low | Critical |
| 7.9% | 62 fewer per 1000 (from 24 fewer to 74 fewer) | |||||||||||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersd6; | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Seriousc | None | 0/90 (0%) | 6/80 (7.5%) | RR 0.07 (0 to 1.2) | 70 fewer per 1000 (from 75 fewer to 15 more) | Very low | Critical |
| - | 7.5% | 70 fewer per 1000 (from 75 fewer to 15 more) | ||||||||||
| Time in hospital6 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | Very seriousa | - | - | - | See footnoteb | Very low | Important |
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to develop pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation (quasi-randomised), allocation concealment and blinding, and a higher drop-out than event rate (Aronovitch 1999). The conventional management group were at higher risk at baseline (Knoll score). There was unclear sequence generation method, no blinding and higher-drop-out rate than the event rate (Russell 2000).
- b
The data were given only for those who developed ulcers - 6/8 who developed ulcers had a length of stay longer than average for the specific diagnosis. The average length of stay for those developing ulcers was 14 days, which was6.7 days longer than the hospital's average of 7.3 days for this Diagnosis Related Group. The authors state that this represents an increase in length of stay of 92%.
- c
The confidence interval crossed 1 MID point.
- d
Aronovitch (1999) used NPUAP and WOCN and Russell (2000) used NPUAP 1997.
Table 73Clinical evidence profile: viscoelastic foam (TEMPUR-PEDIC) A&E overlay and ward mattress versus standard A&E overlay and ward mattress
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Accident and emergency overlay and ward mattress | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – grade 2 and above pressure ulcersc83 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very serious imprecisionb | None | 4/48 (8.3%) | 8/53 (15.1%) | RR 0.55 (0.18 to 1.72) | 68 fewer per 1000 (from 124 fewer to 109 more) | Very low | Critical |
| - | 15.1% | 68 fewer per 1000 (from 124 fewer to 109 more) | ||||||||||
| Incidence of pressure ulcers – all grades of pressure ulcersc83 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | Very serious imprecisionb | None | 12/48 (25%) | 17/53 (32.1%) | RR 0.78 (0.42 to 1.46) | 71 fewer per 1000 (from 186 fewer to 148 more | Very | Critical |
| - | 32.1% | 71 fewer per 1000 (from 186 fewer to 148 more) | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment, blinding and addressing of incomplete outcome data reported by the authors.
- b
The confidence interval crossed both MID points.
- c
EPUAP 1999 grading system.
Table 74Clinical evidence profile: profiling bed with a pressure-reducing foam mattress versus flat-based bed with a pressure-reducing mattress
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Profiling bed | Flat-based bed | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers – all grades of ulcerb104 | ||||||||||||
| 1 | Randomised trial | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 0/35 (0%) | 0/35 (0%) | Not pooled | Not pooled | Low | Critical |
| - | 0% | Not pooled | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear blinding, unclear addressing of incomplete outcome data reported by the authors and a higher drop-out than event rate.
- b
EPUAP 1991 grading system.
Table 75Clinical evidence profile: comparisons between different seat cushions
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other | Seat cushions | Control | Relative (95% CI) | Absolute | ||
| Incidence of pressure ulcers - slab foam versus bespoke contoured foam38; 117 | ||||||||||||
| 2 | Randomised trials | Very seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 104/151 (68.9%) | 102/149 (68.5%) | RR 1.01 (0.86 to 1.17) | 7 more per 1000 (from 96 fewer to 116 more) | Low | Critical |
| Incidence of pressure ulcers - Jay Gel cushion versus foam38 | ||||||||||||
| 1 | Randomised trial | Seriousb | No serious inconsistency | No serious indirectness | Seriousc | None | 17/68 (25%) | 30/7 3 (41.1%) | RR 0.61 (0.37 to 1) | 160 fewer per 1000 (from 259 fewer to 0 more) | Low | Critical |
| Incidence of pressure ulcers- pressure reducing cushion versus standard foam cushion70 | ||||||||||||
| 1 | Randomised trial | No serious risk of bias | No serious inconsistency | No serious indirectness | Very seriousd | None | 6/15 (40%) | 10/1 7 (58.8%) | RR 0.68 (0.33 to 1.42) | 188 fewer per 1000 (from 394 fewer to 247 more) | Low | Critical |
| Incidence of pressure ulcers - skin protection cushion versus segmented foam cushion - sitting related ischial tuberosities27 | ||||||||||||
| 1 | Randomised trial | Seriouse | No serious inconsistency | No serious indirectness | Seriousc | None | 1/113 (0.88%) | 8/11 9 (6.7%) | RR 0.13 (0.02 to 1.04) | 58 fewer per 1000 (from 66 fewer to 3 more) | Low | Critical |
| - | 0% | - | ||||||||||
| Pressure ulcer incidence - skin protection cushion versus segmented foam cushion - combined ischial tuberosities and sacral orcoccyx27 | ||||||||||||
| 1 | Randomised trial | Seriouse | No serious inconsistency | No serious indirectness | Seriousc | None | 12/113 (10.6%) | 21/1 19(17.6%) | RR 0.60 (0.31 to 1.17) | 71 fewer per 1000 (from 122 fewer to 30 more) | Low | Critical |
| 0% | - | |||||||||||
| Withdrawal due to discomfort38 | ||||||||||||
| 1 | Randomised trial | Seriousb | No serious inconsistency | No serious indirectness | Very seriousd | None | 1/83 (1.2%) | 6/80 (7.5%) | RR 0.16 (0.02 to 1.3) | 63 fewer per 1000 (from 73 fewer to 22 more) | Very low | |
| - | 0% | - | ||||||||||
| Acceptability | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Rate of development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time to development of pressure ulcers | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Time in hospital or NHS care | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
| Health-related quality of life | ||||||||||||
| - | - | - | - | - | - | - | - | - | - | - | - | - |
- a
There was unclear sequence generation, allocation concealment and blinding reported by the authors(Conine 1993, Lim 1988).
- b
There was unclear sequence generation and allocation concealment reported by the authors(Conine 1994).There was no participant or healthcare provider blinding but outcome assessors were blinded (Geyer 2001).
- c
The confidence interval crossed 1 MID.
- d
The confidence interval crossed both MIDs.
- e
There were baseline differences. There was a higher drop-out rate than the event rate. The study could not control for the use of other support surfaces (Brienza 2010).
- f
Conine (1993) and (1994) used Exton Smith 1982; Lim (1988) used NPUAP 1989; Geyer (2001) used NPUAP 1992; Brienza (2010) used NPUAP 2001.
Table 76Economic evidence profile: alternating pressure verses alternative foam
| Study | Applicability | Limitations | Other comments | Incremental cost | Incremental effects | Cost effectiveness | Uncertainty |
|---|---|---|---|---|---|---|---|
| Fleurence 2005 65(UK) | Partially applicablea | Potentially serious limitationsb | A decision analytic model which compared 3 alternatives: alternating pressure overlays (AO), alternating pressure mattress replacements (AR), high-specification foam mattresses (SC) | Four week horizon AR-AO = £20.52 SC-AR = £43.21 | Four week horizon (QALYs) AR-AO = 0.00008 SC-AR = -0.00032 | Four week horizon SC is dominated AR v AO = £253,367 per QALY gained | At a ceiling ratio of £5,000/QALY the optimal strategy was SC, beyond this value it switches to AO. Scenario analysis revealed that it was less expensive for the hospital to own devices than to rent them. |
- a
Based on the UK NHS but costs are based on 2003 prices
- b
Quality of life data is obtained from health care professionals rather than from patients, short time horizon may not capture full economic impact of these devices. Estimates of health effect estimated rather than obtained from the literature, baseline health outcomes not based on randomised data.
Table 77Economic evidence profile: comparisons between alternating pressure devices
| Study | Applicability | Limitations | Other comments | Incremental cost | Incremental effects | Cost effectiveness | Uncertainty |
|---|---|---|---|---|---|---|---|
| Fleurence 2005 65(UK) | Partially applicablea | Potentially serious limitationsb | A decision analytic model which compared 3 alternatives: alternating pressure overlays (AO), alternating pressure mattress replacements (AR), high-specification foam mattressesc | Four week horizon AR-AO = £20.52 | Four week horizon (QALYs) AR-AO = 0.00008 | Four week horizon AR v AO = £253,367 per QALY gained | Above a willingness to pay threshold of £5,000 per QALY gained, the optimal strategy is AO. Scenario analysis revealed that it was less expensive for the hospital to own devices than to rent them. |
| Nixon 2006149 (UK) | Partially applicablea | Potentially serious limitationsd | Within trial analysis with analysis of individual level data for time to pressure ulcer development and duration of stay. Patients randomised to receive alternating pressure replacement mattresses (AR) or alternating pressure overlays (AO). | AO – AR: £74.50 | AO – AR: -10.63 days until pressure ulcer development | AR dominates AO with a longer period until pressure ulcer development at a lower cost | Probability AR cost-saving: 64% Three additional scenarios were presented: All mattresses rented rather than purchased , lifespan of both surfaces increased from 2 to 5 years, and lifespan of both surfaces increased to 7 years. AR remained the cost-saving strategy in all 3 scenarios. |
- e
Based on the UK NHS but costs are based on 2003 prices
- c
Quality of life data is obtained from health care professionals rather than from patients, short time horizon may not capture full economic impact of these devices. Estimates of health effect estimated rather than obtained from the literature, baseline health outcomes not based on randomised data.
- d
Results for high specification foam are not presented in this table as they are not directly relevant to the comparison addressed here – see Table 48 for results.
- e
QALYs are not reported. Treatment costs of pressure ulcers are not included (it is stated that this is because 70% of patients with grade 2 pressure ulcers do not receive dressings even though 8 of the PUs developed were grade 3) and all results are based on a within trial analysis which means estimates are taken from 1 trial only.
Table 78Economic evidence profile: high specification foam verses standard practice
| Study | Applicability | Limitations | Other comments | Incremental cost | Incremental effects | Cost effectiveness | Uncertainty |
|---|---|---|---|---|---|---|---|
| Legood 2005115 (UK) | Partially applicablea | Minor limitationsb | High specification foam mattresses versus standard mattresses, based on calculations of additional cost of high specification foam, net of any saving from reduced incidence of pressure ulcers. Patients separated into four risk groups; A has lowest risk and D highest. | Group A: -£2.16 Group B: -£25.79 Group C: -£52.04 Group D: -£104.54 | Group A (Incremental mean incidence of pressure ulcers): -0.0035 Group B: -0.035 Group C: -0.07 Group D: -0.14 | High specification foam dominates standard mattress for all patient risk groups. | An extreme scenario is presented, when only 1 in 1 hundred patients develops a pressure ulcer. The pressure relieving mattress still dominates. |
| Pham 2011a159 (Canada) | Partially applicablec | Potentially serious limitationsd | Markov model Markov model comparing pressure redistribution foam mattresses for all residents to current practice. Model includes states for different grades of pressure ulcer and no pressure ulcer. | -£76 | 0.00085 QALYs | Pressure redistribution mattresses dominate current practice. | Probability cost-effective: 82% at willingness to pay of $50,000 per QALY. When excess mortality associated with pressure ulcers (7.23%) was considered (the ICER was £58,321. When looking at costs from a long-term care perspective the overlays remained dominant. |
| Russell 2003167 (UK) | Partially applicablee | Minor limitationsf | Within trial analysis (RCT) with analysis of individual level data. Comparison of visco-polymer energy absorbing foam mattress (CONFOR-Med)/cushion combination verses standard mattress/cushion combination | -£154 | 0.07 pressure ulcers avoided | Visco-polymer energy absorbing foam mattress dominates standard mattress, with reduced costs and reduced incidence of pressure ulcer. | None reported |
- f
Based on the UK NHS but costs are based on 2004 prices
- f
The baseline probability of developing a pressure ulcer is based on GDG estimate, as it the cost of treating pressure ulcers. Both of these estimates are tested in sensitivity analyses. The model does not address people at long term risk of developing pressure ulcers.
- g
Conducted in a Canadian setting
- h
Utility data is not calculated from EQ-5D or SF-36 data. Baseline health estimates and progression of pressure ulcers through the various stages are estimated from RAI-MDS instead of obtained via a systematic procedure. Total costs and effect sizes are unclear as current practice is reported to include 45.5% of individuals already receiving the intervention, yet it is not clear whether reported per patient results reflect this or not – this should not affect the ICER
- i
Based on the UK NHS but old study; no cost year reported
- j
Only the costs of dressings are included to represent the costs of treating pressure ulcers. Resource use and health outcomes are based on entirely on this study.
Table 79Economic evidence profile: constant low pressure supports compared to standard care
| Study | Applicability | Limitations | Other comments | Incremental cost | Incremental effects | Cost effectiveness | Uncertainty |
|---|---|---|---|---|---|---|---|
| Mistiaen 2010131(Netherlands) | Partially applicablea | Potentially serious limitationsb | Within trial analysis with modelled post trial extrapolation. Patients are randomised to receive usual care plus Australian medical sheepskin, or usual care only. Additional costs of the intervention are weighed against saved costs from reduces pressure ulcers. | £137 | 0.060 pressure ulcers avoided when sheepskin in use | Incremental cost per pressure ulcer avoided: £2,298 | The cost of investment is sensitive to the frequency of AMS washing, and the cost of washing. Treatment costs, initial purchase price, durability of AMS and effectiveness of AMS are less influential. |
| Jackson 2011 96 (US) | Partially applicablec | Potentially serious limitationsd | Analysis of patient level resource use in a before-and-after study, with unit costs applied. A preventative treatment protocol and Clinitron Rite-Hite Air Fluidised Therapy bed compared to Standard care on standard ICU bed. | -£3,624 | 0.68 pressure ulcers avoided when preventative protocol and air fluidised bed in place | Preventative protocol and air fluidised bed dominate standard care | No analysis of uncertainty was undertaken. |
| Vermette201 2 217 (Canada) | Partially applicablee | Potentially serious limitationsf | Analysis of patient level resource use within an RCT, with unit costs applied. An Inflated Static Overlay was compared to Standard care (comprised of Microfluid Static Overlay or Low-Air-Loss Dynamic Mattress). | -£125 | 0.07 pressure ulcers avoided when the inflated static overlay is used | The ISO was shown to be cost saving and more effective (decreased incidence of PU) than standard care. | No analysis of uncertainty was undertaken. |
- a
Conducted in the Netherlands from the perspective of a Dutch nursing home; quality of life is not considered
- b
Only sacral ulcers were considered in the economic analysis, therefore the effectiveness estimate may not be a true reflection of the effectiveness on pressure ulcers overall. In addition 1 particular assumption of the model is that the 3 month estimates of pressure ulcer development obtained from the trial will apply over the 1 year time horizon (ie no further PUs will develop between 3 and 12 months) which may not be realistic. The majority of the parameter inputs are obtained from the associated trial, therefore evidence is based on 1 study only. The model only considers grade 1 and 2 ulcers thus may underestimate the cost of treating pressure ulcers.
- c
Study based in the US; quality of life is not considered.
- d
The cost of the standard care mattresses are not included, thus the costs of standard care are based on treatment costs alone. As no severe pressure ulcers developed in intervention 2, the costs are based only on the rental cost of the device. The unit costs and health outcomes are based on entirely on this stud and are not collect via a systematic proceedure.
- e
Study based in the Canada; quality of life is not considered.
- f
Health outcomes, resource and cost data are based on evidence from 1 trial. This analysis only considers the cost of devices and fails to include the cost of pressure ulcer treatment (amongst other costs). Omission of the treatment costs of pressure ulcers biases away from the more effective intervention.
Table 80Economic evidence profile: constant low pressure supports compared to standard care in operating theatre
| Study | Applicability | Limitations | Other comments | Incremental cost | Incremental effects | Cost effectiveness | Uncertainty |
|---|---|---|---|---|---|---|---|
| Pham 2011160 (Canada) | Partially applicableg | Minor limitationsh | Markov model comparing dry, viscoelastic polymer overlays on operating tables to current practice. Model includes states for different grades of pressure ulcer and no pressure ulcer. Analysis specific to patients undergoing scheduled surgical procedures lasting ≥90mins in the supine or lithotomy position. | -£25 | 0.000006 QALYs (reported as 0.0021 QALDs) | Dry viscose polymer overlays dominates current practice | Probability cost-effective: 99.41% between thresholds $50,000 (£27,304) and $100,000 (£54,609) per QALY The cost-effectiveness of the overlay increased with duration of surgery. The overlay was also cost-effective amongst individuals with low intra-operative risk. The overlay remained cost-effective with an increase in price of the overlays up to $2,000 ($878 in base case), and across the 95% CI of the relative risk estimate of developing pressure ulcers. |
- g
Conducted in a Canadian setting, applicable only to patients undergoing surgery expected to last >90 mins
- k
Utility data is not calculated from EQ-5D or SF-36 data
Table 81Unit costs
| Device | Purchase cost | Rental cost | Source |
|---|---|---|---|
| High specification foam mattresses | |||
| Softform premiere | £199.00 | NA | Correspondence with manufacturer |
| Harvest Reflect 2 Replacement Mattress | £140.00 | NA | Correspondence with manufacturer |
| Harvest Prime Comfort Plus | £120.00 | NA | Correspondence with manufacturer |
| Pentaflex (4 way turn, acute) | £204.14 | NA | Correspondence with manufacturer |
| Constant low pressure | |||
| Breeze | £3,453.70 | £12.85 per daya | Correspondence with manufacturer |
| Alternating pressure | |||
| Nimbus 3 | £3,565.18 | £13.56 per daya | Correspondence with manufacturer |
- a
Minimum of 10 day rental
Table 82Unit costs
| Device | Cost | Source |
|---|---|---|
| High specification foam mattresses and overlays | ||
| Softform incubator pad (high specification foam) | £49.48 | NHS supply chain catalogue1 |
| Softform cot mattress (high specification foam) | £107.63 | NHS supply chain catalogue1 |
| Repose babytherm redistributing overlay (with pump) | £91.55 | NHS supply chain catalogue1 |
| Repose paediatric mattress Overlay (with pump) | £91.55 | NHS supply chain catalogue1 |
| Repose mattress overlay (with pump) | £106.11 | NHS supply chain catalogue1 |
| Softform premiere | £199.00 | Correspondence with manufacturer |
| Dynamic support surfaces | ||
| Nimbus paediatric mattress | £13.56 per day rental (purchase price £3,293) | Correspondence with manufacturer |
| Nimbus 3 mattress | £13.56 per day rental (purchase price £3,565) | Correspondence with manufacturer |
| Wheelchair pressure redistribution | ||
| Stimulite contoured paediatric cushion | £185.00 | Correspondence with manufacturer |
| Occipital pressure redistribution | ||
| Gel-E Donut (soft gel pillow) | £6.83 (based on £82 for 12 for extra small size) | Correspondence with manufacturer |
Note: the costs above are included for illustrative purposes only and should not be interpreted as recommendations in favour of these particular devices. These are list prices only and local prices may vary.