Clinical question

Should alternating pressure (active) air full body support surfaces vs. pressure-redistributing foam (reactive) full body support surfaces be used for people at risk of pressure injuries?

Context

Population:

Intervention:

Comparison:

Main Outcomes:

Setting:

Conflicts of Interest:

Individuals at risk of pressure injuries

alternating pressure (active) air full body support surfaces

pressure-redistributing foam (reactive) full body support surfaces

Any clinical setting

Pressure Injury occurrence

No Guideline Governance Group members or Core Review Group members had a conflict of interest

Evidence to Decision Framework

(Click on the individual judgements for more information)

Summary of Judgements

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

Yes

Small

Moderate

Low

No important uncertainty or variability

Don’t know

Varies

Very low

Probably favors the intervention

Probably increased

Probably yes

Probably yes

1. Problem:
Is the problem (pressure injuries) a priority?

JUDGEMENT

  • No

  • Probably No

  • Probably Yes

  • Yes

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

The problem of preventing pressure injuries is a significant priority to healthcare in most clinical settings. In a stakeholder survey conducted by the Guideline Governance Group in 2021, the target audiences for the guideline, including individuals with or at risk of PIs, their informal carers and health professionals, all identified that receiving clinical guidance on selection of support surfaces is of the highest priority (median ranking 5/5).

In an earlier survey conducted by the International Pressure Injury Guideline, Guideline Governance Group (Haesler, Pittman et al. 2022), 68.6% (263/383) of individuals with or at risk of PIs and 61.5% (523/850) of informal carers rated receiving information on support surfaces to use as important or very important. The median priority ranking for receiving information on support surfaces was 4/5 for both individuals with or at risk of PIs of informal carers (Haesler, Pittman et al. 2022).

2. Desirable Effects:
How substantial are the desirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Outcome alternating pressure (active) air support surfaces Pressure redistributing foam (reactive) support surfaces Difference Relative effect
PI occurrence(Shi, Dumville et al. 2021) 83/1125 (7.4%) 117/1122 (10.4%) 39 fewer PIs per 1,000
(from 69 fewer to 18 more)
RR 0.63
(0.34-1.17)
HRQOL on EQ-5D-5L tool(Nixon, Brown et al. 2019) Explored, but the precise rate of events was not reported Explored, but the precise rate of events was not reported Reported as being not different between group, the precise statistical analysis was not reported Not calculable
HRQOL on PU-QoL-UI tool(Nixon, Brown et al. 2019) Explored, but the precise rate of events was not reported Explored, but the precise rate of events was not reported Reported as being not different between group, the precise statistical analysis was not reported Not calculable

Outcome 1: PI occurrence

The meta-analysis (Shi, Dumville et al. 2021) included four randomized controlled trials (RCTs) (Stapleton 1986, Rosenthal, Felton et al. 2003, Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019) that explored support surfaces/technology directly relevant to the clinical question based on categorization of support surfaces by the authors/researchers at the time the research was undertaken.** The meta-analysis showed that alternating pressure (active) air surfaces are associated with a non-significant lower rate of PI occurrence (RR = 0.63, 95% CI 0.34 to 1.17, p = 0.14), and may reduce the proportion of people who develop a new PI compared to pressure redistribution foam mattresses.

** Support surfaces reported in the research were considered in this Guideline based on their categorization by the researchers (at the time the research was undertaken). Where available, the product name and characteristics were included in the data extraction tables. Product names/technology may have changed. Due to advances in technology, currently available support surfaces in the same category may have different performance characteristics.

Outcome 2: Health related quality of life (HRQOL)

One study(Nixon, Brown et al. 2019) included in the meta-analysis reported 90-day HRQOL for people using an alternating pressure (active) air surface compared with a pressure-redistributing (reactive) foam surface. There were no significant differences between the two groups when HRQOL was measured using the EQ-5D-5L tool (n=267, Z=0.00, p=1.0) or when measured using the PU-QoL-UI tool (n=233, Z=0.00, p=1.0).(Nixon, Brown et al. 2019)

3. Undesirable Effects:
How substantial are the undesirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Outcome alternating pressure (active) air support surfaces Pressure redistributing foam (reactive) support surfaces Difference Relative effect
Any adverse event(Shi, Dumville et al. 2021) - - Uncertain difference -
Mattress related adverse events(Nixon, Brown et al. 2019) 0.1% 0.2% No difference -
Serious adverse events(Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019) - - No difference -
Deaths(Nixon, Brown et al. 2019) 8.1% 8.3% No difference -
Falls(Nixon, Brown et al. 2019) 14.9% 15.7% Higher rate with alternating pressure -
Discomfort and sleep disruption (Sauvage, Touflet et al. 2017) - - Uncertain difference -

In a meta-analysis(Shi, Dumville et al. 2021), data on adverse events were unable to be pooled due to the difference in definitions of adverse event used across the studies.(Rosenthal, Felton et al. 2003, Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019) The evidence was considered very low certainty and it is uncertain if there is any difference.

Serious adverse events

Studies reported that no related and unexpected serious adverse events occurred in either study group (Nixon, Brown et al. 2019). Rates of expected/serious adverse events (including death, re-admission and falls) were not different between alternating pressure (active) air surface and a pressure redistributing foam (reactive) surface(Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019). Falls-related events were slightly higher with alternating pressure air support surfaces.(Nixon, Brown et al. 2019)

Discomfort

Based on very low certainty of evidence from one RCT (Sauvage, Touflet et al. 2017), it is uncertain if there is any difference in comfort between alternating pressure (active) air surfaces and pressure redistributing foam (reactive) surfaces. In this study less than 10% of respondents reported sleep disruption or disruptive noise associated with the support surface.

4. Overall certainty of evidence: What is the overall certainty of the evidence of effects?

JUDGEMENT

  • Very low

  • Low

  • Moderate

  • High

  • No included studies

RESEARCH EVIDENCE

Outcome Relative Importance Certainty of Evidence
PI occurrence CRITICAL LOW

Outcome 1: PI occurrence

In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical importance (score of 7-9).

The certainty of evidence is low. The evidence was downgraded once for risk of bias (Shi, Dumville et al. 2021) because two studies with approximately 50% of weight in the analysis had either one domain at high risk of bias or all domains at unclear risk of bias. Two other studies had several domains at unclear risk of bias. Certainty was also downgraded for moderate imprecision (Shi, Dumville et al. 2021).

5. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?

JUDGEMENT

  • Important uncertainty or variability

  • Possibly important uncertainty or variability

  • Probably no important uncertainty or variability

  • No important uncertainty or variability

RESEARCH EVIDENCE

In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).

6. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?

JUDGEMENT

  • Favors the comparison

  • Probably favors the comparison

  • Does not favor either the intervention or the comparison

  • Probably favors the intervention

  • Favors the intervention

  • Varies

  • Don’t know

RESEARCH EVIDENCE

The evidence on desirable and desirable effects is very low certainty.

7. Resources Required:
How large are resource requirements (costs) of the intervention?

JUDGEMENT

  • Large costs

  • Moderate costs

  • Negligible costs and savings

  • Moderate savings

  • Large savings

  • Varies

  • Don’t know

RESEARCH EVIDENCE

Mean total cost of using alternating pressure (active) air surfaces was statistically significantly lower than using pressure-redistributing (reactive) foam surfaces (£4,482; 95% confidence interval [CI] £4,438 to £4,526 versus £4,621; 95% CI £4,577 to £4665; p < 0.000), due to the difference in health care costs associated with treating PIs that occurred in less time when using pressure-redistributing (reactive) foam surfaces (Nixon, Brown et al. 2019). At the time of this study the National Institute for Health and Care Excellence (NICE) considered a cost per QALY within the range of £20,000–30,000 to be an acceptable cost saving (Nixon, Brown et al. 2019). Cost analysis is limited to aged care settings.

The GGG considered the wide variation in clinical and geographic context and determined that resource requirements vary.

8. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention?

JUDGEMENT

  • Very low

  • Low

  • Moderate

  • High

  • No included studies

RESEARCH EVIDENCE

A cost analysis(Nixon, Brown et al. 2019) included the daily cost of treating a PI (in-patient and community nurse visits costs), end-of-life care costs and additional mattress costs. The Guideline Governance Group were very uncertain that this represents all the resources associated with using a powered support surface.

9. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?

JUDGEMENT

  • Favors the comparison

  • Probably favors the comparison

  • Does not favor either the intervention or the comparison

  • Probably favors the intervention

  • Varies

  • No included studies

RESEARCH EVIDENCE

One RCT(Nixon, Brown et al. 2019) determined that alternating pressure (active) air surfaces are probably modestly cost effective compared with pressure-redistributing (reactive) foam surfaces. Alternating pressure (active) air surfaces had a 99% probability of being cost-effective at a threshold of GBP 20,000. Alternating pressure (active) air surfaces had lower costs and was associated with higher quality-adjusted life-year (QALY) values in the short and long term.(Nixon, Brown et al. 2019, Shi, Dumville et al. 2021) The analysis considered costs in the UK public health system.

A quality improvement program in US operating rooms reported a cost analysis showing an alternating pressure (active) overlay used in the operating room was associated with an OR-related hospital acquired PI cost avoidance of $323,048 for three months (as compared to no alternating pressure overlay), translating to an annualized potential cost saving of almost $1.3 million. A further annualized cost saving of approximately $480,000 was calculated for the reduction of hospital acquired pressure injury during the post-surgery ICU admission period (USD in 2021) (Pittman, Horvath et al. 2021).

10. Inequity:
What would be the impact of recommending the intervention on health inequity?

JUDGEMENT

  • Reduced

  • Probably reduced

  • Probably no impact

  • Probably increased

  • Increased

  • Varies

  • Don’t know

RESEARCH EVIDENCE

The Panel Group noted that there is significant inequity in access to the resources across different health settings and geographic regions. Many people at risk of PIs have no affordable access to alternating pressure (active) air support surfaces. Access can be influenced by health insurance schemes and other funding mechanisms, availability in the region and the way support surfaces are prioritized for use.

The Panel Group noted that people from low economic backgrounds in all geographic regions, including people who are homeless, have reduced access to support surfaces. The Panel Group noted that the rising costs of power could increase the costs of using powered support surfaces and reduce access.

11. Acceptability:
Is the intervention acceptable to key stakeholders?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

Randomized controlled trials (Sauvage, Touflet et al. 2017, Nixon, Brown et al. 2019) and observational studies (Meaume and Marty 2015, Gleeson 2016, Meaume and Marty 2018, Marutani, Okuwa et al. 2019, Meaume, Rousseaux et al. 2021) have reported the experience of patients using alternating pressure (active) air surfaces in a range of clinical settings, including community-based care, stroke care, palliative care and aged care. The studies explore overall satisfaction, ease of movement and reduction in pain. Individuals participating in these studies reported a high rate of positive experiences using an alternating pressure air (active) surface.

With over 20 years of continued use in clinical settings, clinical consensus supports the balance of benefits for alternating pressure (active) support surfaces.

12. Feasibility:
Is the intervention feasible to implement?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • Yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

In a survey of 83 nurses (Meaume and Marty 2018), overall high satisfaction of health professionals with aspects of feasibility when using an alternating pressure (active) air mattress. Alternating pressure (active) air surfaces were rated highly for ease of cleaning (95.5%), implementation (93.2%), ease of turning (85.2%), and ease of assisting the person from a lying to a seated position (75.9%). Similar results were reported for an alternating air pressure (active) overlay (Meaume, Rousseaux et al. 2021).