Clinical question
Should a heel offloading device versus fluid filled bag to offload heels be used for people at risk of heel pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of heel pressure injuries
Heel offloading device
A fluid filled bag to offload heels
Any clinical setting
Heel pressure injury (PI) occurrence
None
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
Large
Varies
Very low
No important uncertainty or variability
Favors the intervention
Varies
No included studies
No included studies
Probably increased
Don’t know
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 local interventions to prevent heel PIs (e.g. skin care, strategies to reduce moisture or friction) as being the highest priority (median ranking 5/5, where 5 is the highest priority).
In an earlier survey conducted by the previous Guideline Governance Group in 2018 (Haesler, Pittman et al. 2022), 87.8% (297/338) of individuals with or at risk of PIs and 88% (602/684) of informal carers rated receiving information on repositioning as important or very important. The median (inter quartile range [IQR]) priority ranking for receiving information on heel PIs was 5 (1) for individuals with or at risk of PIs and 5 (1) for informal carers (possible score range 1 to 5).
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | Heel offloading device |
Fluid filled bag | Difference | Relative effect |
|---|---|---|---|---|
| Heel PI occurrence | 0/15 (0.0%) | 6/15 (40.0%) | 368 fewer PIs per 1,000 (from 400 fewer to 10 more) |
RR 0.08 (0-1.25) |
Outcome 1: Heel PI Occurrence
The meta-analysis included one non randomized comparative study(Bales 2012) that compared using a soft, firm, medical-grade foam heel suspension boot to offload heels and Achilles tendon area to using a fluid filled intravenous bag to for preventing heel PIs. The interventions were trialled in an orthopedic ward setting in adults having hip or knee replacements. The meta-analysis showed that using a heel offloading device was associated with a non-significant lower rate of heel PIs ( 0% versus 40%, RR 0.08, 95% CI 0 to 1.25, p = 0.07), translating to a difference of 368 fewer per 1,000 experiencing a heel PI when a heel offloading device is used. However, it is very uncertain if the result represents a true effect; the true effect lies between 400 fewer people and 10 more people experiencing a PI with a heel offloading device.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Reported undesirable effects for a heel off loading device were very low (0.4%)(Bååth, Engstrom et al. 2016)
The Panel Group noted that using a heel offloading device can reduce the individual’s bed and general mobility and can increase the risk of falls. This should be considered when determining whether a heel offloading device is appropriate for the individual as the reduced mobility can increase the risk of other PIs. The Panel Group also noted that when incorrectly fitted or used, there can be an increased risk of PIs occurring at locations other than the heel.
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 | VERY LOW |
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).
Outcome 1: PI occurrence
The certainty of evidence is very low. The evidence was downgraded twice for risk of bias due to performance and selection bias. The evidence was also downgraded three times for imprecision for an extremely wide 95% confidence interval, a small sample size and small number of events.
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
There were large desirable effects. There is limited evidence on undesirable effects and they likely vary depending on the devices and the individual’s risk factors. If devices are correctly fitted and used, the desirable effects are likely to favour the offloading device. Using fluid filled bag/glove is off-label use and could cause heel PIs if the interface pressure is too high.
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
A heel offloading device costs more than some alternatives The device needs to be selected and fitted appropriately to the individual, and regular assessment is required. The Panel Group indicated that access to a heel offloading device is usually not limited in tertiary hospitals in high resource countries. However, access and cost are limited in the community and in aged care settings in many geographic settings.
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
There is no available evidence.
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
There is no available evidence.
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 indicated that in tertiary settings in high resource countries, a heel offloading device is easily accessible.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In this study, all participants expressed satisfaction with having their heels elevated, regardless of the method used to offload pressure.(Bales 2012) In another study(Bååth, Engstrom et al. 2016) in which the same memory foam heel suspension boot was used for people being transferred in ambulances (n = 205), 39% said it caused friction, 71% described it as ‘warm’ or ‘sweaty’ and 30% rated it as itchy. For positioning, 48% described it as comfortable when lying down and 25% found it comfortable in a side-lying position.(Bååth, Engstrom et al. 2016)
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
Heel offloading devices are in use and appear to be feasible when the patient profile is matched to the intervention. The Panel Group indicated that access to a heel offloading device is usually not limited in tertiary hospitals in high resource countries. However, access and cost are limited in the community and in aged care settings in many geographic settings.
References
Bååth, C., M. Engstrom, L. Gunningberg and A. Muntlin Athlin (2016). "Prevention of heel pressure ulcers among older patients - from ambulance care to hospital discharge: A multi-centre randomized controlled trial." Applied Nursing Research 30: 170-175.
Bales, I. (2012). "A Comparison between the use of intravenous bags and the heelift suspension boot to prevent pressure ulcers in orthopedic patients." Adv Skin Wound Care 25(3): 125-131.
Haesler, E., J. Pittman, J. Cuddigan, S. Law, Y. Y. Chang, K. Balzer, D. Berlowitz, K. Carville, J. Kottner, M. Litchford, Z. Moore, P. Mitchell and D. Sigaudo-Roussel (2022). "An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline." J Tissue Viability 31(1): 1-10.
Lechner, A., S. Coleman, K. Balzer, J. J. Kirkham, D. Muir, J. Nixon and J. Kottner (2022). "Core outcomes for pressure ulcer prevention trials: results of an international consensus study." Br J Dermatol 187(5): 743-752.
