Clinical question
Should heel off loading device versus standard pillows 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
A heel offloading device
Pillows
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
Low
No important uncertainty or variability
Favors the intervention
Varies
No included studies
No included studies
Probably increased
Varies
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 |
Pillows | Difference | Relative effect |
|---|---|---|---|---|
| Reduction in heel PI occurrence | 1/234 (0.4%) | 18/214 (8.4%) | 79 fewer PIs per 1,000 (from 83 fewer to 58 fewer) |
RR 0.06 (0.01-0.31) |
Outcome 1: Heel PI Occurrence
The meta-analysis included two randomized controlled trials(Meyers 2017, Barakat-Johnson, Lai et al. 2022) comparing a heel offloading device[*] to heel elevation using standard pillows (one of the studies used either pillows or a regular foam bootee as a control). The heel offloading device was used in intensive care settings in both settings, and durations of product use ranged from 5 days to 28 days. There was statistically significantly fewer heel PIs in the group receiving a heel offloading device versus a standard pillow (0.4% versus 8.4%, p = 0.0007, RR 0.06, 95% CI 0.01 to 0.31). This translated to a difference of 79 fewer people per 1,000 who might have a PI if a heel offloading device is used. However, there is a high level of uncertainty and the true effect lies between 88 fewer and 58 fewer.
[*] Both studies used the same offloading device, see details about the intervention in the data extraction tables
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Neither of the included studies(Meyers 2017, Barakat-Johnson, Lai et al. 2022) provided information about any adverse events. One study on a different heel offloading boot reported a very low rate of skin damage (0.4%) as an adverse event. (Bååth, Engstrom et al. 2016)
The Panel Group noted that using a heel offloading device can reduce the individual’s bed (which may increase risk of PIs at other anatomical locations) and can reduce general mobility, increasing 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 | LOW |
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcome set 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 low (for the analysis conducted at level of the individual). The evidence was downgraded twice for risk of bias, which was high in at least two domains. The evidence was downgraded for imprecision due to wide confidence intervals.
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 was 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.
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
In contrast to standard pillows that are available in most settings, a heel offloading device costs more. The device needs to be selected and fitted appropriately to the individual, and regular assessment is required. This is likely to be an increased cost compared to using a pillow, but there are no formal studies. 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. However, the Panel Group also noted that standard pillows that are of sufficient quality to offload heels are not necessarily easily accessible in tertiary hospitals.
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
There was no information on acceptability for the specific devices used in these studies. In another study, acceptability is varied and limited to an evaluation of one device. In one trial using a different type of offloading device,(Bååth, Engstrom et al. 2016) individuals rated a heel offloading boot as ‘warm’ or ‘sweaty’ (70%), causing friction (39%) or itchy (30%), and less than half of participants classified the heel offloading boot as comfortable in lying positions.(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.
Barakat-Johnson, M., M. Lai, J. Stephenson, H. Buhr, J. Campbell, A. Dolton, S. Jones, T. Leong, N. Reddy and F. Coyer (2022). "Efficacy of a heel offloading boot in reducing heel pressure injuries in patients in Australian intensive care units: A single-blinded randomised controlled trial." Intensive & critical care nursing 70: 103205.
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.
Meyers, T. (2017). "Prevention of heel pressure injuries and plantar flexion contractures with use of a heel protector in high-risk neurotrauma, medical, and surgical intensive care units: A randomized controlled trial." J Wound Ostomy Continence Nurs 44(5): 429-433.
