Clinical question
Should energy, protein and micronutrient supplementation versus no supplementation be used for people with nutritional risk who are also at risk of pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Background:
Conflicts on Interest:
People with nutritional risk who are at risk of pressure injuries
Energy, protein and micronutrient supplement
No supplement
Any clinical setting
Pressure Injury 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
Small
Trivial
Very low
No important uncertainty or variability
Does not favor either the intervention or the comparison
Moderate costs
No included studies
Varies
Probably increased
Varies
Varies
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 2021, the Guideline Governance Group undertook a stakeholder survey on priority issues to address in the guideline. Receiving clinical guidance on nutritional interventions to prevent pressure injuries was rated as the highest priority by clinicians (median ranking 5/5) and rated as a high priority by researchers, industry representatives and people with or at risk of pressure injuries and their informal carers (median ranking for all these stakeholder groups 4/5).In an earlier survey conducted by the previous Guideline Governance Group in 2018,1 71.8% (275/383) of individuals with or at risk of PIs and 65.3% (555/850) of informal carers rated receiving information on diet and hydration as important or very important.
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | Energy, protein and, micronutrient supplement |
No supplement |
Difference | Relative effect |
|---|---|---|---|---|
| PI occurrence | 172/7696 (22.4%) | 233/865 (26.9%) | 21 fewer per 1000 (from 78 fewer to 52 more) |
RR 0.92 (0.71-1.19) |
Outcome 1: PI Occurrence
The meta-analysis3 included three RCTs4-6 that compared energy-based, protein and micronutrients supplementation regimens to no supplementation/standard diet for people at nutritional risk who are also at risk of PIs. Participants were primarily hospitalized older adults. The studies used a range of nutritional formulas** that provided 400-700kcal/day, with between 14-30% of energy from protein and between 20-36% energy from fat. The comparative intervention was a standard hospital diet in all studies. The interventions were delivered for varied durations (e.g. 14 days in one study6 and 26 weeks in another study4).
The meta-analysis3 showed that energy, protein and micronutrient supplementation might be associated with a lower rate of PI occurrence for people at PI and nutritional risk (RR 0.92, 95% CI 0.71 to 1.19). There is limited confidence in the effect estimate, the true effect of using an energy, protein and micronutrient supplement may be substantially different than the estimate of the effect.3
** Regimens are described in the data extraction tables. Product names may have changed since publication of the studies..
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
No meta-analysis of undesirable effects was available. One of the RCTs 6 reported there was no difference in serious adverse events (mortality) between supplementation and no supplementation. Vitamin and mineral dietary supplements have only a small likelihood of causing any major health risks,7 but many products have not been tested in children.
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 |
Outcome 1: PI occurrence
In a Delphi survey2 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).
Certainty of the evidence was very low. The evidence was downgraded twice for risk of bias and once for indirectness. There was a high risk of bias across all three studies included in the meta-analysis,3 the population was primarily not malnourished, no specific vitamin/mineral deficiencies were identified and the intervention was delivered for more than 14 days in only one study.4
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 survey2 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.2
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
In the Guideline Governance Group’s expert opinion, the balance of effects favours neither the intervention nor comparator.
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 the Panel Group’s expert opinion, nutritional supplementation can be expensive, particularly for homeless people, people living in the community, people in long term institutional settings, and those without access to health insurance. This is a particular concern for people who require supplementation for longer duration. In acute care settings, particularly intensive care, nutritional supplements are usually funded within the costs of health care.
In the Guideline Governance Group’s expert opinion, the above costs represent moderate costs of implementing the nutritional supplementation.
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 research 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
A systematic review8 of cost-effectiveness studies reported seven studies.9-15 Of these, three statistical modelling studies established that nutritional interventions are cost effective.9-11 However, four other studies12-15 reported lack of cost effectiveness for nutritional interventions for preventing PIs. The review notes that a failure to demonstrate an impact of the intervention on clinical outcomes is a limit of many economic evaluations.
In the most recently published cost modelling in the above review was conducted by Tuffaha et. al.11,16 modelling based on data from five RCTs found an estimated cost for providing oral nutritional support (including patient education, monitoring, and high protein oral supplements) for 12 months was associated with a cost saving of approximately AUD $425/person compared with standard nutrition. Quality-adjusted life year (QALY) increased by an average of 0.005. This evidence was of moderate quality and was based on data from up to 20 years old at the time of the study's publication.
The Guideline Governance Group considered the above information and noted that cost effectiveness is highly variable across geographic and clinical contexts.
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
In the Panel Group’s expert opinion, people who are at higher risk of nutritional deficits are also more likely to be unable to access nutritional supplementation due to their social circumstances and the cost of interventions. This includes barriers to accessing a dietitian to evaluate the person’s nutritional needs.
In the Guideline Governance Group’s expert opinion, recommending supplementation with carbohydrate-based energy, protein and micronutrients would likely increase health inequity. There are barriers to accessing supplementation for many people depending on their geographic location and the clinical context
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In the Panel Group’s expert opinion, a wide range of factors influence acceptability of supplements. These include palatability of thickened supplements and altered foods (e.g. pureed or thickened) and the person’s ability to consume the volume of fluid required for some supplements.
In the Guideline Governance Group’s expert opinion, recommending supplementation with carbohydrate-based energy, protein and micronutrients would having varying acceptability from stakeholders.
12. Feasibility:
Is the intervention (limiting sitting time) feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In the Panel Group’s expert opinion, barriers to implementation include access to a registered dietitian/nutritionist to ensure the intervention can be individualized to the person’s needs. Nutritional supplementation is not available in many clinical and geographic contexts, and in some contexts there are rigid referral mechanisms to access registered dietitians/nutritionists and nutritional interventions.
In the Panel Group’s expert opinion, people living in the community (including especially homeless people) may be unable to implement the recommendation due to lack of relevant knowledge to select an appropriate supplement.
In the Guideline Governance Group’s expert opinion, the feasibility of implementing a recommendation to provide supplementation with carbohydrate-based energy, protein and micronutrients varies. In some contexts (e.g. most acute care settings) access to nutritional supplementation and the processes that support implementation (e.g. screening for nutritional deficits, dietician review, access to products) is highly feasible. In other contexts (e.g., community settings, low resource communities) implementing a recommendation to provide nutritional supplementation would not be feasible.
