Clinical question
Should protein supplementation versus no protein supplementation be used for people at nutritional risk who are at risk of pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People with nutritional risk who are at risk of pressure injuries
Protein supplement
No protein supplement
Any clinical setting
Pressure Injury occurrence
No Guideline Governance Group members of 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
Moderate
Trivial
Very low
No important uncertainty or variability
Probably favors the intervention
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 (Haesler, Pittman et al. 2022), 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 | Protein supplement |
No protein supplement |
Difference | Relative effect |
|---|---|---|---|---|
| PI occurrence | 40/2146 (1.8%) | 59/2118 (2.7%) | 7 fewer per 1,000 (from 14 fewer to 4 more) |
RR 0.75 (0.49 to 1.14) |
Outcome 1: PI Occurrence
The meta-analysis (Langer, Wan et al. 2024) included four RCTs (Hartgrink, Wille et al. 1998, Dennis, Lewis et al. 2005, Botella-Carretero, Iglesias et al. 2008, Anbar, Beloosesky et al. 2014) that compared protein supplementation to no protein supplementation for people at nutritional risk who are also at risk of PIs. Participants were primarily older adults undergoing orthopaedic surgery. The studies used a range of commercial nutritional formulas.* Most of the regimens were individualized based on nutritional needs. The comparative interventions were generally described as a standard hospital diet. The studies were of short duration, with supplementation for a maximum of 14 days.
The meta-analysis (Langer, Wan et al. 2024) showed that protein supplementation might be associated with a lower rate of PI occurrence for people at PI and nutritional risk (relative risk [RR] 0.75, 95% confidence interval [CI] 0.49 to 1.14). There is very little confidence that the effect estimate represents a true effect and that using a protein supplement would lead to a reduction in PI occurrence.
* 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
| Outcome | Protein supplement |
No protein supplement |
Difference | Relative effect |
|---|---|---|---|---|
| Adverse gastrointestinal effects |
17/82 (20.73%) | 9/58 (15.52%) | 46 fewer per 1,000 (from 146 fewer to 845 more) |
RR 0.70 (0.06-7.96) |
Gastrointestinal effects
A meta-analysis (Langer, Wan et al. 2024) of two studies (Botella-Carretero, Iglesias et al. 2008, Anbar, Beloosesky et al. 2014) exploring protein supplements versus no protein supplements reported that there is little difference in adverse gastrointestinal events with protein supplementation, but the certainty is very low (RR 0.70, 95% CI 0.06 to 7.96, p = 0.77).
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 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).
Certainty of the evidence was very low. The evidence was downgraded once for risk of bias. There was a high or uncertain risk across all domains in the four studies included in the meta-analysis. Certainty was also downgraded once for imprecision (Langer, Wan et al. 2024). Certainty was downgraded once for indirectness due to concerns about the duration of the intervention. In the included studies the nutrition intervention was delivered for only two weeks, with follow-up at 6 months in one of the studies.
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
In the Guideline Governance Group’s expert opinion, the moderate desirable effect in preventing PI probably outweigh the undesirable effects (a minor increase in the rate of gastrointestinal adverse effects).
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
No included studies
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 review (Wong, Goh et al. 2019) of cost-effectiveness studies reported seven studies. Of these, three statistical modelling studies established that nutritional interventions are cost effective (Padula, Mishra et al. 2011, Banks, Graves et al. 2013, Tuffaha, Roberts et al. 2016). However, four other studies (Rypkema, Adang et al. 2004, Pham, Stern et al. 2011, Chaboyer, Bucknall et al. 2016, Meehan, Loose et al. 2016) 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 recent cost modelling (Tuffaha, Roberts et al. 2015, Tuffaha, Roberts et al. 2016) data from 5 RCTs was included. The modelling reported 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 and a quality-adjusted life year (QALY) increase of an average of 0.005. This evidence was of moderate quality and was but was based on data from up to 20 years old at the time of the study's publication.
Using a high protein oral nutritional supplement for older people undergoing surgery for a fractured hip (Delmi, Rapin et al. 1990) was associated with a significantly shorter hospital stay compared with using a standard hospital diet (24 days versus 40 days), but the risk of bias for this outcome measure was high.
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 protein supplementation 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
There is some evidence that oral nutritional supplements are acceptable to people who at risk of PIs. A meta-analysis (Chen, Zhang et al. 2023) of eight of the studies conducted in older adults undergoing hip fracture surgery reported that compliance with oral nutritional supplements was acceptable across the studies. An RCT (Bourdel-Marchasson, Barateau et al. 2000) reported that adherence to a prescribed oral nutritional supplement by acutely ill adults (n = 295) was approximately 60%, but increased in the second week of the intervention. The researchers surmised that acute illness might decrease a person's appetite, reducing acceptability of an oral nutritional supplement. When a high protein oral nutritional supplement was prescribed for older people undergoing surgery for a fractured hip (Delmi, Rapin et al. 1990) the amount of oral intake was not different in compared to people who ate a standard hospital diet; there appeared to be no disapproval of the intervention.
In the Panel Group’s expert opinion, a wide range of factors influence acceptability of nutritional 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 protein supplementation 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 dietitian 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 dietitians and nutritional interventions.
In the Panel Group’s expert opinion, people living in the community 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 nutritional supplementation 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.
References
Anbar, R., Y. Beloosesky, J. Cohen, Z. Madar, A. Weiss, M. Theilla, T. Koren Hakim, S. Frishman and P. Singer (2014). "Tight calorie control in geriatric patients following hip fracture decreases complications: a randomized, controlled study." Clin Nutr 33(1): 23-28.
Banks, M. D., N. Graves, J. D. Bauer and S. Ash (2013). "Cost effectiveness of nutrition support in the prevention of pressure ulcer in hospitals." Eur J Clin Nutr 67(1): 42-46.
Botella-Carretero, J. I., B. Iglesias, J. A. Balsa, I. Zamarrón, F. Arrieta and C. Vázquez (2008). "Effects of oral nutritional supplements in normally nourished or mildly undernourished geriatric patients after surgery for hip fracture: a randomized clinical trial." JPEN J Parenter Enteral Nutr 32(2): 120-128.
Bourdel-Marchasson, I., M. Barateau, V. Rondeau, L. Dequae-Merchadou, N. Salles-Montaudon, J.-P. Emeriau, G. Manciet, J.-F. Dartigues and f. t. G. Group (2000). "A multi-center trial of the effects of oral nutritional supplementation in critically ill older inpatients." Nutrition 16: 1–5.
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Chen, B., J. H. Zhang, A. D. Duckworth and N. D. Clement (2023). "Effect of oral nutritional supplementation on outcomes in older adults with hip fractures and factors influencing compliance." Bone & Joint Journal 105-B(11): 1149-1158.
Delmi, M., C. H. Rapin, J. M. Bengoa, P. D. Delmas, H. Vasey and J. P. Bonjour (1990). "Dietary supplementation in elderly patients with fractured neck of the femur." Lancet 335(8696): 1013–1016.
Dennis, M. S., S. C. Lewis and C. Warlow (2005). "Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial." Lancet 365(9461): 755-763.
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.
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Langer, G., C. S. Wan, A. Fink, L. Schwingshackl and D. Schoberer (2024). "Nutritional interventions for preventing and treating pressure ulcers." Cochrane Database of Systematic Reviews 2: CD003216.
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.
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Padula, W. V., M. K. Mishra, M. B. F. Makic and P. W. Sullivan (2011). "Improving the quality of pressure ulcer care with prevention: a cost-effectiveness analysis." Medical Care 49(4): 385-392.
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