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National Clinical Guideline Centre (UK). The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. London: National Institute for Health and Care Excellence (NICE); 2014 Apr. (NICE Clinical Guidelines, No. 179.)
11.1. Introduction
Adequate hydration and nutritional intakes of, energy, protein, carbohydrate and micronutrients (vitamins and minerals) are all associated with skin integrity and the prevention of tissue breakdown. It is commonly considered that the development of pressure ulcers can be associated with an inadequate nutritional intake. Those who are underweight, immobile, overweight or obese are also considered as being at increased risk of developing pressure ulcers due to increased pressure reducing oxygen flow to the affected areas. It could therefore be hypothesised that achieving an ideal nutritional state would reduce the risk of developing pressure ulcers. In addition identification of those at risk of malnutrition would help in identifying those at risk of pressure ulcers. The use of validated nutritional screening tools is recommended by NICE clinical guideline 32 ‘Nutrition support for adults’. Once identified as being at risk of malnutrition appropriate treatment to improve nutritional state is required. The GDG considered whether the meeting of general requirements to improve nutritional state would be adequate in preventing pressure ulcer development or whether there were any additional requirements that would further prevent the development of pressure ulcers. Nutritional intervention to improve nutritional state is a lengthy process, starting with a focus on food first and moving to prescribable nutritional supplements when not successful. Prescribable nutritional supplements are sometimes considered a more reliable source of nutrients although palatability can also affect compliance. Whilst these supplements are often used in hospitals, in the community cost for the length of time required for an improvement in nutritional status can become an inhibitive factor.
The GDG was interested in considering whether there was any specific evidence of nutritional or hydration interventions that would help prevent the development of pressure ulcers. They considered studies that reviewed both malnourished and well-nourished populations.
In order to review possible nutritional treatments in preventing pressure ulcers, the GDG included all studies that examined an additional nutritional element above a standard diet. The GDG also searched for any studies that investigated hydration levels and its role in preventing the development of pressure ulcers.
11.2. Review question: What are the most clinically and cost-effective nutritional interventions for the prevention of pressure ulcers?
For full details see review protocol in Appendix C.
11.2.1. Clinical evidence (adults)
There were no limitations on sample size and only direct studies relating to pressure ulcers and nutrition or hydration were included. No indirect interventions, comparisons or outcomes were considered. Only randomised trials were included. Abstracts were not included unless there were no randomised trial full papers for the comparison. No studies were found for hydration strategies to prevent the occurrence of pressure ulcers.
A Cochrane Review by Langer (2003)112 was found and reported 4 studies which are included in this review. The Cochrane Review did not meta-analyse the studies as the population, interventions and outcomes differed. For the purposes of this review, the results have been separated and meta-analysed. Initially, the GDG considered that it was possible to meta-analyse the studies to gain a greater confidence in the evidence and then report on heterogeneity of studies where this existed. Therefore, the Cochrane review was updated with 4 additional studies identified through searches, Dennis (2005)55, Craig (1998)43, Theilla (2007)201 and Oloffson (2007)150. Dennis (2005)55, Craig (1998)43 and Oloffson (2007)150 did not focus on the development of pressure ulcers, but rather pressure ulcers were an event or complication that occurred during these trials.
In total, 5 RCTs comparing participants who received nutritional supplementation in addition to their standard diet (which was the hospital standard diet) to those who received only the standard hospital diet (Bourdel-Marchasson 2000, Houwing 2003,Hartgrink 1998, Delmi 1990 and Dennis 2005) were identified. These studies all included older people in hospital. Houwing (2003) and Hartgrink (1998) included people with a hip fracture, Delmi (1990) included people with fractured neck of femur, Bourdel-Marchasson (2000) included people who were critically ill and Dennis (2005) included people who have had a stroke. The study by Dennis (2005) was not aimed at the prevention of pressure ulcers but the incidence of pressure ulcers was included as a complication. Hartgrink (1998) gave participants a supplement of energy and protein by nasogastric tube compared to the standard hospital diet (Hartgrink 1998). The follow-up period for studies period ranged from 2 weeks to 6 months. The supplements included various compositions of protein, carbohydrate, vitamins and minerals.
One study (Craig 1998) included people with type 2 diabetes. They gave the participants a disease-specific (reduced-carbohydrate and modified fat) formula compared to the standard high carbohydrate formula. Participants were followed up for 3 months. Another study (Theilla 2007) gave people suffering from lung injury a macronutrient diet plus lipids and vitamins compared to a macronutrient diet alone. These people were followed up for 7 days. In 1 RCT (Oloffson 2007) with people who had a femoral neck fracture(where pressure ulcers was a complication), participants were given protein-enriched meals compared to normal postoperative care and were followed up for 4 months. Many of the studies did not specify whether people were malnourished. In the studies where this was specified the majority tended to be malnourished. In the studies where it was not stated there was often the assumption that the population was likely to be malnourished due to being older adults in hospital for fractures such as of the hip.
Studies were meta-analysed together, where they looked at nutritional supplements in addition to standard hospital diet (which mainly included energy and protein) versus the standard hospital diet (Bourdel-Marchasson 2000, Houwing 2003, Hartgrink 198, Delmi 1990 and Dennis 2005). Another meta-analysis of the studies of nutritional supplements included a study (Oloffson, 2007)150 with a protein diet compared to the standard hospital diet since all of the interventions had a high proportion of protein.
Some of the studies gave the results separately by grade of pressure ulcer that occurred as well as all grades of ulcers that occurred. Therefore the results were split to show data for all pressure ulcers and for those with grade 2-4 ulcers (with details of the classification system of grading).
Summary of included studies
| Study | Study design | Population | Interventions/comparison | Outcomes | Follow-up period (weeks) |
|---|---|---|---|---|---|
| Houwing 200391 | RCT Double blind | Older people with hip fracture | Standard diet with additional oral supplementation (high protein enriched with arginine zinc and antioxidants) versus standard diet with a placebo. |
| 28 days |
| Bourdel-Marchasson 200024 | RCT Unblinded | Critically ill older people | Standard diet with additional oral supplementation (protein, fat, carbohydrate and minerals and vitamins) versus standard diet. |
| 15 days. |
| Hartgrink 199888 | RCT Unblinded | Older people with hip fracture | Standard diet with tube feeding (energy, protein, Nutricia) versus standard diet |
| 2 weeks |
| Delmi 199053 | RCT Unblinded | Older people with fractured neck of the femur | Standard diet with additional oral nutrition supplements (protein, carbohydrate, lipid, calcium, vitamin A, vitamin D, vitamins E, B1, B2, B6, B12, C, nicotinamide, folate, calcium pantothenate, biotin, and minerals) versus standard diet |
| Assessed at 14, 21 and 28 days and followed up at 6 months |
| Craig 199843 | RCT double-blinded pilot study | Long term care residents with type 2 diabetes. | Disease-specific (reduced-carbohydrate, modified-fat) formula versus standard high-carbohydrate formula. |
| 3 months |
| Theilla 2007201 | RCT Unblinded | People who are critically ill, mechanically ventilated and suffering from acute lung injury | Macronutrient diet plus lipids (elcosapentanoic acid, gamma-linolenic acid, vitamins A, C and E) versus macronutrient diet read to feed (high fat, low carbohydrate, enteral formula) |
| 7 days |
| Olofsson 2007150 | RCT | Femoral neck fracture patients | Protein-enriched meals versus normal postoperative care |
| 4 months follow-up |
| Dennis 200555 | Multicentre RCT | Elderly adults who have had a stroke and are in hospital | Normal hospital diet plus oral supplements versus normal hospital diet. |
| 6 months follow-up |
Table 41
Clinical evidence profile: nutritional supplement (360mL at 6.27kJml and 62.5gl in protein) plus standard hospital diet versus standard hospital diet (majority were undernourished).
Table 45
Clinical evidence profile: protein-enriched meals versus normal postoperative care (large proportion of participants were malnourished).
Table 46
Clinical evidence profile: oral supplements plus standard hospital diet versus standard hospital diet (mixed population).
The results were pooled for all studies that included an oral supplement compared to normal hospital diet, as the main constituents of the supplement were protein and energy.
Table 47
Clinical evidence profile: nutritional supplementation (supplements or diet containing protein and energy) plus standard hospital diet versus standard hospital diet (mixed population).
The results were pooled for all studies that included nutritional supplementation compared to a normal hospital diet, as the main constituents of the supplement were protein and energy. This included a study of nutritional supplements which were given by tube feeding
11.2.2. Economic evidence (adults)
Published literature
Two studies were included with the relevant comparison.159,168 These are summarised in the economic evidence profile below (Table 48). See also the study selection flow chart in Appendix D and study evidence tables in Appendix H.
Table 48
Economic evidence profile: Nutritional supplementation versus standard care.
Two studies were selectively excluded10,13 – these are summarised in Appendix K, with reasons for exclusion given.
From Table 39 it is clear that both of the included studies found that the nutritional interventions improved clinical outcomes. However, Rypkema and colleagues found that the intervention reduced costs, and Pham and colleagues found that the nutritional intervention increased costs. This is because in the study reported by Rypkema, the reduction in pressure ulcers led to a reduction in nursing days, antibiotics and diagnostics for nosocomial infections, yet in the Pham study the reduction in pressure ulcer incidence was not sufficient for the reduction in treatment costs to outweigh the initial cost of the intervention. Note that the effectiveness evidence in the Pham paper was obtained from a meta-analysis of four RCTs, yet the equivalent evidence in the Rypkema paper was obtained from a single prospective controlled study. A further notable difference is that the 2 studies approach correction of nutritional deficiency differently: Pham and colleagues report daily provision of nutritional supplementation in the intervention group, whereas Rypkema and colleagues explain that the use of nutritional supplementation was actually higher in the control group, as those in the intervention group were more likely to receive protein, energy-enriched meals and drinks prepared by the hospital kitchen. Additional kitchen staff time has been accounted for in the cost analysis, but it is not clear whether the additional food items have been accounted for. In the latter study the use of pressure ulcer prevention mattresses was higher in the intervention group than in the control group, thus the difference in costs and effects may not be solely attributable to the nutritional intervention.
A weakness to the analysis presented by Pham and colleagues, is that the increase in quality of life due to the intervention is only associated with the prevention of pressure ulcers. Therefore when averaged over all patients, the increase in QALYs is just 0.00008. However, in reality, the benefits of correcting nutritional deficiency extend far beyond the prevention of pressure ulcers, and would lead to a much greater increase in quality of life than is captured by this analysis. Therefore the results bias away from the nutritional intervention. In order for the nutritional intervention to be considered cost effective at the £20,000 per QALY threshold, the intervention would need to produce a QALY gain of 0.0241
Unit costs
Unit costs of common nutritional supplements are provided below to aid consideration of cost effectiveness. These costs represent costs per day of supplements used in the prevention of pressure ulcers. These are the list prices, and the GDG acknowledged that the actual price paid is often much lower than those stated in the table below. The specific supplements included are illustrative only, and should not be interpreted as GDG recommendations.
Table 49
Unit cost estimates per day for nutritional supplements in a community setting.
Total costs depend on the duration that nutritional supplementation is provided, and will vary greatly amongst patients. Monthly costs of vitamin C and protein supplementation would be £4.34 and £114.70 respectively.
11.2.3. Clinical evidence (neonates, infants, children and young people)
No RCTs or cohort studies were identified. Recommendations were developed using a modified Delphi consensus technique. Further details can be found in Appendix N.
11.2.4. Economic evidence (neonates, infants, children and young people)
No economic evidence was identified.
11.2.5. Evidence statements
11.2.5.1. Clinical (adults)
11.2.5.1.1. A supplement containing protein, fat, carbohydrates, minerals and vitamins versus standard diet
- One study (n=672) showed there is potentially no clinical difference between a supplement containing protein, fat, carbohydrates, minerals and vitamins and standard diet for reducing the incidence of pressure ulcers, but the direction of effect favoured the supplement (very low quality).
- One study (n=672) reported compliance of 60% for the first week and 99% for the 2nd week for the supplements group. The clinical importance and imprecision is unknown.
- No evidence was found for the following outcomes:
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Time in hospital or NHS care
- Health-related quality of life
11.2.5.1.2. A supplement containing high amounts of protein, arginine, zinc and antioxidants versus a standard diet
- One study (n=103) showed there may be no clinical difference between a supplement containing high amounts of protein, arginine, zinc and antioxidants and a standard diet for reducing the incidence of pressure ulcers (all grades), but the direction of the estimate of effect could favour the supplement (very low quality).
- One study (n=103) showed there may be no clinical difference between a supplement containing high amounts of protein, arginine, zinc and antioxidants and a standard diet for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of the estimate of effect could favour the supplement (very low quality).
- One study (n=103) reported compliance of 70% for a supplement containing high amounts of protein, arginine, zinc and antioxidants. The clinical importance and imprecision is unknown.
- No evidence was found for the following outcomes:
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Time in hospital or NHS care
- Health-related quality of life
11.2.5.1.3. A supplement containing protein, carbohydrate, lipid, calcium, vitamin A, vitamin D, vitamins E, B1, B2, B6, B12, C, nicotinamide, folate, calcium, pantothenate, biotin, and minerals versus a standard diet
- One study (n=52) showed there may be no clinical difference between a supplement containing protein, carbohydrate, lipid, calcium, vitamin A, vitamin D, vitamins E, B1, B2, B6, B12, C, nicotinamide, folate, calcium, pantothenate, biotin, and minerals and standard diet for reducing the incidence of pressure ulcers, but the direction of the estimate of effect could favour the supplement (very low quality).
- One study (n=52) reported a supplement containing protein, carbohydrate, lipid, calcium, vitamin A, vitamin D, vitamins E, B1, B2, B6, B12, C, nicotinamide, folate, calcium pantothenate, biotin, and minerals was said to be well-tolerated and completely ingested and no side-effects were observed. The clinical importance is unknown (very high quality).
- One study (n=52) reported medians for a supplement containing protein, carbohydrate, lipid, calcium, vitamin A, vitamin D, vitamins E, B1, B2, B6, B12, C, nicotinamide, folate, calcium pantothenate, biotin, and minerals and the standard diet for time in hospital. The median for the supplement was 24 days (range 13-157) and 40 days (range 10-259) for the standard diet. No estimate of effect or precision could be derived.
- No evidence was found for the following outcomes:
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Health-related quality of life
11.2.5.1.4. A nutritional supplement (360mL at 6.27kJmL and 62.5gL in protein) versus a standard hospital diet
- One study (n=4023) showed there is potentially no clinical difference between a nutritional supplement (360mL at 6.27kJmL and 62.5gL in protein) and standard hospital diet for reducing the incidence of pressure ulcers, but the direction of the estimate favoured the supplement (low quality).
- One study (n=4023) reported evidence between nutritional supplement (360mL at 6.27kJmL and 62.5gL in protein) and standard hospital diet. There was a crude compliance rate of 96% for the normal diet group, where 48 people who were supposed to receive the normal diet received some supplements. The supplement group had a crude compliance rate of 98%. The clinical importance and imprecision is unknown.
- One study (n=4023) showed there is potentially no clinical difference between a nutritional supplement (360mL at 6.27kJmL and 62.5gL in protein) and standard hospital diet for length of time in hospital, but the direction of effect favoured the standard hospital diet (low quality).
- No evidence was found for the following outcomes:
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Health-related quality of life
11.2.5.1.5. A supplement of tube fed energy and protein versus standard diet
- One study (n= 101) showed there is potentiallly no clinical difference between a supplement of tube fed energy and protein and standard diet for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of effect could favour the supplement (very low quality).
- One study (n= 101) showed there may be no clinical difference between a supplement of tube fed energy and protein and standard diet for reducing the incidence of pressure ulcers (all grades), but the direction of effect could favour the supplement (very low quality).
- No evidence was found for the following outcomes:
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Time in hospital or NHS care
- Health-related quality of life
11.2.5.1.6. A disease-specific supplement (reduced-carbohydrate, modified-fat formula) and a standard high-carbohydrate formula
- One study (n=32) showed there may be no clinical difference between a disease-specific supplement (reduced-carbohydrate, modified-fat formula) and a standard high-carbohydrate formula for reducing the incidence of pressure ulcers, but the direction of effect could favour the supplement (very low quality).
- One study (n=32) reported no differences for number of adverse events reported. The clinical importance and imprecision is unknown.
- No evidence was found for the following outcomes:
- Acceptability of treatment
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Time in hospital or NHS care
- Health-related quality of life
11.2.5.1.7. A macronutrient diet plus lipids (eicosapentanoic acid, gamma-linolenic acid, vitamins A, C and E) versus a macronutrient diet (high fat, low carbohydrate, enteral formula)
- One study (n=96) showed there may be no clinical difference between a macronutrient diet plus lipids (eicosapentanoic acid, gamma-linolenic acid, vitamins A, C and E) and a macronutrient diet (high fat, low carbohydrate, enteral formula) in mechanically ventilated critically ill adults for reducing the incidence of pressure ulcers (all grades), but the direction of effect could favour the supplement (very low quality).
- One study (n=98) showed there may be no clinical difference between a macronutrient diet plus lipids (eicosapentanoic acid, gamma-linolenic acid, vitamins A, C and E) and a macronutrient diet (high fat, low carbohydrate, enteral formula) in mechanically ventilated critically ill adults for reducing the incidence of pressure ulcers (grade 2 and above), but the direction of effect could favour the supplement (very low quality).
- No evidence was found for the following outcomes:
- Acceptability of treatment
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Time in hospital or NHS care
- Health-related quality of life
11.2.5.1.8. A protein-enriched meal versus normal postoperative care
- One study (n=157) showed a protein-enriched meal is potentially more clinically effective at reducing the incidence of pressure ulcers when compared to normal postoperative care (very low quality).
- One study (n=157) showed there is potentially no clinical difference between a protein-enriched meal and normal postoperative care for time in hospital, the direction of effect favoured the protein-enriched meal (low quality).
- No evidence was found for the following outcomes:
- Acceptability of treatment
- Rate of development of pressure ulcers
- Time to development of pressure ulcers
- Health-related quality of life
11.2.5.1.9. Oral supplements versus normal hospital diet
- Five studies pooled (n=4951) showed there is potentially no clinical difference between oral supplements and normal hospital diet for reducing the incidence of pressure ulcers, the direction of effect favoured the oral supplements (very low quality).
11.2.5.1.10. Nutritional supplementation versus normal hospital diet
- Six studies pooled (n=5108) showed there is potentially no clinical difference between nutritional supplementation and normal hospital diet for reducing the incidence of pressure ulcers, the direction of effect favoured the oral supplements (very low quality).
11.2.5.2. Economic (adults)
- One cost-utility analysis found that a strategy of providing daily oral nutritional supplements to high risk residents with recent weight loss was not cost effective (ICER: £5,160,924) compared to standard care. This study was assessed as partially applicable with potentially serious limitations.
- One cost-consequence analysis found that an intervention in which people were screened for malnutrition, dysphagia and dehydration on admission, and treated accordingly, dominated standard care (lower costs and lower incidence of pressure ulcers). This study was assessed as partially applicable with potentially serious limitations.
11.2.5.3. Clinical (neonates, infants, children and young people)
No evidence was identified.
11.2.5.4. Economic (neonates, infants, children and young people)
No evidence was identified.
11.3. Recommendations and link to evidence
11.3.1. Adults
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade off between clinical benefits and harms | The evidence identified was mainly in people whose nutritional status was not adequate and therefore was of limited applicability to people with adequate nutritional status. Each study used different supplementation and results varied. The results of 1 study were contradictory showing that there was a clinical benefit of nutritional supplements in people with a hip fracture for pressure ulcers grade 2 and above, but no difference for all grades of pressure ulcer (including grade 1), whereas another study of people with hip fracture who were tube-fed showed there was no difference. Another 3 studies in people with fractured neck of femur and older people who had had a stroke showed no clinical benefit of supplementation. One study of older people with type 2 diabetes in long-term care showed a clinical benefit for the reduced incidence of pressure ulcers for a reduced-carbohydrate, modified-fat formula compared to a standard high-carbohydrate formula. There was no clinical difference for a macronutrient diet plus lipids compared to a macronutrient ready to feed diet in critically ill, mechanically ventilated people with acute lung injury. Protein enriched meals had a clinical benefit in reducing the incidence of pressure ulcers for older people with femoral neck fractures compared to normal post-operative care. Two studies showed a lower time in hospital for people who received supplementation, whereas 1 found an increased time in hospital for people who received supplementation. The evidence included a variety of components in the supplements, thus it is not possible to isolate which specific component provided benefit. Overall, there was an unclear clinical benefit of nutritional supplementation for the prevention of pressure ulcers in populations which included people who had inadequate nutritional status. As such, the GDG felt that for the prevention of pressure ulcers, it was unlikely that it was beneficial to provide specific nutritional supplementation to people with adequate nutrition and were unable to develop a recommendation in support of providing nutritional supplementation for this population. However, it was acknowledged that in clinical practice, it is likely that people at risk of developing pressure ulcers may also be at risk of having an inadequate nutritional status (for example older people) and it is important that any nutritional deficiency is corrected in these populations. |
| Economic considerations | The economic evidence focused on people who were malnourished. One cost-utility analysis found that daily nutritional supplements were not cost effective in people with recent weight loss (at a threshold of £20,000 per QALY) for the prevention of pressure ulcers. However, the GDG noted that correction of nutritional deficiency has benefits which extend far beyond prevention of pressure ulcers, and such health benefits were not captured in the analysis. The GDG felt strongly that had such health benefits been included in the analysis, correction of nutritional deficiency would have been found cost-effective. Another economic analysis found that a nutritional intervention was cost saving, although the GDG noted the limited applicability and limitations of both of these studies. The GDG decided that there was limited additional benefit to providing extra nutritional supplementation where nutritional status was adequate, and that it would not be cost-effective to do so. |
| Quality of evidence | The GRADE rating of the evidence for the effectiveness of nutritional interventions on the prevention of pressure ulcers was low to very low quality. This was mainly due to serious or very serious imprecision and risk of bias in the studies. In all cases, the population focused on a population of older adults. It was not possible to conduct a meta-analysis of the randomised trials included in the review due to heterogeneity in the components of the supplements used, the population and the outcomes considered. |
| Other considerations | The GDG considered that this recommendation relates to the provision of adequate nutrition and that this should be provided in line with the NICE clinical guideline 138 ‘Patient Experience’ and NICE clinical guideline 32‘Nutrition support in adults’. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that, the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade off between clinical benefits and harms | No data was identified on the effectiveness of hydration strategies for the prevention of pressure ulcers. The GDG did not consider that there would be any benefit for the prevention of pressure ulcers for providing additional subcutaneous or intravenous fluids, where hydration status is adequate. Furthermore, the group felt that there were potential harms associated with providing hydration beyond that needed to achieve adequate hydration status. A recommendation was therefore developed using informal consensus of the GDG. |
| Economic considerations | No economic evidence on the cost effectiveness of hydration strategies in the prevention of pressure ulcers was identified. |
| Quality of evidence | No data was identified on the effectiveness of hydration strategies in the prevention of pressure ulcers. The GDG acknowledged that the nutritional interventions employed may affect hydration, as well as nutritional status. The recommendation was therefore based upon informal consensus of the GDG. |
| Other considerations | The GDG agreed that it was important that people were provided with adequate hydration, regardless of the effectiveness in preventing pressure ulcers. Recommendations on the provision of intravenous fluids for adults will be found in NICE clinical guideline ‘Intravenous fluids therapy in adults’ (currently in development) and NICE clinical guideline 138 ‘Patient experience in adult NHS services’. |
11.3.2. Neonates, infants, children and young people
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus survey to inform the recommendation. The statement was ‘Healthcare professionals should not offer nutritional supplementation to neonates, infants, children or young people at risk of developing pressure ulcers, where nutritional intake is adequate for developmental age and comorbidities.’ Further detail on the Delphi consensus survey can be found in Appendix N. The statement was not accepted by the Delphi consensus panel and was therefore amended by the GDG for inclusion in Round 2 of the survey. Qualitative comments gathered from Round 1 focused on the need to ensure that neonates, infants, children and young people at risk of developing a pressure ulcer are treated on an individual basis, with care tailored to the child. Comments suggested that there were some situations in which the panel felt that it would be appropriate to provide nutritional supplementation for the prevention of pressure ulcers. However, comments identified that this should only be considered after consultation with a paediatric dietitian or dietitian with experience of working with these age groups. The GDG considered the qualitative feedback and felt that the statement should be clarified to emphasise that nutritional supplementation should not be given specifically for the prevention of pressure ulcer in neonates, infants, children and young people who have been identified as having adequate nutritional status following assessment. The GDG therefore amended the statement to ‘Following nutritional assessment, if nutritional status is adequate, taking into account developmental age and comorbidities, healthcare professionals should not give further supplementation specifically for the prevention of pressure ulcers in neonates, infants, children and young people’ for inclusion in Round 2. The statement was included in Round 2 of the survey and was accepted by the Delphi consensus panel. Qualitative responses from the panel generally felt that the statement was improved however, a minority of individuals still felt that there might be situations in which nutritional supplementation would be beneficial in the prevention of pressure ulcers. The GDG considered all the responses and developed a recommendation to reflect the statement, that nutritional supplementation should not be given for the prevention of pressure ulcers. The GDG highlighted that this was in line with the recommendation developed for adults and that, there were no identified benefits in the prevention of pressure ulcers for a population with adequate nutritional status. The GDG acknowledged that individuals with nutritional deficiencies should always have these deficiencies corrected and therefore the recommendation was worded to account for individuals whose nutritional status may not be appropriate for their developmental age or their clinical condition. |
| Economic considerations | The GDG felt there was limited additional benefit to providing extra nutritional supplementation where nutritional status was adequate, and agreed that it would not be cost effective to do so. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey and reached 45% consensus agreement. The statement was therefore amended and included in Round 2 of the consensus, where it reached 77% agreement. Further details can be found in Appendix N. |
| Other considerations | There were no other considerations. |
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG identified that the proportion of people developing new pressure ulcers and patient acceptability were the most critical outcomes to inform decision making, given that the primary goal of pressure ulcer prevention was to limit the number of new ulcers. Acceptability was identified as being critical from the perspective of the patient, as it was noted that this could have a significant impact upon quality of life. Rate of development of new pressure ulcers, time to develop new pressure ulcers, time in hospital or NHS care and health related quality of life were considered important outcomes to inform decision making. |
| Trade-off between clinical benefits and harms | The GDG used 1 statement from the Delphi consensus survey to inform the recommendation. The statement was ‘Healthcare professionals should not offer hydrational supplementation to neonates, infants, children or young people at risk of developing pressure ulcers, where hydrational intake is adequate for developmental age and associated fluid losses.’ Further detail on the Delphi consensus survey can be found in Appendix N. The statement was not accepted by the Delphi consensus panel and was therefore amended by the GDG for inclusion in Round 2 of the survey. Qualitative comments gathered via Round 1 suggested that any decision as to whether the use of further hydration was needed should be made after an assessment. The GDG discussed the comments and amended the statement for inclusion in Round 2 of the survey. The GDG felt that, ensuring necessary hydration was important for all children and young people but the use of further hydration specifically for the prevention of pressure ulcers was inappropriate and potentially harmful. As such, the GDG wished to clarify in Round 2 that hydrational supplementation was not appropriate for the prevention of pressure ulcers if, after assessment, a child is deemed to have an appropriate hydrational status for their developmental age, accounting for any comorbidities. The statement for Round 2 was therefore amended to ‘Following assessment of hydration, if hydrational status is adequate, taking into account developmental age and comorbidities, healthcare professionals should not give further supplementation specifically for the prevention of pressure ulcers in neonates, infants, children and young people.’ The statement was included in Round 2 of the survey and was accepted by the Delphi consensus panel. Qualitative responses from the panel generally felt that the inclusion of the term ‘healthcare professional’ within the statement was inappropriate, as this may include individuals involved in the prescription of fluids. Other comments also highlighted the lack of evidence to support the provision of additional hydration for the prevention of pressure ulcers and emphasised the potential harms in increasing fluid intake. The GDG therefore developed a recommendation to reflect the statement, that additional hydration (in the form of subcutaneous or intravenous fluids) should not be given for the prevention of pressure ulcers. The GDG highlighted that this was in line with the recommendation developed for adults and that, there were no identified benefits in the prevention of pressure ulcers for a population with adequate nutritional status. The GDG acknowledged that individuals with a reduced hydrational status should always have these deficiencies corrected and therefore the recommendation was worded to account for individuals whose hydrational status may not be appropriate for their developmental age or their clinical condition. |
| Economic considerations | The GDG felt it would not benefit the individual to provide additional fluids where hydration status was adequate, and agreed that to do so would not be cost effective. |
| Quality of evidence | No RCTs or cohort studies were identified for neonates, infants, children or young people. Formal consensus using a modified Delphi was therefore used to develop the recommendation. To inform the recommendation, the GDG used 1 statement which was included in Round 1 of the Delphi consensus survey and reached 52% consensus agreement. The statement was therefore amended and included in round 2 of the survey where it reached 75% agreement. Further details can be found in Appendix N. |
| Other considerations | Recommendations on the use intravenous fluids in children and young people can be found in the NICE guideline on intravenous fluids therapy for children, due for publication in 2015. |
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