Hospital Food Should Always Represent the First Line Dietary Measure For

Approach to Oral and Enteral Nutrition in Adults Topic 8

Module 8.2

Hospital Diet and Oral Nutritional Supplements (Sip feeds)

Matthias Pirlich, MD Imperial Oak Outpatient Clinic Endocrinology, Gastroenterology & Clinical Nutrition Berlin, Germany

Dr Kalliopi-Anna Poulia Laiko General Hospital of Athens Athens Greece

Marian de van der Schueren, PhD HAN University of Applied Sciences Nijmegen, NL

Kristina Norman, PhD Dpt. Nutrition and Body composition German Institue of Human Nutrition Potsdam-Rehbrücke Nuthetal, Germany

Learning Objectives  To learn about the importance of hospital food / requirements of hospitalized patients;  To learn about the standards that food service should follow;  To learn about ways to enhance nutritional intake (food fortification, protected meal times, provision of assistance);  To know the types and indications of oral nutritional supplements (ONS);  To know the clinical and economic benefits of ONS.

Contents 1. The importance of hospital food 2. Characteristics of hospital food 2.1 Common types of hospital diets 3. Monitoring and improving food intake during hospitalization 3.1 Protected mealtimes and feeding assistance 3.2 Food fortification 4. Oral nutritional supplements (ONS) – sip feeds 4.1 Definition 4.2 Indication of ONS 4.3 Compliance with and monitoring of ONS 4.4 Clinical effects of ONS 4.5 Economic implications of ONS 5. Summary 6. References

Key Messages  Oral feeding, with either normal food or special and/or fortified diets, is always the first choice to prevent or treat undernutrition in patients;  Measures to enhance palatability, good quality and appearance of hospital food should be taken;  Oral nutritional intake should be carefully monitored, encouraged and supplemented either by energy dense food choices or with food fortification, especially in malnourished patients;  Oral nutritional supplements (ONS) should be used for patients who fail to cover their nutritional needs by hospital food or food fortification;  ONS are effective to increase energy- und protein intake and to improve nutritional and functional status;  ONS have the potential to improve clinical outcomes in terms of morbidity, quality of life, complication rate, length of hospital stay, and mortality;  ONS are cost-effective.

1. The Importance of Hospital Food Maintaining good nutritional status during hospitalization is vital, as undernutrition is associated with increased risk of hospital infections, delayed wound healing, and longer hospital stay, increased cost of treatment and higher morbidity and mortality (1, 2). Disease related malnutrition (DRM) is a significant problem, affecting 20-60% of hospitalised patients (2, 3). During hospitalization this problem is often exacerbated, as hospital procedures may necessitate fasting or skipping meals. The problem of iatrogenic malnutrition was first encapsulated by Butterworth in a 1974 paper describing the negative effect of medical procedures on nutritional status (4). Food intake is a major contributor to quality of life and well-being, not only in health but also in disease. The importance of food was recognised as early as 400 BC by Hippocrates, who stated “Food is your medicine – hence let your medicine be your food”. During hospitalization, all patients have the right to safe, nutritious food. Hospital food can actually cover the needs of the majority of patients and therefore it represents the first-line nutritional measure to tackle hospital malnutrition. Therefore, hospital food provision should be flexible enough to cover several requirements. In order to provide patients with all necessary macro- and micronutrients, it should be of high quality in terms of raw materials, hygiene and preparation. It must also be attractive in both taste and appearance and follow the preferences of the patients whenever possible (5). Finally, it is important to keep in mind that 80-100% of hospitalized patients rely solely on the food provided by the hospital for their needs (6). Patients often cannot express their opinion about the effectiveness of a treatment but they can easily identify poor food. Therefore, maximizing hospital food consumption by ensuring good nutritional quality of the meals provided is a complex and difficult task for dietitians, nutritionists and the catering team. Recognizing the importance of nutrition during the hospital stay, the European Council published the Resolution on Food and Nutritional Care in Hospitals in 2003, in which the 10 key characteristics of good nutritional care in hospital are described as follows (7): 1. All patients are screened on admission to identify the patients who are malnourished or at risk of becoming malnourished. All patients are re-screened weekly. 2. All patients have a care plan which identifies their nutritional care needs and how they are to be met.

3. The hospital includes specific guidance on food services and nutritional care in its Clinical Governance arrangements. 4. Patients are involved in the planning and monitoring arrangements for food service provision. 5. The ward implements Protected Mealtimes to provide an environment conducive to patients enjoying and being able to eat their food. 6. All staff have the appropriate skills and competencies needed to ensure that patients’ nutritional needs are met. All staff receive regular training on nutritional care and management. 7. Hospital facilities are designed to be flexible and patient centred with the aim of providing and delivering an excellent experience of food service and nutritional care 24 hours a day, every day. 8. The hospital has a policy for food service and nutritional care which is patient centred and performance managed in line with home country governance frameworks. 9. Food service and nutritional care is delivered to the patient safely. 10. The hospital supports a multi-disciplinary approach to nutritional care and values the contribution of all staff groups working in partnership with patients and users.

2. Characteristics of Hospital Food

It is important to have in mind that hospitals, by their nature are enviroments with varied and diverse population groups. Therefore, the food service that provides hospital food should be covering needs and providing suitable food for all age groups - from babies to older adults - and foods specific for clinical conditions. In order to plan and provide a hospital menu, information regarding age, gender, cultural, ethic, social and religious diversity, food preferences and special needs should be taken into consideration. Among hospitalised patients we should distinguish two major groups with significantly different needs. The first group comprises the “nutritionally well“ hospital patient, admitted for a short period of time, mostly for a simple medical proccedure or a minor illness, previously healthy and fit, and whose illness will not/does not greatly affect nutritional status. For these patients a dietary plan based on general healthy eating principles is the most appropriate (8). The other group is the nutritionally vulnerable patient at high risk of malnutrition because of:  an acute or chronic illness affecting appetite and nutritional intake  cognitive decline or limited ability to communicate with the medical staff  increased or altered nutritional requirements due to the underlying medical condition (e.g. surgery, burns, trauma, diabetes, chronic kidney disease)  disturbed swallowing or chewing ability, poor dentition or dysphagia For many of these patients it may not be appropriate for a healthy eating style diet to be provided at this time, and they will require menus targeted to their special needs in terms of the provision of energy- and/or protein-dense food choices, electrolyte controlled diets and texture modified food (8). In Table 1 the nutrients/day for nutritionally well and nutritionally vulnerable patients are presented. As for the menu planning standards there are several national guidelines. Among the more detailed ones are the ones presented for the NHS in the UK in which specific recommendations are given regarding menu planning in hospitals (9). Hospital menus should provide:

 A minimum of 300 kcal per main meal and 500 kcal for an energy dense meal and at least 18 g protein with each meal  A minimun of two courses at the midday and evening meals  A vegetarian choice on each eating occasion  A choice of portion sizes for all meals  A variety of snacks, providing a minimum of 150 kcal, at least twice a day. Fruits should always be a choice  Standard recipes should be used  An “out of hours” meal must be available for all patients who miss a meal. The “out of hours” meal should provide at least 300 kcal and 18 g of protein.

Table 1 Provision of nutrients for the hospitalised adult (adapted from (8)) Nutrient (/day) Nutritionally Nutritionally Provided well vulnerable Energy (kcal) 1800-2550 2250-2626 Daily Protein (g) 56 60-75 Daily Total fat (% total ≤35 Not specified Average over a week energy intake) Saturated fat (% ≤11 Not specified Average over a week total energy intake) Carbohydrates (% ≥50 Not specified Average over a week total energy intake) Sodium (mg) <2400 <2400 Daily Calcium (mg) ≥700 ≥700 Average over a week Potassium (mg) 3500 3500 Average over a week Magnesium (mg) 300 Average over a week Average over a week Iron ≥14.8 ≥14.8 Average over a week Vitamin B12 (μg) ≥1.5 ≥1.5 Average over a week Folate and folic acid ≥200 ≥200 Average over a week Vitamin C (mg) ≥40 ≥40 Average over a week Fluid (ml) ≥1500 ≥1500 Daily

2.1 Common Types of Hospital Diets

In the majority of hospitals the diets provided follow a similar rationale, common types of diet covering the needs of typical patient groups. The most common types of diets are: 1. The standard diet, covering the needs of the majority of the “nutritionally well” patients 2. Diets with altered nutrient content (low fibre, clear liquid diets, full liquid diets, soft diet) 3. Diets with modified texture: blenderised, puréed diets (for dysphagia) 4. Protein- and/or energy-enriched diets (for malnutrition) 5. Energy restricted diets (for obesity)

6. Diets for specific medical conditions (Diabetic, Renal, etc) with altered content in macro- (low fat, low in simple carbohydrates, low/high protein) and/or micronutrients (low potassium, low phosphate, low sodium; etc.) 7. Diets with increased meal frequency (e.g. for patients with gastrectomies) 8. Elimination diets (lactose-free, gluten-free, diets free from specific allergens etc) 9. Diets for metabolic disorders (e.g. diet for phenylketonuria)

3. Monitoring and Improving Food Intake During Hospitalization

Ensuring hospital food consumption has been proven to be a significant measure in determining outcome in hospitalised patients. According to NutritionDay results, patients who are allowed to eat and choose to skip their meal have a higher mortality during their stay in the hospital (Fig. 1) (6).

Fig. 1 Decreased meal consumption and risk of death (6)

There are several studies pointing out the fact that during hospital stay nutritional status often deteriorates (2, 10). Taking into account that food intake in hospital is frequently suboptimal (11), there are specific measures that can be taken in order to monitor and when needed enhance and protect food intake during hospital stay.

3.1 Protected Mealtimes and Feeding Assistance

In 2004 the “Protected mealtimes initiative” (PMI) was introduced in UK by the Hospital Caterers Association (HCA) as a part of the Better Hospital Food programme, supported both by the NHS and the Royal College of Nursing (RCN) (12). Protected mealtimes are periods when all ward based activities (where appropriate) stop to enable nurses, ward based teams, catering staff and volunteers to serve food and give assistance and support to patients. The purpose of PMI was to allow patients to eat their meals without

unnecessary interruption within an appealing environment, and to enable nursing staff to provide assistance to those patients unable to eat independently. Although PMI was launched several years ago as a plausible concept, its efficacy has not been establised. According to a systematic review and meta-analysis by Porter et al including 7 studies no significant effect on protein and energy intake was found in favour of implementation of Protected Mealtimes (13). On the other hand in a study by Palmer et al, specific aspects of PMI, i.e requiring and documenting the need for mealtime assistance, introduction of mealtime volunteers, time to eat and appropriate positioning during mealtimes were associated with improved intake (14). The need for assisted eating, i.e. providing help to the patient who is unable to eat alone, ranges from verbal and non-verbal prompts, to physical guiding, to transferring food from the plate to an individual’s mouth. It has been found that up to 70% of elderly hospital patients require some feeding assistance (15). In order to be able easily to identify patients in need of assistance, apart from documenting it in the patients’ files, the use of a red tray for patients in need of feeding assistance has been advocated across UK and Australian hospitals (16). Although some studies have shown that nutritional intake can be improved, the evidence for the effectiveness of feeding assistance in improving patient outcomes is somewhat mixed. Monitoring nutritional intake is very important for the early detection of patients who are not covering their nutritional needs from hospital food. Therefore, supervision of the tray collection and the evaluation of the food left on it is a very important parameter to evaluate nutritional intake of patients during hospitalization. It has been also proposed that day-to-day food consumption is monitored with an on-bed recording system and an easy registration system, similar to the one used for the evaluation of the proportion of food consumed in the NutritionDay project. Electronic apps have also been proposed for the same purpose (Fig. 2).

Fig. 2 NutritionDay monitoring of nutritional intake (https://www.nutritionday.org/cms/upload/pdf/1_for_hospitals/1.3.participate/English_m etric_measures/ND_sheet3_english.pdf) If a patient is at risk of malnutrition and is receiving nutritional therapy of any kind, nutritional intake should be monitored closely in order to be able to intervene with more intensive means of nutritional support. As shown in Fig. 3, the provision of hospital food can be enhanced with food fortification, which is the first step in providing nutritional

support in patients who are able to eat but unable to cover sufficiently their nutritional needs.

Fig. 3 Steps in nutritional support: From food to parenteral nutrition (17)

3.2 Food Fortification

Food fortification is the least intrusive means of nutritional support. It can improve the nutritional intake of patients who are unable to meet their nutritional needs by ordinary hospital food, as it increases the energy and protein density of the meals, with the addition of energy dense and/or nutrient dense food items. Food enrichment is more suitable for patients who have small appetites (e.g. older adults, cancer patients). It is the most economical way of providing nutritional support and at the same time prevents taste fatigue, allowing better compliance and more secure continuation of improved eating patterns. Food enrichment includes the addition of:  Protein, in the form of protein powders, liquid protein supplements, skimmed milk powder, or egg whites  Fat in the form of oils and fats, including cream, butter, and margarine  Carbohydrates in the form of maltodextrin, sugar, dextrose or honey By adding these components to the food, there is naturally a sensoric limitation to the amount of additional energy or protein that can be achieved. Several studies have however shown that enriching food leads to improved nutritional intake in elderly patients who do not manage large amounts of food (18-21). In two systematic reviews food-based fortification yielded positive results in the total amount of ingested calories and protein (22, 23). Examples for food-enrichment are given in Table 2.

Table 2 Examples for food-enrichment and the resulting effects on energy (adopted from 24)

Food enrichment ideas Energy Energy after before (kcal) and % (kcal) added

Whole Milk (500 Add 4 tablespoons of dried skimmed milk 330 538 (63 % extra) ml) powder

Custard (125 ml) Add 1 tablespoon of dried skimmed milk 148 349 (135 % extra) powder and 2 tablespoons of double cream

Milk based soup Add 1 tablespoon of dried skimmed milk 80 280 (250 % extra) (125 ml) powder and 2 tablespoons of double cream

Porridge made Add 1 tablespoon dried skimmed milk 226 426 (88 % extra) with whole milk powder and 2 tablespoons of double cream (200 g)

Mashed potato (1 Add 1 tablespoon of butter and 1 tablespoon 70 183 (160 % extra) scoop) of double cream

Vegetables (2 Add 1 teaspoon of butter 15 52 (246 % extra) tablespoons)

Rice pudding Add 1 tablespoon of dried skimmed milk 106 332 (213 % extra) (125 g) powder, 2 tablespoons of double cream and 2 teaspoons of jam

4. Oral Nutritional Supplements (ONS) – Sip Feeds 4.1 Definition Oral Nutritional Supplements (ONS) are food supplements, which are typically used in addition to the normal diet, when diet alone is insufficient to meet daily nutritional needs. ONS require no or minimal preparation and they are usually consumed between meals in order to provide supplementation of nutritional intake without reducing food intake. ONS are available as ready-made, pre-packed drinks, cream-like preparations, puddings, powders or bars which provide macro- and micronutrients. The industrial production of ONS is regulated by the Commission Directive 1999/21 EC at the European level and in some countries also at national level (25). ONS and enteral formulae for tube feeding are all "dietary foods for special medical purposes" and are designed in a similar manner. However, while tube feeding is always nutritionally complete, i.e. regarding the macronutrient and micronutrient content as the sole source of food, ONS can also be nutritionally incomplete. These ONS do not contain all nutrients in quantities sufficient to meet daily requirements or are (e.g.) enriched with certain nutrients in a higher concentration, and then they are only approved for supplementary nutrition.

The manufacturers are legally obliged to indicate whether the product is suitable for sole nutrition. The most frequently used ONS are nutritionally complete sip feeds. Normo- caloric standard oral nutritional supplements have an energy density of 1-1.2 kcal/ml and a protein content of 15-22% of energy. They are free of gluten and lactose and contain fibre. (Many feeds are milk-derived, and trace amounts of lactose may remain in the final product). For certain indications, e.g. Crohn’s disease, ONS are also available free of fibre. Since ONS are often used for supportive nutrition in the case of malnutrition, high-calorie (energy density >1.2 to 2.5 kcal/ml) and/or high-protein (protein content ≥20% of energy) oral nutritional supplements have increasingly been used in recent years.

Table 3 Specifications of ONS according to (25) Recommended term Definition

Low energy <1.0 kcal/mL

Normocaloric 1.0-1.2 kcal/mL

High energy  1.2 kcal/mL

High protein  20% energy from proteins

High fat >40% of total energy from lipids

MCT-rich Significant amounts of medium-chain triglycerides (MCT)

High MUFA 20 % of total energy from monounsaturated fatty acids (MUFA)

Immune modulating Contain substrates to modulate (enhance or decrease) immune response, eg glutamine and arginine, ω-3 fatty acids, dietary nucleotides, and antioxidants

4.2 Indications for ONS

Oral Nutritional Supplements are used with three main goals (25): . Replacement or supplementation of normal nutrition when diet alone is insufficient to meet daily nutritional requirements due to disease . Treatment of malnutrition . Positive impact on the outcome of disease.

ONS are often used in combination with other measures such as dietary counselling, food fortification or in addition to partial parenteral nutrition. The current ESPEN guidelines on nutritional therapy list a wide range of specific indications in various clinical settings with good scientific evidence and strong consensus among experts. They are presented in Table 4.

Table 4 Indications for the use of ONS according to the ESPEN guidelines 2015 – 2020 (see: https://www.espen.org/guidelines-home/espen-guidelines) Grade of Clinical setting Indication recommendation Treatment of malnutrition and improvement of A Polymorbid medical nutritional status inpatients Maintenance of muscle mass B With malnutrition or risk of Improvement of quality of life B malnutrition Reduction of mortality B COVID-19 infection ICU patients without or with Prevention and treatment of malnutrition - malnutrition

Inflammatory bowel disease Improvement of nutritional status 0 Patients who do not meet their Maintenance of remission in adults GPP energy and/or protein intake.

Crohn´s disease Patients who do not meet their Maintenance of remission GPP energy and/or protein intake. Acute and chronic pancreatitis Improvement of nutritional status GPP Patients who do not meet their energy and/or protein intake. Acute liver failure Patients with mild HE and who GPP Improvement of nutritional status do not meet their energy and/or protein needs. Severe alcoholic hepatitis Improvement of nutritional status Patients who do not meet their Reduction of the risk of infection B energy and/or protein intake. May provide a survival advantage Prevention and treatment of malnutrition Perioperative Reduction of risk factors for postoperative Patients with malnutrition or risk GPP complications of malnutrition Reduction of length of hospital stay and costs Preoperative Patients who do not meet their energy and/or protein intake Prevention of malnutrition GPP unrelated to their nutritional status Preoperative undergoing Prevention and treatment of malnutrition major abdominal surgery Reduction of risk factors for postoperative High-risk patients (old patients A complications with sarcopenia) and Reduction of length of hospital stay and costs malnourished cancer patients Older persons Treatment of malnutrition and improvement of With malnutrition or risk of dietary intake GPP malnutrition Reduction of negative outcomes

Older hospitalized patients Treatment of malnutrition and improvement of With malnutrition or risk of dietary intake and body weight A malnutrition Reduction of risk of complications and readmission

Older patients after hospital Treatment of malnutrition and improvement of discharge dietary intake and body weight A With malnutrition or risk of Reduction of risk of functional decline malnutrition

Older patients with depression Improvement of nutritional status B With malnutrition or risk of malnutrition Older patients with hip Improvement of dietary intake A fracture Reduction of complication rate Older patients with pressure ulcers Improvement of wound healing B With malnutrition Older patients with risk of Prevention of development of pressure ulcers B pressure ulcers Older patients with diabetes Improvement of dietary intake With malnutrition or risk of GPP Reduction of risk of complications and readmission malnutrition

Dementia Improvement of nutritional status Strong

Multiple sclerosis Prevention and treatment of nutritional problems Patients who do not meet their B Improvement of body weight and muscle function energy and/or protein intake.

Stroke Patients who are able to eat, but Prevention and treatment of malnutrition GPP with malnutrition or risk of malnutrition. Maintenance or improvement of nutritional intake (to mitigate metabolic derangements) Maintenance of skeletal muscle mass and physical Cancer patients Strong performance During cancer treatment Reduction of risk of interruptions of scheduled anticancer treatments Improvement of quality of life Maintenance or improvement of nutritional intake (to mitigate metabolic derangements) Postoperative Maintenance of skeletal muscle mass and physical Cancer patients with performance Strong malnutrition Reduction of risk of interruptions of scheduled anticancer treatments Improvement of quality of life Cancer patients (head, neck, Maintenance or improvement of nutritional intake thorax and gastrointestinal Reduction of risk of interruptions of scheduled Strong tract) During radiotherapy anticancer treatments HE: hepatic encephalopathy; ASH: alcoholic steatohepatitis.

Definition of grades of recommendation/ evidence levels Grade of recommendation A/ evidence level I++ or I+: at least one meta-analysis, systematic review or high quality well-conducted randomized study. Grade of recommendation B/ evidence levels II++ or II+, extrapolated evidence of 1++ or 1+: high quality systematic reviews of case control or cohort studies or high quality well-conducted case control or cohort studies. Grade of recommendation 0/ evidence level III or IV, extrapolated evidence of 2++ or 2+: non-analytic studies, e.g. case reports, case series or expert opinion. High quality systematic reviews of case control or cohort or studies or high quality well- conducted case control or cohort studies.

Grade of recommendation GPP: good practice points/expert consensus: recommended best practice based on the clinical experience of the guideline working group. Classification of the strength of consensus: Strong consensus: agreement of >90% of the participants.

4.3 Compliance with and Monitoring of ONS

Prescription of ONS, apart from the indications mentioned above, should be tailored to the patients’ needs and preferences, as these are strongly implicated in the compliance which is vital for the effectiveness of the treatment. In order to achieve good adherence to the dietary plan, a variety of flavours and textures can be used, served at different temperatures, according to the patients’ preferences. In general patients tolerate ONS better when they are served chilled (probably because their sweetness is then less obvious), and taken via a drinking straw, which helps to deliver the supplement to the back of the mouth thus reducing the number of taste (and olfactory) receptors that are stimulated. In the early years, oral nutritional supplements were often perceived as untasty. However, during the last 15 to 20 years, manufacturers have made great efforts to improve both taste and texture, which has significantly improved the acceptance rate. In fact, a large meta-analysis by Hubbard et al (26) summarizing 46 studies with a total of 4328 patients showed that on average 78% of the prescribed ONS packages were consumed, demonstrating satisfactory to good compliance. The compliance in the community setting was significantly higher than in hospitalized patients (80.9% vs. 67.2%, p<0.013). Furthermore, ONS with high energy density ≥2 kcal/ml and a small volume were associated with better compliance than ONS with energy densities of 1-1.3 kcal/ml (91 % vs. 77%, p<0.05%). Acceptance of ONS can be improved by encouragement and explanation of the reasons for and the aims of nutritional support. In order to avoid side effects, such as diarrhoea, nausea, or vomiting, patients should be advised to drink the ONS slowly, and not to consume them with or close to their meals in order to avoid early satiety. The fear that ONS would have only a slight or even negative effect on the total energy and protein intake by reducing the spontaneous food intake, has not been confirmed in studies. In a three-month post-hospital study of malnourished patients, Norman et al (27) showed that high-energy and high-protein oral nutritional supplements resulted in an average additional intake of 700 kcal and 47 g protein per day. The use of ONS, as well as the other forms of nutritional support, including dietary counselling, should, like any other treatment, be monitored. Reviewing the indications, setting goals and assessing the patient at frequent intervals are required in order to facilitate early interventions when these are needed. Moreover, the achievement of the goals or the failure to achieve them, signifies the signal to terminate the use of ONS, change the product or to switch to a more intensive way of providing nutritional support.

4.4 Clinical Effects of ONS

A variety of clinical studies on the benefits of ONS have been conducted in the past 20 years using differently designed ONS in a wide range of clinical settings and treatment durations. Despite this heterogeneity of studies, there are now several systematic reviews and meta-analyses clearly demonstrating the clinical benefit of ONS including improvement of nutritional status and increased nutritional intake, quality of life, muscle strength, reduced length of hospital stay, reduced overall morbidity with fewer

complications, such as wound and chest infections or pressure ulcers, and even reduced mortality (28-31). In an updated Cochrane Review including 62 clinical studies (with a total of 10,187 patients) Milne et al. (28) revealed the association between protein and energy supplementation in malnourished old people and a significant reduction in the complication rate (RR 0.86, 95%-CI: 0.75 to 0.99) and mortality rate (RR 0.79, 95%-CI: 0.64 to 0.97) compared to standard care. Cawood et al. (29) in a systematic review published in 2012 (a total of 36 randomized controlled trials (RCT); 3790 patients; mean age 74 years) showed significant clinical effects of high-protein ONS: reduced complication rates (in 10 RCT), reduced length of hospital stay (9 RCT), decreased readmission rates (2 RCT), improved hand grip strength (4 RCT) and quality of life (6 RCT). Furthermore, a 35 % reduction in the complication rate of surgical patients was observed by Elia et al (30) in a meta-analysis of 7 surgical studies from the UK. These meta-analyses did not consider the results of the NOURISH study (because it was published later) which is so far the largest multicentre, randomized, placebo-controlled and double-blind trial in this field (32). The NOURISH trial was performed in malnourished, older, hospitalized adults with heart or pulmonary diseases randomized to receive either a high-protein ONS containing beta-hydroxy-beta-methylbutyrate (n=328) or placebo (n=324) over a study period of 90 days. The primary composite endpoint (post-discharge incidence of death or non-elective readmission) was similar in both groups, but ONS resulted in improved nutritional status, and more importantly in a significantly lower 90-day mortality rate relative to placebo (4.8 % vs. 9.7 %; p=0.018). The number-needed-to-treat to prevent 1 death was only 20.3. Another more recent randomized trial in 308 older malnourished people in primary care (33) compared ONS and dietary advice (intervention) with dietary advice alone (control) over a study period of 12 weeks. The authors demonstrated a high acceptability of ONS and several benefits: a significant effect on energy and protein intake, and significantly reduced health care use including fewer HCP visits and readmissions, and shorter length of hospital stay.

4.5 Economic Implications of ONS

There has been an increasing interest in the effects of ONS on health care use and costs. In the acute setting, reductions in the length of hospital stay, fewer complications and a reduction in associated costs have been well documented with ONS. Another important parameter, not only for the total health care cost, but also for the quality of life of the patients, is the rate of readmissions to hospital. In a meta-analysis considering 9 RCT Stratton et al (34) showed that ONS use resulted in a significant reduction in the readmission rate. Two systematic reviews by Elia et al. (30, 31) analyzed the cost-effectiveness of ONS in hospital patients, and in community and care home settings. From a subset of 5 surgical studies, it was calculated that using ONS resulted in a significant reduction of complications, reduced length of hospital stay and a cost saving of £772 (~€850) per patient, corresponding to 13.5% of treatment costs. The authors concluded that using standard ONS in the hospital setting is cost-effective. Similar conclusions were drawn in the meta-analysis on ONS in the community and in care home settings: ONS use in the community produces an overall cost advantage or near neutral balance. Cost-effectiveness was also analysed in the NOURHISH study (35) and in a previous study by Norman et al on benign gastrointestinal disease (36). The two

studies calculated the cost of ONS treatment per quality-adjusted life years (QALY) as US $33,800 (~€30,000) (Nourish study) and €12,100 (Norman et al), respectively. Both results are considered cost-effective according to international thresholds (<€50,000 per QALY). The largest analysis on this topic comes from Philipson et al (37). The authors retrospectively analysed data of hospital stays from a database of more than 44 million inpatients; 1.6% (724,027) of these patients received ONS. The patients were matched to controls according to their main diagnosis on admission using a complex statistical process (propensity score). The goal of the analyses was to evaluate the impact of ONS on the length and costs of the hospital stay and the probability of a 30-day readmission in patients at risk. The use of ONS was associated with a mean 2.3 day shorter length of hospital stay (from 10.9 to 8.6 days; 95% CI: -2.42 to -2.16), average lower hospital costs of $4734 (~€4,200) per case (from $21,950 to $ 17,216; 95% CI: -4754 to -4714) and a 2.3% (95% CI: -0.027 to -0.019) lower probability of readmission (from 34.3% to 32.0%). The “return on investment” in terms of reduced episode cost was calculated as US$52 in net savings for every Dollar spent on ONS. Although it is obvious that all these cost calculations are based on assumptions with necessary limitations requiring careful interpretation, there is a growing body of evidence that the use of ONS not only improves nutritional intake and clinical outcomes but is also cost-effective.

5. Summary

Oral feeding with normal food or special and/or fortified diets is always the first choice to prevent or treat undernutrition. Therefore, the provision of high calibre standard hospital food, which will cover the needs of in-patients regarding their clinical condition, their age, and their cultural and religious background should be a priority. In order to enhance palatability, good quality and appearance of hospital food, specific measures should be taken. Policies such as Protected Meal Times help to assure respect of meals and eating in hospitalised patients and to ensure sufficient dietary intake. Oral nutritional intake should be carefully monitored and, where necessary, encouraged and supplemented either by energy dense food choices or with food fortification. In the frequently observed case that these interventions fail to provide significant positive results, Oral Nutritional Supplements (ONS) should be used, particularly so in malnourished and/or older patients. The choice of supplement depends on the nutritional profile and its acceptability to the patient. Good compliance can be achieved by lower volume ONS with high energy density and is essential to the success of nutritional therapy. A growing body of research evidence indicates that ONS are effective in increasing energy and protein intake, in improving nutritional and functional status, and in improving clinical outcomes in terms of morbidity, complication rates, quality of life, length of hospital stay, readmission rates, and reduced mortality. In addition the use of ONS is cost-effective.

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