Study protocol: Cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care

BACKGROUND: Malnutrition is a common consequence of disease in older patients. Both in hospital setting and in community setting oral nutritional support has proven to be effective. However, cost-effectiveness studies are scarce. Therefore, the aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge. METHODS: This study is a randomized controlled trial. Patients are included at hospital admission and followed until three months after discharge. Patients are eligible to be included when they are > or = 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or > or = 5% unintentional weight loss in the previous month and/or > or = 10% unintentional weight loss in the previous six months. We will compare usual nutritional care with transmural nutritional support (energy and protein enriched diet, two additional servings of an oral nutritional supplement, vitamin D and calcium supplementation, and consultations by a dietitian). Each study arm will consist of 100 patients. The primary outcome parameters will be changes in activities of daily living (determined as functional limitations and physical activity) between intervention and control group. Secondary outcomes will be changes in body weight, body composition, quality of life, and muscle strength. An economic evaluation from a societal perspective will be conducted alongside the randomised trial to evaluate the cost-effectiveness of the intervention in comparison with usual care. CONCLUSION: In this randomized controlled trial we will evaluate the effect of transmural nutritional support in malnourished elderly patients after hospital discharge, compared to usual care. Primary endpoints of the study are changes in activities of daily living, body weight, body composition, quality of life, and muscle strength. An economic evaluation will be performed to evaluate the cost-effectiveness of the intervention in comparison with usual care. TRIAL REGISTRATION: Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005)

Physical performance and protein-energy wasting in patients treated with nocturnal haemodialysis compared to conventional haemodialysis: protocol of the DiapriFIT study

Background: Poor physical performance and protein-energy wasting (PEW) are health issues of major concern in haemodialysis patients. The conventional haemodialysis (CHD) regime, three times per week 3-5 h, is subject of discussion because of high morbidity and mortality rates. When patients switch from CHD to longer dialysis sessions, i.e. nocturnal haemodialysis (NHD), improvement in protein intake and increase in body weight is seen. However, it is unclear whether physical performance and more important aspects of PEW, such as body composition, improve as well. Therefore, the aim of this study is to investigate whether physical performance improves and PEW decreases, when patients switch from CHD to NHD. A second aim is to assess the influence of NHD on the biomarkers fibroblast growth factor-23 and sclerostin which are thought to be associated with malnutrition and mortality in patients on haemodialysis. Methods: This study is a prospective multicentre cohort study with an inclusion aim of 50 patients: 25 patients in a control group (three times per week, 3-5 h CHD) and 25 patients in a nocturnal group (three times per week, 7-9 h NHD). Primary outcome is change in physical performance, measured by the Short Physical Performance Battery. Additional measurements are a 6-min walk test, handgrip strength, a physical activity questionnaire and physical activity monitoring. The secondary outcome of the study is PEW, which will be evaluated by body weight, dual-energy X-ray absorptiometry, bio-electrical impedance spectroscopy, mid-upper arm muscle circumference, subjective global assessment, visual analogue scale for appetite and dietary records. Laboratory measurements including fibroblast growth factor-23 and sclerostin, and quality of life assessed with the Kidney Disease Quality of Life-Short Form are also studied. In every patient, four repeated measurements will be performed during one year of follow-up. Discussion: This study will investigate whether physical performance improves and PEW decreases when patients switch from CHD to NHD, compared to a control group who continue treatment with CHD. Strengths of this study are the comparison with a conventional haemodialysis cohort, and the broad variety of objective measurements combined with patient-reported outcomes of physical performance and PEW

Short-term oral nutritional intervention with protein and vitamin D decreases falls in malnourished older adults

OBJECTIVES: To evaluate the effects of a short-term nutritional intervention with protein and vitamin D on falls in malnourished older adults. DESIGN: Randomized controlled trial. SETTING: From hospital admission until 3 months after discharge. PARTICIPANTS: Malnourished older adults (≥ 60) newly admitted to an acute hospital (n = 210). INTERVENTION: Participants were randomized to receive nutritional intervention (energy- and protein-enriched diet, oral nutritional supplements, calcium-vitamin D supplement, telephone counseling by a dietitian) for 3 months after discharge or usual care. MEASUREMENTS: Number of participants who fell, fall incidents, serum 25-hydroxyvitamin D, and dietary intake. Measurements were performed on admission to hospital and 3 months after discharge. RESULTS: Three months after discharge, 10 participants (10%) in the intervention group had fallen at least once, compared with 24 (23%) in the control group (hazard ratio = 0.41, 95% confidence interval (CI) = 0.19-0.86). There were 57 fall incidents (16 in the intervention group; 41 in the control group). A significantly higher intake of energy (280 kcal, 95% CI = 37-524 kcal) and protein (11 g, 95% CI = 1-25 g) and significantly higher serum 25-hydroxyvitamin D levels (10.9 nmol/L, 95% CI = 2.9-18.9 nmol/L) were found in participants in the intervention group than in controls. CONCLUSION: A short-term nutritional intervention consisting of oral nutritional supplements and calcium and vitamin D supplementation and supported by dietetic counseling in malnourished older adults decreases the number of patients who fall and fall incidents

Prevalence of undernutrition in Dutch hospital outpatients

a b s t r a c t a r t i c l e i n f o Background: The prevalence of undernutrition in hospital inpatients is high. Earlier detection and treatment in the hospital outpatient clinic may help to reduce these numbers. The purpose of this study was to assess the prevalence of undernutrition in hospital outpatients in the Netherlands, to determine high risk departments, and to determine the percentage of patients receiving dietetic treatment. Methods: This cross-sectional multicenter study was conducted in nine hospitals. Patients who visited the outpatient clinic on one of the screening days in the period March-May 2008 received a short questionnaire and were weighed. Patients were classified as severely undernourished, moderately undernourished or not undernourished. Results: 2288 patients were included in the study, of which 5% were severely undernourished and 2% were moderately undernourished. The prevalence of severe undernutrition was highest in the outpatient departments of oral maxillofacial surgery (17%), oncology (10%), rehabilitation (8%), gastroenterology (7%) and pulmonology (7%). Only 17% of all severely undernourished and 4% of all moderately undernourished patients reported to receive dietetic treatment. Conclusion: The prevalence of undernutrition in hospital outpatients is generally low but largely undertreated. Future screening should focus on high risk departments

Effectiveness of nutritional interventions in older adults at risk of malnutrition across different health care settings: Pooled analyses of individual participant data from nine randomized controlled trials

Background & aims: Protein-energy malnutrition is a health concern among older adults. Improving nutritional status by increasing energy and protein intake likely benefits health. We therefore aimed to investigate effects of nutritional interventions in older adults (at risk of malnutrition) on change in energy intake and body weight, and explore if the intervention effect was modified by study or participants’ characteristics, analysing pooled individual participant data. Methods: We searched for RCTs investigating the effect of dietary counseling, oral nutritional supplements (ONS) or both on energy intake and weight. Principle investigators of eligible studies provided individual participant data. We investigated the effect of nutritional intervention on meaningful increase in energy intake (>250 kcal/day) and meaningful weight gain (>1.0 kg). Logistic generalized estimating equations were performed and ORs with 95% CIs presented. Results: We included data of nine studies with a total of 990 participants, aged 79.2 ± 8.2 years, 64.5% women and mean baseline BMI 23.9 ± 4.7 kg/m2. An non-significant intervention effect was observed for increase in energy intake (OR:1.59; 95% CI 0.95, 2.66) and a significant intervention effect for weight gain (OR:1.58; 95% CI 1.16, 2.17). Stratifying by type of intervention, an intervention effect on increase in energy intake was only observed for dietary counseling in combination with ONS (OR:2.28; 95% CI 1.90, 2.73). The intervention effect on increase in energy intake was greater for women, older participants, and those with lower BMI. Regarding weight gain, an intervention effect was observed for dietary counseling (OR:1.40; 95% CI 1.14, 1.73) and dietary counseling in combination with ONS (OR:2.48; 95% CI 1.92, 3.31). The intervention effect on weight gain was not influenced by participants’ characteristics. Conclusions: Based on pooled data of older adults (at risk of malnutrition), nutritional interventions have a positive effect on energy intake and body weight. Dietary counseling combined with ONS is the most effective intervention.</p

Effectiveness of nutritional interventions in older adults at risk of malnutrition across different health care settings: Pooled analyses of individual participant data from nine randomized controlled trials

Background & aims: Protein-energy malnutrition is a health concern among older adults. Improving nutritional status by increasing energy and protein intake likely benefits health. We therefore aimed to investigate effects of nutritional interventions in older adults (at risk of malnutrition) on change in energy intake and body weight, and explore if the intervention effect was modified by study or participants’ characteristics, analysing pooled individual participant data. Methods: We searched for RCTs investigating the effect of dietary counseling, oral nutritional supplements (ONS) or both on energy intake and weight. Principle investigators of eligible studies provided individual participant data. We investigated the effect of nutritional intervention on meaningful increase in energy intake (>250 kcal/day) and meaningful weight gain (>1.0 kg). Logistic generalized estimating equations were performed and ORs with 95% CIs presented. Results: We included data of nine studies with a total of 990 participants, aged 79.2 ± 8.2 years, 64.5% women and mean baseline BMI 23.9 ± 4.7 kg/m2. An non-significant intervention effect was observed for increase in energy intake (OR:1.59; 95% CI 0.95, 2.66) and a significant intervention effect for weight gain (OR:1.58; 95% CI 1.16, 2.17). Stratifying by type of intervention, an intervention effect on increase in energy intake was only observed for dietary counseling in combination with ONS (OR:2.28; 95% CI 1.90, 2.73). The intervention effect on increase in energy intake was greater for women, older participants, and those with lower BMI. Regarding weight gain, an intervention effect was observed for dietary counseling (OR:1.40; 95% CI 1.14, 1.73) and dietary counseling in combination with ONS (OR:2.48; 95% CI 1.92, 3.31). The intervention effect on weight gain was not influenced by participants’ characteristics. Conclusions: Based on pooled data of older adults (at risk of malnutrition), nutritional interventions have a positive effect on energy intake and body weight. Dietary counseling combined with ONS is the most effective intervention

Effects of Nutritional Interventions in Older Adults with Malnutrition or at Risk of Malnutrition on Muscle Strength and Mortality: Results of Pooled Analyses of Individual Participant Data from Nine RCTs

Nutritional intervention studies in older adults with malnutrition aim to improve nutritional status. Although these studies show a significant gain in body weight, there is inconsistent evidence of clinical effectiveness on muscle strength and mortality. This study aimed to examine the effects of nutritional interventions on muscle strength and risk of mortality in older adults (malnourished or at risk) and explore whether these effects are influenced by participant characteristics. Individual participant data were used from nine RCTs (community setting, hospital and long-term care; duration 12–24 weeks and included oral nutritional supplements, dietary counseling, or both). Handgrip strength (HGS) was measured in seven RCTs and six RCTs obtained mortality data. A ≥3 kg increase in HGS was considered clinically relevant. Logistic generalized estimating equations analyses (GEE) were used to test intervention effectiveness. GEE showed no overall treatment effect (OR 1.11, 95% CI 0.78–1.59) on HGS. A greater, but not statistically significant, effect on HGS was observed for older (>80 years) versus younger participants. No significant treatment effect was observed for mortality (OR 0.78, 95% CI 0.42–1.46). The treatment effect on mortality was greater but remained non-significant for women and those with higher baseline energy or protein intake. In conclusion, no effects of nutritional interventions were observed on HGS and mortality in older adults (malnourished or at risk). While the treatment effect was modified by some baseline participant characteristics, the treatment also lacked an effect in most subgroups