Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone.

BACKGROUND: Moderate acute malnutrition (MAM) affects 33 million children annually. Investments in formulations of corn-soy blended flours and lipid-based nutrient supplements have effectively improved MAM recovery rates. Information costs and cost-effectiveness differences are still needed. OBJECTIVES: We assessed recovery and sustained recovery rates of MAM children receiving a supplementary food: ready-to-use supplementary food (RUSF), corn soy whey blend with fortified vegetable oil (CSWB w/oil), or Super Cereal Plus with amylase (SC + A) compared to Corn Soy Blend Plus with fortified vegetable oil (CSB+ w/oil). We also estimated differences in costs and cost effectiveness of each supplement. METHODS: In Sierra Leone, we randomly assigned 29 health centers to provide a supplement containing 550 kcal/d for ∼12 wk to 2691 children with MAM aged 6-59 mo. We calculated cost per enrollee, cost per child who recovered, and cost per child who sustained recovery each from 2 perspectives: program perspective and caregiver perspective, combined. RESULTS: Of 2653 MAM children (98.6%) with complete data, 1676 children (63%) recovered. There were no significant differences in the odds of recovery compared to CSB+ w/oil [0.83 (95% CI: 0.64-1.08) for CSWB w/oil, 1.01 (95% CI: 0.78-1.3) for SC + A, 1.05 (95% CI: 0.82-1.34) for RUSF]. The odds of sustaining recovery were significantly lower for RUSF (0.7; 95% CI 0.49-0.99) but not CSWB w/oil or SC + A [1.08 (95% CI: 0.73-1.6) and 0.96 (95% CI: 0.67-1.4), respectively] when compared to CSB+ w/oil. Costs per enrollee [US dollars (USD)/child] ranged from $105/child in RUSF to $112/child in SC + A and costs per recovered child (USD/child) ranged from $163/child in RUSF to $179/child in CSWB w/oil, with overlapping uncertainty ranges. Costs were highest per sustained recovery (USD/child), ranging from $214/child with the CSB+ w/oil to $226/child with the SC + A, with overlapping uncertainty ranges. CONCLUSIONS: The 4 supplements performed similarly across recovery (but not sustained recovery) and costed measures. Analyses of posttreatment outcomes are necessary to estimate the full cost of MAM treatment. This trial was registered at clinicaltrials.gov as NCT03146897.

Use and Costs of Medical Foods and Convenience-Packaged Drugs in the California Workers' Compensation System.

BACKGROUND: Sales of medical foods (MFs) and convenience packages (CPs) are projected to exceed $2 billion in the United States, with an annual growth rate of 10%. Several studies have highlighted the rapid growth of MF use within the California Workers' Compensation System (CAWCS). To curb this growth, California implemented Assembly Bill 378 (AB 378) in 2012 to regulate physicians' incentives to dispense MFs and CPs. AB 378's regulation on only physician-dispensed MFs and CPs and not pharmacy-dispensed MFs and CPs generated a setting for evaluating the differential effect of the bill on MF and CP use and cost. OBJECTIVES: To (a) examine the use and cost of MFs and CPs in the CAWCS that are not for inborn errors of metabolism and (b) evaluate the regulatory effect of AB 378. METHODS: This study adopted a quantitative approach and employed descriptive statistics and t-tests. The analyses used the most recent complete annual claims data from the Workers' Compensation Information System dataset to evaluate MF and CP claims frequencies and dollar amounts reimbursed from 2011 to 2013 and to compare the difference between physician-dispensed and pharmacy-dispensed products. RESULTS: Of 151,107 MFs and CPs billed, 95,528 (63.2%) prescriptions were reimbursed. The reimbursed MFs and CPs accounted for approximately $19 million paid to pharmacies and physicians over 3 years. Physician-dispensed MFs, which were regulated by AB 378 in January 2012, experienced a reduction in mean amount reimbursed by $9.95 (P < 0.001)-from $195.64 to $185.68-compared with the mean amount reimbursed in 2011. Conversely, physician-dispensed CPs, as well as pharmacy-dispensed MFs and CPs, did not experience a decrease in mean amount reimbursed. CONCLUSIONS: The results indicated that AB 378 was associated with a statistically significant reduction in physician-dispensed MFs. Concomitantly, the results from t-tests showed no statistically significant difference in mean amount reimbursed for MFs and CPs to pharmacies before and after AB 378. The finding was expected and as hypothesized because AB 378 did not regulate pharmacy-dispensed MFs and CPs. Legislative measures, such as AB 378 in California, may influence rising costs and use of MFs and CPs in general. Other workers' compensation systems could adopt similar legislation to affect the behavior of physician prescribing of non-inborn errors of metabolism MFs and further test these findings. DISCLOSURES: Funding for this study was contributed by the California Workers' Compensation System. The authors have nothing to disclose.

Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

BACKGROUND: Sodium consumption is a modifiable risk factor for higher blood pressure (BP) and cardiovascular disease (CVD). The US Food and Drug Administration (FDA) has proposed voluntary sodium reduction goals targeting processed and commercially prepared foods. We aimed to quantify the potential health and economic impact of this policy. METHODS AND FINDINGS: We used a microsimulation approach of a close-to-reality synthetic population (US IMPACT Food Policy Model) to estimate CVD deaths and cases prevented or postponed, quality-adjusted life years (QALYs), and cost-effectiveness from 2017 to 2036 of 3 scenarios: (1) optimal, 100% compliance with 10-year reformulation targets; (2) modest, 50% compliance with 10-year reformulation targets; and (3) pessimistic, 100% compliance with 2-year reformulation targets, but with no further progress. We used the National Health and Nutrition Examination Survey and high-quality meta-analyses to inform model inputs. Costs included government costs to administer and monitor the policy, industry reformulation costs, and CVD-related healthcare, productivity, and informal care costs. Between 2017 and 2036, the optimal reformulation scenario achieving the FDA sodium reduction targets could prevent approximately 450,000 CVD cases (95% uncertainty interval: 240,000 to 740,000), gain approximately 2.1 million discounted QALYs (1.7 million to 2.4 million), and produce discounted cost savings (health savings minus policy costs) of approximately $41 billion ($14 billion to $81 billion). In the modest and pessimistic scenarios, health gains would be 1.1 million and 0.7 million QALYS, with savings of $19 billion and $12 billion, respectively. All the scenarios were estimated with more than 80% probability to be cost-effective (incremental cost/QALY < $100,000) by 2021 and to become cost-saving by 2031. Limitations include evaluating only diseases mediated through BP, while decreasing sodium consumption could have beneficial effects upon other health burdens such as gastric cancer. Further, the effect estimates in the model are based on interventional and prospective observational studies. They are therefore subject to biases and confounding that may have influenced also our model estimates. CONCLUSIONS: Implementing and achieving the FDA sodium reformulation targets could generate substantial health gains and net cost savings.

Innovative optimization of ready to use food for treatment of acute malnutrition.

Treatment of acute malnutrition typically requires the provision of ready-to-use food (RUF). Common RUF is effective but expensive, being manufactured from costly ingredients, and shipped worldwide from few global suppliers. I developed a linear programming tool to create RUF optimized for low cost using locally grown crops while maintaining necessary nutritional goals and other constraints. My tool utilizes a database of the nutritional value, price, and water efficiency of suitable ingredients and allows adjustment of constraints, including nutrients, flavour, and crop water efficiency. It is designed to (a) address nutrient requirements conforming to current standards and practice; (b) optimize RUF formulae for low cost using a wide range of ingredients for nutritional value and acceptability improvement; (c) ensure protein quality through protein digestibility corrected amino acid score; and (d) adjust RUF formulae according to locally grown crop selection, local prices, and crop water footprint. The tool creates formulae free of expensive dairy ingredients, ensuring desired protein digestibility corrected amino acid score by automatically balancing proteins with complementary quantities of essential amino acids. Using publicly available data with an application to Nigeria, my tool created RUF formulae suitable for local production using local crops to meet all nutrient requirements at a fraction of the ingredient cost and water footprint of current formulae, demonstrating the tool's effectiveness. Optimization of RUF for low cost using locally grown crops will facilitate local production and reduce ingredient as well as transport costs, so more patients can receive lifesaving treatment.

A Survey of Home Enteral Nutrition Practices and Reimbursement in the Asia Pacific Region.

Literature regarding the use of home enteral nutrition (HEN) and how it is reimbursed in the Asia Pacific region is limited. This research survey aims to determine the availability of HEN, the type of feeds and enteral access used, national reimbursement policies, the presence of nutrition support teams (NSTs), and clinical nutrition education in this region. An electronic questionnaire was sent to 20 clinical nutrition societies and leaders in the Asia Pacific region in August 2017, where thirteen countries responded. Comparison of HEN reimbursement and practice between countries of different income groups based on the World Bank's data was investigated. Financial support for HEN is only available in 40% of the countries. An association was found between availability of financial support for HEN and health expenditure (r = 0.63, p = 0.021). High and middle-upper income countries use mainly commercial supplements for HEN, while lower-middle income countries use mainly blenderized diet. The presence of NSTs is limited, and only present mainly in acute settings. Sixty percent of the countries indicated an urgent need for funding and reimbursement of HEN. This survey demonstrates the varied clinical and economic situation in the Asia Pacific region. There is a lack of reimbursement, clinical support, and inadequate educational opportunities, especially for the lower-middle income countries.

Homemade diet versus diet industrialized for patients using alternative feeding tube at home: an integrative review / La dieta artesanal versus la dieta industrializada en pacientes con nutrición enteral domiciliaria: una revisión integradora

Background: Enteral nutrition therapy can be provided using comercialized products (chemically defined formulas) or blenderized home-made preparations. Objective: To perform an integrative review of the literature comparing the use of both type of formulation. Methods: In this descriptive study papers published in English, Spanish or Portuguese Brazil, in journals indexed in the databases PubMed, EMBASE, Scopus, Web of Science and Bireme without the period 2010 to 2015 were reviewed The terms «enteral nutrition, foods, formulated, diet, homemade diet industrial and artisanal diet» according to the MeSH were used for the search. Results: Twelve articles were selected. Most studies showed a level 4 of evidence and were published in journal in the higher Qualis index. Four aspects were evaluated: comparison between groups studying the clinical effects; comparison of the chemical composition of home-made products; physical-chemical and microbiological analysis of the enteral diets comes; articles on epidemiological Data on home enteral nutrition Conclusion: Industrialized diet is more suitable for patients using alternative feeding supply at home. But it has a higher cost (AU)

Introducción: en la terapia nutricional enteral pueden administrarse productos comerciales con fórmulas químicamente definidas o preparados artesanales compuestas por alimentos naturales y/o procesados. Objetivo: realizar una revisión integradora de la literatura sobre el uso de la dieta artesanal versus industrializada, en pacientes con nutrición enteral. Métodos: estudio descriptivo de los artículos originales que comparaban el uso de fórmulas enterales comerciales con preparados caseros. Se consideraron elegibles los artículos publicados en inglés, español o portugués, en revistas indexadas en las bases de datos: PubMed, Scopus, EMBASE, Web of Science y Bireme en el periodo de 2010 a 2015, a partir de los descriptores: «enteral nutrition, food, formulated, industrialized diet, homemade diet, handmade diet». Para el análisis de los estudios fue utilizado un instrumento específico para evaluación de artículos. Resultados: finalmente se analizaron 12 artículos. La mayoría de los estudios presentó un nivel de evidencia 4 y fueron publicados en revistas de elevado índice Qualis. Los artículos fueron separados en 4 grupos: comparación del uso de las dietas y el efecto en los pacientes que las recibían; evaluación de la composición química de la alimentación enteral artesanal por medio de tablas de composición de alimentos; análisis físico-químico y microbiológico de las dietas enterales artesanales; y artículos que presentaron la situación epidemiológica de la terapia nutricional enteral domiciliaria. Conclusión: la dieta industrializada es la más indicada para pacientes que nutrición enteral en el domicilio, mientras, que los costos generados pueden volverse grandes obstáculos para quien la elija (AU)

The use of oral nutritional supplements in the acute care setting.

Oral nutritional supplements offer support to patients in acute care who are undernourished or at risk of malnutrition. Yet doubts remain over cost and compliance. Omorogieva Ojo, Senior Lecturer in Primary Care at University of Greenwich weighs up the evidence.

Health-Care Costs, Glycemic Control and Nutritional Status in Malnourished Older Diabetics Treated with a Hypercaloric Diabetes-Specific Enteral Nutritional Formula.

Diabetes-specific formulas are an effective alternative for providing nutrients and maintaining glycemic control. This study assesses the effect of treatment with an oral enteral nutrition with a hypercaloric diabetes-specific formula (HDSF) for one year, on health-care resources use, health-care costs, glucose control and nutritional status, in 93 type-2 diabetes mellitus (T2DM) malnourished patients. Changes in health-care resources use and health-care costs were collected the year before and during the year of intervention. Glucose status and nutritional laboratory parameters were analyzed at baseline and one-year after the administration of HDSF. The administration of HDSF was significantly associated with a reduced use of health-care resources, fewer hospital admissions (54.7%; p < 0.001), days spent at hospital (64.1%; p < 0.001) and emergency visits (57.7%; p < 0.001). Health-care costs were reduced by 65.6% (p < 0.001) during the intervention. Glycemic control (short- and long-term) and the need of pharmacological treatment did not change, while some nutritional parameters were improved at one year (albumin: +10.6%, p < 0.001; hemoglobin: +6.4%, p = 0.026). In conclusion, using HDSF in malnourished older type-2 diabetic patients may allow increasing energy intake while maintaining glucose control and improving nutritional parameters. The use of health-care resources and costs were significantly reduced during the nutritional intervention.

Optimizing Ready-to-Use Therapeutic Foods for Protein Quality, Cost, and Acceptability.

This article describes current research on the development of alternative ready-to-use therapeutic foods (RUTFs) in the treatment of severe acute malnutrition. An innovative and versatile linear programming tool has been developed to facilitate the creation of therapeutic formulas that are determined acceptable on multiple levels: costs, ingredient acceptability, availability and stability, nutrient requirements, and personal preferences. The formulas are analyzed for ease of production by Washington University team members and for organoleptic properties acceptability to target populations. In the future, RUTF products that are cost-effective, acceptable, sustainable, and widely available will become a reality.

From diets to foods: using linear programming to formulate a nutritious, minimum-cost porridge mix for children aged 1 to 2 years.

BACKGROUND: Linear programming has been used extensively as a tool for nutritional recommendations. Extending the methodology to food formulation presents new challenges, since not all combinations of nutritious ingredients will produce an acceptable food. Furthermore, it would help in implementation and in ensuring the feasibility of the suggested recommendations. OBJECTIVE: To extend the previously used linear programming methodology from diet optimization to food formulation using consistency constraints. In addition, to exemplify usability using the case of a porridge mix formulation for emergency situations in rural Mozambique. METHODS: The linear programming method was extended with a consistency constraint based on previously published empirical studies on swelling of starch in soft porridges. The new method was exemplified using the formulation of a nutritious, minimum-cost porridge mix for children aged 1 to 2 years for use as a complete relief food, based primarily on local ingredients, in rural Mozambique. RESULTS: A nutritious porridge fulfilling the consistency constraints was found; however, the minimum cost was unfeasible with local ingredients only. This illustrates the challenges in formulating nutritious yet economically feasible foods from local ingredients. The high cost was caused by the high cost of mineral-rich foods. A nutritious, low-cost porridge that fulfills the consistency constraints was obtained by including supplements of zinc and calcium salts as ingredients. CONCLUSIONS: The optimizations were successful in fulfilling all constraints and provided a feasible porridge, showing that the extended constrained linear programming methodology provides a systematic tool for designing nutritious foods.

Ready-to-use foods for management of moderate acute malnutrition: considerations for scaling up production and use in programs.

Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale community-based programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed.

Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed.

Differences in resource utilization between patients with diabetes receiving glycemia-targeted specialized nutrition vs standard nutrition formulas in U.S. hospitals.

OBJECTIVES: The purpose of the study was to compare patient outcomes and costs for patients with diabetes mellitus (DM) receiving glycemia-targeted specialized nutrition (GTSN) with similar patients receiving standard nutrition (STDN) formulas during acute care hospitalizations. RESEARCH DESIGN AND METHODS: The study was designed as a retrospective analysis over a 10-year period (2000-2009) of clinical and cost data from 125,000 hospital inpatient episodes in the Premier Research Database. Patients received either GTSN or STDN, by tube or orally, as a component of comprehensive care for hyperglycemia in patients with DM. To adjust for potential cohort imbalances, GTSN patients were matched with STDN patients on the basis of propensity scores, adjusting for many characteristics, including age, sex, race, All Patient Refined Diagnosis-Related Group (APR-DRG) illness severity, APR-DRG mortality risk, and comorbidities. RESULTS: Tube-fed patients with DM who were provided GTSN had a 0.88-day (95% confidence interval [CI], 0.73-1.02) shorter length of hospital stay (LOS) on average compared with those patients provided STDN. Orally fed patients with DM who were provided GTSN had a 0.17-day (95% CI, 0.14-0.21) shorter LOS than did those patients provided STDN. The shorter LOS associated with GTSN contributed to a cost savings of $2586 for tube-fed patients and $1356 for orally fed patients. CONCLUSIONS: The use of GTSN feeding formulas for patients with DM in acute care hospital settings was associated with reduced LOS and inpatient hospital episode cost in comparison to STDN.

Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study.

BACKGROUND: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently. OBJECTIVE: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness. DESIGN: The observational multicenter study in the group of 456 HEN patients [142 children: 55 girls and 87 boys, mean (±SD) age 8.7 ± 5.9 y; 314 adults: 151 women and 163 men, mean age 59.3 ± 19.8 y] was performed between January 2007 and July 2013. Two 12-mo periods were compared. During the first period, patients were tube fed a homemade diet and were not monitored; during the other period, patients received HEN. HEN included tube feeding and complex monitoring by a nutrition support team. The number of complications, hospital admissions, length of hospital stay, biochemical and anthropometric variables, and costs of hospitalization were compared. RESULTS: Implementation of HEN enabled weight gain and stabilized liver function in both age groups, but it hardly influenced the other tests. HEN implementation reduced the incidence of infectious complications (37.4% compared with 14.9%; P < 0.001, McNemar test), the number of hospital admissions [1.98 ± 2.42 (mean ± SD) before and 1.26 ± 2.18 after EN; P < 0.001, Wilcoxon's signed-rank test], and length of hospital stay (39.7 ± 71.9 compared with 11.9 ± 28.5 d; P < 0.001, Wilcoxon's signed-rank test). The mean annual costs ($) of hospitalization were reduced from 6500.20 ± 10,402.69 to 2072.58 ± 5497.00. CONCLUSIONS: The study showed that HEN improves clinical outcomes and decreases health care costs. It was impossible, however, to determine precisely which factor mattered more: the artificial diet itself or the introduction of complex care.

[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing]. / Étude de l'impact physicochimique et bactériologique d'un montage hebdomadaire de l'automate BAXA(®) Exacta-Mix 2400 sur la fabrication des poches de nutrition parentérale.

INTRODUCTION: The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested. MATERIALS AND METHODS: Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring. RESULTS: All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found. DISCUSSION AND CONCLUSIONS: The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

Cost-effectiveness analysis of immune-modulating nutritional support for gastrointestinal cancer patients.

BACKGROUND & AIM: Immune-modulating nutritional formula containing arginine, omega-3 fatty acids and nucleotides has been demonstrated to decrease complications and length of stay in surgical patients. This study aims at assessing the impact of immune-modulating formula on hospital costs in gastrointestinal cancer surgical patients in Switzerland. METHOD: Based on a previously published meta-analysis, the relative risks of overall and infectious complications with immune-modulating versus standard nutrition formula were computed. Swiss hospital costs of patients undergoing gastrointestinal cancer surgery were retrieved. A method was developed to compute the patients' severity level, not taking into account the complications from the surgery. Incremental costs of complications were computed for both treatment groups, and sensitivity analyses were carried out. RESULTS: Relative risk of complications with pre-, peri- and post-operative use of immune-modulating formula was 0.69 (95%CI 0.58-0.83), 0.62 (95%CI 0.53-0.73) and 0.73 (95%CI 0.35-0.96) respectively. The estimated average contribution of complications to the cost of stay was CHF 14,949 (€10,901) per patient (95%CI 10,712-19,186), independently of case's severity. Based on this cost, immune-modulating nutritional support decreased costs of hospital stay by CHF 1638 to CHF 2488 per patient (€1195-€1814). Net hospital savings were present for baseline complications rates as low as 5%. CONCLUSION: Immune-modulating nutritional solution is a cost-saving intervention in gastrointestinal cancer patients. The additional cost of immune-modulating formula are more than offset by savings associated with decreased treatment of complications.

Economic impact of switching from an open to a closed enteral nutrition feeding system in an acute care setting.

BACKGROUND: This study compared an open-system (OS) enteral nutrition (EN) delivery system with a closed system (CS). Factors evaluated included nursing time for administration, patient safety factors, and cost of formula and supplies. MATERIALS AND METHODS: This study analyzed the cost of formula and supplies in 1 major academic medical center. Data were collected on patients requiring EN in acute care settings. Information collected included formula type and amount of formula ordered and delivered. RESULTS: The average daily cost to feed each adult patient using delivered volume with the OS was $3.84 compared with $4.31 if the patient had been receiving EN from a CS. Considering waste costs, the average cost to feed increased to $4.21 compared with $4.80, respectively. After factoring in increased nursing time with the OS, the cost increased to $9.83. For pediatric patients, formula delivery reached 1 L in only 2% of patient days. The average cost to feed each patient each day using actual delivered volume was $1.89 in the OS and $1.94 in the CS. When factoring in the cost of waste, those costs increased to $2.12 and $3.30, respectively. After factoring in increased nursing time with the OS, the cost increased to $8.92. CONCLUSION: Due to the higher contract price and increased waste of the CS formulas compared with the OS formulas, a higher daily average cost for formula delivered may be incurred by switching to a CS. However, the CS is more cost-effective when factoring in nursing time.

Insurance coverage of medical foods for treatment of inherited metabolic disorders.

PURPOSE: Treatment of inherited metabolic disorders is accomplished by use of specialized diets employing medical foods and medically necessary supplements. Families seeking insurance coverage for these products express concern that coverage is often limited; the extent of this challenge is not well defined. METHODS: To learn about limitations in insurance coverage, parents of 305 children with inherited metabolic disorders completed a paper survey providing information about their use of medical foods, modified low-protein foods, prescribed dietary supplements, and medical feeding equipment and supplies for treatment of their child's disorder as well as details about payment sources for these products. RESULTS: Although nearly all children with inherited metabolic disorders had medical coverage of some type, families paid "out of pocket" for all types of products. Uncovered spending was reported for 11% of families purchasing medical foods, 26% purchasing supplements, 33% of those needing medical feeding supplies, and 59% of families requiring modified low-protein foods. Forty-two percent of families using modified low-protein foods and 21% of families using medical foods reported additional treatment-related expenses of $100 or more per month for these products. CONCLUSION: Costs of medical foods used to treat inherited metabolic disorders are not completely covered by insurance or other resources.

Novedades en la alimentación complementaria para recién nacidos con lactancia materna / New on complementary feeding for infants with breastfeeding

Introducción: La leche materna debería ser el alimento exclusivo de los bebés hasta los 6 meses, pero puede ser necesaria la alimentación complementaria entre los 4 y los 6 meses. Objetivo: Valoración clínica del empleo de una nueva papilla de cereales preparada con agua, en niños de 4 meses de edad con lactancia materna. Material y métodos: Fueron reclutados 30 lactantes sanos, con lactancia materna hasta los 6 meses. A los 4 meses se indicó durante 4 semanas una toma diaria de dichos cereales en sustitución de una toma de leche materna. La composición, preparada al 25% con agua, aporta 106 kcal/100 g. El promedio de ingesta de papilla fue de 190 kcal/día. Se constató una diferencia significativa en el Z-score (p <0,01) para el peso a los 4 meses de 0,15 ± 0,88 frente al peso a los 5meses de 0,40 ± 0,85. Las curvas de talla y perímetro craneal fueron normales. No se alteró el ritmo deposicional y la aceptación de la papilla fue excelente. Conclusión: El nuevo preparado es una magnífica alternativa para iniciar la alimentación complementaria en lactantes con lactancia materna exclusiva que precisen el inicio de dicha alimentación sin incorporar fórmula(AU)

Introduction: Breast milk should be the only food for babies up to six months, but complementary feedings may be necessary between 4-6 months. Aim: Clinical evaluation of the use of a new cereal porridge made with water, in infants 4 months of age with breastfeeding. Material and methods: 30 healthy infants being breastfed up to 6 months of age were recruited. At 4 months, a daily intake of these cereals in place of the breast milk intake was prescribed for 4 weeks. The composition was prepared with 25%water providing 106 kcal/100 g. The average intake was 190kcal slurry/day. A significant difference was found in the Z score (p <0.01) for their weight at 4 months vs 0.15 ± 0.88 at 5months 0.40 ± 0.85. The curves of height, and head circumference were normal. There was no alteration in the depositional, and the acceptance rate was excellent. Conclusion: The new preparation is a great alternative for starting a complementary feeding of infants exclusively on breast milk, who want or require the start of the process without adding formula(AU)

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.