Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group.

BACKGROUND: The term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. OBJECTIVES: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. METHODS: ISPOR's Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. RESULTS: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. CONCLUSIONS: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.

Classifying Enteral Nutrition: Tailored for Clinical Practice.

PURPOSE OF REVIEW: To discuss the different forms of enteral nutrition, while outlining available evidence for its use in specific conditions and how enteral nutrition composition may or may not influence relevant outcomes. RECENT FINDINGS: Enteral nutrition formulas were originally conceived as a liquid form of nutrition for individuals who otherwise could not consume adequate calories through solid food. Over time, the emergence of specialty formulas marketed to benefit specific diseases or conditions has led to a broad range of potentially confusing options. While most options have theoretical benefit for their marketed conditions, the evidence demonstrating practical benefit is not consistent. Overall, the certainty of evidence for specialty formulas remains low or very low. In most instances, one could begin with standard polymeric formula, except in cases where disease-specific formulas are recommended. Much research is nonetheless still needed to clarify whether some disease-specific formulas are truly beneficial or merely theoretical features.

Classification and Nutrition Management of Acute Pancreatitis in the Pediatric Intensive Care Unit.

The aims of this retrospective cohort study were to classify the severity of patients admitted to the pediatric intensive care unit (PICU) with acute pancreatitis (AP) and to identify how many patients received appropriate nutritional management in accordance with more recent guidelines and the outcomes of those patients. Of the 54 children with AP, 12 (22.2%) had a primary diagnosis of AP (50% severe, 17% moderate) whereas 42 (77.8%) had a secondary diagnosis of AP (81% severe, 11.9% moderate). Just under half of the patients (48.1%) had enteral nutrition commenced before the third day of admission (50% with primary AP, 47.6% with secondary AP). The average time to initiation of enteral feeds was 2.3 days for those that received enteral nutrition. 51.8% of patients received parenteral nutrition (25% with primary AP, 59.5% with secondary AP). Most patients received enteral nutrition late and parenteral nutrition was overused in patients with AP admitted to the PICU.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge. Final order.

The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Enteral Access Devices: Types, Function, Care, and Challenges.

Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal (GI) tract but are not able to consume or absorb enough nutrients to sustain adequate nutrition and hydration. For many individuals, enteral nutrition support is a lifesaving modality to prevent or treat a depleted nutrient state that can lead to tissue breakdown, compromised immune function, and poor wound healing. Psychological well-being is also affected with malnutrition and dehydration, triggering feelings of apathy, depression, fatigue, and loss of morale, negatively impacting a patient's ability for self-care. A variety of existing devices can be placed through the nares, mouth, stomach or small intestine to provide liquid nutrition, fluids, and medications directly to the GI tract. If indicated, some of the larger-bore devices may be used for gastric decompression and drainage. These enteral access devices need to be cared for properly to avert patient discomfort, mechanical device-related complications, and interruptions in the delivery of needed nutrients, hydration, and medications. Clinicians who seek knowledge about enteral access devices and actively participate in the selection and care of these devices will be an invaluable resource to any healthcare team. This article will review the types, care, proper positioning, and replacement schedules of the various enteral access devices, along with the prevention and troubleshooting of potential problems.

Proposal for a new practicable categorization system for food for special medical purposes - Enteral nutritional products.

BACKGROUND & AIMS: Changes in the EU regulation on food for specific groups (FSG) [1] and within the German social law [2] combined with various definitions in the legal and the scientific background led to the need for development of a categorization system for "Food for special medical purposes" (FSMP) for enteral use [3]. METHODS: The system was developed by an interdisciplinary working group of two German industry associations, which represent the leading manufacturers and distributors of FSMP in Europe. It aims to minimize the misunderstandings surrounding the different definitions used in relation to enteral nutritional products and incorporate the latest scientific knowledge and medical guidelines [4]. RESULTS: The new proposal consists of a table which shows the product categories and briefly the definitions of the used terms. The text contains the relevant definitions of terms often used within the field of enteral nutrition. CONCLUSION: This provides health care professionals with support and the decision making process for the prescription and use of such products. Additionally it also benefits the responsible authorities to formulate new directives, which are user-friendly and reflect the latest knowledge in medical nutrition.

[The evolution of commercial enteral formulas in Spain in 1988-1991]. / Evolución de las fórmulas enterales comercializadas en España en el período 1988-1991.

Enteral nutrition is an artificial form of nutrition which is expanding an there are thus a great many commercial preparations on the market which are rapidly being developed. This study is a presentation of the quantitative and qualitative changes in these preparations from 1988-1991, classified depending upon their main nutrient: proteins. In global terms, there has been an increase of 18 formulae, distributed among different types, but with the most spectacular increase in special diets. Discussion of the trends observed, which respond to further knowledge on the absorption or tolerance of nutrients and nutritional needs in different pathologies.

Gastrostomía en la nutrición enteral domiciliaria / Gastrostomy in home enteral nutrition

La gastrostomía es el acceso enteral más considerado cuando se requiere una sonda de alimentación a largo plazo. Las técnicas de implantación de la sonda de gastrostomía pueden ser percutánea y quirúrgica. La alimentación por gastrostomía es generalmente bien aceptada en niños y adultos. La gastrostomía es un acceso de gran utilidad y de gran importancia a nivel clínico en la alimentación enteral a largo plazo tanto de niños como adultos.

Access gastrostomy is considered when more enteral feeding tube requires long term. The technical implementation of the gastrostomy tube can be percutaneously and surgically. Gastrostomy feeding is generally well accepted in children and adults. The gastrostomy is a useful access and important at the clinical level in the long-term enteral feeding both children and adults.

Selección de pacientes candidatos a nutrición enteral domiciliaria / Selection of patients candidates home enteral nutrition

La alimentación es una acción fundamental por medio de la cual se adquieren los nutrientes necesarios para la nutrición celular. Todo paciente que cuente con un tracto gastrointestinal funcional puede recibir nutrición enteral domiciliaria (NED). La implementación de la NED, debe contemplar aspectos sociales. La NED tiene como objetivo principal mejorar la calidad de vida del paciente. El paciente y su familia deben recibir y entender correctamente la información necesaria sobre su enfermedad de base y la necesidad de NED.

Food is a basic action through which they acquire the nutrients necessary for cellular nutrition. Any patient that has a functional gastrointestinal tract may receive home enteral nutrition (HEN). The implementation of the HEN should include social aspects. The HEN's main objective is to improve the quality of life of patients. The patient and family should receive and understand properly the necessary information on the underlying disease and the need for HEN.

Nutrición enteral y parenteral en la alimentación del niño con Cáncer / Enteral and parenteral feeding in children with cancer

En muchas oportunidades, en los niños con cáncer, no se logra ofrecer toda la alimentación que el niño requiere por la boca, motivo por el cual son utilizadas algunas alternativas que han demostradas ser eficaces para evitar la malnutrición, como la nutrición enteral y la parenteral, las cuales deben ser determinadas por el pediatra o nutricionista infantl del niño. Cuando la nutrición enteral, no es suficiente, es requerida la nutrición parenteral, incluso en casa.

On many occasions, in children with cancer are not able to provide all nutrition required by the child's mouth, which is why some alternatives are used that have proven effective in preventing malnutrition, such as enteral nutrition and parenteral, which must be determined by the pediatrician or infant nutritionist. When enteral nutrition is insufficient, parenteral nutrition is required, even at home.

Nutrición enteral: primera parte / Enteral nutrition: first part

La nutrición enteral comprende todas las formas de soporte nutricional que implican el empleo de alimentación para propósitos médicos especiales, independientemente de la vía de alimentación, por vía oral o por sonda de alimentación. Debe ser considerada en pacientes con tracto gastrointestinal funcional que requieren apoyo nutricio. Las contraindicaciones son isquemia gastrointestinal, enterocolitis necrosante, íleo paralítico, megacolon tóxico, vómito o diarrea intratable, íleo paralítico, peritonitis difusa, sangrado de tubo digestivo grave y obstrucción intestinal. Las ventajas incluyen, aún cuando sea estimulación, la preservación de la función gastrointestinal, riesgo disminuido de infección y anormalidades metabólicas, atenuación de la respuesta catabólica, aumento de los sistemas antioxidantes, imita la nutrición humana estándar, reducción del tiempo de estancia hospitalaria, limitada traslocación bacteriana, disminuye la frecuencia de sepsis y falla orgánica múltiple, menor costo, fácil manejo y seguridad. Entre las fórmulas de alimentación se encuentran estándar, poliméricas o con proteínas intactas, hidrolizadas o basadas en péptidos, con aminoácidos libres o elementales, poliméricas artesanales, específicas para enfermedades, y modulares.

Enteral nutrition encompasses all forms of nutritional support involving the use of food for special medical purposes, regardless of route of feeding, orally or by feeding tube. It should be considered in patients with functional gastrointestinal tract who require nutritional support. The benefits include stimulation even when the preservation of gastrointestinal function, decreased risk of infection and metabolic abnormalities, catabolic response attenuation, increased antioxidant systems, mimics the standard human nutrition, reduced hospital stay, limited bacterial translocation, decreases the frequency of sepsis and multiple organ failure, lower cost, easy handling and safety. Among the feeding formulas are standard, polymeric or intact proteins, hydrolyzed or based on peptides, free amino acid or elemental, polymeric craft specific diseases, and modular.

Nutrición enteral en hepatopatías crónicas en niños y adolescentes / Enteral nutrition in chronic liver disease in children and adolescents

La desnutrición que se observa en enfermedades hepáticas crónicas en niños se asocia a un aumento de requerimientos por gasto calórico elevado. La historia clínica incluye un recordatorio de alimentación, evaluación clínica, antropometría. Los niños con colestasis deben recibir una dieta hipercalórica. Es fundamental garantizar el aporte calórico calculado completo y la alimentación enteral. Se debe garantizar un crecimiento adecuado en un niño en lista de espera para trasplante. Los niños con enfermedades metabólicas requieren el uso de fórmulas comerciales especiales.

Malnutrition seen in chronic liver disease in children is associated with increased requirements for high caloric expenditure. The medical history includes a reminder of food, clinical evaluation, anthropometry. Children with cholestasis should receive a high calorie diet. It is essential to ensure complete and estimated calorie enteral feeding. It must ensure adequate growth in a child on the waiting list for transplantation. Children with metabolic diseases require the use of special comercial formulations.

Using enteral nutrition formulas.

A review of enteral tube feeding formulations is presented. When choosing an enteral formula product for a patient one must first determine the calorie and protein needs of the patient. Then one must determine the level of gastrointestinal tract function. First ask, to what degree is the small bowel functioning: totally, partially, or not at all? Has the small bowel lost surface area because of atrophy, inflammation, or surgical removal? Is the gut edematous because of hypoalbuminemia or congestive heart failure? Is bowel motility impaired by opioids, anticholinergics, or mechanical ileus? Is digestion limited by pancreatic or bile acid insufficiency? Has absorption been decreased by intestinal ischemia or gastrointestinal bleeding? Decreased surface area, bowel edema, and diminished digestive juices are only partial losses of small bowel function. An elemental formula should be tried first in these situations. Any of the other problems alone or in combination probably preclude the use of the small bowel and the patient will need total parenteral nutrition. If gastrointestinal function is adequate, then other organ failures that result in specific nutrient intolerance must be ruled out. If gastrointestinal function is adequate and no other organ failures preclude the use of a polymeric formula, then one must decide if stress and hypermetabolism are present. Enteral feeding is the preferred method of providing specialized nutrition support. Bowel rest reduces the barrier functions of the gut and malnutrition reduces cell-mediated immunity. The indications and relative contraindications for enteral tube feeding are also reviewed. The rationale for the formula design and the evidence for formula efficacy are presented. Polymeric, elemental, organ-specific, and immune-modulating formulas are discussed. Guidelines for formula selection are suggested.

Artificial nutrition in cancer patients: which route, what composition?

The state of art of artificial nutrition in depleted cancer patients is reviewed in brief. Because cancer cachexia cannot be equated to simple nutrient deficiency but is due instead to complex metabolic abnormalities, the nutritional effects of total parenteral (TPN) and enteral (EN) nutrition are more limited than in starving subjects. TPN and EN usually prevent further deterioration of the nutritional status, although they are not able to fully reverse a state of depletion. There is evidence that quantitative and qualitative modulation of certain nutrients may obtain better results because of a favorable impact on host metabolism. Research in this field is fully warranted. Moreover, the effects of some substrates on tumor metabolism and tumor growth require further investigation to define a nutritional regimen able to maintain the host metabolism with minimum stimulation of tumor growth.

Nonsurgical management of gastric or duodenal perforation from a Wills-Oglesby-type gastrostomy tube.

PURPOSE: To describe the clinical and radiologic appearance of gastrointestinal perforation related to a Wills-Oglesby-type gastrostomy tube, as well as techniques for nonsurgical management. MATERIALS AND METHODS: Five patients with a previously placed 14-F modified Wills-Oglesby-type gastrostomy catheter experienced viscus perforation by the distal limb of the catheter during a 30-month period. RESULTS: The average interval between tube placement and perforation event was 4.3 months. Three patients had migration of the gastrostomy tube into the duodenum and subsequent duodenal perforation. One patient had posterior perforation of the stomach, and one patient developed a gastrocolic fistula. Generalized peritonitis was not present in any patient. All patients were treated successfully without surgery, and tube feedings were re-established in 4-14 days. CONCLUSIONS: Gastrostomy tube-related perforation is an uncommon, delayed complication of percutaneous gastrostomy with the modified Wills-Oglesby-type catheter. Nonsurgical management is feasible in select instances. Because of these gastrointestinal perforations, the gastrostomy tube has been modified (eliminating the distal tip), and no gastrostomy-associated gastrointestinal perforation has been experienced since.

Jejunostomy: techniques, indications, and complications.

Jejunostomy is a surgical procedure by which a tube is situated in the lumen of the proximal jejunum, primarily to administer nutrition. There are many techniques used for jejunostomy: longitudinal Witzel, transverse Witzel, open gastrojejunostomy, needle catheter technique, percutaneous endoscopy, and laparoscopy. The principal indication for a jejunostomy is as an additional procedure during major surgery of the upper digestive tract, where irrespective of the pathology or surgical procedures of the esophagus, stomach, duodenum, pancreas, liver, and biliary tracts, nutrition can be infused at the level of the jejunum. It is also used in laparotomy patients in whom a complicated postoperatory recovery is expected, those with a prolonged fasting period, those in a hypercatabolic state, or those who will subsequently need chemotherapy or radiotherapy. As a sole procedure it is advised for neurologic and congenital illnesses, in geriatric patients who pose difficult care demands, and for patients with tumors of the head and neck. The complications seen with jejunostomy can be mechanical, infectious, gastrointestinal, or metabolic. The rate of technical complications of the Witzel longitudinal technique is 2.1%, for the transverse Witzel up to 6.6%, for the Roux-en-Y 21%, for open gastrojejunostomy from 2%, and for the needle catheter technique from 1.5% with 0.14% mortality. The percutaneous endoscopic procedures have as much as a 12% complication rate; no figures exist for laparoscopy. The complications are moderate and severe: tube dislocation, obstruction or migration of the tube, cutaneous or intraabdominal abscesses, enterocutaneous fistulas, pneumatosis, occlusion, and intestinal ischemia. The infectious complications are aspiration pneumonia and contamination of the diet. The gastrointestinal complications are diarrhea 2.3% to 6.8%, abdominal distension, colic, constipation, nausea, and vomiting. The metabolic complications are hyperglycemia 29%, hypokalemia 50%, water and electrolyte imbalance, hypophosphatemia, and hypomagnesemia. These complications are secondary to inadequate selection of nutrition relative to the characteristics of the patient, to inadequate management of the mixture, and to deficient clinical care. The ideal jejunostomy technique depends on the material resources but more importantly on the experience of the surgeon. The benefits of jejunostomy justify the risks.

Nutrição enteral em Pediatria / Enteral nutrition in Pediatrics

O autor conceitua o que se entende por nutriçäo enteral, apresenta os diferentes tipos de dietas, fórmulas completas, modulares, artesanais e comerciais, analisa as condiçöes que requerem o uso de fórmulas lácteas especiais (prematuridade, imaturidade e inflamaçäo intestinal, alergia ao leite de vaca), as vias e a técnica de administraçäo e de passagem de sonda, cuidados com a dieta enteral e sua monitorizaçäo, particularidades do RN e complicaçöes, finalizando com estudo da interaçäo entre drogas e nutrientes