ESPEN practical guideline: Clinical nutrition in chronic intestinal failure.

BACKGROUND: This practical guideline is based on the ESPEN Guidelines on Chronic Intestinal Failure in Adults. METHODOLOGY: ESPEN guidelines have been shortened and transformed into flow charts for easier use in clinical practice. The practical guideline is dedicated to all professionals including physicians, dieticians, nutritionists, and nurses working with patients with chronic intestinal failure. RESULTS: This practical guideline consists of 112 recommendations with short commentaries for the management and treatment of benign chronic intestinal failure, including home parenteral nutrition and its complications, intestinal rehabilitation, and intestinal transplantation. CONCLUSION: This practical guideline gives guidance to health care providers involved in the management of patients with chronic intestinal failure.

Proactive Risk Assessment through FMEA of Home Parenteral Nutrition Care Processes: A Survey Analysis.

BACKGROUND: Home Parenteral Nutrition (HPN) is a lifesaving clinical care process. However, undetected hazards and vulnerabilities in care transitions from hospital to community care may pose risk to patient's safety. Avoidable complications and adverse events may hinder the benefits of treatment. OBJECTIVE: The analysis carried out aims at framing through Human Factors and Ergonomics (HF/E) the critical issues for patient safety related to clinical care practices for HPN in healthcare organization. METHODS: We present the results of a proactive risk assessment analysis based on the FMEA methodology (Failure Mode and Effects Analysis) carried out in three different areas of the regional health care system of Tuscany, Italy. The clinical risk management and patient safety unit assessed the risk perception of Healthcare Workers (HWs) in regard to patient safety and situational awareness throughout the HPN patient journey. RESULTS: The analysis revealed heterogeneity in the Risk Priority Index (RPI) expressed by HWs. A lower RPI is associated with a HPN process that deploys in continuity between hospital care and community care. A higher RPI is associated with a quality and safety improvement process that is still ongoing. We also observed HWs expressing low RPI in the areas of the region where HPN has a hospital- focused approach and has limited adherence to patient safety requirements. Low RPI for HPN process may relate both to extensively deployed continuity of care and to jeopardized awareness on HPN phases and coordination. The analysis carried out enabled the definition of a common HPN workflow used as reference schema allowing for the definition of a set of recommendations for improving the quality and safety of the care processes. Moreover, the outcome of the proactive risk assessment laid the groundwork for the advancement of the patient safety regional requirements. CONCLUSION: The analysis had the role of promoting the contextualization of the culture of quality and safety within the HPN process resulting in an improved awareness of the criticalities and the role of nutrition units throughout the care process.

Results from an Epidemiological Follow-Up Survey on Home Artificial Nutrition in Switzerland from 2010 to 2015.

BACKGROUND: Home artificial nutrition (HAN) is an established treatment for malnourished patients. Since July 2012, the costs for oral nutrition supplements (ONS) are covered by the compulsory health insurance providers in Switzerland if the patient has a medical indication based on the Swiss Society for Clinical Nutrition guidelines. Therefore, the purpose of our study was to analyse the development of HAN, including ONS, before and after July 2012. METHODS: We obtained the retrospective and anonymized data from the Swiss association for joint tasks of health insurers (SVK), who registered patients on HAN. Since not all health insurers are working with SVK, this retrospective study recorded nearly 65% of all new patients on HAN in Switzerland from January 1, 2010, to December 31, 2015. RESULTS: A total of 33,410 patients (49.1% men and 50.9% women) with a mean BMI of 21.3 ± 4.5 kg/m2 and mean age of 68.9 ± 17.8 years were recorded. The number of patient cases on ONS increased from 808 cases in 2010 to 18,538 cases in 2015, while patient cases on home enteral nutrition (HEN) and home parenteral nutrition (HPN) remained approximately the same. The relative distribution of type of HAN changed from 26.2% cases on ONS, 68.7% cases on HEN and 5.1% cases on HPN in 2010 to 86.1% cases on ONS, 12.8% cases on HEN, and 1.1% cases on HPN in 2015. Treatment duration decreased for ONS from 698 ± 637 days to 171 ± 274 days, for HEN from 416 ± 553 days to 262 ± 459 days, and for HPN from 96 ± 206 days to 72 ± 123 days. Mean costs per patient decreased for ONS from 1,330 CHF in 2010 to 606 CHF in 2015. Total costs for HAN increased from 16,895,373 CHF in 2010 to 32,868,361 CHF in 2015. CONCLUSION: Our epidemiological follow-up study showed an immense increase in number of patients on HAN in Switzerland after July 2012. Due to shorter therapy duration and reduced mean costs per patient, total costs were only doubled while the number of patients increased 7-fold.

ESPEN guideline on home parenteral nutrition.

This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion line and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.

Practical management of home parenteral nutrition in infancy.

The child born today with chronic intestinal failure (IF) can expect to survive throughout childhood and into adult life even if dependent on parenteral nutrition (PN) support. The three major aetiologies of chronic IF are short bowel syndrome (SBS), intestinal dysmotility and mucosal disease. SBS is the commonest of these conditions in infancy, most frequently subsequent to resection for necrotising enterocolits (NEC). The focus of IF management is to ensure appropriate weight gain and growth whilst minimising complications (related to underlying disease as well as to PN) and aiming for intestinal autonomy. Strategies to avoid complications and aid PN weaning include early oral/enteral feed introduction, 'cycling' PN as soon as tolerated, limiting lipid infusions and discharging home on overnight PN with formally trained parents. A newer treatment for SBS is GLP-2 analogue. Multidisciplinary care in a specialist intestinal rehabilitation centre with collaboration with local professional support is key to success.

Intestinal Failure: New Definition and Clinical Implications.

Intestinal failure (IF) is a state in which the nutritional demands of the body are not met by the gastrointestinal absorptive surface. It is a long-recognized complication associated with short bowel syndrome, which results in malabsorption after significant resection of the intestine for many reasons or functional dysmotility. Etiologies have included Crohn's disease, vascular complications, and the effects of radiation enteritis, as well as the effects of intestinal obstruction, dysmotility, or congenital defects. While IF has been long-recognized, it has historically not been uniformly defined, which has made both recognition and management challenging. This review examines the previous definitions of IF as well as the newer definition and classification of IF and how it is essential to IF clinical guidelines.

ESPEN guidelines on chronic intestinal failure in adults.

BACKGROUND & AIMS: Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF. No guidelines (GLs) have been developed that address the global management of CIF. These GLs have been devised to generate comprehensive recommendations for safe and effective management of adult patients with CIF. METHODS: The GLs were developed by the Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. The GRADE system was used for assigning strength of evidence. Recommendations were discussed, submitted to Delphi rounds, and accepted in an online survey of ESPEN members. RESULTS: The following topics were addressed: management of HPN; parenteral nutrition formulation; intestinal rehabilitation, medical therapies, and non-transplant surgery, for short bowel syndrome, chronic intestinal pseudo-obstruction, and radiation enteritis; intestinal transplantation; prevention/treatment of CVC-related infection, CVC-related occlusion/thrombosis; intestinal failure-associated liver disease, gallbladder sludge and stones, renal failure and metabolic bone disease. Literature search provided 623 full papers. Only 12% were controlled studies or meta-analyses. A total of 112 recommendations are given: grade of evidence, very low for 51%, low for 39%, moderate for 8%, and high for 2%; strength of recommendation: strong for 63%, weak for 37%. CONCLUSIONS: CIF management requires complex technologies, multidisciplinary and multiprofessional activity, and expertise to care for both the underlying gastrointestinal disease and to provide HPN support. The rarity of the condition impairs the development of RCTs. As a consequence, most of the recommendations have a low or very low grade of evidence. However, two-thirds of the recommendations are considered strong. Specialized management and organization underpin these recommendations.

Use of intravenous lipids: what do the guidelines say?

The use of intravenous lipids is very frequent in most parenteral nutrition (PN) prescriptions. In this chapter, a systematic review of the literature was performed to compare the position of the various scientific societies (mainly the European Society for Clinical Nutrition and Metabolism, the American Society for Parenteral and Enteral Nutrition, and the German and Canadian Nutrition Societies) in terms of recommendations of when intravenous lipids should be prescribed for different clinical conditions. These recommendations may be supported by strong evidence or, if not available, by expert opinion. These recommendations help the physician in his daily prescription of PN in the hospital and help the patient requiring home PN.

Liver disease in patients qualified for home parenteral nutrition - a consequence of a failure to adjust RTU bags in the primary centre?

UNLABELLED: If planned improperly, parenteral nutrition may result in a number of severe metabolic complications caused by insufficient or excessive delivery of individual nutrients. One of the most common and the most dangerous complication is parenteral nutrition-associated liver disease (PNALD). Such a complication may also result from using RTU (ready-to-use) bags that are not adjusted adequately to individual patients. The aim of the study was the analysis of prevalence and determining the cause of liver disease in patients who had been receiving parenteral nutrition in primary centres prior to the implementation of home parenteral nutrition in the specialist centre. MATERIAL AND METHODS: The study enrolled 146 patients who were referred to the Clinic in the period of 2006-2012 in order to be qualified for home parenteral nutrition. Interview and medical documentation revealed that 100 patients had been receiving parenteral nutrition by means of ready-to-use (RTU) bags in their primary centres. In the remaining 46 patients, such feeding had not been implemented. Upon admission, the following parameters were evaluated: bilirubin, aspartate aminotransferase (AspAT), alanine aminotransferase (AlAT), lactate dehydrogenase (LDH), gamma-glutamyltranspeptidase (GGTP), alkaline phosphatase (AP), triglycerides (TG), cholesterol, protein, albumins, amylase, urea, creatinine and C-reactive protein (CRP). The analysis of the results was conducted with the use of the Student's T-test. RESULTS: The patients who had been receiving parenteral nutrition manifested significantly increased (p < 0.05) levels of total bilirubin, TG, AlAT, LDH, GGTP, AP and CRP. 23% of patients were diagnosed with jaundice, in 70%, GGTP > 100 i.u. and a half manifested biochemical features of cholestasis. No correlation was observed between the CRP level and results of liver function tests. CONCLUSIONS: It was found that there is a correlation between parenteral nutrition with RTU bags and liver disease. The probable cause of liver disease associated with parenteral nutrition received prior to the transfer to the Clinic is excessive administration of lipids. It can be accompanied by excessive administration of glucose. Modification of parenteral nutrition helped to compensate for liver disorders in all patients.

Social circumstances and medical complications in children with intestinal failure.

UNLABELLED: Although most children discharged on home parenteral nutrition (HPN) will achieve enteral autonomy, some remain parenteral nutrition dependent; those who develop life-threatening complications may undergo small bowel transplantation (SBTx). The aim of this study was to investigate the relationship between social circumstances, compliance and complications. SUBJECTS AND METHODS: An observational study in 2008-2012 on 64 children (34 HPN, 30 SBTx) from three units (two regional gastroenterology; one transplant). Social circumstances were assessed routinely as part of discharge planning; adherence by families to home care management was scored, and episodes of catheter-related blood stream infection and graft rejection were recorded for 2 years and related to compliance and social circumstances. RESULTS: A quarter of families had a disadvantaged parent: non-English speaking (n=11), unable to read (n=5), physical disability (n=3), mental health problems disclosed (n=10); 20% children were cared for by a lone parent. Discharge home was delayed by social factors (n=9) and need for rehousing (n=17, 27%). 17/34 (50%) of HPN and 12/30 (40%) of transplant families were assessed as fully adherent. 10 families were assessed as non-adherent, eight were subject to child protection review and care was taken over by another family member (n=3) or foster parents (n=2). The risk of catheter-related blood stream infection was increased by parental disadvantage and age <3 years (p<0.05). Poor compliance was associated with complications in HPN and SBTx recipients. CONCLUSIONS: Children receiving complex home care may be socially isolated and measures to support improved compliance such as increased community support, social care involvement and respite care may improve outcomes.

Identifying patient-centered quality indicators for the care of adult home parenteral nutrition (HPN) patients.

BACKGROUND: Previous qualitative research, aimed at eliciting the experiences and views of home parenteral nutrition (HPN) patients in daily life, revealed little information on HPN care. However, to perform patient-centered care, it is important to understand what "quality of care" means for adult HPN patients. Therefore, the aim of this study was to identify quality indicators through patients' perspectives. MATERIALS AND METHODS: In-depth, face-to-face, semistructured interviews were conducted between June and November 2011 with adult patients who recently started HPN. Patients were selected by purposive sampling. Interviews were audio recorded, transcribed verbatim, and analyzed using a framework approach. Nvivo 9.0 software was used for managing transcripts. RESULTS: Twelve adult patients (7F/5M) were interviewed. At the time of the interview, median HPN experience was 59 days. Two structure, 31 process, and 9 outcome indicators were identified. The majority of process indicators are related to the home nurse, indicating the important role of these healthcare professionals in HPN care. In addition, all interviewees reported communication as an essential aspect of the complex care pathway. The identified outcome indicators are comparable with the indicators that were previously developed by an expert panel. For example, improvement in quality of life during HPN treatment and incidence of catheter-related infections were identified by both groups. CONCLUSION: Interviews with HPN patients revealed an interesting set of indicators that can be used to perform, evaluate, or improve current HPN care and are a starting point for a more patient-centered approach.

Application of the A.S.P.E.N. clinical guideline for nutrition support of hospitalized adult patients with obesity: a case study of home parenteral nutrition.

An A.S.P.E.N. clinical guideline addressing the nutrition support of hospitalized adult patients with obesity was recently published in the Journal of Parenteral and Enteral Nutrition. Among the patient presentations for which this guideline might be used is those who have a gastrointestinal complication after bariatric surgery. A case study is discussed of a 43-year-old woman with a long history of severe obesity who had a bowel obstruction approximately 2 weeks after her laparoscopic sleeve gastrectomy surgery. The patient's treatment plan for bowel rest and home parenteral nutrition was based on the A.S.P.E.N. clinical guideline for patients with obesity. She tolerated the course well and resumed the expected diet advancement and weight loss patterns expected of her weight-loss surgery.

Evaluation of physical stability of all in one parenteral admixtures for pediatric home care with high electrolytes concentrations.

INTRODUCTION: The aim of the study was to evaluate stability of 48 total parenteral admixtures for pediatric patients who require home parenteral nutrition. Admixtures contain high amounts of electrolytes. In a clinical practice electrolytes-enrichment of the parenteral nutrition admixtures is a usual demand, especially on the neonatal/pediatric wards. The supplementation of parenteral nutrition with high concentration of electrolytes is a living problem due to decreased stability of lipid emulsions in nutrition admixtures caused by bivalent cations. METHODS: Preliminary admixtures were prepared in two-chamber ethylene vinyl acetate bags: amino acids, glucose and electrolytes were combined in one chamber and 20% (w/w) lipid emulsions (SMOFlipid®, Intralipid ® or ClinOleic®) were placed separately in the second chamber. Organic salts of calcium and phosphates were used. Pre-admixtures were stored at +4ºC for up to 21 days after preparation. Each composition of admixtures was prepared twice, because contents of the two chambers were combined at t=0 or after 21 days of storage at +4ºC. Visual observations, globule size distribution (using optical microscopy, laser diffraction and photon correlation spectroscopy methods), pH analyses, zeta potential and surface tension were performed after combining all components together with vitamins. RESULTS: Among 48 of investigated admixtures only two were problematic and other may be stored for at least 21 days at 4°C and completed admixtures demonstrated stability for at least 24 h at room temperature. CONCLUSION: It was possible to obtain stable admixtures despite of the high concentration of electrolytes.

Introducción: El objetivo del estudio fue evaluar la estabilidad de un total de 48 preparados o mezclas parenterales para pacientes pediátricos con necesidad de nutrición parenteral domiciliaria. Los preparados contienen cantidades elevadas de electrolitos. En la práctica clínica, el enriquecimiento con electrolitos de los preparados de nutrición parenteral es una demanda habitual, especialmente en las unidades neonatales/pediátricas. El complemento de la nutrición parenteral con altas concentraciones de electrolitos es un problema corrriente debido a la menor estabilidad de las emulsiones lipídicas en preparados de nutrición provocada por cationes bivalentes. Métodos: Se prepararon mezclas preliminares en bolsas de etilenvinilacetato de dos cámaras: se combinó amino ácidos, glucosa y electrolitos en una cámara y en la segunda cámara se puso por separado emulsiones lipídicas 20% (w/w) (SMOFlipid®, Intralipid® o ClinOleic®). Se utilizaron sales orgánicas de calcio y fosfatos. Se almacenaron pre-mezclas a +4ºC durante 21 días después de la preparación. Cada composición de mezcla fue preparada dos veces, dado que el contentido de las dos cámaras se combinó en t=0 o después de 21 días después del almacenamiento a +4ºC. Se realizaron observaciones visuales, distribución del tamaño globular (empleando métodos de microscopía óptica, difracción por láser y espectroscopía de correlación fotónica), análisis de pH, potencial zeta y tensión superficial después de combinar todos los componentes a la vez con vitaminas. Resultados: De los 48 preparados investigados solo dos resultaron problemáticos y el resto se pudo almacenar durante al menos 21 días a 4°C y las mezclas completadas presentaron estabilidad durante al menos 24 h a temperatura ambiente. Conclusión: Fue posible obtener preparados estables a pesar de la alta concentración de electrolitos.

Prescription of trace elements in adults on home parenteral nutrition: current practice based on the Canadian Home Parenteral Nutrition Registry.

BACKGROUND: Since the introduction of long-term parenteral nutrition (PN), morbidity due to inadequate replacement or toxicity of routinely administered trace elements has been well described. After decades of experience, much debate still exists about optimal supplementation. In practice, trace elements (TEs) seem to be frequently provided by prescribing an all-inclusive commercial multi-TE admixture with little dosage flexibility. AIM: Our goal was to review TE supplementation practice among 5 PN support centers across Canada, through a retrospective review of the Canadian Home PN Registry. METHODS: Baseline demographic, clinical, and biochemical parameters along with information regarding the PN prescription of 135 patients with complete records were retrieved from the registry database collected between 2005 and 2007. TE supplementation prescriptions were compared with recent guidelines as well as between groups of patients with different PN indications and dietary intake status. Consent was signed by all participating patients. RESULTS: The average daily PN concentrations of TE were as follows: zinc, 8.6 ± 5.5 mg (130.92 ± 84.23 µmol); manganese, 452 ± 184 µg (8.22 ± 3.34 µmol); selenium, 78 ± 45 µg (0.99 ± 0.57 µmol); chromium, 11 ± 5 µg (0.21 ± 0.10 µmol); copper, 0.64 ± 0.35 mg (10.11 ± 5.58 µmol); and iodine, 77 ± 42 µg (0.61 ± 0.33 µmol). The mean daily supplementation of zinc, manganese, copper, and selenium exceeded published recommendations. Patients' underlying anatomy or indication for PN did not significantly influence decisions regarding replacement standards. CONCLUSION: Parenteral TE supplementation in Canadian PN programs needs to be reviewed and adjusted according to most current guidelines. This may require a reevaluation of the commercial TE preparations currently available in Canada and potential new products worldwide to avoid oversupplementation and potential toxicity.

Quality of care for cancer patients on home parenteral nutrition: development of key interventions and outcome indicators using a two-round Delphi approach.

PURPOSE: Clear recommendations on how to guide patients with cancer on home parenteral nutrition (HPN) are lacking as the use of HPN in this population remains a controversial issue. Therefore, the aims of this study were to rank treatment recommendations and main outcome indicators to ensure high-quality care and to indicate differences in care concerning benign versus malignant patients. METHODS: Treatment recommendations, identified from published guidelines, were used as a starting point for a two-round Delphi approach. Comments and additional interventions proposed in the first round were reevaluated in the second round. Ordinal logistic regression with SPSS 2.0 was used to identify differences in care concerning benign versus malignant patients. RESULTS: Twenty-seven experts from five European countries completed two Delphi rounds. After the second Delphi round, the top three most important outcome indicators were (1) quality of life (QoL), (2) incidence of hospital readmission and (3) incidence of catheter-related infections. Forty-two interventions were considered as important for quality of care (28/42 based on published guidelines; 14/42 newly suggested by Delphi panel). The topics 'Liver disease' and 'Metabolic bone disease' were considered less important for cancer patients, together with use of infusion pumps (p = 0.004) and monitoring of vitamins and trace elements (p = 0.000). Monitoring of QoL is considered more important for cancer patients (p = 0.03). CONCLUSION: Using a two-round Delphi approach, we developed a minimal set of 42 interventions that may be used to determine quality of care in HPN patients with malignancies. This set of interventions differs from a similar set developed for benign patients.

Guidelines recommendations on care of adult patients receiving home parenteral nutrition: a systematic review of global practices.

BACKGROUND & AIMS: Because home parenteral nutrition (HPN) in adult patients can give rise to a variety of complications, good guidance is necessary. To achieve this, clarity and consistency in guidelines are essential. The aim of this review is to identify and compare evidence-based guidelines, and to compile a list of main recommendations, according to their evidence-based grade. METHODS: We searched Medline and the international guideline database for HPN guidelines, performed a content analysis of retrieved guidelines, and evaluated their quality. We then compiled a comparative table of guideline recommendations along with their assigned level of evidence. SUMMARY OF RESULTS: Six systematically developed evidence-based guidelines and one expert opinion-based standard for home care were retrieved. Of these guidelines, two were exclusively devoted to HPN. Although the guidelines generally covered the same topics, most did not provide information on intravenous medication, bone metabolic disease, and indications in patients with malignant disease. Moreover, we found grading discrepancies among various guidelines, as identical recommendations were often labeled with different grades. CONCLUSION: Our comparison of guidelines and standards for HPN revealed substantial differences among recommendations. Identification of these discrepancies and omissions should facilitate the development of more comprehensive and better justified guidelines in the future.