Cost-effectiveness of taurolidine-citrate in a cohort of patients with intestinal failure receiving home parenteral nutrition.

BACKGROUND: Catheter-related bloodstream infections (CRBSIs) in patients receiving home parenteral nutrition (HPN) for chronic intestinal failure (CIF) are associated with significant morbidity and financial costs. Taurolidine is associated with a reduction in bloodstream infections, with limited information on the cost-effectiveness as the primary prevention. This study aimed to determine the cost-effectiveness of using taurolidine-citrate for the primary prevention of CRBSIs within a quaternary hospital. METHODS: All patients with CIF receiving HPN were identified between January 2015 and November 2022. Data were retrospectively collected regarding patient demographics, HPN use, CRBSI diagnosis, and use of taurolidine-citrate. The direct costs associated with CRBSI-associated admissions and taurolidine-citrate use were obtained from the coding department using a bottom-up approach. An incremental cost-effective analysis was performed, with a time horizon of 4 years, to compare the costs associated with primary and secondary prevention against the outcome of cost per infection avoided. RESULTS: Forty-four patients received HPN within this period. The CRBSI rates were 3.25 infections per 1000 catheter days before the use of taurolidine-citrate and 0.35 infections per 1000 catheter days after taurolidine-citrate use. The incremental cost-effectiveness ratio indicates primary prevention is the weakly dominant intervention, with the base case value of $27.04 per CRBSI avoided. This held with one-way sensitivity analysis. CONCLUSION: Taurolidine-citrate in the primary prevention of CRBSIs in patients with CIF receiving HPN is associated with reduced hospital costs and infection rates.

Quality of life assessment instruments in adult patients receiving home parenteral and enteral nutrition: A scoping review.

Quality of life (QoL) assessment is important to evaluate the effect of the intervention for patients treated with home parenteral and enteral nutrition (HPEN). The purpose of this scoping review is to describe, evaluate, and recommend QoL instruments used in adult patients receiving HPEN. We used the Arksey and O'Malley framework and performed literature searches in five databases (PubMed, CINAHL, EMBASE, Web of Science, and Cochrane Library) to identify possibly relevant articles that focused on QoL of adult patients receiving HPEN. Of the studies that qualify for full-text screening, two independent researchers extracted data. Twenty-seven QoL instruments were identified, consisting of seven generic instruments, 12 disease-specific instruments, and eight therapy-specific instruments. The Short Form-36 was the most widely used generic instrument and the European Organization for Research and Treatment of Cancer QLQ-C30 was the most commonly employed disease-specific instrument. The recently developed therapy-specific tools, NutriQoL and HPN-QoL, were increasingly employed in studies either alone or in combination with other types of instruments. Important aspects of each instrument were summarized to aid clinicians and researchers in selecting an appropriate instrument when measuring the QoL of adult HPEN patients. Findings could also help to identify the necessity to develop new tools or to modify pre-existing ones to measure QoL of HPEN patients.

Cost-effectiveness of Intestinal Transplantation Compared to Parenteral Nutrition in Adults.

BACKGROUND: Intestinal transplantation (ITx) is the most expensive abdominal organ transplant. Detailed studies about exact costs and cost-effectiveness compared to home parenteral nutrition (HPN) therapy in chronic intestinal failure are lacking. The aim is to provide an in-depth analysis of ITx costs and evaluate cost-effectiveness compared to HPN. METHODS: To calculate costs before and after ITx, costs were analyzed in 12 adult patients. To calculate the costs of patients with uncomplicated chronic intestinal failure, 28 adults, stable HPN patients were studied. Total costs including surgery, admissions, diagnostics, HPN therapy, medication, and ambulatory care were included. Median (range) costs are given. RESULTS: Costs before ITx were €69 160 (€60 682-90 891) in year 2, and €104 146 (€83 854-186 412) in year 1. After ITx, costs were €172 133 (€122 483-351 407) in the 1st year, €40 619 (€3905-113 154) in the 2nd year, and dropped to €15 743 (€4408-138 906) in the 3rd year. In stable HPN patients, the costs were €83 402 (€35 364-169 146) in the 1st year, €70 945 (€31 955-117 913) in the 2nd year, and stabilized to €60 242 (€29 161-238 136) in the 3rd year. CONCLUSIONS: ITx, although initially very expensive, is cost-effective compared to HPN in adults by year 4, and cost-saving by year 5.

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.

The incidence and management of complications of venous access in home parenteral nutrition (HPN): A 19 year longitudinal cohort series.

BACKGROUNDS AND AIMS: Long term central venous access for Home Parenteral Nutrition (HPN) is associated with catheter related complications. The most studied and well known of these is Catheter Related Blood Stream Infection (CRBSI). This paper looks at other venous access complications, including blocked and damaged catheters, catheter related thrombosis and CRBSI. This paper will also present treatment outcomes for each of these complications. This paper will also examine if there are any correlating patient or catheter related factors that can help predict future catheter related complications. By demonstrating the treatment outcomes for each line complication, it is hoped this will contribute to the literature that could be used for standard setting in complications related to long term central venous access. METHODS: HPN data were analysed from the Greater Glasgow and Clyde (GGC) Home Parenteral Nutrition Database (HPN) which is a comprehensive, prospectively maintained electronic record of all HPN patients treated in GGC. The time period of data collection was 1998-2017. Descriptive statistics were used to report data frequency, age, and catheter days' distributions. Data were not normally distributed and so non-parametric tests were used. Spearman's Rho correlation was used to measure correlation between two numeric groups. Catheter complications were reported as a rate in count data, meaning that more than one event could be recorded per patient, with 1000 catheter days as the person-time denominator. Poisson means test and Fisher exact tests were used to compare different rates, as complications were treated as count data increasing over variable total time periods. P < 0.05 with 95% confidence interval (CI) was considered significant in all tests. Comparisons between binary data sets used two sample t-tests to compare the groups. RESULTS: From 169 patients, 101 (59.8%) were female and 68 (40.2%) were male. The age when first starting HPN ranged from 16 to 79 years old with a median of 56 years. Total catheter days was 173,151 derived from 408 catheter insertions on 169 patients. 282 complications occurred in 85 patients over the study period. An overall catheter complication rate of 1.62/1000 days was found. 84 patients did not experience a single complication. There were 171 proven catheter infections in 66 patients over the study period. Infection rate from the entire period of report was 1.35 infections/1000 catheter days. This decreased over time. Infection was found to be correlated with length of time on HPN, catheter location, catheter diameter and use of Taurolock-Hep100. Thrombosis (n = 16) was associated with total time on HPN (r2 = 0.187, P < 0.05) and the number of infections (r2 = 0.207, P < 0.05). Damage was strongly associated with increasing time on HPN with (r2 of 0.494 and P < 0.005). Blockage was not associated with any patient or catheter factors. Overall catheter salvage rate for CRBSI by antibiotic treatment was 61.87%. Success varied according to organism cultured. Catheter salvage was less successful in other complications and overall catheter salvage rate was 41,115 catheters were salvaged from 282 complications. CONCLUSIONS: This study has provided a baseline for rates of less common venous access complications in HPN and their management. Catheter salvage is possible after at least 41% of complications. It is likely that experience is helpful whether that of individual patient, the team or a clinical network. Our results support the use of smaller central venous catheters, in upper body veins, and the use of Taurolock-Hep100 in patients who have recurrent infections.

The impact of intestinal transplantation on quality of life.

INTRODUCTION: Intestinal failure (IF) and intestinal transplant (ITx) are associated with poor quality of life (QoL). Disease-specific assessment of QoL for IF and ITx is challenging, owing to the different problems encountered. We have sought to compare QoL pre-ITx with post-ITx and have compared generic QoL with a stable IF population. METHODS: Two prospectively maintained databases of patients referred for and undergoing ITx and a chronic (Type 2 & 3) IF cohort were interrogated. QoL instruments used were generic (EQ-5D-5L and SF-36) and disease-specific (HPN-QOL and ITx-QOL). Analysis used Student's t-test and one-way ANOVA with Bonferroni correction for multiple comparisons. Data were collected pre- and post-ITx at 3, 6, 12-months and yearly thereafter. RESULTS: All QoL instruments improved following ITx to levels comparable with a cohort of stable IF patients not requiring ITx. Both the visual analogue score component (EQ-5D-5L) and the effect of underlying illness on QoL (HPN-QOL/ITx-QOL) were higher following ITx than either pre-ITx or when compared with the IF cohort. Effects on general health, ability to eat and drink, to holiday and travel were improved as early as 3 months post-ITx. Other components did not before 6-12 months following ITx, but were maintained to at least 24 months. Patient personal financial pressures are greater following ITx, even in a publicly funded healthcare system. CONCLUSION: ITx has beneficial effects on QoL compared to those assessed for or awaiting ITx. QoL following ITx is similar to patients with IF not requiring ITx. A QoL instrument that covers the journey of patients from IF through ITx would assist longitudinal analysis of the value and timing of ITx at an individual level.

A Pilot Study to Reduce Central Line-Associated Bloodstream Infections in Children From Extremely Low-Income Settings With Intestinal Failure-Meeting the Challenge.

BACKGROUND: Central line-associated bloodstream infections (CLABSIs) are major sources of morbidity, death, and healthcare costs in patients who receive home parenteral nutrition (HPN). The majority of HPN-dependent children in southern Israel reside in poor communities with substandard living conditions, which creates significant challenges for the safe provision of HPN. We developed a pilot intervention that aimed to reduce the rates of CLABSI and central venous catheter (CVC) replacements in this vulnerable population in our region. METHODS: Between 2012 and 2014, all HPN-dependent children with intestinal failure who were treated in our center, received HPN through a Hickman catheter, and experienced at least 1 previous CLABSI episode participated in the intervention. The intervention included home visits to assess the caregivers' CVC-handling technique, instillation of prophylactic ethanol lock solution, and the convening of regular multidisciplinary staff debriefings. We calculated CLABSI and CVC-replacement rates before and after the intervention. RESULTS: Eight patients who served as their own historical controls were included in the intervention (total of 2544 catheter-days during the intervention period). The mean CLABSI rate decreased from 9.62 to 0.79 CLABSI episodes per 1000 catheter-days; the CVC-replacement rate decreased from 2.5 to 1.2 replacements per 1000 catheter-days in the preintervention and intervention periods respectively. The median hospital length of stay and individual monthly cost of medical care decreased compared to those found in the preintervention period. CONCLUSIONS: The results of this study offer a proof of concept for a strategy to reduce CLABSI rates in pediatric patients who reside in remote and low-resource environments and are undergoing HPN.

Advanced liver function assessment in patients with intestinal failure on long-term parenteral nutrition.

BACKGROUND & AIMS: Intestinal failure associated liver disease (IFALD) is one of the leading complications and causes of deaths in adult patients receiving home parenteral nutrition for chronic intestinal failure (CIF). Early diagnosis of IFALD is key to alleviate the progression of hepatic dysfunction. The aim of this study was to evaluate the capability of noninvasive liver function tests. METHODS: 90 adult patients with CIF receiving long-term home parenteral nutrition were included in a prospective cross-sectional study at our department between 2014 and 2017. All participants underwent dynamic liver function assessment (maximum liver function capacity [LiMAx] test, indocyanine green [ICG] test), transient elastography (FibroScan), blood tests and comprehensive nutritional status assessment. Univariate and multivariable analysis were performed to identify predictors of liver function. RESULTS: LiMAx, ICG test, and FibroScan highly correlated with standard liver function tests. Multivariable analysis identified intact ileum (B = 520.895; p = 0.010), digestive anatomy type 3 (B = 75.612; p = 0.025), citrulline level (B = 3.428; p = 0.040), parenteral olive oil intake (B = -0.570; p = 0.043), and oral intake (B = 182.227; p = 0.040) as independent risk factors affecting liver function determined by LiMAx test. ICG test and FibroScan showed no correlation with gastrointestinal and nutrition-related parameters. CONCLUSION: The LiMAx test is significantly associated with widely accepted risk factors for IFALD by multivariable analysis, whereas ICG test and FibroScan failed to show significant correlations. Liver function assessment by LiMAx test may therefore have the potential to detect alterations in liver function and identify patients at risk for the development of IFALD. Longitudinal studies are needed to investigate the impact of liver function determined by LiMAx test on long-term outcome in patients with CIF.

Home parenteral nutrition for people with inoperable malignant bowel obstruction.

BACKGROUND: People with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a tube directly into the gut) nutrition. Parenteral nutrition (PN) is the provision of macronutrients, micronutrients, electrolytes and fluid infused as an intravenous solution and provides a method for these people to receive nutrients. There are clinical and ethical arguments for and against the administration of PN to people receiving palliative care. OBJECTIVES: To assess the effectiveness of home parenteral nutrition (HPN) in improving survival and quality of life in people with inoperable MBO. SEARCH METHODS: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (Ovid), Embase (Ovid), BNI, CINAHL, Web of Science and NHS Economic Evaluation and Health Technology Assessment up to January 2018, ClinicalTrials.gov (http://clinicaltrials.gov/) and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (http://apps.who.int/trialsearch/). In addition, we handsearched included studies and used the 'Similar articles' feature on PubMed for included articles. SELECTION CRITERIA: We included any studies with more than five participants investigating HPN in people over 16 years of age with inoperable MBO. DATA COLLECTION AND ANALYSIS: We extracted the data and assessed risk of bias for each study. We entered data into Review Manager 5 and used GRADEpro to assess the quality of the evidence. MAIN RESULTS: We included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary.The evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN. AUTHORS' CONCLUSIONS: We are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.

Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition.

BACKGROUND: The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter-related bloodstream infections (CRBSIs) in home parenteral nutrition patients. AIMS: To compare the effectiveness and safety of taurolidine and saline. METHODS: This multicentre double-blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre-existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre-existing catheter group, separately. RESULTS: We randomised 105 patients, of which 102 were analysed as modified intention-to-treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009). In the pre-existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03-1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug-related adverse events were rare and generally mild. CONCLUSIONS: In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre-existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT01826526.

The active problem solving of patients dependent on home parenteral nutrition: A qualitative analysis.

BACKGROUND & AIMS: People with chronic, type 3, intestinal failure often require long-term home parenteral nutrition (HPN). People receiving HPN have frequent interactions with their healthcare, due to the need for close monitoring and due to recurrent hospital admissions. Individuals' responses to, and interactions with, their health care service provides are poorly described. We conducted a service evaluation to explore people's experiences of HPN-related healthcare interactions in order to identify how service providers can best meet the individualised needs of patients. METHODS: We interviewed ten people receiving HPN. The participants were asked about their healthcare interactions related to HPN. The data were analysed using a qualitative research method known as interpretive phenomenological analysis. This analytical approach is concerned with the meaning that people ascribe to particular events, in this case their HPN-related healthcare interactions. RESULTS: The participants in this study described a range of psychosocial problems related to their HPN healthcare interactions, including reliance, risk and restrictions. Participants' solutions to these problems included adaptation of their routine, self-guardianship and passivity. Sometimes, these solutions generated secondary problems of their own, including concerns with resource use, negative healthcare interactions and conflicts of responsibility. A range of contextual factors influenced how participants interpreted their healthcare interactions and the solutions available to them. These contextual factors included continuity of healthcare professionals, the attitude of staff, and information and knowledge about HPN. CONCLUSIONS: By attending to the individual meaning ascribed to healthcare events, and the contextual factors that surround these events, we have been able to better understand the decisions made by patients dependent on HPN. This suggests that healthcare professionals may also better understand their patients' decision making by attending to the individual meaning that patients ascribe to healthcare events and to contextual factors. We propose a model to describe the process of problem -> resolution -> problem in which participants are actively engaged.

Longitudinal Bone Mineralization Assessment in Children Treated With Long-Term Parenteral Nutrition for Severe Intestinal Failure.

BACKGROUND: Metabolic bone disease is common in children receiving home parenteral nutrition (HPN) for intestinal failure (IF). Long-term evolution of bone mass in pediatric IF is poorly documented. The aims of this study were (1) to determine the prevalence of low bone mass (LBM) in children receiving HPN for IF, (2) to evaluate the evolution of total bone mineral content (TBMC) during HPN with dual-energy x-ray absorptiometry (DXA), and (3) to identify related factors. METHODS: All children referred in our HPN center from 2004 to 2014 were eligible. Inclusion criteria were HPN dependence due to noninflammatory IF, at least 2 TBMC assessments, and HPN duration of at least 2 years at last DXA. TBMC was expressed in z score for ideal weight for height (WFH). LBM was defined by a TBMC WFH z score ≤-2 standard deviations (SD). RESULTS: A total of 175 DXAs for 31 children were performed, mean of 5.6 ± 2.9 assessments per child. The median time between first and last DXA recorded was 6.2 years (0.7-16.6). At the first DXA, 14 children (45%) had a LBM. TBMC increased by +0.1 ± 0.04 SD per year of HPN (P = .012). The risk of LBM decreased with an odds ratio of 0.9 per year of HPN (95% confidence interval, 0.92-0.99; P = .018). Lean mass z score and calcium parenteral intakes were related to the TBMC improvement. CONCLUSION: LBM is common in pediatric IF, but bone status could improve during HPN in these children.

[Clinical nutrition therapy in patients with short bowel syndrome in line with principles of personalized medicine]. / Klinikai táplálásterápia rövidbél-szindrómában a személyre szabott orvoslás elvei szerint.

Home parenteral nutrition administered in selected care centres has been financed in Hungary since January, 2013. The authors discuss diagnostic issues, treatment and nutrition therapy of short bowel syndrome patients in line with the principles of personalised medicine. The most severe form of short bowel syndrome occurs in patients having jejunostomy, whose treatment is discussed separately. The authors give a detailed overview of home parenteral feeding, its possible complications, outcomes and adaptation of the remaining bowel. They describe how their own care centre operates where they administer home parenteral nutrition to 12 patients with short bowel syndrome (5 females and 7 males aged 51.25±14.4 years). The body mass index was 19.07±5.08 kg/m2 and 20.87±3.3 kg/m2, skeletal muscle mass was 25.7±6.3 kg and 26.45±5.38 kg, and body fat mass was 14.25±8.55 kg and 11.77±2.71 kg at the start of home parenteral nutrition and presently, respectively. The underlying conditions of short bowel syndrome were tumours in 4 patients, bowel ischaemia in four patients, surgical complications in three patients, Crohn's disease in one patient, and Crohn's disease plus tumour in one patient.

Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome.

Home parenteral nutrition (HPN) provides nourishment and hydration to patients with short bowel syndrome and intestinal failure and is thus a life-sustaining therapy for these patients. However, measures of quality of life (QOL) are lower among the HPN-dependent population than among patients with other intestinal diseases who do not require HPN. Multiple factors contribute to lower QOL in HPN-dependent patients, including fears surrounding the increased risk of HPN-associated adverse events, such as catheter-related complications, parenteral nutrition-associated liver disease, and metabolic bone disease. In addition, HPN-dependent patients report impaired sleep and daytime fatigue because of pump noises, equipment alarms, and nocturia. Psychosocial burdens on families of HPN-dependent patients include decreased social activities, disrupted family relationships and friendships, and depression. These families also face imposing financial constraints, including decreased employment and large out-of-pocket expenses for insurance premiums and nonreimbursed copayments, medications, and supplies. Furthermore, HPN technology and HPN-related complications and sequelae contribute to the rapid overall increase in the costs of healthcare systems. Additionally, family caregivers provide unpaid healthcare services for patients who require HPN, often to the detriment of their own physical and mental well-being. Nonetheless, patients dependent on HPN and their caregivers often demonstrate considerable resilience and are frequently able to normalize their response to illness and disability. Interventions that may improve QOL among HPN-dependent patients and caregivers include patient education, affiliation with support groups, treatment of concomitant symptoms, and pharmacotherapies that decrease HPN requirements.

Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study.

BACKGROUND & AIMS: Short bowel syndrome (SBS)-intestinal failure (IF) patients have impaired quality of life (QoL) and suffer from the burden of malabsorption and parenteral support (PS). A phase III study demonstrated that treatment with teduglutide, a glucagon-like peptide 2 analogue, reduces PS volumes by 32% while maintaining oral fluid intake constant; placebo-treated patients had reduced PS by 21%, but oral fluid intake increased accordingly. As effects of teduglutide on QoL are unknown, they were investigated here. METHODS: QoL analyses from a double-blind, randomised Phase III study in 86 SBS-IF patients receiving teduglutide (0.05 mg/kg/day s.c.) or placebo over 24 weeks. At baseline and every 4 weeks, QoL was assessed using the validated SBS-QoL™ scale. RESULTS: PS reductions were associated with QoL improvements (ANCOVA, p = 0.0194, SBS-QoL per-protocol). Compared to baseline, teduglutide significantly improved the SBS-QoL™ total score and the score of 9 of 17 items at week 24. These changes were not significant compared to placebo. Teduglutide-treated patients with remaining small intestine >100 cm experienced more gastrointestinal adverse events (GI-AE), unfavourably affecting QoL. CONCLUSIONS: Overall, PS volume reductions were associated with improvements in SBS-QoL™ scores. The short observation period, imbalances in oral fluid intake in relation to PS reductions, large patient and effect heterogeneity and occurrence of GI-AE in a subgroup of teduglutide-treated patients may account for the inability to show statistically significant effects of teduglutide on SBS-QoL™ scores compared to placebo.

Psychometric properties of the structured Satisfaction Questionnaire with Gastrostomy Feeding (SAGA-8) for caregivers of children with gastrostomy tube nutritional support.

BACKGROUND: To analyse the psychometric properties of the structured Satisfaction Questionnaire with Gastrostomy Feeding (SAGA-8) in parents/caregivers of children with home enteral nutrition (HEN) by gastrostomy tube (GT). METHODS: Eighty-six caregivers (mothers) of paediatric patients with HEN by GT were recruited. Patients suffered from neurological disease (61.6%) and other chronic diseases. The SAGA-8 scale, a structured questionnaire to explore satisfaction with HEN by GT, and the Caregiver Burden Inventory (Zarit) were completed. The discriminating power of each of the SAGA-8 items, internal consistency and external validity were evaluated. An exploratory factor analysis and Kaiser-Meyer-Olkin (KMO) was performed as well. RESULTS: Eighty-four percent of the families expressed high satisfaction with GT feeding. All eight items of SAGA-8 gave additional information. The exploratory factor analysis revealed that a significant part of the items' variability could be explained by two independent factors: Factor 1 (direct benefit), which compiled the variables related to the perception of children's overall improvement by GT feeding; Factor 2 (indirect benefit), which grouped the variables related to a decrease in respiratory infections, feeding time and institutional support. Results from KMO (0.628) indicated the high adequacy of the items assessed in the factorial analysis. Moreover, the questionnaire presented high internal consistency (0.76), and the external validation analysis confirmed the correlation between SAGA-8 and Zarit, thereby emphasising the approptiate use of the SAGA-8 to detect carers' satisfaction. CONCLUSIONS: The SAGA-8 questionnaire has a high discriminatory power to assess the degree of satisfaction experienced by parents/caregivers of children with HEN by GT and, subsequently, the patients' wellbeing.

Home parenteral nutrition support for intestinal failure.

Home parenteral nutrition is a life-saving treatment for many patients with intestinal failure. Expert placement and care of the vascular access device reduces the incidence of access-related complications. Careful monitoring of fluid, electrolyte, and macronutrient and micronutrient status can minimize major organ dysfunction and metabolic complications. A multidisciplined, integrated nutrition support team can allow patients with intestinal failure who need home parenteral nutrition maintain a near-normal life.

Long-term nutritional assessment of patients with severe short bowel syndrome managed with home enteral nutrition and oral intake.

BACKGROUND: Parenteral nutrition (PN) is used to control the nutritional state after severe intestinal resections. Whenever possible, enteral nutrition (EN) is used to promote intestinal rehabilitation and reduce PN dependency. Our aim is to verify whether EN + oral intake (OI) in severe short bowel syndrome (SBS) surgical adult patients can maintain adequate nutritional status in the long term. METHODS: This longitudinal retrospective study included 10 patients followed for 7 post-operative years. Body mass index (BMI), percentage of involuntary loss of usual body weight (UWL), free fat mass (FFM), and fat mass (FM) composition assessed by bioelectric impedance, and laboratory tests were evaluated at 6, 12, 24, 36, 48, 60, 72, and 84 months after surgery. Energy and protein offered in HPN and at long term by HEN+ oral intake (OI), was evaluated at the same periods. The statistical model of generalized estimating equations with p < 0,05 was used. RESULTS: With long term EN + OI there was a progressive increase in the UWL, a decrease in BMI, FFM, and FM (p < 0,05). PN weaning was possible in eight patients. Infection due to central venous catheter (CVC) contamination was the most common complication (1.2 episodes CVC/patient/year). There was an increase in energy and protein intake supply provided by HEN+OI (p < 0.05). All patients survived for at least 2 years, seven for 5 years and six for 7 years of follow-up. CONCLUSIONS: In the long term SBS surgical adult patients fed with HEN+OI couldn't maintain adequate nutritional status with loss of FM and FFM.

Assessment of long chain n-3 polyunsaturated fatty acid status and clinical outcome in adults receiving home parenteral nutrition.

BACKGROUND & AIMS: Long term parenteral nutrition rarely supplies the long chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA). The aim of this study was to assess long chain n-3 PUFA status in patients receiving home parenteral nutrition (HPN). METHODS: Plasma phospholipid fatty acids were measured in 64 adult HPN patients and compared with 54 age, sex and BMI matched controls. Logistic regression analysis was used to identify factors related to plasma fatty acid fractions in the HPN patients, and to identify factors associated with the risk of clinical complications. RESULTS: Plasma phospholipid fractions of EPA, DPA and DHA were significantly lower in patients receiving HPN. Factors independently associated with low fractions included high parenteral energy provision, low parenteral lipid intake, low BMI and prolonged duration of HPN. Long chain n-3 PUFA fractions were not associated with incidence of either central venous catheter associated infection or central venous thrombosis. However, the fraction of EPA were inversely associated with plasma alkaline phosphatase concentrations. CONCLUSIONS: This study demonstrates abnormal long chain n-3 PUFA profiles in patients receiving HPN. Reduced fatty acid intake may be partly responsible. Fatty acid metabolism may also be altered.

Home parenteral and enteral nutrition.

Home parenteral and enteral nutrition (HPEN) has evolved to become a very successful, lifesaving treatment in the management of patients with intestinal and oral failure, respectively. Nevertheless, the provision of HPEN remains intrusive, expensive, and continues to be associated with significant morbidity. The management of HPEN by a nutrition support team that optimally includes an experienced clinician, nurse specialist, dietitian, and pharmacist reduces HPEN-related morbidity and may reduce costs associated with its use. Because clinical expertise in the management of patients receiving HPEN is not widely available, the referral of these patients to experienced centers for periodic assessment should be encouraged.