A one size vial does not fit all: An evaluation of the micronutrient status of adult patients receiving home parenteral nutrition (HPN).

BACKGROUND & AIMS: Patients with chronic intestinal failure require HPN. Previous studies have reported a high prevalence of micronutrient deficiencies. We examined the micronutrient status of our patients receiving. METHODS: We measured vitamins A, E, D, B12, Folate, Zinc, Selenium and Copper. Patients were excluded if they had undergone surgery or amendments in IV or oral micronutrient provision in the past six months. Blood samples were excluded if C-reactive protein was >15 mg/L. Univariate and multivariate analyses were performed on concentrations below normal to determine if clinical or demographic categories were significant. RESULTS: 93 samples were included (33 males:60 females). Samples were excluded due to surgery (n = 8) amendment in micronutrient provision (n = 42) or if C-reactive protein >15 mg/L (n = 18). Vitamins A, D and E were below normal in 26%, 33% and 13% of patients respectively. Lower vitamin A was more likely in patients >50 years (P = 0.02) and lower vitamin E was more likely in men (P = 0.02). No patients had low vitamin B12 or folate whereas 29% and 9% had concentrations above the normal range respectively. Zinc and selenium were below normal in 19% and 13% respectively. Patients with surgical complications were more likely to have lower zinc (P = 0.007) and selenium (P = 0.04). Lower zinc was more likely in patients with a BMI of >25 kg/m2 (P = 0.01) and those who received Additrace® ≤3 day/week (P = 0.06). DISCUSSION: Low and high concentrations were observed in our patients but clinical and demographic factors did not impact consistently on micronutrient concentrations highlighting the importance of ongoing monitoring and adequate supplementation as per ESPEN guidelines. Current micronutrient preparations may be inadequate for some patients with dependent on HPN. Our results indicate a need for a preparation with higher amounts of vitamin D.

WITHDRAWN: Usefulness of nabilone as an antiemetic in persistent vomiting due to refractory gastrointestinal disorders.

Nabilone, a synthetic analogue of delta-9-Tetrahydrocannabinol, is an agonist of cannabinoid receptors (CB-1 and CB-2) approved to treat chemotherapy-induced vomiting refractory to antiemetics. Its use in patients with refractory vomiting due to gastrointestinal dysmotility (GID) has not been reported. Our study aims are to assess nabilone usefulness and side-effects in patients with refractory vomiting due to GID. Patients prescribed nabilone at St. Mark's intestinal rehabilitation unit (January 2017 to September 2022) due to GID vomiting have been retrospectively reviewed. Descriptive analysis has been done. Variables measured: age, sex, comorbidities, antiemetics/prokinetics, enteral or parenteral nutrition, nabilone prescription, subjective symptom improvement and side-effects. Seven patients received nabilone. 5/7 (72%) were females. Median age:25 years (23-37). 3/7 (43%) had gastroparesis (1/3 related to postural orthostatic tachycardia syndrome -POTS- , 1/3 to Ehlers-Danlos' Syndrome, POTS, Crohn's Disease and adrenal insufficiency -AI- and 1/3 to sinus node ablation and AI), 2/7 (29%) had gastroparesis and intestinal dysmotility (1/2 related to POTS and 1/2 related to EDS and other connective tissue diseases) and 2/7 (29%) had intestinal dysmotility (1/2 because of polyglucosan body visceral myopathy and 1/2 to intestinal surgery). All patients had received antiemetics or prokinetics before (median of 5 drugs; 2-11). 1/7 (14%) received enteral supplements, 5/7 (72%) enteral nutrition through enteral tubes and 4/7 (57%) parenteral nutrition. 5/7 (72%) patients received 1mg of nabilone bd orally, 1/7 (14%) 2 mg bd through jejunostomy and 1/7 (14%) started nabilone at 2 mg bd orally, but had to be switched to 1 mg bd because of side-effects. The median treatment's duration was 9 days (7-35). Regarding the efficacy of nabilone, 3/7 (43%) had symptomatic improvement. In terms of side-effects 4/7 (57%) patients reported some incidence under the treatment such as headache, light-headedness, drowsiness, dizziness or hallucinations. Patients with refractory GID vomiting despite multiple anti-sickness are difficult to treat. Nabilone improved symptoms in almost half of the patients although adverse effects appeared in more than 50%. Doses higher than 1 mg bd po did not show benefit. Although our study has important limitations, nabilone might be a temporary measure in these patients. Side-effects should be taken into consideration.

Management of acute mesenteric ischaemia: Results of a worldwide survey.

BACKGROUND: Acute mesenteric ischaemia (AMI) is a condition with high mortality. This survey assesses current attitudes and practices to manage AMI worldwide. METHODS: A questionnaire survey about the practices of diagnosing and managing AMI, endorsed by several specialist societies, was sent to different medical specialists and hospitals worldwide. Data from individual health care professionals and from medical teams were collected. RESULTS: We collected 493 individual forms from 71 countries and 94 team forms from 34 countries. Almost half of respondents were surgeons, and most of the responding teams (70%) were led by surgeons. Most of the respondents indicated that diagnosis of AMI is often delayed but rarely missed. Emergency revascularisation is often considered for patients with AMI but rarely in cases of transmural ischaemia (intestinal infarction). Responses from team hospitals with a dedicated special unit (14 team forms) indicated more aggressive revascularisation. Abdominopelvic CT-scan with intravenous contrast was suggested as the most useful diagnostic test, indicated by approximately 90% of respondents. Medical history and risk factors were thought to be more important in diagnosis of AMI without transmural ischaemia, whereas for intestinal infarction, plasma lactate concentrations and surgical exploration were considered more useful. In elderly patients, a palliative approach is often chosen over extensive bowel resection. There was a large variability in anticoagulant treatment, as well as in timing of surgery to restore bowel continuity. CONCLUSIONS: Delayed diagnosis of AMI is common despite wide availability of an adequate imaging modality, i.e. CT-scan. Large variability in treatment approaches exists, indicating the need for updated guidelines. Increased awareness and knowledge of AMI may improve current practice until more robust evidence becomes available. Adherence to the existing guidelines may help in improving differences in treatment and outcomes.

United Kingdom artificial nutrition database: The changing landscape of adult home parenteral support.

BACKGROUND: The United Kingdom nutrition database monitors the changing landscape of adult home parenteral nutrition support (HPS) to inform clinicians and policy makers of the need for this life-saving treatment. METHODS: The UK database is administered by the British Association for Parenteral and Enteral Nutrition. Data for home parenteral nutrition (HPN) has been collected since 2005 and home intravenous fluids (HIVFs) since 2011. During this study the reporting of data to the database by healthcare workers has been voluntary. Data were analyzed using linear regression. RESULTS: A threefold increase of new registrations for patients receiving HPS was noted on this 10-year period, with a notable increase in the number of patients with advanced malignancy supported with HPS. Crohn's disease and short bowel syndrome were the leading causes for both HPN and HIVF use in the UK. A statistically significant increase in older (P < 0.001) and less independent patients using HPS was noted. CONCLUSION: The prevalence of HPS is steadily increasing in size with the broadening of its acceptable performance status. The launch of the Intestinal Failure Registry and mandatory registration will increase accuracy in data reporting.

Investigating the Relationship between Home Parenteral Support and Needs-Based Quality of Life in Patients with Chronic Intestinal Failure: A National Multi-Centre Longitudinal Cohort Study.

Home parenteral support (HPS) is an essential but potentially burdensome treatment that can affect quality of life (QoL). The aims of this longitudinal study were to understand whether any changes in HPS over time were associated with QoL. The Parenteral Nutrition Impact Questionnaire (PNIQ) was used, and data were collected on HPS prescribed at three time points. Data were analysed using multi-level mixed regression models presented as effect size and were adjusted for confounders. Study recruited 572 participants from 15 sites. Of these, 201 and 145 completed surveys at second and third time-points, respectively. PNIQ score was out of 20 with a higher score indicating poorer QoL. Any reduction in HPS infusions per week was associated with an improved PNIQ score of -1.10 (95% CI -2.17, -0.02) unadjusted and -1.34 (95% CI -2.45, -0.24) adjusted. Per day change to the number of infusions per week was associated with a change in the PNIQ score of 0.32 (95% CI -0.15, 0.80) unadjusted and 0.34 (95% CI -0.17, 0.85) adjusted. This is the largest national study to demonstrate improvements in QoL associated with HPS reduction over time using an HPS-specific and patient-centric tool, adding unique data for use of therapies in intestinal failure.

Gastrointestinal symptoms and nutritional issues in patients with hypermobility disorders: assessment, diagnosis and management.

Patients diagnosed with hypermobile Ehlers-Danlos syndrome and hypermobile spectrum disorders are increasingly presenting to secondary and tertiary care centres with gastrointestinal (GI) symptoms and nutritional issues. Due to the absence of specific guidance, these patients are investigated, diagnosed and managed heterogeneously, resulting in a growing concern that they are at increased risk of iatrogenic harm. This review aims to collate the evidence for the causes of GI symptoms, nutritional issues and associated conditions as well as the burden of polypharmacy in this group of patients. We also describe evidence-based strategies for management, with an emphasis on reducing the risk of iatrogenic harm and improving multidisciplinary team care.

Systematic Review: The Impact and Importance of Body Composition in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Alterations in body composition are common in inflammatory bowel disease [IBD] and have been associated with differences in patient outcomes. We sought to consolidate knowledge on the impact and importance of body composition in IBD. METHODS: We performed a systematic search of MEDLINE, EMBASE and conference proceedings by combining two key research themes: inflammatory bowel disease and body composition. RESULTS: Fifty-five studies were included in this review. Thirty-one focused on the impact of IBD on body composition with a total of 2279 patients with a mean age 38.4 years. Of these, 1071 [47%] were male. In total, 1470 [64.5%] patients had Crohn's disease and 809 [35.5%] had ulcerative colitis. Notably, fat mass and fat-free mass were reduced, and higher rates of sarcopaenia were observed in those with active IBD compared with those in clinical remission and healthy controls. Twenty-four additional studies focused on the impact of derangements in body composition on IBD outcomes. Alterations in body composition in IBD are associated with poorer prognoses including higher rates of surgical intervention, post-operative complications and reduced muscle strength. In addition, higher rates of early treatment failure and primary non-response are seen in patients with myopaenia. CONCLUSIONS: Patients with IBD have alterations in body composition parameters in active disease and clinical remission. The impacts of body composition on disease outcome and therapy are broad and require further investigation. The augmentation of body composition parameters in the clinical setting has the potential to improve IBD outcomes in the future.

Impact of home parenteral nutrition on family members: A national multi-centre cross-sectional study.

BACKGROUND & AIMS: Home parenteral nutrition (HPN) is a necessary treatment for patients with chronic, type 3, intestinal failure (IF). HPN often requires lifestyle adaptations, which are likely to affect quality of life (QoL) in both patients and family members. The aim of this study was to identify the level of burden on family members who are involved with HPN care and to understand specific factors that contribute to any burden. METHODS: Patients over the age of 18 and receiving HPN were identified in IF clinics from multiple centres across the U.K. Eligible patients were asked to complete the parenteral nutrition impact questionnaire (PNIQ) to assess their QoL, while family members were asked to complete the burden scale for family caregivers (BSFC). Logistical regression was undertaken giving adjusted odds ratios (aOR). RESULTS: 678 participants completed the survey representing 339 patients with their appointed family member. Mean PNIQ score was 11.53 (S.D. 5.5), representing a moderate impact of HPN on patients' QoL. On the BSFC scale, 23% of family members reported a moderate to very severe subjective burden indicating an increased risk of psychosomatic symptoms. After adjusting for age and gender, predictors of BSFC included: family members self-reported health status using the EuroQol visual analogue scale (aOR 19.91, 95% CI 1.69, 233.99, p = 0.017) and support received by health services (aOR = 5.83, 95% CI = 1.93, 17.56, p = 0.002). Employment status, disease type, number of nights on HPN and length of time on HPN were not associated with BSFC. CONCLUSIONS: Family members with a poor health status or lack of support by health service were more likely to have a moderate to very severe subjective burden. Tailored support from the multi-professional IF team may reduce the burden experienced by family members of people dependent on HPN.

A new palatable oral rehydration solution: A randomised controlled cross-over study in patients with a high output stoma.

BACKGROUND: Patients with a jejunostomy or high output stoma may need a glucose-sodium oral rehydration solution drink to maintain hydration. These solutions are unpalatable and a new flavoured pre-packaged solution was developed. METHODS: After 8 h of fasting, 27 patients took 500 mL of the modified World Health Organization (WHO) cholera solution or Glucodrate® (Vitaflo) on two occasions in a cross-over random order and urine and stomal output was collected for 6 h. RESULTS: There was a small but significant difference in net sodium absorption in favour of the modified WHO cholera solution (10 ± 28 mmol modified WHO cholera solution vs. -1 ± 26 mmol Glucodrate®, p = 0.01). However the Glucodrate® was more palatable, with 24 patients (89%) preferring it to the modified WHO cholera solution (p < 0.005). CONCLUSIONS: Glucodrate® is a more palatable solution than the modified WHO cholera solution and is almost as effective and so can be used when patients find the modified WHO cholera solution unpalatable.

Standardized documentation and synoptic reporting of complex intestinal anatomy in enteric fistulation and intestinal failure.

AIM: In intestinal failure, delineation of both structure and function are key to controlling symptoms and planning further intervention. We have developed a template for developing an 'anatomy at a glance' patient-specific map to aid decision making and counselling. METHOD: A core dataset was developed and used to create an editable template to demonstrate the gastrointestinal tract, its relationship to the genitourinary tract, and specific anterior abdominal wall features. This was then used to create an anatomical template, specific to each patient, and stored in the electronic patient record and imaging archive. RESULTS: We have developed a technique for integration of multi-modal information into one diagram, easily referenced by the multidisciplinary team. Radiology, endoscopy and previous operation notes can be used to fill out a core dataset, which is then transposed into a standardized template. A worked example is shown. CONCLUSION: The mapping template has been successfully integrated into practice and aided decision making at all stages of the patient's therapeutic journey. It has been found helpful in planning routes of nutrition, preoperative optimization, surgical planning, interpreting postoperative imaging and managing patient expectations.

Outcome of adult patients receiving parenteral support at home: 36 years' experience at a tertiary referral centre.

BACKGROUND AND AIMS: Patients with intestinal failure often need long-term home parenteral support (PS). We aimed to determine how the underlying diagnosis, complications and survival had changed over the last 36 years in the UK's largest IF centre. METHODS: 978 adult home PS patient records were analysed from January 1979 until October 2016. The age, sex, underlying aetiology, complications and survival was compared over 5-year periods. RESULTS: Pre-1990 to 2011-2016, numbers increased from 29 to 451, the mean age of patients increased from 31 ± 16.5 to 52 ± 17.6 years. The percentage of patients with IF due to surgical complications increased (3.4%-28.8%, p < 0.001)), while those with inflammatory bowel disease decreased (37.9%-22.6%, p < 0.001). Complication of home PS reduced: catheter related blood stream infections (CRBSI) 71.4% to 42,2%, CVC thrombosis 34.5%-5.3%. Intestinal failure associated liver disease (IFLAD) 10.3%-1.8%. Patients with dysmotility, scleroderma and a congenital aetiology had the highest incidence of CRBSI and CVC Thrombosis. Overall survival was greater pre-1995 [HR 0.2-0.4 (p = 0.02)] most likely associated with an increase in mean age. Survival for patients without malignancy was 90%, 66%, 55%, 45%, 33% and 25% at 1,5, 10, 15, 20 and 30 years respectively. Multivariate analysis demonstrated a relationship between survival and age of starting home PS; type of home PS; presence or absence of the colon in continuity; and underlying aetiology. CONCLUSION: Demand for home PS is increasing in particular for advanced malignancy, post-surgical complications and older more co-morbid patients. Complications of home PS are reducing over the last 30 years and 10-year survival for non-malignant aetiologies improving. Survival and changes in aetiology in intestinal failure.

Supporting people who have eating and drinking difficulties.

Eating and drinking are essential for maintenance of nutrition and hydration, but are also important for pleasure and social interactions. The ability to eat and drink hinges on a complex and coordinated system, resulting in significant potential for things to go wrong.The Royal College of Physicians (RCP) has published updated guidance on how to support people who have eating and drinking difficulties, particularly towards the end of life.Decisions about nutrition and hydration and when to start, continue or stop treatment are some of the most challenging to make in medical practice. The newly updated guidance aims to support healthcare professionals to work together with patients, their families and carers to make decisions around nutrition and hydration that are in the best interests of the patient. It covers the factors affecting our ability to eat and drink, strategies to support oral nutrition and hydration, techniques of clinically-assisted nutrition and hydration, and the legal and ethical framework to guide decisions about giving and withholding treatment, emphasising the two key concepts of capacity and best interests.This article aims to provide an executive summary of the guidance.

Enteral Autonomy and Days Off Parenteral Support With Teduglutide Treatment for Short Bowel Syndrome in the STEPS Trials.

BACKGROUND: Teduglutide response, in terms of parenteral support (PS) volume reduction, is associated with specific disease characteristics among adults with short bowel syndrome-associated intestinal failure (SBS-IF). Whether these associations apply to PS weaning with teduglutide is unknown. METHODS: Adults with SBS-IF treated with teduglutide in the phase III STEPS study and open-label extensions STEPS-2 and STEPS-3 were included in the analysis. Patients required PS ≥ 3 times weekly for ≥ 12 months at enrollment. The study population was stratified 3 times to create 3 distinct analysis populations based on bowel anatomy, etiology, and baseline PS volume. Outcomes included characteristics of patients who achieved PS independence and total and percentage of patients who had ≥ 1, ≥ 2, and ≥ 3 d/wk off PS at the end of STEPS, STEPS-2, and STEPS-3. RESULTS: Eight of 39 patients who received teduglutide in STEPS obtained PS independence during the STEPS study series. Patients required > 6 months of teduglutide treatment before enteral autonomy was achieved, regardless of underlying disease characteristics. Patients who attained PS independence and greater numbers of days per week off PS tended to have lower baseline PS volumes and noninflammatory bowel disease (non-IBD) etiology. Patients with ≥ 50% colon-in-continuity showed a trend for achieving greater numbers of days per week off PS. CONCLUSION: Although this analysis was limited by low patient numbers, results suggest that SBS-IF characteristics of lower baseline PS volume and non-IBD etiology were associated with PS reduction benefits with teduglutide in terms of days off per week and enteral autonomy.

Acute intestinal failure: International multicenter point-of-prevalence study.

BACKGROUND & AIMS: Intestinal failure (IF) is defined from a requirement or intravenous supplementation due to failing capacity to absorb nutrients and fluids. Acute IF is an acute, potentially reversible form of IF. We aimed to identify the prevalence, underlying causes and outcomes of acute IF. METHODS: This point-of-prevalence study included all adult patients hospitalized in acute care hospitals and receiving parenteral nutrition (PN) on a study day. The reason for PN and the mechanism of IF (if present) were documented by local investigators and reviewed by an expert panel. RESULTS: Twenty-three hospitals (19 university, 4 regional) with a total capacity of 16,356 acute care beds and 1237 intensive care unit (ICU) beds participated in this study. On the study day, 338 patients received PN (21 patients/1000 acute care beds) and 206 (13/1000) were categorized as acute IF. The categorization of reason for PN was revised in 64 cases (18.9% of total) in consensus between the expert panel and investigators. Hospital mortality of all study patients was 21.5%; the median hospital stay was 36 days. Patients with acute IF had a hospital mortality of 20.5% and median hospital stay of 38 days (P > 0.05 for both outcomes). Disordered gut motility (e.g. ileus) was the most common mechanism of acute IF, and 71.5% of patients with acute IF had undergone abdominal surgery. Duration of PN of ≥42 days was identified as being the best cut-off predicting hospital mortality within 90 days. PN ≥ 42 days, age, sepsis and ICU admission were independently associated with 90-day hospital mortality. CONCLUSIONS: Around 2% of adult patients in acute care hospitals received PN, 60% of them due to acute IF. High 90-day hospital mortality and long hospital stay were observed in patients receiving PN, whereas presence of acute IF did not additionally influence these outcomes. Duration of PN was associated with increased 90-day hospital mortality.

Survival and CT defined sarcopenia in patients with intestinal failure on home parenteral support.

BACKGROUND & AIMS: Sarcopenia occurs in patients with intestinal failure (IF) and has been associated with poorer survival in several chronic diseases. CT can measure sarcopenia through a L3 skeletal muscle index (LSMI). We aim to describe the prevalence of sarcopenia in a section of our IF population using LSMI, & evaluate the effect of home parenteral support (PS) on LSMI & survival. Additionally, we aim to assess any association between LSMI, BMI & other anthropometric measurements. METHODS: IF patients on PS treated at St Mark's Hospital between 1/1/2006-1/10/2016 were identified from a prospectively maintained database. Patients were included if they were on PS & had 2 CTs: the first ≤30 days before start of HPN (pre-PS); the second ≥100 days from PS start (post-PS). Patient records were reviewed to obtain clinical & demographic information & date of death. Anthropometric measurements & BMI contemporaneous to CT scans were recorded. RESULTS: 64 patients met inclusion criteria (M:F 1:1). 83% of our cohort had LSMI below previously published thresholds for sarcopenia. Mean (SD) pre-PS LSMI was 36.5 (6.8)cm2/m2. Mean BMI pre-PS was 22.1 (4.8) kg/m2. Both BMI (22.1 kg/m2 to 23.5 kg/m2) p < 0.001) & LSMI (36.5 cm2/m2 to 38.4 cm2/m2) (p = 0.003) increased post-PS. A positive correlation was seen between BMI & LSMI pre (r = 0.47 p < 0.001) & post-PS (r = 0.37 p = 0.003). No correlation was seen between LSMI & anthropometric measurements pre-PS (p = 0.78) or post-PS (p = 0.96). 11 (17%) patients died during the study period; a low LSMI pre-PS was not a risk factor for mortality (HR 0.97 p = 0.55). CONCLUSIONS: This study is the first to look at sarcopenia & survival using CT defined LSMI (CT-LSMI) in the IF population. 83% of our cohort had a pre-PS LSMI below previously published thresholds, yet we found no relationship between lower baseline LSMI & survival. This may reflect the heterogeneity of the prognoses of the IF population, or that parenteral nutrition itself affects survival. Our study showed that LSMI & BMI improved following PS but demonstrated that other anthropometric measurements had poor correlation with LSMI & showed no significant improvement overall after PS, confirming the known problems of inter-operator & patient variability of these measurements. Whilst we found significant correlation between LSMI & BMI, BMI significantly underestimated the presence & degree of sarcopenia. LSMI has the potential to provide an objective & reproducible measure of sarcopenia in IF. Future larger studies should be performed to evaluate associations with patient outcomes & utility in clinical decision making.

Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study.

BACKGROUND & AIMS: Disease-associated factors influence parenteral support (PS) reduction in response to teduglutide in patients with intestinal failure associated-short bowel syndrome (SBS-IF). We sought to determine correlative relationships between plasma citrulline levels, small bowel length, and PS volume. METHODS: A post hoc analysis of plasma citrulline levels from patients in the STEPS 24-week study of teduglutide in patients with SBS-IF. Plasma citrulline was assessed in all patients; patients were stratified 3 times into subgroups based on bowel anatomy, cause of SBS-IF, and baseline PS volumes. Correlation analyses used simple linear regression models. Statistical comparisons between study groups were conducted using 2-sided t tests for 2 independent mean differences. RESULTS: Baseline plasma citrulline correlated with remnant small bowel length (r = 0.355, P = 0.002), but not with baseline PS volume (r = -0.167, P = 0.14), in the overall population. There was a robust correlation between the baseline and Week 24 citrulline (r = 0.705, P < 0.0001), and an inverse correlation between change from baseline in citrulline and PS volume from baseline to Week 24 (r = -0.359, P = 0.001). In all subgroups, patients treated with teduglutide showed numerically greater increases in plasma citrulline at Week 24 compared with placebo. CONCLUSION: Baseline plasma citrulline showed significant correlations with small bowel length in patients with ≥50% colon remaining/no stoma/colon-in-continuity, and patients with SBS-IF causes other than IBD/vascular disease. Citrulline levels may correlate with PS changes in response to teduglutide and more research may reveal a relationship between citrulline levels within the heterogeneous population of patients with SBS-IF. ClinicalTrials.gov NCT00798967, ClinicalTrialsRegister.eu 2008-006193-15.

Needs-based quality of life in adults dependent on home parenteral nutrition.

BACKGROUND & AIMS: Home parenteral nutrition (HPN) provides life sustaining treatment for people with chronic intestinal failure. Individuals may require HPN for months or years and are dependent on regular intravenous infusions, usually 12-14 h overnight between 1 and 7 days each week. This regime can have adverse impact on the life of people dependent on the treatment. The aim of this study was to establish mean values for the Parenteral Nutrition Impact Questionnaire (PNIQ) and to determine the effect of disease, frequency of infusions per week and patient characteristics on quality of life of patients fed HPN. METHOD: The PNIQ was distributed to patients across nine UK HPN clinics. Data were analysed using linear regression, with PNIQ score as the dependent variable and potential confounders as independent variables. Unadjusted and adjusted models are presented. Higher PNIQ scores reflect poorer quality of life. RESULTS: Completed questionnaires were received from 466 people dependent on HPN. Mean PNIQ score was 11.04 (SD 5.79). A higher PNIQ score (effect size 0.52, CI 0.184 to 0.853) was recorded in those dependent on a higher frequency of HPN infusions per week. Respondents with cancer had a similar mean PNIQ score to those with inflammatory bowel disease (mean 10.82, SD 6.00 versus 11.04, SD 5.91). Those with surgical complications reported a poorer QoL (effect size 3.03, CI 0.642 to 5.418) and those with severe gastro-intestinal dysmotility reported a better QoL (effect size -3.03, CI -5.593 to -0.468), compared to other disease states. CONCLUSIONS: This large cohort study of quality of life in chronic intestinal failure demonstrates that HPN impacts individuals differently depending on their underlying disease. Furthermore, since the number of HPN infusions required per week is inversely related to an individual's needs-based quality of life, therapies that reduce PN burden should lead to an improvement in QoL.

Home parenteral nutrition and employment in patients with intestinal failure: Factors associated with return to employment.

BACKGROUND & AIMS: Home parenteral nutrition (HPN) is provided to patients with intestinal failure (IF). HPN can however affect the patients' quality of life and ability to remain in employment. The aim of this study was to determine the effect of HPN on employment and factors associated with the likelihood of maintaining or returning to employment while on HPN. METHODS: Patients with chronic IF were identified from a prospectively maintained IF Unit database. A structured questionnaire was designed to probe employment both before and after starting HPN, intention to work and social welfare status (benefits & pensions). RESULTS: A total of 196 (62.8% females, median age 53 years) patients participated in the study of which 184 (94%) patients were in full or part time employment before their illness. At the time of starting HPN, 102 (52%) patients had the desire to return to work with 19 (18%) and 48 (47%) patients returning to full time or part time employment respectively. Multivariate analysis demonstrated that the frequency of the HPN infusion per week (p = 0.045) and intention to work after starting HPN (p = 0.001) were significantly associated with returning to work. CONCLUSIONS: Patients on HPN can have their employment status affected. The number of days per week on HPN and the desire of the patient to return to employment are significantly associated with employment.

Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial.

BACKGROUND: Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. METHODS/DESIGN: The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. DISCUSSION: Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

Development and validation of the Parenteral Nutrition Impact Questionnaire (PNIQ), a patient-centric outcome measure for Home Parenteral Nutrition.

BACKGROUND & AIMS: Patients with Type 3 Intestinal Failure (IF) who need Home Parenteral Nutrition (HPN) face several clinical, psychological and social problems. The study was designed to produce and test the first patient-centric measure for HPN ('PNIQ: Parenteral Nutrition Impact Questionnaire'). The new measure focused on the extent to which patients were able to fulfil their human needs. METHODS: Questionnaire content was derived from the analysis of transcripts of interviews conducted with UK HPN patients. Cognitive debriefing interviews (CDIs) were performed to ensure patients found the draft scale clear, relevant and accessible. Finally, a test--retest postal validation survey was conducted to reduce the number of items in the scale and to ensure that; it was unidimensional, reproducible and had construct validity. RESULTS: The 30 interview transcripts were analysed to identify issues related to a wide range of needs. Fifteen CDIs showed that patients found the draft scale easy to complete and highly relevant. The postal survey included 233 patients on HPN recruited through two IF units. Items were rejected if they did not fit the Rasch model, had too similar content to other items or displayed differential item functioning related to age, gender or underlying mechanism of IF. A 20-item unidimensional scale was identified with high internal consistency (0.91) and test-retest reliability (0.92). Scores on PNIQ correlated moderately highly with social isolation, emotional reactions and energy level and were related to perceived interference on life of HPN. The underlying cause of IF did not influence the way the scale worked. CONCLUSIONS: The PNIQ is a scientifically rigorous, unidimensional outcome measure that provides a complete assessment of the effect of HPN on everyday life. It will prove useful for measuring patient value in clinical practice and for determining outcome in clinical trials, audit, economic evaluations and outcomes-based reimbursement.