Guidance for assessment of the inflammation etiologic criterion for the GLIM diagnosis of malnutrition: A modified Delphi approach.

BACKGROUND & AIMS: The Global Leadership Initiative on Malnutrition (GLIM) approach to malnutrition diagnosis is based on assessment of three phenotypic (weight loss, low body mass index, and reduced skeletal muscle mass) and two etiologic (reduced food intake/assimilation and disease burden/inflammation) criteria, with diagnosis confirmed by fulfillment of any combination of at least one phenotypic and at least one etiologic criterion. The original GLIM description provided limited guidance regarding assessment of inflammation and this has been a factor impeding further implementation of the GLIM criteria. We now seek to provide practical guidance for assessment of inflammation in support of the etiologic criterion for inflammation. METHODS: A GLIM-constituted working group with 36 participants developed consensus-based guidance through a modified-Delphi review. A multi-round review and revision process served to develop seven guidance statements. RESULTS: The final round of review was highly favorable with 99 % overall "agree" or "strongly agree" responses. The presence of acute or chronic disease, infection or injury that is usually associated with inflammatory activity may be used to fulfill the GLIM disease burden/inflammation criterion, without the need for laboratory confirmation. However, we recommend that recognition of underlying medical conditions commonly associated with inflammation be supported by C-reactive protein (CRP) measurements when the contribution of inflammatory components is uncertain. Interpretation of CRP requires that consideration be given to the method, reference values, and units (mg/dL or mg/L) for the clinical laboratory that is being used. CONCLUSION: Confirmation of inflammation should be guided by clinical judgement based upon underlying diagnosis or condition, clinical signs, or CRP.

Guidance for assessment of the inflammation etiologic criterion for the GLIM diagnosis of malnutrition: A modified Delphi approach.

BACKGROUND: The Global Leadership Initiative on Malnutrition (GLIM) approach to malnutrition diagnosis is based on assessment of three phenotypic (weight loss, low body mass index, and reduced skeletal muscle mass) and two etiologic (reduced food intake/assimilation and disease burden/inflammation) criteria, with diagnosis confirmed by fulfillment of any combination of at least one phenotypic and at least one etiologic criterion. The original GLIM description provided limited guidance regarding assessment of inflammation, and this has been a factor impeding further implementation of the GLIM criteria. We now seek to provide practical guidance for assessment of inflammation. METHODS: A GLIM-constituted working group with 36 participants developed consensus-based guidance through a modified Delphi review. A multiround review and revision process served to develop seven guidance statements. RESULTS: The final round of review was highly favorable, with 99% overall "agree" or "strongly agree" responses. The presence of acute or chronic disease, infection, or injury that is usually associated with inflammatory activity may be used to fulfill the GLIM disease burden/inflammation criterion, without the need for laboratory confirmation. However, we recommend that recognition of underlying medical conditions commonly associated with inflammation be supported by C-reactive protein (CRP) measurements when the contribution of inflammatory components is uncertain. Interpretation of CRP requires that consideration be given to the method, reference values, and units (milligrams per deciliter or milligram per liter) for the clinical laboratory that is being used. CONCLUSION: Confirmation of inflammation should be guided by clinical judgment based on underlying diagnosis or condition, clinical signs, or CRP.

Comparison between self-reported and actigraphy-derived sleep measures in patients receiving home parenteral nutrition: Secondary analysis of observational data.

BACKGROUND: Patients receiving home parenteral nutrition (HPN) frequently report disrupted sleep. However, there are often inconsistencies between objectively measured and questionnaire-derived sleep measures. We compared sleep measures estimated from wrist actigraphy and self-report in adults receiving HPN. METHODS: In this secondary analysis, we pooled data from two sleep-related studies enrolling adults receiving habitual HPN. We compared measures from 7-day averages of wrist actigraphy against comparable responses to a sleep questionnaire. Sleep measures included bedtime, wake time, time in bed, total sleep time, and sleep onset latency (SOL). Spearman correlation coefficients, Bland-Altman plots, and linear regression models for each set of sleep measures provided estimates of agreement. RESULTS: Participants (N = 35) had a mean age of 52 years, body mass index of 21.6 kg/m2 , and 77% identified as female. Correlation coefficients ranged from 0.35 to 0.90, were highest for wake time (r = 0.90) and bedtime (r = 0.74), and lowest for total sleep time (r = 0.35). Actigraphy overestimated self-reported bedtime, wake time, and total sleep time and underestimated self-reported time in bed and SOL. Regression coefficients indicated the highest calibration for bedtime and wake time and lower calibration for time in bed, total sleep time, and SOL. CONCLUSION: We observed strong-to-moderate agreement between sleep measures derived from wrist actigraphy and self-report in adults receiving HPN. Weaker correlations for total sleep time and SOL may indicate low wrist actigraphy sensitivity. Low-quality sleep resulting from sleep disruptions may have also contributed to an underreporting of perceived sleep quantity and lower concordance.

Glycemic and sleep effects of daytime compared with those of overnight infusions of home parenteral nutrition in adults with short bowel syndrome: A quasi-experimental pilot trial.

BACKGROUND: Patients with short bowel syndrome (SBS) dependent on home parenteral nutrition (HPN) commonly cycle infusions overnight, likely contributing to circadian misalignment and sleep disruption. METHODS: The objective of this quasi-experimental, single-arm, controlled, pilot trial was to examine the feasibility, safety, and efficacy of daytime infusions of HPN in adults with SBS without diabetes. Enrolled patients were fitted with a continuous glucose monitor and wrist actigraph and were instructed to cycle their infusions overnight for 1 wk, followed by daytime for another week. The 24-h average blood glucose, the time spent >140 mg/dL or <70 mg/dL, and sleep fragmentation were derived for each week and compared using Wilcoxon signed-rank test. Patient-reported quality-of-life outcomes were also compared between the weeks. RESULTS: Twenty patients (mean age, 51.7 y; 75% female; mean body mass index, 21.5 kg/m2) completed the trial. Overnight infusions started at 21:00 and daytime infusions at 09:00. No serious adverse events were noted. There were no differences in 24-h glycemia (daytime-median: 93.00 mg/dL; 95% CI: 87.7-99.9 mg/dL, compared with overnight-median: 91.1 mg/dL; 95% CI: 89.6-99.0 mg/dL; P = 0.922). During the day hours (09:00-21:00), the mean glucose concentrations were 13.5 (5.7-22.0) mg/dL higher, and the time spent <70 mg/dL was 15.0 (-170.0, 22.5) min lower with daytime than with overnight HPN. Conversely, during the night hours (21:00-09:00), the glucose concentrations were 16.6 (-23.1, -2.2) mg/dL lower with daytime than with overnight HPN. There were no differences in actigraphy-derived measures of sleep and activity rhythms; however, sleep timing was later, and light at night exposure was lower with daytime than with overnight HPN. Patients reported less sleep disruptions due to urination and fewer episodes of uncontrollable diarrhea or ostomy output with daytime HPN. CONCLUSIONS: Daytime HPN was feasible and safe in adults with SBS and, compared with overnight HPN, improved subjective sleep without increasing 24-h glucose concentrations. This trial was registered at clinicaltrials.gov as NCT04743960 (https://classic. CLINICALTRIALS: gov/ct2/show/NCT04743960).

Amplifying the lived experiences of parenteral nutrition consumers through the thematic analysis of social media posts.

BACKGROUND: Consumers of parenteral nutrition (PN) and their caregivers use social media to seek advice and support from their peers and to share experiences. We aimed to leverage posts from a social media patient community to identify common lived experiences of consumers of PN to prioritize opportunities for support through advocacy, education, and research. METHODS: Anonymous posts with high engagement were collected over 4 months from a PN-focused social media support group platform. No personal information was collected or analyzed. Post content was reviewed for demographic characteristics. Thematic analysis involved inductive coding to identify content-based keywords. Keywords were then used to form major themes and subthemes that were then quantified by post counts. RESULTS: A total of 306 social media posts were analyzed. Most were from adult PN consumers (80.4%) and pertained to home-based PN (82%). Equivalent number of posts (5%) were from new consumers and those who had not yet started or restarting PN. The analysis revealed 12 major themes with 2-11 subthemes each, spanning medical, nutrition, emotional, and social aspects. The most prevalent theme was "Best practices, care, and safety of PN use" (36.9%), covering posts seeking guidance on line care, personal hygiene, equipment use, and vascular access devices. Others included "Symptoms" (23.9%) and "Patient safety concerns of PN handling by healthcare providers" (16.0%). CONCLUSIONS: The identified themes provide a broader understanding of contemporary shared lived experiences and concerns relevant to PN consumers and their caregivers. Given the evolving nature of daily stressors, periodic reanalysis may be necessary.

Infusion timing and sleep habits of adults receiving home parenteral and enteral nutrition: A patient-oriented survey study.

BACKGROUND: The emerging field of chrononutrition investigates the effects of the timing of nutritional intake on human physiology and disease pathology. It remains largely unknown when patients receiving home nutrition support routinely administer home parenteral nutrition (HPN) and/or home enteral nutrition (HEN). METHODS: The present descriptive study included data collected from a patient-oriented survey designed to assess the timing of infusions and sleep habits of patients receiving HPN and HEN in the United States. RESULTS: A total of 100 patients were included. Patients had a mean age of 44.1 years and 81% were female. Among 73 patients supported with HPN and 27 patients supported with HEN, 86% and 44% reported overnight infusions, respectively. The median start and end times of overnight infusions were 2100 (interquartile range [IQR] = 1900-2200) and 0800 (IQR = 0700-1000), respectively, for HPN and 2000 (IQR = 1845-2137) and 0845 (IQR = 0723-1000), respectively, for HEN. Overnight infusions started 2.0 h (IQR = 1.1-3.0) and 2.0 h (IQR = 0.6-3.3) before bedtime for HPN and HEN, respectively, and stopped 12.9 min (IQR = -21.3 to 29.1) and 30.0 min (IQR = -17.1 to 79.3) after wake time for HPN and HEN, respectively. Sleep disruption because of nutrition support or urination was most common among patients receiving infusions overnight compared with those receiving infusions continuously or during the daytime. CONCLUSIONS: Our survey study focusing on a novel and medically relevant dimension of nutrition found that most HPN-dependent and HEN-dependent patients receive infusions overnight while asleep. Our findings suggest that overnight infusions coinciding with sleep may result in sleep and circadian disruption.

Sleep patterns of patients receiving home parenteral nutrition: A home-based observational study.

BACKGROUND: Patients supported with home parenteral nutrition (HPN) often report poor sleep; however, limited research has been conducted to objectively measure sleep patterns of HPN-dependent patients. METHODS: We aimed to characterize the sleep patterns of patients receiving HPN through 7-day actigraphy in a home-based observational study. Sleep measures of clinical importance were derived from actigraphy, including sleep duration, sleep efficiency, sleep onset latency, and wake after sleep onset. Participants also completed validated sleep surveys. RESULTS: Twenty participants completed all study procedures (mean [SD]: age = 51.6 [13.9] years, body mass index = 21.4 [4.6], and 80% female). The population median (IQR) for sleep duration, sleep efficiency, sleep onset latency, and wake after sleep onset was 6.9 (1.1) h, 83.3% (7.8%), 11.8 (7.1) min, and 57.2 (39.9) min, respectively, and 55%, 60%, 35%, and 100% of participants did not meet the recommendations for these measures from the National Sleep Foundation. Sixty-five percent of participants reported napping at least once during the 7-day period. Based on the Insomnia Severity Index, 70% of participants were classified as having subthreshold or more severe insomnia. Based on the Pittsburgh Sleep Quality Index, 85% were classified as having significant sleep disturbance. CONCLUSION: Most HPN-dependent patients likely have disrupted sleep largely driven by difficulty maintaining sleep. The extent to which HPN contributed to poor sleep cannot be elucidated from this observational study. Addressing known factors that contribute to sleep disruption and considering sleep interventions may improve the overall quality of life of patients receiving HPN.

Learn Intestinal Failure Tele-ECHO Project: An innovative online telementoring and case-based learning clinic.

Intestinal failure (IF) is a rare chronic disease requiring intravenous (IV) fluids or parenteral nutrition (PN) dependency for optimal patient health and sustenance. The complex care is best managed by specialized multidisciplinary teams. Patients who have limited access to intestinal rehabilitation centers often receive IV/PN care from clinicians lacking specialty expertise. An innovative videoconferencing project was launched in May 2019 to provide online telementoring and case-based learning in IF. The Extension for Community Healthcare Outcomes (ECHO) model was adopted to provide education and virtual support via the Learn Intestinal Failure Tele-ECHO (LIFT-ECHO) project. Online clinics include patient case presentations, moderated discussion, best-practice recommendations, and didactic continuing education lectures on IF- and PN-related topics. Participation is interprofessional and international. Via knowledge dissemination and specialty mentorship, LIFT-ECHO is expected to improve healthcare for patients with IF and transform care delivery by overcoming the limitations in access to expertise.

Clinical Nutrition Research and the COVID-19 Pandemic: A Scoping Review of the ASPEN COVID-19 Task Force on Nutrition Research.

The purpose of this scoping review by the American Society for Parenteral and Enteral Nutrition (ASPEN) Coronavirus Disease 2019 (COVID-19) Nutrition Task Force was to examine nutrition research applicable to the COVID-19 pandemic. The rapid pace of emerging scientific information has prompted this activity to discover research/knowledge gaps. This methodology adhered with recommendations from the Joanna Briggs Institute. There were 2301 citations imported. Of these, there were 439 articles fully abstracted, with 23 main topic areas identified across 24 article types and sourced across 61 countries and 51 specialties in 8 settings and among 14 populations. Epidemiological/mechanistic relationships between nutrition and COVID-19 were reviewed and results mapped to the Population, Intervention, Comparator, Outcome, and Time (PICO-T) questions. The aggregated data were analyzed by clinical stage: pre-COVID-19, acute COVID-19, and chronic/post-COVID-19. Research gaps were discovered for all PICO-T questions. Nutrition topics meriting urgent research included food insecurity/societal infrastructure and transcultural factors (pre-COVID-19); cardiometabolic-based chronic disease, pediatrics, nutrition support, and hospital infrastructure (acute COVID-19); registered dietitian nutritionist counseling (chronic/post-COVID-19); and malnutrition and management (all stages). The paucity of randomized controlled trials (RCTs) was particularly glaring. Knowledge gaps were discovered for PICO-T questions on pediatrics, micronutrients, bariatric surgery, and transcultural factors (pre-COVID-19); enteral nutrition, protein-energy requirements, and glycemic control with nutrition (acute COVID-19); and home enteral and parenteral nutrition support (chronic/post-COVID-19). In conclusion, multiple critical areas for urgent nutrition research were identified, particularly using RCT design, to improve nutrition care for patients before, during, and after COVID-19.

Home Parenteral Nutrition Patient-Reported Outcome Questionnaire: Sensitive to Quality of Life Differences Among Chronic and Prolonged Acute Intestinal Failure Patients.

BACKGROUND: Patient-reported outcome (PRO) measures often address quality of life (QOL) and help improve communication and shared decision-making. The home parenteral nutrition patient-reported outcome questionnaire (HPN-PROQ) was developed for patients to self-assess factors that influence QOL. The aim of this study was to establish construct validity. METHOD: Responses were analyzed for 77 HPN-dependent patients with chronic and prolonged acute intestinal failure. General linear modeling was conducted to describe patterns of interactions and association between items included in the HPN-PROQ. RESULTS: Most patients (78%) had chronic intestinal failure. Mean HPN duration was 3.3 ± 0.6 years. Underlying illness had a moderate or major effect on QOL for 88%; 59% reported their QOL had been negatively impacted by HPN. There was no difference in QOL among chronic patients, depending on how important they rated "being able to do what I want to do" (P = .1), whereas prolonged acute intestinal failure patients had significantly lower QOL if they rated "being able to do what I want to do" extremely vs very important (adjusted P = .02). Confidence with ability to perform HPN procedures was associated with understanding the need for HPN (P < .01). As ratings increased for emotional difficulty in coping with HPN so did HPN impact on QOL (linear trend P < .01). CONCLUSION: Construct validity of the HPN-PROQ was evident. The HPN-PROQ considers the unique experience of living with a complex nutrition therapy.

[ASPEN-FELANPE Clinical Guidelines: Nutrition Support of Adult Patients with Enterocutaneous Fistula]. / Guías Clínicas ASPEN-FELANPE: Terapia Nutricional en Pacientes Adultos con Fístulas Enterocutáneas.

INTRODUCTION: Background: the management of patients with enterocutaneous fistula (ECF) requires an interdisciplinary approach and poses a significant challenge to surgeons, gastroenterologists, intensivists, wound/stoma care specialists, and nutrition support clinicians. Available guidelines for optimizing nutritional status in these patients are often vague, based on limited and dated clinical studies, and typically rely on individual or institutional experience. Specific nutrient requirements, appropriate route of feeding, role of immune-enhancing nutrients, and use of somatostatin analogs in the management of patients with ECF remain a challenge for the clinician. The purpose of this clinical guideline is to develop recommendations for the nutritional care of adult patients with ECF. Methods: a systematic review of the best available evidence to answer a series of questions regarding clinical management of adults with ECF was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. An anonymous consensus process was used to develop the clinical guideline recommendations prior to peer review and approval by the A.S.P.E.N. and FELANPE Board of Directors. Questions: in adult patients with enterocutaneous fistula: 1) What factors best describe nutritional status? 2) What is the preferred route of nutritional therapy (oral diet, EN or PN)? 3) What protein and energy intake provide best clinical outcomes? 4) Is fistuloclysis associated with better outcomes than standard care? 5) Are immune-enhancing nutrients associated with better outcomes? 6) Does the use of somatostatin provide better outcomes than standard medical therapy? 7) When is home parenteral nutrition support indicated?

INTRODUCCIÓN: Introducción: el manejo de las fístulas enterocutáneas (FEC) es un reto que requiere enfoque interdisciplinario y plantea un desafío importante. Las guías para optimizar el estado nutricional en estos pacientes están basadas en estudios que dependen de la experiencia individual y, ocasionalmente, institucional; que se focalizan en el tratamiento integral de las FEC, centrándose en el manejo médico y quirúrgico, mientras que la terapia nutricional se revisa solo superficialmente. Los requerimientos nutricionales, vía de administración, uso de inmunonutrición y de análogos de la somatostatina en el tratamiento de estos pacientes no están bien definidos. El objetivo de esta guía es desarrollar recomendaciones específicas para la terapia nutricional de los pacientes adultos con FEC. Método: revisión sistemática de la mejor evidencia disponible para responder a una serie de preguntas sobre la terapia nutricional de los adultos con FEC, evaluada utilizando la metodología GRADE. Se utilizó un proceso de consenso anónimo para desarrollar las recomendaciones de la guía clínica antes de la revisión por pares y la aprobación por las Juntas Directivas de ASPEN y FELANPE. Preguntas: 1) ¿Qué factores describen mejor el estado nutricional de los adultos con FEC? 2) ¿Cuál es la mejor vía para administrar la terapia nutricional (oral, nutrición enteral o parenteral)? 3) ¿Qué aporte energético y proteico proporciona mejores resultados clínicos? 4) ¿El uso de la fistuloclisis se asocia a mejores resultados? 5) ¿Las fórmulas inmunomoduladoras se asocian a mejores resultados? 6) ¿El uso de la somatostatina proporciona mejores resultados? 7) ¿Cuándo está indicada la terapia nutricional parenteral domiciliaria?

Guías Clínicas ASPEN-FELANPE: Terapia Nutricional en Pacientes Adultos con Fístulas Enterocutáneas / ASPEN-FELANPE Clinical Guidelines: Nutrition Support of Adult Patients with Enterocutaneous Fistula

INTRODUCCIÓN: el manejo de las fístulas enterocutáneas (FEC) es un reto que requiere un enfoque interdisciplinario y plantea un desafío importante. Las guías para optimizar el estado nutricional en estos pacientes están basadas en estudios que dependen de la experiencia individual y, ocasionalmente, institucional; que se focalizan en el tratamiento integral de las FEC, centrándose en el manejo médico y quirúrgico, mientras que la terapia nutricional se revisa solo superficialmente. Los requerimientos nutricionales, la vía de administración, el uso de inmunonutrición y el de análogos de la somatostatina en el tratamiento de estos pacientes no están bien definidos. El objetivo de esta guía clínica es desarrollar recomendaciones específicas para la terapia nutricional de los pacientes adultos con FEC. MÉTODO: revisión sistemática de la mejor evidencia disponible para responder a una serie de preguntas sobre la terapia nutricional de los adultos con FEC, evaluada utilizando la metodología GRADE. Se utilizó un proceso de consenso anónimo para desarrollar las recomendaciones de la guía clínica antes de la revisión por pares y la aprobación por las Juntas Directivas de ASPEN y FELANPE. Preguntas: 1) ¿Qué factores describen mejor el estado nutricional de los adultos con FEC? 2) ¿Cuál es la mejor vía para administrar la terapia nutricional (oral, nutrición enteral o parenteral)? 3) ¿Qué aporte energético y proteico proporciona mejores resultados clínicos? 4) ¿El uso de la fistuloclisis se asocia a mejores resultados? 5) ¿Las fórmulas inmunomoduladoras se asocian a mejores resultados? 6) ¿El uso de la somatostatina proporciona mejores resultados? 7) ¿Cuándo está indicada la terapia nutricional parenteral domiciliaria?

BACKGROUND: the management of patients with enterocutaneous fistula (ECF) requires an interdisciplinary approach and poses a significant challenge to surgeons, gastroenterologists, intensivists, wound/stoma care specialists, and nutrition support clinicians. Available guidelines for optimizing nutritional status in these patients are often vague, based on limited and dated clinical studies, and typically rely on individual or institutional experience. Specific nutrient requirements, appropriate route of feeding, role of immune-enhancing nutrients, and use of somatostatin analogs in the management of patients with ECF remain a challenge for the clinician. The purpose of this clinical guideline is to develop recommendations for the nutritional care of adult patients with ECF. METHODS: a systematic review of the best available evidence to answer a series of questions regarding clinical management of adults with ECF was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. An anonymous consensus process was used to develop the clinical guideline recommendations prior to peer review and approval by the A.S.P.E.N. and FELANPE Board of Directors. Questions: in adult patients with enterocutaneous fistula: 1) What factors best describe nutritional status? 2) What is the preferred route of nutritional therapy (oral diet, EN or PN)? 3) What protein and energy intake provide best clinical outcomes? 4) Is fistuloclysis associated with better outcomes than standard care? 5) Are immune-enhancing nutrients associated with better outcomes? 6) Does the use of somatostatin provide better outcomes than standard medical therapy? 7) When is home parenteral nutrition support indicated?

Nutrition Management of Home Parenteral Nutrition Among Patients With Enterocutaneous Fistula in the Sustain Registry.

BACKGROUND: Home parenteral nutrition (HPN) is a vital therapy for patients who have the diagnosis of enterocutaneous fistula (ECF), yet little is known about how these patients are managed. This research compares nutrition management of adults with ECF as the indication for HPN therapy to those with other indications. METHODS: This is an analysis of data from adult HPN patients in the Sustain registry enrolled between August 2011 and February 2014 who have the diagnosis of ECF or other indication for HPN who served as the control group. Differences between the ECF and control group were assessed by t test, analysis of variance, or χ2 as appropriate. RESULTS: There were 141 HPN patients with ECF and 632 control patients. Patients with ECF were older (55 vs 50 years, P < .001), more frequently had a goal for future surgery (30% vs 15%, P = .010), had greater prevalence of overweight/obesity (33% vs 20%, P = .04), and had a lower serum albumin (2.98 ± 0.65 g/dL vs 3.16 ± 0.66 g/dL, P = .006) than controls. The diet order was more frequently nil per os (NPO) in patients with ECF (48% vs 22%, P < .001), and amino acid content of HPN was greater (111.90 ± 29.11 vs 102.06 ± 27.84, P < .001) than in controls. There were no differences in patterns of weight change by ECF or control groups, although underweight patients gained, normal-weight patients maintained, and overweight/obese patients lost weight and serum albumin increased similarly. CONCLUSIONS: The HPN management of patients with ECF is similar to other HPN patients other than greater provision of protein, more frequent NPO status, and a goal for future surgery.

Content Validation of a Home Parenteral Nutrition-Patient-Reported Outcome Questionnaire.

BACKGROUND: Patient-reported outcome (PRO) instruments collect information from patients about health conditions and disease management, including quality of life (QOL). Clinicians acknowledge patient concerns about QOL but need guidance to assess the nature and severity of individually experienced problems. The Home Parenteral Nutrition (HPN)-Patient-Reported Outcome Questionnaire (PROQ) was developed for use during medical appointments or homecare visits to address this gap. The purpose of this research was to provide evidence that the HPN-PROQ items and scale possess content validity. METHODS: A mixed-method study design was used. In phase 1, cognitive interviews (CIs) were conducted with 32 HPN patients. Thematic analysis was used to assess participant understanding of the instructions, items, and response scales and overall utility of the HPN-PROQ. In phase 2, 13 expert clinicians evaluated the relevance of items to the HPN population using the Content Validity Index (CVI) to produce item-level (I-CVI) and scale-level (S-CVI) scores. Items with an I-CVI score ≥0.783 were retained. RESULTS: Fifty-four percent of items were deemed as being comprehensible, acceptable, and clear; 25% were revised; and 11% were deleted. In phase 2, 79% of items were rated highly relevant. The S-CVI score was 0.96. The final HPN-PROQ contains 34 items. CONCLUSION: This study established acceptable content validity of the HPN-PROQ. This PROQ may help foster patient-clinician communication about lifestyle adaptation and QOL.

ASPEN-FELANPE Clinical Guidelines.

BACKGROUND: The management of patients with enterocutaneous fistula (ECF) requires an interdisciplinary approach and poses a significant challenge to physicians, wound/stoma care specialists, dietitians, pharmacists, and other nutrition clinicians. Guidelines for optimizing nutrition status in these patients are often vague, based on limited and dated clinical studies, and typically rely on individual institutional or clinician experience. Specific nutrient requirements, appropriate route of feeding, role of immune-enhancing formulas, and use of somatostatin analogues in the management of patients with ECF are not well defined. The purpose of this clinical guideline is to develop recommendations for the nutrition care of adult patients with ECF. METHODS: A systematic review of the best available evidence to answer a series of questions regarding clinical management of adults with ECF was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group. An anonymous consensus process was used to develop the clinical guideline recommendations prior to peer review and approval by the ASPEN Board of Directors and by FELANPE. QUESTIONS: In adult patients with enterocutaneous fistula: (1) What factors best describe nutrition status? (2) What is the preferred route of nutrition therapy (oral diet, enteral nutrition, or parenteral nutrition)? (3) What protein and energy intake provide best clinical outcomes? (4) Is fistuloclysis associated with better outcomes than standard care? (5) Are immune-enhancing formulas associated with better outcomes than standard formulas? (6) Does the use of somatostatin or somatostatin analogue provide better outcomes than standard medical therapy? (7) When is home parenteral nutrition support indicated?

Central venous catheter infections in home parenteral nutrition patients: Outcomes from Sustain: American Society for Parenteral and Enteral Nutrition's National Patient Registry for Nutrition Care.

BACKGROUND: Home parenteral nutrition (HPN) is a high-cost, complex nutrition support therapy that requires the use of central venous catheters. Central line-associated bloodstream infections (CLABSIs) are among the most serious risks of this therapy. Sustain: American Society for Parenteral and Enteral Nutrition's National Patient Registry for Nutrition Care (Sustain registry) provides the most current and comprehensive data for studying CLABSI among a national cohort of HPN patients in the United States. This is the first Sustain registry report detailing longitudinal data on CLABSI among HPN patients. OBJECTIVE: To describe CLABSI rates for HPN patients followed in the Sustain registry from 2011-2014. METHODS: Descriptive, χ2, and t tests were used to analyze data from the Sustain registry. RESULTS: Of the 1,046 HPN patients from 29 sites across the United States, 112 (10.7%) experienced 194 CLABSI events during 223,493 days of HPN exposure, for an overall CLABSI rate of 0.87 episodes/1,000 parenteral nutrition-days. Although the majority of patients were female (59%), adult (87%), white (75%), and with private insurance or Medicare (69%), CLABSI episodes per 1,000 parenteral nutrition-days were higher for men (0.69 vs 0.38), children (1.17 vs 0.35), blacks (0.91 vs 0.41), and Medicaid recipients (1.0 vs 0.38 or 0.39). Patients with implanted ports or double-lumen catheters also had more CLABSIs than those with peripherally inserted or central catheters or single-lumen catheters. Staphylococci were the most commonly reported pathogens. These data support findings of smaller studies about CLABSI risk for children and by catheter type and identify new potential risk factors, including gender, race, and insurance type. CONCLUSIONS: Additional studies are needed to determine effective interventions that will reduce HPN-associated CLABSI.

Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry.

BACKGROUND: Home parenteral nutrition (HPN) is a vital lifesaving therapy for patients who are unable to maintain weight, fluid balance, nutrition, and functional status via oral or enteral nutrition alone. There are few current data sources describing HPN prevalence, patient demographics, or long-term outcomes in the United States. OBJECTIVE: To describe demographics and baseline characteristics of patients receiving HPN therapy. METHODS: This is a descriptive analysis of data from the first cohort of HPN patients at time of enrollment in the SustainTM Registry between August 2011 and February 2014. RESULTS: There were 1251 patients enrolled from 29 sites. Eighty-five percent of patients were adults, with a mean age of 51.3 ± 15.3 years. Fifteen percent were pediatric, with a mean age of 4.9 ± 4.9 years. For both age groups, short-bowel syndrome was the most frequently reported HPN indication (24%). Adults most commonly had a peripherally inserted central catheter (47%) or a tunneled catheter (43%) for HPN administration. In contrast, most pediatric patients (72%) had a tunneled catheter. Most patients received parenteral nutrition daily and consumed some oral nutrition. Twenty-eight percent of all patients were expected to require HPN indefinitely. CONCLUSIONS: This is the first report of descriptive data from the Sustain Registry. The data reveal important characteristics of patients receiving HPN in 29 U.S. sites.

The Impact of Long-Term Home Parenteral Nutrition on the Patient and the Family: Achieving Normalcy in Life.

Home parenteral nutrition (HPN) is a technologically complex, life-sustaining therapy for individuals who have intestinal failure. Accepting an invasive lifelong therapy like HPN is challenging for patients and their family caregivers. There is a desire to maintain a sense of normalcy in life and to carry on as usual. Using qualitative methodology, the authors explored and described the lived experience of HPN-dependent adults and identified normalization as a repeating and strong theme. Understanding how individuals adapt, cope, or experience this complex therapy provides insight into how they manage their lives in as normal a way as possible. By understanding the perspective of normalization, home infusion nurses and nutrition support clinicians can embrace caregiving strategies and tools consistent with the changing social environment in which the HPN experience is lived.