Vitamin Needs and Treatment for Chronic Kidney Disease Patients.

This paper summarizes the biochemistry, metabolism, and dietary needs of vitamins in patients with chronic kidney disease (CKD) and kidney transplant recipients. Evidence indicates that the dietary intake, in vivo synthesis, urinary excretion or metabolism of different vitamins may be substantially altered in kidney failure. There are discrepancies in vitamin status assessment depending on whether the assay is functional or measuring the blood vitamin level. Whether vitamin supplements should be routinely prescribed for patients with CKD is controversial. Because low dietary intake and compounds that interfere with vitamin activity are not uncommon in patients with CKD, and water-soluble vitamin supplements appear safe and not costly, the authors recommend that supplements of the water-soluble vitamins should be routinely offered to these individuals. More research is needed to assess vitamin nutrition and function and to determine the daily vitamin needs for all patients with CKD.

Academy of Nutrition and Dietetics Commentary on the Phosphorus Recommendation in the KDOQI Clinical Practice Guidelines for Nutrition in CKD: 2020 Update.

The Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Nutrition in Chronic Kidney Disease: 2020 Update recommends adjusting dietary phosphorus to maintain a serum phosphate goal for hemodialysis patients in the normal range (0.81 to 1.45 mmol/L [2.5 to 4.5 mg/dL]). This is lower than the serum phosphate goal used by many dialysis centers (0.97 to 1.78 mmol/L [3.0 and 5.5 mg/dL]). Although context and clinical judgment must always be considered when providing individualized care to patients, a guideline implementation study conducted from December 2020 to December 2022 found that, based on their documentation, registered dietitian nutritionists from two national dialysis chains are almost universally using dialysis center goals instead of the lower phosphate goal recommended by the guideline. This commentary discusses the possible barriers to implementing the Kidney Disease Outcomes Quality Initiative 2020 nutrition guideline's phosphorus recommendation and proposes a systems level approach to promote and support adoption of the recommendation. Calls to action for potential changes in clinician practices, organizational/institutional culture, and government regulations are put forth.

Predictors of nutrition care process knowledge and use among dietitians internationally.

BACKGROUND: The nutrition care process (NCP) and its associated standardised terminology (NCPT, referred to collectively as NCP/T) forms a problem-solving framework fundamental to dietetic practice. Global implementation would assist in confirming outcomes from dietetic care, but implementation rates have varied between countries. We investigated which factors predict NCP/T knowledge and use among dietetic professionals in an international cohort, aiming to understand how implementation can be strengthened. METHODS: The validated International NCP Implementation Survey was disseminated to dietitians in 10 countries via professional networks. Implementation, attitudes and knowledge of the NCP/T along with workplace and educational data were assessed. Independent predictive factors associated with higher NCP/T knowledge and use were identified using backward stepwise logistic regression. RESULTS: Data from 6149 respondents was used for this analysis. Enablers that were independent predictors of both high knowledge and frequent use of NCP/T were peer support, recommendation from national dietetic association and workplace requirements (all p < 0.001). Country of residence and working in clinical settings (p < 0.001) were demographic characteristics that were independent predictors of high knowledge and frequent use of NCP/T. A high knowledge score was an independent predictor of frequent NCP/T use (p = 0.002). CONCLUSIONS: Important modifiable enablers for NCP knowledge and use rely on organisational management. National dietetic organisations and key stakeholders such as employers are encouraged to integrate active NCP/T support in their leadership initiatives. This could take the form of policies, formalised and structured training strategies, and informatics initiatives for the integration in electronic health records.

Protocol for the IMPACT Trial: Improving Healthcare Outcomes in American Transplant Recipients Using Culturally-Tailored Novel Technology.

Kidney transplant (KT) recipients face post-transplant health issues. Immunosuppressive agents can cause hyperlipidemia, hypertension, post-transplant diabetes, and glomerulopathy. Post-transplant weight gain and decreased activity are associated with poor quality of life, sleep, and cardiometabolic outcomes. This study will test the feasibility and acceptability of a culturally tailored diet and exercise intervention for KT patients delivered immediately post-transplant using novel technology. A registered dietitian nutritionist (RDN) and physical rehabilitation therapist will examine participants' cultural background, preferences, and health-related obstacles (with consultation from the transplant team) to create an individualized exercise and meal plan. The RDN will provide medical nutrition therapy via the nutrition care process throughout the course of the intervention. The Twistle Patient Engagement Platform will be used to deliver and collect survey data, communicate with participants, and promote retention. Outcomes to be assessed include intervention feasibility and acceptability and intervention efficacy on patients' adherence, medical, quality of life, and occupational outcomes.

Evaluating the Implementation of Evidence-based Kidney Nutrition Practice Guidelines: The AUGmeNt Study Protocol.

Evidence-based nutrition practice guidelines (EBNPGs) inform registered dietitian nutritionist (RDN) care for patients with chronic kidney disease grade 5 treated by dialysis; however, there has been little evaluation of best practices for implementing EBNPGs. In this effectiveness-implementation hybrid study with a quasi-experimental design, United States RDNs in hemodialysis clinics will document initial and follow-up nutrition care for patients with chronic kidney disease grade 5 treated by dialysis using the Academy of Nutrition and Dietetics Health Informatics Infrastructure before and after being randomly assigned to a training model: (1) EBNPG knowledge training or (2) EBNPG knowledge training plus an implementation toolkit. The aims of the study include examining congruence of RDN documentation of nutrition care with the EBNPG; describing common RDN-reported EBNPG acceptability, adoption, and adaptation issues; and determining the feasibility of estimating the impact of RDN care on nutrition-related patient outcomes. The AUGmeNt study can inform effective development and implementation of future EBNPGs. Keywords: Chronic kidney diseases; medical nutrition therapy; implementation science; clinical practice guideline; nutrition care process terminology; dietitian.

Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism.

Poor nutritional status and protein-energy wasting are common among maintenance dialysis patients and associated with unfavorable outcomes. Providing foods, meal trays, snack boxes, and/or oral nutritional supplements during hemodialysis can improve nutritional status and might also reduce inflammation, enhance health-related quality of life, boost patient satisfaction, and improve survival. Potential challenges include postprandial hypotension and other hemodynamic instabilities, aspiration risk, gastrointestinal symptoms, hygiene issues, staff burden, reduced solute removal, and increased costs. Differing in-center nutrition policies exist within organizations and countries around the world. Recent studies have demonstrated clinical benefits and highlight the need to work toward clear guidelines. Meals or supplements during hemodialysis may be an effective strategy to improve nutritional status with limited reports of complications in real-world scenarios. Whereas larger multicenter randomized trials are needed, meals and supplements during hemodialysis should be considered as a part of the standard-of-care practice for patients without contraindications.

Using a web-based nutrition algorithm in hemodialysis patients.

OBJECTIVES: The purpose of this study was to test the ability of a newly developed nutrition algorithm on (1) clinical utility and (2) ability to capture patient outcomes. RESEARCH DESIGN: This was a prospective observational study, using a practice based research network structure, involving renal dietitians and hemodialysis [HD] patients. SETTING: This study took place in HD outpatient units in five different countries. SUBJECTS: Hundred chronic HD patients were included in this study. To select subjects, dietitians screened and consented patients in their facilities until 4 patients "at nutrition risk" based on the algorithm screening tool were identified. Inclusion criteria were patients aged older than 19 years, not on hospice or equivalent, able to read the informed consent and ask questions, and receiving HD. MAIN OUTCOME MEASURE: The ability of the algorithm screening tool is to identify patients at nutrition risk, to guide clinicians in logical renal-modified nutrition care process chains including follow-up on relevant parameters, and capture change in outcomes over 3 months. Statistics were performed using SPSS version 20.0 and significance was set at P < .05. RESULTS: One hundred patients on HD, enrolled by 29 dietitians, were included in this analysis. The average number of out-of-range screening parameters per patient was 3.7 (standard deviation 1.5, range 1-7), and the most prevalent risk factors were elevated parathyroid hormone (PTH; 62.8%) and low serum cholesterol (56.5%). At the initial screening step, 8 of the 14 factors led to chains with nonrandom selection patterns (by χ(2) test with P < .05). In the subsequent diagnosis step, patients diagnosed within the insufficient protein group (n = 38), increased protein intake by 0.11 g/kg/day (P = .022). In patients with a diagnosis in the high PTH group, PTH decreased by a mean of 176.85 pg/mL (n = 19, P = .011) and in those with a diagnosis in the high phosphorous group, serum phosphorous decreased by a mean of 0.91 mg/dL (n = 33, P = .006). Finally, the relative likelihood of each assessment being completed after making the related diagnosis at the previous visit compared with those for whom that diagnosis was not made was assessed, including the likelihood of a patient's protein intake assessed after a diagnosis in the insufficient protein group was made (odds ratio = 4.08, P < .05). CONCLUSIONS: This study demonstrates the clinical utility of a web-based HD-specific nutrition algorithm, including the ability to track changes in outcomes over time. There is potential for future research to use this tool and investigate the comparative impact of nutrition interventions.

SGA scores have poor correlation with serum albumin in obese hemodialysis patients: a secondary analysis.

OBJECTIVE: The objective of this study was to determine the relationship between serum albumin and the Subjective Global Assessment (SGA) in a sample of obese hemodialysis (HD) patients. DESIGN AND METHOD: Study subjects (N = 253) included patients who were categorized into well-nourished (68%, SGA score 6-7) and malnourished (score 1-5) groups, and, on the basis of the body mass index (BMI), into obese (BMI > 30 kg/m(2); 35%) and nonobese (BMI < 30 kg/m(2)). The mean baseline data (±standard deviation) were as follows: age, 63.5 ± 14.3 years; BMI, 29 ± 8 kg/m(2); and serum albumin, 3.8 ± 0.4 mg/dL (bromocresol green). The secondary analysis of data from the SGA Validation Project and Nutrition Algorithm Preliminary Report determined the relationship between the 7-point SGA and serum albumin concentrations in a sample of obese HD patients. Data were analyzed at Case Western Reserve University from a total of 253 HD patients. MAIN OUTCOME MEASURE: The SGA scores in the BMI groups were compared with serum albumin as an objective measure of nutrition and inflammation risk. RESULTS: By using analysis of variance, the obese and nonobese populations showed statistically significant differences in SGA scores (obese: P < .3468, nonobese: P < .0080) and serum albumin values (obese, P < .0943; nonobese, P < .0183) between well-nourished and malnourished groups. A multivariable nominal logistic fit was used to predict SGA group with age and gender as covariates. Serum albumin values (P < .0057) and BMI values greater than 30 (P < .0090) predicted SGA group. CONCLUSION: The secondary analysis showed that SGA does not correlate well with serum albumin; thus, it may not be a valid nutrition assessment tool among obese HD patients.

The Value of an Ecological Approach to Improve the Precision of Nutritional Assessment: Addressing Contributors and Implications of the "Multiple Burdens of Malnutrition".

Globally, children are exposed to multiple health risks associated with diet and nutrition. Rather than simply being a condition of having too much or too little food, malnutrition is more a syndrome comprising multiple burdens of coexisting and reciprocal malnutrition, infection, or other conditions. Importantly, children with such syndromes (e.g., stunting and anemia, which are neither specific nor necessarily sensitive to nutritional status) are more likely to also have irreversible functional outcomes such as poor growth, impaired immune function, or cognitive delays. The global health community has identified nutrition-related targets (e.g., Sustainable Development Goals (SDGs) and World Health Organization (WHO) Global Nutrition Targets) that, for multiple reasons, are difficult to address. Moreover, as the complexity of the global health context increases with persistent pandemics of infectious diseases and the rising prevalence of noncommunicable diseases, there is a growing appreciation that conditions selected as nutrition/health targets indeed represent syndromes for which nutritional status serves as both an input and outcome. In recognition of the impact of these combined challenges and the role of the multiple manifestations of malnutrition, we suggest an approach to nutritional assessment that is intended to improve the precision of context-specific, equitable approaches to health promotion, disease prevention, and treatment.

Completion of a Nutrition-Focused Physical Exam with hospitalized adults and pediatric patients: Secondary analysis of a prospective cohort study.

BACKGROUND: Nutrition-Focused Physical Exam (NFPE) feasibility is not well-studied. We describe registered dietitian nutritionist (RDN)-reported NFPE completion for hospitalized adult and pediatric patients overall and by assessment parameters. METHODS: Trained RDNs systematically conducted NFPEs for hospitalized adult and pediatric patients during the Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition Indicators to diagnose Malnutrition multisite cohort study (ClinicalTrials.gov: NCT03928548). RDNs reported their ability to evaluate assessment sites for subcutaneous fat and muscle loss, fluid accumulation, and micronutrient status and to complete handgrip strength (adults and children ≥6 years) and mid-upper arm circumference measurements (children). RDNs noted if they could complete the full NFPE; if not, they noted challenges. We descriptively summarized results and used multilevel logistic regression models to examine relationships between patient characteristics and NFPE completion. RESULTS: RDNs from 39 adult and 29 pediatric US hospitals conducted NFPEs for 327 adults and 214 children aged 1 month to 17.9 years. RDNs reported completing the examination for 44% (n = 145) of adults and 15% (n = 33) of children. They successfully evaluated 25 of 27 and 19 of 26 unique NFPE components in >80% of adults and children, respectively. Common reasons the full NFPE was not completed were limited mobility in adults and patient refusal in children. RDNs had lower odds of completing NFPEs in adults with lower vs higher education levels or higher vs lower nutrition complexity and in younger vs older children. CONCLUSION: RDNs evaluated NFPE components for a high proportion (>80%) of hospitalized patients.

Predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators to diagnose malnutrition tool in hospitalized adults: a cohort study.

BACKGROUND: The lack of a widely accepted, broadly validated tool for diagnosing malnutrition in hospitalized patients limits the ability to assess the integral role of nutrition as an input and outcome of health, disease, and treatment. OBJECTIVES: This study aimed to evaluate the predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (ASPEN) indicators to diagnose malnutrition (AAIM) tool and determine if it can be simplified. METHODS: A prospective cohort study was conducted from August 2019 to September 2022 with 32 hospitals in United States. At baseline, 290 adult patients were evaluated for a diagnosis of malnutrition using the AAIM tool, which assesses weight loss, inadequate energy intake, subcutaneous fat and muscle loss, edema, and hand grip strength. Healthcare outcomes were extracted from the medical record: composite incidence of emergency department (ED) visits and hospital readmissions within 90 d postdischarge; length of hospital stay (LOS); and Medicare Severity Disease Related Group (MS-DRG) relative weight (i.e., healthcare resource utilization). We used multilevel, multivariable negative binomial or generalized linear regression models to evaluate relationships between malnutrition diagnosis and healthcare outcomes. RESULTS: After adjusting for disease severity and acuity and sociodemographic characteristics, individuals diagnosed with severe malnutrition had a higher incidence rate of ED visits and hospital readmissions (incidence rate ratio: 1.89; 95% CI: 1.14, 3.13; P = 0.01), and individuals diagnosed with moderate malnutrition had a 25.2% longer LOS (95% CI: 2.0%, 53.7%; P = 0.03) and 15.1% greater healthcare resource utilization (95% CI: 1.6%, 31.9%; P = 0.03) compared with individuals with no malnutrition diagnosis. Observed relationships remained consistent when only considering malnutrition diagnoses supported by at least 2 of these indicators: weight loss, subcutaneous fat loss, muscle wasting, and inadequate energy intake. CONCLUSIONS: Findings from this multihospital study confirm the predictive validity of the original or simplified AAIM tool and support its routine use for hospitalized adult patients. This trial was registered at clinicaltrials.gov as NCT03928548 (https://classic. CLINICALTRIALS: gov/ct2/show/NCT03928548).

Advancing Nutrition and Dietetics Research in Global Food and Nutrition Security: A Roundtable Meeting Report.

Food and nutrition security remains a relevant issue globally, impacting nutritional status and other health outcomes. This is further complicated by various environmental factors that impact stable access to, availability of, and utilization of nutritious foods. Nutrition and dietetics practitioners play an important role in the identification and treatment of food and nutrition security and are also well positioned to advance research that can support food and nutrition security solutions. To address this important issue, the Academy of Nutrition and Dietetics' Council on Research convened a Global Food and Nutrition Security Research Task Force (Task Force). To leverage existing information and expertise in this area and identify the need for future evidence, the Task Force hosted a virtual roundtable with key internal and external stakeholders. This 2-day event included discussions on research gaps, potential entry points for nutrition and dietetics practitioners, and important equity considerations in the area of food and nutrition security research. The identified research gaps included the need for standardized terminology for consistent data collection, the need for validated screening and assessment tools that can be used across settings and also assess diet quality, additional translational and implementation science research, multi-sectoral and multi-pronged approaches, interdisciplinary collaboration with community partners, incorporation of research into policy development, and additional evidence on food systems approaches to target food and nutrition security. To more clearly identify the entry points for practitioners, five examples from various countries were included to identify food and nutrition security issues and how nutrition and dietetics practitioners can be involved in research to address food and nutrition security. The Task Force would like this information to inform a research agenda and be leveraged by the larger scientific community to drive future funding and research opportunities for food and nutrition professionals on this topic.

Global Leadership Initiative on Malnutrition (GLIM) for the diagnosis of malnutrition - a framework for consistent dietetic practice.

Malnutrition is an alarming and ongoing healthcare problem globally. Malnutrition has a negative impact on the individual patient, leading to poorer clinical outcomes and increased mortality, but also poses an economic burden on society. Proper identification and diagnostics are prerequisites for initiation of treatment. In 2019, the Global Leadership Initiative on Malnutrition, a consensus-based global framework to uniformly diagnose malnutrition across populations, healthcare settings, and countries was published. Identifying and treating malnutrition is an interdisciplinary team effort. Nonetheless, the nutrition and dietetics profession is specifically trained for diagnosing and treating nutrition(-related) conditions, and therefore has a key role in the interdisciplinary team in implementing the GLIM framework in clinical practice. For the nutrition and dietetics profession, GLIM offers a great opportunity for moving both the scientific and clinical knowledge of malnutrition management forward. While the GLIM framework has been extensively studied since its launch, various knowledge gaps still remain. For the nutrition and dietetics profession, these knowledge gaps mainly relate to the GLIM implementation process, to the role of GLIM in relation to the nutrition care process, and to treatment strategies for various nutrition-related conditions. In this opinion paper, we aimed to describe the rationale for implementing the GLIM framework in clinical dietetic practice, and propose a research agenda based on knowledge gaps regarding GLIM in relation to nutrition care from a dietetic point of view.

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.

Renal dietitians lack time and resources to follow the NKF KDOQI guidelines for frequency and method of diet assessment: results of a survey.

OBJECTIVE: This study was conducted to determine how often renal dietitians assess patients' diets and what methods they use to collect and analyze the data. DESIGN AND METHODS: Data were collected through an anonymous online survey. The survey was distributed to renal dietitians during the winter of 2012. SUBJECTS: Currently practicing renal dietitian members of the International Society for Renal Nutrition and Metabolism, the National Kidney Foundation Council on Renal Nutrition, the Academy of Nutrition and Dietetics Renal Practice Group, and the RenalRD listserve were invited to participate. Of 599 usable responses received, 91% worked in the United States. The main outcome measure was dietitian compliance with Kidney Disease Outcomes Quality Initiative (KDOQI) nutrition assessment guidelines. RESULTS: Most dietitians collect dietary intake data when certain laboratory results are abnormal (70%) whereas 6.5% biannually collect dietary intake data (recommended by KDOQI). The most common reasons for not collecting dietary intake data more frequently were lack of time (42%) and software (25%). Most dietitians determine the frequency of dietary intake assessment on their own (60%) whereas 10% follow the KDOQI guidelines. The most common method of dietary intake data collection was a typical day recall (50%), although 8% reported using a 3-day food record as recommended by KDOQI. The most common method for analyzing dietary intake data was "estimate in my head" (62%) followed by calculate by hand (24.5%). CONCLUSION: Renal dietitians do not follow the KDOQI guidelines for diet assessment because of time constraints. Research must explore which nutrition assessment tools may improve patient outcomes and can also be completed within the time allotted for nutrition care.

Use of the subjective global assessment to predict health-related quality of life in chronic kidney disease stage 5 patients on maintenance hemodialysis.

OBJECTIVE: The purpose of this study was to determine whether a subjective global assessment (SGA) score was predictive of health-related quality of life (HRQoL) in stage 5 chronic kidney disease patients on maintenance hemodialysis (MHD). DESIGN AND SETTING: This was a cross-sectional secondary data analysis of MHD patients receiving therapy 3 times a week at dialysis centers located in the United States, Canada, and New Zealand. Nutritional status was assessed using the 7-point SGA. HRQoL was determined using the Medical Outcomes Study 36-item Short Form (SF-36). RESULTS: The study sample consisted of 94 men (n = 47, 50%) and women (n = 47, 50%), with a mean age of 64.9 ± 12.9 years. The mean SGA score at the end point of the study (6 months) was 5.8 ± 1.1. Participants had a mean HRQoL physical health score of 36.5 ± 9.3 at 6 months, indicating a worse physical health state. The HRQoL mental health summary score was within the normal range (50.5 ± 11.1). After controlling for confounders in the hierarchical regression models, the SGA score significantly predicted HRQoL physical health (R(2) change = 0.124; P = .012). No association was found between the SGA score and HRQoL mental health (P = .925). CONCLUSIONS: The SGA score is a significant predictor of HRQoL physical health. Given that nutritional status impacts HRQoL and that decreased HRQoL in patients on MHD is associated with mortality, complications, and reduced compliance with treatment, using the SGA to measure nutritional status can be a tool to help identify dialysis patients with a lower HRQoL in terms of physical health.

The "Breastmilk Ecology: Genesis of Infant Nutrition (BEGIN)" Project - executive summary.

The public health community has come to appreciate that a deeper understanding of the biology of human milk is essential to address ongoing and emerging questions about infant feeding practices. The critical pieces of that understanding are that 1) human milk is a complex biological system, a matrix of many interacting parts that is more than the sum of those parts, and 2) human milk production needs to be studied as an ecology that consists of inputs from the lactating parent, their breastfed baby, and their respective environments. The "Breastmilk Ecology: Genesis of Infant Nutrition (BEGIN)" Project was designed to examine this ecology as well as its functional implications for both the parent and infant and to explore ways in which this emerging knowledge can be expanded via a targeted research agenda and translated to support the community's efforts to ensure safe, efficacious, and context-specific infant feeding practices in the United States and globally. The five working groups of the BEGIN Project addressed the following themes: 1) parental inputs to human milk production and composition; 2) the components of human milk and the interactions of those components within this complex biological system; 3) infant inputs to the matrix, emphasizing the bidirectional relationships associated with the breastfeeding dyad; 4) the application of existing and new technologies and methodologies to study human milk as a complex biological system; and 5) approaches to translation and implementation of new knowledge to support safe and efficacious infant feeding practices.

Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record.

From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequency with which local review and approval and three different reliance options (ways to establish a reliance agreement between the sIRB and the relying institution) were used during this period in a multisite, non-federally funded study (ClinicalTrials.gov identifier: NCT03928548). Using general linear models, we analyzed the relationships between local reliance or approval and sIRB of record approval times and (a) the regulatory option selected and (b) relying-site and process characteristics. Eighty-five sites received sIRB approval through 72 submissions (40% using local review, 46% using the SMART IRB agreement, 10% using an IRB authorization agreement, and 4% using a letter of support). Median time to establish a local reliance or study approval and sIRB approval were longest for sites using a SMART IRB agreement. Study-site region and the time of submission were significantly associated with local reliance or approval time, which averaged 129 and 107 days faster for Midwestern (p = 0.03) or Western (p = 0.02) sites, respectively, and 70 days slower for Northeastern sites (p = 0.42) compared with sites in the South, and 91 days slower when regulatory communication was initiated during or after February 2019 compared with before (p = 0.02). Similar relationships between sIRB approval time and region and time frame were observed; in addition, approval time was 103 days slower for sites affiliated with a research 1 (R1) university versus not (p = 0.02). Region of the country, time frame, and R1 university affiliation were associated with variations in study-site activation in a non-federally funded, multisite study.

Evidence for human milk as a biological system and recommendations for study design-a report from "Breastmilk Ecology: Genesis of Infant Nutrition (BEGIN)" Working Group 4.

Human milk contains all of the essential nutrients required by the infant within a complex matrix that enhances the bioavailability of many of those nutrients. In addition, human milk is a source of bioactive components, living cells and microbes that facilitate the transition to life outside the womb. Our ability to fully appreciate the importance of this matrix relies on the recognition of short- and long-term health benefits and, as highlighted in previous sections of this supplement, its ecology (i.e., interactions among the lactating parent and breastfed infant as well as within the context of the human milk matrix itself). Designing and interpreting studies to address this complexity depends on the availability of new tools and technologies that account for such complexity. Past efforts have often compared human milk to infant formula, which has provided some insight into the bioactivity of human milk, as a whole, or of individual milk components supplemented with formula. However, this experimental approach cannot capture the contributions of the individual components to the human milk ecology, the interaction between these components within the human milk matrix, or the significance of the matrix itself to enhance human milk bioactivity on outcomes of interest. This paper presents approaches to explore human milk as a biological system and the functional implications of that system and its components. Specifically, we discuss study design and data collection considerations and how emerging analytical technologies, bioinformatics, and systems biology approaches could be applied to advance our understanding of this critical aspect of human biology.