Predictive Validity of the Academy of Nutrition and Dietetics/American Society for Parental Nutrition Indicators to Diagnose Malnutrition and the Screening Tool for Risk on Nutritional Status and Growth among Hospitalized Children Relative to Medical Outcomes.

OBJECTIVE: To evaluate predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Indicators to diagnose pediatric malnutrition (AAIMp) and the Screening Tool for Risk on Nutritional Status and Growth (STRONGkids) in regard to pediatric patient outcomes in US hospitals. STUDY DESIGN: A prospective cohort study (Clinical Trial Registry: NCT03928548) was completed from August 2019 through January 2023 with 27 pediatric hospitals or units from 18 US states and Washington DC. RESULTS: Three hundred and forty-five children were enrolled in the cohort (n = 188 in the AAIMp validation subgroup). There were no significant differences in the incidence of emergency department visits and hospital readmissions, hospital length of stay (LOS), or health care resource utilization for children diagnosed with mild, moderate, or severe malnutrition using the AAIMp tool compared with children with no malnutrition diagnosis. The STRONGkids tool significantly predicted more emergency department visits and hospital readmissions for children at moderate and high malnutrition risk (moderate risk - incidence rate ratio 1.65, 95% CI: 1.09, 2.49, P = .018; high risk - incidence rate ratio 1.64, 95% CI: 1.05, 2.56, P = .028) and longer LOS (43.8% longer LOS, 95% CI: 5.2%, 96.6%, P = .023) for children at high risk compared with children at low risk after adjusting for patient characteristics. CONCLUSIONS: Malnutrition risk based on the STRONGkids tool predicted poor medical outcomes in hospitalized US children; the same relationship was not observed for a malnutrition diagnosis based on the AAIMp tool.

Patient Malnutrition Risk or Number of Initial Nutrition Intervention Categories Can Be Used to Develop Registered Dietitian Nutritionist Staffing Models in the Inpatient Adult and Pediatric Hospital Setting: A Cohort Study.

BACKGROUND: More data are needed to guide evidence-based, inpatient registered dietitian nutritionist (RDN) staffing models. OBJECTIVE: Identify relationships between: 1) patient malnutrition risk or intervention categories and estimated total RDN care time ("care time"); and 2) care time and emergency department (ED) visits. DESIGN: This study was a prospective cohort study with data collection via RDN surveys, patient interviews, and medical record review. PARTICIPANTS/SETTING: Adult (n = 550) and pediatric (n = 345) patients enrolled at 32 adult and 27 pediatric US hospitals from August 2019 to January 2023. MAIN OUTCOME MEASURES: Care time and ED visits within 90 days of hospital discharge were measured. STATISTICAL ANALYSIS: Multilevel, generalized linear, and negative binomial regression models were used to evaluate relationships between patient characteristics and Box-Cox-transformed care time and the relationship between Box-Cox-transformed care time and total ED visits. RESULTS: After adjusting for patient characteristics, adult patients classified as at malnutrition risk vs not at risk required a mean of 8% (95% CI 5% to 11%) more care time. Pediatric patients at medium or high compared with low malnutrition risk needed a mean of 21% (95% CI 4% to 40%) and 31% (95% CI 12% to 54%) more care time, respectively. Number of initial RDN interventions categories per patient (0 to 1 vs 2 to 3 or 4+) was associated with a mean of 10% (95% CI 7% to 14%) or 8% (95% CI 2% to 15%) more care time for adults and 17% (95% CI 5% to 32%) and 39% (95% CI 21% to 61%) more care time for children, respectively. More estimated total RDN care time was associated with significantly higher incidence rate ratios of ED visits (adults: incidence rate ratio 2.8; 95% CI 1.1 to 7.2; children: incidence rate ratio 1.7; 95% CI 1.02 to 2.8). CONCLUSIONS: Patient malnutrition risk or breadth of nutrition interventions required can inform nutrition department staffing. Intervention studies may better define relationships between care time and medical outcomes.

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).

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.

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.

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.

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.

Perspective: Nutritional Status as a Biological Variable (NABV): Integrating Nutrition Science into Basic and Clinical Research and Care.

The field of nutrition has evolved from one focused primarily on discovery of the identities, metabolic functions, and requirements for essential nutrients to one focused on the application of that knowledge to the development and implementation of dietary recommendations to promote health and prevent disease. This evolution has produced a deeper appreciation of not only the roles of nutrients, but also factors affecting their functions in increasingly complex global health contexts. The intersection of nutrition with an increasingly more complex global health context necessitates a view of nutritional status as a biological variable (NABV), the study of which includes an appreciation that nutritional status is: 1) not limited to dietary exposure; 2) intimately and inextricably involved in all aspects of human health promotion, disease prevention, and treatment; and 3) both an input and an outcome of health and disease. This expanded view of nutrition will inform future research by facilitating considerations of the contexts and variability associated with the many interacting factors affecting and affected by nutritional status. It will also demand new tools to study multifactorial relations to the end of increasing precision and the development of evidence-based, safe, and effective standards of health care, dietary interventions, and public health programs.

Executive summary: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project.

Preterm birth (infants born at <37 wk of gestational age) is a significant clinical and public health challenge in the United States and globally. No universally accepted practice guidelines exist for the nutritional care of preterm infants. To address the current state of knowledge and to support systematic reviews that will be used to develop evidence-informed guidance, a consortium consisting of the American Academy of Pediatrics, the ASN, the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, the Food and Drug Administration, the CDC, the USDA/Agricultural Research Service (USDA/ARS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development/NIH initiated the Pre-B Project. The project included the constitution of 4 thematic working groups charged with the following tasks: 1) develop a series of topics/questions for which there is sufficient evidence to support a systematic review process to be conducted by the Academy of Nutrition and Dietetics' Evidence Analysis Library (EAL), leading to the development of new guidelines for nutritional care of preterm infants, and 2) develop a targeted research agenda to address priority gaps in our understanding of the role of nutrition in the health and development of preterm/neonatal intensive care unit infants. This review consists of a project overview including a summary of a workshop hosted by the USDA/ARS Children's Nutrition Research Center and summary reports of the 4 working groups established to address the following themes: 1) nutrient specifications, 2) clinical/practical issues in enteral feeding, 3) gastrointestinal and surgical issues, and 4) current standards for assessing infant feeding outcomes. These reports will serve as the basis for the ultimate guideline development process to be conducted by the Academy of Nutrition and Dietetics' EAL.

Working group reports: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project.

The "Evaluation of the Evidence to Support Practice Guidelines for the Nutritional Care of Preterm Infants: The Pre-B Project" is the first phase in a process to present the current state of knowledge and to support the development of evidence-informed guidance for the nutritional care of preterm and high-risk newborn infants. The future systematic reviews that will ultimately provide the underpinning for guideline development will be conducted by the Academy of Nutrition and Dietetics' Evidence Analysis Library (EAL). To accomplish the objectives of this first phase, the Pre-B Project organizers established 4 working groups (WGs) to address the following themes: 1) nutrient specifications for preterm infants, 2) clinical and practical issues in enteral feeding of preterm infants, 3) gastrointestinal and surgical issues, and 4) current standards of infant feeding. Each WG was asked to 1) develop a series of topics relevant to their respective themes, 2) identify questions for which there is sufficient evidence to support a systematic review process conducted by the EAL, and 3) develop a research agenda to address priority gaps in our understanding of the role of nutrition in health and development of preterm/neonatal intensive care unit infants. This article is a summary of the reports from the 4 Pre-B WGs.

Development and Validation of the Guide for Effective Nutrition Interventions and Education (GENIE): A Tool for Assessing the Quality of Proposed Nutrition Education Programs.

OBJECTIVE: To develop and validate the Guide for Effective Nutrition Interventions and Education (GENIE), a checklist of research-based quality indicators for nutrition education programs. DESIGN: A prospective test of criterion validity and inter-rater reliability of a new tool comparing expert assessments and trained reviewer GENIE scores of the same nutrition education proposals. PARTICIPANTS: Ten nutrition education experts; 13 volunteer reviewers. VARIABLES MEASURED: GENIE's face, content, and criterion validity and inter-rater reliability compared using expert assessments and reviewer objective and subjective scores. ANALYSIS: Reviewer scores compared using Spearman correlation. Inter-rater reliability tested using intra-class correlation (ICC), Cronbach alpha, and ANOVA. Criterion validity tested using independent t test and point bi-serial correlation to compare reviewer with expert scores. RESULTS: Correlation found between total objective and total subjective scores. Agreement found between reviewers across proposals and categories considering subjective scores (F = 7.21, P < .001; ICC = 0.76 [confidence interval, 0.53-0.92]) and objective scores (F = 7.88, P < .001; ICC = 0.82 [confidence interval, 0.63-0.94]). Relationship was not significant (r = .564, P = .06) between expert and reviewer proposal scoring groups (high, medium, and low). CONCLUSIONS AND IMPLICATIONS: Results support the validity and reliability of GENIE as a tool for nutrition education practitioners, researchers, and program funding agencies to accurately assess the quality of a variety of nutrition program plans.

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.