Optimizing clinical nutrition research: the role of adaptive and pragmatic trials.

Evidence-based nutritional recommendations address the health impact of suboptimal nutritional status. Efficacy randomized controlled trials (RCTs) have traditionally been the preferred method for determining the effects of nutritional interventions on health outcomes. Nevertheless, obtaining a holistic understanding of intervention efficacy and effectiveness in real-world settings is stymied by inherent constraints of efficacy RCTs. These limitations are further compounded by the complexity of nutritional interventions and the intricacies of the clinical context. Herein, we explore the advantages and limitations of alternative study designs (e.g., adaptive and pragmatic trials), which can be incorporated into RCTs to optimize the efficacy or effectiveness of interventions in clinical nutrition research. Efficacy RCTs often lack external validity due to their fixed design and restrictive eligibility criteria, leading to efficacy-effectiveness and evidence-practice gaps. Adaptive trials improve the evaluation of nutritional intervention efficacy through planned study modifications, such as recalculating sample sizes or discontinuing a study arm. Pragmatic trials are embedded within clinical practice or conducted in settings that resemble standard of care, enabling a more comprehensive assessment of intervention effectiveness. Pragmatic trials often rely on patient-oriented primary outcomes, acquire outcome data from electronic health records, and employ broader eligibility criteria. Consequently, adaptive and pragmatic trials facilitate the prompt implementation of evidence-based nutritional recommendations into clinical practice. Recognizing the limitations of efficacy RCTs and the potential advantages of alternative trial designs is essential for bridging efficacy-effectiveness and evidence-practice gaps. Ultimately, this awareness will lead to a greater number of patients benefiting from evidence-based nutritional recommendations.

Nutrition Research Funding Trends and Focus Areas at the US National Cancer Institute.

BACKGROUND: Evidence for diet and nutrition's role in the cancer continuum is inconsistent and requires further study. Although more investigation is needed, the National Cancer Institute (NCI) funding for nutrition has decreased. METHODS: To examine nutrition research funding at the NCI, a portfolio analysis was undertaken for fiscal year (FY) 2018. Nutrition and other cancer-related terms were searched using the National Institutes of Health Query View and Report grants management dashboard. Grants were categorized by mechanism, funding status, applicant characteristics, funding opportunity announcement type, award type, and study characteristics. RESULTS: A total of 18 233 NCI grant applications were submitted in FY 2018; 12% were funded. Of the 653 nutrition-related grant applications received, 69 (11%) were funded. Funding status of nutrition grants did not differ statistically based on the type of funding opportunity announcement and were higher for applications classified as investigator initiated. Early stage investigators' nutrition applications were funded less than other investigators. Only 4% and 6% of overall and funded nutrition grant applications were submitted by registered dietitian nutritionist primary investigators, respectively. Average FY 2018 award amounts for funded nutrition and overall grant applications were approximately US $399 000 and approximately US $703 000, respectively. Although the percentage of NCI nutrition grants funded was similar to other grant funding at NCI in FY 2018, between FY 2012 and FY 2018, NCI decreased overall nutrition funding by 44%. CONCLUSIONS: Average grant award amounts for nutrition were less compared with overall NCI-funded grant applications and other topics. Our analysis highlights potential opportunities for greater investment in nutrition research at the NCI.

Monitoring Rates of Malnutrition Risk in Outpatient Cancer Centers Utilizing the Malnutrition Screening Tool Embedded into the Electronic Health Record.

BACKGROUND: The risk of malnutrition in patients with cancer is well documented. However, screening to identify patients at risk in ambulatory cancer centers is not standardized nor uniform. The 2-question Malnutrition Screening Tool (MST) is validated in the ambulatory oncology setting and endorsed by the Academy of Nutrition and Dietetics. OBJECTIVE: To test the feasibility of operationalizing and standardizing malnutrition risk assessment across 2 large ambulatory cancer centers by embedding the MST into the electronic health record (EHR) with the goal of identifying and quantifying the prevalence of malnutrition risk in outpatient settings. DESIGN: A Quality Assurance Performance Improvement project was conducted to evaluate malnutrition screening practices by leveraging the EHR. Work standards were developed, implemented, and evaluated to assess the feasibility of utilizing de-identified MST data, entered as discrete variables in an EHR flowsheet, to track monthly MST completion rates and to identify and quantify patients being treated for cancer scoring at risk for impaired nutritional status. PARTICIPANTS/SETTING: Data from 2 large adult ambulatory community cancer centers in the upper Midwest were collected between April 2017 and December 2018. RESULTS: Over a 20-month period, the average monthly MST completion rate was 74%. Of those with completed MST screens, the average percentage of patients identified at nutritional risk (MST score ≥2) was 5% in medical oncology and 12% in radiation oncology. CONCLUSION: It is feasible to (1) integrate and standardize data collection of the MST into existing EHR flowsheets and (2) identify and quantify patients at risk for malnutrition on a consistent basis.

Inadequate Nutrition Coverage in Outpatient Cancer Centers: Results of a National Survey.

Cancer-related malnutrition is associated with poor health outcomes, including decreased tolerance to cancer therapy, greater treatment toxicities, and increased mortality. Medical nutrition therapy (MNT) optimizes clinical outcomes, yet registered dietitian nutritionists (RDNs), the healthcare professionals specifically trained in MNT, are not routinely employed in outpatient cancer centers where over 90% of all cancer patients are treated. The objective of this study was to evaluate RDN staffing patterns, nutrition services provided in ambulatory oncology settings, malnutrition screening practices, and referral and reimbursement practices across the nation in outpatient cancer centers. An online questionnaire was developed by the Oncology Nutrition Dietetic Practice Group (ON DPG) of the Academy of Nutrition and Dietetics and distributed via the ON DPG electronic mailing list. Complete data were summarized for 215 cancer centers. The mean RDN full-time equivalent (FTE) for all centers was 1.7 ± 2.0. After stratifying by type of center, National Cancer Institute-Designated Cancer Centers (NCI CCs) employed a mean of 3.1 ± 3.0 RDN FTEs compared to 1.3 ± 1.4 amongst non-NCI CCs. The RDN-to-patient ratio, based on reported analytic cases, was 1 : 2,308. Per day, RDNs evaluated and counseled an average of 7.4 ± 4.3 oncology patients. Approximately half (53.1%) of the centers screened for malnutrition, and 64.9% of these facilities used a validated malnutrition screening tool. The majority (76.8%) of centers do not bill for nutrition services. This is the first national study to evaluate RDN staffing patterns, provider-to-patient ratios, and reimbursement practices in outpatient cancer centers. These data indicate there is a significant gap in RDN access for oncology patients in need of nutritional care.

Nutrigenomics and Cancer Prevention.

Mounting evidence continues to point to dietary habits as a modifier of cancer risk and tumor behavior; although it is clear that considerable variability occurs across studies. While genetic public health messages can be developed, the use of mean values may result in underexposure to some essential and nonessential food components, yet precipitate overexposure to nutrients. Undeniably, inconsistencies in the literature may reflect variation in timing of exposures to specific dietary constituents, interactions with the food matrix, processing technologies, or the genomic variation among individuals, which can influence absorption, metabolism, and/or the molecular target. Inter-individual variability in genetics, epigenetics, transcriptomics, proteomics, metabolomics, or microbiomics can influence the magnitude and direction of response to bioactive food components, as briefly reviewed in this article. Unquestionably, understanding nutrigenomics holds promise to reveal those who will benefit most from dietary interventions plus identify any who might be placed at risk due to overexposures.

Improving nutritional screening of hospitalized patients: the role of prealbumin.

BACKGROUND: Limited resources prevent hospitals from having all patients formally evaluated by a nutrition expert. Thus, hospitals rely on nutrition-screening tools to identify malnourished patients. The purpose of this study was to determine the effectiveness of a nutrition-screening protocol, prealbumin (PAB), retinol binding protein (RBP), and albumin (ALB) in identifying malnourished hospitalized patients. METHODS: A nutrition screening protocol was prospectively used in medical and surgical patients and consisted of a nurse administering a questionnaire to patients and requesting formal evaluation by a registered dietitian (RD) only if nutritional issues were identified. Patients also had ALB, PAB, and RBP drawn, which were used to both screen and identify the malnourished. PAB, RBP, and ALB were compared as predictors of RD classification of patient nutritional status. RESULTS: The nutrition-screening protocol classified 104 of 320 patients (33%) as malnourished. However, 43% of the patients were not deemed at nutritional risk according to this protocol and therefore did not receive RD assessment. PAB was a significant predictor of RD-determined nutritional status (p < .05), whereas RBP and ALB were not. PAB screening/assessment identified 50% (162/320) of the patients as being malnourished. Notably, 50% of the patients (71 of 142) who were not evaluated by an RD were identified as malnourished using PAB criteria. The nutrition-screening protocol took 1.2 days longer to determine malnourishment compared with PAB (p = .0021). CONCLUSIONS: Use of screening questionnaires may miss or delay identification of malnourished patients. PAB screening/assessment may improve identification of those patients requiring nutrition intervention and thus enhance the care of hospitalized individuals.