Altered dietary salt intake for people with chronic kidney disease.

BACKGROUND: Evidence indicates that reducing dietary salt may reduce the incidence of heart disease and delay decline in kidney function in people with chronic kidney disease (CKD). This is an update of a review first published in 2015. OBJECTIVES: To evaluate the benefits and harms of altering dietary salt for adults with CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 6 October 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials comparing two or more levels of salt intake in adults with any stage of CKD. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for eligibility, conducted risk of bias evaluation and evaluated confidence in the evidence using GRADE. Results were summarised using random effects models as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). MAIN RESULTS: We included 21 studies (1197 randomised participants), 12 in the earlier stages of CKD (779 randomised participants), seven in dialysis (363 randomised participants) and two in post-transplant (55 randomised participants). Selection bias was low in seven studies, high in one and unclear in 13. Performance and detection biases were low in four studies, high in two, and unclear in 15. Attrition and reporting biases were low in 10 studies, high in three and unclear in eight. Because duration of the included studies was too short (1 to 36 weeks) to test the effect of salt restriction on endpoints such as death, cardiovascular events or CKD progression, changes in salt intake on blood pressure and other secondary risk factors were examined. Reducing salt by mean -73.51 mmol/day (95% CI -92.76 to -54.27), equivalent to 4.2 g or 1690 mg sodium/day, reduced systolic/diastolic blood pressure by -6.91/-3.91 mm Hg (95% CI -8.82 to -4.99/-4.80 to -3.02; 19 studies, 1405 participants; high certainty evidence). Albuminuria was reduced by 36% (95% CI 26 to 44) in six studies, five of which were carried out in people in the earlier stages of CKD (MD -0.44, 95% CI -0.58 to -0.30; 501 participants; high certainty evidence). The evidence is very uncertain about the effect of lower salt intake on weight, as the weight change observed (-1.32 kg, 95% CI -1.94 to -0.70; 12 studies, 759 participants) may have been due to fluid volume, lean tissue, or body fat. Lower salt intake may reduce extracellular fluid volume in the earlier stages of CKD (-0.87 L, 95% CI -1.17 to -0.58; 3 studies; 187 participants; low certainty evidence). The evidence is very uncertain about the effect of lower salt intake on reduction in antihypertensive dose (RR 2.45, 95% CI 0.98 to 6.08; 8 studies; 754 participants). Lower salt intake may lead to  symptomatic hypotension (RR 6.70, 95% CI 2.40 to 18.69; 6 studies; 678 participants; moderate certainty evidence). Data were sparse for other types of adverse events. AUTHORS' CONCLUSIONS: We found high certainty evidence that salt reduction reduced blood pressure in people with CKD, and albuminuria in people with earlier stage CKD in the short-term. If such reductions could be maintained long-term, this effect may translate to clinically significant reductions in CKD progression and cardiovascular events. Research into the long-term effects of sodium-restricted diet for people with CKD is warranted.

Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer.

BACKGROUND: Weight loss remains significant in patients with head and neck cancer, despite prophylactic gastrostomy and intensive dietary counseling. The aim of this study was to improve outcomes utilising an early nutrition intervention. METHODS: Patients with head and neck cancer at a tertiary hospital in Australia referred for prophylactic gastrostomy prior to curative intent treatment were eligible for this single centre randomised controlled trial. Exclusions included severe malnutrition or dysphagia. Patients were assigned following computer-generated randomisation sequence with allocation concealment to either intervention or standard care. The intervention group commenced supplementary tube feeding immediately following tube placement. Primary outcome measure was percentage weight loss at three months post treatment. RESULTS: Recruitment completed June 2015 with 70 patients randomised to standard care (66 complete cases) and 61 to intervention (56 complete cases). Following intention-to-treat analysis, linear regression found no effect of the intervention on weight loss (10.9±6.6% standard care vs 10.8±5.6% intervention, P=0.930) and this remained non-significant on multivariable analysis (P=0.624). No other differences were found for quality of life or clinical outcomes. No serious adverse events were reported. CONCLUSIONS: The early intervention did not improve outcomes, but poor adherence to nutrition recommendations impacted on potential outcomes.

Altered dietary salt intake for people with chronic kidney disease.

BACKGROUND: Salt intake shows great promise as a modifiable risk factor for reducing heart disease incidence and delaying kidney function decline in people with chronic kidney disease (CKD). However, a clear consensus of the benefits of reducing salt in people with CKD is lacking. OBJECTIVES: This review evaluated the benefits and harms of altering dietary salt intake in people with CKD. SEARCH METHODS: We searched the Cochrane Renal Group's Specialised Register to 13 January 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared two or more levels of salt intake in people with any stage of CKD. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for eligibility and conducted risk of bias evaluation. Results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) and 95% CI for continuous outcomes. Mean effect sizes were calculated using the random-effects models. MAIN RESULTS: We included eight studies (24 reports, 258 participants). Because duration of the included studies was too short (1 to 26 weeks) to test the effect of salt restriction on endpoints such as mortality, cardiovascular events or CKD progression, changes in salt intake on blood pressure and other secondary risk factors were applied. Three studies were parallel RCTs and five were cross-over studies. Selection bias was low in five studies and unclear in three. Performance and detection biases were low in two studies and unclear in six. Attrition and reporting biases were low in four studies and unclear in four. One study had the potential for high carryover effect; three had high risk of bias from baseline characteristics (change of medication or diet) and two studies were industry funded.There was a significant reduction in 24 hour sodium excretion associated with low salt interventions (range 52 to 141 mmol) (8 studies, 258 participants: MD -105.86 mmol/d, 95% CI -119.20 to -92.51; I(2) = 51%). Reducing salt intake significantly reduced systolic blood pressure (8 studies, 258 participants: MD -8.75 mm Hg, 95% CI -11.33 to -6.16; I(2) = 0%) and diastolic blood pressure (8 studies, 258 participants: MD -3.70 mm Hg, 95% CI -5.09 to -2.30; I(2) = 0%). One study reported restricting salt intake reduced the risk of oedema by 56%. Salt restriction significantly increased plasma renin activity (2 studies, 71 participants: MD 1.08 ng/mL/h, 95% CI 0.51 to 1.65; I(2) = 0%) and serum aldosterone (2 studies, 71 participants: 6.20 ng/dL (95% CI 3.82 to 8.58; I(2) = 0%). Antihypertensive medication dosage was significantly reduced with a low salt diet (2 studies, 52 participants): RR 5.48, 95% CI 1.27 to 23.66; I(2) = 0%). There was no significant difference in eGFR (2 studies, 68 participants: MD -1.14 mL/min/1.73 m(2), 95% CI -4.38 to 2.11; I(2) = 0%), creatinine clearance (3 studies, 85 participants): MD -4.60 mL/min, 95% CI -11.78 to 2.57; I(2) = 0%), serum creatinine (5 studies, 151 participants: MD 5.14 µmol/L, 95% CI -8.98 to 19.26; I(2) = 59%) or body weight (5 studies, 139 participants: MD -1.46 kg; 95% CI -4.55 to 1.64; I(2) = 0%). There was no significant change in total cholesterol in relation to salt restriction (3 studies, 105 participants: MD -0.23 mmol/L, 95% CI -0.57 to 0.10; I(2) = 0%) or symptomatic hypotension (2 studies, 72 participants: RR 6.60, 95% CI 0.77 to 56.55; I(2) = 0%). Salt restriction significantly reduced urinary protein excretion in all studies that reported proteinuria as an outcome, however data could not be meta-analysed. AUTHORS' CONCLUSIONS: We found a critical evidence gap in long-term effects of salt restriction in people with CKD that meant we were unable to determine the direct effects of sodium restriction on primary endpoints such as mortality and progression to end-stage kidney disease (ESKD). We found that salt reduction in people with CKD reduced blood pressure considerably and consistently reduced proteinuria. If such reductions could be maintained long-term, this effect may translate to clinically significant reductions in ESKD incidence and cardiovascular events. Research into the long-term effects of sodium-restricted diet for people with CKD is warranted, as is investigation into adherence to a low salt diet.

Developing and evaluating interventions that are applicable and relevant to inpatients and those who care for them; a multiphase, pragmatic action research approach.

BACKGROUND: Randomised controlled trials may be of limited use to evaluate the multidisciplinary and multimodal interventions required to effectively treat complex patients in routine clinical practice; pragmatic action research approaches may provide a suitable alternative. METHODS: A multiphase, pragmatic, action research based approach was developed to identify and overcome barriers to nutritional care in patients admitted to a metropolitan hospital hip-fracture unit. RESULTS: Four sequential action research cycles built upon baseline data including 614 acute hip-fracture inpatients and 30 purposefully sampled clinicians. Reports from Phase I identified barriers to nutrition screening and assessment. Phase II reported post-fracture protein-energy intakes and intake barriers. Phase III built on earlier results; an explanatory mixed-methods study expanded and explored additional barriers and facilitators to nutritional care. Subsequent changes to routine clinical practice were developed and implemented by the treating team between Phase III and IV. These were implemented as a new multidisciplinary, multimodal nutritional model of care. A quasi-experimental controlled, 'before-and-after' study was then used to compare the new model of care with an individualised nutritional care model. Engagement of the multidisciplinary team in a multiphase, pragmatic action research intervention doubled energy and protein intakes, tripled return home discharge rates, and effected a 75% reduction in nutritional deterioration during admission in a reflective cohort of hip-fracture inpatients. CONCLUSIONS: This approach allowed research to be conducted as part of routine clinical practice, captured a more representative patient cohort than previously reported studies, and facilitated exploration of barriers and engagement of the multidisciplinary healthcare workers to identify and implement practical solutions. This study demonstrates substantially different findings to those previously reported, and is the first to demonstrate that multidisciplinary, multimodal nutrition care reduces intake barriers, delivers a higher proportional increase in protein and energy intake compared with baseline than other published intervention studies, and improves patient outcomes when compared with individualised nutrition care. The findings are considered highly relevant to clinical practice and have high translation validity. The authors strongly encourage the development of similar study designs to investigate complex health problems in elderly, multi-morbid patient populations as a way to evaluate and change clinical practice.

A randomized trial of sodium-restriction on kidney function, fluid volume and adipokines in CKD patients.

BACKGROUND: Dietary sodium restriction is a key management strategy in chronic kidney disease (CKD). Recent evidence has demonstrated short-term reduction in blood pressure (BP) and proteinuria with sodium restriction, however the effect on other cardiovascular-related risk factors requires investigation in CKD. METHODS: The LowSALT CKD study involved 20 hypertensive Stage III-IV CKD patients counselled by a dietitian to consume a low-sodium diet (<100 mmol/day). The study was a randomised crossover trial comparing 2 weeks of high-sodium (additional 120 mmol sodium tablets) and low-sodium intake (placebo). Measurements were taken after each crossover arm including BP (peripheral and central), adipokines (inflammation markers and adiponectin), volume markers (extracellular-to-intracellular [E/I] fluid ratio; N-terminal pro-brain natriuretic peptide [NT-proBNP]), kidney function (estimated Glomerular Filtration Rate [eGFR]) and proteinuria (urine protein-creatinine ratio [PCR] and albumin-creatinine ratio [ACR]). Outcomes were compared using paired t-test for each cross-over arm. RESULTS: BP-lowering benefits of a low-sodium intake (peripheral BP (mean ± SD) 148/82 ± 21/12 mmHg) from high-sodium (159/87 ± 15/10 mmHg) intake were reflected in central BP and a reduction in eGFR, PCR, ACR, NTproBNP and E/I ratio. There was no change in inflammatory markers, total or high molecular weight adiponectin. CONCLUSIONS: Short-term benefits of sodium restriction on BP were reflected in significant change in kidney function and fluid volume parameters. Larger, long-term adequately powered trials in CKD are necessary to confirm these results. TRIAL REGISTRATION: Universal Trial Number U1111-1125-2149 registered on 13/10/2011; Australian New Zealand Clinical Trials Registry Number ACTRN12611001097932 registered on 21/10/2011.

Taste perception in kidney disease and relationship to dietary sodium intake.

Taste abnormalities are prevalent in Chronic Kidney Disease (CKD) potentially affecting food palatability and intake, and nutrition status. The TASTE CKD study aimed to assess taste and explore the relationship of dietary sodium intake with taste disturbance in CKD subjects. This was a cross-sectional study of 91 adult stage 3-5 CKD participants (78% male) aged 65.9 ± 13.5 years with mean estimated glomerular filtration rate of 33.1 ± 12.7 ml/min/1.73 m(2), and 30 controls (47% male) aged 55.2 ± 7.4 years without kidney dysfunction. Taste assessment was performed in both groups, presenting five basic tastes (sweet, sour, salty, umami and bitter) in blinded 2 ml solution which the participants tasted, identified (identification) and rated perceived strength (intensity) on a 10 cm visual analogue scale. Sodium intake was measured in the CKD group using validated food frequency questionnaire to determine high or low sodium intake (cut-off 100 mmol sodium/day). Differences between groups (CKD vs controls; high vs low sodium intake) were analysed using chi-square for identification and t-test for intensity. Multivariate analysis was used to adjust for age and gender differences between CKD and controls. The control group identified mean 3.9 ± 1.0 tastants correctly compared with 3.0 ± 1.2 for CKD group (p < 0.001), which remained significant after adjustment for age and gender. After adjustment for age and gender, sour identification and intensity and salty and umami intensity were impaired in CKD compared with controls. Participants with low sodium intake were more likely to correctly identify salty and umami, and rated intensity of umami and bitter significantly higher than those with high sodium intake. These findings add to the body of evidence suggesting that taste changes occur with CKD, independent of age and gender differences, with specific impairment in sour, umami and salty tastes. Our finding that sodium intake is related to umami and bitter disturbance as well as salty taste warrants further investigation.

A randomized trial of dietary sodium restriction in CKD.

There is a paucity of quality evidence regarding the effects of sodium restriction in patients with CKD, particularly in patients with pre-end stage CKD, where controlling modifiable risk factors may be especially important for delaying CKD progression and cardiovascular events. We conducted a double-blind placebo-controlled randomized crossover trial assessing the effects of high versus low sodium intake on ambulatory BP, 24-hour protein and albumin excretion, fluid status (body composition monitor), renin and aldosterone levels, and arterial stiffness (pulse wave velocity and augmentation index) in 20 adult patients with hypertensive stage 3-4 CKD as phase 1 of the LowSALT CKD study. Overall, salt restriction resulted in statistically significant and clinically important reductions in BP (mean reduction of systolic/diastolic BP, 10/4 mm Hg; 95% confidence interval, 5 to 15 /1 to 6 mm Hg), extracellular fluid volume, albuminuria, and proteinuria in patients with moderate-to-severe CKD. The magnitude of change was more pronounced than the magnitude reported in patients without CKD, suggesting that patients with CKD are particularly salt sensitive. Although studies with longer intervention times and larger sample sizes are needed to confirm these benefits, this study indicates that sodium restriction should be emphasized in the management of patients with CKD as a means to reduce cardiovascular risk and risk for CKD progression.

Prevalence, risk factors, and clinical outcomes of vitamin C deficiency in adult hospitalized patients in high-income countries: a scoping review.

BACKGROUND: Assessment for vitamin C deficiency (VCD) is rarely undertaken in an acute hospital setting in high-income countries. However, with growing interest in VCD in community settings, there is emerging evidence investigating the prevalence and impact of VCD during hospitalization. OBJECTIVES: In this scoping review, the prevalence of VCD in adult hospitalized patients is explored, patient characteristics are described, and risk factors and clinical outcomes associated with VCD are identified. METHODS: A systematic scoping review was conducted in accordance with the PRISMA-ScR framework. The Ovid MEDLINE, Ovid Embase, Scopus, CINAHL Plus, Allied and Complementary Medicine Database, and the Cochrane Library databases were searched for interventional, comparative, and case-series studies that met eligibility criteria, including adult hospital inpatients in high-income countries, as defined by the Organization for Economic Co-operation and Development, that reported VCD prevalence using World Health Organization reference standards. These standards define VCD deficiency as plasma or serum vitamin C level <11.4 µmol/L, wholeblood level <17 µmol/L, or leukocytes <57 nmol/108 cells. RESULTS: Twenty-three articles were included, representing 22 studies. The cumulative prevalence of VCD was 27.7% (n = 2494; 95% confidence interval [CI], 21.3-34.0). High prevalence of VCD was observed in patients with severe acute illness and poor nutritional status. Scurvy was present in 48% to 62% of patients with VCD assessed in 2 studies (n = 71). Being retired (P = 0.015) and using excessive amounts of alcohol and tobacco (P = 0.0003) were independent risk factors for VCD (n = 184). Age was not conclusively associated with VCD (n = 631). Two studies examined nutrition associations (n = 309); results were inconsistent. Clinical outcomes for VCD included increased risk of frailty (adjusted odds ratio, 4.3; 95%CI, 1.33-13.86; P = 0.015) and cognitive impairment (adjusted odds ratio, 2.93; 95%CI, 1.05-8.19, P = 0.031) (n = 160). CONCLUSIONS: VCD is a nutritional challenge facing the healthcare systems of high-income countries. Research focused on early identification and treatment of patients with VCD is warranted. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework ( https://doi.org/10.17605/OSF.IO/AJGHX ).

Quantifying the severity of sarcopenia in patients with cancer of the head and neck.

BACKGROUND & AIMS: Existing skeletal muscle index (SMI) thresholds for sarcopenia are inconsistent, and do not reflect severity of depletion. In this study we aimed to define criterion values for moderate and severe skeletal muscle depletion based on the risk of mortality in a population of patients with head and neck cancer (HNC). Additionally, we aimed to identify clinical and demographic predictors of skeletal muscle depletion, evaluate the survival impact of skeletal muscle depletion in patients with minimal nutritional risk or good performance status, and finally, benchmarking SMI values of patients with HNC against healthy young adults. METHODS: Population cohort of 1231 consecutive patients and external validation cohorts with HNC had lumbar SMI measured by cross-sectional imaging. Optimal stratification determined sex-specific thresholds for 2-levels of SMI depletion (Class I and II) based on overall survival (OS). Adjusted multivariable regression analyses (tumor site, stage, performance status, age, sex, dietary intake, weight loss) determined relationships between 2-levels of SMI depletion and OS. RESULTS: Mean SMI (cm2/m2) was 51.7 ± 9.9 (males) and 39.8 ± 7.1 (females). The overall and sex-specific population demonstrated an increased risk of mortality associated with decreasing SMI. Sex-specific SMI (cm2/m2) depletion thresholds for 2-levels of muscle depletion determined by optimal stratification for males and females, respectively (male: 45.2-37.5, and <37.5; female: 40.9-34.2, and <34.2). In the overall population, Normal SMI, Class I and II SMI depletion occurred in 65.0%, 24.0%, and 11.0%, respectively. Median OS was: Normal SMI (114 months, 95% CI, 97.1-130.8); Class I SMI Depletion (42 months, 95% CI, 28.5-55.4), and Class II SMI Depletion (15 months, 95% CI, 9.8-20.1). Adjusted multivariable analysis compared with Normal SMI (reference), Class I SMI Depletion (HR, 1.49; 95% CI, 1.18-1.88; P < .001), Class II SMI Depletion (HR, 1.91; 95% CI, 1.42-2.58; P < .001). CONCLUSIONS: Moderate and severe SMI depletion demonstrate discrimination in OS in patients with HNC. Moderate and severe SMI depletion is prevalent in patients with minimal nutrition risk and good performance status. Benchmarking SMI values against healthy young adults exemplifies the magnitude of SMI depletion in patients with HNC and may be a useful method in standardizing SMI assessment.

Role of nutrition impact symptoms in predicting nutritional status and clinical outcome in hemodialysis patients: a potential screening tool.

OBJECTIVE: This study aims to establish the utility of the Nutrition Impact Symptoms (NIS), a part of the Patient-Generated Subjective Global Assessment (PG-SGA) as a nutritional screening tool in patients receiving hemodialysis (HD). DESIGN: This was a prospective observational study. SETTING: The study took place in a single public tertiary in-center dialysis facility in Australia. SUBJECTS: Patients included 213 individuals receiving maintenance HD for at least 3 months who were older than 18 years of age (mean age, 58.9 ± 16.3 years; 55.4% [n = 118] male patients). MAIN OUTCOME MEASURE: Malnutrition, which was classified by the Subjective Global Assessment rating (SGA, B or C) and the nutrition-related clinical outcome (decline in weight [>5%], SGA, reduction in serum albumin [>5 g/L]), or 12-month mortality. RESULTS: Patients assessed as malnourished totaled 23.5% (n = 50). Total PG-SGA and NIS scores showed a comparable ability to predict malnutrition (area under the curve, 0.93 [95% confidence interval {CI}, 0.90-0.97] and 0.86 [95% CI, 0.80-0.93], respectively). NIS (score ≥2) was independently related to poor nutrition-related clinical outcome (odds ratio [OR], 3.03; 95% CI, 1.47-6.20) and mortality (OR, 1.11; 95% CI, 1.03-1.20) adjusted for age, dialysis vintage, serum albumin level, and comorbidities. CONCLUSIONS: NIS score is a promising nutritional screening tool for the identification of patients receiving hemodialysis who are at risk of malnutrition and poor clinical outcome. Further research is required to investigate the reliability and utility of this tool in a larger population group.

An Umbrella Review and Meta-analysis of Interventions, Excluding Enteral and Parenteral Nutrition, Initiated in the Hospital for Adults with or at Risk of Malnutrition.

BACKGROUND: Multiple systematic reviews and meta-analyses (SRMAs) on various nutritional interventions in hospitalized patients with or at risk of malnutrition are available, but disagreements among findings raise questions about their validity in guiding practice. OBJECTIVES: We conducted an umbrella review (a systematic review of systematic reviews in which all appropriate studies included in SRMAs are combined) to assess the quality of reviews, identify the types of interventions available (excluding enteral and parenteral nutrition), and re-analyze the effectiveness of interventions. METHODS: The databases MEDLINE/PubMed, CINAHL, Embase, The Cochrane Library, and Google Scholar were searched. AMSTAR-2 was used for quality assessment and GRADE for certainty of evidence. Updated meta-analyses with risk of bias (ROB) by Cochrane ROB 2.0 were performed. Pooled effects were reported as relative risk (RR), with zero-events and publication bias adjustments, and trial sequential analysis (TSA) performed for mortality, readmissions, complications, length of stay, and quality of life. RESULTS: A total of 66 randomized controlled trials were cited by the 19 SRMAs included in this umbrella review, and their data extracted and analyzed. Most clinical outcomes were discordant with variable effect sizes in both directions. In trials with low ROB, interventions targeting nutritional intake reduce mortality at 30 d (15 studies, n: 4156, RR: 0.72, 95% CI: 0.55, 0.94, P: 0.02, I2: 6%, Certainty: High), 6 mo (27 studies, n: 6387, RR: 0.81, 95% CI: 0.71, 0.92, P = 0.001, I2: 4%, Certainty: Moderate), and 12 mo (27 studies, n: 6387, RR: 0.80, 95% CI: 0.67, 0.95, P: 0.01, I2: 33%, Certainty: Moderate), with TSA verifying an adequate sample size and robustness of the meta-analysis. CONCLUSION: Existing evidence is sufficient to show that nutritional intervention is effective for mortality outcomes at 30 d, 6 mo, and 12 mo. Future clinical trials should focus on the effect of nutritional interventions on other clinical outcomes. TRIAL REGISTRATION NUMBER: The protocol is registered on PROSPERO (CRD42022341031).

The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study): protocol of a randomized trial.

BACKGROUND: Despite evidence implicating dietary sodium in the pathogenesis of cardiovascular disease (CVD) in chronic kidney disease (CKD), quality intervention trials in CKD patients are lacking. This study aims to investigate the effect of reducing sodium intake on blood pressure, risk factors for progression of CKD and other cardiovascular risk factors in CKD. METHODS/DESIGN: The LowSALT CKD study is a six week randomized-crossover trial assessing the effect of a moderate (180 mmol/day) compared with a low (60 mmol/day) sodium intake on cardiovascular risk factors and risk factors for kidney function decline in mild-moderate CKD (stage III-IV). The primary outcome of interest is 24-hour ambulatory blood pressure, with secondary outcomes including arterial stiffness (pulse wave velocity), proteinuria and fluid status. The randomized crossover trial (Phase 1) is supported by an ancillary trial (Phase 2) of longitudinal-observational design to assess the longer term effectiveness of sodium restriction. Phase 2 will continue measurement of outcomes as per Phase 1, with the addition of patient-centered outcomes, such as dietary adherence to sodium restriction (degree of adherence and barriers/enablers), quality of life and taste assessment. DISCUSSION: The LowSALT CKD study is an investigator-initiated study specifically designed to assess the proof-of-concept and efficacy of sodium restriction in patients with established CKD. Phase 2 will assess the longer term effectiveness of sodium restriction in the same participants, enhancing the translation of Phase 1 results into practice. This trial will provide much-needed insight into sodium restriction as a treatment option to reduce risk of CVD and CKD progression in CKD patients. TRIAL REGISTRATION: Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932.

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis.

BACKGROUND: Nutrition support is associated with improved survival and nonelective hospital readmission rates among malnourished medical inpatients; however, limited evidence supporting dietary counseling is available. We intend to determine the effect of dietary counseling with or without oral nutrition supplementation (ONS), compared with standard care, on hospitalized adults who are malnourished or at risk of malnutrition. METHODS: We searched MEDLINE/PubMed, CINAHL, Embase, Scopus, The Cochrane Library, and Google Scholar for studies listed from January 1, 2011, to August 31, 2021. Meta-analysis was performed to obtain pooled risk ratios (RRs) and 95% CIs to estimate the effect. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used to assess the certainty of the evidence. RESULTS: Sixteen studies were identified. Compared with standard care, dietary counseling with or without ONS probably does not reduce inpatient rates of 30-day mortality (RR = 1.24; 0.60-2.55; I2 = 45%; P = 0.56; moderate certainty), slightly reduces 6-month mortality (RR = 0.83; 0.69-1.00; I2 = 16%; P = 0.06; high certainty), reduces complications (RR = 0.85; 0.73-0.98; I2 = 0%; P = 0.03; high certainty), and may slightly reduce readmission (RR = 0.83; 0.66-1.03; I2 = 55%; P = 0.10; low certainty) but may not reduce length of stay (mean difference: -0.75 days; -1.66-0.17; I2 = 70%; P = 0.11; low certainty). Intervention may result in slight improvements in nutrition status/intake and weight/body mass index (low certainty). CONCLUSIONS: There is an increase in the certainty of evidence regarding the positive impact of dietary counseling on outcomes. Future studies should standardize and provide details/frequencies of counseling methods and ONS adherence to determine dietary counseling effectiveness.

A Multi-Site, International Audit of Malnutrition Risk and Energy and Protein Intakes in Patients Undergoing Treatment for Head Neck and Esophageal Cancer: Results from INFORM.

Patients with foregut tumors are at high risk of malnutrition. Nutrition care focuses on identifying individuals at risk of malnutrition and optimizing nutrient intake to promote the maintenance of body weight and lean body mass. This multi-center prospective, longitudinal study audited nutrition care practices related to screening for risk of malnutrition (Patient-Generated Subjective Global Assessment Short Form; PG-SGA SF), and nutrition interventions prescribed (route; adequacy of energy and protein intakes). Audits occurred at four time periods: baseline (before treatment) and at 2, 4, and 6 months after starting cancer treatment; 170 patients (esophageal (ESO; n = 51); head and neck (HN; n = 119)) were enrolled. Nutrition risk (PG-SGA SF score ≥ 4) was prevalent at every time period: HN (baseline: 60%; 6 months 66%) and ESO (77%; 72%). Both groups had significant (p < 0.001) weight losses over the 6 month audit period (HN = 13.2% ESO = 11.4%). Enteral nutrition (EN) was most likely to be prescribed at 2 months for HN and at 4 and 6 months for ESO. Target prescribed energy and protein intakes were not met with any nutrition intervention; although adequacy was highest for those receiving EN. Nutrition care practices differed for HN and ESO cancers and there may be time points when additional nutrition support is needed.

Nutritional status and skeletal muscle status in patients with head and neck cancer: Impact on outcomes.

BACKGROUND: Computed tomography (CT)-defined skeletal muscle depletion and malnutrition are demonstrated as poor prognostic factors in patients with head and neck cancer (HNC), however to date, have only been explored in isolation. We aimed to describe body composition profile and examine the impact of nutritional status as well as independently and concurrently occurring body composition features on overall survival, treatment completion, unplanned admissions and length of stay (LOS) in patients undergoing radiotherapy (RT) or chemoradiotherapy (CRT) of curative intent for HNC. METHODS: This work is a retrospective, observational study of patients who had completed treatment of curative intent for HNC. Scored Patient-Generated Subjective Global Assessment (PG-SGA) was used to determine nutritional status. Tissue-density data were derived at the third lumbar vertebra (L3) with sarcopenia and myosteatosis defined by published, sex-specific threshold values stratified by body mass index for skeletal muscle index (cm2 /m2 ) and skeletal muscle radiodensity (SMR, Hounsfield Unit). RESULTS: Pre-treatment data (n = 277: 78% male, mean (SD) age 60 (13) years) revealed the prevalence of malnutrition (24.9%), sarcopenia (52.3%), myosteatosis (82.3%), and concurrently occurring sarcopenia and myosteatosis (39.7%). Malnutrition was independently associated with reduced OS for patients with moderate [hazard ratio (HR) 2.57; 95% confidence interval (CI) 1.45-4.55, P = 0.001] and severe (HR 3.19; 95% CI 1.44-7.07, P = 0.004) malnutrition on multivariable analysis but not sarcopenia (HR 1.09; 95% CI 0.70-1.71), P = 0.700 or myosteatosis (HR 1.28; 95% CI 0.57-2.84), P = 0.500). Malnutrition was associated with treatment discontinuation (P < 0.001), not completing RT as planned (P < 0.001), unplanned hospital admission (P = 0.021), and greater LOS (P < 0.001). Skeletal muscle status features were associated with unplanned hospital admissions for those with no features (32%), with sarcopenia only (50%), myosteatosis only (25%), and concurrent sarcopenia and myosteatosis (50%), P < 0.001. Similarly, a clinically relevant greater median (Q1, Q3) LOS was observed for those with sarcopenia only [5 (3, 32)], myosteatosis only [10 (5, 30)], concurrent sarcopenia, and myosteatosis [14 (4, 33)] days vs. those with no features [3 (2, 11)] days, P = 0.2. CONCLUSIONS: Malnutrition was a more powerful prognostic indicator than CT-defined skeletal muscle depletion and was independently associated with reduced OS in patients undergoing RT or CRT of curative intent for HNC. CT-defined skeletal muscle depletion studies should recognize the multifaceted nature of human body composition and also measure nutritional status using validated methods in order to move towards developing a typology of high risk criteria for this complex patient group.

Medical Nutrition Reimbursement in Singapore: Who Are the Patients Receiving MediFund Assistance? An Audit of Clinical Outcomes and Issues Pertaining to Reimbursement in a Public Hospital in Singapore.

BACKGROUND: Financial reimbursement (MediFund) of medical nutrition products (MNPs) was recently implemented in some of the public hospitals in Singapore for patients with financial difficulties. This study aimed to investigate the sustainability of this policy and the benefits conferred. METHODS: We performed a 1-year retrospective audit of patients in a tertiary hospital who received MediFund. Demographics, presupport and postsupport clinical outcomes, and cost of support were determined and analyzed. RESULTS: A total of 129 patients received MediFund for MNPs. The median length of financial support was 115 days (interquartile range, 37-269). Overall, body mass index increased after nutrition support (20.9 ± 5.1 vs 20.4 ± 5.3; P = .012). There was a significant decrease in the number of malnourished patients (final, 55.1% vs initial, 86.8%; P < .001) and a significant increase in 7-point subjective global assessment scores (final, 4.9 ± 1.3 vs initial, 4.1 ± 1.3; P < .001) after MNP support. MNP adherence was high for 88.5% of patients who returned for follow-up appointments. Patients who defaulted follow-up appointments were more likely to have 30-day readmission (50% vs 19.5%; P < .001) and had higher mortality rates (35.7% vs 10.3%; P < .001). Total reimbursement of S $108,960 was provided to subsidize MNPs over 1 year. CONCLUSION: Supporting patients with financial difficulties led to an improvement in their nutrition status. Regular dietitian reviews of patients and monitoring compliance to consumption of MNPs are essential to ensure patients benefit from the support.

The Association Between Computed Tomography-Defined Sarcopenia and Outcomes in Adult Patients Undergoing Radiotherapy of Curative Intent for Head and Neck Cancer: A Systematic Review.

BACKGROUND: Computed tomography (CT)-defined sarcopenia is a demonstrated poor prognostic factor in patients with cancer; however, its influence on outcomes for patients with head and neck cancer (HNC) has not been established. OBJECTIVE: This review synthesizes current knowledge regarding the association between CT-defined sarcopenia and outcomes for adult patients undergoing radiotherapy with or without other treatment modalities of curative intent for HNC. METHODS: A systematic review of the literature published between January 2004 and June 2019 was conducted in Medline, Embase, Cumulative Index of Nursing and Allied Health Literature, Allied and Complementary Medicine Database, and PubMed. Empirical studies of CT-defined sarcopenia in adult patients (≥18 years) with HNC who had completed radiotherapy of curative intent with or without other treatment modalities were included. Outcomes reported included survival, prolonged radiotherapy breaks, and chemotherapy toxicity. Study quality was assessed using the American Academy of Nutrition and Dietetics Quality Criteria Checklist. Synthesis of outcomes and clinical relevance was performed using the Grading of Recommendations Assessment, Development, and Evaluation system. RESULTS: Of 11 studies (n = 3,461) identified, 3 were positive and 8 were neutral quality. Studies were heterogeneous in HNC diagnosis, ethnicity, definition of sarcopenia, CT level of evaluation, and skeletal muscle index threshold value. Eight definitions for sarcopenia were identified with pretreatment prevalence of 6.6% to 70.9% and posttreatment prevalence of 12.4% to 65.8%. Pretreatment sarcopenia was independently associated with reduced: overall survival (OS), 3-year OS, disease-free survival, prolonged radiotherapy breaks, and chemotherapy-related toxicities. Posttreatment sarcopenia was independently associated with reduced OS and 5-year OS. The overall certainty of evidence according to Grading of Recommendations Assessment, Development and Evaluation criteria was low for OS; 3-year, 5-year, and 10-year OS; locoregional control; locoregional failure; progression-free survival; metastasis-free survival, disease-specific survival; and disease-free survival and very low for distant metastasis, prolonged radiotherapy breaks, and chemotherapy toxicity-related outcomes. CONCLUSIONS: CT-defined sarcopenia is independently associated with reduced OS and treatment completion in patients with HNC and holds a clinically meaningful prognostic value. The certainty of the evidence requires strengthening with further research. Understanding the impact sarcopenia has on outcomes for these patients has implications for informing potential nutrition interventions and facilitating individualized care.

Translating Evidence-Based Guidelines into Practice-Are We Getting It Right? A Multi-Centre Prospective International Audit of Nutrition Care in Patients with Foregut Tumors (INFORM).

Malnutrition is highly prevalent in patients with foregut tumors comprising head and neck (HNC) and esophageal (EC) cancers, negatively impacting outcomes. International evidence-based guidelines (EBGs) for nutrition care exist; however, translation of research evidence into practice commonly presents considerable challenges and consequently lags. This study aimed to describe and evaluate current international nutrition care practices compared with the best-available evidence for patients with foregut tumors who are at high risk of malnutrition. A multi-centre prospective cohort study enrolled 170 patients commencing treatment of curative intent for HNC (n = 119) or EC (n = 51) in 11 cancer care settings in North America, Europe and Australia between 2016 and 2018. Adherence criteria were derived from relevant EBG recommendations with pooled results for participating centres reported according to the Nutrition Care Model at either system or patient levels. Adherence to EBG recommendations was: good (≥80%) for performing baseline nutrition screening and assessment, perioperative nutrition assessment and nutrition prescription for energy and protein targets; moderate (≥60 to 80%) for utilizing validated screening and assessment tools and pre-radiotherapy dietitian consultation; and poor (60%) for initiating post-operative nutrition support within 24 h and also dietetic consultation weekly during radiotherapy and fortnightly for 6 weeks post-radiotherapy. In conclusion, gaps in evidence-based cancer nutrition care remain; however, this may be improved by filling known evidence gaps through high-quality research with a concurrent evolution of EBGs to also encompass practical implementation guidance. These should aim to support multidisciplinary cancer clinicians to close evidence-practice gaps throughout the patient care trajectory with clearly defined roles and responsibilities that also address patient-reported concerns.

Best Evidence to Best Practice: Implementing an Innovative Model of Nutrition Care for Patients with Head and Neck Cancer Improves Outcomes.

Malnutrition is prevalent in patients with head and neck cancer (HNC), impacting outcomes. Despite publication of nutrition care evidence-based guidelines (EBGs), evidence-practice gaps exist. This study aimed to implement and evaluate the integration of a patient-centred, best-practice dietetic model of care into an HNC multidisciplinary team (MDT) to minimise the detrimental sequelae of malnutrition. A mixed-methods, pre-post study design was used to deliver key interventions underpinned by evidence-based implementation strategies to address identified barriers and facilitators to change at individual, team and system levels. A data audit of medical records established baseline adherence to EBGs and clinical parameters prior to implementation in a prospective cohort. Key interventions included a weekly Supportive Care-Led Pre-Treatment Clinic and a Nutrition Care Dashboard highlighting nutrition outcome data integrated into MDT meetings. Focus groups provided team-level evaluation of the new model of care. Economic analysis determined system-level impact. The baseline clinical audit (n = 98) revealed barriers including reactive nutrition care, lack of familiarity with EBGs or awareness of intensive nutrition care needs as well as infrastructure and dietetic resource limitations. Post-implementation data (n = 34) demonstrated improved process and clinical outcomes: pre-treatment dietitian assessment; use of a validated nutrition assessment tool before, during and after treatment. Patients receiving the new model of care were significantly more likely to complete prescribed radiotherapy and systemic therapy. Differences in mean percentage weight change were clinically relevant. At the system level, the new model of care avoided 3.92 unplanned admissions and related costs of $AUD121K per annum. Focus groups confirmed clear support at the multidisciplinary team level for continuing the new model of care. Implementing an evidence-based nutrition model of care in patients with HNC is feasible and can improve outcomes. Benefits of this model of care may be transferrable to other patient groups within cancer settings.

Implementation of standardized nutrition guidelines by renal dietitians is associated with improved nutrition status.

OBJECTIVE: Standardized nutrition guidelines that focus on a nutrition care process have been used by dietitians treating renal patients in Australia for over 3 years. We show the impact of this implementation on the nutritional status of a cohort of hemodialysis patients. DESIGN: We conducted a retrospective observational study, investigating a cohort of maintenance hemodialysis patients after the implementation of a systematic approach to the patient's nutritional care. SETTING: This study took place in public and private in-center hemodialysis units. PATIENTS: Patients included a cohort of 65 maintenance hemodialysis patients (mean age +/- SD, 64 +/- 15 years; 58% male; dialysis vintage median [interquartile range], 22 [10 to 46] months). INTERVENTIONS: All participants were provided with a dietary interview at least every 6 months, with intensive follow-up where required, and were monitored monthly regarding weight and biochemistry. Outcomes were assessed annually between May 2004 and December 2006, after the implementation of this model of care. MAIN OUTCOME MEASURE: Energy and protein intake according to dietary interview, nutritional status according to subjective global assessment, and data regarding dry weight and biochemistry (including albumin, potassium, and phosphate) were collected by the dietitian at each facility. Change in each outcome measure over time was assessed using repeated-measures analysis. RESULTS: The proportion of patients with malnutrition (subjective global assessment B or C) decreased from 14% at baseline to 3% after 2 years. Serum albumin, potassium, and dry weight remained stable throughout the study period, and there was a significant decrease in serum phosphate over time (mean +/- SD,1.8 +/- 0.5 to 1.5 +/- 0.5 mmol/L, P = .004). Dietary energy and protein intake changed significantly over the study period (P = .001 and P = .022, respectively), with the highest mean intake recorded during the final follow-up assessment. CONCLUSIONS: The implementation of a systematic approach to patient care, in line with nutrition management guideline recommendations, was associated with an improvement in nutritional status and dietary intake in this cohort of maintenance hemodialysis patients, without the need for increased resources or dietitian time.