"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality.

BACKGROUND & AIMS: Malnutrition is a common problem among hospitalized patients due to increased nutrient requirements and reduced food intake or uptake of nutrients. The aim of this prospective cohort study was to investigate the association of nutritional risk status (at or not at risk by NRS-2002) as well as energy and protein intake, use of oral nutritional supplements (ONS) and snack meals in at risk patients during hospitalization and adverse outcomes (length of stay (LOS), readmissions and mortality) at three-months follow-up. METHODS: Data were collected at baseline and at three-months follow-up in patients hospitalized at 31 units at a Danish University Hospital. Diet records were performed at baseline by using the nurses' quartile nutrition recording methods. Data about disease and clinical outcomes were collected from electronic medical records at baseline and three-months follow-up. RESULTS: A total of 318 patients were included. Patients at nutritional risk (n = 149, 47%) had higher risk of longer LOS (≥20 days (OR = 4.24 [1.81;9.95] and ≥30 days OR = 2.50 [1.22;5.14])), having one readmission (OR = 1.86 [1.15;3.01]) and death (OR = 2.56 [1.27;5.20]) compared to patients not at nutritional risk (n = 169, 53%). A longer LOS was associated with patients who achieved ≥75% of energy and protein requirements, consumed snack meals incl. and excl. oral nutritional supplements. Readmissions in patients at nutritional risk during the three-months were not associated with food intake during the index hospitalization. Mortality was observed in 43 of the 318 (13.5%) hospitalized patients. A lower mortality was associated with increased energy and protein intake in patients at nutritional risk. CONCLUSIONS: The results of this study indicate a longer LOS, higher readmission rate and increased mortality in patients at nutritional risk compared to patients not at risk. Patients at nutritional risk had lower risk of three-month mortality and longer LOS during index hospitalization with increased energy and protein intake. Readmissions in patients at nutritional risk were not affected by food intake. The association of nutritional risk with poorer outcomes indicates that good nutritional care including constant attention to food-intake during hospitalization can be beneficial regarding mortality.

The effect of nutritional interventions in acute radiation-induced diarrhoea in patients with primary pelvic cancer: A systematic review.

Acute radiation-induced diarrhoea (RID) is a well-known side effect of external radiation therapy for pelvic cancer. Acute RID is an unresolved clinical problem in approximately 80% of patients. We investigated the effect of nutritional interventions on acute RID in patients with pelvic cancer treated with curative radiotherapy. A search was conducted using PubMed, Embase.com, CINAHL, and Cochrane Library, from 1 January 2005 until 10 October 2022. We included randomised controlled trials or prospective observational studies. Eleven of the 21 identified studies had low quality of evidence, mainly because of low patient numbers distributed among several cancer diagnoses, and non-systematic assessment of acute RID. Interventions included probiotics (n = 6), prebiotics (n = 6), glutamine (n = 4), and others (n = 5). Five studies, of which two provided high quality evidence, showed that probiotics improved acute RID. Future well-designed studies investigating the effects of probiotics on acute RID are warranted. PROSPERO ID: CRD42020209499).

Are nutritional sufficiency of ≥75% energy and protein requirements relevant targets in patients at nutritional risk? - A one month follow-up study.

BACKGROUND & AIM: Nutrient intake in patients at nutritional risk was recorded with the aim of reaching at least 75% of estimated requirements for energy and protein. However, the cutoff at 75% has only been sparsely investigated. The aim of this study was to re-evaluate the 75% cutoff of estimated energy and protein requirements among patients at or not at nutritional risk in relation to 30-day mortality and readmissions. METHODS: A 30-day follow-up study was performed among hospitalized patients in 31 units at a Danish University Hospital. Data was collected using the nurses' quartile nutrition registration method and electronic patient journals. All patients were screened using the NRS-2002 and classified as either at nutritional risk (NRS-2002, score ≥3) or not at nutritional risk (NRS-2002, score <3). Energy and protein requirements were estimated using weighted Harris-Benedict equation and 1.3 g/kg/day, respectively. RESULTS: In total, 318 patients were included in this study. Patients at nutritional risk were older, lower BMI, male, more comorbidities and a longer primary length of stay compared to patients not at nutritional risk (p < 0.05). After 30-day follow-up, mortality was higher among patients at risk (9.5% vs. 2.0%, p < 0.05). Patients at nutritional risk showed increased risk of mortality if they did not achieve 75% of estimated requirements (energy: OR = 8.08 [1.78; 36.79]; protein: OR = 3.40 [0.74; 15:53]). Furthermore, predicted probability of mortality decreased with increased energy and protein intakes. No significant associations were found for readmissions achieving 75% of estimated energy or protein requirements. A cutoff of 76-81% for energy and 58-62% for protein was equivalent with accepting a 6-8% mortality rate. CONCLUSION: The results of this study indicate that an energy intake ≥75% of estimated requirement among patients at nutritional risk has a preventative effect regarding mortality within one month, but not for readmissions.

GLIM diagnosed malnutrition predicts clinical outcomes and quality of life in patients with non-small cell lung cancer.

BACKGROUND & AIMS: The high prevalence of malnutrition in non-small cell lung cancer (NSCLC) patients has numerous negative consequences on patients' outcome when undergoing anti-neoplastic treatment. The Global Leadership Initiative on Malnutrition (GLIM) criteria for diagnosis of malnutrition are currently being verified; however, studies validating GLIM criteria in NSCLC patients are lacking. This study aimed to evaluate clinical outcomes and Quality of Life (QoL) in malnourished compared to well-nourished NSCLC patients to determine the predictive validity of GLIM criteria. METHODS: We collected data on adverse events, survival, and QoL from NSCLC patients undergoing first line anti-neoplastic treatment collected from two prospective trials. Patients were categorized by GLIM criteria as malnourished or well-nourished, based on non-volitional weight loss, low Body Mass Index, reduced muscle mass (Computed Tomography-scans), reduced food intake (24-h recall), and inflammatory condition (modified Glasgow Prognostic Score). Differences in descriptive data, adverse events, survival, and QoL between the malnourished and well-nourished patients were analyzed. RESULTS: Overall, 120 patients were included in the study. Malnourished patients compared to well-nourished patients had significantly worse outcome in terms of treatment cessation (n = 21 vs 13, p = 0.049), disease progression (n = 20 vs 12, p = 0.034) and shorter overall survival (HR 2.0, 95% CI: 1.2, 3.4, p = 0.009). Stratifying by severity, moderately malnourished patients had a shorter overall survival compared to well-nourished patients (HR 2.1, 95% CI: 1.2, 3.6, p = 0.007). Malnutrition at baseline was associated with poor QoL by lower physical (p < 0.001) and role functioning (p = 0.011), more symptoms of fatigue (p = 0.001), nausea and vomiting (p = 0.009), pain (p < 0.001), dyspnea (p = 0.032), appetite loss (p < 0.001), and constipation (p = 0.029). No significant differences were found in hospitalization, dose reductions, or treatment postponement. CONCLUSIONS: Malnutrition defined by GLIM criteria in NSCLC patients was associated with more frequent early cessation of anti-neoplastic treatment, shorter overall survival, and poorer QoL compared to well-nourished patients.

High-protein diet during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease.

INTRODUCTION: The prevalence of cachexia in patients with chronic obstructive pulmonary disease (COPD) is high and associated with reduced quality of life, increased mortality and morbidity. We aimed to test the effect of a high protein diet combined with exercise on fat-free mass (FFM), functional capacity, symptom burden and dyspnoea. METHODS: Outpatients with COPD and severe or very severe (GOLD grade III-IV) disease and malnutrition commencing pulmonary rehabilitation were randomised to a high-protein diet or standard care. FFM was measured by bio-impedance analysis (BIA), mid-upper arm circumference (MUAC) and mid-thigh circumference (MTC), peripheral muscle function by six-minute walking distance (6MWD) and handgrip strength (HGS), symptoms by the COPD Assessment Trial (CAT) and dyspnoea by the Medical Research Council dyspnoea scale and Borg scores; all at baseline and after 12 weeks. RESULTS: Ten out of 13 randomised patients completed the trial. The intervention group was superior to the control group with respect to 6MWD (97 ± 93 m, p = 0.04) at 12 weeks. No differences were observed between the groups in HGS, anthropometrics, symptom burden or dyspnoea. CONCLUSION: In patients with COPD attending rehabilitation, a high protein diet combined with physical exercise had a clinically relevant effect on walking distance. FUNDING: none. TRIAL REGISTRATION: NCT04888182.

Translation and cultural adaptation of the scored Patient-Generated Subjective Global Assessment (PG-SGA©).

BACKGROUND AND AIM: The Patient-Generated Subjective Global Assessment (PG-SGA©) is a globally used malnutrition screening, assessment, triage and monitoring tool. The aim of this study was to perform a linguistic and content validation of the translated and culturally adapted version of the PG-SGA for the Danish setting. METHOD: The study was conducted according to the International Society of Pharmaeconomics and Outcomes Research (ISPOR) Principles of Good Practice for the Translational and Cultural Adaptation Process for Patient-Reported Outcomes Measures. Cancer patients (n = 121) and healthcare professionals (HCPs, n = 80) participated in the cognitive debriefing. A questionnaire was used in the cognitive debriefing in which comprehensibility, difficulty, and content validity (relevance) were quantified by a 4-point scale. Item and scale indices were calculated using the average item ratings divided by the number of respondents for content validity (Item-CVI, Scale-CVI), comprehensibility (Item-CI, Scale-CI) and difficulty (Item-DI, Scale-DI). As pre-defined, item indices <0.78 required further analysis of the item, and scale indices ≥0.90 were defined as excellent and 0.80-0.89 as acceptable. RESULTS: The patient component of the PG-SGA was rated as excellent content validity (Scale-CVI = 0.95) by HCPs and easy to comprehend (Scale-CI = 0.97) and use (Scale-DI = 0.92) by patients. The professional component of the PG-SGA was rated as acceptable content validity (Scale-CVI = 0.80), but below acceptable for comprehension (Scale-CI = 0.71) and difficulty (Scale-DI = 0.69). The physical exam was rated the least comprehensible Item-CI = 0.51-0.70) and most difficult (Item-DI = 0.33-0.063). CONCLUSION: The PG-SGA was successfully translated and culturally adapted to the Danish setting. Patients found it easy to understand and to complete. Except for the physical exam, HCPs rated the PG-SGA as relevant, comprehensive, and easy to use. Training of HCPs is recommended before implementing the tool into clinical practise.

Measurement of body composition: Agreement between methods of measurement by bioimpedance and computed tomography in patients with non-small cell lung cancer.

BACKGROUND AND AIMS: Cancer cachexia is a muscle wasting syndrome which is promoted by the presence of inflammation and metabolic changes. Cancer cachexia has shown predictable for survival, progression of physical impairment as well as patient-reported outcomes. Being able to identify these patients with a clinically applicable method for measuring body composition could lead to early nutritional intervention, possibly preventing progression of cancer cachexia. This study aimed to investigate the agreement between body composition recorded with bioelectrical impedance analysis (BIA) and software analysis of CT scans of patients suffering from cancer with a special emphasis on muscle mass. METHODS: This is a cross-sectional study of newly diagnosed patients with non-small cell lung cancer. All patients had muscle mass (MM) and fat mass (FM) measured by BIA with Tanita Segmental Body Composition Analyzer (BC-418) and by software analysis of CT scans at L3-level with VikingSlice. Secondary parameters (systemic inflammation, physical performance and electrolyte balance) were investigated for possible pitfalls of BIA. Patients who fulfilled best standard practice for BIA measurements, including 4 h of fasting, absence of oedema and no metallic implants, participated in a subgroup analysis. Agreement between method of measurements is investigated with the Bland and Altman method and pitfalls with paired t-test. A satisfactory agreement of BIA and CT measurements is established as ±10%. RESULTS: A total of 60 patients participated in the study amongst which 37 participated in the subgroup analysis. The bias between methods of measurement for MM was 4.74 ± 11.55% (P = 0.002) with limits of agreement (LoA) of -17.91 to 27.38%. In the subgroup analysis, the bias of MM was 3.06 ± 10.71% (P = 0.091) and LoA were -17.94 to 24.06%. In the analysis of secondary parameters, significant differences between methods were found in patients with normal hand grip strength (1.83 kg, P = 0.023) and those performing under gender and age-specific cut-offs in the 30-s sit to stand test (5.15 kg, P = 0.009). CONCLUSIONS: BIA and CT image analysis were not comparable for body composition measurements. BIA overestimated MM and underestimated FM with LoA outside that of the clinically assessed acceptable difference. Bias was reduced and LoA narrowed in the subgroup analysis however not to acceptable levels. This study finds it possible that patients with low physical performance are liable to larger overestimations of MM with BIA than those with normal physical performance.

Feasibility of a multimodal intervention on malnutrition in patients with lung cancer during primary anti-neoplastic treatment.

BACKGROUND: Wasting of body mass and skeletal muscle frequently develops in patients with cancer and is associated with impaired functional ability and poor clinical outcome and quality of life. This study aimed to evaluate the feasibility and explore the effect of a multimodal intervention targeting nutritional status in patients with non-small cell lung cancer receiving primary anti-neoplastic treatment. Additionally, predictive and prognostic factors of gaining skeletal muscle were explored. METHODS: This was a single-centre multimodal intervention trial using a historical control group. The multimodal intervention involved fish oil intake (2 g of eicosapentaenoic acid or docosahexaenoic acid daily), regular dietary counselling and unsupervised physical exercise twice weekly during the first three cycles of primary anti-neoplastic treatment. Feasibility was assessed through recruitment rate, completion rate and compliance rate with the intervention. Differences in skeletal muscle, body weight, and physical function between the intervention and historical control groups were analysed. Factors contributing to increased skeletal muscle were explored using univariate and multivariate ordinal logistic regression analyses. RESULTS: The recruitment and completion rates were 0.48 (n = 59/123) and 0.80 (n = 46/59), respectively. The overall compliance rate with all five individual interventions was 0.60 (n = 28/47). The individual compliance rates were 0.81 (n = 38/47) with fish oil intake, 0.94 (n = 44/47) with energy intake, 0.98 (n = 46/47) with protein intake, 0.51 (n = 24/47) with resistance exercise and 0.57 (n = 27/47) with aerobic exercise. No mean differences in skeletal muscle, body weight, or physical function were found between the intervention and control groups. However, a larger proportion of patients in the intervention group gained skeletal muscle (p < 0.02). The identified contributing factors of muscle gain were weight gain (OR, 1.3; p = 0.01), adherence to treatment plan (OR, 4.6; p = 0.02), stable/partial response (OR, 3.3; p = 0.04) and compliance to the intervention (OR, 7.4; p = 0.01). Age, sex, tumour stage, performance status, treatment type and baseline cachexia did not predict muscle gain. CONCLUSION: This three-dimensional intervention in patients with lung cancer undergoing primary anti-neoplastic treatment was feasible and increased the proportion of patients gaining skeletal muscle. Dietary counselling and fish oil use were useful strategies. The motivation for conducting unsupervised physical intervention was low. Clinical trials.gov identifier: NCT04161794.

Exploring the dietary protein intake and skeletal muscle during first-line anti-neoplastic treatment in patients with non-small cell lung cancer.

BACKGROUND: Loss of skeletal muscle mass is the corner stone of cancer cachexia, but no effective therapies are yet identified. The optimal protein quantity and pattern to support muscle mass maintenance in cancer patients is unknown. The aim of the current exploratory study was to observe the pattern and quantity of dietary protein intake as well as the prevalence of muscle wasting in patients with inoperable non-small cell lung cancer (NSCLC) undergoing primary anti-neoplastic treatment. The secondary aim was to assess the potential contributory factors associated with maintenance of muscle mass. METHOD: A longitudinal observational study was conducted in patients with NSCLC undergoing first line of anti-neoplastic treatment. Nutrient intake was assessed by repeated 24-h recalls and skeletal muscle by routine thoraco-abdominal CT scans at baseline and after three cycles of treatment. Descriptive analyses, paired samples t-test, binomial logistic and linear regression analyses were performed. RESULTS: Out of 186 consecutively screened patients, 62 were included and 52 patients were available for analysis. Protein intake increased from baseline to follow up, but were lower in muscle wasters (1.0 g/kg/d) than in muscle maintainers (1.4 g/kg/d). The majority of the meals contributed less than 20 g of protein and less than 10% of the meals contributed at least 40 g of protein. Significant loss of skeletal muscle area was observed in 26 out of 52 patients. A higher protein intake (OR 18.7, p = 0.01), energy intake (OR 1.1, p = 0.04) and stable body weight (OR 1.2, p = 0.03) were associated with muscle maintenance in the univariate regression, whereas age, sex, cachexia, tumour stage, treatment adherence and response did not. In the multivariate regression, a trend was seen for protein intake (OR 35.2, p = 0.08) and body weight (OR 1.2, p = 0.06). CONCLUSION: Muscle wasting occurred frequently and early during primary anti-neoplastic treatment. Protein intake seems important for maintaining skeletal muscle. Validated dietary methods in cancer patients must be identified and the optimal protein quantity and intake pattern to support muscle maintenance should be explored in future trials.

Effects of current parenteral nutrition treatment on health-related quality of life, physical function, nutritional status, survival and adverse events exclusively in patients with advanced cancer: A systematic literature review.

BACKGROUND: The aim was to evaluate the effects of current parenteral nutrition (PN) treatment on clinical outcomes in patients with advanced cancer. METHODS: This review was conducted according to the PRISMA guidelines (PROSPERO ID: 4201707915). RESULTS: Two underpowered randomized controlled trials and six observational studies were retrieved (n = 894 patients). Health-related quality of life and physical function may improve during anti-neoplastic treatment in who PN treatment is the only feeding opportunity, but not necessarily in patients able to feed enterally. Nutritional status may improve in patients regardless of anti-neoplastic treatment and gastrointestinal function. PN treatment was neither superior to fluid in terminal patients nor to dietary counselling in patients able to feed enterally in regards to survival. The total incidence of adverse events was low. CONCLUSION: Current PN treatment in patients with advanced cancer is understudied and the level of evidence is weak.

Lower mortality after early supervised pulmonary rehabilitation following COPD-exacerbations: a systematic review and meta-analysis.

BACKGROUND: Pulmonary rehabilitation (PR), delivered as a supervised multidisciplinary program including exercise training, is one of the cornerstones in the chronic obstructive pulmonary disease (COPD) management. We performed a systematic review and meta-analysis to assess the effect on mortality of a supervised early PR program, initiated during or within 4 weeks after hospitalization with an acute exacerbation of COPD compared with usual post-exacerbation care or no PR program. Secondary outcomes were days in hospital, COPD related readmissions, health-related quality of life (HRQoL), exercise capacity (walking distance), activities of daily living (ADL), fall risk and drop-out rate. METHODS: We identified randomized trials through a systematic search using MEDLINE, EMBASE and Cocharne Library and other sources through October 2017. Risk of bias was assessed regarding randomization, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases using the Cochrane Risk of Bias tool. RESULTS: We included 13 randomized trials (801 participants). Our meta-analyses showed a clinically relevant reduction in mortality after early PR (4 trials, 319 patients; RR = 0.58 (95% CI: [0.35 to 0.98])) and at the longest follow-up (3 trials, 127 patients; RR = 0.55 (95% CI: [0.12 to 2.57])). Early PR reduced number of days in hospital by 4.27 days (1 trial, 180 patients; 95% CI: [- 6.85 to - 1.69]) and hospital readmissions (6 trials, 319 patients; RR = 0.47 (95% CI: [0.29 to 0.75])). Moreover, early PR improved HRQoL and walking distance, and did not affect drop-out rate. Several of the trials had unclear risk of bias in regard to the randomization and blinding, for some outcome there was also a lack of power. CONCLUSION: Moderate quality of evidence showed reductions in mortality, number of days in hospital and number of readmissions after early PR in patients hospitalized with a COPD exacerbation. Long-term effects on mortality were not statistically significant, but improvements in HRQoL and exercise capacity appeared to be maintained for at least 12 months. Therefore, we recommend early supervised PR to patients with COPD-related exacerbations. PR should be initiated during hospital admission or within 4 weeks after hospital discharge.

Danish evidence-based clinical guideline for use of nutritional support in pulmonary rehabilitation of undernourished patients with stable COPD.

BACKGROUND AND AIMS: Disease-related under-nutrition is a common problem in individuals with COPD. The rationale for nutritional support in pulmonary rehabilitation therefore seems obvious. However there is limited evidence regarding the patient-relevant outcomes i.e. activities of daily living (ADL) or quality of life. Therefore the topic was included in The Danish Health and Medicines Authority's development of an evidence-based clinical guideline for rehabilitation of patients with stable COPD. METHODS: The methods were specified by The Danish Health and Medicines Authority as part of a standardized approach to evidence-based national clinical practice guidelines. They included formulation of a PICO with pre-defined criteria for the Population, Intervention, Control and Outcomes. Existing guidelines or systematic reviews were used after assessment using the AGREE II tool or AMSTAR, if possible. We identified primary studies by means of a systematic literature search (July to December 2013), and any identified studies were then quality assessed using the Cochrane risk of bias tool and the GRADE approach. The extracted data on our pre-defined outcomes were summarized in meta-analyses when possible, or meta-analyses from existing guidelines or systematic reviews were adapted. The results were used for labeling and wording of the recommendations. RESULTS: Data from 12 randomized controlled trials were included in a systematic review, which formed the basis for our recommendations as no new primary studies had been published. There were evidence of moderate quality that nutritional support for undernourished patients with COPD lead to a weight gain of 1.7kg (95% confidence interval: 1.3 to 2.2kg), but the effect was quantified as a mean change from baseline, which is less reliable. There were evidence of moderate quality that nutritional therapy does not increase in the 6 minute walking distance of 13 m (95% confidence interval: -27 to 54 m) when results in the intervention and control groups were compared at 9-16 weeks of follow-up. There was evidence of very low quality for an increase in lean body mass. The studies did not demonstrate an effect on either quality of life or ADL in patients with COPD. Some pre-defined outcomes (adverse events, hospital admissions and mortality) were not quantified. CONCLUSION: The evidence base for nutritional supplementation in rehabilitation of COPD patients is weak and any effect was limited to surrogate markers, such as increased weight and lean body mass, while an effect could not be seen on patient-relevant outcomes such as quality of life or activities of daily living. The intervention was given a weak recommendation.