Priority setting for adult malnutrition and nutritional screening in healthcare: a James Lind Alliance.

BACKGROUND: Malnutrition is one the greatest global health challenges of our generation, leading to the increased utilisation of healthcare resources, as well as morbidity and mortality. Research has primarily been driven by industry, academia and clinical working groups and has had little involvement from patients and carers. The project described in the present study aimed to establish a priority setting partnership allowing patients, carers and healthcare professionals an opportunity to influence the research agenda. METHODS: A national survey was conducted to gather malnutrition uncertainties and identify key issues (i.e. areas within scope where an evidence-base is lacking) from those with experience of malnutrition. Uncertainties were analysed according to themes. Similar questions were grouped and summary questions were developed. A second survey was conducted and respondents were asked to choose their 10 most important summary questions. A workshop was conducted to finalise the top 10 research priorities from the most frequently indicated uncertainties on the interim survey. RESULTS: Overall, 1128 uncertainty questions were submitted from 268 people. The interim survey had 71 responses and a list of the top 26 questions was generated for the workshop. There were 26 questions discussed, ranked and agreed by healthcare professionals, carers and patients at the workshop. The top 10 research priorities were then chosen. These included questions on oral nutritional supplements, vulnerable groups, screening, community care, use of body mass index and technology. CONCLUSIONS: The top 10 research priorities in malnutrition and nutritional screening have been identified from a robust process involving patients, carers and healthcare professionals.

Supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults: a systematic review of nonrandomised studies.

BACKGROUND: Supportive interventions for enhancing dietary intake in malnourished or nutritionally at risk adults are frequently recommended. A recent systematic review of randomised controlled trials identified limited and poor quality evidence to support their use. Observational studies have been shown to compliment and extend their evidence. This review aimed to synthesise evidence from nonrandomised studies aiming to improve nutritional intake in nutritionally vulnerable individuals and to describe their effects on cost, nutritional, clinical and patient centred outcomes. METHODS: Systematic searches of 10 electronic databases were undertaken to May 2013. Reference lists of identified studies and systematic reviews were scrutinised and hand searching of relevant meeting abstracts was undertaken. Titles and abstracts were reviewed, data extracted by two research-ers working independently and summarised using a structured narrative format. RESULTS: Forty-one studies (n = 3751 participants) were identified for inclusion. Interventions identified included changes to the organisation of nutritional care (n = 15), changes to the feeding environment (n = 11), modification to meals (n = 6), supplementation of meals (n = 7) and recipients of home delivered meals (n = 2). Eighteen of 23 studies reported improvements in nutritional intake; however, effects on nutritional status, clinical outcomes and costs were reported in few studies and findings were inconsistent. Eighteen studies reported patient experience, highlighting benefits to nutritional status most commonly as judged by the carers but the methods used lacked rigour. CONCLUSIONS: This systematic review describes a range of interventions that may be implemented in clinical practice. A limited range of outcomes are reported and it is difficult to draw any meaningful conclusions on the effect of the different methods.

Royal College of Physicians Intercollegiate Stroke Working Party evidence-based guidelines for the secondary prevention of stroke through nutritional or dietary modification.

BACKGROUND: Each year, 15 million people worldwide and 110,000 people in England have a stroke. Having a stroke increases the risk of having another. There are a number of additional known risk factors that can be modified by diet. The present study aimed to systematically review key nutrients and diets and their role in secondary prevention, as well as provide evidence-based guidelines for use in clinical practice. The work was conducted as part of the process to develop the 4th edition of the Royal College of Physicians' (RCP) National Clinical Guideline (NCG) for Stroke. METHODS: Questions were generated by the research team, in consultation with the Virtual Stroke Group, an online professional interest group, and the RCP Intercollegiate Stroke Working Party Guideline Development Group. Nine questions covering several individual nutrients and diet combinations were defined and searches conducted up until 31 October 2011 using five electronic databases (Embase, Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library and Web of Science). All included studies were assessed for quality and risk of bias using van Tulder criteria for randomised controlled trials (RCTs) and Quality of Reporting of Meta-analyses (QUORUM) criteria for systematic reviews. RESULTS: Of 4287 abstracts were identified, 79 papers were reviewed and 29 systematic reviews and RCTs were included to provide evidence for the secondary prevention components of the guidelines. For each question, evidence statements, recommendations and practical considerations were developed. CONCLUSIONS: This systematic review process has resulted in the development of evidence-based guidelines for use in clinical practice and has identified areas for further research.

Royal College of Physicians Intercollegiate Stroke Working Party evidence-based guidelines for the nutritional support of patients who have had a stroke.

BACKGROUND: Stroke affects 15 million people each year worldwide and is one of the world's leading causes of death and physical disability. Stroke can result in a decline in nutritional status and this is associated with increased mortality and poor outcomes. The present work aimed to systematically review key aspects of the nutritional support of stroke patients at risk of malnutrition and to provide evidence-based guidelines for use in clinical practice. The work was conducted as part of the process to develop the 4th edition of the Royal College of Physicians' (RCP) 'National Clinical Guideline (NCG) for Stroke'. METHODS: Questions were generated by the search team, together with contributions from members of the Virtual Stroke Group and the RCP Intercollegiate Stroke Working Party Guideline Development Group. Six questions covering several areas of nutritional support after stroke were defined and searches were conducted through to 31 October 2011 using five electronic databases (Embase, Medline, CINAHL, Cochrane Library and Web of Science). All included studies were assessed for quality and risk of bias using the van Tulder criteria for randomised controlled trials (RCTs) and the Quorum criteria for systematic reviews. RESULTS: In total, 4215 abstracts were identified, 24 papers were reviewed and 13 systematic reviews and RCTs were included to provide evidence for the nutritional support components of the guidelines. For each question, evidence statements, recommendations and practical considerations were developed. CONCLUSIONS: This systematic review process has resulted in the development of evidence-based guidelines for use in clinical practice and has identified areas for further research.

Malnutrition and cachexia are associated with poor CAR T-cell therapy outcomes including survival.

BACKGROUND & AIMS: Chimeric Antigen Receptor (CAR) T-cell therapy has emerged as a revolutionary treatment for patients with refractory or relapsed B-cell malignancies. However, a significant proportion of patients experience negative outcomes, including severe inflammatory toxicities and relapse. Cachexia and malnutrition are known secondary syndromes in many cancer patients, attributed to the effects of active malignancy, systemic inflammation, and cumulative treatment burden; however, further research is required to accurately characterise these issues in CAR T-cell patients. The aims of this service evaluation were to explore the changes in nutritional status (malnutrition and cachexia) in CAR T-cell therapy patients and the potential impact on patient outcomes including survival. Additionally, we describe the utilisation of dietetic resources in this specific patient population in a London tertiary referral centre. METHODS: Adult haematology patients receiving licensed CD19-targeting CAR T-cell therapy at University College London Hospital between 01/04/19 and 01/09/21 were included. Data were collected from the time of treatment consent, and throughout admission to day of discharge: body weight (BW), C-reactive protein, albumin, lactate dehydrogenase, nutrition-risk screening scores (hospital-specific) and dietetic input. Clinical outcomes such as 12-month all-cause mortality, intensive care unit (ICU) admission, high-grade toxicities, and length of hospital stay (LoS) were also recorded. Cachexia and malnutrition were defined using the modified Glasgow Prognostic Score (mGPS) and Global Leadership Initiative on Malnutrition (GLIM) consensus, respectively. RESULTS: 114 patients (55.6 ± 15.1 years; 57% males) with B-cell non-Hodgkin's lymphoma (n = 109) and B-cell acute lymphoblastic leukaemia (n = 5), receiving axicabtagene ciloleucel (n = 89) and tisagenlecleucel (n = 25) were included. Median LoS for treatment was 34 (27-38) days. Prior to treatment, 31.5% of patients developed malnutrition, with pre-cachexia/refractory cachexia (mGPS) identified in 43.6% of patients. This altered nutritional status pre-treatment was significantly associated with adverse patient outcomes post-infusion; mGPS was independently associated with inferior overall survival (HR = 3.158, CI = 1.36-7.323, p = 0.007), with malnutrition and mGPS associated with increased LoS (p = 0.037), sepsis (p = 0.022) and ICU admission (p = 0.039). During admission, patients experienced significant BW loss (-5.6% (-8.8 to -2.4); p=<0.001), with 68.4% developing malnutrition. Malnutrition screening during admission identified 57% patients at-risk, with 66.6% of patients referred to dietetics; however, there was a lack of malnutrition screening and dietetic referrals prior to treatment. CONCLUSION: Pre-treatment malnutrition and cachexia was significantly associated with adverse CAR T patient outcomes, including mGPS cachexia status independently associated with inferior overall survival. Further research in this novel space is essential to confirm the extent and impact of nutritional issues, to assist with implementing dietetic pathways, and to identify potential interventions with a view to optimising outcomes.

Dietary counselling with or without oral nutritional supplements in the management of malnourished patients: a systematic review and meta-analysis of randomised controlled trials.

Dietary counselling and oral nutritional supplements (ONS) are recommended for managing malnutrition. A recent systematic review demonstrated (in separate analyses) that dietary counselling and dietary counselling with ONS improved energy intake, weight and some indices of body composition, although there was considerable heterogeneity. The present analysis aimed to examine the effects on mortality and nutritional indices of dietary counselling given with or without ONS and to explore the heterogeneity in the meta-analyses aiming to characterise the groups most likely to benefit from these interventions. A systematic review and meta-analysis was performed using Cochrane methodology. Twenty-six studies were included in the analysis: 12 comparing dietary counselling with usual care and 14 comparing dietary counselling and ONS if required with usual care (2123 participants). Quality of studies varied. Dietary counselling given with or without ONS had no effect on mortality [relative risk (fixed) = 1.12; 95% confidence interval = 0.86-1.46] but was associated with significant but heterogeneous benefits to weight [mean difference (random) = 1.7 kg; 95% confidence interval = 0.86-2.55], energy intake and some aspects of body composition. Subgroup analyses taking into account clinical background, age, nutritional status, type and length of intervention failed to reveal any differences in mortality, weight change and energy intake between groups. There were insufficient data on functional outcomes to explore these findings. Dietary counselling given with or without ONS is effective at increasing nutritional intake and weight but adequately-powered studies in similar patient populations and standardised for factors that might account for variations in response are required.

Systematic review of nutrition support interventions in adult haematology and oncology patients receiving CAR T cell therapy.

BACKGROUND & AIMS: Chimeric Antigen Receptor (CAR) T cell therapy is a novel adoptive immunotherapy that is revolutionising the treatment of haematological malignancies and solid tumours. Maintaining a patient's nutritional status and implementing nutrition support interventions have been shown to improve certain patient outcomes in standard anti-cancer therapies; however, guidance for nutrition support interventions in CAR T cell therapy are lacking. The primary aim of this review was to determine the impact of nutrition support interventions on patient-centred outcomes for adult CAR T cell therapy haematology and oncology patients. The patient-centred outcomes of interest included nutritional status and dietary intake, morbidity, functional status, and mortality. Our secondary aim was to describe the nutrition implications that have been acknowledged (but not fully evaluated) in CAR T cell therapy, and to guide future research and practice. METHODS: Four electronic databases (CENTRAL, Embase, MEDLINE and CINAHL) were searched to January 2021, with additional records identified through handsearching and snowballing. Studies considered eligible for inclusion were randomised control trials (RCT), quasi-RCTs, cohort and observational studies, assessing nutrition support interventions (oral, enteral and/or parenteral) in adult haematology and oncology patients receiving CAR T cell therapy or adoptive immunotherapy. No publication status, year or language restrictions were applied. RESULTS: Two authors reviewed the title and abstracts of 1181 retrieved records; however no studies were eligible for inclusion in this systematic review. CONCLUSIONS: We are currently unable to identify if there is an association between nutrition support interventions and outcomes in CAR T cell therapy for adults with haematological malignancies or solid tumours. Lower quality clinical studies and animal models were identified that permitted us to qualitatively describe the risks for poor nutritional status in this population. This empty review confirms the need for research into the potential impact of nutrition support in CAR T cell therapy, including well-designed RCTs.

Dietary counselling and food fortification in stable COPD: a randomised trial.

BACKGROUND: Malnutrition in chronic obstructive pulmonary disease (COPD) is associated with a poor prognosis, yet evidence to support the role of dietary counselling and food fortification is lacking. A study was undertaken to assess the impact of dietary counselling and food fortification on outcome in outpatients with COPD who are at risk of malnutrition. METHODS: A randomised controlled unblinded trial was performed in 59 outpatients with COPD (6 months intervention and 6 months follow-up). The intervention group received dietary counselling and advice on food fortification and the controls received a dietary advice leaflet. Outcome measures were nutritional status, respiratory and skeletal muscle strength, respiratory function, perceived dyspnoea, activities of daily living (ADL) and quality of life. RESULTS: The intervention group consumed more energy (difference 194 kcal/day; p = 0.02) and protein (difference 11.8 g/day; p<0.001) than controls. The intervention group gained weight during the intervention period and maintained weight during follow-up; the controls lost weight throughout the study. Significant differences were observed between the groups in St George's Respiratory Questionnaire total score (difference 10.1; p = 0.02), Short Form-36 health change score (difference 19.2; p = 0.029) and Medical Research Council dyspnoea score (difference 1.0; p = 0.03); the difference in ADL score approached statistical significance (difference 1.5; p = 0.06). No differences were observed between groups in respiratory function or skeletal and respiratory muscle strength. Improvements in some variables persisted for 6 months beyond the intervention period. CONCLUSION: Dietary counselling and food fortification resulted in weight gain and improvements in outcome in nutritionally at-risk outpatients with COPD, both during and beyond the intervention period.

A review of the evidence for the impact of improving nutritional care on nutritional and clinical outcomes and cost.

BACKGROUND: The association between malnutrition and poor clinical outcome is well-established, yet most research has focussed on the role of artificial nutritional support in its management. More recently, emphasis has been placed on the provision of adequate nutritional care, including nutritional screening and the routine provision of food and drink. The aim of this literature review is to establish the evidence for the efficacy of interventions that might result in improvements in nutritional and clinical outcomes and costs. METHODS: A structured literature review was conducted investigating the role of nutritional care interventions in adults, and their effects on nutritional and clinical outcomes and costs, in all healthcare settings. Ten databases were searched electronically using keywords relating to nutritional care, patient outcomes and healthcare costs. High quality trials were included where available. RESULTS: Two hundred and ninety-seven papers were identified and reviewed. Of these, only two randomised, controlled trials and six other trials were identified that addressed the major issues. A further 99 addressed some aspects of the provision of nutritional care, although very few formally evaluated nutritional or clinical outcomes and costs. CONCLUSIONS: This review reveals a serious lack of evidence to support interventions designed to improve nutritional care, in particular with reference to their effects on nutritional and clinical outcomes and costs. The review suggests that screening alone may be insufficient to achieve beneficial effects and thus more research is required to determine the most cost-effective interventions in each part of the nutritional care pathway, in a variety of healthcare settings and across all age ranges, to impact upon nutritional and clinical outcomes.

Dietary advice for illness-related malnutrition in adults.

BACKGROUND: Illness-related malnutrition has been reported in 10% to 55% of ill people in hospital and the community in areas of food sufficiency. Dietary advice encouraging the use of energy- and nutrient-rich foods rather than oral nutritional supplements has been suggested for managing illness-related malnutrition. OBJECTIVES: To examine evidence that dietary advice to improve nutritional intake in adults with illness-related malnutrition improves survival, weight and anthropometry; to estimate the size of any additional effect of nutritional supplements given in combination with dietary advice. SEARCH STRATEGY: Relevant publications were identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Additional studies were sought by contacting dietitians, clinicians and the manufacturers of nutritional supplements. Last search: September 2007 SELECTION CRITERIA: Randomised controlled trials of dietary advice in people with illness-related malnutrition compared with:(1) no advice;(2) oral nutritional supplements; and(3) dietary advice plus oral nutritional supplements. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility, methodological quality and extracted data. MAIN RESULTS: Thirty-six studies (37 comparisons) met the inclusion criteria with 2714 randomised participants. Twelve trials (comparing dietary advice plus supplements if required with no advice) identified during searching are included as a separate comparison. Follow up ranged from 18 days to 24 months. No comparison showed a significant difference in mortality. There are several significant results for change in weight and other nutritional indices favouring nutritional intervention, but the precise contributions of the different strategies have yet to be determined. It is uncertain whether nutritional supplements and dietary advice produce the same effects. There was insufficient evidence to draw conclusions about clinical outcomes and cost. Few data were available for other outcomes. AUTHORS' CONCLUSIONS: This review highlights the lack of evidence for the provision of dietary advice in managing illness-related malnutrition. Dietary advice plus nutritional supplements may be more effective than dietary advice alone or no advice in enhancing short-term weight gain, but whether this is sustainable, or whether survival and morbidity are improved remains uncertain. A large adequately-powered randomised controlled trial is needed comparing the efficacy of different therapies to increase dietary intake in people with illness-related malnutrition and examining the impact of this on clinical function and survival.