Nature of the evidence base and approaches to guide nutrition interventions for individuals: a position paper from the Academy of Nutrition Sciences.

This Position Paper from the Academy of Nutrition Sciences is the third in a series which describe the nature of the scientific evidence and frameworks that underpin nutrition recommendations for health. This paper focuses on evidence which guides the application of dietary recommendations for individuals. In some situations, modified nutrient intake becomes essential to prevent deficiency, optimise development and health, or manage symptoms and disease progression. Disease and its treatment can also affect taste, appetite and ability to access and prepare foods, with associated financial impacts. Therefore, the practice of nutrition and dietetics must integrate and apply the sciences of food, nutrition, biology, physiology, behaviour, management, communication and society to achieve and maintain human health. Thus, there is huge complexity in delivering evidence-based nutrition interventions to individuals. This paper examines available frameworks for appraising the quality and certainty of nutrition research evidence, the development nutrition practice guidelines to support evidence implementation in practice and the influence of other sources of nutrition information and misinformation. The paper also considers major challenges in applying research evidence to an individual and suggests consensus recommendations to begin to address these challenges in the future. Our recommendations target three groups; those who deliver nutrition interventions to individuals, those funding, commissioning or undertaking research aimed at delivering evidence-based nutrition practice, and those disseminating nutritional information to individuals.

What do readers want? Results of an online survey to involve readers in updating the seventh edition of the Manual of dietetic practice.

BACKGROUND: The Manual of dietetic practice ('Manual') is the core textbook for qualified and student dietitians. A survey was conducted to explore views on the scope, content and presentation of the Manual to inform the forthcoming edition. METHODS: The survey comprised of questions on demographics, structure, content, access (print/digital), missing topics, strengths and weaknesses. It was distributed to members of the British Dietetic Association (BDA) and other relevant groups in August 2022. Responses are presented as frequencies and free text as themes. RESULTS: Of 1179 responses, 91% were from professionals, of whom 72% were registered dietitians with a mean of 12.7 years (range: 1-44) in practice: 60% worked in the United Kingdom with 52% based in a clinical setting. The printed version was preferred: 59% professionals, 60% students, 94% professionals and 88% students were satisfied with the structure; however, 26% professionals and 22% students identified content that was lacking or outdated, including mental health and sustainability. The strengths were its comprehensive coverage and respected contributing authors. Weaknesses included the cost, size, lack of visual aids and currency. Professionals indicated the seventh edition should focus on more practical information required for clinical practice, whereas students wanted more emphasis on summarised information and visual formats. CONCLUSIONS: The survey proved a valuable method to engage with the readership to ensure the next edition reflected their requirements. Although nearly all respondents were satisfied with the scope and content, the results highlighted those topics lacking and/or outdated. Results also showed that the next edition should focus on practical information required for clinical practice, with more summarised and visual formats.

Natural Protein Intake in Children with Phenylketonuria: Prescription vs. Actual Intakes.

In phenylketonuria (PKU), an important component of the UK dietary management system is a 50 mg phenylalanine (Phe)/1 g protein exchange system used to allocate the Phe/natural protein intakes according to individual patient tolerance. Any foods containing protein ≤ 0.5 g/100 g or fruits/vegetables containing Phe ≤ 75 mg/100 g are allowed without measurement or limit. In children with PKU, we aimed to assess the difference between the prescribed natural protein intake and their actual consumed intake, and to calculate the natural protein/Phe intake from foods given without measurement or restriction. Over a 6-month duration, three one-day diet diaries were collected every month by caregivers of children with PKU at the beginning of a follow-up study. Dietary intakes of Phe, as well as natural and total protein intakes, were calculated using Nutritics® (v5.09). Weekly blood Phe spots were collected by caregivers. The target blood Phe level was ≤360 µmol/L for ages up to 12 years and ≤600 µmol/L for ages ≥12 years. Sixteen early treated children (69% females) with PKU were recruited. The median age was 11 years (range: 9-13), and most had classical PKU (n = 14/16). A median of 18 (range 12-18) one-day diaries and 22 blood spots were analysed for each subject over 6 months. The median prescribed natural protein was 6 g/day (range: 3-27), but when calculated, the actual median intake from all foods consumed was 10 g/day (range: 4-37). The median prescribed Phe was 300 mg/day (range: 150-1350), but the actual median intake was 500 mg/day (range: 200-1850). The median difference between the prescribed and actual natural protein daily intakes was +4 g/day (range: -2.5 to +11.5), with a median percentage increase of 40% for natural protein/Phe intake (p < 0.001). The median blood Phe level was 250 µmol/L (range 20-750), with 91% of blood Phe levels within the target range. Only one patient (11 years) had less than 75% of their blood Phe levels within the target range. The UK Phe exchange system provides flexibility in the dietary management of PKU. With this method, the actual natural protein intake was 167% higher than the prescribed amount. Although this led to a variable daily protein intake, the majority of children (n = 15/16) experienced no deterioration in their metabolic control.

A dietitian-led low-FODMAP diet webinar: a pre-post study evaluating its impact on symptoms of irritable bowel syndrome.

BACKGROUND: Evidence suggests that the low fermentable oligo-, di-, mono-saccharides, and polyols (FODMAP) diet improves irritable bowel syndrome (IBS) symptoms when delivered by a dietitian. However, demand for dietetic appointments exceeds supply. Prerecorded webinars are acceptable and cost-effective for delivering first-line IBS dietary advice. METHODOLOGY: This study, using a pre-post design, aimed to evaluate the effectiveness of a low-FODMAP diet restriction phase webinar at improving IBS symptoms. Participants with self-reported IBS symptoms were asked to report their IBS symptoms, stool frequency, stool consistency and IBS medication use, before and 8 weeks postwebinar via an online questionnaire. The presence and severity of participants' symptoms and bowel habits were captured using validated tools and a global symptom question. RESULTS: In total 228 participants responded to both pre- and postsurveys. A statistically significant improvement in all symptoms was observed 8 weeks postwebinar (p < 0.05). The proportion of participants rating their overall symptoms as moderate-to-severe reduced from 85.5% at baseline to 34.6% postwebinar (50.9% reduction [p < 0.001]). The proportion of participants reporting normal stool consistency and frequency significantly increased postwebinar (23.2%-39.9% [p < 0.001] and 76.3%-89% [p < 0.001], respectively). Satisfactory relief of symptoms increased from 16.7% to 53.1%, (p < 0.001) 8 weeks postwebinar. CONCLUSIONS: These results are comparable with literature on the efficacy of face-to-face delivery of low-FODMAP diet education. Dietitians should consider directing triaged patients with IBS, who have tried first-line dietary advice, to this webinar as an alternative or alongside current practice.

A case study of the impact of a dietitian in the multi-disciplinary team within primary care: a service evaluation.

BACKGROUND: Expanding the primary care workforce to alleviate general practitioner (GP) workload, improve access and improve quality of care is a current UK strategy. Evidence suggests dietitians can improve patient outcomes and make cost savings. The present study aimed to evaluate a dietitian working as an expert generalist and first contact practitioner (FCP) in a general practice multi-disciplinary team (MDT) to provide appropriate care to patients and reduce GP workload. METHODS: A dietitian was employed for 6 months at 0.6 full-time equivalents in a group of general practices in Devon, UK. Data were collected on the referral source, patient satisfaction, health outcomes and changes in prescribing data for all patients seen by the dietitian. Focus groups and interviews provided data to understand the experience of introducing a dietitian into the team. RESULTS: This model of service delivery showed the dietitian acting as an expert generalist, a FCP and able to educate the MDT. A range of professionals within the MDT referred patients with a wide range of diagnoses (both paediatric and adults) and the dietitian acted as a FCP for 29% of patients. Saving were made for the optimisation of medicine management. CONCLUSIONS: The dietitian can improve patient-centred care for several patient groups; enhance learning for staff around nutrition and dietary issues; and contribute to more efficient working and cost savings around prescription of nutritional products. This was an evaluation of one service and further research is needed to understand the value dietitians can contribute and the factors supporting effective and efficient working in this context.

Phenylalanine Tolerance over Time in Phenylketonuria: A Systematic Review and Meta-Analysis.

In phenylketonuria (PKU), natural protein tolerance is defined as the maximum natural protein intake maintaining a blood phenylalanine (Phe) concentration within a target therapeutic range. Tolerance is affected by several factors, and it may differ throughout a person's lifespan. Data on lifelong Phe/natural protein tolerance are limited and mostly reported in studies with low subject numbers. This systematic review aimed to investigate how Phe/natural protein tolerance changes from birth to adulthood in well-controlled patients with PKU on a Phe-restricted diet. Five electronic databases were searched for articles published until July 2020. From a total of 1334 results, 37 articles met the eligibility criteria (n = 2464 patients), and 18 were included in the meta-analysis. The mean Phe (mg/day) and natural protein (g/day) intake gradually increased from birth until 6 y (at the age of 6 months, the mean Phe intake was 267 mg/day, and natural protein intake was 5.4 g/day; at the age of 5 y, the mean Phe intake was 377 mg/day, and the natural protein intake was 8.9 g/day). However, an increase in Phe/natural protein tolerance was more apparent at the beginning of late childhood and was >1.5-fold that of the Phe tolerance in early childhood. During the pubertal growth spurt, the mean natural protein/Phe tolerance was approximately three times higher than in the first year of life, reaching a mean Phe intake of 709 mg/day and a mean natural protein intake of 18 g/day. Post adolescence, a pooled analysis could only be performed for natural protein intake. The mean natural protein tolerance reached its highest (32.4 g/day) point at the age of 17 y and remained consistent (31.6 g/day) in adulthood, but limited data were available. The results of the meta-analysis showed that Phe/natural protein tolerance (expressed as mg or g per day) increases with age, particularly at the beginning of puberty, and reaches its highest level at the end of adolescence. This needs to be interpreted with caution as limited data were available in adult patients. There was also a high degree of heterogeneity between studies due to differences in sample size, the severity of PKU, and target therapeutic levels for blood Phe control.

Preliminary Data on Free Use of Fruits and Vegetables Containing Phenylalanine 76-100 mg/100 g of Food in 16 Children with Phenylketonuria: 6 Months Follow-Up.

In phenylketonuria (PKU), a previous intervention study assessing the patients ability to tolerate fruits and vegetables containing phenylalanine 76-100 mg/100 g without limit or measurement, found that an extra 50 mg/day phenylalanine, but not 100 mg/day, was tolerated from these fruits and vegetables. In a further 6-month extension study, we examined the effect of the 'free' use of this group of fruits and vegetables on blood phenylalanine control. For 6 months, the patients ate fruits and vegetables containing phenylalanine 76-100 mg/100 g without limit or measurement. Three-day diet diaries and the patients' weights were collected monthly. Blood phenylalanine spots were collected weekly aiming for blood phenylalanine levels <360 µmol/L. Retrospective blood phenylalanine was collected 6 months pre-trial. All 16 patients (69% females) from the intervention study took part in the extension study. Most of the patients (n = 14/16) had classical PKU with a median age of 10.5 years (range: 6-13). There was no statistically significant difference in the median blood phenylalanine pre-study (270, range: 50-760 µmol/L) compared to the 6-month extension study (250, range: 20-750 µmol/L) (p= 0.4867). The patients had a median of 21 and 22 bloodspots, pre- and post-trial, respectively. In the extension study, the patients had an actual mean intake of 11 g/day (4-37) natural protein and 65 g/day (60-80) protein equivalent from a protein substitute. The mean phenylalanine intake was 563 mg/day (200-1850) with only 19 mg/day (0-146) phenylalanine from fruits and vegetables containing phenylalanine 76-100 mg/100 g. The weight z-scores remained unchanged (1.52 vs. 1.60, p = 0.4715). There was no adverse impact on blood phenylalanine control when fruits and vegetables containing phenylalanine 76-100 mg/100 g were eaten without limit or measurement. However, the fruits and vegetable portion sizes eaten were small (60 g/week). Further longitudinal work is necessary to examine the 'free' use of fruits and vegetables containing phenylalanine 76-100 mg/100 g on metabolic control in patients with PKU.

Alcohol Consumption and Measures of Sarcopenic Muscle Risk: Cross-Sectional and Prospective Associations Within the UK Biobank Study.

Alcohol intake is a major modifiable risk factor for many diseases. Alcohol can also damage skeletal muscle health during ageing which in turn increases risk of sarcopenia, frailty and falls but this relationship is understudied. The aim of this study was to model the relationship between a full range of alcohol consumption and components of sarcopenic risk, skeletal muscle mass and function, in middle-aged and younger older-aged men and women. A cross-sectional analyses was undertaken of 196,561 white participants from the UK Biobank with longitudinal analysis also in 12,298 of these participants, with outcome measures for the latter repeated after around four years. For the cross-sectional analysis fractional polynomial curves were fitted in models of measures of skeletal muscle mass, appendicular lean mass/body mass index (ALM/BMI), fat-free mass as a percentage of body weight (FFM%) and grip strength, all predicted from alcohol consumption with models fitted for men and women separately. Alcohol consumption at baseline was based on the mean of up to five dietary recalls, typically over 16 months. Linear regression was used for longitudinal analyses to model the effects of alcohol consumption groups on these measures. All models were adjusted for covariates. In the cross-sectional analysis, modelled values of the muscle mass measures all showed a peak at medium levels of alcohol consumption and a steep decline with increasing alcohol consumption. Modelled differences in muscle mass from zero consumption of alcohol to 160 g/d ranged from 3.6 to 4.9% for ALM/BMI for men and women, respectively, and 3.6 to 6.1% for FFM%. Grip strength consistently increased with alcohol consumption. No association between alcohol consumption and muscle measures were seen in the longitudinal results. Our results suggest that higher levels of alcohol consumption could have detrimental effects on muscle mass in middle- and older-aged men and women.

Developing a consensus to support health and social care professionals and patients manage nutrition in the context of COVID-19 recovery.

BACKGROUND: The long-term effects on people who have had COVID-19 affect nutrition and can be influenced by diet conversely. Specific nutritional guidelines, however, were scarce at the beginning of 2020, and empirical literature was also lacking. Conventional research methodologies needed to be adapted to review the available literature that could be relevant to the United Kingdom and policy documents as well as collect the views of health and care staff. The aim of this paper is to describe the method to develop consensus statements from experts to address the necessary nutritional support and what emerged from this. METHODS: A nominal group technique (NGT) was adapted to the virtual world; we purposefully selected a range of professionals (dietitians, nurses, occupational therapists, etc.) and patients with long-term effects of COVID to present them with the most updated evidence and aim to reach key guidelines to address COVID-19 recovery. RESULTS: We were able to reach consensus statements that were developed and reviewed by relevant healthcare staff at the front line to address the nutritional needs of patients recovering from COVID-19 and those suffering from its long-term effects. This adapted NGT process led us to understand that a virtual repository of concise guidelines and recommendations was needed. This was developed to be freely accessed by both patients recovering from COVID-19 and health professionals who manage them. CONCLUSIONS: We successfully obtained key consensus statements from the adapted NGT, which showed the need for the nutrition and COVID-19 knowledge hub. This hub has been developed, updated, reviewed, endorsed and improved across the subsequent 2 years.

A core outcome set for childhood epilepsy treated with ketogenic diet therapy (CORE-KDT study): International parent and health professional consensus.

OBJECTIVE: Ketogenic diet therapy (KDT) can result in benefits (seizure-related and non-seizure-related) for children with drug-resistant epilepsy. However, clinical trials report a wide range of outcomes, making synthesis of evidence difficult, and do not adequately reflect parent views on important outcomes for their child. To address this, we established the first international parent, health professional, and researcher consensus to develop a core outcome set, guided by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative (COMET registration #1116). METHODS: Ethical approval was granted (London-Surrey REC19/LO/1680). A scoping review and interviews with parents identified a comprehensive list of potentially important outcomes, followed by a two-round online Delphi survey of parents and health professionals to prioritize outcomes of importance for inclusion in a core outcome set. This informed a stakeholder consensus meeting and consultation process to finalize the core outcome set. RESULTS: In total, 97 outcomes were identified; 90 from the scoping review and seven from parent interviews. These were rationalized to 77 by the study advisory group, then rated in the first Delphi round by 49 parents and 96 health professionals, who suggested 12 new outcomes for rating in Round 2. Sixty-six percent of participants (30 parents and 66 professionals) completed Round 2, where 22 outcomes met criteria for inclusion. In the consensus meeting (nine parents and 13 professionals), 27 undecided outcomes were discussed and scored; one further outcome reached consensus for inclusion. After consultation and ratification, 14 outcomes across five domains were included in the core outcome set. SIGNIFICANCE: A core outcome set for childhood epilepsy treated with KDT has been developed, incorporating the views of international parents and professionals. Implementation in research and clinical settings will standardize outcome selection and reporting, facilitate data synthesis, and ultimately enhance the relevance of outcomes to parents, researchers, and health professionals.

Handgrip Strength Index: A Novel Parameter Which Quantifies Clinical Weakness in People on Haemodialysis.

OBJECTIVE: The muscle strength in people on haemodialysis is associated with nutritional status, quality of life, functional independence, and survival. Handgrip Strength (HGS) is simple to measure, but clinical interpretation is limited by the lack of reference ranges for a haemodialysis population. This study aims to define a novel parameter, HGS index, which quantifies degree of clinical weakness specific to a haemodialysis population and to test if this predicts survival. METHODS: In a cross-sectional single center study HGS was measured in stable participants on haemodialysis. HGS in the well-nourished subgroup, was used to develop a predictive equation for "expected" HGS according to demographic variables. This then was compared to observed HGS resulting in HGS index (%), an individualized parameter indicating weakness due to clinical variables while accounting for demographic contributors to strength. The association between HGS index and survival was explored in all participants. RESULTS: Among 427 well-nourished individuals on haemodialysis, HGS was strongly associated with demographic variables and predicted in males by the equation: HGS (kg) = 0.38∗height (cm) - 0.31∗age (years) - 18, and in females by the equation: HGS (kg) = 0.25∗height (cm) - 0.11∗age (years) - 16. Among 547 participants (22% with protein energy wasting), lower HGS index was associated with diabetes (P = .004), lower body mass index (BMI) (P = .005), lower albumin (P = .033), and longer dialysis vintage (P = .007). Over a mean observation period of 2.8 years, quintile of HGS index was strongly associated with survival (P = .023), and in a Cox proportional hazards model, the independent predictors of mortality were age, albumin, BMI and HGS index. CONCLUSION: HGS index, defined as observed relative to expected HGS, is an individualized measure of clinical weakness. It is a novel parameter which independently predicts survival. HGS index improves the detection of clinically relevant muscle weakness in people on haemodialysis, opening up the possibility of earlier, individualized interventions, and improving outcomes in this vulnerable group.

Nature of the evidence base and strengths, challenges and recommendations in the area of nutrition and health claims: a position paper from the Academy of Nutrition Sciences.

The regulation of health claims for foods by the Nutrition and Health Claims Regulation is intended, primarily, to protect consumers from unscrupulous claims by ensuring claims are accurate and substantiated with high quality scientific evidence. In this position paper, the Academy of Nutrition Sciences uniquely recognises the strengths of the transparent, rigorous scientific assessment by independent scientists of the evidence underpinning claims in Europe, an approach now independently adopted in UK. Further strengths are the separation of risk assessment from risk management, and the extensive guidance for those submitting claims. Nevertheless, four main challenges in assessing the scientific evidence and context remain: (i) defining a healthy population, (ii) undertaking efficacy trials for foods, (iii) developing clearly defined biomarkers for some trial outcomes and (iv) ensuring the composition of a food bearing a health claim is consistent with generally accepted nutrition principles. Although the Regulation aims to protect the consumer from harm, we identify some challenges from consumer research: (i) making the wording of some health claims more easily understood and (ii) understanding the implications of the misperceptions around products bearing nutrition or health claims. Recommendations are made to overcome these challenges. Further, the Academy recommends that a dialogue is developed with the relevant national bodies about Article 12(c) in the Regulation. This should further clarify the GB Guidance to avoid the current non-level playing field between health professionals and untrained 'influencers' who are not covered by this Article about the communication of authorised claims within commercial communications.

Impact of a dietitian in general practice: paediatric food allergy.

BACKGROUND: Food allergy in infants and young children places a significant burden on primary care. This study evaluated a dietetic-led paediatric food allergy service, which attempts to provide more rapid access to the dietitian and reduce the need for general practitioner (GP) and secondary care appointments. METHODS: Two community dietetic services for children referred with food allergy were compared. The first was dietetic-led care where dietitians train community children's nurses to recognise potential cases of food allergy, undertake basic diagnostic assessment and subsequently refer to the dietitian. The other was a more traditional dietetic community service where patients were referred predominantly by the GP or secondary care. RESULTS: In dietetic-led care 86 patients were seen, compared to 96 in dietetic community care. Dietetic-led care received fewer referrals from the GP, 36% versus 67% (p < 0.001); GP appointments for allergy-related conditions prior to dietetic referral were lower, 3 versus 6 visits (p = 0.001); and input from secondary care was also lower, 8 versus 25 patients (p = 0.002) compared with dietetic community care. Children referred to dietetic-led care were younger, 78% <6 months versus 40% (p < 0.001) in dietetic community care. CONCLUSIONS: Dietetic-led care describes a model that has the potential to reduce GP and secondary care appointments, identify patients more quickly and reduce the time to receive dietetic input, thereby resolving symptoms more quickly and reducing prescribed medications. This model demonstrates the importance of integrated care and multidisciplinary working, offering a solution to reducing GP workload while maintaining or improving patient care.

Impact of Fruit and Vegetable Protein vs. Milk Protein on Metabolic Control of Children with Phenylketonuria: A Randomized Crossover Controlled Trial.

Fruits and vegetables containing phenylalanine ≤ 75 mg/100 g (except potatoes) have little impact on blood phenylalanine in phenylketonuria (PKU). In a randomized, controlled, crossover intervention trial, we examined the effect of increasing phenylalanine intake from fruits and vegetables, containing phenylalanine 76−100 mg /100 g, compared with milk protein sources on blood phenylalanine control. This was a five-phase study (4 weeks each phase). In Phase A, patients remained on their usual diet and then were randomly allocated to start Phase B and C (an additional phenylalanine intake of 50 mg/day, then 100 mg from fruits and vegetables containing phenylalanine 76−100 mg/100 g) or Phase D and E (an additional phenylalanine intake of 50 mg/day then 100 mg/day from milk sources). There was a 7-day washout with the usual phenylalanine-restricted diet between Phase B/C and D/E. Blood phenylalanine was measured on the last 3 days of each week. If four out of six consecutive blood phenylalanine levels were >360 µmol/L in one arm, this intervention was stopped. Sixteen patients (median age 10.5 y; range 6−12 y) were recruited. At baseline, a median of 6 g/day (range: 3−25) natural protein and 60 g/day (range: 60−80) protein equivalent from protein substitute were prescribed. Median phenylalanine levels were: Phase A­240 µmol/L; Phase B­260 µmol/L; Phase C­280 µmol/L; Phase D­270 µmol/L and Phase E­280 µmol/L. All patients tolerated an extra 50 mg/day of phenylalanine from fruit and vegetables, containing phenylalanine 76−100 mg/100 g, but only 11/16 (69%) tolerated an additional 100 mg /day. With milk protein, only 8/16 (50%) tolerated an extra 50 mg/day and only 5/16 (31%) tolerated an additional 100 mg/day of phenylalanine. Tolerance was defined as maintaining consistent blood phenylalanine levels < 360 µmol/L throughout each study arm. There was a trend that vegetable protein had less impact on blood phenylalanine control than milk protein, but overall, the differences were not statistically significant (p = 0.152). This evidence supports the PKU European Guidelines cutoff that fruit and vegetables containing 76−100 mg phenylalanine/100 g should be calculated as part of the phenylalanine exchange system. Tolerance of the 'free use' of these fruits and vegetables depends on inter-patient variability but cannot be recommended for all patients with PKU.

The CORE-KDT study: a mixed methods protocol to establish core outcomes for refractory childhood epilepsy treated with ketogenic diet therapy.

BACKGROUND: A core outcome set defines the minimum outcomes that should be included in clinical trials, audit or practice. The aim being to increase the quality and relevance of research by ensuring consistency in the measurement and reporting of outcomes. Core outcome sets have been developed for a variety of disease states and treatments. However, there is no established set of core outcomes for refractory childhood epilepsy treated with ketogenic diet therapy. This should be developed using a patient-centred approach to ensure the outcomes measured are relevant to patients and clinical practice. METHODS: This is a mixed methods study of four phases to develop a core outcome set for refractory childhood epilepsy treated with ketogenic diet therapy. In phase 1, a systematic scoping review of the literature will establish which outcomes are measured in trials of refractory epilepsy treated with ketogenic diet therapy. In phase 2, qualitative interviews with parents and carers will aim to identify the outcomes of importance to these stakeholders. Phase 3 will see a comprehensive list of outcomes collated from the first two phases, grouped into domains according to an outcome taxonomy. Phase 4 will invite parents, health care professionals and researchers to participate in a two-round Delphi study to rate the importance of the presented outcomes. Following which, the core outcome set will be ratified at a face to face consensus meeting. DISCUSSION: This study will guide outcome measurement in future studies of childhood epilepsy treated with ketogenic diet therapy and clinical practice through audit and service evaluation.

Effectiveness of general practitioner-delivered nutrition care interventions on dietary and health outcomes in adults with diet-related chronic conditions: a systematic review protocol.

OBJECTIVE: This systematic review will evaluate the effectiveness of nutrition care interventions delivered by general practitioners versus usual care or no care on dietary and health outcomes in adults with diet-related chronic conditions or risk states. INTRODUCTION: General practitioners are usually the first contacts in the health care system for patients with diet-related chronic conditions. While there is some evidence that general practitioners can be effective in delivering nutrition care for a number of outcomes, to inform future care, an update of the evidence is required as well as an examination of which components are associated with positive outcomes. INCLUSION CRITERIA: Published studies will be included if they report on adults with or at risk of diet-related chronic conditions; one-on-one nutrition care interventions individually delivered by general practitioners during primary care consultations; usual or no care as comparators; dietary and/or health outcomes with a minimum three-month follow-up; and randomized controlled trials. Included studies will be available in, or able to be translated into, English and will have no date restrictions. METHODS: The databases to be searched will include CINAHL, Embase, MEDLINE, and ProQuest Nursing and Allied Health. Following deduplication, two reviewers will independently screen the titles and abstracts in Covidence, followed by the full texts of potentially relevant studies. Disagreements will be resolved through discussion or with a third reviewer. Included studies will be critically appraised and data will be extracted using a modified JBI tool. Findings will be reported in tables and narrative synthesis, and pooled with statistical meta-analysis, where possible. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42021289011.