The Dutch Dystrophinopathy Database: A National Registry with Standardized Patient and Clinician Reported Real-World Data1.

Background: Duchenne and Becker muscular dystrophy lack curative treatments. Registers can facilitate therapy development, serving as a platform to study epidemiology, assess clinical trial feasibility, identify eligible candidates, collect real-world data, perform post-market surveillance, and collaborate in (inter)national data-driven initiatives. Objective: In addressing these facets, it's crucial to gather high-quality, interchangeable, and reusable data from a representative population. We introduce the Dutch Dystrophinopathy Database (DDD), a national registry for patients with DMD or BMD, and females with pathogenic DMD variants, outlining its design, governance, and use. Methods: The design of DDD is based on a system-independent information model that ensures interoperable and reusable data adhering to international standards. To maximize enrollment, patients can provide consent online and participation is allowed on different levels with contact details and clinical diagnosis as minimal requirement. Participants can opt-in for yearly online questionnaires on disease milestones and medication and to have clinical data stored from visits to one of the national reference centers. Governance involves a general board, advisory board and database management. Results: On November 1, 2023, 742 participants were enrolled. Self-reported data were provided by 291 Duchenne, 122 Becker and 38 female participants. 96% of the participants visiting reference centers consented to store clinical data. Eligible patients were informed about clinical studies through DDD, and multiple data requests have been approved to use coded clinical data for quality control, epidemiology and natural history studies. Conclusion: The Dutch Dystrophinopathy Database captures long-term patient and high-quality standardized clinician reported healthcare data, supporting trial readiness, post-marketing surveillance, and effective data use using a multicenter design that is scalable to other neuromuscular disorders.

A longitudinal follow-up study of parent-reported family impact and quality of life in young patients with traumatic and non-traumatic brain injury.

PURPOSE: Brain injuries (traumatic-/nontraumatic, TBI/nTBI) in young patients may lead to problems e.g., decreased health-related quality of life (HRQoL), and causes family impact. Knowledge regarding the family impact and the relationship with patients' HRQoL over time is scarce. This follow-up study describes family impact/HRQoL and their mutual relationship in young patients (5-24 years) after TBI/nTBI. MATERIALS AND METHODS: Parents of patients that were referred to outpatient rehabilitation completed the PedsQL™Family-Impact-Module questionnaire to assess the family impact and the parent-reported PedsQL™Generic-core-set-4.0 to assess patients' HRQoL (lower scores: more family impact/worse HRQoL). Questionnaires were completed at the time of referral to rehabilitation (baseline) and one/two years later (T1/T2). Linear-mixed models were used to examine family impact/HRQoL change scores, and repeated-measure correlations (r) to determine longitudinal relationships. RESULTS: Two-hundred-forty-six parents participated at baseline, 72 (at T2), median patient's age at baseline was 14 years (IQR:11-16), and 181 (74%) had TBI. Mean (SD) PedsQL™Family-Impact-Module score at baseline was 71.7 (SD:16.4) and PedsQL™Generic-core-set-4.0: 61.4 (SD:17.0). Over time, PedsQL™Family-Impact-Module scores remained stable, while PedsQL™Generic-core-set-4.0 scores improved significantly(p < 0.05). A moderately strong longitudinal correlation was found between family impact&HRQoL (r = 0.51). CONCLUSIONS: Family impact does not tend to decrease over time but remained a considerable problem, although patients' HRQoL improved. Next to focusing on patients' HRQoL, it remains important to consider family impact and offer family support throughout rehabilitation.IMPLICATIONS FOR REHABILITATIONThis longitudinal study found that in young patients with traumatic brain injury (TBI) or non-traumatic brain injury (nTBI) referred for rehabilitation there is a considerable impact on the family until two years after referral, whereas the patients' health-related quality of life (HRQoL) improved significantly.Improvements in patients' quality of life status may not automatically lead to a decrease of family impact.Rehabilitation clinicians should monitor the impact on the family over time and provide long-term family support with special attention to parental worrying when needed.Clinicians should be aware that, despite significant differences between the clinical characteristics of patients with TBI and nTBI, the courses of family impact are very similar.

Do German university medical centres promote robust and transparent research? A cross-sectional study of institutional policies.

BACKGROUND: In light of replication and translational failures, biomedical research practices have recently come under scrutiny. Experts have pointed out that the current incentive structures at research institutions do not sufficiently incentivise researchers to invest in robustness and transparency and instead incentivise them to optimize their fitness in the struggle for publications and grants. This cross-sectional study aimed to describe whether and how relevant policies of university medical centres in Germany support the robust and transparent conduct of research and how prevalent traditional metrics are. METHODS: For 38 German university medical centres, we searched for institutional policies for academic degrees and academic appointments as well as websites for their core facilities and research in general between December 2020 and February 2021. We screened the documents for mentions of indicators of robust and transparent research (study registration; reporting of results; sharing of research data, code and protocols; open access; and measures to increase robustness) and for mentions of more traditional metrics of career progression (number of publications; number and value of awarded grants; impact factors; and authorship order). RESULTS: While open access was mentioned in 16% of PhD regulations, other indicators of robust and transparent research were mentioned in less than 10% of institutional policies for academic degrees and academic appointments. These indicators were more frequently mentioned on the core facility and general research websites. Institutional policies for academic degrees and academic appointments had frequent mentions of traditional metrics. CONCLUSIONS: References to robust and transparent research practices are, with a few exceptions, generally uncommon in institutional policies at German university medical centres, while traditional criteria for academic promotion and tenure still prevail.

Development and validation of ion-pairing HPLC-CAD chromatography for measurement of Islatravir's phosphorylated intermediates.

Biocatalytic processes have become more prevalent in the pharmaceutical industry, leading to analytical challenges not faced when characterizing more traditional synthetic routes. A novel one-pot biocatalytic process has been established for Islatravir, an HIV reverse transcriptase translocation inhibitor for the treatment and prevention of HIV-1. As a one-pot reaction, the Islatravir chemistry contains multiple intermediates that are not isolated. Additionally, these unisolated intermediates have no chromophores, making traditional LC-UV techniques ineffective for characterization. A hydrophilic interaction chromatography (HILIC) method with a charged aerosol detector (CAD) was initially developed, however numerous inorganic species present in the one-pot reaction were retained; this led to co-elution of compounds and poor peak shapes. An innovative ion-pairing LC method was developed in order to resolve inorganic species, intermediates, and the API, for use during in-process control of the Islatravir biocatalytic reaction. Aided by a volatile ion-pairing reagent compatible with the CAD, this method successfully retains and resolves the highly polar intermediates of interest and Islatravir API. This novel method was successfully validated and has allowed the Islatravir biocatalytic process to be fully characterized from the early intermediates through the final API within the one-pot reaction without the need for isolations. This novel ion-pairing HPLC-CAD technique lays the groundwork for method development on current and future biocatalytic-produced drug substances.

Towards a paradigm shift in pediatric rehabilitation: accelerating the uptake of evidence on participation into routine clinical practice.

PURPOSE: Evidence for the importance of focusing on participation to promote health and wellbeing in childhood-onset disability exists, but practice is slow to change. This paper provides a knowledge translation roadmap to accelerate uptake of participation evidence into day-to-day practice. MATERIALS AND METHODS: A structured roadmap to guide knowledge translation initiatives for implementing participation-based practices in co-creation with service users was developed based on elements from: the Five-factorframework for predicting implementation outcomes, the Cultural Cone framework, and the Knowledge-to-Action model. RESULTS: Guiding principles paired with examples of multi-component knowledge implementation strategies to facilitate readiness for change by stakeholders at the micro (e.g., client/family, service providers), meso (e.g., administrators within organisations such as rehabilitation centres, hospitals, schools) and macro (e.g., local and governmental policy, regulatory bodies) levels are introduced. Solution-based strategies are provided to facilitate "readiness to change" for each stakeholder group. The strategies are examples for successful implementation of evidence-based interventions/approaches that can be contextualized across settings. CONCLUSIONS: The knowledge translation roadmap can assist children and families, service providers, administrators, and policymakers to bridge existing knowledge-to-practice gaps surrounding participation. Partnering and collaborating through a "family-clinician-manager-community leader-policymaker" synergy is key for achieving strategic practice change focussed on participation.Implications for RehabilitationSound evidence surrounding the topic of participation, including effective assessments and interventions, is available and ready for use.Shifting towards participation-focused practices for children and youth with disabilities requires a systemic multi-level KT approach.Our Participation-KT roadmap, comprised of a framework and a list of principles and strategies for implementation, can be used to guide all stakeholders to foster a shift in practice.Forming partnerships and working collaboratively with all stakeholders is key for successful implementation.

Parent-reported family impact in children and young adults with acquired brain injury in the outpatient rehabilitation setting.

Purpose: To increase knowledge/awareness on family impact (FI) after acquired brain injury (ABI) in rehabilitation settings, it is essential to investigate the associations between patient-functioning and impact on families. This has been explored in hospital-based cohorts, but not in rehabilitation settings.Methods: A cross-sectional, multi-center study among parents of children/young adults (aged 5-24 years) with ABI referred to rehabilitation was performed. Patient/injury/family-characteristics were noted, and parents completed the PedsQL™Family-Impact-Module and PedsQL™generic-core-4.0 to assess FI and health-related quality of life (HRQoL). Univariate- and multivariable-regression analyses were performed to investigate associations between HRQoL/patient/injury/family-related factors and FI.Results: 246 families participated; patients' median age was 14 year (IQR 11-16), 65 had non-traumatic-brain-injury (nTBI) (26%), 127 were female. FI was found to be considerable (median FIM-score 71.9, IQR:60-85). Especially referral to rehabilitation >6 months after onset, diminished patients' mental/emotional health and HRQoL (child/family factors), and premorbid problems were associated with higher FI.Conclusions: In this rehabilitation cohort, pediatric ABI caused considerably higher FI than in hospital-based studies with referral to rehabilitation >6 months, diminished child/family factors and presence of premorbid problems increasing FI. Assessing and monitoring FI and its associated factors enables professionals to individualize treatment, psychoeducation, support and follow-up.

Absence of colon as the predominant risk factor for liver fibrosis in adults requiring home parenteral nutrition.

BACKGROUND: Liver fibrosis is a well-known complication of long-term use of parenteral nutrition in patients with intestinal failure associated to the nutrient composition in parenteral nutrition. This study investigates the prevalence of significant liver fibrosis and identifies risk factors for liver fibrosis. METHODS: This was a retrospective study of 35 parenteral nutrition-dependent patients with intestinal failure and 54 patients with intestinal insufficiency and oral nutrition only with a valid liver stiffness measurement obtained with transient elastography from November 2016 to August 2018. Clinical and demographic parameters including age, fat mass index and fat-free mass index, intact colon or colectomy, and nutritional management were analyzed for their association with liver stiffness. RESULTS: A prevalence for liver fibrosis (liver stiffness >7.0 kPa) was established at 37.1% in parenteral nutrition-dependent patients and at 22.2% in patients on oral nutrition. Several factors were significantly and independently associated with liver fibrosis including lipids in home parenteral nutrition (OR 10.66, p = 0.010) and colectomies (OR 3.24, p = 0.036). CONCLUSION: More than a third of patients receiving home parenteral nutrition have liver fibrosis. Several risk factors were demonstrated such as the amount of lipids and performed colectomies despite current international guidelines for lipids are followed. Our findings emphasize suggest a new perspective to prevent significant hepatic complications: colectomies.

Design of an in vitro biocatalytic cascade for the manufacture of islatravir.

Enzyme-catalyzed reactions have begun to transform pharmaceutical manufacturing, offering levels of selectivity and tunability that can dramatically improve chemical synthesis. Combining enzymatic reactions into multistep biocatalytic cascades brings additional benefits. Cascades avoid the waste generated by purification of intermediates. They also allow reactions to be linked together to overcome an unfavorable equilibrium or avoid the accumulation of unstable or inhibitory intermediates. We report an in vitro biocatalytic cascade synthesis of the investigational HIV treatment islatravir. Five enzymes were engineered through directed evolution to act on non-natural substrates. These were combined with four auxiliary enzymes to construct islatravir from simple building blocks in a three-step biocatalytic cascade. The overall synthesis requires fewer than half the number of steps of the previously reported routes.

Revealing the inner workings of the power function algorithm in Charged Aerosol Detection: A simple and effective approach to optimizing power function value for quantitative analysis.

In recent years, charged aerosol detection (CAD) has become a valuable tool for fast and efficient quantitative chromatographic analysis of drug substances with weak UV absorption. In analytical method development using CAD, the power function settings available in the instrument software are key for linearization of the signal response with respect to analyte concentration. However, the relatively poor understanding of the power function algorithm has limited a more widespread use of CAD for quantitative assays, especially in the late stage of method validation and GMP laboratories. Herein, we present an approach to understand the inner workings of the power function value (PFV), the PFV optimization algorithm, as well as a method to determine the optimum PFV based on the signals acquired at PFV = 1 (default CAD settings). The exponent and the constant in the PFV equation used for modeling follow a trend as a function of PFV. The CAD signal at any PFV was modeled based on the signal acquired at PFV = 1, the modelling was successful for two analytes at different concentration levels on two different CAD detectors of the same model. This method reveals the functionality of the PFV which substantially simplifies the workflow needed to optimize the detector signal. The accuracy between the experimental and theoretical results showed high correlation and always resulted in the same optimum PFV determined by both ways. The approach described in this investigation simplifies the selection of the optimum PFV at which the signal is more linear, the signal-to-noise is higher, and the area reproducibility is better. The power function algorithm elucidated herein enables determination of optimum PFV from minimal experimental output and excellent overall accuracy. This paper provides an approach that includes no data transformation outside the vendor software, a very important requirement to easily validate and report results in a GMP environment.

Longitudinal alterations in nutrient intake and food pattern in patients with non-small cell lung cancer during anti-neoplastic treatment: a cohort study.

BACKGROUND: Unintentional weight loss is frequently observed in cancer patients. Nutritional therapy is essential, and dietary counselling is the first step. The present study aimed to explore the nutrient intake and food patterns in weight-stable and weight-losing patients with non-small cell lung cancer (NSCLC) during anti-neoplastic treatment. METHODS: Patients with NSCLC (n = 62) were observed during first-line systemic anti-neoplastic treatment. Body weight and dietary intake were assessed on the first and second cycle, and after completing three cycles of treatment. Longitudinal changes were analysed in three groups: weight stable, weight losers and mixed weight. RESULTS: Nutrient intake did not change during treatment in weight stable, although weight losers significantly increased the relative protein intake. Weight stable maintained the food pattern during treatment apart from a decreased consumption of oral nutritional support (ONS). At baseline, weight losers were characterised by pretreatment weight loss, high consumption of ONS, as well as low consumption of grains and animal products. During treatment, weight losers increased the consumption of protein, fatty foods and ONS but decreased the consumption of sweets and alcohol. CONCLUSIONS: Large heterogeneity in nutrient and food intake was observed in NSCLC patients during anti-neoplastic treatment. Weight losers and weight stable had a similar nutrient intake although protein intake increased in weight losers. Grains and animal products were lower and ONS higher in weight losers compared to weight stable during treatment. Weight losers further increased the consumption of ONS and fatty foods, while the consumption of sweets and alcohol decreased during treatment.

Multi-column ultra-high performance liquid chromatography screening with chaotropic agents and computer-assisted separation modeling enables process development of new drug substances.

Modern process research and development can often be hampered by the tedious method development required to chromatographically resolve mixtures of chemical species with very similar physical properties. Herein, we describe a simple approach for the development and implementation of an efficient ultra-high performance liquid chromatography (UHPLC) assay that is extensively applied to the separation and analysis of multicomponent reaction mixtures of closely related pharmaceutical intermediates and impurities. Methods are optimized using multi-column and multi-solvent UHPLC screening in conjunction with chromatography simulation software (ACD Labs/LC Simulator). This approach is implemented to enable the separation, identification, mapping and control of impurities formed within the process chemistry optimization of the dimeric catalyst used in the synthesis of new drug substances. The final method utilized a sub-2 µm C18 stationary phase (2.1 mm I.D. × 50 mm length, 1.7 µm particle size ACQUITY UPLC BEH C18) with a non-conventional chaotropic mobile phase buffer (35 mM potassium hexafluorophosphate in 0.1% phosphoric acid/acetonitrile) in order to achieve baseline separation of all reaction components. The chromatographic simulation and modeling strategy served to generate 3D resolution maps with robust separation conditions that match the outcome of subsequent experimental data (overall ΔtR < 0.35%). Our multi-column UHPLC screening with computer-assisted chromatographic modeling is a great addition to the toolbox of synthetic chemists and can be a powerful tool for streamlining process chemistry optimization in organic chemistry laboratories across both academic and industrial sectors.

Respiratory and upper limb function as outcome measures in ambulant and non-ambulant subjects with Duchenne muscular dystrophy: A prospective multicentre study.

The field of translational research in Duchenne muscular dystrophy (DMD) has been transformed in the last decade by a number of therapeutic targets, mostly studied in ambulant patients. A paucity of studies focus on measures that capture the non-ambulant stage of the disease, and the transition between the ambulant and non-ambulant phase. In this prospective natural history study, we report the results of a comprehensive assessment of respiratory, upper limb function and upper limb muscle strength in a group of 89 DMD boys followed in 3 European countries, 81 receiving corticosteroids, spanning a wide age range (5-18 years) and functional abilities, from ambulant (n = 60) to non-ambulant (n = 29). Respiratory decline could be detected in the early ambulatory phase using Peak Expiratory Flow percentage predicted (PEF%), despite glucocorticoid use (mean annual decline: 4.08, 95% CI [-7.44,-0.72], p = 0.02 in ambulant; 4.81, 95% CI [-6.79,-2.82], p < 0.001 in non-ambulant). FVC% captured disease progression in non-ambulant DMD subjects, with an annual loss of 5.47% (95% CI [-6.48,-4.45], p < 0.001). Upper limb function measured with the Performance of Upper Limb (PUL 1.2) showed an annual loss of 4.13 points (95% CI [-4.79,3.47], p < 0.001) in the non-ambulant cohort. Measures of upper limb strength (MyoGrip and MyoPinch) showed a continuous decline independent of the ambulatory status, when reported as percentage predicted (grip force -5.51%, 95% CI [-6.54,-4.48], p < 0.001 in ambulant and a slower decline -2.86%; 95% CI -3.29,-2.43, p < 0.001, in non-ambulant; pinch force: -2.66%, 95% CI [-3.82,-1.51], p < 0.001 in ambulant and -2.23%, 95% CI [-2.92,-1.53], p < 0.001 in non-ambulant). Furthermore, we also explored the novel concept of a composite endpoint by combining respiratory, upper limb function and force domains: we were able to identify clear clinical progression in patients in whom an isolated measurement of only one of these domains failed to appreciate the yearly change. Our study contributes to the field of natural history of DMD, linking the ambulant and non-ambulant phases of the disease, and suggests that composite scores should be explored further.

Protein and energy intake improved by in-between meals: An intervention study in hospitalized patients.

BACKGROUND/AIM: Disease related malnutrition is a major problem in hospitals. Malnutrition in hospitalized patients is caused by many factors. Among these factors are decreased appetite and early satiety, and reaching nutritional requirements in nutritional risk patients is a challenge when using ordinary energy and protein dense food. The aim of this study was to examine if total protein and energy intake in medical and surgical patients at nutritional risk could be improved by protein fortified and energy rich in-between meals. METHODS: An assortment of fortified in-between meals including 10 g of protein was developed based on patient preferences and served in the Departments of Lung Medicine and Abdominal Surgery for a period of three months. Nutrition intake was recorded before and after intervention. RESULTS: Food intake records were collected from a total of 92 patients, (46 before and 46 after intervention). The total amount of protein intake per in-between meal was increased from 2,6 g to 10,3 g. Total daily protein intake increased from 49% to 88% (p < 0.00) and total energy intake from 74% to 109% (p < 0.00) of requirements. CONCLUSION: Protein and energy intake for surgical and medical patients at in-between meals as well as total daily intake increased significantly. Recommended average level for individually measured requirements was reached.

Insufficient intake of energy and protein is related to physical functional capacity among COPD patients referred to municipality based pulmonary rehabilitation.

BACKGROUND: Malnutrition is frequent in COPD. Malnourished patients participating in pulmonary rehabilitation (PR) may benefit less and even worsen prognosis. The aim of this study was to investigate energy and protein intake in outpatients with COPD referred to municipality based PR and to investigate the relation to functional capacity. METHODS: COPD patients referred to PR at five Danish municipals were assessed for energy and protein intake by self-reported intake record and 24-hour recall by a dietician. Nutritional status was assessed by BMI, weight loss, and eating validation scheme, functional status by 30-seconds chair stand (30s-CST), and 6-minutes walking test (6MWT), and severity of disease by FEV1 and mMRC. RESULTS: We included 79 patients (41% male and 73% above 65 + y). Ninety-six% had a FEV1 below 80%, 59% had a mMRC-score of 3 + and 14% had a BMI below 20 kg/m2. Fifty-one % and 41% of the patients had insufficient intake of protein and energy, respectively, defined as an average intake below the 75% of the recommended. Kruskal Wallis test showed a significant positive association between protein intake and 30s-CST (p = 0.012) and 6MWT (p = 0.024) but no association with energy intake. CONCLUSIONS: Among patients with COPD referred for PR, there is a high prevalence of insufficient intake of energy and protein. This causes concern, as the physical training, which is the main component of PR, is likely to be futile unless the patients obtain a sufficient intake of energy and protein during the pulmonary; rehabilitation program.

Generic gas chromatography flame ionization detection method using hydrogen as the carrier gas for the analysis of solvents in pharmaceuticals.

Within the pharmaceutical industry, the determination of residual solvents by Gas Chromatography Flame Ionization Detection (GC-FID) is a highly utilized analytical test that often employs helium (He) as the carrier gas. However, many do not realize that helium is a non-renewable resource that will eventually become progressively more difficult to source. In recent years, analytical chemists are increasingly adopting hydrogen (H2) in place of helium for routine GC analysis. In this study, a simple and efficient generic/universal GC-FID method using H2 as the carrier gas has been developed with the capability of baseline resolution of over 30 of the most commonly used solvents in development and manufacturing with a method run time of less than eight minutes. The use of this method for the separation and analysis of solvents within a pharmaceutical manufacturing process is demonstrated with additional method validation data presented using five different diluents as a means to increase flexibility for the chromatographer. Furthermore, it is the recommendation of the authors that the current compendia for residual solvent analysis be updated to allow for hydrogen as a carrier gas. The similarity between He and H2 observed within this study supports the use of hydrogen as a suitable replacement for helium, and an update of the EU and USP compendia for residual solvent analysis should be made to reflect this.

Generic gas chromatography-flame ionization detection method for quantitation of volatile amines in pharmaceutical drugs and synthetic intermediates.

Volatile amines are among the most frequently used chemicals in organic and pharmaceutical chemistry. Synthetic route optimization often involves the evaluation of several different amines requiring the development and validation of analytical methods for quantitation of residual amine levels. Herein, a simple and fast generic GC-FID method on an Agilent J&W CP-Volamine capillary column (using either He or H2 as the carrier gas) capable of separating over 25 volatile amines and other basic polar species commonly used in pharmaceutical chemistry workflows is described. This 16min method is successfully applied to the analysis and quantitation of volatile amines in a variety of pharmaceutically-related drugs and synthetic intermediates. Method validation experiments showed excellent analytical performance in linearity, recovery, repeatability, and limit of quantitation and detection. In addition, diverse examples for the application of this method to the simultaneous determination of other amine-related chemicals in reaction mixtures are illustrated, thereby indicating that these GC-FID method conditions can be effectively used as starting point during method development for the analysis of other basic polar species beyond the validated list of amines described in this study.

ESPEN guidelines on definitions and terminology of clinical nutrition.

BACKGROUND: A lack of agreement on definitions and terminology used for nutrition-related concepts and procedures limits the development of clinical nutrition practice and research. OBJECTIVE: This initiative aimed to reach a consensus for terminology for core nutritional concepts and procedures. METHODS: The European Society of Clinical Nutrition and Metabolism (ESPEN) appointed a consensus group of clinical scientists to perform a modified Delphi process that encompassed e-mail communication, face-to-face meetings, in-group ballots and an electronic ESPEN membership Delphi round. RESULTS: Five key areas related to clinical nutrition were identified: concepts; procedures; organisation; delivery; and products. One core concept of clinical nutrition is malnutrition/undernutrition, which includes disease-related malnutrition (DRM) with (eq. cachexia) and without inflammation, and malnutrition/undernutrition without disease, e.g. hunger-related malnutrition. Over-nutrition (overweight and obesity) is another core concept. Sarcopenia and frailty were agreed to be separate conditions often associated with malnutrition. Examples of nutritional procedures identified include screening for subjects at nutritional risk followed by a complete nutritional assessment. Hospital and care facility catering are the basic organizational forms for providing nutrition. Oral nutritional supplementation is the preferred way of nutrition therapy but if inadequate then other forms of medical nutrition therapy, i.e. enteral tube feeding and parenteral (intravenous) nutrition, becomes the major way of nutrient delivery. CONCLUSION: An agreement of basic nutritional terminology to be used in clinical practice, research, and the ESPEN guideline developments has been established. This terminology consensus may help to support future global consensus efforts and updates of classification systems such as the International Classification of Disease (ICD). The continuous growth of knowledge in all areas addressed in this statement will provide the foundation for future revisions.

Functional training and timed nutrition intervention in infectious medical patients.

BACKGROUND/OBJECTIVES: Bed rest and decreased nutrition intake in hospitalized patients have been shown to impair the clinical course negatively, including reduced function after hospital stay. Recent reviews have shown that early physical rehabilitation for acute hospitalized old adults leads to functional benefits. The aim of our study was to assess whether it was possible to influence nutrition intake, loss of muscle function and quality of life, with an evidence-based intervention in acutely ill hospitalized infectious medical patients. SUBJECTS/METHODS: For potentially frail patients, functional training three times weekly, and an individually adjusted self-training program for use 1-2 times daily, was given by a physiotherapist. Oral nutritional supplement with 5-10 g whey protein was timed straight after training 2 times daily, and dietetic advice was provided. A historical control group was used to compare nutrition intake. Functional measures and health-related quality of life (HRQoL) were done on admission and discharge. RESULTS: The study included 59 patients in the intervention group. Historic control included 145. Energy and protein intake increased by 3053 kJ (P<0.001) and 28 g of protein (P<0.001), compared with historic controls. Functional parameters (De Mortons Mobility Index (DEMMI), Timed Up and Go and the 30-s chair test) and HRQoL improved significantly for the overall group, most remarkably in patients >70 years of age, from hospitalization to discharge. CONCLUSION: The intervention with dietician and timed oral supplement to functional training by physiotherapist in hospitalized infectious medical patients improved function as well as nutrition intake and HRQoL.

Individualised dietary counselling for nutritionally at-risk older patients following discharge from acute hospital to home: a systematic review and meta-analysis.

BACKGROUND: Many older patients are undernourished after hospitalisation. Undernutrition impacts negatively on physical function and the ability of older patients to perform activities of daily living at home after discharge from acute hospital. The present study aimed to evaluate the evidence for an effect of individualised dietary counselling following discharge from acute hospital to home on physical function, and, second, on readmissions, mortality, nutritional status, nutritional intake and quality of life (QoL), in nutritionally at-risk older patients. METHODS: A systematic review of randomised controlled trials was conducted. The overall quality of the evidence was assessed according to Grading of Recommendations Assessment, Development and Evaluation system (GRADE) criteria. RESULTS: Four randomised controlled trials (n = 729) were included. Overall, the evidence was of moderate quality. Dietitians provided counselling in all studies. Meta-analyses showed a significant increase in energy intake [mean difference (MD) = 1.10 MJ day(-1), 95% confidence interval (CI) = 0.66-1.54, P < 0.001], protein intake (MD = 10.13 g day(-1), 95% CI = 5.14-15.13, P < 0.001) and body weight (BW) (MD = 1.01 kg, 95% CI = 0.08-1.95, P = 0.03). Meta-analyses revealed no significant effect on physical function assessed using hand grip strength, and similarly on mortality. Narrative summation of effects on physical function using other instruments revealed inconsistent effects. Meta-analyses were not conducted on QoL and readmissions as a result of a lack of data. CONCLUSIONS: Individualised dietary counselling by dietitians following discharge from acute hospital to home improved BW, as well as energy and protein intake, in older nutritionally at-risk patients, although without clearly improving physical function. The effect of this strategy on physical function and other relevant clinical outcomes warrants further investigation.

Effect of meal portion size choice on plate waste generation among patients with different nutritional status. An investigation using Dietary Intake Monitoring System (DIMS).

BACKGROUND: The trolley meal system allows hospital patients to select food items and portion sizes directly from the food trolley. The nutritional status of the patient may be compromised if portions selected do not meet recommended intakes for energy, protein and micronutrients. The aim of this study was to investigate: (1) the portion size served, consumed and plate waste generated, (2) the extent to which the size of meal portions served contributes to daily recommended intakes for energy and protein, (3) the predictive effect of the served portion sizes on plate waste in patients screened for nutritional risk by NRS-2002, and (4) to establish the applicability of the dietary intake monitoring system (DIMS) as a technique to monitor plate waste. METHODS: A prospective observational cohort study was conducted in two hospital wards over five weekdays. The DIMS was used to collect paired before- and after-meal consumption photos and measure the weight of plate content. RESULTS: The proportion of energy and protein consumed by both groups at each meal session could contribute up to 15% of the total daily recommended intake. Linear mixed model identified a positive relationship between meal portion size and plate waste (P = 0.002) and increased food waste in patients at nutritional risk during supper (P = 0.001). CONCLUSION: Meal portion size was associated with the level of plate waste produced. Being at nutritional risk further increased the extent of waste, regardless of the portion size served at supper. The use of DIMS as an innovative technique might be a promising way to monitor plate waste for optimizing meal portion size servings and minimizing food waste.