Do cognitive abilities reduce eyewitness susceptibility to the misinformation effect? A systematic review.

The fact that memories can be distorted by post-event misinformation has cast considerable doubt over the dependability of eyewitness evidence in legal contexts. However, despite its adverse practical implications, the misinformation effect is likely an unavoidable distortion stemming from the reconstructive nature of episodic memory. Certain cognitive abilities have been reported to offer protection against misinformation, suggesting that mechanisms aside from episodic memory may also be underpinning this type of memory distortion. The purpose of this review was to collate findings of associations between eyewitness misinformation susceptibility and individual differences in cognitive ability in adults aged 18 and over. Nine studies met the eligibility criteria for this review, including 23 distinct associations. Using a narrative synthesis, three categories of cognitive ability were identified as influencing susceptibility to misinformation: general intelligence and reasoning, perceptual abilities, and memory abilities. Across almost all categories, higher levels of ability were associated with reduced susceptibility to misinformation. While there is no indication that any one trait provides total immunity to the misinformation effect, there is a reasonable amount of evidence to suggest that several cognitive abilities create variance in individual levels of susceptibility. Future research should investigate not only if but how these cognitive abilities protect against misinformation distortions, for example, by contributing to more detailed encoding of the memory, enhancing discrepancy detection in the face of post-event misinformation, or improving source-monitoring during an eyewitness memory test.

Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review.

OBJECTIVES: The use of parenteral systemic anticancer therapy (SACT) has led to improved cancer survival. A quality assurance (QA) system of the aseptic compounding process is necessary to ensure safe and consistent production of parenteral SACT. This scoping review identifies international evidence and practice relating to QA standards in the preparation of parenteral SACT in healthcare establishments. METHODS: Standards relating to aseptic compounding in hospital pharmacies and literature exploring the aseptic compounding of parenteral SACT were included. Literature relating to the non-aseptic compounding of medicines and records specific to sterile manufacturing in industrial settings were excluded. A search of several electronic databases, trial registries, the grey literature and websites of key European hospital pharmacy groups and accreditation bodies was conducted on 16 March 2022. A narrative discussion was performed by country, and content analysis of articles was conducted. RESULTS: Thirty-seven records were included. Standards reviewed covered the work environment, the preparation process and the safety of the workers who are potentially exposed to hazardous chemicals. It was a common practice to include frequent audits to ensure adherence to standards. Some standards also recommended external inspections to allow for further learnings. Periodic reviews are encouraged to ensure standards maintain relevance. National standards of the countries reviewed were based on international standards, with minor adaptations for local conditions. CONCLUSIONS: The main limitation of this review is that it is limited to countries with a high human development index. The review shows that the use of an internationally recognised standard as a basis for national standards is best practice, and will allow for relevance into the future.

Interacting with patients at risk of self-harm or suicide - A qualitative study of community pharmacists and pharmacy staff.

Background: Suicide and self-harm are significant public health concerns. Community pharmacies are accessible and frequented regularly by the public, making them well positioned to identify and intervene with those at risk. The aims of this research project are to evaluate pharmacy staff experiences of dealing with people at risk of suicide/self-harm, and explore how best to support staff during these interactions. Methods: Semi-structured online and telephone interviews were conducted with a sample of community pharmacists and community pharmacy staff (CPS) in the south west of Ireland. Interviews were audio recorded and transcribed verbatim. The Braun and Clarke approach to inductive thematic analysis was used to analyse the data. Results: Thirteen semi-structured qualitative interviews were conducted in November-December 2021. Most participants had encountered a person at risk of suicide/self-harm in their practice, however participants described a lack of training and guidelines around how to navigate these scenarios. Three major themes emerged: (i) Interacting with patients at risk of suicide/self-harm- facilitators and barriers; (ii) Referrals and signposting; (iii) Addressing uncertainty. Positive relationships between the person and pharmacy staff facilitated interactions, while privacy, time constraints and uncertainty among staff were seen as barriers. Participants felt it was necessary to refer at-risk people to other supports, and made suggestions for increasing staff confidence through the implementation of support tools within the pharmacy setting. Conclusions: This study highlights that at present, community pharmacy staff feel uncertain regarding how to handle interactions with people at risk of suicide/self-harm, due to lack of training and supports. Future research should focus on building upon existing resources and obtaining specialist and stakeholder input to produce the most effective support tool(s), tailored to the pharmacy setting.

The efficacy of interventions in reducing belief in conspiracy theories: A systematic review.

Conspiracy beliefs have become a topic of increasing interest among behavioural researchers. While holding conspiracy beliefs has been associated with several detrimental social, personal, and health consequences, little research has been dedicated to systematically reviewing the methods that could reduce conspiracy beliefs. We conducted a systematic review to identify and assess interventions that have sought to counter conspiracy beliefs. Out of 25 studies (total N = 7179), we found that while the majority of interventions were ineffective in terms of changing conspiracy beliefs, several interventions were particularly effective. Interventions that fostered an analytical mindset or taught critical thinking skills were found to be the most effective in terms of changing conspiracy beliefs. Our findings are important as we develop future research to combat conspiracy beliefs.

Healthcare Costs and Health-Related Quality of Life in Older Multimorbid Patients After Hospitalization.

Objectives: We identified factors associated with healthcare costs and health-related quality of life (HRQoL) of multimorbid older adults with polypharmacy. Methods: Using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid older people) trial, we described the magnitude and composition of healthcare costs, and time trends of HRQoL, during 1-year after an acute-care hospitalization. We performed a cluster analysis to identify groups with different cost and HRQoL trends. Using multilevel models, we also identified factors associated with costs and HRQoL. Results: Two months after hospitalization monthly mean costs peaked (CHF 7'124) and HRQoL was highest (0.67). They both decreased thereafter. Age, falls, and comorbidities were associated with higher 1-year costs. Being female and housebound were negatively associated with HRQoL, while moderate alcohol consumption had a positive association. Being independent in daily activities was associated with lower costs and higher HRQoL. Conclusion: Although only some identified potential influences on costs and HRQoL are modifiable, our observations support the importance of prevention before health deterioration in older people with multimorbid illness and associated polypharmacy.

Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission.

INTRODUCTION: Multimorbidity and polypharmacy are risk factors for drug-related hospital admissions (DRAs) in the ageing population. DRAs caused by medication errors (MEs) are considered potentially preventable. The STOPP/START criteria were developed to detect potential MEs in older people. OBJECTIVE: The aim of this study was to assess the detectability of MEs with a STOPP/START-based in-hospital medication review in older people with polypharmacy and multimorbidity prior to a potentially preventable DRA. METHODS: Hospitalised older patients (n = 963) with polypharmacy and multimorbidity from the intervention arm of the OPERAM trial received a STOPP/START-based in-hospital medication review by a pharmacotherapy team. Readmissions within 1 year after the in-hospital medication review were adjudicated for drug-relatedness. A retrospective assessment was performed to determine whether MEs identified at the first DRA were detectable during the in-hospital medication review. RESULTS: In total, 84 of 963 OPERAM intervention patients (8.7%) were readmitted with a potentially preventable DRA, of which 72 patients (n = 77 MEs) were eligible for analysis. About half (48%, n = 37/77) of the MEs were not present during the in-hospital medication review and therefore were not detectable at that time. The pharmacotherapy team recommended a change in medication regimen in 50% (n = 20/40) of present MEs, which corresponds to 26% (n = 20/77) of the total identified MEs at readmission. However, these recommendations were not implemented. CONCLUSION: MEs identified at readmission were not addressed by a prior single in-hospital medication review because either these MEs occurred after the medication review (~50%), or no recommendation was given during the medication review (~25%), or the recommendation was not implemented (~25%). Future research should focus on optimisation of the timing and frequency of medication review and the implementation of proposed medication recommendations. REGISTRATION: ClinicalTrials.gov identifier: NCT02986425. December 8, 2016. FUNDING: European Union HORIZON 2020, Swiss State Secretariat for Education, Research and Innovation (SERI), Swiss National Science Foundation (SNSF).

Diet-Microbiota Interplay: An Emerging Player in Macrophage Plasticity and Intestinal Health.

Inflammatory bowel diseases (IBD) are chronic disorders of the gastrointestinal tract with an increasing prevalence worldwide. Targeted therapies for IBD are limited by several factors, including the therapeutic ceiling and the high incidence of non-responders or loss-of-response. In order to improve therapeutic efficacy, there is critical need to decipher disease pathogenesis, currently not well understood. Macrophages, innate immune cells that exhibit high plasticity, perpetuate inflammatory signalling in IBD through excessive release of inflammatory mediators. In recent years, pioneering research has revealed the importance of the interplay between macrophages and gut microbiota in maintaining intestinal homeostasis. Particular attention is focusing on microbiota-derived metabolites, believed to possess immunomodulatory properties capable of manipulating macrophage plasticity. Microbiota-derived short-chain fatty acids (SCFAs) and indole compounds, along with dietary sourced omega-3 (ω-3) polyunsaturated fatty acids (PUFA), exert anti-inflammatory effects, attributable to interactions with macrophages. Before we can effectively incorporate these metabolites into IBD therapies, a deeper understanding of microbiota-macrophage interactions at a molecular level is necessary. Therefore, the aim of this review is firstly to detail current knowledge regarding how diet and microbiota-derived metabolites modify macrophage plasticity. Later, we discuss the concept of therapeutic strategies directed at microbiota-macrophage interactions, which could be highly valuable for IBD therapies in the future.

Cost-effectiveness of a structured medication review approach for multimorbid older adults: Within-trial analysis of the OPERAM study.

BACKGROUND: Inappropriate polypharmacy has been linked with adverse outcomes in older, multimorbid adults. OPERAM is a European cluster-randomized trial aimed at testing the effect of a structured pharmacotherapy optimization intervention on preventable drug-related hospital admissions in multimorbid adults with polypharmacy aged 70 years or older. Clinical results of the trial showed a pattern of reduced drug-related hospital admissions, but without statistical significance. In this study we assessed the cost-effectiveness of the pharmacotherapy optimisation intervention. METHODS: We performed a pre-planned within-trial cost-effectiveness analysis (CEA) of the OPERAM intervention, from a healthcare system perspective. All data were collected within the trial apart from unit costs. QALYs were computed by applying the crosswalk German valuation algorithm to EQ-5D-5L-based quality of life data. Considering the clustered structure of the data and between-country heterogeneity, we applied Generalized Structural Equation Models (GSEMs) on a multiple imputed sample to estimate costs and QALYs. We also performed analyses by country and subgroup analyses by patient and morbidity characteristics. RESULTS: Trial-wide, the intervention was numerically dominant, with a potential cost-saving of CHF 3'588 (95% confidence interval (CI): -7'716; 540) and gain of 0.025 QALYs (CI: -0.002; 0.052) per patient. Robustness analyses confirmed the validity of the GSEM model. Subgroup analyses suggested stronger effects in people at higher risk. CONCLUSION: We observed a pattern towards dominance, potentially resulting from an accumulation of multiple small positive intervention effects. Our methodological approaches may inform other CEAs of multi-country, cluster-randomized trials facing presence of missing values and heterogeneity between centres/countries.

Gut Microbiota, Macrophages and Diet: An Intriguing New Triangle in Intestinal Fibrosis.

Intestinal fibrosis is a common complication in inflammatory bowel disease (IBD) without specific treatment. As macrophages are the key actors in inflammatory responses and the wound healing process, they have been extensively studied in chronic diseases these past decades. By their exceptional ability to integrate diverse stimuli in their surrounding environment, macrophages display a multitude of phenotypes to underpin a broad spectrum of functions, from the initiation to the resolution of inflammation following injury. The hypothesis that distinct macrophage subtypes could be involved in fibrogenesis and wound healing is emerging and could open up new therapeutic perspectives in the treatment of intestinal fibrosis. Gut microbiota and diet are two key factors capable of modifying intestinal macrophage profiles, shaping their specific function. Defects in macrophage polarisation, inadequate dietary habits, and alteration of microbiota composition may contribute to the development of intestinal fibrosis. In this review, we describe the intriguing triangle between intestinal macrophages, diet, and gut microbiota in homeostasis and how the perturbation of this discreet balance may lead to a pro-fibrotic environment and influence fibrogenesis in the gut.

A mixed methods analysis of the monitoring of oral anti-cancer therapies.

PURPOSE: Oral anti-cancer therapies offer advantages over parenteral therapies in terms of their non-invasive nature and reduced intrusiveness. However, the shift from directly observed administration of these therapies to home administration means that continuous monitoring is needed. The oral anti-cancer therapy market is rapidly growing, with an ever-increasing number of new medicines available for the patients presenting with cancer illnesses. This study aims to (i) evaluate both the cost of providing monitoring consultations of oral anti-cancer therapies, and (ii) to assess the experience of cancer therapy nurses responsible for the monitoring and their opinions of the quality of the service. METHODS: This study provides a mixed methods evaluation of the monitoring of oral anti-cancer therapies. Nurses were asked to record the time taken for them to perform their monitoring duties, and staff related costs were calculated using publicly available salary data. Patient-related costs were calculated using the Human Capital method. Nurses were asked to discuss their experience of monitoring oral anti-cancer therapies in semi-structured interviews. These interviews were subsequently analysed using thematic analysis. RESULTS: 201 recordings and their associated costs were documented. The median consultation time was 33 min, costing €22.10 using Clinical Nurse Specialist salary figures and €26.51 using Advanced Nurse Practitioner salary figures. The associated patient cost was €14.06. Themes of the effect of Covid-19 on the service, expanding and complicated care package requirements, the need for dedicated oral clinics and the future of the service emerged from the interview data. CONCLUSION: The monitoring service provided by nurses may be undervalued. The commitment to fully dedicated oral anti-cancer therapy clinics and an increase in staff to align with the ongoing increase in service demand is seen as vital for the continued safe and effective delivery of this specialist cancer service.

Optimizing Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older Adults (OPERAM): cluster randomised controlled trial.

OBJECTIVE: To examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital. DESIGN: Cluster randomised controlled trial. SETTING: 110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belgium, and Republic of Ireland) defined by attending hospital doctors. PARTICIPANTS: 2008 older adults (≥70 years) with multimorbidity (≥3 chronic conditions) and polypharmacy (≥5 drugs used long term). INTERVENTION: Clinical staff clusters were randomised to usual care or a structured pharmacotherapy optimisation intervention performed at the individual level jointly by a doctor and a pharmacist, with the support of a clinical decision software system deploying the screening tool of older person's prescriptions and screening tool to alert to the right treatment (STOPP/START) criteria to identify potentially inappropriate prescribing. MAIN OUTCOME MEASURE: Primary outcome was first drug related hospital admission within 12 months. RESULTS: 2008 older adults (median nine drugs) were randomised and enrolled in 54 intervention clusters (963 participants) and 56 control clusters (1045 participants) receiving usual care. In the intervention arm, 86.1% of participants (n=789) had inappropriate prescribing, with a mean of 2.75 (SD 2.24) STOPP/START recommendations for each participant. 62.2% (n=491) had ≥1 recommendation successfully implemented at two months, predominantly discontinuation of potentially inappropriate drugs. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group. In the intention-to-treat analysis censored for death as competing event (n=375, 18.7%), the hazard ratio for first drug related hospital admission was 0.95 (95% confidence interval 0.77 to 1.17). In the per protocol analysis, the hazard ratio for a drug related hospital admission was 0.91 (0.69 to 1.19). The hazard ratio for first fall was 0.96 (0.79 to 1.15; 237 v 263 first falls) and for death was 0.90 (0.71 to 1.13; 172 v 203 deaths). CONCLUSIONS: Inappropriate prescribing was common in older adults with multimorbidity and polypharmacy admitted to hospital and was reduced through an intervention to optimise pharmacotherapy, but without effect on drug related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimisation interventions that reduce inappropriate prescribing and improve patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02986425.

A qualitative evaluation of community and acute hospital nursing oncology services in Ireland.

PURPOSE: Cancer patients are a particularly vulnerable population group, facing an increase in physical, mental, logistical and financial difficulties. This, as well as Ireland's increased focus on primary care with the Sláintecare health plan, led to the development of the Community Oncology Nursing Programme, where community nurses are trained to provide cancer care in the community. This paper sought to explore the lived experiences of the patients and nurses involved in this programme in order to examine its impact as well as determine facilitators and roadblocks for future development. METHODS: A qualitative examination of the service was carried out by interviewing cancer patients receiving care as part of the programme as well as the nurses delivering care, both in the community and hospital day-ward. Thematic analysis was used. RESULTS: Themes of improved patient experience, nurse-patient relationship, the importance of location and roadblocks to further implementation of the programme emerged. There was a universal belief that the programme offered benefits to the patient and improved their care in some manner. CONCLUSIONS: The Community Oncology Nursing Programme has been well received by both nurses and patients. The service provided by community nurses as part of this programme offers benefits to patients and an improved cancer service.

A cost comparison study to review community versus acute hospital models of nursing care delivered to oncology patients.

PURPOSE: Ireland's Sláintecare health plan is placing an increased focus on primary care. A community oncology nursing programme was developed to train community nurses to deliver care in the community. While the initial pilot was proven to be clinically safe, no cost evaluation was carried out. This study aims to compare the costs of providing cancer support services in a day-ward versus in the community. METHODS: 183 interventions (40 in day-ward and 143 in community) were timed and costed using healthcare professional salaries and the Human Capital method. RESULTS: From the healthcare provider perspective, the day-ward was a significantly cheaper option by an average of €17.13 (95% CI €13.72 - €20.54, p < 0.001). From the societal perspective, the community option was cheaper by an average of €2.77 (95% CI -€3.02 - €8.55), although this was a non-significant finding. Sensitivity analyses indicate that the community service may be significantly cheaper from the societal perspective. CONCLUSIONS: Given the demand for cost-viable options for primary care services, this programme may represent a national option for cancer care in Ireland when viewed from the societal perspective.

Exposure to selected preservatives in personal care products: case study comparison of exposure models and observational biomonitoring data.

Exposure models provide critical information for risk assessment of personal care product ingredients, but there have been limited opportunities to compare exposure model predictions to observational exposure data. Urinary excretion data from a biomonitoring study in eight individuals were used to estimate minimum absorbed doses for triclosan and methyl-, ethyl-, and n-propyl- parabens (TCS, MP, EP, PP). Three screening exposure models (European Commission Scientific Commission on Consumer Safety [SCCS] algorithms, ConsExpo in deterministic mode, and RAIDAR-ICE) and two higher-tier probabilistic models (SHEDS-HT, and Creme Care & Cosmetics) were used to model participant exposures. Average urinary excretion rates of TCS, MP, EP, and PP for participants using products with those ingredients were 16.9, 3.32, 1.9, and 0.91 µg/kg-d, respectively. The SCCS default aggregate and RAIDAR-ICE screening models generally resulted in the highest predictions compared to other models. Approximately 60-90% of the model predictions for most of the models were within a factor of 10 of the observed exposures; ~30-40% of the predictions were within a factor of 3. Estimated exposures from urinary data tended to fall in the upper range of predictions from the probabilistic models. This analysis indicates that currently available exposure models provide estimates that are generally realistic. Uncertainties in preservative product concentrations and dermal absorption parameters as well as degree of metabolism following dermal absorption influence interpretation of the modeled vs. measured exposures. Use of multiple models may help characterize potential exposures more fully than reliance on a single model.

Aggregate exposure modelling of vitamin A from cosmetic products, diet and food supplements.

Realism is important in estimating consumer exposure to a substance, especially when accounting for exposure from multiple sources. Humans are exposed to vitamin A from food, dietary supplements and cosmetics products. A probabilistic aggregate exposure model was developed for estimating exposure distributions to vitamin A (as retinol equivalents) in pre-/post-menopausal, and menopausal women in European and US populations. Data from large dietary surveys were used, together with realistic and extreme case scenarios of cosmetics product use (including occurrence data for vitamin A presence in 17 cosmetic products). Results of absorbed exposure estimates were expressed as µg/kg bw/day by incorporating dermal and oral bioavailability data. The mean and 95th percentile (P95) aggregate exposures were below the EU Tolerable Upper Intake Limit (3000 µg/day; 45 µg/kg/day internal exposure dose (IED)), providing positive assurances of safety. The major source of vitamin A exposure is the diet, with cosmetics providing only a small fraction of total exposure (2-5% at P95). In addition to providing a realistic assessment of total vitamin A exposure, this work provides a case study on how to approach future complex aggregate exposure questions.

Cost Minimization Analysis of Intravenous or Subcutaneous Trastuzumab Treatment in Patients With HER2-Positive Breast Cancer in Ireland.

BACKGROUND: Two large acute Irish University teaching hospitals changed the manner in which they treated human epidermal growth factor receptor (HER)2-positive breast cancer patients by implementing the administration of trastuzumab via the subcutaneous (SC) route into their clinical practice. The study objective is to compare the trastuzumab SC and trastuzuamb intravenous (IV) treatment pathways in both hospitals and assess which route is more cost-effective and time saving in relation to active health care professional (HCP) time. MATERIALS AND METHODS: A prospective observational study in the form of cost minimization analysis constituted the study design. Active HCP time for trastuzumab SC- and IV-related tasks were recorded. Staff costs were calculated using fully loaded salary costs. Loss of productivity costs for patients were calculated using the human capital method. RESULTS: On average, the total HCP time saved per trastuzumab SC treatment cycle relative to trastuzumab IV treatment cycle was 59.21 minutes. Time savings in favor of trastuzumab SC resulted from quicker drug reconstitution, no IV catheter installation/removal, and less HCP monitoring. Over a full treatment course of 17 cycles, average HCP time saved accumulates to 16.78 hours, with an estimated direct cost saving of €1609.99. Loss of productivity for patients receiving trastuzumab IV (2.15 days) was greater than that of trastuzumab SC (0.60 days) for a full treatment course. CONCLUSION: Trastuzumab SC treatment has proven to be a more cost-effective option than trastuzumab IV treatment that generated greater HCP time savings in both study sites. Healthcare policymakers should consider replacing trastuzumab IV with trastuzumab SC treatment in all eligible patients.

ExpoQual: Evaluating measured and modeled human exposure data.

Recent rapid technological advances are producing exposure data sets for which there are no available data quality assessment tools. At the same time, regulatory agencies are moving in the direction of data quality assessment for environmental risk assessment and decision-making. A transparent and systematic approach to evaluating exposure data will aid in those efforts. Any approach to assessing data quality must consider the level of quality needed for the ultimate use of the data. While various fields have developed approaches to assess data quality, there is as yet no general, user-friendly approach to assess both measured and modeled data in the context of a fit-for-purpose risk assessment. Here we describe ExpoQual, an instrument developed for this purpose which applies recognized parameters and exposure data quality elements from existing approaches for assessing exposure data quality. Broad data streams such as quantitative measured and modeled human exposure data as well as newer and developing approaches can be evaluated. The key strength of ExpoQual is that it facilitates a structured, reproducible and transparent approach to exposure data quality evaluation and provides for an explicit fit-for-purpose determination. ExpoQual was designed to minimize subjectivity and to include transparency in aspects based on professional judgment. ExpoQual is freely available on-line for testing and user feedback (exposurequality.com).

Investigation of the potential for a simplified exposure tool in medical nutrition (SETIM) to minimise exposures to sweeteners in young patients aged 1-3 years with PKU and CMPA.

Children with phenylketonuria (PKU) and severe cow's milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) in addition to having restricted intake of normal foods. These vulnerable patients are exposed to artificial sweeteners from the consumption of a combination of both free and prescribed foods. Young patients with PKU and CMPA aged from 1 to 3 years have a higher risk of exceeding the acceptable daily intake (ADI) for sweeteners than age-matched healthy children. A probabilistic modelling approach has been adapted successfully to assess the exposure of young patients with PKU and CMPA to low-calorie sweeteners. To assist professionals in the screening and formulation of foods containing food additives for such patients, a simplified exposure method/tool has been developed. The tool is intended to ensure that total dietary exposure can be considered. The simplified tool is not intended to replace the probabilistic model but may be used as a screening tool to determine if further investigation on exposure is warranted. The aim of this study was to develop and validate this simplified exposure tool to support those currently used by healthcare professionals (HCPs) using data available from the probabilistic modelling of exposure in young children with PKU and CMPA. The probabilistic model does not allow for swift screening of exposure scenarios nor is the present EFSA Food Additive Intake Assessment Model (FAIM) fully suitable for application to medical foods. The simplified exposure tool in medical nutrition (SETIM) reported here is both reliable and consistent and provides additive usage levels which minimise regular exposure above the ADI in patients. In addition to the usefulness of SETIM for the medical nutrition industry, the tool has the potential to enhance the practice of evidence-based medical nutrition by official risk assessment bodies, registration authorities and healthcare professionals.

Predictive modelling of the exposure to steviol glycosides in Irish patients aged 1-3 years with phenylketonuria and cow's milk protein allergy.

Children with Phenylketonuria (PKU) and severe cow's milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) as well as restricted amounts of normal foods. These patients are exposed to artificial sweeteners from the consumption of a combination of free and prescribed foods. Young patients with PKU and CMPA have a higher risk of exceeding acceptable daily intakes (ADI) for additives than age-matched healthy children. A predictive modelling approach has been adapted successfully to assess the additive exposure of young patients with PKU and CMPA to artificial sweeteners. Steviol glycosides (E960) are at various stages of regulatory approval for the various food categories in the EU but are not as yet permitted for use in products intended for young children. The aim of this study was to predict potential steviol glycoside exposure in young children with PKU and CMPA considering the potential for future provisions for the use of this sweetener. The recent introduction of steviol glycosides means that no exposure data are available for children with CMPA and PKU. Food consumption data were derived from the food consumption survey data of healthy young children in Ireland from the National Preschool and Nutrition Survey (NPNS, 2010-11). Specially formulated amino acid-based FSMPs are used to replace whole or milk protein foods and were included in the exposure model to replace restricted foods. The recommendations to ensure adequate protein intake in these patients were used to determine FSMP intake. Exposure assessment results indicated that the maximum permitted level (MPL) for FSMPs would warrant careful consideration to avoid exposures above the ADI. These data can be used to inform recommendations for the medical nutrition industry.