The UK research ethics committee: Making the case for better serving the underserved - can we do better?

Research ethics committees exist internationally to review research proposals to protect the rights and safety of human participants and researchers involved in research. These committees recruit a panel of expert and lay members, mostly on an unpaid voluntary basis, with relevant scientific experience to appraise these studies. Contemporary data in the UK show that women and people over 55 years old are overrepresented in these committee panels in the Health Research Authority, suggesting that there are potential barriers to inclusivity and participation. A variety of global approaches to tackle these barriers include targeting specific populations, such as faith or community leaders, or implementing quotas have been adopted. Further research is needed to understand likely barriers preventing participation in research ethics committees in the UK and how they may be overcome.

Micronutrient supplement recommendations in pregnancy vary across a geographically diverse range of countries: a narrative review.

Specific food supplements are essential during preconception and pregnancy to ensure adequate intake of vitamins and minerals to support fetal growth and development and metabolic changes in the maternal body. Our objective was to identify food supplement recommendations, particularly those of folic acid, iron, Vitamin D, and iodine, during preconception and/or pregnancy across a geographically diverse range of countries. Further, we investigated whether country location and income-level related to the recommendations. We performed an electronic search and identified country-specific preconception and pregnancy food supplement recommendations, policy documents, and official guidelines of national organizations informing recommendations. To ensure the data were as accurate as possible, country-specific experts were contacted. Data were collected in 2017 and reevaluated in 2022. Country income level was determined by the World Bank classification. Each inspected country (n = 43) recommended folic acid supplementation, typically 400 µg/day, before and during pregnancy. About half of the countries recommended an iron supplement (dose range, 16-195 mg/day) and one quarter Vitamin D (typically 10 µg/d in higher latitudes) and iodine (150-200 µg/day). Country location and income level had some influence on the recommendations. Vitamin D was more often recommended in higher latitude, high-income countries. Almost all upper-middle and lower-middle income countries recommended iron supplementation, whereas less than one third of high-income countries had a corresponding recommendation. Findings suggest that food supplement recommendations for pregnant women vary across countries, likely influenced by geographic location as well as income level. These data may be used in the harmonization of food supplement recommendations.

Developing sustainable patient and public involvement in mesothelioma research: multi-method exploration with researchers, patients, carers, and patient organisations.

BACKGROUND: Rare diseases where prognosis is poor provide limited scope for patient and public involvement (PPI). One such disease is mesothelioma, a cancer of the lung pleura or of the peritoneum caused by exposure to asbestos, where PPI is poorly documented. We undertook to explore how PPI could be facilitated in mesothelioma research. METHODS: An online survey with mesothelioma researchers (n = 23) assessed the perceived benefits and challenges of PPI in mesothelioma. Six online workshops and thirteen in-depth interviews with patients and the public explored their views on how PPI could be increased in mesothelioma and their motivations to become PPI representatives in the future. The survey data were analysed using descriptive statistics and the interviews, using Thematic Analysis. RESULTS: In the survey, 26% (n = 6) of the researchers did not include PPI in their research, while 74% (n = 17) did, finding it most beneficial at the stages of applying for funding and dissemination. The main perceived benefits of PPI were clarifying the research question and outcome measures, making research more credible and relevant to patients' needs, and increasing its impact. The main perceived challenges to PPI were the general poor prognosis in mesothelioma, and funding timescales which hindered timely recruitment of PPI representatives. The analysis of the interviews with the patients and public revealed three main themes: "Motivations to become a PPI representative in the future", "Understanding the nature of PPI during the project", and "Perceived challenges to PPI in mesothelioma". Altruism and the need for hope were the main reasons to wish to become involved in PPI in the future. For many participants, the project proved to be a journey of understanding the nature of PPI, a concept that was not easy to grasp from the start. The participants perceived certain barriers to PPI such as high symptom burden in mesothelioma, the abstract concept of PPI, and the use of scientific language. CONCLUSIONS: The present research provides a detailed picture of the benefits and challenges of PPI in mesothelioma. We recommend long-term engagement with mesothelioma support groups so that researchers achieve meaningful and sustainable PPI in mesothelioma research.

Patient and public involvement (PPI) in research means research that is done 'with' or 'by' the public, not 'to', 'about', or 'for' them. Involving patients, family caregivers or the public (e.g. coordinators of patient organisations) in research activities means that they contribute to how research is designed, conducted, or disseminated. However, some diseases where patients have a short prognosis after diagnosis make it harder for patients or their family members to get involved. In this project we explored the perspectives of patients, public, and researchers on how PPI could be increased and maintained in research on mesothelioma­a rare cancer of the lining of the lung or of the peritoneum caused by exposure to asbestos. We conducted an online survey with mesothelioma researchers, and they indicated a number of PPI benefits but also challenges such as finding people living with mesothelioma well enough to participate. We also conducted six online workshops and thirteen interviews with patients, family members and coordinators of mesothelioma patient organisations­these were not PPI representatives but participants in research. All participants in the project were motivated by the wish to enhance outcomes for other patients. Their understanding of PPI improved during the project and they saw a number of challenges to others becoming involved in PPI, such as its abstract nature and the use of scientific language. We recommend that researchers engage long-term with mesothelioma support groups so that they have opportunities to explain what PPI means and involve people affected by mesothelioma in research.

Exploring early career researchers' perspectives of training and funding opportunities: Motivations and setbacks when applying for the UK's National Institute for Health and Care Research's fellowships and research funding.

Despite the availability of training and funding opportunities with the UK's National Institute for Health and Care Research (NIHR), early career researchers (ECRs) invariably experience concern in sustaining an academic career in health research given the uncertainties of success following rejection from peer-reviewed funding bodies. The objective of this study was to consider what motivates ECRs when applying for funding to NIHR programmes and how they overcome funding setbacks. Eleven ECRs took part in a one-to-one virtual in-depth interview; the sample included more women (n = 8) than men (n = 3) and participants included pre-doctoral researchers (n = 5), and both doctoral (n = 2) and post-doctoral (n = 4) ECRs. The interviews were analysed using the logic of a systems theory framework identifying factors impacting on ECRs occurring within an individual, within their social system and within their broader environment. The central themes that emerged from the data focussed on: (1) facilitators for ECRs to apply for NIHR funding; (2) exploring ECRs' setbacks and disappointments; (3) improving chances of funding; and (4) deciding to apply with a view to re-applying in future. The participants' responses provided an honest and frank reflection of the uncertainties and challenges as ECRs in the current climate. Further strategies to support ECRs could be facilitated through local NIHR infrastructure, mentorship, better access to local support networks and hard-wiring research into an organisation's strategic priorities.

Food Supplement Use Differs from the Recommendations in Pregnant Women: A Multinational Survey.

The aim was to investigate, among pregnant women, (1) the use of food supplements and (2) the awareness of food supplement recommendations and beliefs about food supplement use in four European countries: Finland, Italy, Poland, and the United Kingdom. The participants (n = 1804) completed an online questionnaire with predefined statements. Daily intakes of vitamins and minerals were calculated using uploaded pictures or weblinks of the supplement packages. Country differences were assessed. Most participants (91%) used at least one food supplement during pregnancy. A prenatal multivitamin was the most commonly used supplement type (84% of the users), and 75% of the participants thought consumption of multivitamin is recommended. Of the participants, 81% knew that folic acid is recommended during pregnancy while 58% knew the recommendation for vitamin D. In 19% of the supplement users, the daily safe upper intake limit of at least one nutrient was exceeded. Nevertheless, most participants agreed that they knew which supplements (91%) and doses of supplements (87%) needed to be used during pregnancy. To conclude, the majority of the participants used food supplements, but lower proportions knew and adhered to the recommended intakes. Between-country differences were observed in the use and knowledge of and beliefs regarding supplements. The results suggest a need for assessment and monitoring of supplement use in antenatal care to ensure appropriate use.

Use of non-sterile gloves in the ward environment: an evaluation of healthcare workers' perception of risk and decision making.

BACKGROUND: Studies have found that inappropriate use of non-sterile gloves (NSG) can affect hand hygiene compliance; the main risks are missing opportunities for hand hygiene and gloves being a vector for microbial transmission. AIM: The aims of this study were to explore the accuracy of healthcare worker (HCW) risk assessment and decision making regarding the use of NSG. METHODS: The study was conducted in two acute NHS Trusts and a community social enterprise. A cross-sectional survey was carried out, followed by qualitative semi-structured interviews. FINDINGS: There were highly significant differences at the 95% probability level between staff groups, unqualified staff being significantly more likely than qualified staff to report NSG use when not indicated (P < 0.0001). The primary motivating factor for staff to wear NSG was for personal protection; the secondary factor being the protection of patients. Staff were also motivated by a desire to create an image of professionalism. Respondents were more likely to follow the lead of seniors in their own profession. DISCUSSION: The results suggest a necessity for change interventions aimed at unqualified staff such as healthcare assistants (HCAs). It would be beneficial to review the indications for glove use and amend organisational policies accordingly. Leaders in each professional staff group would be required to influence practice across organisations, taking into account motivating factors, and in association with multi-modal interventions to improve practice.

The effect of diet on the physical and mental development of children: views of parents and teachers in four European countries.

Although the impact of diet on physical health is an important public health issue, less attention has been devoted to the relationship between nutrition and children's mental development. The views of parents and teachers about the extent to which diet affects physical and mental development of children were compared in four European countries. An online questionnaire (developed in English and translated) was circulated through a market research agency. Participants were parents or teachers of children aged 4-10 years without learning or behavioural issues. Questionnaires were returned by 1606 parents (401 in England, Germany and Hungary; 403 in Spain) and 403 teachers (100 in each country, except for 103 in Hungary). Teachers were older than parents (35·3 % v. 18·3 % over 45 years; P<0·001) and less likely to smoke (15·9 % v. 26·3 %, P<0·001). There was no difference between the proportions of parents and teachers who felt that a child's physical development depended very much/extremely (v. moderately/slightly/not at all) on diet (overall 79·8 %). Lower proportions of both groups thought that mental development was very much/extremely influenced by diet (67·4 %). In the regression modelling, believing that physical and mental performance was greatly influenced by diet was significantly and positively associated with living in Hungary, scoring higher on a measure of General Health Interest and (parents only) level of education attained. Differences existed among countries in most views. Lower levels of awareness of the importance of diet for brain development and cognition (compared with physical health outcomes) indicate the potential for educating consumers, especially parents with lower educational attainment.

Are the Claims to Blame? A Qualitative Study to Understand the Effects of Nutrition and Health Claims on Perceptions and Consumption of Food.

Nutrition and Health Claims (NHCs) have been found to influence perceptions of food and consumption behaviour. While previous quantitative research has identified factors that may explain these effects, the current study aimed to address the dearth of in-depth exploration as to the underlying reasons why and how claims may impact upon perceptions and behaviour and the relationships between key factors. Seventy-eight participants took part in 10 focus groups. Discussions were transcribed verbatim and Nvivo 11 was used for thematic analysis. Six themes were developed from the data: 1. Target populations for NHCs; 2. Influence of NHCs on purchasing behaviour; 3. Characteristics/perceptions of products displaying NHCs; 4. Believability of NHCs; 5. Superior yet superficial knowledge; 6. Consumption of products displaying NHCs. Knowledge was a key factor influencing how much individuals believe claims (Believability of NHCs) and their perceptions (Characteristics/perceptions of products displaying NHCs). These perceptions and the characteristics of products displaying claims also impacted believability, as well as purchasing behaviour and consumption. Future research should be cognisant of the role of knowledge and characteristics or perceptions of products in the relationship between NHCs and consumer behaviour, and modelling of these relationships would allow their relative strength to be identified.

Herbal supplements in the print media: communicating benefits and risks.

BACKGROUND: The rise in use of food supplements based on botanical ingredients (herbal supplements) is depicted as part of a trend empowering consumers to manage their day-to-day health needs, which presupposes access to clear and accurate information to make effective choices. Evidence regarding herbal supplement efficacy is extremely variable so recent regulations eliminating unsubstantiated claims about potential effects leave producers able to provide very little information about their products. Medical practitioners are rarely educated about herbal supplements and most users learn about them via word-of-mouth, allowing dangerous misconceptions to thrive, chief among them the assumption that natural products are inherently safe. Print media is prolific among the information channels still able to freely discuss herbal supplements. METHOD: This study thematically analyses how 76 newspaper/magazine articles from the UK, Romania and Italy portray the potential risks and benefits of herbal supplements. RESULTS: Most articles referenced both risks and benefits and were factually accurate but often lacked context and impartiality. More telling was how the risks and benefits were framed in service of a chosen narrative, the paucity of authoritative information allowing journalists leeway to recontextualise herbal supplements in ways that serviced the goals and values of their specific publications and readerships. CONCLUSION: Providing sufficient information to empower consumers should not be the responsibility of print media, instead an accessible source of objective information is required.

Understanding How Consumers Categorise Health Related Claims on Foods: A Consumer-Derived Typology of Health-Related Claims.

The Nutrition and Health Claims Regulation (NHCR) EC No 1924/2006 aims to provide an appropriate level of consumer protection whilst supporting future innovation and fair competition within the EU food industry. However, consumers' interpretation of health claims is less well understood. There is a lack of evidence on the extent to which consumers are able to understand claims defined by this regulatory framework. Utilising the Multiple Sort Procedure (MSP), a study was performed (N = 100 participants across five countries: Germany, the Netherlands, Slovenia, Spain and the United Kingdom) to facilitate development of a framework of health-related claims encompassing dimensions derived from consumers. Our results provide useful insight into how consumers make sense of these claims and how claims may be optimised to enhance appropriate consumer understanding. They suggest consumers may not consciously differentiate between a nutrition claim and a health claim in the way that regulatory experts do and provide insight into where this might occur. A consumer-derived typology of health-related claims based on three key dimensions is proposed: (1) Familiarity with the nutrient, substance or food stated in the claim; (2) statement type in terms of simplicity/complexity; (3) relevance of the claim, either personally or for a stated population group.

Acceptability to patients, carers and clinicians of an mHealth platform for the management of Parkinson's disease (PD_Manager): study protocol for a pilot randomised controlled trial.

BACKGROUND: Parkinson's disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice. METHODS/DESIGN: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson's disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson's diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD_Manager vs control, stratifying by age (1 ≤ 70 : 1 > 70) and gender (60% M: 40% F). The PD_Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD_Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework. DISCUSSION: Information gathered will inform further development of the PD_Manager system and a larger effectiveness trial. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN17396879 . Registered on 15 March 2017.

The role of causal models and beliefs in interpreting health claims.

OBJECTIVE: Health claims on food packaging are regulated to inform and protect consumers; however, many consumers do not accurately interpret the meaning of the claims. Whilst research has shown different types of misinterpretation, it is not clear how those interpretations are formed. The aim of this study was to elicit the causal beliefs and causal models about food and health held by consumers, that is their understanding of the causal relationships between nutrients, health outcomes, and the causal pathways connecting them, and investigate how well this knowledge explains the variation in inferences they draw about health benefits from health claims. METHOD: A total of 400 participants from Germany, the Netherlands, Spain, Slovenia, and the United Kingdom were presented with seven authorized health claims and drew inferences about the health benefits of consuming nutrients specified in the claim. Then, their personal causal models of health were elicited along with their belief in the truth and familiarity with the claims. RESULTS: The strength of inferences about health benefits that participants drew from the claims was predicted independently by the strength of the relevant causal pathways within the causal model, and belief in the truth of the claim, but not familiarity with the claim. Participants drew inferences about overall health benefits of the nutrients by extrapolating from their causal models of health. CONCLUSION: Consumers' interpretation of claims is associated with their belief in the claim and their causal models of health. This prior knowledge is used to interpret the claim and draw inferences about overall health benefits that go beyond the information in the claim. Therefore, efforts to improve consumers' understanding and interpretation of health claims must address both their wider causal models of health and their knowledge of specific claims. Statement of Contribution What is already known on this subject? Health claims influence the likelihood of buying a product. But consumers do not accurately understand or interpret health claims. What does this study add? Consumers' interpretation of health claims is mediated by their personal causal model of health. Consumers draw inferences that go beyond what is claimed by extrapolating from their personal causal model of health. Consumers are also influenced directly by their belief in the claim, but not frequency of exposure to it.

The Impact of Nutrition and Health Claims on Consumer Perceptions and Portion Size Selection: Results from a Nationally Representative Survey.

Nutrition and health claims on foods can help consumers make healthier food choices. However, claims may have a 'halo' effect, influencing consumer perceptions of foods and increasing consumption. Evidence for these effects are typically demonstrated in experiments with small samples, limiting generalisability. The current study aimed to overcome this limitation through the use of a nationally representative survey. In a cross-sectional survey of 1039 adults across the island of Ireland, respondents were presented with three different claims (nutrition claim = "Low in fat"; health claim = "With plant sterols. Proven to lower cholesterol"; satiety claim = "Fuller for longer") on four different foods (cereal, soup, lasagne, and yoghurt). Participants answered questions on perceived healthiness, tastiness, and fillingness of the products with different claims and also selected a portion size they would consume. Claims influenced fillingness perceptions of some of the foods. However, there was little influence of claims on tastiness or healthiness perceptions or the portion size selected. Psychological factors such as consumers' familiarity with foods carrying claims and belief in the claims were the most consistent predictors of perceptions and portion size selection. Future research should identify additional consumer factors that may moderate the relationships between claims, perceptions, and consumption.

Exploring the psychological health of emergency dispatch centre operatives: a systematic review and narrative synthesis.

BACKGROUND: The study objective was to investigate and synthesize available evidence relating to the psychological health of Emergency Dispatch Centre (EDC) operatives, and to identify key stressors experienced by EDC operatives. METHODS: Eight electronic databases (Embase, PubMed, Medline, CINAHL, PsycInfo, PsycArticles, The Psychology and Behavioural Sciences Collection, and Google Scholar) were searched. All study designs were included, and no date limits were set. Studies were included if they were published in English, and explored the psychological health of any EDC operatives, across fire, police, and emergency medical services. Studies were excluded if they related solely to other emergency workers, such as police officers or paramedics. Methodological quality of included studies was assessed using checklists adapted from the Critical Appraisal Skills Programme. A narrative synthesis was conducted, using thematic analysis. RESULTS: A total of 16 articles were included in the review. Two overarching themes were identified during the narrative synthesis: 'Organisational and Operational Factors' and 'Interactions with Others'. Stressors identified included being exposed to traumatic calls, lacking control over high workload, and working in under-resourced and pressured environments. Lack of support from management and providing an emotionally demanding service were additional sources of stress. Peer support and social support from friends and family were helpful in managing work-related stress. DISCUSSION: EDC operatives experience stress as a result of their work, which appears to be related to negative psychological health outcomes. Future research should explore the long-term effects of this stress, and the potential for workplace interventions to alleviate the negative impacts on psychological health. PROSPERO REGISTRATION NUMBER: CRD42014010806.

Importance of mental performance in parental choice of food for children aged 4-10 years: a study in four European countries.

OBJECTIVE: Typically, attention focuses on how nutrition affects physical health. The present study investigated the importance that parents attach to the impact of diet on mental performance when choosing food for their child. DESIGN: Questionnaire. SETTING: Four European countries. SUBJECTS: Parents of children aged 4-10 years (n 1574): England (n 397), Germany (n 389), Hungary (n 398) and Spain (n 390). RESULTS: Most parents (80-85 %) considered the effect of food on four elements of mental performance (child's ability to learn, attention, behaviour, mood) to be moderately, very, extremely (v. slightly, not at all) important in food choices; over 90 % considered healthiness of food and making food appealing to their child important; 79·8 % cost; 76·8 % convenience. Belief that food affects mental performance was 57·4 % (ability to learn), 60·5 % (attention); less than 40 % of parents agreed they were aware which foods had an effect. Parents with lower general interest in healthy eating were less likely to consider the effect of food on mental performance elements as important. Respondents from Germany were more likely to rate mental performance as important (except behaviour); those in Hungary less likely. The most important influence on parents' decisions about feeding their child was their own experience, except Spain, where family/friends/health professionals were more important. CONCLUSIONS: Nutrition affects brain development and cognitive functioning. Low prioritisation of the effect of food on mental performance indicates potential for educating parents.

Usage of Plant Food Supplements (PFS) for weight control in six European countries: results from the PlantLIBRA PFS Consumer Survey 2011-2012.

BACKGROUND: Obesity is increasing worldwide and weight-control strategies, including the consumption of plant food supplements (PFS), are proliferating. This article identifies the herbal ingredients in PFS consumed for weight control and by overweight/obese dieters in six European countries, and explores the relationship between their consumption and their self-reported BMI. METHODS: Data used were a subset from the PlantLIBRA PFS Consumer Survey 2011-2012, a retrospective survey of 2359 PFS consumers. The survey used a bespoke frequency-of-PFS-usage questionnaire. Analyses were performed in two consumer subsamples of 1) respondents taking the products for "body weight reasons", and 2) "dieters for overweight/obesity", to identify the herbal ingredients consumed for these reasons. The relationship between the 5 most consumed herbal ingredients and self-reported BMI in groups 1 and 2 is explored by comparing BMI proportions of consumers vs. non-consumers (using Chi-squared test). RESULTS: 252 PFS (8.8 %) were consumed for "body weight reasons" (by 240 PFS consumers); 112 PFS consumers (4.8 %) were "dieting for overweight/obesity". Spain is the country where consuming herbal ingredients for body weight control and dieting were most popular. Artichoke was the most consumed herbal ingredient. Considering only the 5 top products consumed by those who responded "body weight", when using the total survey sample, a greater proportion of BMI ≥ 25 was observed among consumers of PFS containing artichoke and green tea as compared to non-consumers (58.4 % vs. 49.1 % and 63.2 % vs. 49.7 % respectively). Considering only the 5 top products consumed by "dieters" and using only the "dieters" sample, a lower proportion of BMI ≥ 25 was observed among pineapple-containing PFS consumers (38.5 % vs. 81.5 %); however, when using the entire survey sample, a greater proportion of BMI ≥ 25 was observed among artichoke-containing PFS consumers (58.4 % vs. 49.1 %). CONCLUSIONS: A comparison of results among the scarce publications evaluating the use of weight-loss supplements at the population level is limited. Nevertheless every hint is important in finding out which are the self-treatment strategies used by overweight/obese individuals in European countries. Although limited by a small sample size, our study represents a first attempt at analysing such data in six EU countries. Our findings should encourage the conduction of further studies on this topic, long-term and large sample-sized studies, ideally conducted in the general population.

Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries.

BACKGROUND: The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described. OBJECTIVES: To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011-2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey. SUBJECTS/SETTING: From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS. RESULTS: Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems. CONCLUSIONS: Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals.

Prevalence of Nutrition and Health-Related Claims on Pre-Packaged Foods: A Five-Country Study in Europe.

This study is part of the research undertaken in the EU funded project CLYMBOL ("Role of health-related CLaims and sYMBOLs in consumer behaviour"). The first phase of this project consisted of mapping the prevalence of symbolic and non-symbolic nutrition and health-related claims (NHC) on foods and non-alcoholic beverages in five European countries. Pre-packaged foods and drinks were sampled based on a standardized sampling protocol, using store lists or a store floor plan. Data collection took place across five countries, in three types of stores. A total of 2034 foods and drinks were sampled and packaging information was analyzed. At least one claim was identified for 26% (95% CI (24.0%-27.9%)) of all foods and drinks sampled. Six percent of these claims were symbolic. The majority of the claims were nutrition claims (64%), followed by health claims (29%) and health-related ingredient claims (6%). The most common health claims were nutrient and other function claims (47% of all claims), followed by disease risk reduction claims (5%). Eight percent of the health claims were children's development and health claims but these were only observed on less than 1% (0.4%-1.1%) of the foods. The category of foods for specific dietary use had the highest proportion of NHC (70% of foods carried a claim). The prevalence of symbolic and non-symbolic NHC varies across European countries and between different food categories. This study provides baseline data for policy makers and the food industry to monitor and evaluate the use of claims on food packaging.

Usage of plant food supplements across six European countries: findings from the PlantLIBRA consumer survey.

BACKGROUND: The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health, and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, plant food supplements (PFS)). However there is a scarcity of data on the usage of such products at European level. OBJECTIVE: To provide an overview of the characteristics and usage patterns of PFS consumers in six European countries. DESIGN: Data on PFS usage were collected in a cross-sectional, retrospective survey of PFS consumers using a bespoke frequency of PFS usage questionnaire. SUBJECTS/SETTING: A total sample of 2359 adult PFS consumers from Finland, Germany, Italy, Romania, Spain and the United Kingdom. DATA ANALYSES: Descriptive analyses were conducted, with all data stratified by gender, age, and country. Absolute frequencies, percentages and 95% confidence intervals are reported. RESULTS: Overall, an estimated 18.8% of screened survey respondents used at least one PFS. Characteristics of PFS consumers included being older, well-educated, never having smoked and self-reporting health status as "good or very good". Across countries, 491 different botanicals were identified in the PFS products used, with Ginkgo biloba (Ginkgo), Oenothera biennis (Evening primrose) and Cynara scolymus (Artichoke) being most frequently reported; the most popular dose forms were capsules and pills/tablets. Most consumers used one product and half of all users took single-botanical products. Some results varied across countries. CONCLUSIONS: The PlantLIBRA consumer survey is unique in reporting on usage patterns of PFS consumers in six European countries. The survey highlights the complexity of measuring the intake of such products, particularly at pan-European level. Incorporating measures of the intake of botanicals in national dietary surveys would provide much-needed data for comprehensive risk and benefit assessments at the European level.

Nutrition and neurodevelopment in children: focus on NUTRIMENTHE project.

There is growing evidence that early nutrition affects later cognitive performance. The idea that the diet of mothers, infants, and children could affect later mental performance has major implications for public health practice and policy development and for our understanding of human biology as well as for food product development, economic progress, and future wealth creation. To date, however, much of the evidence is from animal, retrospective studies and short-term nutritional intervention studies in humans. The positive effect of micronutrients on health, especially of pregnant women eating well to maximise their child's cognitive and behavioural outcomes, is commonly acknowledged. The current evidence of an association between gestational nutrition and brain development in healthy children is more credible for folate, n-3 fatty acids, and iron. Recent findings highlight the fact that single-nutrient supplementation is less adequate than supplementation with more complex formulae. However, the optimal content of micronutrient supplementation and whether there is a long-term impact on child's neurodevelopment needs to be investigated further. Moreover, it is also evident that future studies should take into account genetic heterogeneity when evaluating nutritional effects and also nutritional recommendations. The objective of the present review is to provide a background and update on the current knowledge linking nutrition to cognition and behaviour in children, and to show how the large collaborative European Project NUTRIMENTHE is working towards this aim.