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PurposeRandomised controlled trials identify causal links between variables but not why an outcome has occurred. This analysis sought to determine how psychological factors assessed at baseline influenced response to personalised nutrition.Design/methodology/approachWeb-based, randomised, controlled trial (RCT) was conducted across seven European countries. Volunteers, both male and female, aged over 18 years were randomised to either a non-personalised (control) or a personalised (treatment) dietary advice condition. Linear mixed model analysis with fixed effects was used to compare associations between internal and external health locus of control (HLoC), nutrition self-efficacy (NS-E) and self-report habit index (S-RHI) at baseline (N = 1444), with healthy eating index (HEI) and Mediterranean diet index (MDI) scores between conditions post-intervention (N = 763).FindingsAn increase in MDI scores was observed between baseline and six months in the treatment group which was associated with higher NS-E (p p p p p = 0.009). Interaction between time and condition indicated increased HEI scores (p p = 0.032). Internal HLoC had no effect on MDI or HEI.Originality/valuePsychological factors associated with behaviour change need consideration when tailoring dietary advice. Those with weaker habit strength will require communication focussed upon establishing dietary habits and support in integrating advised changes into daily routine. Information on habit strength can also be used to inform how progress towards dietary goals is monitored and fed back to the individual. Those with stronger habit strength are more likely to benefit from personalised nutrition.

Aim There has been an increase in the development of technologies that can deliver personalised dietary advice. Devising healthy, sustainable dietary plans will mean taking into consideration extrinsic factors such as individual social circumstances. The aim of this study was to identify societal groups more or less receptive to and likely to engage with personalised nutrition initiatives. Sample and methods Volunteers were recruited via a social research agency from within the UK. The resultant sample (N = 1061) was 49% female, aged 18-65 years. Results MANOVA (Tukey HSD applied) indicated that females and younger people (aged 18-29 years) had more favourable attitudes and were more likely to intend to adopt personalised nutrition. There were no differences in attitude toward or intention to adopt personalised nutrition between different education levels, income brackets or occupational groups. Conclusion These results imply that females and younger people may be most likely to adopt personalised nutrition in the future. Initiatives to promote healthy eating should target males and older people.

Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

Background/Aims: Personalised nutrition has potential to revolutionise dietary health promotion if accepted by the general public. We studied trust and preferences regarding personalised nutrition services, how they influence intention to adopt these services, and cultural and social differences therein. Methods: A total of 9,381 participants were quota-sampled to be representative of each of 9 EU countries (Germany, Greece, Ireland, Poland, Portugal, Spain, the Netherlands, the UK, and Norway) and surveyed by a questionnaire assessing their intention to adopt personalised nutrition, trust in service regulators and information sources, and preferences for service providers and information channels. Results: Trust and preferences significantly predicted intention to adopt personalised nutrition. Higher trust in the local department of health care was associated with lower intention to adopt personalised nutrition. General practitioners were the most trusted of service regulators, except in Portugal, where consumer organisations and universities were most trusted. In all countries, family doctors were the most trusted information providers. Trust in the National Health Service as service regulator and information source showed high variability across countries. Despite its highest variability across countries, personal meeting was the preferred communication channel, except in Spain, where an automated internet service was preferred. General practitioners were the preferred service providers, except in Poland, where dietitians and nutritionists were preferred. The preference for dietitians and nutritionists as service providers highly varied across countries. Conclusion: These results may assist in informing local initiatives to encourage acceptance and adoption of country-specific tailored personalised nutrition services, therefore benefiting individual and public health.

Personalized nutrition allows individual variation in dietary, lifestyle, anthropometric, phenotypic, and/or genomic information to be considered when giving dietary advice. Compared to “generic” dietary health messages, personalized dietary advice has been shown more likely to result in healthy dietary change. Personalized regimes can help clients in this endeavor by putting them in control and taking into consideration the individual’s propensity for behavior change, motives for food choice, as well as social and lifestyle factors impacting upon the eating context. Provision of personalized nutrition services across Europe should consider intercountry differences in perceived barriers to the uptake of personalized nutrition including those associated with the process from the collecting of information and taking of biological samples through to how the results are interpreted and delivered. Irrespective of European country, potential consumers appear to trust health professionals such as dietitians over commercial agents to provide personalized nutrition. Dieticians therefore are likely to play a key role in making personalized nutrition happen in the future. Organizations representing nutrition and dietetics professionals will need to be consulted for guidance on how to address the ethical and legal issues around personalized nutrition and regulate practice. A future is envisaged where commercial personalized nutrition will work with existing health providers in bringing the benefits of personalized nutrition to the wider public.

The development and implementation of core outcome sets can help support the generation of high-quality evidence for pharmaceutical care research, which in turn can help improve outcomes for patients. The concept of COSs is relatively new and a robust, evidence-based methodology for developing and implementing COSs is not yet fully established. The processes described in the COMET Handbook (Version 1.0) represents what is known to be best practice at the time of publication. However, there remain some uncertainties regarding the impact of different methodological decisions made during the development of a COS. For example, how to choose the best consensus technique, or how outcomes are prioritized for inclusion in a COS. Furthermore, guidance regarding how to reduce the number of outcomes specified in a COS to a number that can practicably be measured and reported in an RCT is needed. The handbook is likely to be updated periodically as more research is undertaken [4]. A key message for COS developers is to be transparent with regard to the methods used during COS development studies. An accurate description of how and why key decisions during the COS development process are made, and the outcome of those decisions, will not only encourage uptake of the developed COS but will help guide the refinement of COS development methodology.

BACKGROUND: Inappropriate polypharmacy is a particular concern in older people and is associated with negative health outcomes. Choosing the best interventions to improve appropriate polypharmacy is a priority, hence interest in appropriate polypharmacy, where many medicines may be used to achieve better clinical outcomes for patients, is growing. This is the second update of this Cochrane Review.OBJECTIVES: To determine which interventions, alone or in combination, are effective in improving the appropriate use of polypharmacy and reducing medication-related problems in older people.SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers up until 7 February 2018, together with handsearching of reference lists to identify additional studies.SELECTION CRITERIA: We included randomised trials, non-randomised trials, controlled before-after studies, and interrupted time series. Eligible studies described interventions affecting prescribing aimed at improving appropriate polypharmacy in people aged 65 years and older, prescribed polypharmacy (four or more medicines), which used a validated tool to assess prescribing appropriateness. These tools can be classified as either implicit tools (judgement-based/based on expert professional judgement) or explicit tools (criterion-based, comprising lists of drugs to be avoided in older people).DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed abstracts of eligible studies, extracted data and assessed risk of bias of included studies. We pooled study-specific estimates, and used a random-effects model to yield summary estimates of effect and 95% confidence intervals (CIs). We assessed the overall certainty of evidence for each outcome using the GRADE approach.MAIN RESULTS: We identified 32 studies, 20 from this update. Included studies consisted of 18 randomised trials, 10 cluster randomised trials (one of which was a stepped-wedge design), two non-randomised trials and two controlled before-after studies. One intervention consisted of computerised decision support (CDS); and 31 were complex, multi-faceted pharmaceutical-care based approaches (i.e. the responsible provision of medicines to improve patient's outcomes), one of which incorporated a CDS component as part of their multi-faceted intervention. Interventions were provided in a variety of settings. Interventions were delivered by healthcare professionals such as general physicians, pharmacists and geriatricians, and all were conducted in high-income countries. Assessments using the Cochrane 'Risk of bias' tool, found that there was a high and/or unclear risk of bias across a number of domains. Based on the GRADE approach, the overall certainty of evidence for each pooled outcome ranged from low to very low.It is uncertain whether pharmaceutical care improves medication appropriateness (as measured by an implicit tool), mean difference (MD) -4.76, 95% CI -9.20 to -0.33; 5 studies, N = 517; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the number of potentially inappropriate medications (PIMs), (standardised mean difference (SMD) -0.22, 95% CI -0.38 to -0.05; 7 studies; N = 1832; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PIMs, (risk ratio (RR) 0.79, 95% CI 0.61 to 1.02; 11 studies; N = 3079; very low-certainty evidence). Pharmaceutical care may slightly reduce the number of potential prescribing omissions (PPOs) (SMD -0.81, 95% CI -0.98 to -0.64; 2 studies; N = 569; low-certainty evidence), however it must be noted that this effect estimate is based on only two studies, which had serious limitations in terms of risk bias. Likewise, it is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PPOs (RR 0.40, 95% CI 0.18 to 0.85; 5 studies; N = 1310; very low-certainty evidence). Pharmaceutical care may make little or no difference in hospital admissions (data not pooled; 12 studies; N = 4052; low-certainty evidence). Pharmaceutical care may make little or no difference in quality of life (data not pooled; 12 studies; N = 3211; low-certainty evidence). Medication-related problems were reported in eight studies (N = 10,087) using different terms (e.g. adverse drug reactions, drug-drug interactions). No consistent intervention effect on medication-related problems was noted across studies.AUTHORS' CONCLUSIONS: It is unclear whether interventions to improve appropriate polypharmacy, such as reviews of patients' prescriptions, resulted in clinically significant improvement; however, they may be slightly beneficial in terms of reducing potential prescribing omissions (PPOs); but this effect estimate is based on only two studies, which had serious limitations in terms of risk bias.

Social Cognitive Theory has been used to explain findings derived from focus group discussions ( N = 4) held in the United Kingdom with the aim of informing best practice in personalised nutrition. Positive expectancies included weight loss and negative expectancies surrounded on-line security. Monitoring and feedback were crucial to goal setting and progress. Coaching by the service provider, family and friends was deemed important for self-efficacy. Paying for personalised nutrition symbolised commitment to behaviour change. The social context of eating, however, was perceived a problem and should be considered when designing personalised diets. Social Cognitive Theory could provide an effective framework through which to deliver personalised nutrition.

BACKGROUND: Personalised nutrition (PN) may promote public health. PN involves dietary advice based on individual characteristics of end users and can for example be based on lifestyle, blood and/or DNA profiling. Currently, PN is not refunded by most health insurance or health care plans. Improved public health is contingent on individual consumers being willing to pay for the service.METHODS: A survey with a representative sample from the general population was conducted in eight European countries (N= 8233). Participants reported their willingness to pay (WTP) for PN based on lifestyle information, lifestyle and blood information, and lifestyle and DNA information. WTP was elicited by contingent valuation with the price of a standard, non-PN advice used as reference.RESULTS: About 30% of participants reported being willing to pay more for PN than for non-PN advice. They were on average prepared to pay about 150% of the reference price of a standard, non-personalised advice, with some differences related to socio-demographic factors.CONCLUSION: There is a potential market for PN compared to non-PN advice, particularly among men on higher incomes. These findings raise questions to what extent personalized nutrition can be left to the market or should be incorporated into public health programs.

OBJECTIVES: To develop a core outcome set (COS) for use in effectiveness trials of interventions aiming to improve the appropriateness of polypharmacy in older people in primary care.DESIGN: Standard COS development methodology was followed, comprising identification of outcomes of studies from an update of a Cochrane systematic review and previously collected qualitative data and an online Delphi consensus exercise involving three rounds.PARTICIPANTS: An international panel of 160 stakeholders comprising 120 healthcare experts and a public participant panel of 40 older people.MEASUREMENTS: Outcomes identified from studies included in the Cochrane review and secondary analysis of previously collected qualitative data were scored on a 9-point Likert scale using the GRADE scoring system anchored at 1 (not important) and 9 (critical). Consensus criteria for the COS were defined as 70% or more of participants scoring the outcome as critical and 15% or fewer scoring the outcome as not important.RESULTS: Twenty-nine outcomes identified from the Cochrane review and existing qualitative data were included in the Delphi exercise. The final COS comprised 16 outcomes. The 7 highest-ranked outcomes were serious adverse drug reactions, medication appropriateness, falls, medication regimen complexity, quality of life, mortality, and medication side effects.CONCLUSION: A COS for interventions aiming to improve the appropriateness of polypharmacy for older people in primary care has been developed. Future work will focus on identifying appropriate tools to measure these outcomes and testing the implementation of the COS.

ObjectiveThe present study explored associations between food choice motives, attitudes towards and intention to adopt personalised nutrition, to inform communication strategies based on consumer priorities and concerns.Design/SettingA survey was administered online which included the Food Choice Questionnaire (FCQ) and items assessing attitudes towards and intention to adopt personalised nutrition.SubjectsNationally representative samples were recruited in nine EU countries (n 9381).ResultsStructural equation modelling indicated that the food choice motives ‘weight control’, ‘mood’, ‘health’ and ‘ethical concern’ had a positive association and ‘price’ had a negative association with attitude towards, and intention to adopt, personalised nutrition. ‘Health’ was positively associated and ‘familiarity’ negatively associated with attitude towards personalised nutrition. The effects of ‘weight control’, ‘ethical concern’, ‘mood’ and ‘price’ on intention to adopt personalised nutrition were partially mediated by attitude. The effects of ‘health’ and ‘familiarity’ were fully mediated by attitude. ‘Sensory appeal’ was negatively and directly associated with intention to adopt personalised nutrition.ConclusionsPersonalised nutrition providers may benefit from taking into consideration the importance of underlying determinants of food choice in potential users, particularly weight control, mood and price, when promoting services and in tailoring communications that are motivationally relevant.

Personalised diets based on people’s existing food choices, and/or phenotypic, and/or genetic information hold potential to improve public dietary-related health. The aim of this analysis, therefore, has been to examine the degree to which factors which determine uptake of personalised nutrition vary between EU countries to better target policies to encourage uptake, and optimise the health benefits of personalised nutrition technology. A questionnaire developed from previous qualitative research was used to survey nationally representative samples from 9 EU countries (N = 9381). Perceived barriers to the uptake of personalised nutrition comprised three factors (data protection ; the eating context ; and, societal acceptance). Trust in sources of information comprised four factors (commerce and media ; practitioners ; government ; family and, friends). Benefits comprised a single factor. Analysis of Variance (ANOVA) was employed to compare differences in responses between the United Kingdom ; Ireland ; Portugal ; Poland ; Norway ; the Netherlands ; Germany ; and, Spain. The results indicated that respondents in Greece, Poland, Ireland, Portugal and Spain, rated the benefits of personalised nutrition highest, suggesting a particular readiness in these countries to adopt personalised nutrition interventions. Greek participants were more likely to perceive the social context of eating as a barrier to adoption of personalised nutrition, implying a need for support in negotiating social situations while on a prescribed diet. Those in Spain, Germany, Portugal and Poland scored highest on perceived barriers related to data protection. Government was more trusted than commerce to deliver and provide information on personalised nutrition overall. This was particularly the case in Ireland, Portugal and Greece, indicating an imperative to build trust, particularly in the ability of commercial service providers to deliver personalised dietary regimes effectively in these countries. These findings, obtained from a nationally representative sample of EU citizens, imply that a parallel, integrated, public-private delivery system would capture the needs of most potential consumers.

This analysis has been conducted to explore the validity and reliability of the Food Choice Questionnaire (FCQ) across 9 European countries. Variation in the factor structure and the perceived importance of food choice motives have been compared cross-nationally. Volunteers (N = 9381) were recruited from an existing panel of a social research agency to take part in the Food4Me survey in Germany, Greece, Ireland, Poland, Portugal, Spain, the Netherlands, the UK and Norway. The survey was administeredon-line. Configural, metric and scalar invariance fell within acceptable limits and were consistent across the 9 countries. All reliability parameters were above acceptable levels. Factor analysis confirmed that all items loaded onto the same 9 factors established by Steptoe and Pollard (1995). There was highly significant agreement in the relative importance of food choice factors between countries. Price was ranked as most important food choice factor in five countries (Spain, Greece, Ireland, Portugal and the Netherlands), sensory appeal was ranked first for three countries (Norway, Germany and the UK) while natural contentwas ranked as the most important factor in Poland. Familiarity and ethical concern were consistently ranked as least important in all countries. These data suggest that the FCQ is a suitable tool for exploring food choice motives across different European populations. Differences in relative importance of factors within countries may need to be taken into account in dietary health intervention and food product development.

The notion of educating the public through generic healthy eating messages has pervaded dietary health promotion efforts over the years and continues to do so through various media, despite little evidence for any enduring impact upon eating behaviour. There is growing evidence, however, that tailored interventions such as those that could be delivered online can be effective in bringing about healthy dietary behaviour change. The present paper brings together evidence from qualitative and quantitative studies that have considered the public perspective of genomics, nutrigenomics and personalised nutrition, including those conducted as part of the EU-funded Food4Me project. Such studies have consistently indicated that although the public hold positive views about nutrigenomics and personalised nutrition, they have reservations about the service providers’ ability to ensure the secure handling of health data. Technological innovation has driven the concept of personalised nutrition forward and now a further technological leap is required to ensure the privacy of online service delivery systems and to protect data gathered in the process of designing personalised nutrition therapies. Personalised nutrition: Nutrigenomics: Benefit: Risk: Information technology: Food4Me

Background: The task of revising dietary folate recommendations for optimal health is complicated by a lack of data quantifying the biomarker response that reliably reflects a given folate intake. Objective: We conducted a dose-response meta-analysis in healthy adults to quantify the typical response of recognized folate biomarkers to a change in folic acid intake. Design: Electronic and bibliographic searches identified 19 randomized controlled trials that supplemented with folic acid and measured folate biomarkers before and after the intervention in apparently healthy adults aged >= 18 y. For each biomarker response, the regression coefficient (beta) for individual studies and the overall pooled beta were calculated by using random-effects meta-analysis. Results: Folate biomarkers (serum/plasma and red blood cell folate) increased in response to folic acid in a dose-response manner only up to an intake of 400 mu g/d. Calculation of the overall pooled beta for studies in the range of 50 to 400 mu g/d indicated that a doubling of folic acid intake resulted in an increase in serum/plasma folate by 63% (71% for microbiological assay; 61% for nonmicrobiological assay) and red blood cell folate by 31% (irrespective of whether microbiological or other assay was used). Studies that used the microbiological assay indicated lower heterogeneity compared with studies using nonmicrobiological assays for determining serum/plasma (I-2 = 13.5% compared with I-2 = 77.2%) and red blood cell (I-2 = 45.9% compared with I-2 = 70.2%) folate. Conclusions: Studies administering >400 mu g folic acid/d show no dose-response relation and thus will not yield meaningful results for consideration when generating dietary folate recommendations. The calculated folate biomarker response to a given folic acid intake may be more robust with the use of a microbiological assay rather than alternative methods for blood folate measurement.

The aim of this research was to explore consumer perceptions of personalised nutrition and to compare these across three different levels of “medicalization”: lifestyle assessment (no blood sampling); phenotypic assessment (blood sampling); genomic assessment (blood and buccal sampling). The protocol was developed from two pilot focus groups conducted in the UK. Two focus groups (one comprising only “older” individuals between 30 and 60 years old, the other of adults 18–65 yrs of age) were run in the UK, Spain, the Netherlands, Poland, Portugal, Ireland, Greece and Germany (N = 16). The analysis (guided using grounded theory) suggested that personalised nutrition was perceived in terms of benefit to health and fitness and that convenience was an important driver of uptake. Negative attitudes were associated with internet delivery but not with personalised nutrition per se. Barriers to uptake were linked to broader technological issues associated with data protection, trust in regulator and service providers. Services that required a fee were expected to be of better quality and more secure. An efficacious, transparent and trustworthy regulatory framework for personalised nutrition is required to alleviate consumer concern. In addition, developing trust in service providers is important if such services to be successful