Dr Mark Andrew Pilling

Background Interventions that alter aspects of the physical environments in which unhealthy behaviours occur have the potential to change behaviour at scale, i.e., across populations, and thereby decrease the risk of several diseases. One set of such interventions involves reducing serving sizes, which could reduce alcohol consumption. The effect of modifying the available range of serving sizes of wine in a real-world setting is unknown. We aimed to assess the impact on the volume of wine sold of removing the largest serving size by the glass from the options available in licensed premises. Methods and findings The study was conducted between September 2021 and May 2022 in 21 licensed premises in England that sold wine by the glass in serving sizes greater than 125 ml (i.e., 175 ml or 250 ml) and used an electronic point of sale till system. It used an A-B-A reversal design, set over 3 four-weekly periods. “A” represented the nonintervention periods during which standard serving sizes were served and “B” the intervention period when the largest serving size for a glass of wine was removed from the existing range in each establishment: 250 ml (18 premises) or 175 ml (3 premises). The primary outcome was the daily volume of wine sold, extracted from sales data. Twenty-one premises completed the study, 20 of which did so per protocol and were included in the primary analysis. After adjusting for prespecified covariates, the intervention resulted in −420·8 millilitres (ml) (95% confidence intervals (CIs) −681·4 to −160·2 p = 0·002) or −7·6% (95% CI −12·3%, −2·9%) less wine being sold per day. There was no evidence that sales of beer …

Background:It is recognised that longer-term needs after stroke may not be well addressed by current services. The aim of this programme of research was to develop a novel primary care model to address these needs and to evaluate this new approach.Objectives:The work was divided into three workstreams:1. development of a primary care model2. development of a ‘Managing Life After Stroke’programme (including self-management) for people with stroke

MethodsPotentially eligible stroke survivors were identified from stroke registers of five participating general practices in the East of England. A GP in each practice reviewed a random sample of patients to confirm eligibility. Inclusion criteria were confirmed diagnosis of stroke, good understanding of English and capacity to provide written informed consent. People with terminal illness, severe depression or other severe comorbidities were excluded. In order to identify carers to take part, we asked stroke survivors who had agreed to participate the question:‘Which family member or friend gives you the most help and support following your stroke?’

Aims The study aimed to estimate the impact of introducing a draught alcohol-free beer, thereby increasing the relative availability of these products, on alcohol sales and monetary takings in bars and pubs in England. Design Randomised crossover field trial. Participants Fourteen venues that did not previously sell draught alcohol-free beer. Intervention Venues completed two intervention periods and two control periods in a randomised order over 8 weeks. Intervention periods involved replacing one draught alcoholic beer with an alcohol-free beer. Control periods operated business as usual. Measurements: The primary outcome was mean weekly volume (in litres) of draught alcoholic beer sold. The secondary outcome was mean weekly revenue (in GBP [£]) from all drinks. Analyses adjusted for randomised order; special events; season; and busyness. Findings The adjusted mean difference in weekly sales of draught alcoholic beer was-20 litres (95% CI-41 to+ 0.4), equivalent to a 4% reduction (95% CI 8% reduction to 0.1% increase) in the volume of alcoholic draught beer sold when draught alcohol-free beer was available. Excluding venues that failed at least one fidelity check resulted in an adjusted mean difference of-29 litres per week (95% CI-53 to-5), equivalent to a 5% reduction (95% CI 8% reduction to 0.8% reduction). The adjusted mean difference in weekly revenue was+ 61 GBP per week (95% CI-328 to+ 450), equivalent to a 1% increase (95% CI 5% decrease to 7% increase) when draught alcohol-free beer was available. Conclusions Introducing a draught alcohol-free beer in bars and pubs may reduce the volume of draught …

Descriptive statistics (mean scores, mean%, weighted mean% across GP practices where applicable) were calculated for intervention fidelity assessments (ie audio-and video-recorded training, self-reported receipt questionnaires, audio-recorded structured reviews, self-reported delivery questionnaires) and study process data (ie participant and practice characteristics, GP practice notes from structured reviews) using MS Excel. Data were analysed by GP practice. Each component was scored either as ‘done’(score: 2/2),‘partially done’(score: 1/2) or ‘not done’(score: 0/2). Total scores and percentages of these were calculated and then averaged for each practice. A weighted mean was calculated across practices. Fidelity scores between 80% and 100% represented ‘high fidelity’, scores between 51% and 79% represented ‘moderate fidelity’and< 50% represented ‘low fidelity’.

A cost-effectiveness analysis was performed using the 12-month data of the IPCAS trial, a two-arm cluster RCT with general practice as the unit of randomisation. One arm received a new model of care for stroke survivors, and the other arm received usual care. Volume of resource use was recorded adopting the UK NHS perspective and costed using national sources. Quality of life was captured using the EQ-5D-5L questionnaire and used to estimate QALYs to 12 months. Missing data were handled using multiple imputations, and mean costs and QALYs for each trial arm were compared. The differences in mean costs and QALYs per patient were combined to obtain an ICER, which was compared to the recommended UK cost-effectiveness threshold.

BackgroundStroke is the third most important cause of disability burden (Feign et al., 2014, Lozano et al., 2012).

1. I confirm that I have read the information sheet dated 12.3. 2021 (version 1.0) for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. 2. I understand that information gathered in this study will be stored anonymously and securely and may be used for future research 3. Understand that personal information collected during the study (eg, email address) may be looked at by individuals from the University of Cambridge or the University of Bristol, or regulatory authorities; 4. I understand that the anonymous information gathered in this study may be made available as ‘Open Data’, which means the anonymised data will be publicly available and may be used for purposes not related to this task; 5. I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason

Existing regulation in the UK states that the term ‘milk’ can only be used in labelling to describe products that originate from animals. We conducted an observational study, which surveyed the availability and labelling of milk substitutes in UK supermarkets, and an online experimental study, which assessed the impact of using the term ‘milk’ on milk substitute labelling. In the experimental study, 352 UK adults were randomised to one of the two conditions where they saw milk substitutes that were either labelled with UK regulations (e.g., soya drink) or using the term ‘milk’ (e.g., soya milk). Our primary aims were to assess whether adding the term ‘milk’ to labels would (1) more accurately communicate the uses of milk substitutes or (2) confuse consumers about which products come from an animal source. In our observational study, milk substitutes were readily available and labelling varied significantly. In our …

BackgroundSmaller serving sizes of alcoholic drinks could reduce alcohol consumption across populations thereby lowering the risk of many diseases. The effect of modifying the available range of serving sizes of beer and cider in a real-world setting has yet to be studied. The current study assessed the impact on beer and cider sales of adding a serving size of draught beer and cider (2/3 pint) that was between the current smallest (1/2 pint) and largest (1 pint) standard serving sizes.MethodsTwenty-two licensed premises in England consented to taking part in the study. The study used an ABA reversal design, set over three 4-weekly periods, with A representing the non-intervention periods, during which standard serving sizes were served and B the intervention period when a 2/3 pint serving size of draught beer and cider was added to the existing range, along with smaller 1/2 pint and larger 1 pint serving sizes …

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines”. The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals as members of the Trials Methodology Research Partnership Adaptive Designs Working Group, which is jointly funded by the Medical Research Council and the National Institute for Health and Care Research. Two topics arose frequently in the discussion: the emphasis on legislation, and the absence of questions on data sharing. It is our opinion that the proposals rely heavily on legislation to change practice. However, clinical trials are heterogeneous, and as a result some trials will struggle to comply with all of the …

Background Increasing the availability of non-alcoholic options is a promising population-level intervention to reduce alcohol consumption, currently unassessed in naturalistic settings. This study in an online retail context aimed to estimate the impact of increasing the proportion of non-alcoholic (relative to alcoholic) drinks, on selection and purchasing of alcohol. Methods and results Adults (n = 737) residing in England and Wales who regularly purchased alcohol online were recruited between March and July 2021. Participants were randomly assigned to one of 3 groups: “25% non-alcoholic/75% alcoholic”; “50% non-alcoholic/50% alcoholic”; and “75% non-alcoholic/25% alcoholic,” then selected drinks in a simulated online supermarket, before purchasing them in an actual online supermarket. The primary outcome was the number of alcohol units selected (with intention to purchase); secondary outcomes included actual purchasing. A total of 607 participants (60% female, mean age = 38 years [range: 18 to 76]) completed the study and were included in the primary analysis. In the first part of a hurdle model, a greater proportion of participants in the “75% non-alcoholic” group did not select any alcohol (13.1%) compared to the “25% non-alcoholic” group (3.4%; 95% confidence interval [CI] −2.09, −0.63; p < 0.001). There was no evidence of a difference between the “75% non-alcoholic” and the “50% non-alcoholic” (7.2%) groups (95% CI 0.10, 1.34; p = 0.022) or between the “50% non-alcoholic” and the “25% non-alcoholic” groups (95% CI −1.44, 0.17; p = 0.121). In the second part of a hurdle model in participants (559/607) selecting any …

In the 1930s, Psychologists began developing Multiple-Factor Analysis to decompose multivariate data into a small number of interpretable factors without any a priori knowledge about those factors. In this form of factor analysis, the Varimax factor rotation redraws the axes through the multi-dimensional factors to make them sparse and thus make them more interpretable. Charles Spearman and many others objected to factor rotations because the factors seem to be rotationally invariant. Despite the controversy, factor rotations have remained widely popular among people analyzing data. Reversing nearly a century of statistical thinking on the topic, we show that the rotation makes the factors easier to interpret because the Varimax performs statistical inference; in particular, principal components analysis (PCA) with a Varimax rotation provides a unified spectral estimation strategy for a broad class of semi …

Reference 1. Cicero et al. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic

A between-subjects randomised controlled trial, in online purchasing context. Participants were adults (n= 737) over the age of 18, who regularly purchased alcohol online. Participants were randomised to one of three groups varying in the proportions of alcoholic vs. Non-alcoholic drinks i.‘25% non-alcoholic/75% alcoholic’; ii.‘50% non-alcoholic/50% alcoholic’; iii.‘75% non-alcoholic/25% alcoholic’Participants completed a shopping task, they selected drinks in a simulated online supermarket, before purchasing them in an actual online supermarket The primary outcome was the number of alcohol units selected (with intention to purchase); secondary outcomes included actual purchasing. A readme. txt file has been included.

Correction: Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing - PMC Back to Top Skip to main content NIH NLM Logo Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation Search PMC Full-Text Archive Search in PMC Advanced Search User Guide Journal List Trials v.24; 2023 PMC10664262 Other Formats PDF (621K) Actions Cite Collections Share Permalink Copy RESOURCES Similar articles Cited by other articles Links to NCBI Databases Journal List Trials v.24; 2023 PMC10664262 As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn …

Public support for many policies that tackle obesity by changing environments is low. This may reflect commonly held causal beliefs about obesity, namely that it is due to failures of self-control rather than environmental influences. Several studies have sought to increase public support by changing these and similar causal beliefs, with mixed results. The current review is the first systematic synthesis of these studies. Searches of PsycInfo, Medline, Web of Science, Scopus, and Open Grey yielded 20 eligible studies (N = 8977) from 11,776 abstracts. Eligible studies were controlled experiments with an intervention group that communicated information about the environment’s role in obesity, and a measure of support for environment-based obesity policies. The protocol was prospectively registered on PROSPERO. Meta-analyses showed no evidence that communicating information about the environment’s …

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BackgroundInterventions that alter the availability of healthier and less healthy products, within the environments from which they are purchased or consumed, can facilitate healthier consumption (Allan et al., 2017; Grech and Allman-Farinelli, 2015; Pechey et al., 2019; Hollands et al., 2019). These can be classified as Availability x Product interventions, based on the Typology of Interventions in Proximal Physical Micro‐Environments (TIPPME)(Hollands et al., 2017).A Cochrane review of the impact of reducing the availability of less healthy products on their selection and consumption, reported large effects on selection and a moderate effect on consumption (Hollands et al., 2019). However, concerns regarding study quality and sample size were identified and uncertainty for the reliability of these findings remains. In addition, the review only identified studies related to food products and the effectiveness of availability interventions for reducing alcohol consumption is unknown.

This randomised online experiment aimed to investigate how eco-labelling and social nudging influenced sustainable food choice, as well as consider the effect of motivation to act sustainably. Participants were UK adults ≥18 years (n = 1399). Participants were asked to choose a hypothetical meal (beef, chicken or vegetarian burrito) and were randomly allocated to one of three conditions varying in labelling: eco-labelling; social nudge or control (no label). Co-primary outcomes were the frequency that the vegetarian and chicken burritos were chosen (i.e., the more sustainable food choices). There was evidence that more vegetarian (OR = 3.3 [95% CI 2.0, 5.3]) and chicken (OR = 2.5 [95% CI 1.8, 3.4]) burrito choices were made in the eco-label condition, over the beef burrito, compared to the control condition. In the social nudge condition, there was evidence that participants chose a vegetarian burrito over a beef …