Background In the UK, over 100,000 people have a stroke annually. Over 1.3 million live with the effects of stroke, including problems with mobility, communication, cognition, anxiety, depression and fatigue. Previous research has tested single interventions to improve stroke outcomes in separate, fixed design, parallel-group trials. Evidence generation has been slow and inefficient. Adaptive trial designs are required, to better understand multiple treatments, targeting multiple questions simultaneously. We undertook to develop the first efficient adaptive platform trial protocol, aligned with national research priorities for ‘Life After Stroke’. Methods We embedded PPI activities throughout the platform development and co-developed resources to maximise equality, diversity, and inclusion. We established an inclusive multidisciplinary collaboration to inform design choices and future UK-wide platform delivery. We scrutinised existing research to identify candidate interventions and relevant outcomes; agreeing these with collaborators and PPI. We undertook detailed simulations to inform choice of platform design (adaptive elements, allocation, numbers of interventions, decision criteria for dropping/adding arms, interim analyses timing/frequency; intermediate outcomes choice). We explored barriers to trial and intervention participation through in-person and virtual meetings. To facilitate rapid trial set-up, we engaged with stroke research leaders and data providers; reviewed platform randomisation requirements; and widely disseminated our learning. Results We developed an efficient, adaptive trial protocol, which is feasible, inclusive and acceptable to stroke survivors and services and submitted a funding application for a platform trial testing at least five pre-determined non-pharmacological interventions for post-stroke emotional difficulties, the top research priority for ‘Life After Stroke’. Conclusions The complex and inclusive platform trial design has only been possible through UK-wide multidisciplinary collaboration with stroke researchers, trialists, clinicians, methodologists, third sector, and patient and public contributors. Such a trial would be a step-change in trial design, reducing research waste and accelerating evidence generation to inform improved stroke service provision world-wide.

Being critically ill can result in cognitive change. Cognitive functioning should be screened at different points in the care pathway, and it is important to understand patient's experience of this process. A service evaluation examined fifteen in-patients' and eleven outpatients' experiences of completing the Addenbrookes Cognitive Examination-III (ACE-III) using thematic analysis. Four themes emerged: (1) willingness & acceptability (2) strengths and weaknesses (3) factors affecting performance and (4) improving delivery. Generally, patients accepted the ACE-III and valued cognitive screening. Consideration is given to areas for development.

BACKGROUND:Undertaking Patient and Public Involvement (PPI) when developing health and social care research grant applications is critical. However, researchers may not have any funding to undertake PPI when developing grants. In response, the National Institute for Health and Care Research- Research Design Service for Yorkshire and the Humber in the United Kingdom, provided Public Involvement Fund Awards of up to £600 to fund PPI activity when researchers were developing grant applications. Researchers provided post-activity reports about how they utilised the Public Involvement Fund. These reports were analysed with the aim of evaluating the usefulness of the Public Involvement Fund and to provide learning about supporting researchers to undertake PPI when developing grants.METHODS:The project was a qualitative document analysis of 55 reports. Initially a researcher coded four reports and three Public Contributors provided feedback. Researchers coded the remaining reports and identified key findings. A workshop was held with the three Public Contributors to develop the findings.RESULTS:Researchers accessing the Public Involvement Fund award were generally early career researchers or clinicians who did not have other sources of funding for pre-grant PPI input. Researchers felt the award was useful in enabling them to conduct PPI, which strengthened their grant applications. Some researchers found that the award limit of £600 and guidance encouraging expenditure within three months, made it difficult to undertake PPI throughout the full grant development process. Instead, the majority of researchers consulted Public Contributors on one or two occasions. Researchers struggled to recruit diverse members or run group sessions due to the time pressures of grant deadlines. Researchers wanted training on undertaking PPI alongside the financial support.CONCLUSIONS:Researchers, especially early career researchers found having a Public Involvement Fund award instrumental in enabling them to undertake PPI when developing grant applications. It would be beneficial for similar schemes to be widely available. Schemes need to provide sufficient funding to enable meaningful PPI and allow researchers to hold the award for long enough to facilitate involvement during the whole grant development process. Researchers continue to need training on undertaking PPI.

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m 2 (followed up at 2 years) to 1.1 kg/m 2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.

In this reflective paper we outline and discuss our art-based Patient and Public Involvement (PPI) approach. This exercise held two broad objectives. Firstly, to assist policy makers in understanding the types of interventions communities will find acceptable to address the problem of poor air quality, and secondly, to ascertain community views about our research plans to explore the impact of the planned interventions on neighbourhoods. We reflect on both our approach and the emergent conversations from the PPI activity. Attendees contributed to the process and stressed the importance of not burdening poor neighbourhoods with costly charges as that would ameliorate one health problem but generate others as a consequence of additional financial burden. Equally, they stressed the need to conduct research on matters which they could connect with such as the impact of clean air plans on young children and how information about air pollution is disseminated in their neighbourhoods as and when research findings emerge. This paper offers a conceptual analysis of the art-based PPI method and uniquely draws a connection to the philosophical traditions of Ludwig Wittgenstein. Specifically, we demonstrate how art is conducive to creating a dialogue which is specifically helpful for PPI purposes for both researchers and implementers, and conversely, why traditional conversational approaches may have fallen short of the adequacy mark in this regard.

Background: Critical illness can have a long-term impact. A service evaluation was conducted in a hospital in the south west of Britain with an adult inter-connected general, surgical and neurological intensive care unit (ICU). The aim of the service evaluation was to generate knowledge on experiences of psychological and physical rehabilitation in intensive care, on other hospital wards and at home to inform the development of an Intensive Care follow up clinic. Method: Data was collected from two sources. A week of ICU discharges was randomly selected, and a sample of 30 patients generated. All were sent information sheets and consent forms and offered telephone appointments. 12 participants took part in telephone interviews. The second source of participants was the ICU Expert by Experience group. Informed consent was gained with eight participants taking part. The data was analysed using thematic analysis, employing initial open coding to build a framework of emergent themes. A research group was formed to facilitate cross coding of extracts. Results: The analysis identified three overarching themes: sense making difficulties; rehabilitation context; and sense of self. The theme of sense making difficulties had sub-themes of memory gaps, delirium, lack of information and anxiety. The theme of rehabilitation context had sub-themes of ICU environment, transitions, isolation and abandonment and valued support. Conclusion: the process of sense making can be difficult, is filtered through contextual factors, and may influence sense of self. The results have been used to inform the development of an ICU follow up clinic.

Introduction: Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias, and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings. Method: We invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children’s centre managers (n = 7), children’s centre staff (n = 15), and parents (n = 29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis. Results Potential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre’s (including control group centres). ‘Sharing of best practice’ by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles. Conclusions The extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common practice of knowledge sharing amongst community teams means that this clustering approach is also likely to be most suitable for other trials based within these settings. We provide recommendations (e.g. cluster randomisation, training intervention facilitators on implications of contamination) to help reduce the impact of contamination in public health intervention trials with or without clustering, whilst enabling transfer of knowledge where appropriate. Trial registration: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017

BackgroundCommunity based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to: assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures.MethodsWe conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children’s centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to ‘standard care’ control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews.ResultsWe recruited two local authorities and 12 children’s centres within eight months. 117 parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were acceptable. Contamination was likely, though the impact of this on behaviour was unclear.ConclusionOur findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.Trial registrationClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017

Following a disaster, the majority of families rebuild their homes themselves. In this paper, we consider how the physical environment influences such 'self-recovery' by investigating disasters in the Philippines (typhoons Haiyan in 2013 and Haima in 2016) and Nepal (the Gorkha earthquake 2015). Despite the many differences in the disaster contexts, there are some common barriers to self-recovery (and building back better) in a substantially changed and dynamic multi-hazard, post-disaster environment. These are related to changes in water supply (shortage or surplus), impacts of post-disaster geohazard events on infrastructure (particularly affecting transport) and the availability of technical advice. People face a broad spectrum of challenges as they recover and tackling these 'geo-barriers' may help to create a more enabling environment for self-recovery. The findings point to what needs to be in place to support self-recovery in dynamic physical environments, including geoscience information and advice, and restoration of infrastructure damaged by natural hazard events. Further research is necessary to understand the issues this raises for the shelter and geoscience communities, particularly around availability of geoscience expertise, capacity and information at a local scale.

Background In the UK, rates of childhood obesity remain high. Community based programmes for child obesity prevention are available to be commissioned by local authorities. However, there is a lack of evidence regarding how programmes are commissioned and which attributes of programmes are valued most by commissioners. The aim of this study was to determine the factors that decision-makers prioritise when commissioning programmes that target childhood obesity prevention. Methods An online discrete choice experiment (DCE) was used to survey commissioners and decision makers in the UK to assess their willingness-to-pay for childhood obesity programmes. Results A total of 64 commissioners and other decision makers completed the DCE. The impact of programmes on behavioural outcomes was prioritised, with participants willing to pay an extra £16,600/year if average daily fruit and vegetable intake increased for each child by one additional portion. Participants also prioritised programmes that had greater number of parents fully completing them, and were willing to pay an extra £4810/year for every additional parent completing a programme. The number of parents enrolling in a programme (holding the number completing fixed) and hours of staff time required did not significantly influence choices. Conclusions Emphasis on high programme completion rates and success increasing children’s fruit and vegetable intake has potential to increase commissioning of community based obesity prevention programmes.

Searchable abstracts of presentations at key conferences in obesity ISSN 2632-9808 (online)