Process Evaluation of a Collaborative Social Media Health Campaign: An Analysis of Partner and User Engagement.

Collaborative health promotion campaigns are advantageous because they extend the resources and reach of any single organization. Yet, they can be challenging because they require partner commitment and compromise. On social media, however, these campaigns are especially beneficial due to the high demand for ongoing content that facilitates user engagement. This study is a content analysis of an annual collaborative campaign, Preteen Vaccine Week, conducted by the California Department of Public Health (CDPH) to promote preteen immunizations. Campaign partners are encouraged to use creative assets provided by CDPH and to follow a themed content calendar. Message characteristics and audience engagement were evaluated for 2 years of the campaign (2019-2020). Results indicate that when there was a specific health issue scheduled as the daily theme, 85% of posts reflected that health topic. However, when the theme was general awareness, only 15% of posts aligned. Furthermore, the majority of posts included supplemental audiovisual assets of which nearly half were provided by CDPH. These findings suggest partners attempted to work together. Analyses of message characteristics indicate there was little effort to encourage online user engagement; however, a majority of messages included a call-to-action. These findings indicate that health organizations continue to use social media much like they use mass media: for information dissemination and behavioral recommendations.

Patient preferences for treatment in steroid resistant ulcerative colitis - a discrete-choice experiment.

BACKGROUND AND AIM: Understanding treatment preferences in those patients who are not responding to corticosteroids for ulcerative colitis is important in informing treatment choices. This study aimed to assess the relative importance of treatment characteristics to patients by conducting a discrete-choice experiment. METHODS: Patients completed the questionnaire online. All data were collected between September and December 2020. Participants were shown 13 discrete-choice experiment tasks - a series of side-by-side comparisons of competing, hypothetical treatment characteristics and asked to select a preferred treatment. Survey responses were analysed using descriptive statistics and regression analyses. RESULTS: 115 patients completed the study. Patient preferences were strongest for treatments with a lower chance of side effects, this attribute had the most influence on the choice of treatment patients preferred. The second most important attribute was an improvement in maintaining remission. Conversely, route and frequency of administration were least important on the choice of treatment patients preferred. Respondents were willing to make trade offs and accept treatment benefits to compensate them for receiving a treatment with a less desirable attribute level. Participants were willing to accept a larger benefit of 45% improvement in maintenance of remission to accept a treatment with a higher probability of side effects. The benefit required was smaller with a 10% improvement in remission required to accept a treatment with a lower probability of side effects. CONCLUSION: Quantifying preferences helps to identify and prioritise treatment characteristics that are important to patients. The results highlight the importance of careful discussion of side effects, including the magnitude of risk, using visualisation tools during a patient consultation to support decisions.

The use of co-production, co-design and co-creation to mobilise knowledge in the management of health conditions: a systematic review.

BACKGROUND: Knowledge mobilisation is a term used in healthcare research to describe the process of generating, sharing and using evidence. 'Co'approaches, such as co-production, co-design and co-creation, have been proposed as a way of overcoming the knowledge to practice gap. There is a need to understand why researchers choose to adopt these approaches, how they achieve knowledge mobilisation in the management of health conditions, and the extent to which knowledge mobilisation is accomplished. METHODS: Studies that explicitly used the terms co-production, co-design or co-creation to mobilise knowledge in the management of health conditions were included. Web of Science, EMBASE via OvidSP, MEDLINE via OvidSP and CINHAL via EBSCO databases were searched up to April 2021. Quality assessment was carried out using the Joanna Briggs Institute qualitative quality assessment checklist. Pluye and Hong's seven steps for mixed studies reviews were followed. Data were synthesised using thematic synthesis. RESULTS: Twenty four international studies were included. These were qualitative studies, case studies and study protocols. Key aspects of 'co'approaches were bringing people together as active and equal partners, valuing all types of knowledge, using creative approaches to understand and solve problems, and using iterative prototyping techniques. Authors articulated mechanisms of action that included developing a shared understanding, identifying and meeting needs, giving everyone a voice and sense of ownership, and creating trust and confidence. They believed these mechanisms could produce interventions that were relevant and acceptable to stakeholders, more useable and more likely to be implemented in healthcare. Varied activities were used to promote these mechanisms such as interviews and creative workshops. There appeared to be a lack of robust evaluation of the interventions produced so little evidence in this review that 'co'approaches improved the management of health conditions. CONCLUSION: Those using 'co'approaches believed that they could achieve knowledge mobilisation through a number of mechanisms, but there was no evidence that these led to improved health. The framework of key aspects and mechanisms of 'co'approaches developed here may help researchers to meet the principles of these approaches. There is a need for robust evaluation to identify whether 'co'approaches produce improved health outcomes. TRIAL REGISTRATION: PROSPERO CRD42020187463 .

A comparison of the acceptability and psychometric properties of scales assessing the impact of type 1 diabetes on quality of life-Results of 'YourSAY: Quality of Life'.

AIMS: To compare the acceptability, reliability and validity of five contemporary diabetes-specific quality of life (QoL) scales among adults with type 1 diabetes in the United Kingdom and Australia. METHODS: Adults with type 1 diabetes (UK = 1139, Australia = 439) completed a cross-sectional, online survey including ADDQoL-19, DCP, DIDP, DSQOLS and Diabetes QoL-Q, presented in randomised order. After completing each scale, participants rated it for clarity, relevance, ease of completion, length and comprehensiveness. We examined scale acceptability (scale completion and user ratings), response patterns, structure (exploratory and confirmatory factor analyses) and validity (convergent, concurrent, divergent and known groups). To assess cross-country reproducibility, analyses conducted on the UK dataset were replicated in the Australian dataset. RESULTS: Findings were largely consistent between countries. All scales were acceptable to participants: ≥90% completing all items, and ≥80% positive user ratings, except for DSQOLS' length. Scale structure was not supported for the DCP. Overall, in terms of acceptability and psychometric evaluation, the DIDP was the strongest performing scale while the ADDQoL-19 and Diabetes QoL-Q scales also performed well. CONCLUSIONS: These findings suggest that the recently developed brief (7 items), neutrally worded DIDP scale is acceptable to adults with type 1 diabetes and has the strongest psychometric performance. However, questionnaire selection should always be considered in the context of the research aims, study design and population, as well as the wider published evidence regarding both the development and responsiveness of the scales.

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

AIMS: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. METHODS: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians). RESULTS: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management. CONCLUSIONS: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.

The nutritional management of people living with amyotrophic lateral sclerosis: A national survey of dietitians.

BACKGROUND: People living with amyotrophic lateral sclerosis (ALS) face many challenges with respect to taking adequate nutrition. Growing evidence links weight loss with negative prognostic outcomes. We aimed to explore the practice of dietitians in the UK with regard to the nutritional management of ALS. METHODS: A national online survey was disseminated via professional groups, social media and newsletters to UK healthcare professionals between September and November 2018. The survey examined the nutritional management of ALS. Dietitian responses are reported in the present study. RESULTS: In total, 130 dietitians responded to the survey. Two-thirds reported that ALS comprised less than 20% of their total patient caseload. Forty-two percent reported that nutritional screening took place in their organisation. One-half of dietitians reported that patients were referred for dietetic assessment at 'about the right time', although 44% reported referrals were made too late. The majority (83%) of dietitians used resting energy expenditure predictive equations not validated in ALS. When setting weight goals, dietitians reported most frequently recommending weight maintenance if the patient's body mass index was 18.5-25 kg m-2 (72%), 25-30 kg m-2 (98%), and > 30 kg m-2 (79%). In addition, 43% reported that people with ALS were not weighed sufficiently frequently. CONCLUSIONS: Although the importance of early nutritional assessment is recognised, the timeliness of dietetic input and on-going monitoring of nutritional status in ALS care might not currently be ideal. Dietitians report using energy requirement predictive equations and setting weight goals that may not promote positive outcomes. Further research is required to understand the optimal nutritional management of ALS.

Cross-sectional survey research investigating how medical students use clinical photographs to support their learning.

This study explored students' use of clinical photographs within seven medical schools in England. The design used was cross-sectional survey research. The data collection method was a self-completion online survey. A total of 283 students participated in the study. The proportion of students using clinical photographs was 87%, p = .217. The medical subject discipline in which clinical photographs were considered by students as most useful were dermatology (71%). The proportion for those 'Very' or 'Quite' likely to access an image library made available through their medical school was 92%. The main barrier to using existing photographic resources was awareness.

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.

BACKGROUND: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. METHODS: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. RESULTS: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. CONCLUSIONS: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements.

Follow-Up Support for Effective type 1 Diabetes self-management (The FUSED Model): A systematic review and meta-ethnography of the barriers, facilitators and recommendations for sustaining self-management skills after attending a structured education programme.

BACKGROUND: People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia. However, many struggle to sustain these improvements over time. To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants' self-management behaviours after attending structured education and their need for support to sustain improvements in glycaemic control. METHODS: We undertook a meta-ethnography of relevant qualitative studies, identified using systematic search methods. Studies were included which focused on participants' experiences of self-managing type 1 diabetes after attending structured education which incorporated training in flexible intensive insulin therapy. A line of argument approach was used to synthesise the findings. RESULTS: The search identified 18 papers from six studies. The studies included were judged to be of high methodological quality. The line of argument synthesis developed the Follow-Up Support for Effective type 1 Diabetes self-management (FUSED) model. This model outlines the challenges participants encounter in maintaining diabetes self-management practices after attending structured education, and describes how participants try to address these barriers by adapting, simplifying or personalising the self-management approaches they have learned. To help participants maintain the skills taught during courses, the FUSED model presents ten recommendations abstracted from the included papers to provide a logic model for a programme of individualised and responsive follow-up support. CONCLUSIONS: This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour. To help people sustain diabetes self-management skills after attending structured education, it is recommended that support be provided over the longer-term by appropriately trained healthcare professionals which is responsive to individuals' needs. Although developed to inform support for people with type 1 diabetes, the FUSED model provides a framework that could also be applied to support individuals with other long term conditions which require complex self-management skills to be learned and sustained over time. TRIAL REGISTRATION: PROSPERO registration: CRD42017067961 .

Can more appropriate support and services be provided for people who attend the emergency department frequently? National Health Service staff views.

BACKGROUND: Interventions designed to help Emergency Department (ED) staff manage frequent attenders are labour-intensive and only benefit a small sample of frequent attenders. We aimed to use the in-depth knowledge of health professionals with experience of working with ED frequent attenders to understand the challenges of managing this group of patients and their opinions on providing more appropriate support. METHODS: Semi-structured interviews were conducted with medical and nursing ED staff, mental health liaison nurses and general practitioners (GPs). Interviews covered the following: definitions and experiences of treating frequent attenders and thoughts on alternative service provision. Vignettes of frequent attenders were used to elicit discussions on these topics. Thematic analysis of transcribed interviews was undertaken. RESULTS: Twelve health professionals were interviewed. Three groups of frequent attenders were identified: people with long-term physical conditions, mental health problems and health-related anxiety. Underlying reasons for attendance differed between the groups, highlighting the need for targeted interventions. Suggested interventions included improving self-management of long-term physical conditions; creating a 'go-to' place away from the ED for patients experiencing a mental health crisis; increasing the provision of mental health liaison services; and for patients with health-related anxiety, the role of the GP in the patients' care pathway was emphasised, as were the benefits of providing additional training for ED staff to help identify and support this group. CONCLUSION: Interventions to address frequent attendance should focus on redirection to and liaison with more appropriate services, located on the hospital site or in the community, tailored to each identified patient group.

Implementing solutions to improve and expand telehealth adoption: participatory action research in four community healthcare settings.

BACKGROUND: Adoption of telehealth has been slower than anticipated, and little is known about the service improvements that help to embed telehealth into routine practice or the role of frontline staff in improving adoption. This paper reports on participatory action research carried out in four community health settings using telehealth for patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure. METHODS: To inform the action research, in-depth case studies of each telehealth service were conducted (May 2012-June 2013). Each service was then supported by researchers through two cycles of action research to implement changes to increase adoption of telehealth, completed over a seven month period (July 2013-April 2014). The action research was studied via observation of multi-stakeholder workshops, analysis of implementation plans, and focus groups. RESULTS: Action research participants included 57 staff and one patient, with between eight and 20 participants per site. The case study findings were identified as a key source of information for planning change, with sites addressing common challenges identified through this work. For example, refining referral criteria; standardizing how and when patients are monitored; improving data sharing; and establishing evaluation processes. Sites also focused on raising awareness of telehealth to increase adoption in other clinical teams and to help secure future financial investment for telehealth, which was required because of short-term funding arrangements. Specific solutions varied due to local infrastructures, resources, and opinion, as well as previous service developments. Local telehealth champions played an important role in engaging multiple stakeholders in the study. CONCLUSIONS: Action research enabled services to make planned changes to telehealth and share learning across multiple stakeholders about how and when to use telehealth. However, adoption was impeded by continual changes affecting telehealth and wider service provision, which also hindered implementation efforts and affected motivation of staff to engage with the action research, particularly where local decision-makers were not engaged in the study. Wider technological barriers also limited the potential for change, as did uncertainties about goals for telehealth investment, thereby making it difficult to identify outcomes for demonstrating the added value over existing practice.

Examining the use of telehealth in community nursing: identifying the factors affecting frontline staff acceptance and telehealth adoption.

AIMS: To examine frontline staff acceptance of telehealth and identify barriers to and enablers of successful adoption of remote monitoring for patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure. BACKGROUND: The use of telehealth in the UK has not developed at the pace and scale anticipated by policy. Many existing studies report frontline staff acceptance as a key barrier, however data are limited and there is little evidence of the adoption of telehealth in routine practice. DESIGN: Case studies of four community health services in England that use telehealth to monitor patients with Chronic Obstructive Pulmonary Disease and Chronic Heart Failure. METHODS: Thematic analysis of qualitative interviews with 84 nursing and other frontline staff; and 21 managers and key stakeholders; data collected May 2012-June 2013. FINDINGS: Staff attitudes ranged from resistance to enthusiasm, with varied opinions about the motives for investing in telehealth and the potential impact on nursing roles. Having reliable and flexible technology and dedicated resources for telehealth work were identified as essential in helping to overcome early barriers to acceptance, along with appropriate staff training and a partnership approach to implementation. Early successes were also important, encouraging staff to use telehealth and facilitating clinical learning and increased adoption. CONCLUSIONS: The mainstreaming of telehealth hinges on clinical 'buy-in'. Where barriers to successful implementation exist, clinicians can lose faith in using technology to perform tasks traditionally delivered in person. Addressing barriers is therefore crucial if clinicians are to adopt telehealth into routine practice.

Measuring Health-Related Quality of Life in Amyotrophic Lateral Sclerosis: A Systematic Review and Conceptual Framework.

BACKGROUND AND OBJECTIVES: The assessment of health-related quality of life (HRQoL) in patients with amyotrophic lateral sclerosis (ALS) is heterogeneous and inconsistent. The objectives of this study were (1) to develop a comprehensive conceptual framework of HRQoL in ALS and (2) map the content of existing patient-reported outcome measures (PROMs) used in ALS to this novel framework. METHODS: Our model of HRQoL in ALS (Health-related Quality of life in Amyotrophic Lateral Sclerosis, QuALS) was developed from a systematic literature review and consultative input from key stakeholders (patients, carers, and health care professionals). Five electronic databases were searched in April 2022. Primary studies of any design that assessed HRQoL in ALS by using a multi-item PROM and/or qualitative methods were identified. Using an a priori framework, HRQoL themes were extracted and iteratively modified from the content of each PROM and qualitative study quotations identified in the literature. The conceptual framework was ratified by stakeholders with lived experience and clinical experts. The QuALS framework was used to map the content of identified PROMs and qualitative studies based on thematic coverage. RESULTS: QuALS covers 3 high-level domains of HRQoL (physical, psychological, and social functioning) and consists of 7 themes (Activities; Physical Health; Autonomy; Cognition; Feelings and Emotions; Self-identity; Relationships), characterized by 42 subthemes. Of 8,220 studies identified, 274 were included in the review that informed QuALS. In these studies, 111 PROMs were used to assess at least 1 aspect of HRQoL, and 11 studies used qualitative methods. Of the 3 high-level domains, physical functioning was the most commonly assessed, particularly within ALS-specific PROMs where almost one-quarter of PROMs exclusively assessed physical functioning. None of the PROMs or qualitative studies identified assessed all aspects of HRQoL in the QuALS framework. DISCUSSION: This study presents a new comprehensive conceptual framework of HRQoL in ALS (QuALS), informed by a robust systematic review of existing literature and stakeholder input, incorporating lived experience. QuALS provides a valuable resource for researchers and clinicians interested in taking a holistic approach to assessing and understanding the full impact of ALS on HRQoL and how this may be affected by treatments.

Patient, carer and healthcare professional perspectives on increasing calorie intake in Amyotrophic Lateral Sclerosis.

OBJECTIVES: Research suggests that higher Body Mass Index is associated with improved survival in people with Amyotrophic Lateral Sclerosis (pwALS). Yet, understanding of the barriers and enablers to increasing calorie intake is limited. This study sought to explore these issues from the perspective of pwALS, informal carers, and healthcare professionals. METHODS: Interviews with 18 pwALS and 16 informal carers, and focus groups with 51 healthcare professionals. Data were analysed using template analysis and mapped to the COM-B model and Theoretical Domains Framework (TDF). RESULTS: All three COM-B components (Capability, Opportunity and Motivation) are important to achieving high calorie diets in pwALS. Eleven TDF domains were identified: Physical skills (ALS symptoms); Knowledge (about high calorie diets and healthy eating); Memory, attention, and decision processes (reflecting cognitive difficulties); Environmental context/resources (availability of informal and formal carers); Social influences (social aspects of eating); Beliefs about consequences (healthy eating vs. high calorie diets); Identity (interest in health lifestyles); Goals (sense of control); Reinforcement (eating habits); and Optimism and Emotion (low mood, poor appetite). DISCUSSION: To promote high calorie diets for pwALS, greater clarity around the rationale and content of recommended diets is needed. Interventions should be tailored to patient symptoms, preferences, motivations, and opportunities.

Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit-risk assessment: the BRAINS study including expert workshop.

Background: Randomised controlled trials are designed to assess the superiority, equivalence or non-inferiority of a new health technology, but which trial design should be used is not always obvious in practice. In particular, when using equivalence or non-inferiority designs, multiple outcomes of interest may be important for the success of a trial, despite the fact that usually only a single primary outcome is used to design the trial. Benefit-risk methods are used in the regulatory clinical trial setting to assess multiple outcomes and consider the trade-off of the benefits against the risks, but are not regularly implemented in publicly funded trials. Objectives: The aim of the project is to aid the design of clinical trials with multiple outcomes of interest by defining when each trial design is appropriate to use and identifying when to use benefit-risk methods to assess outcome trade-offs (qualitatively or quantitatively) in a publicly funded trial setting. Methods: A range of methods was used to elicit expert opinion to answer the project objectives, including a web-based survey of relevant researchers, a rapid review of current literature and a 2-day consensus workshop of experts (in 2019). Results: We created a list of 19 factors to aid researchers in selecting the most appropriate trial design, containing the following overarching sections: population, intervention, comparator, outcomes, feasibility and perspectives. Six key reasons that indicate a benefit-risk method should be considered within a trial were identified: (1) when the success of the trial depends on more than one outcome; (2) when important outcomes within the trial are in competing directions (i.e. a health technology is better for one outcome, but worse for another); (3) to allow patient preferences to be included and directly influence trial results; (4) to provide transparency on subjective recommendations from a trial; (5) to provide consistency in the approach to presenting results from a trial; and (6) to synthesise multiple outcomes into a single metric. Further information was provided to support the use of benefit-risk methods in appropriate circumstances, including the following: methods identified from the review were collated into different groupings and described to aid the selection of a method; potential implementation of methods throughout the trial process were provided and discussed (with examples); and general considerations were described for those using benefit-risk methods. Finally, a checklist of five pieces of information that should be present when reporting benefit-risk methods was defined, with two additional items specifically for reporting the results. Conclusions: These recommendations will assist research teams in selecting which trial design to use and deciding whether or not a benefit-risk method could be included to ensure research questions are answered appropriately. Additional information is provided to support consistent use and clear reporting of benefit-risk methods in the future. The recommendations can also be used by funding committees to confirm that appropriate considerations of the trial design have been made. Limitations: This research was limited in scope and should be considered in conjunction with other trial design methodologies to assess appropriateness. In addition, further research is needed to provide concrete information about which benefit-risk methods are best to use in publicly funded trials, along with recommendations that are specific to each method. Study registration: The rapid review is registered as PROSPERO CRD42019144882. Funding: Funded by the Medical Research Council UK and the National Institute for Health and Care Research as part of the Medical Research Council-National Institute for Health and Care Research Methodology Research programme.

Randomised controlled trials are considered the best way to gather evidence about potential NHS treatments. They can be designed from different perspectives depending whether the aim is to show that a new treatment is better than, equal to or no worse than the current best available treatment. The selection of this design relates to the single most important outcome; however, often multiple outcomes can be affected by a treatment. For example, a new treatment may improve disease management but increase side effects. Patients want a treatment to work but not at the price of poor quality of life; therefore, a trade-off must be made, and the recommended treatment depends on this trade-off. Benefit­risk methods can assess the trade-off between multiple outcomes and can include patient preference. These methods could improve the way that decisions are made about treatments in the NHS, but there is currently limited research about the use of these methods in publicly funded trials. The aim of this report is to improve the design of clinical trials by helping researchers to select the most appropriate trial design and to decide when to include a benefit­risk method. The recommendations were created using the opinions of experts within the field and consisted of a survey, review of the literature and a workshop. The project created a list of 19 factors that can assist researchers to select the most appropriate trial design. Furthermore, six key areas were identified in which researchers may consider including a benefit­risk method within a trial. Finally, if a benefit­risk assessment is being used, a checklist of items has been created that identifies the information important to include in reports. This report is, however, limited in its applicability and further research should extend this work, as well as provide more detail on individual methods that are available.

I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO® based therapy ('Play Brick Therapy') clubs in school environments.

LAY ABSTRACT: Autism is characterised by keen interests and differences in social interactions and communication. Activities that help autistic children and young people with social skills are commonly used in UK schools. LEGO® based therapy is a new activity that provides interesting and fun social opportunities for children and young people and involves building LEGO® models together. This study looked at LEGO® based therapy for the social skills of autistic children and young people in schools. It was a randomised controlled trial, meaning each school was randomly chosen (like flipping a coin) to either run LEGO® based therapy groups in school over 12 weeks and have usual support from school or other professionals, or only have usual support from school or other professionals. The effect of the LEGO® based therapy groups was measured by asking children and young people, their parents/guardians, and a teacher at school in both arms of the study to complete some questionnaires. The main objective was to see if the teacher's questionnaire answers about the children and young people's social skills changed between their first and second completions. The social skills of participants in the LEGO® based therapy groups were found to have improved in a small way when compared to usual support only. The study also found that LEGO® based therapy was not very costly for schools to run and parents/guardians and teachers said they thought it was good for their children and young people. We suggest further research into different potential benefits of LEGO® based therapy.

Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT.

Background: Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO® (LEGO System A/S, Billund, Denmark) based therapy, a group social skills intervention, aims to be more interesting and engaging. Objective: To evaluate the clinical effectiveness of LEGO® based therapy on the social and emotional skills of children and young people with autism spectrum disorder in school settings compared with usual support. Secondary objectives included evaluations of cost-effectiveness, acceptability and treatment fidelity. Design: A cluster randomised controlled trial randomly allocating participating schools to either LEGO® based therapy and usual support or usual support only. Setting: Mainstream schools in the north of England. Participants: Children and young people (aged 7-15 years) with autism spectrum disorder, their parent/guardian, an associated teacher/teaching assistant and a facilitator teacher/teaching assistant (intervention schools only). Intervention: Schools randomised to the intervention arm delivered 12 weekly sessions of LEGO® based therapy, which promotes collaborative play and encourages social problem-solving in groups of three children and young people with a facilitator (trained teacher or teaching assistant). Participants received usual support from school and community services. Participants in the control arm received usual support only. Research assistants and statisticians were blind to treatment allocation. Main outcome measure: The social skills subscale of the Social Skills Improvement System (SSIS), completed by the children and young people's unblinded teacher pre randomisation and 20 weeks post randomisation. The SSIS social skills subscale measures social skills including social communication, co-operation, empathy, assertion, responsibility and self-control. Participants completed a number of other pre- and post-randomisation measures of emotional health, quality of life, loneliness, problem behaviours, academic competence, service resource utilisation and adverse events. Results: A total of 250 children and young people from 98 schools were randomised: 127 to the intervention arm and 123 to the control arm. Intention-to-treat analysis of the main outcome measure showed a modest positive difference of 3.74 points (95% confidence interval -0.16 to 7.63 points, standardised effect size 0.18; p = 0.06) in favour of the intervention arm. Statistical significance increased in per-protocol analysis, with a modest positive difference (standardised effect size 0.21; p = 0.036). Cost-effectiveness of the intervention was found in reduced service use costs and a small increase in quality-adjusted life-years. Intervention fidelity and acceptability were positive. No intervention-related adverse events or effects were reported. Conclusions: The primary and pre-planned sensitivity analysis of the primary outcome consistently showed a positive clinical difference, with modest standardised effect sizes of between 0.15 and 0.21. There were positive health economics and qualitative findings, corroborated by the difference between arms for the majority of secondary outcomes, which were not statistically significant but favoured the intervention arm. Post hoc additional analysis was exploratory and was not used in drawing this conclusion. Given the small positive change, LEGO® based therapy for children and young people with autism spectrum disorder in schools should be considered. Limitations: The primary outcome measure was completed by an unblinded teacher (rather than by the facilitator). Future work: The study team recommends future research into LEGO® based therapy, particularly in school environments. Trial registration: This trial is registered as ISRCTN64852382. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/49/32) and is published in full in Public Health Research; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information.

Autism spectrum disorder is characterised by difficulties with social relationships and communication, which can make it difficult to make friends. Social skills training is commonly used to help children and young people learn different social skills, but some children and young people do not enjoy these therapies. LEGO^® (LEGO System A/S, Billund, Denmark) based therapy takes a new approach by focusing on making the process interesting and fun. This research investigated the effect of LEGO^® based therapy groups in schools on the social and emotional abilities of children and young people with autism spectrum disorder. It was a randomised controlled trial, so each school that was taking part was randomly chosen to provide either usual support (from the school or NHS services) or 12 sessions of LEGO^® based therapy with a trained school staff member as well as usual support. Children and young people played one of three roles ­ the 'engineer' (gives instructions), the 'supplier' (finds the pieces) or the 'builder' (builds the model) ­ and worked together. Questionnaires completed by children and young people, their parents/guardians and teachers were used to look at the intervention's effects. The main objective was to see if there was a change in social skills measured by a teacher-completed questionnaire. Results showed that the social skills of children and young people in the LEGO^® based therapy groups did improve a little. We found that the intervention is not very costly for schools to run. Many parents/guardians and teachers thought that the intervention was beneficial and that the children and young people enjoyed it.

Understanding the current nutritional management for people with amyotrophic lateral sclerosis - A mapping review.

BACKGROUND & AIMS: Poor nutritional outcomes are observed in people with Amyotrophic Lateral Sclerosis (pwALS) including weight loss and poor dietary intake. Surveys of healthcare professionals have highlighted the lack of evidence and knowledge regarding nutritional management of ALS throughout the disease course. Furthermore, national evidence-based guidance is lacking. This mapping review aims to understand the structure and input of nutritional management services for pwALS. METHODS: Systematic searches were conducted across eight electronic databases to identify qualitative and quantitative research on structure and input of nutritional care in ALS. Supplementary searches included grey literature, citation and reference list searching of included studies and key reviews, web searching and contacting experts and organisations that provide ALS services to identify guidelines. Study selection and data extraction were undertaken independently by at least two reviewers. Data was synthesised using a narrative approach. RESULTS: One hundred and nine documents were identified. These consisted of journal articles, guidelines and related documents that contributed evidence towards mapping of nutritional management of pwALS. No evidence on commissioning of nutritional care was identified. Guidelines provided high-level overviews and gave general guidance or recommendations for care; however, these typically focused on gastrostomy with limited guidance on broader aspects, including oral nutrition support. Evidence from primary studies found nutritional care delivery in ALS consisted of multiple types of nutritional management, at different time points during the disease course and involving a range of professionals. There was little evidence relating to proactive nutritional care. Details of healthcare setting, number of professionals involved in care, team composition and how services were delivered in community settings were sparse. Although the role of the speech and language therapist in swallowing assessment and provision of advice on the management of swallowing difficulties was consistent; there was limited evidence on care provided by dietitians. In addition, a small number of studies reported on the use of screening tools. Overall, evidence was consistent that weight management, including monitoring of weight change by professionals and patients, was central and recommended that this should be part of nutritional assessment and follow-up. CONCLUSIONS: The evidence identified in this mapping review has highlighted the requirement for further primary research providing specific details on how nutritional management of pwALS is structured and delivered.

Co-design of digital learning resources for care workers: reflections on the neurocare knowhow project.

Neurocare Knowhow is an online learning platform for care workers who support people with neurological conditions. Care workers often do not receive specialist training around neurological conditions and can experience anxiety and apprehension about caring for this group. Neurocare Knowhow aims to increase care workers' knowledge and confidence. Featuring flexible and personalisable digital features, in combination with documentary video and audio, it offers an alternative to traditional e-learning, moving away from longform didactic courses to flexible on-the-go learning. This co-design project worked closely with people with neurological conditions, their families, care workers and care organisation managers to validate the need and develop a proof of concept pilot. Co-design activity took place across multiple workshops in person and online. These gathered detailed insights into preferred features that support engaging online learning. The platform offers learning across diverse neurological conditions as a whole, with a focus on shared symptoms and challenges encountered by people with neurological conditions. Ongoing development to scale the pilot up to meet an anticipated national audience includes a focus on artificial intelligence to support searches at a moment of need and a range of personalisable features for individual and team learning.