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Abstract Background Children’s physical activity in England is more dependent on active clubs after the COVID-19 pandemic. However, it is unclear how the COVID-19 pandemic and related cost-of-living crisis have impacted on active club participation, costs and provision. This mixed-methods natural experiment explored school-based and community-based active clubs after lockdowns, using a unique combination of data sources to highlight implications for policy and practice post-COVID-19. Methods Cross-sectional questionnaire data on school and community active clubs were collected from 10-11-year-old children pre-COVID-19 in 2017-18 (N = 1,296; 50 schools), in 2021 (N = 393; 23 schools), and 2022 (N = 463; 27 schools). Club participation and attendance frequency were modelled using logistic and Poisson mixed effects models, adjusted for child age, gender and household education. In 2021 and 2022, parents reported expenditure on community-based clubs and schools provided data on school-based club provision, with data summarised descriptively. Qualitative data were collected in 2021 and 2022, with one-to-one interviews with school staff (N = 18) and parents (N = 43), and twelve child focus groups (N = 92), and analysed using the framework method. Results School-based active club participation was higher in 2022 compared to pre-pandemic (50% /43%), while community-based club participation was lower (74%/80%). Children attended 0.3 fewer clubs per week. Those from lower education households were less likely to participate in both types of active clubs, and girls less likely to attend community clubs. In 2022, the median cost of community and school club sessions were £6.67 and £3.88 respectively, with 52% of school-based clubs free to parents. Schools offered an average of 3.4 active clubs per week for 10-11-year-olds in 2022, with 34% partly/wholly subsidised. Qualitative analysis highlighted the impact of the cost-of-living crisis and COVID-19 pandemic on family resources, encouraging a shift to more affordable and convenient school-based active clubs, which negatively impacted the community-based active club environment. However, many schools struggled to meet this increased demand. Conclusions Findings emphasise the importance for policymakers to support schools to meet increased demand for clubs and community clubs to increase affordable and convenient physical activity opportunities. Targeted support is needed to prevent socioeconomic and gender inequalities.

Background and objectives The COVID-19 lockdowns impacted physical activity for all, but especially parents, because they had to balance home, work and leisure activities. Motivation for exercise is consistently shown to be associated with physical activity levels. Self-determination theory provides a framework through which the motivation for exercise and its social-contextual antecedents can be explored. The purpose of this study is to explore the role of motivation in determining physical activity in parents and carers of English primary school children before, during and after the COVID-19 lockdowns. Design, setting and participants This study uses a mixed-methods design combining quantitative data and individual interviews. Participants were all parents/carers of children in year 6 (aged 10–11 years) at English primary schools in the United Kingdom. Methods Quantitative data were collected on three occasions: between March 2017 and May 2018 (Wave 0, N = 1296), between May and December 2021 (Wave 1, N = 393) and between January and July 2022 (wave 2, N = 436). Motivation for exercise was assessed using the Behavioural Regulations in Exercise Questionnaire-2 and moderate-to-vigorous physical activity was estimated via waist-worn accelerometers. Data were analysed via regression models. Interviews with a subsample of parents (N = 43) were conducted on two occasions: between September and December 2021 and between February and July 2022. Interviews covered the impact of the pandemic on children and parents’ physical activity and changes over time. This study focuses on discussions around the parents’ own physical activity behaviour and their motivation. The framework method was used for analysis. Results In separate linear regression models, intrinsic and identified regulation were associated with higher moderate-to-vigorous physical activity in waves 0 and 2. Amotivation was associated with lower moderate-to-vigorous physical activity in waves 0 and 2. In fully adjusted multivariable regression models, identified regulation was associated with a 4.9-minute increase in moderate-to-vigorous physical activity and introjected regulation was associated with a 2.3-minute decrease in moderate-to-vigorous physical activity at wave 0. Associations with moderate-to-vigorous physical activity were different in wave 2, with introjected regulation changing direction and a negative association with amotivation, although confidence intervals were wide due to smaller sample sizes. In the interviews, parents spoke of the effects that the COVID-19 lockdowns had on their motivation to be physically active in four theoretically driven themes: (1) motivation for physical activity, (2) perceived autonomy for physical activity, (3) perceived competence for physical activity and (4) perceived relatedness for physical activity. Limitations The smaller sample sizes for waves 1 and 2 may have limited the ability to identify associations between behavioural regulations and moderate-to-vigorous physical activity post pandemic. Across all waves, parents were predominantly active, females, white and from higher socioeconomic areas and therefore may not reflect broader experiences. Conclusions and future work Autonomous motivation, especially enjoyment and the importance for mental and physical well-being, was a key driver in keeping parents active during lockdowns and remains important for physical activity post lockdown, with introjected regulation potentially playing an increased role. Parents’ interviews highlighted that while for some the lockdowns promoted autonomous motivation for exercise, others had enduring negative influences on their autonomy, competence and relatedness, which could be detrimental to their well-being. Strategies that focus on offering a range of novel activities for parents and that bring parent groups together may be effective. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847. Plain language summary What was the question? The COVID-19 pandemic affected parents’ ability to be active. Motivation is important for taking part in physical activity. We wanted to know how motivation for exercise had changed since before the pandemic and how it might still impact parents’ physical activity. What did we do? We asked groups of parents of children in year 6 (aged 10–11 years) to complete a questionnaire and wear a device that measures physical activity. One group did this before the pandemic and two groups did this after the lockdowns. We also spoke to parents two times after schools reopened. We asked about their physical activity, what they felt helped or stopped them being active and how this changed during the pandemic. What did we find? Motivation plays a part in how much physical activity parents do. Enjoying activities, being active because it is part of your identity and being active due to health make parents more active. Some parents felt they were more active in the first lockdown, as they had more time, freedom and a choice of new and exciting activities, while others felt the lockdowns led to them being less active. This was due to a loss of connection with other people and feeling less confident in their physical activity. What does this mean? This means that it is important that parents are well-supported in their physical activity post pandemic efforts to help parents be active should focus on creating opportunities for parents to try new activities opportunities for parents to be active together might lead to more physical activity, improved connections with others and better well-being.

Background The COVID-19 lockdowns and social distancing measures, including school closures, had a major impact on children’s physical activity in England, with data showing an initial reduction in activity in the short-term post-lockdown phase of the pandemic followed by a recovery on average in the medium-term post-lockdown period. The school environment is an important context for child physical activity. The purpose of this study is to understand the changes that took place to school physical activity environments once schools reopened after lockdowns. This information will improve understanding of why changes to children’s physical activity have occurred over the course of the pandemic and the implications for future promotion of physical activity in schools. Methods Interviews with parents (n = 43), school staff (n = 18) and focus groups with 10- to 11-year-old children (participant n = 92) were conducted at two time points: between September–December 2021 and February–July 2022. Interview and focus group guides covered the impact of the pandemic on child physical activity and changes to this over time. The framework method was used for analysis. Results Three themes and three subthemes were generated: (1) the return to school; (2) over-pressured staff and environment and (3) the uneven impact of the pandemic. Theme 3 consists of three subthemes: (a) retained pandemic policies, (b) impact on physical activity culture and (c) different children need different things. Limitations and future work Conducting this research in schools during ongoing COVID-19 disruptions was a challenge and may have limited school and participant participation, particularly school staff. The parent interview sample is predominantly female, active and of higher socioeconomic status, so the experiences of male, less active and lower socioeconomic parents are limited. This study suggests that the impact of COVID-19 on child physical activity is uneven, affecting some children more than others. Future work is therefore needed to explore the details of this potential diverging experience. Conclusion The COVID-19 pandemic, school closures and post-lockdown school policies have impacted upon primary school physical activity environments. The post-lockdown school environment is highly pressured, impacting the extent to which schools can support and encourage child physical activity. Future research is needed to further explore the impact of post-lockdown changes on physical activity environments in schools, particularly over the longer term, as schools continue to adapt post lockdowns. Strategies required to support school physical activity environments must be context specific and sensitive to these changes, pressures and needs. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847. Plain language summary Why did we do this study? Schools are important spaces for children’s physical activity. Children can be active in physical education lessons, break times, after-school clubs and travelling to school. School closures and other COVID-19 restrictions affected children’s physical activity. We wanted to know how physical activity in primary schools might have changed since the pandemic. What did we do? We spoke to school staff, pupils and parents two times after schools reopened. We asked about children’s physical activity, and if or how this had changed over the course of the pandemic. We asked school staff about school policies around physical activity. What did we find? When children went back to school, schools needed a ‘recovery’ approach. Children’s academic, social and physical skills had been affected. For this time schools prioritised physical activity, but this was short-lived. Since then, schools have been highly pressured. They have had to ‘catch up’ on missed learning, staff are overloaded and some pupils are still affected by the lockdowns. Physical activity policies in schools have changed, but in many different ways. Some have kept social distancing policies; others feel their school culture has changed. Additionally, pupil ability and needs are more polarised. These factors have shaped, but are also shaped by, the high pressure in schools. What does this mean for children’s physical activity? Supporting changing child needs in highly pressured schools is hard for state primary schools. Changes to school physical activity policies need to be understood and evaluated. Strategies to ease pressure in schools are needed to support physical activity.

IntroductionSupporting adolescents with their health and wellbeing is an international public health priority. Schools are well placed to universally detect unmet health needs and support pupils. This study aimed to evaluate the effectiveness of a digital health and wellbeing screening tool, called the 'Digital Health Contact' (DHC) implemented in schools in the East Midlands of England. The DHC, delivered by Public Health Nurses (School Nurses) (PHN(SN)), aims to identify pupils with unmet health needs (via a 'red flag' system) and provide appropriate support.Materials and methodsUsing data from 22 schools which took part in the DHC and 14 schools which did not take part, across three academic years (2018-2020), we conducted a controlled interrupted timeseries analysis with negative binomial regression to explore the effect of the DHC on the number of annual referrals to PHN(SN). Using DHC data from 164 pupils, we further conducted a Difference-in-Difference analysis to explore the impact of 'red flag' and referral via the DHC in Year 9 (age 13-14) on the number of red flags in Year 11 (age 15-16).ResultsAcross all schools, the mean annual number of referrals increased over the three year follow-up period. In the adjusted model, the number of referrals was comparable between schools taking part in the DHC and non-participating schools (0.15 referrals [95% CI -0.21, 0.50]). Red flag score was not significantly different among Year 11 pupils, after being referred via the DHC in Year 9 (-0.36 red flags [95% CI -0.97, 0.24]).DiscussionThe DHC, and similar screening tools, have the potential to raise awareness of the health and wellbeing support in schools and provide an additional pathway of referral to this support for pupils with unmet health needs, without replacing the traditional pathway where pupils refer themselves or are referred by teachers.

Abstract Background The COVID-19 pandemic significantly impacted children’s physical activity. Recent evidence indicated children’s accelerometer-measured physical activity levels have, on average, returned to near pre-pandemic levels in 2022, though sedentary behaviour remains higher. However, insufficient physical activity levels among children continues to be a critical public health issue in the UK, with only 41% meeting physical activity guidelines. This study aimed to provide in-depth analysis of how the pandemic has shaped children’s physical activity patterns beyond the short-term periods following lockdowns and identify the new challenges to engaging children in physical activity. Methods One-to-one interviews with parents (n = 22), school staff (n = 9), and six focus groups with children aged 10–11 years (n = 45) were conducted between February and July 2022. Topics explored changes to children’s physical activity and sedentary behaviour patterns, including screen-viewing, and factors influencing any changes. The framework method was used for analysis. Results Five themes were generated. Theme 1 described residual lockdown habits, including increased screen-viewing within the home, while activities outside the home continued to feel less spontaneous. Theme 2 highlighted an interrupted development of social, emotional, and physical skills among children compared to what would be expected pre-pandemic. This coincided with Theme 3 which reflected increased mental health challenges among families, creating complex barriers to children’s physical activity. A new normal for child physical activity was evoked and explored in Theme 4, with greater dependence on structured and organised activities. However, Theme 5 highlighted that girls and children with lower socio-economic position may be especially at risk of decreased physical activity. Conclusions There is a new normal for children’s physical activity that is characterised by increased dependence on structured and organised physical activities, such as active clubs, and less on unstructured and spontaneous physical activities, such as physical play. While this may suit many children, girls and children from lower socio-economic households face barriers to participating in the new normal. It is important that affordable and equitable opportunities are provided to all children to prevent physical activity and health inequalities.

Abstract Background The COVID-19 pandemic has resulted in marked impacts on children’s physical activity, with large reductions in moderate-to-vigorous physical activity (MVPA) reported during lockdowns. Previous evidence showed children’s activity levels were lower and sedentary time higher immediately post-COVID lockdown, while there was little change in parental physical activity. We need to know if these patterns persist. Methods Active-6 is a natural experiment using repeated cross-sectional data conducted in two waves. Accelerometer data were collected on 393 children aged 10–11 and their parents from 23 schools in Wave 1 (June 2021-December 2021), and 436 children and parents from 27 schools in Wave 2 (January 2022-July 2022). These were compared to a pre-COVID-19 comparator group (March 2017-May 2018) of 1,296 children and parents in the same schools. Mean minutes of accelerometer-measured MVPA and sedentary time were derived for week- and weekend-days and compared across waves via linear multilevel models. We also analysed the date of data collection as a time series, to explore temporal patterns via generalised additive mixed models. Results There was no difference in children’s mean MVPA in Wave 2 (weekdays: -2.3 min; 95% CI: -5.9, 1.3 and weekends: 0.6 min; 95% CI: -3.5, 4.6) when compared to the pre-COVID-19 data. Sedentary time remained higher than pre-pandemic by 13.2 min (95% CI:5.3, 21.1) on weekdays. Differences compared to pre-COVID-19 changed over time, with children’s MVPA decreasing over winter, coinciding with COVID-19 outbreaks, and only returning to pre-pandemic levels towards May/June 2022. Parents’ sedentary time and weekday MVPA was similar to pre-COVID-19 levels, with MVPA higher than pre-pandemic by 7.7 min (95% CI: 1.4, 14.0) on weekends. Conclusion After an initial drop, children’s MVPA returned to pre-pandemic levels by July 2022, while sedentary time remained higher. Parents’ MVPA remained higher, especially at weekends. The recovery in physical activity is precarious and potentially susceptible to future COVID-19 outbreaks or changes in provision, and so robust measures to protect against future disruptions are needed. Furthermore, many children are still inactive, with only 41% meeting UK physical activity guidelines, and so there is still a need to increase children’s physical activity.

Abstract Background In the UK, one in five households with children experienced food insecurity in 2022, defined as a household-level economic and social condition of limited or uncertain access to adequate food. Free school meals are a public health intervention aimed at reducing food insecurity amongst children. The provision of universal free school meals (UFSM) to secondary school-aged children is a novel and untested intervention in the UK. This study is a process evaluation of a pilot of UFSM in two secondary schools in England. The aim was to understand the feasibility, acceptability, cost implications and lessons for the implementation of UFSM. Methods 20 parents, 28 students and 8 school staff from two intervention schools participated in online qualitative interviews, as well as 4 staff from non-intervention schools. The Framework Method of thematic analysis was applied. These data were supplemented with student-led observations of school meal times, and school lunch uptake-data and cost information provided by the local authority delivering the pilot. Results UFSM in secondary schools is a feasible and acceptable intervention, with coherent goals of increased access to a healthy meal, reduced food insecurity and better nutrition. All participants perceived these goals were met. Acceptability was further enhanced by the perception that UFSM were supporting a greater proportion of low-income families than the national, targeted Free School Meal scheme, as well as being easier to implement. Potential barriers to implementation include limited school kitchen and dining infrastructure, meal quality and choice, and increased queuing times. Participants’ concerns that UFSM may benefit middle- and high- income families not in need were not as prevalent as the perception that UFSM was an effective way to support all families with secondary-aged children experiencing food insecurity. Conclusion This small-scale pilot study suggests that UFSM in secondary schools is feasible and acceptable, but more evidence is required from larger studies on the impact on long-term health, psychosocial and educational outcomes. Future, larger studies should also include detailed economic evaluations so this approach can be compared with other possible interventions.

Abstract Background Restrictions during the COVID-19 pandemic have led to increased screen-viewing among children, especially during strict periods of lockdown. However, the extent to which screen-viewing patterns in UK school children have changed post lockdowns is unclear. The aim of this paper is to examine how screen-viewing changed in 10–11-year-old children over the 2020–21 COVID-19 pandemic, how this compares to before the pandemic, and the influences on screen-viewing behaviour. Methods This is a mixed methods study with 10–11-year-olds from 50 schools in the Greater Bristol area, UK. Cross-sectional questionnaire data on minutes of weekday and weekend television (TV) viewing and total leisure screen-viewing were collected pre-COVID-19 in 2017–18 (N = 1,296) and again post-lockdowns in 2021 (N = 393). Data were modelled using Poisson mixed models, adjusted for age, gender, household education and seasonality, with interactions by gender and household education. Qualitative data were drawn from six focus groups (47 children) and 21 one-to-one parent interviews that explored screen-viewing behaviour during the pandemic and analysed using the framework method. Results Total leisure screen-viewing was 11% (95% CI: 12%-18%) higher post-lockdown compared to pre-COVID-19 on weekdays, and 8% (95% CI: 6%-10%) on weekends, equating to around 12–15 min. TV-viewing (including streaming) was higher by 68% (95% CI: 63%-74%) on weekdays and 80% (95% CI: 75%-85%) on weekend days. Differences in both were higher for girls and children from households with lower educational attainment. Qualitative themes reflected an unavoidable increase in screen-based activities during lockdowns, the resulting habitualisation of screen-viewing post-lockdown, and the role of the parent in reducing post-2020/21 lockdown screen-viewing. Conclusions Although screen-viewing was higher post-lockdown compared to pre-COVID-19, the high increases reported during lockdowns were not, on average, sustained post-lockdown. This may be attributed to a combination of short-term fluctuations during periods of strict restrictions, parental support in regulating post-lockdown behaviour and age-related, rather than COVID-19-specific, increases in screen-viewing. However, socio-economic differences in our sample suggest that not all families were able to break the COVID-19-related adoption of screen-viewing, and that some groups may need additional support in managing a healthy balance of screen-viewing and other activities following the lockdowns.

Abstract Background Dental caries in childhood is a burden on the daily lives of children and their families, and associated with poor oral health in adulthood. In England, dental caries is the most common reason for young children to be admitted to hospital. It is believed that most tooth extractions (due to decay) for children aged 10 years and under, could be avoided with improved prevention and early management. National public health policy recommendations in England include specific oral health initiatives to tackle tooth decay. One of these initiatives is delivered as part of the Healthy Child Programme and includes providing workforce training in oral health, integrating oral health advice into home visits, and the timely provision of fluoride toothpaste. This protocol seeks to assess the delivery of the First Dental Steps intervention and uncertainties related to the acceptability, recruitment, and retention of participants. Methods This study seeks to explore the feasibility and acceptability of the First Dental Steps intervention and research methods. First Dental Steps intervention will be delivered in local authority areas in South West England and includes oral health training for health visitors (or community nursery nurses) working with 0–5-year-olds and their families. Further, for vulnerable families, integrating oral health advice and the provision of an oral health pack (including a free flow cup, an age appropriate toothbrush, and 1450 ppm fluoride toothpaste) during a mandated check by a health visitor. In this study five local authority areas will receive the intervention. Interviews with parents receiving the intervention and health visitors delivering the intervention will be undertaken, along with a range of additional interviews with stakeholders from both intervention and comparison sites (four additional local authority areas). Discussion This protocol was written after the start of the COVID-19 pandemic, as a result, some of the original methods were adjusted specifically to account for disruptions caused by the pandemic. Results of this study will primarily provide evidence on the acceptability and feasibility of both the First Dental Steps intervention and the research methods from the perspective of both families and stakeholders.

Abstract Background Active-6 is exploring how the COVID-19 pandemic has impacted physical activity behaviour among Year 6 children (aged 10–11 years) and their parents in Southwest England. Initial findings from the Active-6 project have shown a 7–8 min decrease in moderate-to-vigorous physical activity and an increase in sedentary behaviour among children following the easing of restrictions in the UK in latter half of 2021. This finding suggests that the pandemic has had a persistent impact on child physical activity behaviour. This paper explored the possible mechanisms behind these changes. Methods Interviews with parents (n = 21), members of school staff (n = 9) and focus groups with children aged 10–11 years (n = 47) were conducted between August and December 2021 to discuss the impact of the pandemic on child physical activity behaviour. The framework method was used for analysis. Results Five themes spanning two key stages of the pandemic were described. Three themes related to the period of lockdowns and fluctuating restrictions (March 2020 – April 2021). These included: Theme 1) Lockdown: A short-lived adventure; Theme 2) Access to facilities during restrictions; and Theme 3) The importance of the parent. A further two themes were identified related to the period following the gradual easing of restrictions in April 2021. These included: Theme 4) An overwhelming return to normal; and Theme 5) Reopening fatigue. Conclusions The analysis suggested that feelings of novelty experienced during the initial stages of lockdown waned as restrictions were prolonged, creating an increasingly challenging period for parents and their children. However, during periods of restrictions, the importance of parental encouragement and access to appropriate facilities in the local and home environment helped facilitate physical activity. Following the easing of COVID-19 restrictions, emotional overwhelm and physical fatigue among children, stemming from a sedentary and socially isolated life in lockdown and other restrictions, were key contributors to the decreased moderate to vigorous physical activity and increased sedentary behaviour that was observed in a related quantitative study.

Abstract Background Restrictions due to the coronavirus disease 2019 (COVID-19) pandemic reduced physical activity provision for both children and their parents. Recent studies have reported decreases in physical activity levels during lockdown restrictions, but these were largely reliant on self-report methods, with data collected via unrepresentative self-report surveys. The post-pandemic impacts on children’s activity levels remain unknown. A key question is how active children become once lockdown restrictions are lifted. Methods Active-6 is a repeated cross-sectional natural experiment. Accelerometer data from 1296 children aged 10–11 and their parents were collected in 50 schools in the Greater Bristol area, UK in March 2017-May 2018 (pre-COVID-19 comparator group), and compared to 393 children aged 10–11 and parents in 23 of the same schools, collected in May-December 2021. Mean minutes of accelerometer-measured moderate-to-vigorous physical activity (MVPA) were derived for weekdays and weekend and compared pre- and post-lockdown via linear multilevel models. Results After adjusting for seasonality, accelerometer wear time and child/parent demographics, children’s mean weekday and weekend MVPA were 7.7 min (95% CI: 3.5 to 11.9) and 6.9 min (95% CI: 0.9 to 12.9) lower in 2021 than in 2018, respectively, while sedentary time was higher by 25.4 min (95% CI: 15.8 to 35.0) and 14.0 min (95% CI: 1.5 to 26.5). There was no evidence that differences varied by child gender or household education. There was no significant difference in parents’ MVPA or sedentary time, either on weekdays or weekends. Conclusions Children’s MVPA was lower by 7–8 min/day in 2021 once restrictions were lifted than before the pandemic for all groups, on both weekdays and weekends. Previous research has shown that there is an undesirable age-related decline in children’s physical activity. The 8-min difference reported here would be broadly comparable to the decline that would have previously been expected to occur over a three-year period. Parents’ physical activity was similar to pre-pandemic levels. Our results suggest that despite easing of restrictions, children’s activity levels have not returned to pre-pandemic levels. There is an urgent need to understand why these changes have occurred and how long they are maintained.

Abstract Background Supporting children and young people’s (CYP) mental and physical health is a global policy priority but detecting need and facilitating access to health services and support is challenging. This paper explores professional stakeholders’ perspectives of the acceptability, utility and effectiveness of a school-based online health and wellbeing screening tool, the Digital Health Contact (DHC). The DHC, delivered by Public Health School Nurses (PHSN), aims to identify, and put in place strategies to support, unmet health needs among CYP. Methods We employed a qualitative study design, using semi-structured interviews. Fourteen key stakeholders involved in the design and implementation of the DHC (commissioners, providers, PHSN and healthcare staff, school leaders) were purposively sampled. Data were analysed thematically. Results Our analysis generated two key themes: the perceived benefits of the DHC; and challenges in delivering the DHC. Stakeholders perceived the universal application of the DHC with linked follow-up intervention as an effective means of identifying and supporting CYP with unmet needs, and an efficient way to target limited service resources. There were barriers around enabling school engagement in the DHC, typically in terms of logistics, school infrastructure, and perspectives of fit with schools. These barriers were seen as being negated through developing effective working relationships between schools and PHSN. Effective relationships could highlight the potential benefits of participation. Overall, the DHC was seen as a valuable and effective use of resources, with a low burden on school staff. Conclusions The DHC, as a universal school-based health and wellbeing screening tool with linked follow-up intervention, has great potential in identifying and supporting unmet health needs among CYP. The perspectives and experiences of those involved in delivering the DHC highlight important considerations which may enable effective implementation and delivery of school screening programmes across other areas.

Background: Surgery for established cataract is highly cost-effective and uncontroversial, yet uncertainty remains for individuals about when to proceed and when to delay surgery during the earlier stages of cataract. Objective: We aimed to improve decision-making for cataract surgery through the development of evidence-based clinical tools that provide general information and personalised risk/benefit information. Design: We used a mixed methodology consisting of four work packages. Work package 1 involved the development and psychometric validation of a brief, patient self-reported measure of visual difficulty from cataract and its relief from surgery, named Cataract Patient-Reported Outcome Measure, five items (Cat-PROM5). Work package 2 involved the review and refinement of risk models for adverse surgical events (posterior capsule rupture and visual acuity loss related to cataract surgery). Work package 3 involved the development of prediction models for the Cat-PROM5-based self-reported outcomes from a cohort study of 1500 patients; assessment of the validity of preference-based health economic indices for cataract surgery and the calibration of these to Cat-PROM5; assessment of patients’ and health-care professionals’ views on risk–benefit presentation formats, the perceived usefulness of Cat-PROM5, the value of personalised risk–benefit information, high-value information items and shared decision-making; development of cataract decision aid frequently asked questions, incorporation of personalised estimates of risks and benefits; and development of a cataract decision quality measure to assess the quality of decision-making. Work package 4 involved a mixed-methods feasibility study for a fully powered randomised controlled trial of the use of the cataract decision aid and a qualitative study of discordant or mismatching perceptions of outcome between patients and health-care professionals. Setting: Four English NHS recruitment centres were involved: Bristol (lead centre), Brighton, Gloucestershire and Torbay. Multicentre NHS cataract surgery data were obtained from the National Ophthalmology Database. Participants: Work package 1 – participants (n = 822) were from all four centres. Work package 2 – electronic medical record data were taken from the National Ophthalmology Database (final set > 1M operations). Work package 3 – cohort study participants were from Bristol (n = 1200) and Gloucestershire (n = 300); qualitative and development work was undertaken with patients and health-care professionals from all four centres. Work package 4 – Bristol, Brighton and Torbay participated in the recruitment of patients (n = 42) for the feasibility trial and recruitment of health-care professionals for the qualitative elements. Interventions: For the feasibility trial, the intervention was the use of the cataract decision aid, incorporating frequently asked questions and personalised estimations of both adverse outcomes and self-reported benefit. Main outcome measures: There was a range of quantitative and qualitative outcome measures: questionnaire psychometric performance metrics, risk indicators of adverse surgical events and visual outcome, predictors of self-reported outcome following cataract surgery, patient and health-care practitioner views, health economic calibration measures and randomised controlled trial feasibility measures. Data sources: The data sources were patient self-reported questionnaire responses, study clinical data collection forms, recorded interviews with patients and health-care professionals, and anonymised National Ophthalmology Database data. Results: Work package 1 – Cat-PROM5 was developed and validated with excellent to good psychometric properties (Rasch reliability 0.9, intraclass correlation repeatability 0.9, unidimensionality with residual eigenvalues ≤ 1.5) and excellent responsiveness to surgical intervention (Cohen delta –1.45). Work package 2 – earlier risk models for posterior capsule rupture and visual acuity loss were broadly affirmed (C-statistic for posterior capsule rupture 0.64; visual acuity loss 0.71). Work package 3 – the Cat-PROM5-based self-reported outcome regression models were derived based on 1181 participants with complete data (R2 ≈ 30% for each). Of the four preference-based health economic indices assessed, two demonstrated reasonable performance. Cat-PROM5 was successfully calibrated to health economic indices; adjusted limited dependent variable mixture models offered good to excellent fit (root-mean-square error 0.10–0.16). The personalised quantitative risk information was generally perceived as beneficial. A cataract decision aid and cataract decision quality measure were successfully developed based on the views of patients and health-care professionals. Work package 4 – data completeness was good for the feasibility study primary and secondary variables both before and after intervention/surgery (data completeness range 100–88%). Considering ability to recruit, the sample size required, instrumentation and availability of necessary health economic data, a fully powered randomised controlled trial (patients, n = 800, effect size 0.2 standard deviations, power 80%; p = 0.05) of the cataract decision aid would be feasible following psychometric refinement of the primary outcome (the cataract decision quality measure). The cataract decision aid was generally well-received by patients and health-care professionals, with cautions raised regarding perceived time and workload barriers. Discordant outcomes mostly related to patient dissatisfaction, with no clinical problem found. Limitations: The National Ophthalmology Database data are expected to include some errors (mitigated by large multicentre data aggregations). The feasibility randomised controlled trial primary outcome (the cataract decision quality measure) displayed psychometric imperfections requiring refinement. The clinical occurrence of discordant outcomes is uncommon and the study team experienced difficulty identifying patients in this situation. Future work: Future work could include regular review of the risk models for adverse outcomes to ensure currency, and the technical precision of complex-numbers analysis of refractive outcome to invite opportunities to improve post-operative spectacle-free vision. In addition, a fully powered randomised controlled trial of the cataract decision aid would be feasible, following psychometric refinement of the primary outcome (the cataract decision quality measure); this would clarify its potential role in routine service delivery. Conclusions: In this research programme, evidence-based clinical tools have been successfully developed to improve pre-operative decision-making in cataract surgery. These include a psychometrically robust, patient-reported outcome measure (Cat-PROM5); prediction models for patient self-reported outcomes using Cat-PROM5; prediction models for clinically adverse surgical events and adverse visual acuity outcomes; and a cataract decision aid with relevant general information and personalised risk/benefit predictions. In addition, the successful mapping of Cat-PROM5 to existing health economic indices was achieved and the performances of indices were assessed in patients undergoing cataract surgery. A future full-powered randomised controlled trial of the cataract decision aid would be feasible (patients, n = 800, effect size 0.2 standard deviations, power 80%; p = 0.05). Trial registration: This trial is registered as ISRCTN11309852. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 9. See the NIHR Journals Library website for further project information.

This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact. This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews. Trial registration: ISRCTN14392301 (registered on 14th June 2021) Contact for Public & Scientific Queries: Mark Brewin, sft.elabs@nhs.net Public Title: Early Laser for Burn Scars (ELABS): a trial of the effectiveness and cost of the treatment of hypertrophic burn scars with laser Countries of Recruitment: England & Scotland Protocol Version: v11, October 2021

Introduction Cerebral visual impairment (CVI) refers to a spectrum of brain-related vision problems. CVI is associated with poor educational and mental health outcomes. An intervention has been developed to help children with CVI, involving input from clinicians, teachers and parents. The effectiveness of this intervention needs to be evaluated. This study aims to guide any refinements to the intervention or the design of a future cluster-randomised trial that may be needed.Methods and analysis This study will include all methods anticipated for a future cluster-randomised controlled trial. Eight primary schools will be recruited and randomised to receive the intervention or carry on with usual practice. The intervention will comprise an information pack for schools and access to a local paediatric ophthalmology clinic (who are prepared to assess them for CVI), for up to 5% of participating children. Outcome assessments will be carried out at baseline (before randomisation) and after 4–5 months of intervention period. Assessments will include children’s self-reported quality of life, their learning ability and behaviour as reported by teachers, and family functioning reported by parents. Cost data will include service use, family expenditure on additional support (eg, private appointments and administration) and school spending and resource used in helping children with special educational needs or disability. A process evaluation (PE) will collect additional data relating to the implementation of the intervention and the trial processes, in the school and clinic settings. The protocol for the PE will be reported separately.Ethics and dissemination Ethical permission was obtained from the University of Bristol Faculty of Health Sciences Ethical Committee. The results will inform the design of a future trial to assess the effectiveness and cost-effectiveness of the intervention and will be shared with participants, CVI-support groups and peer-viewed journals.Trial registration number ISRCTN13762177; Pre-results.

Introduction Brain-related visual impairments, also known as cerebral visual impairment (CVI), are related to damage or poor function in the vision-related areas of the brain. There is broad agreement that CVI is an appropriate term to describe visual impairments that are not accounted by disorders of the eye or optic nerve, but differences remain as to which impairments can be included in this term. The CVI project is a programme of work that includes the development of a complex intervention to share knowledge with teachers, so that they can make both targeted and universal changes to support children with CVI. A feasibility study for a cluster-randomised controlled trial to evaluate this intervention is underway. This paper describes the protocol for an accompanying process evaluation to explore how the intervention is implemented and provide context for the interpretation of the feasibility trial outcomes.Methods and analysis A logic model has been developed to guide data collection. Both qualitative and quantitative data will be collected to assess the feasibility and acceptability of the intervention, the study design and explore how any changes that occur are brought about. Interviews with key primary school staff and parents will investigate responses to the intervention and trial processes. Surveys will collect data on intervention implementation and knowledge of CVI. Photographs of classroom walls will document any changes to visual clutter and document analysis will look for changes to school special educational needs and disability (SEND) policies.Ethics and dissemination Ethical approval was granted by the University of Bristol Faculty of Health Sciences Ethics Committee. Findings will contribute to the development of a full-scale cluster-randomised controlled trial to assess the effectiveness of the intervention with adequate statistical power. The results will also support the refinement of the intervention and its underlying theory.

Abstract Background Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. Methods This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7–8) and 5 (aged 9–10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment. Discussion This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy. Trial registration ISRCTN: 12698269 . Date protocol registered 27th October 2016.

BackgroundThe prevalence of chronic kidney disease (CKD) is high in general populations around the world. Targeted testing and screening for CKD are often conducted to help identify individuals that may benefit from treatment to ameliorate or prevent their disease progression.AimsThis systematic review examines the methods used in economic evaluations of testing and screening in CKD, with a particular focus on whether test accuracy has been considered, and how analysis has incorporated issues that may be important to the patient, such as the impact of testing on quality of life and the costs they incur.MethodsArticles that described model-based economic evaluations of patient testing interventions focused on CKD were identified through the searching of electronic databases and the hand searching of the bibliographies of the included studies.ResultsThe initial electronic searches identified 2,671 papers of which 21 were included in the final review. Eighteen studies focused on proteinuria, three evaluated glomerular filtration rate testing and one included both tests. The full impact of inaccurate test results was frequently not considered in economic evaluations in this setting as a societal perspective was rarely adopted. The impact of false positive tests on patients in terms of the costs incurred in re-attending for repeat testing, and the anxiety associated with a positive test was almost always overlooked. In one study where the impact of a false positive test on patient quality of life was examined in sensitivity analysis, it had a significant impact on the conclusions drawn from the model.ConclusionFuture economic evaluations of kidney function testing should examine testing and monitoring pathways from the perspective of patients, to ensure that issues that are important to patients, such as the possibility of inaccurate test results, are properly considered in the analysis.