Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson’s disease—STARTUP

Introduction Parkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK. Objectives Conduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. Methods and analysis An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks. A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan Ethics and dissemination East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. Trial registration number ISRCTN12437878; Pre-results

Headteachers’ prior beliefs on child health and their engagement in school based health interventions: a qualitative study

Background: Schools play an important role in promoting the health of children. However, little consideration is often given to the influence that headteachers' and school staff's prior beliefs have on the implementation of public health interventions. This study examined primary school headteachers' and school health co-ordinators' views regarding child health in order to provide greater insights on the school's perspective for those designing future school-based health interventions. Methods: A qualitative study was conducted using 19 semi-structured interviews with headteachers, deputy headteachers and school health co-ordinators in the primary school setting. All transcripts were analysed using thematic analysis. Results: Whilst many participants in this study believed good health was vital for learning, wide variance was evident regarding the perceived health of school pupils and the magnitude of responsibility schools should take in addressing child health behaviours. Although staff in this study acknowledged the importance of their role, many believed the responsibility placed upon schools for health promotion was becoming too much; suggesting health interventions need to better integrate school, parental and societal components. With mental health highlighted as an increasing priority in many schools, incorporating wellbeing outcomes into future school based health interventions is advocated to ensure a more holistic understanding of child health is gained. Conclusion: Understanding the health beliefs of school staff when designing interventions is crucial as there appears to be a greater likelihood of interventions being successfully adopted if staff perceive a health issue as important among their pupils. An increased dependability on schools for addressing health was expressed by headteachers in this study, highlighting a need for better understanding of parental, child and key stakeholder perspectives on responsibility for child health. Without this understanding, there is potential for certain child health issues to be ignored.10 page(s

Involving the headteacher in the development of school-based health interventions: A mixed-methods outcome and process evaluation using the RE-AIM framework

Although interventions delivered in school settings have the potential to improve children’s health and well-being, the implementation of effective interventions in schools presents challenges. Previous research suggests facilitating greater autonomy for schools to select interventions aligned to their needs could improve implementation and maintenance. The aim of this mixed-methods outcome and process evaluation was to explore whether involving headteachers in the developmental stages of health interventions influenced adoption, effectiveness (e.g. pupil fitness and physical activity, assessed quantitatively), implementation and maintenance (assessed quantitatively and qualitatively). Three UK primary schools were provided with a choice of five evidence-based physical activity interventions: Playground scrapstore, daily classroom refreshers, alternative afterschool clubs, parent and child afterschool activities and an ‘In the Zone’ playground intervention. To evaluate the impact of this autonomous approach, semi-structured interviews with headteachers (n=3), teachers (n=3), and a private coach, and focus groups with pupils aged 9-11 (n=6, 31 pupils, 15 boys), were undertaken. This was alongside an outcome and process evaluation, guided by the RE-AIM framework. This study assessed the impacts on adoption, implementation and maintenance of the autonomous approach and the effect on physical activity (seven day accelerometry – GENEActiv) and aerobic fitness (20m shuttle run). All three schools adopted different intervention components; alternative afterschool clubs, parent and child afterschool activities and daily classroom refreshers. Headteachers welcomed greater autonomy in developing school-based interventions and appreciated the more collaborative approach. Mixed results were reported for the effectiveness, implementation and maintenance of the interventions adopted. Allowing pupils choice and promoting a positive school environment were key factors for enhancing engagement. Moreover, promoting inclusive physical activity projects with a consideration of existing curriculum pressures aided implementation. This mixed-methods study provides valuable insights about autonomous approaches to inform further development, implementation and maintenance for future interventions

Active Children Through Individual Vouchers Evaluation: A Mixed-Method RCT

Introduction Physical activity declines in adolescence, especially among those in deprived areas. Research suggests this may result from accessibility barriers (e.g., cost and locality). The Active Children Through Individual Vouchers Evaluation RCT aimed to improve the fitness and heart health of teenagers in Wales with the help of teenagers who co-produced the study. Study design This study was a mixed-method RCT. Setting/participants Before data collection, which took place at baseline, 6 months, and 12 months for both arms, 7 schools were randomized by an external statistician (4 intervention schools, n=524; 3 control schools, n=385). Intervention The Active Children Through Individual Vouchers Evaluation intervention included provision of activity vouchers (£20 per month), a peer mentoring scheme, and support worker engagement for 12 months between January and December 2017. Data analysis occurred February–April 2018. Main outcome measures Data included measures of cardiovascular fitness, cardiovascular health (blood pressure and pulse wave analysis), motivation, and focus groups. Results The intervention showed a trend to improve the distance ran (primary outcome) and was significant in improving the likelihood of intervention teenagers being fit (OR=1.21, 95% CI=1.07, 1.38, p=0.002). There was a reduction in teenagers classified as having high blood pressure (secondary outcome) in the intervention group (baseline, 5.3% [28/524]; 12 months, 2.7% [14/524]). Data on where teenagers used vouchers and evidence from focus groups showed that teenagers wanted to access more unstructured, informal, and social activities in their local areas. Conclusions Active Children Through Individual Vouchers Evaluation identified methods that may have a positive impact on cardiovascular fitness, cardiovascular health, and perspectives of activity. Consulting with teenagers, empowering them, and providing more local opportunities for them to take part in activities that are fun, unstructured, and social could positively impact teenage physical activity

Predictors of cardiovascular health in teenagers (aged 13–14 years): a cross-sectional study linked with routine data

Objective To examine the predictors of cardiovascular health in teenagers (aged 13–14 years). Methods Measures of arterial stiffness (augmentation index [AI]), blood pressure and cardiovascular fitness were taken from 234 teenage children (n=152 boys) and subsequently linked to routine data (birth and general practice records, education data and hospital admission data). Deprivation at school and at individual level was measured at birth, at 1 year old, at 13 years old and at secondary school using the Welsh Index of Multiple Deprivation (WIMD) Multivariate regression analysis determined associations between routinely collected data and cardiovascular measures. Results Teenagers had higher augmentation index (2.41 [95% CI: 1.10 to 3.72]), ran fewer metres (-130.08 metres [95% CI: -234.35 to -25.78]) in the Cooper Run Test if they attended a more deprived school. However, higher individual level deprivation was associated with greater fitness (199.38 metres [95% CI: 83.90 to 314.84]). Higher systolic blood pressure was observed in first born children (10.23 mmHg [95% CI: 1.58 to 18.88]) and in those who were never breastfed (4.77 mmHg [95% CI: 1.10 to 8.42]). Conclusions Improving heart health in deprived areas requires multi-level action across childhood namely, active play and programmes that promote physical activity and fitness and, the promotion of breastfeeding. Recognition of the important early indicators and determinants of cardiovascular health supports further development of the evidence base to encourage policy-makers to implement preventative measures in young people

Teenage recommendations to improve physical activity for their age group: a qualitative study

Abstract Background It is recommended that young people should engage in 60 min of moderate-to-vigorous activity (MVPA) a day for health benefits, but few teenagers actually meet this recommendation. Policy-makers play a vital role in designing physical activity initiatives, but they generally do this with little or no input from the intervention recipients. This study explores the recommendations made by teenagers to improve activity provision, uptake and sustainability of physical activity engagement for both themselves and their peers. Methods Thirteen focus groups were carried out in seven secondary schools in South Wales, United Kingdom. Participants (n = 78) were recruited from a larger mixed-method randomised control trial, which involved the implementation of a voucher scheme to promote physical activity in teenagers (aged 13–14). Thematic analysis was undertaken to identify key issues from the perspective of the teenage participants. Results Six key recommendations were identified following analysis of the focus groups: i) Lower/remove the cost of activities without sacrificing the quality, ii) Make physical activity opportunities more locally accessible, iii) Improve the standards of existing facilities, iv) Make activities more specific to teenagers v) Give teenagers a choice of activities/increase variety of activity and vi) Provide activities that teenage girls enjoy (e.g., fun, sociable and not competitive sport). Throughout the focus groups, the increased opportunity to participate in unstructured activity was a key recommendation echoed by both boys and girls in all themes. Conclusion There is a disconnect between what is available and what teenagers want to do. Policy-makers and those involved in physical activity delivery (e.g., schools, local council and local activity providers) should include young people in designing interventions and facilities to ensure they are meeting the needs of this age group and providing the right opportunities for teenagers to be active. That is unstructured, local, low cost, fun, sociable opportunities and the right facilities to be active

What works best when implementing a physical activity intervention for teenagers? Reflections from the ACTIVE Project: a qualitative study

Objective This paper explores what aspects of a multicomponent intervention were deemed strengths and weaknesses by teenagers and the local council when promoting physical activity to young people. Design Qualitative findings at 12 months from a mixed method randomised control trial. Methods Active Children Through Incentive Vouchers—Evaluation (ACTIVE) gave teenagers £20 of activity enabling vouchers every month for a year. Peer mentors were also trained and a support worker worked with teenagers to improve knowledge of what was available. Semistructured focus groups took place at 12 months to assess strengths and weaknesses of the intervention. Eight focus groups (n=64 participants) took place with teenagers and one additional focus group was dedicated to the local council’s sport development team (n=8 participants). Thematic analysis was used to analyse the data. Results Teenagers used the vouchers on three main activities: trampolining, laser tag or the water park. These appeal to both genders, are social, fun and require no prior skill or training. Choice and financial support for teenagers in deprived areas was considered a strength by teenagers and the local council. Teenagers did not engage with a trained peer mentor but the support worker was considered helpful. Conclusions The ACTIVE Project’s delivery had both strengths and weakness that could be used to underpin future physical activity promotion. Future interventions should focus on improving access to low cost, fun, unstructured and social activities rather than structured organised exercise/sport. The lessons learnt from this project can help bridge the gap between what is promoted to teenagers and what they actually want from activity provision

Hypergraph models of biological networks to identify genes critical to pathogenic viral response

Background: Representing biological networks as graphs is a powerful approach to reveal underlying patterns, signatures, and critical components from high-throughput biomolecular data. However, graphs do not natively capture the multi-way relationships present among genes and proteins in biological systems. Hypergraphs are generalizations of graphs that naturally model multi-way relationships and have shown promise in modeling systems such as protein complexes and metabolic reactions. In this paper we seek to understand how hypergraphs can more faithfully identify, and potentially predict, important genes based on complex relationships inferred from genomic expression data sets. Results: We compiled a novel data set of transcriptional host response to pathogenic viral infections and formulated relationships between genes as a hypergraph where hyperedges represent significantly perturbed genes, and vertices represent individual biological samples with specific experimental conditions. We find that hypergraph betweenness centrality is a superior method for identification of genes important to viral response when compared with graph centrality. Conclusions: Our results demonstrate the utility of using hypergraphs to represent complex biological systems and highlight central important responses in common to a variety of highly pathogenic viruses

Active children through incentive vouchers – evaluation (ACTIVE): a mixed-method feasibility study

BackgroundAdolescents face many barriers to physical activity, demonstrated by the decline in physical activity levels in teenage populations. This study aimed to assess the feasibility of overcoming such barriers via the implementation of an activity-promoting voucher scheme to teenagers in deprived areas.MethodsAll Year 9 pupils (n = 115; 13.3 ± 0.48 years; 51 % boys) from one secondary school in Wales (UK) participated. Participants received £25 of activity vouchers every month for six months for physical activity or sporting equipment. Focus groups (n = 7), with 43 pupils, and qualitative interviews with teachers (n = 2) were conducted to assess feasibility, in addition to a process evaluation utilising the RE-AIM framework. Quantitative outcomes at baseline, five months (during intervention) and twelve months (follow-up) included: physical activity (accelerometer), aerobic fitness (12 min Cooper run) and self-reported activity (PAQ-A). Motivation to exercise (BREQ-2) was measured three months post-baseline and at follow-up.ResultsQualitative findings showed that vouchers encouraged friends to socialise through activity, provided opportunities to access local activities that pupils normally could not afford, and engaged both those interested and disinterested in physical education. Improvements in weekend moderate-to-vigorous physical activity and reductions in sedentary behaviour were observed in both sexes. Boys’ fitness significantly improved during the voucher scheme. ‘Non-active’ pupils (those not meeting recommended guidelines of 60 mins∙day−1) and those with higher motivation to exercise had higher voucher use.ConclusionsAdolescents, teachers and activity providers supported the voucher scheme and felt the vouchers enabled deprived adolescents to access more physical activity opportunities. Voucher usage was associated with improved attitudes to physical activity, increased socialisation with friends and improved fitness and physical activity; presenting interesting avenues for further exploration in a larger intervention trial