Search

Abstract Background Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. Methods A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. Results Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. Conclusions Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population’s particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

Abstract Background UK and global policies recommend whole-school approaches to improve childrens’ inadequate physical activity (PA) levels. Yet, recent meta-analyses establish current interventions as ineffective due to suboptimal implementation rates and poor sustainability. To create effective interventions, which recognise schools as complex adaptive sub-systems, multi-stakeholder input is necessary. Further, to ensure ‘systems’ change, a framework is required that identifies all components of a whole-school PA approach. The study’s aim was to co-develop a whole-school PA framework using the double diamond design approach (DDDA). Methodology Fifty stakeholders engaged in a six-phase DDDA workshop undertaking tasks within same stakeholder (n = 9; UK researchers, public health specialists, active schools coordinators, headteachers, teachers, active partner schools specialists, national organisations, Sport England local delivery pilot representatives and international researchers) and mixed (n = 6) stakeholder groupings. Six draft frameworks were created before stakeholders voted for one ‘initial’ framework. Next, stakeholders reviewed the ‘initial’ framework, proposing modifications. Following the workshop, stakeholders voted on eight modifications using an online questionnaire. Results Following voting, the Creating Active Schools Framework (CAS) was designed. At the centre, ethos and practice drive school policy and vision, creating the physical and social environments in which five key stakeholder groups operate to deliver PA through seven opportunities both within and beyond school. At the top of the model, initial and in-service teacher training foster teachers’ capability, opportunity and motivation (COM-B) to deliver whole-school PA. National policy and organisations drive top-down initiatives that support or hinder whole-school PA. Summary To the authors’ knowledge, this is the first time practitioners, policymakers and researchers have co-designed a whole-school PA framework from initial conception. The novelty of CAS resides in identifying the multitude of interconnecting components of a whole-school adaptive sub-system; exposing the complexity required to create systems change. The framework can be used to shape future policy, research and practice to embed sustainable PA interventions within schools. To enact such change, CAS presents a potential paradigm shift, providing a map and method to guide future co-production by multiple experts of PA initiatives ‘with’ schools, while abandoning outdated traditional approaches of implementing interventions ‘on’ schools.

Abstract Background There is growing interest in school-based interventions which deliver opportunities for additional physical activity time outside of physical education (PE). A practical and cost-effective approach may be school running programmes. Consequently, many school-based running initiatives are currently being implemented in a grass-roots style movement across the UK. However, research on the implementation of physical activity programmes in schools is notably underdeveloped. Therefore, this qualitative study aimed to better understand the barriers and facilitators to the implementation of a running programme, Marathon Kids (MK), within primary schools in England. Methods Two sets of semi-structured interviews were conducted, the first with each of the three core members of staff responsible for MK, and the second with each of the MK school staff Champions from 20 primary schools. Also, nine focus groups were conducted with 55 pupils (6–10 years) from five of the schools; all were analysed using thematic analysis. Results Three themes were identified surrounding the barriers and facilitators to implementation: features of the programme (e.g. ethos and resources), school climate (e.g. culture; whole school engagement; PE and physical activity policies and goals; and physical environment) and programme implementation decisions (e.g. aspirations and planning and sustainability). Conclusion Findings suggest that the barriers and facilitators to implementation are wide-ranging and include programme, organisational and system-level factors. Collectively pointing towards the need for a preparation period before implementation to understand schools’ readiness to implement and context-specific factors, both regarding organisational capacity and programme specific capacity.

The adoption of school-based running programs has rapidly increased over the last five years in the UK and globally. However, there is currently a lack of information on how these initiatives are implemented, and whether they are generalizable and/or sustainable. This study evaluated the implementation (including reach, fidelity, and dose) of a school-based running program over seven months to inform future delivery. This observational study used a mixed-method, single-group, before-and-after design strengthened by multiple interim measurements to evaluate the implementation of an optional school-based running program. Five state-funded primary schools in Leicestershire, UK, participated, with 17 teachers and 189 (81 boys (47.4%) and 90 girls (52.6%)) Year 5 pupils (aged 9–10 years) from eight classes. During the 2016/2017 academic year, data were collected via several measures (including interviews, focus groups, observations, questionnaires, and teacher implementation logs) at multiple levels (i.e., school and individual) and at multiple time points during implementation. Follow up qualitative data were also collected during 2017/2018. The school-based running program achieved good reach, with 100% of pupils opting to participate at some point during the academic year. All schools implemented the program with good fidelity, although the level of implementation varied between schools and over time. The average number of sessions held per week ranged from 0.94–3.89 with the average distance accumulated per pupil per week ranging from 0.02 to 2.91 kilometers and boys being more likely than girls to be classed as high-level participators. Despite an initial drop off in participation over time, all schools remained engaged in the program and continued to implement it until the end of the school year. Contextual features (e.g., staff capacity and resources) differed between schools and influenced the quality of implementation and the frequency of delivery. The school-based running program is simple, inexpensive, and versatile and can be implemented by schools with relative ease. However, schools are diverse settings, with unique challenges to ongoing delivery. Thus, planned adaptations, specific to each school’s context, are likely necessary to sustain participation in the longer term and should be considered prior to implementation.

Introduction: School-based running programs that promote daily (or regular) walking/jogging/running are an emerging public health initiative. However, evaluation of these programs has predominantly used quantitative measures that limit understanding and explanations of contextual influences on pupil participation. Therefore, the aim of this study was to qualitatively explore pupils' experiences of participating in a primary-school-based running program (Marathon Kids) to provide relevant insights and inform program developments.Methods: Nine semistructured focus groups were conducted with a purposeful sample of 50 pupils (26 girls and 24 boys) between 6 and 10 years of age from 5 primary schools in England. All schools had delivered the running program for 5-9 months during the 2015-16 academic year. Transcripts were analyzed using an inductive thematic approach.Results: Pupils identified a range of organizational, interpersonal, and intrapersonal factors that they believed influenced their participation in the program. Six themes were identified as being important to pupils' experiences: Marathon Kids as an enabling program, pupils' autonomy to participate, peer influence on participation (e.g., development of social cohesion), teacher influence on delivery (e.g., fidelity of implementation), logistics and suitability of the school environment, and appropriateness of program resources.Conclusions: School-based running programs can offer an enjoyable physical activity experience for children; however, it is important to understand how current delivery approaches influence pupils' participation. Aspects that were believed to facilitate enjoyment included pupil autonomy to participate, perceived benefits of participation (including psychosocial outcomes), and a supportive school environment. Further research is required to identify the type and level of support required by schools to sustain pupil participation in running programs so that their perceived value is maintained. [ABSTRACT FROM AUTHOR]