Pragmatic trials of non-NHS interventions: experiences from a Randomised Controlled Trial of the Strengthening Families 10-14 UK Programme (SFP10-14 UK)

Background: Pragmatic trials of public health interventions outside the NHS are relatively scarce, much needed and face particular challenges. These include funding, of intervention costs in particular; trial implementation in professional and organisational cultures unused to randomised trial procedures, including randomisation, maintaining the counterfactual, recruitment; and relevance of findings for and translation into policy and practice. Objectives: The current NPRI funded trial of SFP 10-14 UK is presented as a case study to discuss these issues, solutions and remaining barriers. The SFP 10-14 UK programme aims to strengthen areas of family life that protect against substance misuse, for example, parenting, communication, and young people’s resilience skills. The SFP 10-14 UK is being delivered by statutory and voluntary agencies in six local authority areas across Wales, and is offered to mixed groups comprised of families from the general population, and families who may experience/present challenges within a group setting. Methods: The trial aims to recruit 748 families, 374 of whom will be randomised to receive the usual services available to families within their local area. 374 families will receive the SFP 10-14 UK in addition to usual care. Families are identified by staff employed within the statutory services and voluntary sectors and referred to embedded research staff for recruitment. Results: Challenges encountered related to a lack of awareness of the randomised trial as a research paradigm among staff and key referring agencies, related concerns about the ethics of randomisation and the maintenance of the counterfactual among the usual care group, and challenges regarding the maintenance of recruitment and intervention fidelity. Whilst a challenge in itself, partnership working with delivery agencies, programme trainers, and the Welsh Assembly Government at all stages of the development, funding and conduct of the trial has proved an important strategy to overcome these issues. Conclusions: This trial seeks to generate evidence on the effectiveness and cost effectiveness of the SFP10-14 UK which is of direct relevance to policy makers, commissioners and practitioners. The trial highlights that strategic partnership working, the winning of ‘hearts and minds’ regarding the ethics and operationalisation of randomisation, and maintaining the balance between internal and external validity are key areas of focus for the successful conduct of pragmatic trials in non-NHS settings. The lessons learnt from its implementation will be important for future multi-sector/agency policy trials and for role out of the intervention if found to be efficacious

The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability

Background: Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. / Methods: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. / Discussion: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field. / Trial registration: ISRCTN7041947

Cultural adaptation and intervention integrity: a response to Skärstrand, Sundell and Andréasson

Commentarie

Early Positive Approaches to Support (E-PAtS) for Families of Young Children With Intellectual Disability: A Feasibility Randomised Controlled Trial

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS. Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures. Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial. Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers. Clinical Trial Registration: https://www.isrctn.com, identifier: ISRCTN70419473

Green Plants in the Red: A Baseline Global Assessment for the IUCN Sampled Red List Index for Plants

Plants provide fundamental support systems for life on Earth and are the basis for all terrestrial ecosystems; a decline in plant diversity will be detrimental to all other groups of organisms including humans. Decline in plant diversity has been hard to quantify, due to the huge numbers of known and yet to be discovered species and the lack of an adequate baseline assessment of extinction risk against which to track changes. The biodiversity of many remote parts of the world remains poorly known, and the rate of new assessments of extinction risk for individual plant species approximates the rate at which new plant species are described. Thus the question ‘How threatened are plants?’ is still very difficult to answer accurately. While completing assessments for each species of plant remains a distant prospect, by assessing a randomly selected sample of species the Sampled Red List Index for Plants gives, for the first time, an accurate view of how threatened plants are across the world. It represents the first key phase of ongoing efforts to monitor the status of the world’s plants. More than 20% of plant species assessed are threatened with extinction, and the habitat with the most threatened species is overwhelmingly tropical rain forest, where the greatest threat to plants is anthropogenic habitat conversion, for arable and livestock agriculture, and harvesting of natural resources. Gymnosperms (e.g. conifers and cycads) are the most threatened group, while a third of plant species included in this study have yet to receive an assessment or are so poorly known that we cannot yet ascertain whether they are threatened or not. This study provides a baseline assessment from which trends in the status of plant biodiversity can be measured and periodically reassessed

Adapting evidence-informed population health interventions for new contexts: a scoping review of current practice

Background Implementing evidence-informed population health interventions in new contexts often requires adaptations. While the need to adapt interventions to better fit new contexts is recognised, uncertainties remain regarding why and when to adapt (or not), and how to assess the benefits (or not) of adaptation. The ADAPT Study aims to develop comprehensive guidance on adaptation. This scoping review informs guidance development by mapping and exploring how adaptation has been undertaken in practice, in public health and health services research. Methods We searched seven databases from January 2000 and October 2018 to identify eligible studies for this scoping review and a related systematic review of adaptation guidance. We mapped the studies of adaptation by coding data from all eligible studies describing the methods, contexts, and interventions considered for adaptation. From this map, we selected a sample of studies for in-depth examination. Two reviewers extracted data independently into seven categories: description, key concepts, types, rationale, processes, evaluation methods, evaluation justification, and accounts of failures and successes. Results We retrieved 6694 unique records. From 429 records screened at full text, we identified 298 eligible studies for mapping and selected 28 studies for in-depth examination. The majority of studies in our map focused on micro- (i.e., individual-) level interventions (84%), related to transferring an intervention to a new population group within the same country (62%) and did not report using guidance (73%). Studies covered a range of topic areas, including health behaviour (24%), mental health (19%), sexual health (16%), and parenting and family-centred interventions (15%). Our in-depth analysis showed that adaptation is seen to save costs and time relative to developing a new intervention, and to enhance contextual relevance and cultural compatibility. It commonly follows a structured process and involves stakeholders to help with decisions on what to adapt, when, and how. Conclusions Adaptation has been undertaken on a range of health topics and largely in line with existing guidance. Significant gaps relate to adaptation of macro- (e.g., national-) level interventions, consideration of programme theories, mechanisms and contexts (i.e., a functional view of interventions), nuances around stakeholder involvement, and evaluation of the adapted interventions. Registration Open Science Framework, 2019, osf.io/udzma

Bursaries, writing grants and fellowships: a strategy to develop research capacity in primary health care

BACKGROUND: General practitioners and other primary health care professionals are often the first point of contact for patients requiring health care. Identifying, understanding and linking current evidence to best practice can be challenging and requires at least a basic understanding of research principles and methodologies. However, not all primary health care professionals are trained in research or have research experience. With the aim of enhancing research skills and developing a research culture in primary health care, University Departments of General Practice and Rural Health have been supported since 2000 by the Australian Government funded 'Primary Health Care Research Evaluation and Development (PHCRED) Strategy'. A small grant funding scheme to support primary health care practitioners was implemented through the PHCRED program at Flinders University in South Australia between 2002 and 2005. The scheme incorporated academic mentors and three types of funding support: bursaries, writing grants and research fellowships. This article describes outcomes of the funding scheme and contributes to the debate surrounding the effectiveness of funding schemes as a means of building research capacity. METHODS: Funding recipients who had completed their research were invited to participate in a semi-structured 40-minute telephone interview. Feedback was sought on acquisition of research skills, publication outcomes, development of research capacity, confidence and interest in research, and perception of research. Data were also collected on demographics, research topics, and time needed to complete planned activities. RESULTS: The funding scheme supported 24 bursaries, 11 writing grants, and three research fellows. Nearly half (47%) of all grant recipients were allied health professionals, followed by general practitioners (21%). The majority (70%) were novice and early career researchers. Eighty-nine percent of the grant recipients were interviewed. Capacity, confidence, and level of research skills in ten core areas were generally considered to have improved as a result of the award. More than half (53%) had presented their research and 32% had published or submitted an article in a peer-reviewed journal. CONCLUSION: A small grant and mentoring scheme through a University Department can effectively enhance research skills, confidence, output, and interest in research of primary health care practitioners