Early evaluation of the Children and Young People's Mental Health Trailblazer programme:a rapid mixed-methods study

BACKGROUND: The Children and Young People’s Mental Health Trailblazer programme is funding the creation of new mental health support teams to work in schools and further education colleges. Mental health support teams directly support children and young people with ‘mild to moderate’ mental health problems and work with school and college staff to promote well-being for all. A new workforce of education mental health practitioners is being trained for the teams. OBJECTIVE(S): The National Institute for Health and Care Research Birmingham, RAND and Cambridge Evaluation Rapid Evaluation Centre and Policy Innovation and Evaluation Research Unit undertook an early evaluation of the Trailblazer programme to examine the development, implementation and early progress of mental health support teams in the programme’s first 25 ‘Trailblazer’ sites. DESIGN: A mixed-methods evaluation, comprising three work packages: 1. Establishing the baseline and understanding the development and early impacts of the Trailblazer sites, including two rounds of surveys with key informants and participating education settings in all 25 sites. 2. More detailed research in five purposively selected Trailblazer sites, including interviews with a range of stakeholders and focus groups with children and young people. 3. Scoping and developing options for a longer-term assessment of the programme’s outcomes and impacts. Fieldwork was undertaken between November 2020 and February 2022. The University of Birmingham Institute for Mental Health Youth Advisory Group was involved throughout the study, including co-producing the focus groups with children and young people. RESULTS: Substantial progress had been made implementing the programme, in challenging circumstances, and there was optimism about what it had the potential to achieve. The education mental health practitioner role had proven popular, but sites reported challenges in retaining education mental health practitioners, and turnover left mental health support teams short-staffed and needing to re-recruit. Education settings welcomed additional mental health support and reported positive early outcomes, including staff feeling more confident and having faster access to advice about mental health issues. At the same time, there were concerns about children who had mental health problems that were more serious than ‘mild to moderate’ but not serious enough to be accepted for specialist help, and that the interventions offered were not working well for some young people. Mental health support teams were generally spending more time supporting children with mental health problems than working with education settings to develop ‘whole school’ approaches to mental health and well-being, and service models in some sites appeared to be more clinically oriented, with a strong focus on mental health support teams’ therapeutic functions. LIMITATIONS: Despite efforts to maximise participation, survey response rates were relatively low and some groups were less well represented than others. We were not able to gather sufficiently detailed data to develop a typology of Trailblazer sites, as was planned. CONCLUSIONS: Key lessons for future programme implementation include: - Whether mental health support teams should expand support to children and young people with more complex and serious mental health problems. - How to keep the twin aims of prevention and early intervention in balance. - How to retain education mental health practitioners once trained. FUTURE WORK: The findings have important implications for the design of a longer-term impact evaluation of the programme, which is due to commence in summer 2023

Mixed-methods exploration of views on choice in a university asymptomatic COVID-19 testing programme.

Funder: Wellcome TrustFunder: Healthcare Improvement Studies Institute (THIS Institute), University of CambridgeFunder: Health Foundation; Id: http://dx.doi.org/10.13039/501100000724Asymptomatic COVID-19 testing programmes are being introduced in higher education institutions, but stakeholder views regarding the acceptability of mandating or incentivizing participation remain little understood. A mixed-method study (semi-structured interviews and a survey including open and closed questions) was undertaken in a case study university with a student testing programme. Survey data were analysed descriptively; analysis for interviews was based on the framework method. Two hundred and thirty-nine people participated in the study: 213 in the survey (189 students, 24 staff), and 26 in interviews (19 students, 7 staff). There was majority (62%) but not universal support for voluntary participation, with a range of concerns expressed about the potentially negative effects of mandating testing. Those who supported mandatory testing tended to do so on the grounds that it would protect others. There was also majority (64%) opposition to penalties for refusing to test. Views on restricting access to face-to-face teaching for non-participants were polarized. Three-quarters (75%) supported incentives, though there were some concerns about effectiveness and unintended consequences. Participants emphasized the importance of communication about the potential benefits of testing. Preserving the voluntariness of participation in student asymptomatic testing programmes is likely to be the most ethically sound policy unless circumstances change.Caitriona Cox, lead researcher, is a National Institute for Health Research (NIHR) academic clinical fellow. This study is funded by Mary Dixon-Woods’ NIHR Senior Investigator award (NF-SI-0617-10026), by the Wellcome Trust through a contract award for a project on ethical issues in COVID-19 testing, and by The Healthcare Improvement Studies Institute (THIS Institute), University of Cambridge. THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK

Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom

The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. It has also stimulated research in a wide range of areas including rapid diagnostics, novel therapeutics, use of technology to track patients and vaccine development. Here, we describe our experience of rapidly setting up and delivering a novel COVID-19 vaccine trial, using clinical and research staff and facilities in three National Health Service Trusts in Cambridgeshire, United Kingdom. We encountered and overcame a number of challenges including differences in organisational structures, research facilities available, staff experience and skills, information technology and communications infrastructure, and research training and assessment procedures. We overcame these by setting up a project team that included key members from all three organisations that met at least daily by teleconference. This group together worked to identify the best practices and procedures and to harmonise and cascade these to the wider trial team. This enabled us to set up the trial within 25 days and to recruit and vaccinate the participants within a further 23 days. The lessons learned from our experiences could be used to inform the conduct of clinical trials during a future infectious disease pandemic or public health emergency

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Communicating research evidence to boards in health and care organisations:a scoping study

Boards in health and care organisations in England play a key role in the governance, strategy, direction and culture of an organisation. It is therefore important to ensure that board decisions are informed by the best available evidence from a range of sources, including service evaluations, organisational performance data, research and evidence-based guidelines. However, there is a scarcity of evidence about how boards use research evidence, defined as evidence stemming from generalisable empirical research, to carry out their roles. THIS Institute commissioned RAND Europe and the Health Services Management Centre (HSMC) at the University of Birmingham to conduct a scoping study on how health and care boards use research evidence. The focus was on NHS Trust boards and the boards of Sustainability and Transformation Partnerships (STPs) or Integrated Care Systems (ICSs). The principal data collection method was qualitative interviews with diverse members of health and care boards to obtain insights into the perceptions and experiences of board members in a range of roles and circumstances. The findings are predominantly based on evidence from 17 interviews. Given the importance of the COVID-19 pandemic at the time of this research, we were also asked to consider whether and how research evidence was used by boards in shaping their response to COVID-19. We focused on two areas specifically: (i) personal protective equipment (PPE) and (ii) the use of remote consultations and remote patient monitoring