Infrastructure challenges to doing health research "where populations with the most disease live" in Covid times-a response to Rai et al. (2021).

BACKGROUND: The failure of randomised controlled trials to adequately reflect areas of highest health need have been repeatedly highlighted. This has implications for the validity and generalisability of findings, for equity and efficiency, but also for research capacity-building. Rai et al. (BMC Med Res Methodol 21:80, 2021) recently argued that the poor alignment between UK clinical research activity (specifically multi-centre RCTs) and local prevalence of disease was, in part, the outcome of behaviour and decision-making by Chief Investigators involved in trial research. They argued that a shift in research culture was needed. Following our recent multi-site mixed methods evaluative study about NHS 111 online we identify some of the additional structural barriers to delivering health research "where populations with the most disease live", accounting for the Covid-19 disruption to processes and delivery. METHODS: The NHS 111 study used a mixed-method research design, including interviews with healthcare staff and stakeholders within the primary, urgent and emergency health care system, and a survey of users and potential users of the NHS 111 online service. This paper draws on data collated by the research team during site identification and selection, as we followed an action research cycle of planning, action, observation and reflection. The process results were discussed among the authors, and grouped into the two themes presented. RESULTS: We approached 22 primary and secondary care sites across England, successfully recruiting half of these. Time from initial approach to first participant recruitment in successful sites ranged from one to ten months. This paper describes frontline bureaucratic barriers to research delivery and recruitment in the local Clinical Research Network system and secondary care sites carrying large research portfolios, alongside the adaptive practices of research practitioners that mitigate these. CONCLUSIONS: This paper augments the recommendations of Rai et al., describing delays encountered during the COVID-19 pandemic, and suggesting in addition to cultural change, it may be additionally important to dismantle infrastructural barriers and improve support to research teams so they can conduct health research "where populations with the most disease live".

Infrastructure challenges to doing health research “where populations with the most disease live” in Covid times—a response to Rai et al. (2021)

Background The failure of randomised controlled trials to adequately reflect areas of highest health need have been repeatedly highlighted. This has implications for the validity and generalisability of findings, for equity and efficiency, but also for research capacity-building. Rai et al. (BMC Med Res Methodol 21:80, 2021) recently argued that the poor alignment between UK clinical research activity (specifically multi-centre RCTs) and local prevalence of disease was, in part, the outcome of behaviour and decision-making by Chief Investigators involved in trial research. They argued that a shift in research culture was needed. Following our recent multi-site mixed methods evaluative study about NHS 111 online we identify some of the additional structural barriers to delivering health research “where populations with the most disease live”, accounting for the Covid-19 disruption to processes and delivery. Methods The NHS 111 study used a mixed-method research design, including interviews with healthcare staff and stakeholders within the primary, urgent and emergency health care system, and a survey of users and potential users of the NHS 111 online service. This paper draws on data collated by the research team during site identification and selection, as we followed an action research cycle of planning, action, observation and reflection. The process results were discussed among the authors, and grouped into the two themes presented. Results We approached 22 primary and secondary care sites across England, successfully recruiting half of these. Time from initial approach to first participant recruitment in successful sites ranged from one to ten months. This paper describes frontline bureaucratic barriers to research delivery and recruitment in the local Clinical Research Network system and secondary care sites carrying large research portfolios, alongside the adaptive practices of research practitioners that mitigate these. Conclusions This paper augments the recommendations of Rai et al., describing delays encountered during the COVID-19 pandemic, and suggesting in addition to cultural change, it may be additionally important to dismantle infrastructural barriers and improve support to research teams so they can conduct health research “where populations with the most disease live”.

Delivering Covid-19 research during the UK pandemic: Experiences of a local research taskforce.

AIM: During the COVID-19 pandemic in the UK, clinical research nurses had to work in new ways and under significant pressure to generate evidence for the developing health crisis. Research nurse support needs, personal and professional challenges have not been explored. This study addresses that gap, generating learning for continued support and development of the research nurse specialty and its ability to respond to public health priorities. DESIGN: We employed a qualitative exploratory approach through online open-ended interviews to explore research nurses' experiences of delivering research during the pandemic using principles of Grounded Theory. METHODS: Fifteen research nurses in the local research taskforce were identified through purposive sampling. Qualitative interviews were conducted online between November 2020 and January 2021 and analysed using the principles of constructivist grounded theory. RESULTS: Three themes of adapting to uncertainty, inclusive leadership and finding validity in the stretch zone were generated in the analysis. CONCLUSION: A model of inclusive leadership and support can facilitate high-functioning performance in a research team, supporting a rapid, confident and efficient response to research needs. IMPACT: Research nurses, a previously invisible workforce, have proved critical to the pandemic response. This study explores the experiences of a team of redeployed research nurses and develops a theory of their experience as they were undertaking the rapid delivery of urgent public health studies during COVID-19. What was found was a process of adaptation and resilience through collaborative teamwork, a strong sense of purpose and role validation enabled by an inclusive leadership style. This work will drive future development of a model of research nursing with a focus on collaboration between research and clinical colleagues.