Insights into the implementation of a whole genome sequencing report form (SRF) to reduce nosocomial SARS-CoV-2 within UK hospitals: a qualitative process evaluation using normalisation process theory (preprint)

Background Here we report on a process evaluation conducted as part of a large multisite non-randomised trial of the effectiveness of a whole genome sequence report form (SRF) to reduce nosocomial SARS-CoV-2 through changing infection prevention and control (IPC) behaviours during the COVID − 19 pandemic. We detail how the SRF was implemented across a heterogeneous purposive sub-sample of hospital trial sites (n = 5/14). Methods We conducted in-depth interviews from diverse professional staff (N = 39). Inductive thematic analysis initially explored participants’ accounts of implementing the SRF. The resulting data driven themes, concerning the way the SRF was used within sites, were then coded in relation to the key tenets of normalisation process theory (NPT). Results Factors that enabled the implementation of the SRF included: elements of the context such as health care professional passion; the existence of whole genome sequencing (WGS) infrastructure; effective communication channels, the creation of new connections across professionals and teams; the integration of SRF-led discussions within pre-existing meetings and the ability of a site to achieve a rapid turnaround time. In contrast, we found factors that constrained the use of the SRF included elements of the context such as the impact of the Alpha-variant overwhelming hospitals. In turn, dealing with COVID-19 breached the limited capacity of infection prevention and control (IPC) to respond to the SRF and ensure its routinisation. Conclusion We show preliminary support for the SRF being an acceptable, useable and potentially scalable way of enhancing existing IPC activities. However, the context of both the trial and the alpha wave of COVID-19 limit these insights. Clinical trial number https://www.isrctn.com/ISRCTN50212645, Registration date 20/05/2020

A qualitative process evaluation using the behaviour change wheel approach: Did a whole genome sequence report form (SRF) used to reduce nosocomial SARS-CoV-2 within UK hospitals operate as anticipated? (preprint)

PurposeTo conduct a process evaluation of a whole genome sequence report form (SRF) used to reduce nosocomial SARS-CoV-2 through changing infection prevention and control (IPC) behaviours. Here using qualitative behavioural analyses we report how the SRF worked. MethodsPrior to a multisite non-randomised trial of its effectiveness, the SRF was coded in relation to its putative behaviour change content (using the theoretical domains framework (TDF), the behaviour change wheel (BCW) and the behaviour change technique taxonomy (BCTTv1)). After the SRF had been used, through the peak of the Alpha variant, we conducted in-depth interviews from diverse professional staff (N=39) from a heterogeneous purposive sub-sample of hospital trial sites (n=5/14). Deductive thematic analysis explored participants accounts of using the SRF according to its putative content in addition to inductive exploration of their experiences. ResultsWe found empirical support for the putative theoretical mechanisms of Knowledge and Behavioural regulation, as well as for intervention functions of Education and Persuasion and Enablement, and for particular BCTs 1.2 Problem solving, 2.6 Biofeedback, 2.7 Feedback on outcomes of behaviour, and 7.1 Prompts and cues. Most participants found the SRF useful and believed it could shape IPC behaviour. ConclusionsOur process evaluation of the SRF provided granular and general support for the SRF working to change IPC behaviours. Our analysis highlighted useful SRF content. However, we also note that, without complementary work on systematically embedding the SRF within routine practice and wider hospital systems, it may not reach its full potential to reduce nosocomial infection. What is already known on this subject?O_LIHealth psychology remains under-exploited within infection prevention and control (IPC) interventions C_LIO_LIFor genomic insights to be understood by a range of health care professionals and elicit changes in IPC behaviour, ways of translating complex genomic insights into a simple format are needed. These simple translation tools can be described as whole genome sequence report forms (SRFs) C_LIO_LINothing is currently known about the use of SRFs, for SARS-CoV-2 or other infections, to change hospital-based IPC behaviour. C_LIO_LIHealth psychological tools such as the behaviour change wheel (BCW), the theoretical domains framework (TDF), and the behaviour change technique taxonomy (BCTTv1) are widely used to develop behaviour change interventions but are rarely used to evaluate them C_LIO_LIContemporary guidance on conducting process evaluations highlights the value of explicitly theorising how an intervention is intended to work before systematically examining how it actually worked in practice C_LI What does this study add?O_LIThe paper presents a novel worked example of using tools from health psychology within a qualitative process evaluation of using an SRF during the COVID-19 pandemic in UK hospitals C_LIO_LIThis paper is the first to report how people experienced using whole genome sequence report forms (SRFs) in order to change hospital-based IPC behaviour C_LIO_LIWe provide qualitative evidence detailing empirical support for much of the SRFs putative content, including casual mechanisms Knowledge and Behavioural regulation, intervention functions such as Education and Enablement, and for particular BCTs: 1.2 Problem solving, 2.6 Biofeedback, 2.7 Feedback on outcomes of behaviour, and 7.1 Prompts and cues C_LI

How acceptable is rapid whole genome sequencing for infectious disease management in hospitals? Perspectives of those involved in managing nosocomial SARS-CoV-2 (preprint)

Structured summary Background Whole genome sequencing (WGS) for managing healthcare associated infections (HCAIs) has developed considerably through experiences with SARS-CoV-2. We interviewed various healthcare professionals (HCPs) with direct experience of using WGS in hospitals (within the COG-UK Hospital Onset COVID-19 Infection (HOCI) study) to explore its acceptability and future use. Method An exploratory, cross-sectional, qualitative design employed semi-structured interviews with 39 diverse HCPs between December 2020 and June 2021. Participants were recruited from five sites within the larger clinical study of a novel genome sequencing reporting tool for SARS-CoV-2 (the HOCI study). All had experience, in their diverse roles, of using sequencing data to manage nosocomial SARS-CoV-2 infection. Deductive and inductive thematic analysis identified themes exploring aspects of the acceptability of sequencing. Findings The analysis highlighted the overall acceptability of rapid WGS for infectious disease using SARS-CoV-2 as a case study. Diverse professionals were largely very positive about its future use and believed that it could become a valuable and routine tool for managing HCAIs. We identified three key themes ‘1) ‘Proof of concept achieved’; 2) ‘Novel insights and implications’; and 3) ‘Challenges and demands’. Conclusion Our qualitative analysis, drawn from five diverse hospitals, shows the broad acceptability of rapid sequencing and its potential. Participants believed it could and should become an everyday technology capable of being embedded within typical hospital processes and systems. However, its future integration into existing healthcare systems will not be without challenges (e.g., resource, multi-level change) warranting further mixed methods research.

Evaluating the effectiveness of rapid SARS-CoV-2 genome sequencing in supporting infection control teams: the COG-UK hospital-onset COVID-19 infection study (preprint)

Introduction Viral sequencing of SARS-CoV-2 has been used for outbreak investigation, but there is limited evidence supporting routine use for infection prevention and control (IPC) within hospital settings. Methods We conducted a prospective non-randomised trial of sequencing at 14 acute UK hospital trusts. Sites each had a 4-week baseline data-collection period, followed by intervention periods comprising 8 weeks of 'rapid' (<48h) and 4 weeks of 'longer-turnaround' (5-10 day) sequencing using a sequence reporting tool (SRT). Data were collected on all hospital onset COVID-19 infections (HOCIs; detected [≥]48h from admission). The impact of the sequencing intervention on IPC knowledge and actions, and on incidence of probable/definite hospital-acquired infections (HAIs) was evaluated. Results A total of 2170 HOCI cases were recorded from October 2020-April 2021, with sequence reports returned for 650/1320 (49.2%) during intervention phases. We did not detect a statistically significant change in weekly incidence of HAIs in longer-turnaround (IRR 1.60, 95%CI 0.85-3.01; P=0.14) or rapid (0.85, 0.48-1.50; P=0.54) intervention phases compared to baseline phase. However, IPC practice was changed in 7.8% and 7.4% of all HOCI cases in rapid and longer-turnaround phases, respectively, and 17.2% and 11.6% of cases where the report was returned. In a per-protocol sensitivity analysis there was an impact on IPC actions in 20.7% of HOCI cases when the SRT report was returned within 5 days. Conclusion While we did not demonstrate a direct impact of sequencing on the incidence of nosocomial transmission, our results suggest that sequencing can inform IPC response to HOCIs, particularly when returned within 5 days.

Gay, Bisexual and other Men who have Sex with Men (GBMSM) remote mental health help-seeking during Covid-19 (preprint)

Gay, bisexual and other men who have sex with men (GBMSM) experience far worse mental health (MH) than wider society. This disparity was exacerbated by additional ‘unique to sexual minority status’ COVID-19 stressors. This sequential, mixed-methods study examined MH help-seeking among GBMSM in the UK and Ireland during the first COVID-19 lockdown. Quantitative survey data (n=1,368), analysed with logistic regression, suggested GBMSM experiencing moderate-to-severe anxiety and those with a past MH diagnosis were most likely to seek MH support. Thematic analysis of qualitative interview (n=18) data identified multiple barriers and enablers to GBMSM seeking MH help, who focused on GBMSM-facing organisations and population-wide online resources. Finally, the behaviour change wheel was used to generate theoretically informed recommendations to promote MH help-seeking among GBMSM in Scotland. We discuss how applying these recommendations in the short, medium and long term will begin to address GBMSM’s MH needs, post COVID-19.

What have we learned about what works in sustaining mental health care and support services during a pandemic? Transferable insights from the COVID-19 response (preprint)

Efforts have been made to adapt the delivery of mental health care and support services to the demands of COVID-19. Here we detail the perspectives and experiences of mental health workers (MHWs), in relation to what they found helpful when adapting mental health services during the COVID-19 pandemic and responding to its demands. We were interested in exploring what has helped to support MHWs’ own health and wellbeing given that staff wellbeing is central to sustaining the delivery of quality mental health services moving forward. Individual interviews were conducted with MHWs (n = 30) during the third COVID-19 lockdown. Interviews were audio-recorded, transcribed and managed using NVIVO. Qualitative data was analyzed using an inductive thematic approach. Three major themes were created, which emphasized the importance of: (1) 'self-care and peer support (checking in with each other)', (2) 'team cohesion and collaboration' and (3) 'visible and supportive management and leadership (new ways of working)'. Our findings emphasize the importance of individual, team and systems-based support in helping MHWs maintain their own wellbeing, whilst adapting and responding to the challenges in providing mental health care and support during this pandemic. Guidance and direction from management, with adaptive leadership in providing sustained, efficient, and equitable delivery of mental healthcare, is essential. Our findings support future policy, research and mental health practice developments through sharing important salutogenic lessons learned and transferable insights which may help with preparedness for future pandemics.

Protocol for the COG-UK hospital onset COVID-19 infection (HOCI) multicentre interventional clinical study: evaluating the efficacy of rapid genome sequencing of SARS-CoV-2 in limiting the spread of COVID-19 in United Kingdom NHS hospitals (preprint)

IntroductionNosocomial transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a significant cause of mortality in National Health Service (NHS) hospitals during the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study is to evaluate the impact of rapid whole genome sequencing of SARS-CoV-2, supported by a novel probabilistic reporting methodology, to inform infection prevention and control (IPC) practice within NHS hospital settings. Methods and analysisCOG-UK HOCI (COG-UK Consortium Hospital-Onset COVID-19 Infections study) is a multicentre, prospective, interventional, superiority study. Eligible patients must be admitted to hospital with first confirmed SARS-CoV-2 PCR positive test result >48h from time of admission, where COVID-19 diagnosis was not suspected upon admission. The projected sample size for 14 participating sites covering all study phases over winter-spring 2020/2021 in the United Kingdom is 2,380 patients. The intervention is the return of a sequence report, within 48 hours in one phase (rapid local lab) and within 5-10 days in a second phase (mimicking central lab use), comparing the viral genome from an eligible study participant with others within and outside the hospital site. The primary outcomes are the incidence of Public Health England (PHE)/IPC-defined SARS-CoV-2 hospital-acquired infection during the baseline and two interventional phases, and proportion of hospital-onset cases with genomic evidence of transmission linkage following implementation of the intervention where such linkage was not suspected by initial IPC investigation. Secondary outcomes include incidence of hospital outbreaks, with and without sequencing data; actual and desirable changes to IPC actions; periods of healthcare worker (HCW) absence. A process evaluation using qualitative interviews with HCWs will be conducted alongside the study and analysis, underpinned by iterative programme theory of the sequence report. Health economic analysis will be conducted to determine cost-benefit of the intervention, and whether this leads to economic advantages within the NHS setting. Ethics and disseminationThe protocol has been approved by the National Research Ethics Service Committee (Cambridge South 20/EE/0118). This manuscript is based on version 5.0 of the protocol. The study findings will be disseminated through peer-reviewed publications. Study Registration numberISRCTN50212645 Strengths and limitations of this studyO_LIThe COG-UK HOCI study harnesses the infrastructure of the UKs existing national COVID-19 genome sequencing platform to evaluate the specific benefit of sequencing to hospital infection control. C_LIO_LIThe evaluation is thought to be the first interventional study globally to assess effectiveness of genomic sequencing for infection control in an unbiased patient selection in secondary care settings. C_LIO_LIA range of institutional settings will participate, from specialist NHS-embedded or academic centres experienced in using pathogen genomics to district general hospitals. C_LIO_LIThe findings are likely to have wider applicability in future decisions to utilise genome sequencing for infection control of other pathogens (such as influenza, respiratory syncytial virus, norovirus, clostridium difficile and antimicrobial resistant pathogens) in secondary care settings. C_LIO_LIThe study has been awarded UK NIHR Urgent Public Health status, ensuring prioritised access to NIHR Clinical Research Network (CRN) research staff to recruit patients. C_LIO_LIThe study does not have a randomised controlled design due to the logistics of managing this against diverse standard practice. C_LI

Sharing positive changes made during COVID-19 national lockdown: a multi-method co-production study (preprint)

Objectives: A multi-method co-production study was designed to share psychosocial insights into the adoption of positive changes made during COVID-19 national lockdown in Scotland. We examined: i) the psychosocial patterning of positive changes, ii) the psychosocial processes by which positive change was realised, and worked with partner organizations to share our insights. Method: A sequential multi-method design included an online survey (n=2445) assessing positive changes in sleep and physical activity patterns, socio-demographics, mood, social support, coping, and resilience, with multivariate logistic regression analysis. We also employed interviews with a purposive diverse sub-sample of people self-reporting high levels of positive change (n=48) and used thematic analysis. Finally, partnership work translated insights into positive change-sharing targeted resources. Results: The survey identified positive change was significantly patterned by age, gender and vulnerability to COVID-19. Higher positive reframing and higher active coping were associated with higher levels of cross-domain positive change. Higher symptoms of depression, planning, and self-distraction were associated with less cross-domain positive change. Thematic analysis showed the centrality of perceptions of time, opportunities to self-reflect and engage with the natural world, access support in diverse ways, actively build routine and purposefully build self-efficacy and a sense of control were key to initiating positive change. Our partner organizations focused on the rapid co-production of a series of online resources that shared study insights. Conclusions: Our study, based around a salutogenic ethos and the constraints of COVID-19, sought to identify and share insights into achieving positive changes at a time of international crisis.

Social patterning and stability of COVID-19 vaccination acceptance in Scotland: Will those most at risk accept a vaccine? (preprint)

Vaccination is central to controlling COVID-19. Its success relies on having safe and effective vaccines and also on high levels of uptake by the public over time. Addressing questions of population-level acceptability, stability of acceptance and sub-population variation in acceptability are imperative. Using a prospective design, a repeated measures two-wave online survey was conducted to assess key sociodemographic variables and intention to accept a COVID-19 vaccine. The first survey (time 1) was completed by 3436 people during the period of national lockdown in Scotland and the second survey (n = 2016) was completed two months later (time 2) when restrictions had been eased. At time one, 74% reported being willing to receive a COVID-19 vaccine. Logistic regression analyses showed that there were clear sociodemographic differences in intention to accept a vaccine for COVID-19 with intention being higher in participants of white ethnicity in comparison to Black, Asian, and minority ethnic (BAME) groups, and in those with higher income levels and higher education levels. Intention was also higher in those who were shielding due to underlying medical conditions. Our results suggest that future interventions such as mass media and social marketing need to be targeted to a range of sub-populations and diverse communities.

Changes in physical activity, sitting and sleep across the COVID-19 national lockdown period in Scotland. (preprint)

We examine the impact of the COVID-19 outbreak and concomitant restrictions (i.e. lockdown) on 24-hour movement behaviors (i.e. physical activity, sitting, sleep) in a purposive sample of people (n=3230) reporting change recruited on-line. Participants self-reported time spent in moderate-to-vigorous physical activity (MVPA), walking, sitting and sleep prior to lockdown (T1), during the first national lockdown (T2) and as restrictions initially started to ease (T3). For each 24-hour movement behavior, category-shifts are reported (positive, negative or did not change), as well as the percentage of participants recording positive/negative changes across clusters of behaviors and the percentage of participants recording improvement or maintenance of change across time. From T1 to T2 walking decreased, whereas MVPA, sitting and sleep increased, from T2 to T3 levels returned to pre-lockdown for all but MVPA. Participants who changed one behavior positively were more likely to report a positive change in another and 50% of those who reported positive changes from T1 to T2 maintained or improved further when restrictions started to ease. The current study showed that a large proportion of the sample reported positive changes, most notably those displaying initially poor levels of each behavior. These findings will inform salutogenic intervention development.

What have we learned about positive changes experienced during COVID-19 lockdown? Evidence of the social patterning of change (preprint)

BackgroundMultiple studies have highlighted the negative impact of COVID-19 and its particular effects on vulnerable sub-populations. Complementing this work, here, we report on the social patterning of self-reported positive changes experienced during COVID-19 national lockdown in Scotland. MethodsThe CATALYST study collected data from 3342 adults in Scotland during weeks 9-12 of a national lockdown. Participants completed an online questionnaire providing data on key sociodemographic and health variables, and completed a measure of positive change. The positive change measure spanned diverse domains (e.g., more quality time with family, developing new hobbies, more physical activity, and better quality of sleep). We used univariate analysis and stepwise regression to examine the contribution of a range of sociodemographic factors (e.g., age, gender, ethnicity, educational attainment, and employment status) in explaining positive change. ResultsThere were clear sociodemographic differences across positive change scores. Those reporting higher levels of positive change were female, from younger age groups, married or living with their partner, employed, and in better health. ConclusionOverall our results highlight the social patterning of positive changes during lockdown in Scotland. These findings begin to illuminate the complexity of the unanticipated effects of national lockdown and will be used to support future intervention development work sharing lessons learned from lockdown to increase positive health change amongst those who may benefit.

Towards intervention development to increase the uptake of COVID-19 vaccination among those at high risk: outlining evidence-based and theoretically informed future intervention content (preprint)

ObjectivesDevelopment of a vaccine against COVID-19 will be key to controlling the pandemic. We need to understand the barriers and facilitators to receiving a future COVID-19 vaccine so that we can provide recommendations for the design of interventions aimed at maximising public acceptance. DesignCross-sectional UK survey with older adults and patients with chronic respiratory disease. MethodsDuring the UKs early April 2020 lockdown period, 527 participants (311 older adults, mean age = 70.4 years; 216 chronic respiratory participants, mean age = 43.8 years) completed an online questionnaire assessing willingness to receive a COVID-19 vaccine, perceptions of COVID-19, and intention to receive influenza and pneumococcal vaccinations. A free text response (n=502) examined barriers and facilitators to uptake. The Behaviour Change Wheel informed the analysis of these responses, which were coded to the Theoretical Domains Framework (TDF). Behaviour change techniques (BCTs) were identified. ResultsEighty-six percent of respondents want to receive a COVID-19 vaccine. This was positively correlated with the perception that COVID-19 will persist over time, and negatively associated with perceiving the media to have over-exaggerated the risk. The majority of barriers and facilitators were mapped onto the beliefs about consequences TDF domain, with themes relating to personal health, health consequences to others, concerns of vaccine safety, and severity of COVID-19. ConclusionsWillingness to receive a COVID-19 vaccination is currently high among high-risk individuals. Mass media interventions aimed at maximising vaccine uptake should utilise the BCTs of information about health, emotional, social and environmental consequences, and salience of consequences. Statement of ContributionO_ST_ABSWhat is already known on this subject?C_ST_ABSO_LIUptake of a vaccine for COVID-19 will be vital for controlling the pandemic, but the success of this strategy relies on public acceptance of the vaccine. C_LIO_LIUptake of vaccinations and public confidence in vaccines has been falling in recent years. C_LIO_LIEvidence suggests that 74% of the French population want to receive a COVID-19 vaccination. C_LI What does this study add?O_LIThis study found that 86% of our sample of high-risk participants in the UK are willing to receive a future vaccine for COVID-19. C_LIO_LIThis study showed that perceived barriers and facilitators to uptake of the COVID-19 vaccination concentrated on the beliefs about consequences TDF domain. C_LIO_LIThis study suggests that the content of mass media interventions to improve vaccine uptake should focus on the BCTs of information about health, emotional, social and environmental consequences, and salience of consequences. These techniques should be pitched in relation to both self and, most importantly, to others. C_LI