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Background/aims: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration. Methods: We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper. Results: Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies. Conclusions: Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit's experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations. [ABSTRACT FROM AUTHOR]

Health Pathfinder is a multilevel system change intervention initiated to transform the health response to domestic violence and abuse in eight sites in England. The current study drew upon interviews with health professionals ( n  = 27) and victim-survivors ( n  = 20) to provide a realist account of how this intervention achieved its goals. Findings show that five change mechanisms explain why Health Pathfinder was effective as an ecological intervention: awareness, expertise, relationships, empowerment, and evidence. Positive progress in respect of each mechanism had meaningful impacts on victim-survivor experiences of enquiry, disclosure, and uptake of services and had the potential to meaningfully impact health inequities., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Role models have been identified as a potential means to tackle the persisting low levels of physical activity among young girls. The aim of this research was to explore the involvement of community- and peer role models within the CHARMING (CHoosing Active Role Models to INspire Girls) intervention, an intervention which aims to increase and sustain physical activity among 9-10-year-old girls. The research questions were, is it feasible and acceptable to recruit role models? and what are the perceived barriers and facilitators to the inclusion of peer role models within the intervention?, Methods: A mixed methods process evaluation was embedded within a larger feasibility study, involving three secondary schools and four adjoining primary schools in South Wales, United Kingdom. One-to-one interviews were conducted with teachers (N = 10) across the seven schools and community role models (N = 10). Focus groups were conducted with 18 peer role models (older girls from adjoining secondary schools) and 18 girls aged 9-10-years who had participated in the intervention. Primary school teachers kept observation logs of each intervention session. A researcher completed observation logs of two random sessions per school. Qualitative data were analysed using thematic analysis with a combined deductive and inductive coding approach. Observation data were analysed using descriptive statistics. Data were triangulated and comparative analyses conducted across schools., Results: Twenty-three peer role models (aged 12-16-years) and 16 community role models participated in intervention delivery. Overall, the inclusion of both types of role models was shown as acceptable and feasible within the CHARMING intervention. Observation data highlighted key areas (i.e., intervention components delivered inconsistently) for further qualitative exploration. Six themes were identified during analyses; reach and access, communication, logistics, existing systems, interpersonal relationships, and perceived impacts. Themes were intertwined across the barriers and facilitators of recruitment and implementation. Areas for future improvement were highlighted., Conclusions: Findings can be used to optimise the CHARMING intervention and inform wider interventions or policies employing several role models across settings to promote physical activity among children., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Wastewater surveillance has proved to be a valuable tool to track the COVID-19 pandemic. However, most studies using wastewater surveillance data revolve around establishing correlations and lead time relative to reported case data. In this perspective, we advocate for the integration of wastewater surveillance data with dynamic within-host and between-host models to better understand, monitor, and predict viral disease outbreaks. Dynamic models overcome emblematic difficulties of using wastewater surveillance data such as establishing the temporal viral shedding profile. Complementarily, wastewater surveillance data bypasses the issues of time lag and underreporting in clinical case report data, thus enhancing the utility and applicability of dynamic models. The integration of wastewater surveillance data with dynamic models can enhance real-time tracking and prevalence estimation, forecast viral transmission and intervention effectiveness, and most importantly, provide a mechanistic understanding of infectious disease dynamics and the driving factors. Dynamic modeling of wastewater surveillance data will advance the development of a predictive and responsive monitoring system to improve pandemic preparedness and population health., Competing Interests: Declaration of Competing Interest The authors declare they have no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

We introduce a two-strain model with asymmetric temporary immunity periods and partial cross-immunity. We derive explicit conditions for competitive exclusion and coexistence of the strains depending on the strain-specific basic reproduction numbers, temporary immunity periods, and degree of cross-immunity. The results of our bifurcation analysis suggest that, even when two strains share similar basic reproduction numbers and other epidemiological parameters, a disparity in temporary immunity periods and partial or complete cross-immunity can provide a significant competitive advantage. To analyze the dynamics, we introduce a quasi-steady state reduced model which assumes the original strain remains at its endemic steady state. We completely analyze the resulting reduced planar hybrid switching system using linear stability analysis, planar phase-plane analysis, and the Bendixson-Dulac criterion. We validate both the full and reduced models with COVID-19 incidence data, focusing on the Delta (B.1.617.2), Omicron (B.1.1.529), and Kraken (XBB.1.5) variants. These numerical studies suggest that, while early novel strains of COVID-19 had a tendency toward dramatic takeovers and extinction of ancestral strains, more recent strains have the capacity for co-existence.

We consider the dynamics of a virus spreading through a population that produces a mutant strain with the ability to infect individuals that were infected with the established strain. Temporary cross-immunity is included using a time delay, but is found to be a harmless delay. We provide some sufficient conditions that guarantee local and global asymptotic stability of the disease-free equilibrium and the two boundary equilibria when the two strains outcompete one another. It is shown that, due to the immune evasion of the emerging strain, the reproduction number of the emerging strain must be significantly lower than that of the established strain for the local stability of the established-strain-only boundary equilibrium. To analyze the unique coexistence equilibrium we apply a quasi steady-state argument to reduce the full model to a two-dimensional one that exhibits a global asymptotically stable established-strain-only equilibrium or global asymptotically stable coexistence equilibrium. Our results indicate that the basic reproduction numbers of both strains govern the overall dynamics, but in nontrivial ways due to the inclusion of cross-immunity. The model is applied to study the emergence of the SARS-CoV-2 Delta variant in the presence of the Alpha variant using wastewater surveillance data from the Deer Island Treatment Plant in Massachusetts, USA., (© 2023. The Author(s).)

Wastewater-based surveillance (WBS) has been widely used as a public health tool to monitor SARS-CoV-2 transmission. However, epidemiological inference from WBS data remains understudied and limits its application. In this study, we have established a quantitative framework to estimate COVID-19 prevalence and predict SARS-CoV-2 transmission through integrating WBS data into an SEIR-V model. We conceptually divide the individual-level viral shedding course into exposed, infectious, and recovery phases as an analogy to the compartments in a population-level SEIR model. We demonstrated that the effect of temperature on viral losses in the sewer can be straightforwardly incorporated in our framework. Using WBS data from the second wave of the pandemic (Oct 02, 2020-Jan 25, 2021) in the Greater Boston area, we showed that the SEIR-V model successfully recapitulates the temporal dynamics of viral load in wastewater and predicts the true number of cases peaked earlier and higher than the number of reported cases by 6-16 days and 8.3-10.2 folds (R = 0.93). This work showcases a simple yet effective method to bridge WBS and quantitative epidemiological modeling to estimate the prevalence and transmission of SARS-CoV-2 in the sewershed, which could facilitate the application of wastewater surveillance of infectious diseases for epidemiological inference and inform public health actions., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objective: Women of reproductive age who have autoimmune rheumatic diseases [ARDs] have expressed a need to be better supported with making decisions about pregnancy. Women with ARDs want their motherhood identities and associated preferences to be taken into account in decisions about their healthcare. The aim of this study was to explore the interplay between illness and motherhood identities of women with ARDs during preconception decision making., Methods: Timeline-facilitated qualitative interviews with women diagnosed with an ARD [18-49 years old]. Participants were purposively sampled based on the following three criteria: thinking about getting pregnant, currently pregnant, or had young children. Interviews were thematically analysed., Results: Twenty-two women were interviewed face-to-face [N = 6] or over the telephone [N = 16]. Interview length ranged from 20 minutes to 70 minutes, with a mean length of 48 minutes. Three main themes were identified: prioritisation, discrepancy, and trade-off. Difficulties in balancing multiple identities in healthcare encounters were reported. Women used 'self-guides' as a reference for priority setting in a dynamic process that shifted as their level of disease activity altered and as their motherhood identity became more or less of a focus at a given point in time. Women's illness and motherhood identities did not present in isolation but were intertwined., Conclusions: Findings highlight the need for holistic person-centred care that supports women with the complex and emotive decisions relating to preconception decision-making. In practice, health professionals need to consider women's multiple and sometimes conflicting identities, and include both their condition and family associated goals and values within healthcare communication., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Williams et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Breastfeeding rates in many Global North countries are low. Qualitative research highlights that breastfeeding in public is a particular challenge, despite mothers often having the legal right to do so. To identify barriers and facilitators, we systematically searched the qualitative research from Organisation for Economic Co-operation and Development countries relating to breastfeeding in public spaces from 2007 to 2021. Data were analysed using the Thematic Synthesis technique. The review was registered with PROSPERO (registration number: CRD42017081504). Database searching identified 3570 unique records. In total, 74 papers, theses, or book chapters, relating to 71 studies, were included, accounting for over 17,000 mothers. Overall, data quality was high. Our analysis identified that five core factors influenced mothers' thought processes and their breastfeeding in public behaviour: legal system; structural (in)equality; knowledge; beliefs and the social environment. Macro-level factors relating to legislation and inequality urgently require redress if breastfeeding rates are to be increased. Widespread culture change is also required to enhance knowledge, change hostile beliefs and thus the social environment in which mother/infant dyads exist. In particular, the sexualisation of breasts, disgust narratives and lack of exposure among observers to baby-led infant feeding patterns resulted in beliefs which created a stigmatising environment. In this context, many mothers felt unable to breastfeed in public; those who breastfed outside the home were usually highly self-aware, attempting to reduce their exposure to conflict. Evidence-based theoretically informed interventions to remove barriers to breastfeeding in public are urgently required., (© 2022 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.)

We introduce a distributed-delay differential equation disease spread model for COVID-19 spread. The model explicitly incorporates the population's time-dependent vaccine uptake and incorporates a gamma-distributed temporary immunity period for both vaccination and previous infection. We validate the model on COVID-19 cases and deaths data from the state of Michigan and use the calibrated model to forecast the spread and impact of the disease under a variety of realistic booster vaccine strategies. The model suggests that the mean immunity duration for individuals after vaccination is 350 days and after a prior infection is 242 days. Simulations suggest that both high population-wide adherence to vaccination mandates and a more-than-annually frequency of booster doses will be required to contain outbreaks in the future.

Background: It is estimated that around 160,000 households in Britain experience homelessness each year, although no definitive statistics exist. Between March and September 2020, as part of the initial 'Everyone In' government response to COVID-19 in England, 10,566 people were living in emergency accommodation and nearly 18,911 people had been moved into settled accommodation. However, some forms of temporary accommodation may not be suitable as shared facilities make it impossible for people to adhere to government guidelines to reduce the spread of COVID-19., Methods: This is parallel group, pilot randomised controlled trial. The target is to recruit three local authorities, each of which will recruit 50 participants (thus a total of approximately 150 participants). Individuals are eligible if they are aged 18 and over, in a single-person homeless household, temporarily accommodated by the LA with recourse to public funds. Participants will be randomised to receive settled accommodation (intervention group) or temporary accommodation (control group). The intervention group includes settled housing such as Private Rented Sector (low and medium support), Social Housing (low and medium support), and Housing First (High support). The control group will maintain treatment as usual. The follow-up period will last 6 months. The primary outcome is to assess the feasibility of recruitment, retention, and acceptability of trial processes against progression criteria laid out in a traffic light system (green: all criteria are met, the trial should progress as designed in this pilot; amber: the majority of criteria are met and with adaptations to methods all criteria could be met; red: the minority of criteria are met and the pilot RCT should not proceed). Secondary outcomes include assessment of completeness of data collection at 3 and 6 months and percentage of participants consenting to data linkage, as well as a process evaluation and economic evaluation., Discussion: This trial will address feasibility questions associated with progression to a fully powered effectiveness trial of models of housing to reduce risk of COVID-19 infection and homelessness., Trial Registration: ISRCTN69564614 . Registered on December 16, 2020., (© 2022. The Author(s).)

Background: In the UK, there is evidence that girls' physical activity tends to decline to a greater extent than boys as they enter adolescence. 'Role models' could play a vital role in inspiring girls to become or remain physically active. The CHARMING Programme is a primary school-based community linked role-model programme, co-developed in 2016, with children, parents, schools and wider stakeholders. It involves different types of physical activity delivered for 1-h each week by a community provider and peer role models (e.g. older girls from secondary schools) joining in with the sessions. The programme ultimately aims to increase and sustain physical activity levels among 9-10-year-old girls. This study aims to assess the feasibility and acceptability of the CHARMING Programme and of evaluating it using a randomised trial., Methods: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation and health economic evaluation. Approximately 90 Year 5 (i.e. 9-10-year-old) girls will be recruited across six primary schools in Mid-South Wales. Participating schools will be allocated to the programme: control on a 2:1 basis; four intervention schools will run the CHARMING Programme and two will continue with usual practice. A survey and accelerometer will be administered at baseline and repeated at 12 months. Interviews and focus groups will be conducted post-intervention delivery. The primary aim is to assess feasibility of a future randomised trial via the recruitment of schools, participants and role models; randomisation; retention; reach; data collection completion rates; programme adherence; and programme fidelity, views on intervention acceptability and programme barriers and facilitators. Secondary aims are to evaluate established physical activity outcome measures for children plus additional health economic outcomes for inclusion in a future full-scale trial., Discussion: The results of this study will inform decisions on whether and how to proceed to a full-scale evaluation of the effectiveness and cost-effectiveness of the CHARMING Programme to improve or sustain physical activity., Trial Registration: ClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021., (© 2021. The Author(s).)

Public perceptions of pandemic viral threats and government policies can influence adherence to containment, delay, and mitigation policies such as physical distancing, hygienic practices, use of physical barriers, uptake of testing, contact tracing, and vaccination programs. The UK COVID-19 Public Experiences (COPE) study aims to identify determinants of health behaviour using the Capability, Opportunity, Motivation (COM-B) model using a longitudinal mixed-methods approach. Here, we provide a detailed description of the demographic and self-reported health characteristics of the COPE cohort at baseline assessment, an overview of data collected, and plans for follow-up of the cohort. The COPE baseline survey was completed by 11,113 UK adult residents (18+ years of age). Baseline data collection started on the 13th of March 2020 (10-days before the introduction of the first national COVID-19 lockdown in the UK) and finished on the 13th of April 2020. Participants were recruited via the HealthWise Wales (HWW) research registry and through social media snowballing and advertising (Facebook®, Twitter®, Instagram®). Participants were predominantly female (69%), over 50 years of age (68%), identified as white (98%), and were living with their partner (68%). A large proportion (67%) had a college/university level education, and half reported a pre-existing health condition (50%). Initial follow-up plans for the cohort included in-depth surveys at 3-months and 12-months after the first UK national lockdown to assess short and medium-term effects of the pandemic on health behaviour and subjective health and well-being. Additional consent will be sought from participants at follow-up for data linkage and surveys at 18 and 24-months after the initial UK national lockdown. A large non-random sample was recruited to the COPE cohort during the early stages of the COVID-19 pandemic, which will enable longitudinal analysis of the determinants of health behaviour and changes in subjective health and well-being over the course of the pandemic., Competing Interests: The authors have declared that no competing interests exist.