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AnteayerBMJ Open

Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study

Por: Loria · V. · Aparicio · A. · Hildesheim · A. · Cortes · B. · Barrientos · G. · Retana · D. · Sun · K. · Ocampo · R. · Prevots · D. R. · Zuniga · M. · Waterboer · T. · Wong-McClure · R. · Morera · M. · Butt · J. · Binder · M. · Abdelnour · A. · Calderon · A. · Gail · M. H. · Pfeiffer · R. M.
Purpose

The RESPIRA cohort aims to describe the nature, magnitude, time course and efficacy of the immune response to SARS-CoV-2 infection and vaccination, population prevalence, and household transmission of COVID-19.

Participants

From November 2020, we selected age-stratified random samples of COVID-19 cases from Costa Rica confirmed by PCR. For each case, two population-based controls, matched on age, sex and census tract were recruited, supplemented with hospitalised cases and household contacts. Participants were interviewed and blood and saliva collected for antibodies and PCR tests. Participants will be followed for 2 years to assess antibody response and infection incidence.

Findings to date

Recruitment included 3860 individuals: 1150 COVID-19 cases, 1999 population controls and 719 household contacts from 304 index cases. The age and regional distribution of cases was as planned, including four age strata, 30% rural and 70% urban. The control cohort had similar sex, age and regional distribution as the cases according to the study design. Among the 1999 controls recruited, 6.8% reported at enrolment having had COVID-19 and an additional 12.5% had antibodies against SARS-CoV-2. Compliance with visits and specimens has been close to 70% during the first 18 months of follow-up. During the study, national vaccination was implemented and nearly 90% of our cohort participants were vaccinated during follow-up.

Future plans

RESPIRA will enable multiple analyses, including population prevalence of infection, clinical, behavioural, immunological and genetic risk factors for SARS-CoV-2 acquisition and severity, and determinants of household transmission. We are conducting retrospective and prospective assessment of antibody levels, their determinants and their protective efficacy after infection and vaccination, the impact of long-COVID and a series of ancillary studies. Follow-up continues with bimonthly saliva collection for PCR testing and biannual blood collection for immune response analyses. Follow-up will be completed in early 2024.

Trial registration number

NCT04537338.

Protocol for a realist evaluation of Recovery College dementia courses: understanding coproduction through ethnography

Por: Birt · L. · West · J. · Poland · F. · Wong · G. · Handley · M. · Litherland · R. · Hackmann · C. · Moniz-Cook · E. · Wolverson · E. · Teague · B. · Mills · R. · Sams · K. · Duddy · C. · Fox · C.
Introduction

Support following a dementia diagnosis in the UK is variable. Attending a Recovery College course with and for people with dementia, their supporters and healthcare professionals (staff), may enable people to explore and enact ways to live well with dementia. Recovery Colleges are established within mental health services worldwide, offering peer-supported short courses coproduced in partnership between staff and people with lived experience of mental illness. The concept of recovery is challenging in dementia narratives, with little evidence of how the Recovery College model could work as a method of postdiagnostic dementia support.

Methods and analysis

Using a realist evaluation approach, this research will examine and define what works, for whom, in what circumstances and why, in Recovery College dementia courses. The ethnographic study will recruit five case studies from National Health Service Mental Health Trusts across England. Sampling will seek diversity in new or long-standing courses, delivery methods and demographics of population served. Participant observations will examine course coproduction. Interviews will be undertaken with people with dementia, family and friend supporters and staff involved in coproducing and commissioning the courses, as well as people attending. Documentary materials will be reviewed. Analysis will use a realist logic of analysis to develop a programme theory containing causal explanations for outcomes, in the form of context-mechanism-outcome-configurations, at play in each case.

Ethics and dissemination

The study received approval from Coventry & Warwickshire Research Ethics Committee (22/WM/0215). Ethical concerns include not privileging any voice, consent for embedded observational fieldwork with people who may experience fluctuating mental capacity and balancing researcher ‘embedded participant’ roles in publicly accessible learning events. Drawing on the realist programme theory, two stakeholder groups, one people living with dementia and one staff will work with researchers to coproduce resources to support coproducing Recovery College dementia courses aligned with postdiagnostic services.

How can NHS trusts in England optimise strategies to improve the mental health and well-being of hospital doctors? The Care Under Pressure 3 (CUP3) realist evaluation study protocol

Por: Bramwell · C. · Carrieri · D. · Melvin · A. · Pearson · A. · Scott · J. · Hancock · J. · Pearson · M. · Papoutsi · C. · Wong · G. · Mattick · K.
Introduction

The growing incidence of mental ill health in doctors was a major issue in the UK and internationally, even prior to the COVID-19 pandemic. It has significant and far-reaching implications, including poor quality or inconsistent patient care, absenteeism, workforce attrition and retention issues, presenteeism, and increased risk of suicide. Existing approaches to workplace support do not take into account the individual, organisational and social factors contributing to mental ill health in doctors, nor how interventions/programmes might interact with each other within the workplace. The aim of this study is to work collaboratively with eight purposively selected National Health Service (NHS) trusts within England to develop an evidence-based implementation toolkit for all NHS trusts to reduce doctors’ mental ill health and its impacts on the workforce.

Methods and analysis

The project will incorporate three phases. Phase 1 develops a typology of interventions to reduce doctors’ mental ill health. Phase 2 is a realist evaluation of the existing combinations of strategies being used by acute English healthcare trusts to reduce doctors’ mental ill health (including preventative promotion of well-being), based on 160 interviews with key stakeholders. Phase 3 synthesises the insights gained through phases 1 and 2, to create an implementation toolkit that all UK healthcare trusts can use to optimise their strategies to reduce doctors’ mental ill health and its impact on the workforce and patient care.

Ethics and dissemination

Ethical approval has been granted for phase 2 of the project from the NHS Research Ethics Committee (REC reference number 22/WA/0352). As part of the conditions for our ethics approval, the sites included in our study will remain anonymous. To ensure the relevance of the study’s outputs, we have planned a wide range of dissemination strategies: an implementation toolkit for healthcare leaders, service managers and doctors; conventional academic outputs such as journal manuscripts and conference presentations; plain English summaries; cartoons and animations; and a media engagement campaign.

What are effective vaccine distribution approaches for equity-deserving and high-risk populations during COVID-19? Exploring best practices and recommendations in Canada: protocol for a mixed-methods multiple case codesign study

Por: Aggarwal · M. · Katz · A. · Kokorelias · K. M. · Wong · S. T. · Aghajafari · F. · Ivers · N. M. · Martin-Misener · R. · Aubrey-Bassler · K. · Breton · M. · Upshur · R. E. G. · Kwong · J. C.
Introduction

The WHO has stated that vaccine hesitancy is a serious threat to overcoming COVID-19. Vaccine hesitancy among underserved and at-risk communities is an ongoing challenge in Canada. Public confidence in vaccine safety and effectiveness and the principles of equity need to be considered in vaccine distribution. In Canada, governments of each province or territory manage their own healthcare system, providing an opportunity to compare and contrast distribution strategies. The overarching objective of this study is to identify effective vaccine distribution approaches and advance knowledge on how to design and implement various strategies to meet the different needs of underserved communities.

Methods and analysis

Multiple case studies in seven Canadian provinces will be conducted using a mixed-methods design. The study will be informed by Experience-Based CoDesign techniques and theoretically guided by the Socio-Ecological Model and the Vaccine Hesitancy Matrix frameworks. Phase 1 will involve a policy document review to systematically explore the vaccine distribution strategy over time in each jurisdiction. This will inform the second phase, which will involve (2a) semistructured, in-depth interviews with policymakers, public health officials, researchers, providers, groups representing patients, researchers and stakeholders and (2b) an analysis of population-based administrative health data of vaccine administration. Integration of qualitative and quantitative data will inform the identification of effective vaccine distribution approaches for various populations. Informed by this evidence, phase 3 of the study will involve conducting focus groups with multiple stakeholders to codesign recommendations for the design and implementation of effective vaccine delivery strategies for equity-deserving and at-risk populations.

Ethics and dissemination

This study is approved by the University of Toronto’s Health Sciences Research Ethics Board (#42643), University of British Columbia Behavioural Research Ethics Board (#H22-01750-A002), Research Ethics Board of the Nova Scotia Health Authority (#48272), Newfoundland and Labrador Health Research Ethics Board (#2022.126), Conjoint Health Research Ethics Board, University of Calgary (REB22-0207), and University of Manitoba Health Research Board (H2022-239). The outcome of this study will be to produce a series of recommendations for implementing future vaccine distribution approaches from the perspective of various stakeholders, including equity-deserving and at-risk populations.

Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study

Por: Joeris · A. · Sprague · S. · Blauth · M. · Gosch · M. · Wattanapanom · P. · Jarayabhand · R. · Poeze · M. · Wong · M. K. · Kwek · E. B. K. · Hegeman · J. H. · Perez-Uribarri · C. · Guerado · E. · Revak · T. J. · Zohner · S. · Joseph · D. · Phillips · M. R.
Introduction

Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.

Methods

The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.

Results

GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (–$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (–$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).

Conclusions

This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.

Level of evidence

Economic, level 2.

Trial registration number

NCT02297581.

Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study

Por: Knutson · K. L. · Pershing · M. L. · Abbott · S. · Alexandria · S. J. · Chiluka · S. · Chirinos · D. · Giachello · A. · Gupta · N. · Harrington · K. · Rittner · S. S. · Sorond · F. · Wong · M. · Vu · T.-H. T. · Zee · P. C. · Carnethon · M. R.
Introduction

Cognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or Hispanic/Latinx. Poor sleep is strongly associated with the development of vascular and metabolic diseases, which correlate with cognitive dysfunction. Therefore, sleep may contribute to observed disparities in cognitive disorders. The Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO) is a longitudinal, observational cohort study that focuses on gathering data to better understand racial/ethnic sleep disparities and illuminate the relationship among sleep, race and ethnicity and changes in cognitive function. This investigation may help inform targeted interventions to minimise disparities in cognitive health among ageing adults.

Methods and analysis

The DISCO study will examine up to 495 individuals aged 55 and older at two time points over 24 months. An equal number of black, white and Hispanic/Latinx individuals will be recruited using methods aimed for adults traditionally under-represented in research. Study procedures at each time point will include cognitive tests, gait speed measurement, wrist actigraphy, a type 2 home polysomnography and a clinical examination. Participants will also complete self-identified assessments and questionnaires on cognitive ability, sleep, medication use, quality of life, sociodemographic characteristics, diet, substance use, and psychological and social health.

Ethics and dissemination

This study was approved by the Northwestern University Feinberg School of Medicine Institutional Review Board. Deidentified datasets will be shared via the BioLINCC repository following the completion of the project. Biospecimen samples from the study that are not being analysed can be made available to qualified investigators on review and approval by study investigators. Requests that do not lead to participant burden or that conflict with the primary aims of the study will be reviewed by the study investigators.

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