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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion
Objectives: The primary objective is to evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. Secondary objectives include assessment of the ability of camostat to reduce the requirement for Coronavirus disease 2019 (COVID-19) related hospital admission and to reduce the requirement for supplementary oxygen and ventilation as treatment for SARS-CoV-2 infection, to evaluate overall mortality related to COVID-19 and to evaluate the efficacy of camostat by effect on clinical improvement. Research objectives include to assess change in COVID-19 symptom severity, to evaluate the ability of camostat to reduce viral load throughout duration of illness as well as translational research on host and viral genomics, serum antibody production, COVID-19 diagnostics, and validation of laboratory testing methods and biomarkers. Trial design: SPIKE-1 is a randomised, multicentre, prospective, open label, community-based clinical trial. Eligible patients will be randomised 1:1 to the camostat treatment arm and control arm (best supportive care). The trial is designed to include a pilot phase recruiting up to 50 patients in each arm. An initial review at the end of the pilot phase will allow assessment of available data and inform the requirement for any protocol adaptations to include refinement of eligibility criteria to enrich the patient population and sample size calculations. Up to 289 additional patients will be randomised in the continuation phase of the trial. A formal interim analysis will be performed once 50% of the maximum sample size has been recruited Participants: The trial will recruit adults (≥ 18 years) who score moderate to very high risk according to COVID-age risk calculation, with typical symptoms of COVID-19 infection as per Public Health England guidance or equivalent organisations in the UK, Health Protection Scotland, Public Health Wales, Public Health Agency (Northern Ireland) and with evidence of current COVID-19 infection from a validated assay. The trial is being conducted in the UK and patients are recruited through primary care and hospital settings. Intervention and comparator: Eligible patients with be randomised to receive either camostat tablets, 200 mg four times daily (qds) for 14 days (treatment arm) or best supportive care (control arm). Main outcomes: Primary outcome measure: the rate of hospital admissions requiring supplemental oxygen. Secondary outcome measures include: the rate of COVID-19 related hospital admission in patients with SARS-CoV-2 infection; the number of supplementary oxygen-free days and ventilator-free days measured at 28 days from randomisation; the rate of mortality related to COVID-19 one year from randomisation; the time to worst point on the nine-point category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019)) or deterioration of two points or more, within 28 days from randomisation. Research outcomes include the assessment of change in COVID-19 symptom severity on days 1-14 as measured by (1) time to apyrexia (maintained for 48 hrs) by daily self-assessment of temperature, time to improvement (by two points) in peripheral oxygenation saturation defined by daily self-assessment of fingertip peripheral oxygenation saturation levels, (3) assessment of COVID-19 symptoms using the Flu-iiQ questionnaire (determined by app recording and/or daily video call (or phone) consultation and (4) assessment of functional score (where possible) at screening, day 7 and 14. The ability of camostat to reduce viral load throughout duration of illness will be assessed by (1) change in respiratory (oropharyngeal/nasopharyngeal swab RT-PCR) log10 viral load from baseline to Days 7 and 14, (2) change in respiratory (saliva RT-PCR) log10 viral load from baseline to Days 1-14 and (3) change in upper respiratory viral shedding at Day 1 -14 measured as time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs by qPCR. Additional translational research outcomes include assessment of host and viral genomics, serum antibody production and COVID-19 diagnostics at baseline and on Days 7 and 14. Randomisation: Eligible patients will be randomised using an interactive web response system (IWRS) in a 1:1 ratio to one of two arms: (1) treatment arm or (2) control arm. Blinding (masking): The trial is open-label. Numbers to be randomised (sample size): The trial is designed to include a pilot and a continuation phase. Up to 100 patients (randomised 1:1 treatment and control arm) will be recruited in the pilot phase and a maximum of 289 patients (randomised 1:1 treatment and control) will be recruited as part of the continuation phase. The total number of patients recruited will not exceed 389. Trial Status: Protocol version number v3 25 September 2020. Trial opened to recruitment on 04 August 2020. The authors anticipate recruitment to be completed by October 2021. Trial registration: EudraCT 2020-002110-41; 18 June 2020 ClinicalTrials.gov NCT04455815; 02 July 2020 Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). Unpublished PK data provided under confidentiality agreement to the trial Sponsor has been removed from the background section of the protocol to allow for publication of the trial protocol. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Prospective SARS-CoV-2 cohort study among primary health care providers during the second COVID-19 wave in Flanders, Belgium.
BACKGROUND: Primary health care providers (PHCPs) are assumed to be at high risk of a COVID-19 infection, as they are exposed to patients with usually less personal protective equipment (PPE) than other frontline health care workers (HCWs). Nevertheless, current research efforts focussed on the assessment of COVID-19 seroprevalence rates in the general population or hospital HCWs. OBJECTIVE: We aimed to determine the seroprevalence in PHCPs during the second SARS-CoV-2 wave in Flanders (Belgium) and compared it to the seroprevalence in the general population. We also assessed risk factors, availability of PPE and attitudes towards the government guidelines over time. METHODS: A prospective cohort of PHCPs (n = 698), mainly general practitioners, was asked to complete a questionnaire and self-sample capillary blood by finger-pricking at five distinct points in time (June-December 2020). We analysed the dried blood spots for IgG antibodies using a Luminex multiplex immunoassay. RESULTS: The seroprevalence of PHCPs remained stable between June and September (4.6-5.0%), increased significantly from October to December (8.1-13.4%) and was significantly higher than the seroprevalence of the general population. The majority of PHCPs were concerned about becoming infected, had adequate PPE and showed increasing confidence in government guidelines. CONCLUSIONS: The marked increase in seroprevalence during the second COVID-19 wave shows that PHCPs were more at risk during the second wave compared to the first wave in Flanders. This increase was only slightly higher in PHCPs than in the general population suggesting that the occupational health measures implemented provided sufficient protection when managing patients.
Predictors for sexual dysfunction in the first year postpartum: a systematic review and meta-analysis.
BACKGROUND: Pregnancy and childbirth increase the risk for pelvic floor dysfunction, including sexual dysfunction. So far, the mechanisms and the extent to which certain risk factors play a role, remain unclear. OBJECTIVES: In this systematic review of literature, we aimed to determine the risk factors for sexual dysfunction in the first year after childbirth. SEARCH STRATEGY: We searched MEDLINE, Embase and CENTRAL using the search strategy: Sexual dysfunction AND Obstetric events. SELECTION CRITERIA: We included original English, comparative studies that used validated questionnaires and the ICS/IUGA terminology for sexual dysfunction, dyspareunia and vaginal dryness. DATA COLLECTION AND ANALYSIS: We assessed the quality and the risk of bias of the included studies with the Newcastle Ottawa Scale. We extracted the reported data and we performed random-effects meta-analysis to obtain the summary Odds Ratios (OR) with 95% Confidence Intervals. Heterogeneity across studies was assessed using the I2 statistic. MAIN RESULTS: Anal sphincter injury was associated with increased odds for both sexual dysfunction (OR:3.00[1.28-7.03]) and dyspareunia (OR:1.92[1.47-2.52]). Episiotomy was associated with dyspareunia (OR:1.64[1.25-2.14]) but not with sexual dysfunction (OR:1.90[0.94-3.84]). Compared to spontaneous birth, caesarean section reduced the odds for dyspareunia (OR:0.68[0.54-0.86]), but not for sexual dysfunction (OR:1.14[0.89-1.46]). Instrumental vaginal birth increased the odds for sexual dysfunction (OR:1.70[1.05-2.76]), yet no difference was found for dyspareunia (OR:1.82[0.88-3.75]). One study of low quality reported on vaginal dryness and found no association with obstetric events. CONCLUSIONS: Perineal trauma, rather than the mode of birth, increases the odds for sexual dysfunction in the first year after childbirth.
Building youth and family resilience for better mental health: developing and testing a hybrid model of intervention in low- and middle-income countries
Summary Resilience is a dynamic, multi-level, multi-systemic process of positive adaptation at the individual, family and community levels. Promoting resilience can be a cost-effective form of preventive and early intervention, offering significant health advantages for young people throughout their lives. Developing resiliency interventions for youth and their families in low- and middle-income countries (LMICs), particularly in the context of the ongoing pandemic, is especially important given a lack of services and trained specialists, and poor levels of public spend on mental health, alongside marked and clustered psychosocial disadvantages and adverse childhood experiences. We propose a ‘hybrid’ model targeting 10- to 17 year-old children and their families, and options to engage through communities, schools and the family unit. These options will enhance individual and family resilience, and possibly buffer against adversity. The adaptations respect cultural and health beliefs, take account of structural drivers of inequalities and are suitable for LMICs.
The NICE Evidence Standards Framework for digital health and care technologies – Developing and maintaining an innovative evidence framework with global impact
Objective: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. Methods: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. Results: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. Conclusions: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE’s ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.
The epidemiology of alopecia areata: a population-based cohort study in UK primary care.
BACKGROUND: There is a lack of population-based information on the disease burden and management of alopecia areata. OBJECTIVE: To describe the epidemiology of alopecia areata, focusing on incidence, demographics, and patterns of healthcare utilisation. METHODS: Population-based cohort study of 4.16 million adults and children, using UK electronic primary care records from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database, 2009-2018. Incidence and point prevalence of alopecia areata was estimated. Variation in alopecia areata incidence by age, sex, deprivation, geographical distribution and ethnicity was examined. Patterns of healthcare utilisation were evaluated in people with incident alopecia areata. RESULTS: Alopecia areata incidence was 0.26 per 1,000 person-years. Alopecia areata point prevalence in 2018 was 0.58% in adults. Alopecia areata onset peaked at age 25-29 for both sexes, although the peak was broader in females. People of non-white ethnicity were more likely to present with alopecia areata, especially those of Asian ethnicity (Incidence rate ratio 3.32 [95% confidence interval 3.11-3.55]). Higher alopecia areata incidence was associated with social deprivation (IRR most vs least deprived quintile 1.47 [1.37-1.59]) and urban-living (IRR 1.23 [1.14-1.32]). People of higher social deprivation were less likely to be referred for specialist dermatology review. CONCLUSION: By providing the first large-scale estimates of the incidence and point prevalence of AA, our study helps to understand the burden of AA on the population. Understanding the variation in AA onset between different population groups may give insight into the pathogenesis of AA and its management.
Case study research for better evaluations of complex interventions: rationale and challenges
Background: The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear. Main body: Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechanisms and the necessary and sufficient conditions (contexts) for intervention implementation and effects. This is essential evidence not just for researchers concerned about internal and external validity, but also research users in policy and practice who need to know what the likely effects of complex programmes or interventions will be in their settings. The health sciences have much to learn from scholarship on case study methodology in the social sciences. However, there are multiple challenges in fully exploiting the potential learning from case study research. First are misconceptions that case study research can only provide exploratory or descriptive evidence. Second, there is little consensus about what a case study is, and considerable diversity in how empirical case studies are conducted and reported. Finally, as case study researchers typically (and appropriately) focus on thick description (that captures contextual detail), it can be challenging to identify the key messages related to intervention evaluation from case study reports. Conclusion: Whilst the diversity of published case studies in health services and public health research is rich and productive, we recommend further clarity and specific methodological guidance for those reporting case study research for evaluation audiences.
Estimating the Effect of Healthcare-Associated Infections on Excess Length of Hospital Stay Using Inverse Probability-Weighted Survival Curves
Background: Studies estimating excess length of stay (LOS) attributable to nosocomial infections have failed to address time-varying confounding, likely leading to overestimation of their impact. We present a methodology based on inverse probability-weighted survival curves to address this limitation. Methods: A case study focusing on intensive care unit-acquired bacteremia using data from 2 general intensive care units (ICUs) from 2 London teaching hospitals were used to illustrate the methodology. The area under the curve of a conventional Kaplan-Meier curve applied to the observed data was compared with that of an inverse probability-weighted Kaplan-Meier curve applied after treating bacteremia as censoring events. Weights were based on the daily probability of acquiring bacteremia. The difference between the observed average LOS and the average LOS that would be observed if all bacteremia cases could be prevented was multiplied by the number of admitted patients to obtain the total excess LOS. Results: The estimated total number of extra ICU days caused by 666 bacteremia cases was estimated at 2453 (95% confidence interval [CI], 1803-3103) days. The excess number of days was overestimated when ignoring time-varying confounding (2845 [95% CI, 2276-3415]) or when completely ignoring confounding (2838 [95% CI, 2101-3575]). Conclusions: ICU-acquired bacteremia was associated with a substantial excess LOS. Wider adoption of inverse probability-weighted survival curves or alternative techniques that address time-varying confounding could lead to better informed decision making around nosocomial infections and other time-dependent exposures.
Management of penicillin allergy in primary care: a qualitative study with patients and primary care physicians
Background: Six percent of patients are allergic to penicillin according to their medical records. While this designation protects a small number of truly allergic patients from serious reactions, those who are incorrectly labelled may be denied access to recommended first line treatment for many infections. Removal of incorrect penicillin allergy may have positive health consequences for the individual and the general population. We aimed to explore primary care physicians’ (PCPs) and patients’ views and understanding of penicillin allergy with a focus on clinical management of infections in the face of a penicillin allergy record. Methods: We conducted an interview study with 31 patients with a penicillin allergy record, and 19 PCPs in the North of England. Data were analysed thematically. Results: Patients made sense of their allergy status by considering the timing and severity of symptoms. Diagnosis of penicillin allergy was reported to be ‘imperfect’ with PCPs relying on patient reports and incomplete medical records. PCPs and patients often suspected that an allergy record was incorrect, but PCPs were reluctant to change records. PCPs had limited knowledge of allergy services. PCPs often prescribed alternative antibiotics which were easy to identify. Both patients and PCPs differed in the extent to which they were aware of the negative consequences of incorrect penicillin allergy records, their relevance and importance to their lives, and management of penicillin allergy. Conclusions: PCPs and patients appear insufficiently aware of potential harms associated with incorrect penicillin allergy records. Some of the problems experienced by PCPs could be reduced by ensuring the details of newly diagnosed reactions to antibiotics are clearly documented. In order for PCPs to overturn more incorrect penicillin records through appropriate use of allergy services, more information and training about these services will be needed.
Foreign objects in college bodies: young women’s feelings about long-acting reversible contraception (LARC)
© 2020, © 2020 Taylor & Francis Group, LLC. Long-acting reversible contraceptives (LARC) are now recommended for use among nulliparous young women to prevent unintended pregnancy. While research has explored LARC knowledge, attitudes, and use among young women in the United States, college women’s feelings about LARC have received limited attention. This article reports findings from a focus group study conducted with a convenience sample of 45 women, ages 18–25 years, enrolled in a large public university in the southeastern USA in April 2017. Focus groups combined LARC users and non-users and elicited a range of positive and negative affective responses to LARC. Some participants had an aversion to LARC because they perceived them to be unnatural, while others felt a sense of security because of their long-term effectiveness. Feelings about the location and mode of insertion for the intrauterine device (IUD) versus the implant played a significant role in the decision to use a specific LARC method: some found being able to feel the implant in their arm reassuring, while others found it disturbing and preferred the IUD. College-going LARC users also appear to be effective advocates for LARC use among their peers.
‘You just have to learn to keep moving on’: young women’s experiences with unplanned pregnancy in the Cook Islands
© 2017, © 2017 Informa UK Limited, trading as Taylor & Francis Group. The Cook Islands is one of several countries in the Pacific region that has high rates of teenage pregnancy and birth. While the social determinants of pregnancy and early motherhood are well established in the global context, little is known about how Cook Islands young women who become pregnant before age 20 make sense of their experiences. Drawing on individual interviews with a purposive sample of 10 young mothers, this paper examines the phenomenology of early pregnancy from their perspectives. Structural, cultural and individual factors emerged as salient themes in participants’ accounts. Qualitative analysis revealed that nearly all the pregnancies were unplanned and every participant reacted negatively when she learned she was pregnant. While some participants wanted to terminate their pregnancies, lack of access to safe, legal and affordable abortion care limited their options. Ultimately, while nearly all participants wished they had been able to delay motherhood, they expressed happiness and pride about their new-found status as mothers. These findings allow for a fuller understanding of factors shaping young women’s experiences of pregnancy in the Cook Islands, which have policy implications for reproductive health and rights.
Protocol for ‘virtual presence’: a qualitative study of the cultural dialectic between loneliness and technology
IntroductionMost research on loneliness comes from the health sciences, statistically seeking to measure the health-related effects of feeling alone or isolated. There is a need to expand on this understanding and explore loneliness as a more complex social phenomenon. In this article, we present a qualitative design for studying the intersection between loneliness, technology and culture. Conceptualising this as the cultural dialectic between loneliness and technology, we aim to unpack the reciprocal ways by which understandings of loneliness shape technology, while technologies also affect society’s understandings of loneliness. In elucidating this dialectic, we aim to develop new knowledge and a novel theoretical framework for understanding loneliness and its technological solutions, which, in turn, can enable better solutions to contemporary problems of loneliness.Methods and analysisWe will adopt a qualitative approach that combines interviews, participant observation and textual analysis to explore loneliness and its technological solutions from the perspectives of policy-makers, producers, professionals and users in Norway and the UK. The data will be analysed through an analytical framework combining insights from discourse theory and philosophical debates on presence, which will allow us to capture and rethink fundamental assumptions about loneliness and technology. Outcomes will be revised understandings of loneliness, relevant to researchers, entrepreneurs, policy-makers, clinicians, educators and the broader public.Ethics and disseminationThe project has been evaluated and approved by the data protection officer at Oslo Metropolitan University and by the Norwegian Social Science Data Services. Additional ethical approval for data collection in the UK has been provided by the University of Oxford Interdivisional Research Ethics Committee. Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications, international conference presentations and lay media.