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Stakeholder views on the implementation of the UK's Antimicrobial Resistance (AMR) National Action Plan (2019-2024) in relation to AMR in the environment.
Get PDFBACKGROUND: Antimicrobial resistance (AMR) in the environment is an important component of One Health AMR research and is increasingly incorporated into AMR National Action Plans (NAPs), including the UK's AMR NAP 'Tackling antimicrobial resistance 2019-2024'. However, implementation of the environmental commitments has yet to be evaluated. OBJECTIVE: In this study, we aimed to understand UK stakeholder perspectives on the delivery and implementation of the environmental components of the UK's AMR NAP 2019-2024, with a particular focus on wastewater, which could be used to inform the 2024-2029 NAP. METHODS: We undertook semi-structured, qualitative interviews with informed UK stakeholders to discuss how the NAP had been implemented and future directions relevant to environmental AMR. RESULTS: Two main themes emerged from the interviews: 1) the perception of 'risk', and 2) barriers that have hampered policy action. Some wanted more evidence to inform policy and mitigations, particularly concerning the relative risk posed by different pollution sources in driving and maintaining AMR in the environment, and the risk posed by transmission of AMR from the environment to humans. Where evidence was lacking, several academics and regulators proposed that policy action could be justified based on the precautionary principle. CONCLUSIONS: Although we do not know the impact environmental exposure plays in driving clinical AMR infections relative to other sources, evidence suggests that exposure to environmental and wastewater sources may play a role, and thus requires policy interventions. Government leadership is critical for ensuring the uptake of environmental AMR research to inform mitigation and interventions based on the precautionary principle
Team-based motivational engagement intervention in young people with first-episode psychosis: the EYE-2 cluster RCT with economic and process evaluation.
Get PDFBACKGROUND: Early Intervention in Psychosis services improves outcomes for young people with psychosis, but 25% disengage in the first 12 months with costs to their mental health. OBJECTIVES: To refine a toolkit and training and evaluate effectiveness, implementation, and cost-effectiveness of the Early Youth Engagement-2 intervention to reduce disengagement. DESIGN: Cluster randomised controlled trial with economic and process evaluation. RANDOMISATION: Randomisation at team level stratified by site. MASKING: Research assistants, outcome assessors and statisticians were masked to treatment allocation for the primary disengagement and cost-effectiveness outcomes. Participants and teams administering the interventions were unmasked. SETTING: Twenty Early Intervention in Psychosis teams in five sites across England. PARTICIPANTS: A total of 1027 young people (14-35 years) with first-episode psychosis (F20-29, 31; ICD-10); 20-282 Early Intervention in Psychosis staff. INTERVENTION: Team-based motivational engagement (Early Youth Engagement-2) intervention, delivered by Early Intervention in Psychosis clinicians alongside standardised Early Intervention in Psychosis, supported by the implementation toolkit (training, website and booklet series). COMPARISON: Standardised Early Intervention in Psychosis, including National Institute for Health and Care Excellence guidelines approved interventions. MAIN OUTCOME MEASURES: Primary outcome - time to disengagement over 26 months (days from date of allocation to care co-ordinator to date of last contact following refusal to engage with service, or lack of response to contact for consecutive 3-month period). Secondary outcomes - mental health, recovery, quality of life, service use, at 6 and 12 months. Economic outcomes - National Health Service mental healthcare costs, wider societal care costs, clinical and social outcomes over 12 months; cost-effectiveness. Process evaluation outcomes - fidelity to the Early Youth Engagement-2 model, implementation process scores, therapeutic alliance, qualitative outcomes. RESULTS: Disengagement was 16% across both arms. The multivariable Cox regression on 1005 participants estimated an adjusted hazard ratio for Early Youth Engagement-2 + standardised Early Intervention in Psychosis (n = 652) versus standardised Early Intervention in Psychosis service alone (n = 375) of 1.07 (95% confidence interval 0.76 to 1.49; p = 0.713). There were no observed differences between arms for any secondary outcomes. The health economic evaluation indicated lower mean mental healthcare costs of -£788 (95% CI -£3571 to £1994) and marginally improved mental health states for intervention participants. Early Youth Engagement-2 participants spent 30 more days per year in education and training (95% CI 1.52 to 53.68; probability positive outcome for the intervention: 99%), but these outcomes must be viewed very cautiously as only 22% of the sample provided data. The process evaluation revealed heterogeneous implementation fidelity and constant pressure to adapt to widespread disruption from COVID-19. There was no effect on therapeutic alliance: the most likely active change mechanism was through psychoeducation. LIMITATIONS: Lower than expected disengagement, high loss to follow-up and impact of COVID-19 on fidelity, implementation and outcomes. CONCLUSIONS: In the primary clinical effectiveness analysis, 95% confidence limits ruled out a reduction of more than 24% in the risk of disengagement with the Early Youth Engagement-2 intervention. In a cost-effectiveness analysis, estimates fell in the direction of dominance of the Early Youth Engagement-2 intervention (reduced costs, marginally better mental health states). FUTURE WORK: Dissemination of the booklet and website resources and an adapted version of the model as stand-alone tools for use in good-practice routine Early Intervention in Psychosis care. STUDY REGISTRATION: This study is registered as ISRCTN 51629746. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/31/87) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 33. See the NIHR Funding and Awards website for further award information
Attentes méthodologiques pour la démonstration de l’efficacité des produits de santé par les études observationnelles
Get PDFLa problématique de l’évaluation de l’efficacité des technologies de santé (médicaments, dispositifs, etc.) par les études observationnelles prend de plus en plus d’importance depuis que les agences d’enregistrement et d’accès au marché envisagent de les considérer dans leur processus d’évaluation. Dans ce contexte, les études observationnelles doivent être capables d’apporter de réelles démonstrations, d’un niveau de fiabilité comparable à celles produites par l’approche classique basée sur l’essai randomisé et contrôlé (RCT). L’objectif de la table ronde a été d’établir les critères d’acceptabilité pour qu’une étude observationnelle (« non-randomized, non-interventional study ») puisse prétendre apporter ces démonstrations, et éventuellement servir d’étude confirmatoire pour les autorités d’enregistrement et d’accès au marché, la construction des stratégies thérapeutiques ou l’élaboration des recommandations. Pour cela, l’étude doit être une véritable étude de confirmation respectant la démarche hypothético-déductive et garantissant l’absence de HARKing et de p-hacking en attestant de l’élaboration d’un protocole et d’un plan d’analyse statistique, enregistrés avant toute analyse inférentielle. Elle doit aussi s’inscrire dans une démarche formalisée d’inférence causale et montrer qu’elle permet d’identifier correctement l’estimand causal recherché. L’étude doit garantir l’absence de biais de confusion résiduelle à l’aide d’une prise en compte de tous les facteurs de confusion affectant la comparaison, ceux-ci devant être déterminés par une approche formelle (de type graphique de causalité, DAGs). Les diagnostics de biais de confusion résiduel par analyse de falsification et de nullification doivent montrer leur absence. L’étude doit être à faible risque de biais, en particulier de biais de sélection, entre autres en utilisant un design d’émulation d’essai cible. Le risque alpha global doit être strictement contrôlé. L’absence de publication sélective de résultat et de biais de sélection doit être garantie
Moral panic in medical education: analysing responses to a global regulatory policy
Get PDFBackground: The World Federation for Medical Education (WFME) is a global non-statutory, not-for-profit, non-governmental organisation that announced a recognition programme for regulatory agencies in 2010, responding to an accreditation policy by the Educational Commission for Foreign Medical Graduates (ECFMG) in the US. While WFME's role has expanded globally, no studies have examined stakeholder perceptions of this recognition programme in Global South contexts.
Objective: To examine social media discourse about WFME to understand how it is perceived by medical education stakeholders, with particular focus on responses to the recognition programme.
Methods: A systematic search of Twitter posts referencing WFME over a 360-day period (August 2021-August 2022) was conducted using Twitter API. Posts were analysed thematically using Cohen's Moral Panic framework and contextualised with newspaper articles and webinar content. Moral Foundations Theory was applied to understand underlying psychological drivers of responses.
Results: 294 tweets were analysed, with 94% (276) relating to Pakistan’s medical regulatory agencies seeking WFME recognition. Analysis revealed that responses aligned with Cohen's five stages of moral panic: identification (20%), amplification (30%), anxiety (27%), gatekeeping (13%), and submergence (10%). The Pakistan Medical Commission was positioned as a “folk devil,” with discourse reflecting multiple moral foundations including care/harm, fairness/cheating, and authority/subversion.
Conclusions: This case study demonstrates how global recognition policies can generate moral panic in the Global South, particularly in the context of unstable governance. The findings highlight unintended consequences of the WFME recognition programme in Pakistan and suggest the need for more nuanced understanding of how policies originating in the Global North impact medical education communities worldwide
Serological survey to determine measles and rubella immunity gaps across age and geographic locations in The Gambia: a study protocol.
Get PDFVaccine coverage and disease surveillance data are valuable for monitoring protection against vaccine-preventable diseases; however, they do not directly measure population immunity. High-quality, representative serological studies can provide key insights into immunity gaps, outbreak susceptibility, and inform targeted vaccination strategies, even in high-performing immunization programs. This study aims to estimate location-specific and age-specific immunity profiles for measles and rubella while evaluating the predictive value of indirect immunity estimates derived from vaccination and surveillance data against direct serological measurements. Additionally, it seeks to model the risk of measles outbreaks and assess the impact of mitigation strategies. A multi-stage, stratified cluster sampling design will be implemented across six districts in The Gambia's North Bank and Upper River Regions. Survey clusters (i.e. 5 km × 5 km areas) encompassing all settlements within their boundaries will be selected, proportionally to district population sizes. Cluster selection ensures representativeness of both the population and vaccine coverage within each district. Based on detecting a 10% difference in protective immunity across vaccine coverage levels, power analysis assumes an intraclass correlation coefficient (ICC) of 0.01. In each cluster, 70 children aged 9 months to 14 years will be recruited, yielding a total sample size of 1,750 children across 25 selected clusters. Dried blood samples will be collected and tested for anti-measles and anti-rubella IgG using enzyme immunoassays (EIA). District-specific measles seroprevalence will be estimated using a hierarchical spatial model. This study will generate key evidence needed to refine immunization strategies and reduce the risk of measles and rubella outbreaks
Exercise-based Cardiac Rehabilitation for Coronary Heart disease - the CaReMATCH individual participant data meta-analysis.
Get PDFAims: The effectiveness of exercise-based cardiac rehabilitation (ExCR) for coronary heart disease (CHD) has been debated during the past decade. The objectives of the Cardiac Rehabilitation Meta-Analysis of Trials in people with CHD using individual participant data (IPD) (CaReMATCH) study were to: (1) provide contemporary estimates on the effectiveness of ExCR for CHD; and (2) examine potential differential effects of ExCR across subgroups. Methods: Individual participant data from randomized controlled trials comparing ExCR to no ExCR controls were pooled. To reflect contemporary ExCR practice, trials had to be published since 2010. The outcomes of all-cause and cardiovascular (CVD)-related mortality and hospitalization, and health-related quality of life (HRQoL) were analysed. Results: From 30 eligible trials (10,677 participants), IPD were obtained from 8 trials (4,975 participants, 93.5% post-myocardial infarction). Compared to controls, participation in ExCR resulted in a lower risk for all cause (hazard ratio [HR] 0.68, 95% confidence interval [CI]: 0.53, 0.87) and CVD-related hospitalization (HR 0.62, 95% CI: 0.47, 0.83), and higher HRQoL up to 12 months follow-up (mean difference in utility index: 0.032, 95% CI: 0.003, 0.061). No differences were found in all-cause and CVD mortality (HR 0.99, 95% CI: 0.74, 1.32; HR 0.80, 95% CI: 0.32, 2.04, respectively). Subgroup analyses showed stronger improvements of HRQoL with ExCR in people with lower HRQoL and lower education level, and larger reductions in hospitalization risk in those with a lower left ventricular ejection fraction, lower baseline exercise capacity, beta-blockers use, and with a previous history of cardiovascular disease. No other subgroup effects were observed. Conclusion: Our IPD meta-analysis, reflecting trials published since 2010, highlighted that contemporary ExCR is effective in reducing risk of hospitalization and improving HRQoL in those with CHD. Importantly, we reveal treatment benefits to be robust and consistent across most participant subgroups. Together, these data support the class I recommendation of international clinical guidelines that ExCR should be offered to all people with CHD
Infection prevention and control risk factors for SARS-CoV-2 infection in health workers: a global, multi-centre, case-control study.
Get PDFBACKGROUND: Health workers were at higher risk for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during the coronavirus disease 2019 (COVID-19) pandemic due to occupational risk factors. This study aimed to characterize these risk factors as part of the World Health Organization (WHO) Unity Studies initiative.
METHODS: This global, multi-centre, nested, case-control study was conducted in 121 healthcare facilities in 21 countries. Cases were health workers who tested positive for SARS-CoV-2 infection with documented occupational exposure to COVID-19 patients in the 14 days pre-enrolment. Controls were enrolled from the same facilities with similar exposure but negative serology. Case and control status was confirmed with serological testing at baseline and after 3-4 weeks. Demographic and infection risk factor data were collected using structured questionnaires.
FINDINGS: Between June 2020 and December 2021, data were obtained for 1213 cases and 1844 controls. Risk of SARS-CoV-2 infection was associated with non-adherence to personal protective equipment (PPE) guidelines [adjusted odds ratio (aOR) 1.67, 95% confidence interval (CI) 1.32-2.12] and not performing hand hygiene consistently after patient contact (aOR 2.52, 95% CI 1.72-3.68). Direct close contact with COVID-19 patients was also associated with increased risk of SARS-CoV-2 infection, particularly during prolonged contact (>15 min). Items associated with lower risk of SARS-CoV-2 infection were use of a respirator during aerosol-generating procedures; and use of gloves, and a gown or coverall during contact with contaminated materials/surfaces. No difference was observed between health workers using respirators vs surgical masks for routine care.
CONCLUSION: Appropriate implementation of infection prevention and control measures and use of PPE remain a priority to protect health workers from SARS-CoV-2 infection
Abnormal T-Cell activation and cytotoxic T-Cell frequency discriminate symptom severity in myalgic encephalomyelitis/chronic fatigue syndrome.
No full textBACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating but poorly-understood disease. ME/CFS symptoms include immune system effects alongside incapacitating fatigue and post-exertional disease exacerbation. Symptom severity can range from mild to severe and whilst symptoms can fluctuate, few people fully recover. METHODS: Immunological profiles of people living with ME/CFS were analysed by flow cytometry, focusing on cytotoxic cells, to determine whether people with mild/moderate (n = 43) or severe ME/CFS (n = 53) expressed different immunological markers. Flow cytometry data were tested for normality and the two clinical groups were compared by t-test or Mann-Whitney U-test as appropriate. RESULTS: People with mild/moderate ME/CFS had increased expression of cytotoxic effector molecules alongside enhanced proportions of early-immunosenescence cells, determined by the CD28-CD57- phenotype, indicative of persistent viral infection. In contrast, people with severe ME/CFS had higher proportions of activated circulating lymphocytes, determined by CD69+ and CD38+ expression, and expressed more pro-inflammatory cytokines, including interferon-γ, tumour necrosis factor and interleukin-17, following stimulation in vitro, indicative of prolonged non-specific inflammation. These changes were consistent across different cell types including CD8+ T cells, mucosal associated invariant T cells and Natural Killer cells, indicating generalised altered cytotoxic responses across the innate and adaptive immune system. CONCLUSIONS: These immunological differences likely reflect different disease pathogenesis mechanisms occurring in the two clinical groups, opening up opportunities for the development of prognostic markers and stratified treatments
Spatiotemporal effects on dengue incidence based on a large cluster randomized study
Get PDFA recent large-scale cluster randomized test-negative study assessed the impact of a mosquito-based intervention on the incidence of clinical dengue showing a protective efficacy of 77.1% (95% CI: (65.3%, 84.9%)). While the intervention was randomized at a cluster-level, human and mosquito movement suggest potential violations in assumptions necessary for intention-to-treat analyses to produce accurate estimates of the full intervention effect due to spatial clustering of dengue cases, and/or potential non-independence in the intervention arising from spillover of the intervention (or control) across cluster boundaries. We address these distinct but related effects using two approaches. First, we examine whether a clustering effect exists, that is, whether the presence of a recent dengue case in the sample within a specified distance from a residence raises the risk of dengue. Second, we use cluster reallocation techniques to examine intervention spillover effects. We find strong spatial effects of the presence of dengue cases on the risk of clinical dengue that exhibit both serospecificity and a dose response, more evident in control than intervention clusters at least on an additive scale. Contrarily, there is no evidence of any appreciable local spillover effect from intervention to control clusters, or vice versa, in terms of either the risk of dengue infection or the level of disease clustering
Efforts to increase uptake of cervical cancer screening in the absence of a national programme in Ghana: a qualitative study of stakeholders' experience.
Get PDFBACKGROUND: Cervical cancer is the fourth most frequently diagnosed cancer in women globally. Ghana, West of Sub-Saharan Africa (SSA), is reported to have a high crude cervical cancer incidence of 18.3 per 100,000 women. Cervical cancer screening (CCS) uptake in Ghana has been reported to be between 0.8% and 12%. Ghana, like many developing countries worldwide, are yet to experience the benefits of organised screening. This study sought to understand the direct and indirect actions of key stakeholders in Ghana that contributed to the promotion of CCS in a country without a population-based screening programme. METHODOLOGY: Primary qualitative data was obtained from 16 stakeholders using in-depth interviews via ZOOM virtual platform. Stakeholders were those involved in the delivery of CCS activities and were identified through purposive and snowball sampling. Transcripts were manually created from verbatim accounts of interviews. Data was managed in NVivo software and analysed using an inductive approach to qualitative data evaluation. Emerging themes were drawn out by thematic analysis. RESULTS: Key findings identified were intra-health facility-based factors that promoted CCS including cost control measures, screening methods, opportunistic CCS, promotion linked activities and innovative health practices. Additionally, sponsored mass CCS, staff training, policy advocacy and proactive health promotion and education were extra-health facility-based factors that stakeholders felt led to CCS uptake at the facility and community levels. Stakeholders played an active role in promoting CCS using health education through health promotional measures such as mass media advertisements, electronic fliers, creating social media content especially during the Cervical Cancer Awareness Month (CCAM) in January. CCS costs were often reduced during in January because of negotiations with non-governmental organisations and corporate bodies, ultimately resulting in sponsored mass cervical cancer screening which improved cervical cancer screening uptake. CONCLUSION: In the absence of a national cervical cancer screening programme, the study found out that it is the contributions of committed stakeholders that may be ensuring the continued existence of CCS services in Ghana. The goodwill that is shown by society during the CCAM in January should be harnessed to broaden the scope and reach of cervical screening activities beyond January