“Just as curry is needed to eat rice, antibiotics are needed to cure fever”–a qualitative study of individual, community and health system-level influences on community antibiotic practices in rural West Bengal, India

Objectives
To understand community antibiotic practices and their drivers, comprehensively and in contextually sensitive ways, we explored the individual, community and health system-level factors influencing community antibiotic practices in rural West Bengal in India.

Design
Qualitative study using focus group discussions and in-depth interviews.

Setting
Two contrasting village clusters in South 24 Parganas district, West Bengal, India. Fieldwork was conducted between November 2019 and January 2020.

Participants
98 adult community members (42 men and 56 women) were selected purposively for 8 focus group discussions. In-depth interviews were conducted with 16 community key informants (7 teachers, 4 elected village representatives, 2 doctors and 3 social workers) and 14 community health workers.

Results
Significant themes at the individual level included sociodemographics (age, gender, education), cognitive factors (knowledge and perceptions of modern antibiotics within non-biomedical belief systems), affective influences (emotive interpretations of appropriate medicine consumption) and economic constraints (affordability of antibiotic courses and overall costs of care). Antibiotics were viewed as essential fever remedies, akin to antipyretics, with decisions to halt mid-course influenced by non-biomedical beliefs associating prolonged use with toxicity. Themes at the community and health system levels included the health stewardship roles of village leaders and knowledge brokering by informal providers, pharmacists and public sector accredited social health activists. However, these community resources lacked sufficient knowledge to address people’s doubts and concerns. Qualified doctors were physically and socially inaccessible, creating a barrier to seeking their expertise.

Conclusions
The interplay of sociodemographic, cognitive and affective factors, and economic constraints at the individual level, underscores the complexity of antibiotic usage. Additionally, community leaders and health workers emerge as crucial players, yet their knowledge gaps and lack of empowerment pose challenges in addressing public concerns. This comprehensive analysis highlights the need for targeted interventions that address both individual beliefs and community health dynamics to promote judicious antibiotic use.

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Prevalence of depression, stress and suicide tendency among individuals with long COVID and determinants: a protocol of a systematic review and meta-analysis

Background
It is well known that the COVID-19 pandemic has had a devastating impact on mental health, especially among individuals with long COVID. This systematic review and meta-analysis aims to investigate the prevalence of depression, stress and suicide tendencies among individuals with long COVID, as well as to explore the factors that contribute to these conditions.

Methods and analysis
A comprehensive review of literature will be conducted in various databases of including PubMed, including Medline, Embase, PsycINFO, CINAHL and Cochrane Library. The studies to be included in this review will be published in the English language, and the time frame of included studies will be from the date of inception of COVID-19 until 30 December 2023. Two independent reviewers will identify studies for inclusion based on a screening questionnaire, and the JBI standardised critical appraisal checklist for studies reporting prevalence data will be used to assess the methodological quality. The strength of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. To analyse the data, a robust Bayesian approach will be applied using the STATA software package (V.14; STATA) and JASP software. The findings of this systematic review and meta-analysis will provide valuable insights into the prevalence of depression, stress and suicide tendencies among individuals with long COVID, as well as the factors that contribute to these conditions.

Ethics and dissemination
There is no research ethics board approval required. The dissemination plan is to publish results in a peer-reviewed academic journal.

PROSPERO registration number
CRD42022346858.

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Assessing the heterogeneity of the impact of COVID-19 incidence on all-cause excess mortality among healthcare districts in Lombardy, Italy, to evaluate the local response to the pandemic: an ecological study

Objectives
The fragmentation of the response to the COVID-19 pandemic at national, regional and local levels is a possible source of variability in the impact of the pandemic on society. This study aims to assess how much of this variability affected the burden of COVID-19, measured in terms of all-cause 2020 excess mortality.

Design
Ecological retrospective study.

Setting
Lombardy region of Italy, 2015–2020.

Outcome measures
We evaluated the relationship between the intensity of the epidemics and excess mortality, assessing the heterogeneity of this relationship across the 91 districts after adjusting for relevant confounders.

Results
The epidemic intensity was quantified as the COVID-19 hospitalisations per 1000 inhabitants. Five confounders were identified through a directed acyclic graph: age distribution, population density, pro-capita gross domestic product, restriction policy and population mobility.
Analyses were based on a negative binomial regression model with district-specific random effects. We found a strong, positive association between COVID-19 hospitalisations and 2020 excess mortality (p

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Adaptive coping strategies among individuals living with long-term chikungunya disease: a qualitative study in Curacao

Objective
Long-term chikungunya disease is characterised by persistent rheumatic symptoms following chikungunya virus infection. As there is no specific treatment available, affected individuals need strategies to adapt. However, research on these is scarce. This study aimed to explore which adaptive coping strategies are employed to manage persistent rheumatic symptoms in daily life.

Setting
The study was conducted in Curacao.

Design and participants
An explorative qualitative study was conducted between September and October 2020, among a purposive sample of adults, 19 women and 4 men affected by long-term chikungunya disease. In-depth interviews were semi-structured and transcribed verbatim. The data were analysed using inductive thematic analysis.

Results
The disease duration for all participants ranged between 68 and 74 months (6 years). In narrating their experiences of coping with long-term chikungunya disease, four themes were identified: (1) learning to live with the disease; (2) resilience for dealing with pain; (3) maintaining positive self-image and attitude; and (4) coping through spirituality.

Conclusion
To live with long-term chikungunya disease with dignity in spite of physical pain and discomfort, participants tried to retain a sense of control of oneself and one’s lives, to not let the disease take over, focusing on the positive in their lives, and finding strength and remain hopeful. Interventions such as cognitive–behavioural therapy and mindfulness exercises may be effective in strengthening or regain affected individual’s sense of competence and control by fostering adaptive coping skills and resilience. Subsequently, these interventions may improve health-related quality of life when rheumatic symptoms persist following chikungunya virus infection.

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Developing interfaith interventions to address hesitancy towards COVID-19 vaccination: protocol for a focus group-based, exploratory qualitative study

Introduction
The COVID-19 pandemic demonstrated how vaccine hesitancy impacts are translated nationally and internationally. A predictor of vaccine hesitancy is religious beliefs (eg, the body being sacred and should be healed by God). Additionally, the perceived content of vaccines can conflict with religious dietary restrictions. Despite the main faith organisations in the UK endorsing COVID-19 vaccination, vaccine hesitancy remains a challenge. Most faith-based research and interventions have been investigated in individual faiths, in isolation from others. Therefore, the aim of our research is to inform the development of interfaith interventions to address COVID-19 vaccine hesitancy, following the identification of potential facilitators and barriers and codesign of interfaith intervention(s).

Methods and analysis
We will facilitate six face-to-face focus groups in London, each comprising eight participants. There will also be the option of joining an online focus group. A semistructured topic guide will include questions on experiences around interfaith, vaccine hesitancy, facilitators and barriers, and potential interfaith interventions to increase vaccine acceptance. Focus group participants will be invited to join a subsequent interfaith codesign workshop where the researchers will share the tentative findings and facilitate discussion to develop one or more interventions. Purposive sampling will be used to recruit 48 participants from different faith groups, ethnicities and backgrounds to capture diversity in the sample. Reflexive thematic analysis will guide a systematic process of constant comparison, coding data into categories and refining into overarching themes.

Ethics and dissemination
The University College London (UCL) Research Ethics Committee granted ethics approval (Project ID 4359.006) on 3 May 2022. Minor amendments to the study were approved on 15 May 2023 to accommodate participants’ requests for online or face-to-face focus groups at a UCL venue. Informed consent is required from all participants. The findings will be disseminated in journals and to the public and key stakeholders.

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Neurological Improvement by One-Thirds Is Associated With Early Recanalization in Stroke With Large Vessel Occlusion

Stroke, Ahead of Print. BACKGROUND:A proportion of large vessel occlusion strokes demonstrate early recanalization, obviating the initial intention to proceed to endovascular thrombectomy. Neurological improvement is a possible surrogate marker for reperfusion. We aimed to determine the optimal threshold of neurological improvement, as defined by the National Institutes of Health Stroke Scale (NIHSS), which best associates with early recanalization.METHODS:We retrospectively analyzed consecutive patients with large vessel occlusion transferred from primary stroke centers to a tertiary comprehensive stroke center in Melbourne, Australia, for possible endovascular thrombectomy from January 2018 to December 2022. Absolute and percentage changes in NIHSS between transfer, as well as other definitions of neurological improvement, were compared using receiver operating characteristic curve analysis for association with recanalization as defined by the absence of occlusion in the internal carotid artery, middle cerebral artery (M1 or M2 segments), or basilar artery on repeat vascular imaging.RESULTS:Six hundred and fifty-four transferred patients with large vessel occlusion were included in the analysis: mean age was 68.8±14.0 years, 301 (46.0%) were women, and 338 (52%) received intravenous thrombolytics. The proportion of extracranial internal carotid artery, intracranial internal carotid artery, M1, proximal M2, and basilar artery occlusion was 18.8%, 13.6%, 48.3%, 15.0%, and 4.3%, respectively, on initial computed tomography angiogram. Median NIHSSprimary stroke centerand NIHSScomprehensive stroke centerscores were 15 (interquartile range, 9–18) and 13 (interquartile range, 8–19), respectively. Early recanalization occurred in 82 (13%) patients. NIHSS reduction of ≥33% was the best tradeoff between sensitivity (64%) and specificity (83%) for identifying recanalization. NIHSS reduction of ≥33% had the highest discriminative ability to predict recanalization (area under the curve, 0.735) in comparison with other definitions of neurological improvement.CONCLUSIONS:One-third neurological improvement between the primary hospital and tertiary center was the best predictor of early recanalization.

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Forecasting disease trajectories in critical illness: comparison of probabilistic dynamic systems to static models to predict patient status in the intensive care unit

Objective
Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

Design
We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

Setting and participants
We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

Results
5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

Conclusion
We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

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Analysis and clinical determinants of post-COVID-19 syndrome in the Lombardy region: evidence from a longitudinal cohort study

Objective
To define macro symptoms of long COVID and to identify predictive factors, with the aim of preventing the development of the long COVID syndrome.

Design
A single-centre longitudinal prospective cohort study conducted from May 2020 to October 2022.

Setting
The study was conducted at Luigi Sacco University Hospital in Milan (Italy). In May 2020, we activated the ARCOVID (Ambulatorio Rivalutazione COVID) outpatient service for the follow-up of long COVID.

Participants
Hospitalised and non-hospitalised patients previously affected by COVID-19 were either referred by specialists or general practitioners or self-referred.

Intervention
During the first visit, a set of questions investigated the presence and the duration of 11 symptoms (palpitations, amnesia, headache, anxiety/panic, insomnia, loss of smell, loss of taste, dyspnoea, asthenia, myalgia and telogen effluvium). The follow-up has continued until the present time, by sending email questionnaires every 3 months to monitor symptoms and health-related quality of life.

Primary and secondary outcome measures
Measurement of synthetic scores (aggregation of symptoms based on occurrence and duration) that may reveal the presence of long COVID in different clinical macro symptoms. To this end, a mixed supervised and empirical strategy was adopted. Moreover, we aimed to identify predictive factors for post-COVID-19 macro symptoms.

Results
In the first and second waves of COVID-19, 575 and 793 patients (respectively) were enrolled. Three different post-COVID-19 macro symptoms (neurological, sensorial and physical) were identified. We found significant associations between post-COVID-19 symptoms and (1) the patients’ comorbidities, and (2) the medications used during the COVID-19 acute phase. ACE inhibitors (OR=2.039, 95% CI: 1.095 to 3.892), inhaled steroids (OR=4.08, 95% CI: 1.17 to 19.19) and COVID therapies were associated with increased incidence of the neurological macro symptoms. Age (OR=1.02, 95% CI: 1.01 to 1.04), COVID-19 severity (OR=0.42, 95% CI: 0.21 to 0.82), number of comorbidities (OR=1.22, 95% CI: 1.01 to 1.5), metabolic (OR=2.52, 95% CI: 1.25 to 5.27), pulmonary (OR=1.87, 95% CI: 1.10 to 3.32) and autoimmune diseases (OR=4.57, 95% CI: 1.57 to 19.41) increased the risk of the physical macro symptoms.

Conclusions
Being male was the unique protective factor in both waves. Other factors reflected different medical behaviours and the impact of comorbidities. Evidence of the effect of therapies adds valuable information that may drive future medical choices.

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Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Introduction
The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis
A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination
The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number
NCT05683795.

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Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Introduction
Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis
StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination
The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number
ISRCTN88667898.

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Missed opportunities in hospital quality measurement during the COVID-19 pandemic: a retrospective investigation of US hospitals CMS Star Ratings and 30-day mortality during the early pandemic

Objectives
In the USA and UK, pandemic-era outcome data have been excluded from hospital rankings and pay-for-performance programmes. We assessed the relationship between US hospitals’ pre-pandemic Centers for Medicare and Medicaid Services (CMS) Overall Hospital Star ratings and early pandemic 30-day mortality among both patients with COVID and non-COVID to understand whether pre-existing structures, processes and outcomes related to quality enabled greater pandemic resiliency.

Design and data source
A retrospective, claim-based data study using the 100% Inpatient Standard Analytic File and Medicare Beneficiary Summary File including all US Medicare Fee-for-Service inpatient encounters from 1 April 2020 to 30 November 2020 linked with the CMS Hospital Star Ratings using six-digit CMS provider IDs.

Outcome measure
The outcome was risk-adjusted 30-day mortality. We used multivariate logistic regression adjusting for age, sex, Elixhauser mortality index, US Census Region, month, hospital-specific January 2020 CMS Star rating (1–5 stars), COVID diagnosis (U07.1) and COVID diagnosisxCMS Star Rating interaction.

Results
We included 4 473 390 Medicare encounters from 2533 hospitals, with 92 896 (28.2%) mortalities among COVID-19 encounters and 387 029 (9.3%) mortalities among non-COVID encounters. There was significantly greater odds of mortality as CMS Star Ratings decreased, with 18% (95% CI 15% to 22%; p

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