Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.
MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.
This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.
Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.
The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.
Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of
The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal
The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.
Development and prospective application of an early warning system for dengue epidemics using routine historical surveillance data. A weekly intercept-only negative binomial regression model was fitted using historical probable and confirmed dengue data. A range of threshold definitions was explored using three model-estimated percentiles of weekly dengue case counts.
Dengue is endemic in Puerto Rico with irregular occurrence of large epidemics with substantial impact on health burden and health systems. Probable and confirmed dengue data are routinely collected from all hospitals and private clinics.
A total of 86 282 confirmed or probable dengue virus cases were reported from 1 January 1986 to 30 June 2024, with an annual mean of 2212 cases (median: 1533; range: 40–10 356).
The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.
The 75th percentile threshold aligned best with historical epidemic classifications, balancing false alarms and missed detections. This model provides a robust method for defining thresholds, accounting for skewed data, using all historical data and improving on traditional methods like endemic channels.
In March 2024, PRDH declared a public health emergency due to an early, out-of-season surge in cases that exceeded the epidemic alert threshold developed in this study. This real-time application highlights the value of these thresholds to support dengue epidemic detection and public health response. Integrating thresholds with other tools and strategies can enhance epidemic preparedness and management.
Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.
VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.
Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.
There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.
This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.
This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.
Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.
A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.
Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.
Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.
A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p
This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.
In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children
Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.
This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.
Malawi’s prisons are overcrowded, contributing to tuberculosis (TB) and Human Immunodeficiency Virus (HIV) transmission and service delivery gaps for both conditions. We applied an empirically supported three-stage model of HIV/TB care to guide the improvement of TB/HIV service delivery in select Malawian prisons.
We conducted a pilot implementation research study using multimethods from May 2022 to April 2023.
Two semi-urban prisons in Malawi.
We purposively sampled participants detained at the study sites during the study period.
We collected data on sociodemographics, medical history and screening results for sexually transmitted infections (STIs), HIV and TB results. We conducted in-depth interviews with prison professional staff and used content analysis to explore the feasibility of implementing the three-stage model of HIV and TB care in Malawian prisons.
Mean participant age was 35 years (SD 12.2 years). We screened 100 out of 647 (15%) incarcerated people for TB/HIV according to the three-stage model and identified the following: five cases of TB disease; two cases of HIV-associated TB; seven persons living with HIV; eight persons diagnosed and treated for STIs, including genital ulcer disease and syphilis. For those tested for HIV at entry, midpoint and exit screening, there was no documented case of seroconversion during the incarceration period. There was evidence of potential STI transmission during incarceration, as suggested by a 4% rate of new urethral discharge among participants. Qualitative data suggest that it is feasible to implement the three-stage model of HIV/TB in the Malawi prison setting.
We found evidence of HIV, TB and STIs among incarcerated people in two semi-urban prisons in Malawi, with low HIV status awareness on prison entry. It is feasible to implement the three-stage model of HIV/TB in prison settings, although with material support to overcome implementation challenges. Coordination with Ministry of Health officials could facilitate model feasibility and sustainability in Malawi’s prisons.
Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).
We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.
The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).
In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.
Former COVID-19 patients and controls participated in this cohort study.
Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p
Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.
The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).
Canadian guidelines recommend HIV testing for individuals being evaluated for syphilis. Our objective was to examine three aspects of HIV testing (ie, if an HIV test occurred, the timing of the HIV test in relation to the syphilis test and the proportion with a positive HIV test result) among syphilis tests between 2017 and 2022 from individuals with no evidence of a previous HIV diagnosis.
This study is a retrospective analysis of comprehensive laboratory testing data from Ontario’s provincial public health laboratory.
Direct fluorescent antibody (DFA) and serological non-prenatal syphilis tests were conducted from 1 January 2017 to 31 December 2022, from individuals aged ≥15 years with no evidence of a previous HIV diagnosis (n=3 001 058 total tests). Positive syphilis tests were categorised using the rapid plasma reagin (RPR) titre as ‘current’ (DFA+/RPR≥1:8) or ‘historical’ (RPR
The number and proportion of syphilis tests with a corresponding HIV test on the same day or within 7, 28, 90 or 180 days, and, among those with an HIV test within 28 days, the number and proportion with an HIV-positive test result.
From 2017 to 2022, 1 516 726 and 1 484 332 syphilis tests among males and females, respectively, were included in the analysis. Individuals with a positive syphilis result were less likely to be tested for HIV within 28 days of their syphilis test compared with those with a negative syphilis test result (74.7% vs 91.1% in males, 97.5% CI (–0.17 to –0.16); 65.2% vs 92.4% in females, 97.5% CI (–0.28 to –0.26)). Males with ‘current’ positive syphilis test results were less likely than males with ‘historical’ positive syphilis results to be tested for HIV within 28 days (69.1% vs 76.6%, 97.5% CI (–0.084 to –0.066)); this was not true in females (67.1% vs 64.4%, 97.5% CI (0.0062 to 0.049)). Males overall and males with ‘current’ syphilis were more likely to be diagnosed as HIV-positive (p
Most individuals who tested for syphilis at Public Health Ontario were also tested for HIV; however, those who tested positive for syphilis were less likely to be tested, representing an opportunity for enhanced HIV testing. Ensuring that individuals with syphilis are tested for HIV may help identify previously undiagnosed individuals living with HIV.
Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.
This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.
The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.
Not applicable (this is an observational study).
The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.
A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.
Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.
From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.
Blood samples were screened for the detection of anti-Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.
Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.
The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.
Treatment of the two billion people with tuberculosis (TB) infection worldwide is crucial to prevent progression to TB disease and thereby prevent further transmission. However, TB is associated with fear and stigma, and knowledge gaps about TB disease are widespread, complicating adherence to treatment. As increasing knowledge about TB can reduce stigma and increase adherence to treatment, we developed an educational film about TB infection and disease. After showing the film to people with TB, our qualitative study aimed to evaluate the film and to explore perceptions, fears and possible knowledge gaps.
We conducted a qualitative study, with in-depth interviews (n=13), at two Infectious Disease Outpatient Departments in Sweden. Included research participants were adults with TB infection or TB disease. After informed consent, the participants watched the film, available in Swedish, English, Somali and Tigrinya. Subsequently, in-depth interviews, using a topic guide, were conducted, transcribed, and a reflexive thematic analysis was performed.
All participants considered the film to be a valuable addition to the written and oral information they had previously received. Identified themes included the perception of TB infection being a deadly, non-curable disease, and many feared being contagious. However, the film challenged these fears and increased the understanding of TB infection being treatable and non-infectious. Another theme revealed that TB-related stigma was experienced in encounters with healthcare professionals in Sweden.
Our educational film was perceived to increase understanding about TB symptoms, transmission and treatment. Implementing the film in Infectious Disease Departments across Sweden may contribute to decreasing stigma and enhancing awareness of the importance of treatment adherence, an outcome that warrants further investigation post-implementation.
Many patients with tuberculosis (TB) suffer from a huge economic burden, even though TB services are often provided free of charge at the point of care. Costs can create significant barriers, hindering patients’ access to TB treatment. These costs include direct medical costs (such as consultation fees), direct non-medical costs (such as transportation costs) and indirect costs (such as wages foregone). This systematic review aims to synthesise the best available evidence on economic evaluations of patient-cost studies on self-administered treatment (SAT) for drug-sensitive TB compared with facility-based directly observed treatment, short-course (FB DOTS), globally.
We will conduct a systematic review following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and search PubMed, Academic Search Complete, Scopus, CINAHL Plus (EBSCO) and Google Scholar for articles published up to 2025, without date restrictions. Eligible studies must be full or partial (cost analyses without effectiveness data) economic evaluations conducted globally, comparing SAT to FB DOTS regarding TB patient costs. Grey literature will be included. Exclusion criteria include studies not reporting patient costs between SAT and FB DOTS, and non-economic evaluations (non-original research). Two independent reviewers will conduct the screening, data extraction and quality assessment. A quality assessment will be performed using the Consolidated Health Economic Evaluation Reporting Standards statement, the Consensus on Health Economic Criteria checklist and the ROBINS-I tool.
Ethics approval is not required for this systematic review because it does not use individual patient data. Instead, we will use publicly available economic evaluation research studies. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.
CRD42024591221.
Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.
The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.
The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.
ClinicalTrials.gov, NCT06418048.
To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.
Triangulation to integrate quantitative and qualitative data.
Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.
A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.
To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.
Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.
There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.
This study aimed to investigate the characteristics and management of influenza-like illnesses (ILIs) in the outpatient and inpatient settings in Vietnam.
A cross-sectional, observational study.
We conducted a questionnaire survey of 407 individuals with ILI symptoms who presented to public community health centres and the paediatric ward of a public hospital in the city of Nha Trang, Khanh Hoa Province, Vietnam, from December 2022 to March 2023.
Not applicable.
No primary and secondary outcomes were pre-specified because this study was an explanatory study. The basic characteristics of the participants are presented using descriptive statistics. We conducted multivariable logistic regression analysis to examine the factors associated with the prescription of antibiotics to outpatients with ILIs.
A total of 198 outpatients and 200 inpatients were enrolled in the study. Most inpatients were children under 5 years of age and experienced longer illness durations and higher costs, with almost all patients receiving antibiotics. The rate of antimicrobial prescription for ILIs was 79.3% for outpatients and 99.5% for inpatients. The median health-related quality of life score of participants aged ≥18 years during illness was 0.796 (IQR 0.674–0.922). Logistic regression analysis indicated a negative association between a definite diagnosis of viral infection by rapid diagnostic test and outpatient antibiotic prescription (OR: 0.20, p=0.006).
This study underscores the widespread inappropriate antimicrobial use for ILIs in a community in Vietnam, which contributes to an avoidable economic and health burden. The results of this study suggest that implementing diagnostic tools may support antimicrobial stewardship efforts.
This scoping review aimed to map studies on behaviour change interventions that address antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings.
This review is based on the Joanna Briggs Institute guidelines for scoping reviews, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
A literature search in January 2024 and May 2024 was performed across Medline, Embase, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, EThOS and Google Scholar was performed.
Eligible studies described behaviour change interventions in primary and community care settings, published from 2000 onward across all countries.
Descriptive data relating to study details and intervention functions were gathered and organised according to the Capability, Opportunity, Motivation and Behaviour change framework in a predeveloped data extraction sheet. Dual data extraction occurred, and inter-rater reliability results are reported (K=0.83).
The scoping review identified 38 eligible studies, which consisted of randomised controlled trials (7/38), cluster randomised controlled trials (6/38), randomised experiments (5/38), cross-sectional studies (5/38), qualitative investigations (5/38) and quasi-experimental designs (4/38). Most interventions focused on educational resources (15/38), digital tools (7/38) and community campaigns (6/38), with fewer targeting decision-making processes (4/38) or psychological drivers of antibiotic-seeking behaviour (3/38). Only one study was conducted in low-income and middle-income countries, and only one separately assessed behaviour change as a measured outcome.
This scoping review highlights a wide range of research methodologies within the topic area. There was some limited evidence of intervention efficacy for antibiotic prescription rates, particularly interventions focused on enhancing knowledge and access to resources. However, more emphasis is needed on standardising outcome measures and evaluating long-term outcomes.
The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.
To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.
Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.
Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).
Active school staff employed in these three school districts.
COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.
Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.
Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p
The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.
To identify the patterns of tuberculosis (TB) notification rates and examine their relationship with social and economic determinants in Nepal between 2020 and 2023.
Cross-sectional study.
Nepal.
All TB cases across all ages.
Prevalence of TB cases.
This cross-sectional spatial analysis used the data set of the National Tuberculosis Control Centre, Nepal, covering the Fiscal Year (FY) 2020–2021 to 2022–2023. Moran’s I and Local Indicators of Spatial Association were employed to detect the spatial autocorrelation between the prevalence of TB and associated social and demographic factors.
The overall prevalence rate for TB in FY 2020–2021 was 98.08 per 100 000 population. This increased to 129.82 per 100 000 population in FY 2021–2022, followed by a slight decrease to 128.39 per 100 000 population in FY 2022–2023. The highest TB prevalence was observed in Kathmandu, with 146 cases per 100 000 population in 2020–2021, and in Dang district, the rate decreased from 215–191 per 100 000 population. We investigated the spatial patterns of TB prevalence and highlighted the geographic areas in each district in Nepal from 2021 to 2023 with Moran’s I of 0.558, 0.614 and 0.596, respectively. The consistent identification of High-High clusters in specific districts like Banke, Kapilbastu and Parsa across all 3 years periods highlighted persistent high-risk areas for TB transmission in Nepal.
This study emphasised the strong spatial associations and the complex, diverse aspects of TB transmission shaped by demographic and socioeconomic factors. Our results highlighted the need for tailored public health approaches that account for specific social determinants to address TB effectively.