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Una molecola potrebbe spiegare la riduzione della massa muscolare nel diabete di tipo 2
I ricercatori del Karolinska Institutet hanno identificato una molecola chiamata TMEM9B-AS1, un […]
Chi guida oggi la sanità pubblica? L’identikit dei direttori generali in Italia
Nel cuore delle aziende sanitarie pubbliche italiane si trova una figura chiave, spesso poco conosciuta fuori dai circuiti istituzionali, ma determinante per la salute del sistema: il direttore generale. È…
Principal investigators experience of COVID-19 therapeutic clinical trials in Japan: a qualitative study
Objective
During the COVID-19 pandemic, many clinical trials were conducted to identify effective COVID-19 therapeutics. However, while a large amount of resources was invested and significant numbers of patients participated, this did not necessarily have an impact on clinical practice. To face these issues, initiatives such as the 100 Days Mission have been set out globally. Yet, limited data exist on the context surrounding the implementation of clinical trials at a national level during a health emergency. The study explored experiences and perceptions of principal investigators in conducting clinical trials for COVID-19 therapeutics in Japan.
Design
A qualitative study was conducted using semistructured interviews. The obtained data were inductively analysed using thematic analysis.
Setting and participants
We interviewed 15 principal investigators between September and November 2022 who conducted investigator-initiated clinical trials on the development of COVID-19 therapeutics in Japan.
Results
Three themes were generated: structural barriers, fragmented efforts and limited evidence generation. Structural barriers and fragmented efforts comprised four subthemes: individual, institutional, interinstitutional and policy/regulatory levels. Structural barriers at all levels included (1) limitations of individual capabilities, (2) the double burden of clinical practice and research, (3) inefficient interinstitutional collaboration and (4) regulatory frameworks and available resources that interrupt stakeholders’ actions, leading to limited evidence generation despite the fragmented efforts of principal investigators and other stakeholders.
Conclusions
This study illustrated that the efforts of Japanese principal investigators did not necessarily pay off in identifying therapeutics. A strategic and systematic approach for an improved national clinical trial ecosystem must be sought during the interpandemic period to overcome structural barriers in harmonisation with the global stakeholders.
Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial
Background
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.
Methods and analysis
A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.
Ethics and dissemination
Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.
Trial registration number
The study was registered on clinicaltrials.gov (NCT06192862).
[Articles] Global outbreaks of respiratory syncytial virus infections from 1960 to 2025: a systematic review and meta-analysis
RSV outbreaks have contributed significantly to global morbidity since the 1960s, with increasing reports over time. While the CFRs have decreased, they remain high in certain subgroups based on age, genotype, and outbreak setting. The pooled attack rate remains substantial, particularly in healthcare settings involving RSV-B genotypes and among immunosuppressed populations. This meta-analysis underscores the importance of targeted vaccination and treatment strategies for controlling RSV outbreaks worldwide in the future.
Incidence, progression and predictors of chronic kidney disease among adult HIV/AIDS patients on antiretroviral treatment in comprehensive specialised hospitals in the Amhara Region, Ethiopia, 2022: a multi-centre retrospective follow-up study
Objective
To assess the incidence, progression and predictors of chronic kidney disease among adult patients living with HIV/AIDS who are receiving antiretroviral therapy.
Design
An institution-based, multicentre retrospective follow-up study was conducted among a randomly selected sample of 535 adult patients. Data were entered into Epi Data version 4.6.0 and analysed using STATA version 14.0. A Cox proportional hazards regression model was fitted to identify independent predictors of chronic kidney disease incidence. Variables with p
Is exposure to cement dust and heavy metals associated with reduced pulmonary function? A cross-sectional study among cement factory workers in Türkiye
Objectives
To assess the relation of exposure to cement dust and heavy metal (aluminium, cadmium and lead) exposures to pulmonary function among male cement plant workers. The study also aimed to evaluate dose–response relationships and prevalence and severity of respiratory symptoms among exposure categories compared with a control group.
Design
Cross-sectional study.
Setting
Secondary-level occupational health clinic in Ankara, Türkiye.
Participants
461 male non-smoking cement plant employees were included in total. Participants were categorised into packaging (n=101), milling (n=162) and office unexposed workers (n=198). Inclusion criteria were more than 70% work history in the cement industry and exclusion of pre-existing respiratory disease and missing data from the participants.
Interventions
Not applicable.
Primary and secondary outcome measures
Pulmonary function tests (forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC and peak expiratory flow (PEF)) and urinary, cadmium and blood lead concentrations were measured. Lung function impairment was the primary outcome measure; secondary outcomes included metal exposure—pulmonary measure correlations.
Results
Significant negative correlations existed between FEV1 and urine aluminium (r=–0.622, p
Understanding Predictors of Lifelong Initiation and Follow-up Treatment for adolescents and youth living with HIV (UPLIFT): an integrated prospective cohort in Eastern Cape, South Africa
Purpose
Adolescents living with HIV (ALHIV) are a priority population for achieving global HIV prevention and treatment targets but experience poorer outcomes than adults. Long-term follow-up is essential to understand their transition into adulthood. By linking self-reported survey data with routine laboratory records, we established a social science clinical cohort of ALHIV South Africa’s Eastern Cape to explore factors shaping their long-term health and well-being.
Participants
Eligible participants were adolescents who were part of a three-wave quantitative cohort of ALHIV and not living with HIV (2014–2018) and had consented (adolescent and caregiver) to having their self-reported interviews linked with routine health records (n=1563). Adolescents were recruited into the existing three-wave cohort through clinic and community-based methods (97% enrolment, >90% retention over three waves). Between 2019 and 2022, we abstracted laboratory test records from the National Health Laboratory Services database for all eligible participants, with matching based on demographic variables. Individuals with at least one HIV-related record form our ‘lifelong social science cohort’, a total of 956 ALHIV (852 of 1107 ALHIV and 104 of 456 HIV-uninfected).
Findings to date
A total of 32 886 laboratory test records from 2004 to 2023 were matched through three rounds of data extraction, using iteratively refined record-linking searches. Most records were viral load (8864) and CD4 count (6801) results, with a median of 10 (IQR: 7–14) and 8 (IQR: 5–11) tests per matched adolescent, respectively. Overall, 956 of 1563 adolescents (61%) were successfully linked to laboratory data, including 852 of 1107 (77%) ALHIV. Analysis of the matched cohort survey-laboratory data provided several insights. Self-reported antiretroviral therapy adherence was strongly associated with viral suppression, even after adjusting for covariates. The strongest predictors of suppression were not reporting missed doses in the past 3 days, past week and not missing clinic appointments in the past year. Among adolescent girls and young women living with HIV, access to safe and affordable facilities, and kind and respectful staff were associated with a higher likelihood of multiple improved HIV-related outcomes, including viral suppression. Exposure to sexual and intimate partner violence predicted worse viral load outcomes among adolescents.
Future plans
This integrated prospective cohort provides an opportunity to characterise long-term HIV treatment outcomes among ALHIV in Africa. We will investigate how individual, familial, community and healthcare experiences in childhood, and adolescence shape these outcomes. Since the COVID-19 pandemic happened during the period of matched data, we will also investigate the potential effect of the COVID-19 pandemic on adolescent HIV treatment outcomes, with potential subgroup analyses for individuals with available COVID-19-related results.
Association between loneliness and depression, anxiety and anger during the COVID-19 pandemic: a nationwide population-based survey
Objectives
This study aims to determine the association between loneliness and depression, anxiety and anger with a representative sample of the general population in Korea, which are the most prevalent mental health problems during the pandemic.
Design
Cross-sectional study.
Setting
National survey across all 17 provinces in South Korea between December 2021 and January 2022.
Participants
We conducted a national survey on 2699 participants aged 19–84 years using proportional stratified sampling. Using the UCLA Loneliness Scale and standardised questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7) and anger (Patient-Reported Outcomes Measurement Information System-Anger), we explored the prevalence and association of loneliness with these mental health outcomes.
Primary and secondary outcome measures
Primary outcomes included the prevalence and co-occurrence of depression, anxiety and anger across different levels of loneliness.
Results
Of total, 20.7% and 2.1% experienced moderately high and high levels of loneliness, respectively. Among participants with high levels of loneliness, 11.8%, 5.9% and 11.8% had depression, anxiety and anger, respectively, and 28.7% of them had depression, anxiety and anger together. The adjusted prevalence of depression was 0.2 (95% CI 0.0 to 0.5), 8.2 (95% CI 6.7 to 9.7), 31.3 (95% CI 27.4 to 35.3) and 63.5 (95% CI 50.1 to 76.8) for low, moderate, moderately high and high levels of loneliness, respectively. Similarly, increased adjusted prevalence of anxiety and anger was observed ㅈwith higher levels of loneliness.
Conclusions
Lonely people have a higher risk of depression, anxiety and anger. Identifying individuals who may be vulnerable to loneliness is important for early intervention.
Developing a core outcome set for gender-affirming healthcare in transgender and gender diverse adults in Sweden using the Delphi approach: a study protocol
Introduction
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.
Methods
Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.
Analysis
The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.
Ethics and dissemination
The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.
Trial registration number
COMET registration number 3223.
Development and preliminary evaluation in community mental health teams of a cervical screening informed-choice tool for women with severe mental illness in England: a mixed-method study
Objectives
Women with severe mental illness (SMI) face barriers to cervical cancer screening, leading to lower participation and poorer outcomes. This research aimed to develop and test an informed-choice tool to help women with SMI make informed decisions about screening attendance.
Design
The tool was developed using a realist review of physical health interventions and a systematic review of informed-choice tools for people with SMI. A mixed-methods approach informed its development. Usability and acceptability were assessed through semistructured interviews and the think-aloud method with service users (n=18), clinicians (n=16) and key informants. A preliminary proof-of-concept (n=25) evaluated the impact on decisional conflict—the uncertainty around making value-sensitive choices.
Setting and participants
Conducted in two National Health Service (NHS) Mental Health Trusts (urban and rural). Participants included women with SMI accessing secondary mental healthcare, clinicians and service user groups. A key informants’ group guided clinical content.
Intervention
A cervical screening informed-choice leaflet and an accompanying video.
Results
The tool was usable and acceptable, especially for women overdue or never screened. It may reduce decisional conflict and increase screening uptake, potentially improving survival. An National Institute for Health and Care Research (NIHR)-funded feasibility trial (Improving uptake of cervical screening in people with severe mental illness (OPTMISE)) is underway. The current UK government guidance on Support for people who find it hard to attend cervical screening due to having a mental health condition or having experienced trauma or abuse is based on this research.
Conclusions
Future research may involve further assessments of the real-world impact of the tool and its adaptation to other health-related decisions.
Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study
Background
Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.
Objective
This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.
Design
A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p
Patient and caregiver perspectives on treatment strategies and care priorities of childhood steroid-sensitive nephrotic syndrome: a qualitative study
Objectives
We explored the experiences of treatment strategies for steroid-sensitive nephrotic syndrome (SSNS) and care priorities among children living with the condition and their caregivers.
Design
A qualitative study using semistructured interviews. Data were analysed using reflexive thematic analysis. We coded transcripts in duplicate and developed themes that integrate key concepts across roles.
Setting
Southern Alberta, Canada.
Participants
A purposive sample of children aged 8–18 years, with SSNS and their caregivers from a paediatric nephrotic syndrome cohort.
Results
28 individuals (10 children and 18 caregivers) participated in this study. All had experienced a relapse after initial diagnosis and steroid treatment. Participants identified how their experiences with SSNS treatments influenced their willingness to accept further steroids and other second-line agents. Findings are elaborated across the following four themes: (1) reluctant acceptance of steroids (steroid aversion, lack of personalised steroid dosing, altered self-regulation and acknowledging steroid effectiveness); (2) coping with unexpected relapses (repeating the cycle, restricted life participation and tempered optimism); (3) uncertainty about second-line therapies (striving for stability, cumulative burden of adverse effects and exploring alternatives) and (4) directing attention to unmet treatment needs and priorities (mechanistic approaches to therapy, steroid minimisation, child and family involvement and enhanced social supports).
Conclusions
Children with SSNS and their caregivers expressed a dislike of steroids and a desire for individualised treatment protocols. Investigation into therapeutic alternatives for SSNS should integrate patients’ preferences, values and care priorities.
Association of triglyceride-glucose index with in-hospital outcomes in patients with acute myocardial infarction: a retrospective, single-centre, cohort study in China
Objectives
To investigate the association between triglyceride-glucose (TyG) index levels at hospital admission and the risk of in-hospital adverse events, including all-cause mortality, in patients with acute myocardial infarction (AMI). The primary hypothesis was that higher TyG index levels are associated with greater risk of adverse in-hospital outcomes.
Design
Retrospective cohort study.
Setting
Tertiary hospital inpatient care in China. The study included consecutively hospitalised patients with AMI between 1 August 2011 and 10 January 2022.
Participants
A total of 3458 patients with AMI were included. The mean age was 60.8 years, and 78.4% were men. Patients were excluded if they had incomplete data for TyG index calculation or outcome ascertainment.
Interventions
No therapeutic intervention was assigned; the study was observational. TyG index was calculated using fasting triglycerides and fasting plasma glucose levels at admission.
Primary and secondary outcome measures
The primary outcome was all-cause in-hospital mortality. Secondary outcomes included cardiogenic shock and fatal rapid arrhythmia. Outcomes were identified through standardised clinical records.
Results
Among 3458 patients, 375 (10.84%) died during hospitalisation, 236 (6.84%) developed cardiogenic shock and 147 (4.25%) experienced fatal rapid arrhythmia. After multivariable adjustment, higher TyG index levels were significantly associated with increased odds of all-cause mortality (OR, 1.27; 95% CI, 1.02 to 1.57; p
Implementation of an intervention to scale up coverage of pneumonia management in children younger than 5 years in a north Indian district: protocol for a quasi-experimental, mixed-methods, pre-post implementation study
Introduction
The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.
Method and analysis
This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.
Ethics and dissemination
Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022–17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.
Study registration
Clinical Trials Registry – India, CTRI/2021/03/031622.