Duration of COVID-19 symptoms in children: a longitudinal study in a Rio de Janeiro favela, Brazil

Objectives
COVID-19 in children is generally of short duration, but some may take longer to recover. This study investigated the time to symptom resolution following SARS-CoV-2 infection among children in a community setting on the outskirts of an urban centre in Brazil.

Design
Prospective cohort study.

Setting
This is a community-based cohort of children living in Manguinhos, a favela in Rio de Janeiro. The cohort was followed through home visits and telephone monitoring of symptoms. The analysis focused on symptomatic children from this cohort with confirmed SARS-CoV-2 infection. Recovery time was defined as the interval between the first date with symptoms and the first date without symptoms following a positive SARS-CoV-2 test.

Participants
A total of 1276 children (boys and girls aged 2–

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Associations between optimism and mental health in postradiotherapy cancer survivors: a cross-sectional survey study

Objectives
Cancer patients often experience psychological distress, while optimism has been identified as a protective factor. However, the mental health of postradiotherapy cancer survivors and its association with optimism remain largely unexplored. This study assesses the mental health status and optimism levels of postradiotherapy cancer survivors and evaluates their associations.

Design
Cross-sectional survey study.

Participants
114 Hong Kong cancer survivors who (1) were aged 18 years or above and (2) had received radiotherapy for their cancer treatment and finished the radiotherapy within the previous 3 years (2021–2024).

Outcome measures
Mental health was assessed using the Chinese Depression, Anxiety and Stress Scale, and optimism was measured using the Revised Life Orientation Test. Correlation and regression analyses were used to examine the associations between these measures.

Results
Participants reported overall low optimism with mild to moderate depression, anxiety and stress. Strong negative correlations were identified between optimism and depression (r=–0.833, p

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Prospective multicentre randomised controlled trial to assess the clinical effectiveness of the novel CirrhoCare digital therapeutic management system: a study protocol

Introduction
Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

Methods and analysis
CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.
214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.
The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

Ethics and dissemination
CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

Trial registration number
ISRCTN11380842.

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GRACE: protocol for a UK, secondary care, multicentre, assessor-blinded randomised controlled trial with a non-inferiority comparison to evaluate graduated compression stockings as an adjunct to extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention

Introduction
Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.
HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.
Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.

Methods and analysis
GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.
The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.

Ethics and dissemination
On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.

Trial registration number
ISRCTN11667770.

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Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial

Introduction
Depression is characterised by disruptions in brain circuitry, and interventions like intermittent theta burst stimulation (iTBS) offer the potential for normalising these circuits and improving clinical symptoms. However, personalised treatment targets for depression remain underexplored. This trial aims to evaluate the clinical efficacy of iTBS as an additional treatment to a stable antidepressant regimen in patients with treatment-resistant depression (TRD) by modulating brain circuits identified through personalized brain functional sectors compared with sham treatment. This work is a part of the China Study to Predict Optimised Treatment bioMarkers of Individualised Neuromodulation in Depression project.

Methods and analysis
This is a multi-centre, double-blind, sham-controlled randomised trial, with a 2:1 allocation ratio to 21 days of active or sham iTBS. A total of 360 eligible participants, diagnosed with current treatment-resistant unipolar major depressive disorder, who have been on a stable antidepressant regimen for at least 4 weeks and are experiencing moderate-to-severe depressive episodes, will be recruited from seven clinical centres in China. The primary outcome is the change in the Montgomery–Asberg Depression Rating Scale immediately following 21-day treatment. Secondary outcomes include response rate and remission rate, change in the Hamilton Rating Scale for Depression, efficacy sustainability and recurrence within 6 months post-treatment. Additionally, safety, blinding, dropout and potential moderators of response will be examined.

Ethics and dissemination
The study has been approved by each centre’s ethics committee, with the first ethical approval granted by the Ethics Committee of Beijing Anding Hospital on 30 December 2022 (approval 2022206FS-2). Written informed consent will be obtained from all participants prior to enrolment. The study results will be published in relevant peer-reviewed journals.

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Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups

Introduction
Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.

Methods and analysis
The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.

Ethics and dissemination
The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.

Trial registration details
ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.

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Investigating the long-term public health and co-benefit impacts of an urban greenway intervention in the UK: a natural experiment evaluation – study protocol

Introduction
Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.

Methods and analysis
The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.

Ethics and dissemination
To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.

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Evaluation of optical sensor technology for the early detection of peripheral intravenous infiltration in neonates: a retrospective cohort study

Objective
This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Design
Single-centre, retrospective, observational cohort study.

Setting
Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

Participants
All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

Interventions
The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

Outcome measurements
The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Results
Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

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Strengthening universities response to sexual harassment with an equity approach: the UNI4EQUITY mixed-methods study protocol

Introduction
Preventing online and offline sexual harassment (SH) is a public health priority, due to its worldwide magnitude and short- and long-term consequences to the victims and survivors. Universities are environments that may facilitate different forms of conflicts, including SH, but they also play a key role in preventing and addressing them. This paper describes ‘Uni4Equity’, a European project funded by the CERV-2022-DAPHNE Programme of the European Union (Ref. 101094121-Uni4Equity) aimed to reinforce universities’ readiness to identify, map and respond to online and offline SH at workplace and other relevant settings (classrooms, digital space), with an explicit (but not exclusive) focus on minority social groups. More specifically, the project will address the research needs of conducting multidimensional diagnosis of SH at universities (scale and determinants) as a basis for preventive actions; assessing the effectiveness of preventive interventions such as social media campaigns and training workshops; creating a university culture that actively rejects SH; improving access to existing support services; and contributing to the acknowledgement of universities as an asset in preventing this issue.

Methods and analyses
The project follows an exploratory sequential design for the period 2023–2026. In phase 1, a mixed-method initial assessment based on online surveys, semistructured interviews and desk reviews is planned in six targeted universities: University of Alicante, Adam Mickiewicz University (AMU), University of Maia, University of Applied Sciences Burgenland (UASB), University of Antwerp (UAntwerp), University of Verona. Phase 2 integrates long-term and large-scale interventions at different levels of prevention (primary, secondary and tertiary) and implementation (interpersonal, institutional and social). These interventions combine online and offline training programmes addressed to students and staff, arrangements with internal and external support services and improvements in access to information and resources, including SH protocols and regulations. Phase 3 consists of qualitative and quantitative evaluations of the different Uni4Equity interventions and a final evaluation of the global impact of the project.

Ethics and dissemination
Ethical approval was obtained by the different universities research ethics committees (Universidad de Alicante, vice-rectorate for research: Ref. no. UA-2023-03-27; Università di Verona, Comitato di Approvazione per la Ricerca sulla Persona: Ref. no. UNIVR-24/2023; UAntwerp, Ethics Committee for the Social Sciences and Humanities: Ref. no. EX_SHW_2023_38_1; AMU, Ethics Committee for Research Involving Human Participants, Ref. no. UAM_19/2022/2023; UASB, Ethics Committee: Ref. no. UASB _28/08/2023; Universidade da Maia, Conselho de Ética e Deontologia: Ref. no. UMAIA_ 151/2023).
The research team will disseminate findings through peer-reviewed journal articles, presentations in scientific national and international events, policy briefs, infographics, videos and short reports.

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Association between anti-Mullerian hormone levels and age in women with endometriosis: insights from a population-based study

Background
While previous studies have shown an association between anti-Mullerian hormone (AMH) levels and endometriosis, there are limited data on the relationship between AMH levels and age among women with endometriosis.

Objectives
The present study aimed to investigate the associations between age and AMH levels in women with and without endometriosis.

Design and setting
A cross-sectional, population-based study using data from the ongoing Tehran Lipid and Glucose Study.

Participants
A total of 1005 eligible reproductive-age women were selected. These participants were categorised into two groups: women with confirmed endometriosis (n=305) and controls (n=700).

Interventions
None.

Outcome measures
Association between AMH levels and age among women with endometriosis and healthy controls, using linear, quadratic and segmented regression analyses.

Results
A total of 1005 women aged 18–48 years participated in the study, including 305 (30.3%) with endometriosis and 700 (69.7%) healthy controls. Women with endometriosis had significantly lower AMH levels compared with healthy controls (1.99±1.42 vs 2.30±1.61 ng/mL; p=0.029). In healthy controls, an increase of 1 year was associated with –0.15 ng/mL of AMH (95% CI: –0.17 to –0.14). Segmented regression identified a threshold at 27 years (1.92), with a sharper decline below this age (slope: –0.35, 95% CI: –0.47 to –0.23; p

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Assessment of COVID-19 hospitalisation cost and its associated factors in Nepal: a descriptive cross-sectional study

Objective
This study aimed to assess the coronavirus disease 2019 (COVID-19) hospitalisation costs and its associated factors on Nepalese households during the second wave of the pandemic, within the context of Nepal’s COVID-19 response.

Design
A cost-descriptive cross-sectional study.

Setting
Kathmandu Metropolitan City, Nepal.

Participants
We enrolled 306 hospitalised patients.

Outcome
Telephonic interviews were conducted with COVID-19 patients between May and July 2022. Cost was assessed from a patient’s perspective. We assessed factors associated with the medical cost of COVID-19 treatment services using a generalised linear model with gamma distribution and log link in both bivariable and multivariable models for estimating coefficients and confidence intervals. Data were analysed using STATA version 13, adjusting for the potential confounders: socio-demographic characteristics, type of hospital, intensive care unit (ICU) requirement, lead time to hospital admission and number of days at hospital stay.

Results
The total median cost for hospitalisation was US$ 754.9. The median direct medical, direct non-medical and indirect costs were US$ 624.4, US$ 49.3 and US$ 493.02, respectively. After adjusting for potential confounders, the cost of COVID-19 treatment was 6.9 times higher among those admitted to private hospital (95% CI 5.72 to 8.32, p

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Impact of left ventricular end-diastolic pressure on clinical outcomes in patients with ST-elevation myocardial infarction (Hunter LVEDP Study): a prospective, single-centre study

Objectives
Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Design
Prospective, single-centre study.

Participants
Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

Primary outcome measure
The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

Results
A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

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[Articles] Effectiveness of introducing pulse oximetry and clinical decision support algorithms for the management of sick children in primary care in India and Tanzania on hospitalisation and mortality: the TIMCI pragmatic cluster randomised controlled trial

When implemented in routine health systems at primary care level in India and Tanzania, contrary to expectations, pulse oximetry and CDSAs were not found to increase rates of hospitalisation within 24 h of primary care referral, nor to decrease deaths, or delayed or un-referred hospitalisations. Wider health system challenges, including referral barriers, inequitable oxygen access and hospital care quality must be addressed if the potential of these tools in delivering child outcome benefits is to be realised.

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