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Diurnal variations to proinflammatory markers in individuals with diabetes compared to healthy controls: protocol for a systematic review and meta-analysis

Por: Reid · A. G. · Wu · C. Y. · Nguyen · T. H. O. · Symons · R. C. A. · Britten-Jones · A. C. · Downie · L. E.
Introduction

Diabetes mellitus is a highly prevalent metabolic disorder associated with chronic, low-grade inflammation. Of recent interest is the association between diabetes and circadian rhythm disruption. The aim of this review is to evaluate and synthesise clinical evidence for whether diabetes affects homeostatic diurnal patterns to proinflammatory markers in the human body. This could inform the optimal timing of immune-targeted therapies over the course of the day.

Methods and analysis

This systematic review will include primary clinical research studies reporting on diurnal variations, defined as an afternoon/evening (PM) minus a morning (AM) value, within a timeframe of 12±4 hours, for predefined proinflammatory markers, in individuals with diabetes (type 1 or type 2) compared with healthy controls. A search of online databases (Cochrane CENTRAL, Ovid MEDLINE and Ovid Embase) will be performed. Grey literature searches will be performed in clinical trial registries. Two review authors will independently screen retrieved citation records at the title/abstract and full-text levels. Study quality will be assessed using an appropriate National Institute of Health quality assessment tool. A meta-analysis will be performed if more than one study reports equivalent data for any outcome. Statistical heterogeneity will be assessed using the 2 test. Where a meta-analysis is not possible or unlikely to be meaningful, a narrative synthesis of the findings will be provided.

Ethics and dissemination

Ethics approval is not required for this systematic review as no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD420251115780.

Effects of argipressin on intraoperative fluid administration in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC): study protocol of a randomised clinical trial (HiPress Trial)

Por: van Zwol · J. · Aalbers · A. G. J. · van den Brom · C. E. · Hollmann · M. W. · Hulst · A. H. · Lameris · W. · Tuinman · P. R. · Vlaar · A. P. J. · Veelo · D. P. · Hemmes · S. N. T.
Introduction

Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.

Methods and analysis

HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).

Ethics and dissemination

The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.

Trial registration number

Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00

Unveiling the burden of long covid in hospital and community settings: findings from the Post-Acute Sequelae of SARS-CoV-2 Network (PASCNET) cohort study in Italys pandemic epicentre

Por: Antolini · L. · Valsecchi · M. G. · Bussi · A. · La Piana · G. · Pagani · E. · Pascarella · M. G. · Patroni · A. · Pellegrino · I. · Pozzi · A. · Sorlini · M. · Ticozzelli · M. · Villa · M. · Zappa · M. · Russo · A. G. · Lucifora · C.
Objectives

Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.

Design

Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.

Setting

Multicentre study involving seven public hospitals and general practitioners across Lombardy.

Participants

Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).

Intervention

This is an observational study with no active intervention.

Primary and secondary outcome measures

Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.

Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.

Results

Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.

Conclusions

PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.

Determinants of human papillomavirus vaccine non-uptake among adolescent girls in Ethiopia: evidence from National Immunization Survey

Por: Assefa · K. T. · Worku · A. G. · Muche · A. A. · Geremew · B. M. · Woldetsadik · M. A. · Alemu · K.
Objective

To assess determinants of human papillomavirus (HPV) vaccine non-uptake among adolescent girls in Ethiopia.

Design

Community-based cross-sectional study.

Setting

Ethiopia.

Participants

A weighted sample of 5341 adolescent girls.

Methods

A secondary analysis was conducted using the 2024 Ethiopian National Immunization Evaluation Survey dataset. A two-stage stratified sampling technique was used to select 467 enumeration areas (EAs). Within each EA, 30 households with adolescent girls aged 15–18 were systematically selected. Data were collected using a semi-structured questionnaire. Mixed-effects logistic regression was used to identify individual-level and/or household-level, and community-level determinants. Associations were presented using adjusted ORs with 95% CIs and statistical significance was set at p

Results

Individual and household-level determinants of HPV vaccine non-uptake include age 17–18 years (adjusted OR (AOR)=1.41; 95% CI 1.16 to 1.72), illiteracy (AOR=3.03; 95% CI 2.14 to 4.28), not currently attending school (AOR=2.84; 95% CI 2.24 to 3.60), poor knowledge (AOR=8.91; 95% CI 6.63 to 11.99), unfavourable attitude (AOR=4.24; 95% CI 3.34 to 5.37) and living in the poorest households (AOR=1.48; 95% CI 1.04 to 2.10). Community-level determinants were urban residence (AOR=1.40; 95% CI 1.01 to 1.95); and living in Addis Ababa (AOR=2.73; 95% CI 1.29 to 5.74), Afar (AOR=4.73; 95% CI 2.08 to 10.77), Dire Dawa (AOR=2.69; 95% CI 1.21 to 5.98), Harari (AOR=2.09; 95% CI 1.05 to 4.14) and Somali (AOR=3.68; 95% CI 1.61 to 8.38).

Conclusion

The determinants of HPV vaccine non-uptake were older age (17–18), illiteracy, school non-attendance, poor knowledge, unfavourable attitude, living in the poorest households, urban residence and living in Addis Ababa, Afar, Dire Dawa, Harari and Somali. The findings call for improved health literacy, knowledge and attitude through health extension programmes and targeted outreach in underserved urban and pastoralist settings.

Detection of age-related vision reduction in general practice in Denmark (DETECT): a study protocol for a feasibility and cohort study

Por: Brost · A. G. · Petersen · M. L. · Steinbo · E. K. F. · Siersma · V. · Bach-Holm · D. · Line · K. · Kristensen · M. · Waldorff · F. B. · Sandholdt · C. T.
Introduction

Vision reduction is linked to reduced quality of life, self-care capacity, increased fall risk, cognitive decline and depression. Prevalence increases with age. In response, WHO recommends regular vision assessment at primary care level, such as general practice (GP), for adults +50 years. However, research on detection of age-related vision reduction in GP is limited. The objective is to assess the feasibility and clinical utility of implementing vision screening in Danish general practice following an annual control consultation for patients aged ≥70 years with minimum one chronic condition.

Methods and analysis

Complex health intervention in a Danish general practice setting. Testing a patient baseline questionnaire with 18 items on self-reported vision and quality of life in combination with three vision tests: Colenbrander Mixed Contrast Card Test for near vision, Amsler Grid test and Confrontational Visual Field Test. 18–20 GP clinics and 450 patients are planned to be included. After GP consultation, all patients visit a collaborating optometrist for a comprehensive vision assessment including refraction, intraocular pressure measurement, fundus photography and optical coherence tomography (OCT). Data and pictures from the optometrist are evaluated by an ophthalmologist, who refers to further follow-up and/or treatment if deemed necessary.

Feasibility outcomes: patient recruitment rate, patient adherence, as well as patients’ and health providers’ experiences with the intervention. Clinical outcomes: GP staff assessment of patient vision and patient-reported assessment compared with ophthalmologic assessment. This includes identifying the need for new glasses and detecting eye diseases that require further evaluation, monitoring or treatment. This study will provide evidence on the feasibility of integrating vision screening into routine general practice, potentially helping expedient referrals and improving detection and access to primary eye-health care for older adults.

Ethics and dissemination

The study is registered and approved by Danish Research Ethics and Data Protection, VEK F-23070033 and in ClinicalTrials.gov: NCT07015034. Findings will be disseminated in peer-review journals, academic conferences and with the public through patient organisations and public health events.

Trial registration number

ClinicalTrials.gov; identifier: NCT07015034.

Multicentre prospective trial of abbreviated MRI using gadoxetic acid versus CT for detection of late recurrent HCC (AMRICT): study protocol

Por: Park · H. J. · Lee · D. H. · Chang · W. · Kim · H. Y. · Kim · D. H. · Choi · W.-M. · Chung · S. W. · Choi · J. · Lee · D. · Shim · J. H. · Lee · H. C. · Lim · Y.-S. · Kim · S.-O. · Singal · A. G. · Kim · S. Y.
Introduction

Hepatocellular carcinoma (HCC) recurs in most patients after curative treatment. Late recurrence (>2 years after curative treatment) typically indicates de novo tumours in the residual liver. Although contrast-enhanced computed tomography (CECT) and MRI are widely used for post-treatment follow-up, they each have limitations including radiation exposure, high cost and limited access. The abbreviated MRI using gadoxetic acid versus multiphasic CECT for detection of late recurrent HCC after curative treatment (AMRICT) trial aims to compare gadoxetic acid-enhanced abbreviated MRI using hepatobiliary phase imaging (HBP-AMRI) and multiphasic CECT for detecting late recurrent HCC after curative treatment.

Methods and analysis

This prospective multicentre intra-individual comparison trial will enrol 455 participants who have undergone surgical resection or local ablation for HCC and remained recurrence-free for over 2 years. Each participant will undergo two imaging sessions at 6±2 month intervals, using both HBP-AMRI and multiphasic CECT. The primary endpoint is the detection rate of all-stage HCC. The secondary endpoints include the false referral rate of all-stage HCC and detection and false referral rates of Barcelona Clinic Liver Cancer stage 0–A HCC and of stage 0 HCC. Structured imaging protocols and quality assessments will be implemented for both modalities.

Ethics and dissemination

This study was approved by the Institutional Review Boards of the three participating institutions (approval number: 2023–1630 (Asan Medical Center), H-2407-146-1556 (Seoul National University Hospital) and B-2410-929-401 (Seoul National University Bundang Hospital)) and registered at ClinicalTrials.gov (NCT06537193). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

ClinicalTrials.gov: NCT06537193. Participant enrolment began on 12 December 2024, and is ongoing.

Utilisation of brain MRI for the diagnosis of dementia in low and middle-income countries: systematic review and meta-analysis

Por: Nassanga · R. · Nakasujja · N. · Mubuuke · A. G. · Lwere · K. · Kawooya · M. G. · Ocan · M. · Kaddumukasa · M.
Objectives

To synthesise the prevalence and patterns of dementia-relevant structural brain MRI abnormalities in adults with suspected or confirmed dementia in low- and middle-income countries (LMICs), and to summarise MRI protocols and the incremental diagnostic contribution of MRI beyond cognitive screening.

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE, Web of Science and PsycINFO (January 1990–27 January 2025), plus reference list screening and targeted manual searches.

Eligibility criteria

Observational or diagnostic-accuracy studies from World Bank-defined LMICs including adults (≥50 years) with suspected or confirmed dementia who underwent brain MRI as part of diagnostic evaluation.

Data extraction and synthesis

Two reviewers independently screened, extracted data and assessed risk of bias using ROBINS-I. Random-effects models pooled prevalence of dementia-relevant MRI abnormalities; diagnostic-accuracy outcomes were synthesised narratively due to heterogeneous reference standards and incomplete reporting.

Results

39 LMIC studies were included; 23 studies (2513 participants) contributed to the meta-analysis. Dementia-relevant MRI abnormalities (defined as ≥1 clinically relevant structural abnormality per study definition) were present in 1248/2513 participants. The pooled prevalence of dementia-relevant MRI abnormalities was 58% (95% CI 43% to 72%), with substantial heterogeneity (I²=95%) and a wide prediction interval (8–96%), indicating marked between-study variability; this estimate should be interpreted as a descriptive summary of study-level proportions rather than a precise population parameter.

Conclusions

Brain MRI frequently demonstrates dementia-relevant pathology in LMIC clinical cohorts, usually with mixed neurodegenerative-vascular patterns. Structured visual ratings may add aetiologic specificity beyond cognitive screening, but pooled estimates should be interpreted as summaries of heterogeneous study-level findings rather than precise population parameters, given high heterogeneity and risk of bias.

PROSPERO registration number

CRD42024510241.

Patient and public involvement and engagement in target trial emulation framework: a scoping review protocol

Por: Egesa · I. J. · Baldwin · F. D. · Wells · M. · Maden · M. · Mbizvo · G. K. · Marson · A. G. · Tudur-Smith · C.
Introduction

Target trial emulation (TTE) has emerged as a methodological framework to strengthen causal inference from observational health data when randomised controlled trials are infeasible. The credibility of TTE studies depends not only on rigorous design and transparent reporting, but also on their relevance and acceptability to patients and the public. Patient and public involvement and engagement (PPIE) has been shown to enhance the relevance, transparency and impact of health research by shaping research priorities, informing study design and ensuring outcomes reflect patient perspectives. However, the extent to which PPIE has been incorporated into TTE studies remains unclear. This scoping review aims to systematically map the use and reporting of PPIE in published TTE studies.

Methods and analysis

This review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews checklist. We will search MEDLINE (Ovid) and Embase (Ovid) from January 2011 to present, limited to English-language publications. Eligible studies will be studies that self-identify as using the TTE framework and report empirical analyses of health outcomes using observational or trial data. We will exclude protocols, methodological or simulation-only studies, preprints, conference abstracts and grey literature. Three reviewers will independently screen titles and abstracts, and then full texts, with disagreements resolved by discussion or adjudication. Data extraction will include study characteristics and PPIE information guided by the Guidance for Reporting Involvement of Patients and the Public 2-Short Form checklist. Findings will be summarised using descriptive statistics, tables, figures and narrative synthesis.

Ethics and dissemination

Ethics approval is not required, as this review will use publicly available data. Results will be disseminated through a peer-reviewed publication and presented at conferences.

Deaths with preceding hospitalisations within 180 days in eight countries in sub-Saharan Africa and South Asia: A secondary descriptive analysis of the Child Health and Mortality Prevention Surveillance (CHAMPS) network

Por: Varo · R. · Cole · K. · Madewell · Z. J. · Iglesias · J. F. · Igunza · K. A. · Akelo · V. · Mugah · C. · Onyango · D. · Were · J. A. · Madhi · S. A. · Dangor · Z. · Johnstone · S. · Lala · S. G. · Ruder · T. · Mandomando · I. · Kincardett · M. · Xerinda · E. G. · Scott · J. A. G. · Assefa
Objectives

To describe (1) the proportion of deaths that were in recently hospitalised children and (2) causes of mortality among deceased children aged 0–59 months with preceding hospitalisations who enrolled in a mortality surveillance programme.

Design

Descriptive study using prospectively collected data.

Setting

Eight Child Health and Mortality Prevention Surveillance (CHAMPS) community and healthcare sites in sub-Saharan Africa and South Asia.

Participants

Deaths among children aged 0–59 months enrolled in CHAMPS 2016–2023.

Interventions

None.

Primary and secondary outcome measures

Deaths with antecedent hospitalisations within 180 days of death. Causes of death determined by expert panels who reviewed clinical data and histopathologic and microbiologic results from postmortem minimally invasive tissue sampling.

Results

CHAMPS enrolled 8548 deaths; we excluded 3688 neonates who died before discharge or ≤24 hours of birth and 482 with unclear information on antecedent hospitalisations. Out of the 4378 remaining deaths, 16.7% (95% CI 15.7% to 17.9%) were deaths that occurred within 180 days of a hospitalisation (n=733/4378). Of these, 55.7% (95% CI 52.0% to 59.3%) occurred outside healthcare facilities. Among included deaths with minimally invasive tissue sampling completed (n=337), lower respiratory tract infections (41.2%, 95% CI 36.0% to 46.7%), sepsis (39.8%, 95% CI 34.5% to 45.2%) and undernutrition (n=92, 27.3%, 95% CI 22.7% to 32.4%) were most common causes of death among cases with antecedent hospitalisations. The greatest proportion of deaths with antecedent hospital admissions occurred among cases aged 1–11 months (48.0%, 95% CI 44.4% to 51.7%), compared with those aged 0–1 months (21.7%, 95% CI 18.8% to 24.9%) and those aged 1–5 years (30.3%, 95% CI 27.0% to 33.8%). Moreover, the greatest proportion of deaths with antecedent hospital admissions occurred among infants/children with weight-for-age Z-score of

Conclusions

We observed a high proportion of deaths with antecedent hospitalisations within 180 days among young children across eight sites in sub-Saharan Africa and Asia. Among those deaths, children aged 1–11 months and undernourished infants were over-represented, suggesting early follow-up as a potential point to focus targeted support and future research.

Random-effects modelling of timely initiation of breastfeeding in Tanzania: What predicts the practice?

Por: Tibenderana · J. R. · Musa · K. M. · Pius · A. G. · Kagasyeko · J. N. · Kessy · S. A.
Objective

To determine individual and community-level predictors associated with timely initiation of breastfeeding among women in Tanzania.

Design

Analytical cross-sectional study.

Setting

This was an analytical cross-sectional study that used the 2022 Tanzania Demographic and Health Survey, which was conducted across all regions of Tanzania.

Participants

Data from 4308 women were included.

Primary outcome

The outcome variable was timely initiation of breastfeeding, defined as starting breastfeeding within the first hour after birth, coded as 1 if timely and 0 otherwise. Mixed-effects generalised linear model (family- Binomial and link-logit) approach was used to account for the hierarchical structure of the data. Four models were constructed to assess individual and community-level predictors. Adjusted prevalence ratios (APRs) with 95% CIs were reported.

Results

Women aged 25–34 years were significantly more likely to initiate breastfeeding within 1 hour (APR=1.40; 95% CI 1.18 to 1.65). Vaginal delivery was strongly associated with the timely initiation of breastfeeding (TIBF) (APR=10.13; 95% CI 7.84 to 13.09), whereas home delivery (APR=0.29; 95% CI 0.24 to 0.36) was negatively associated with TIBF. Multiparity (APR=1.22; 95% CI 1.04 to 1.43) increased the likelihood of TIBF. Women in the richest wealth category were less likely to practise TIBF (APR=0.70; 95% CI 0.51 to 0.96). Approximately 12.3% of the variation in TIBF was explained by cluster-level differences.

Conclusions

Both individual and community-level factors influence TIBF in Tanzania, highlighting the need for strong communication between mothers and healthcare providers to consistently promote its importance across all ages and wealth groups.

Barriers and facilitators to implementing a shared decision-making tool for anticoagulant-related drug-drug interactions: a qualitative study across three academic medical centres in the USA

Por: Becker · R. A. · Bonnet · K. · Shah · M. V. · Dang · E. · Ancker · J. S. · Malone · D. C. · Trinkley · K. E. · Gomez-Lumbreras · A. · Del Fiol · G. · Kawamoto · K. · Tawfik · A. G. · Cornia · R. · Jones · A. E. · Mitchell · J. · Reese · T. J.
Objectives

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Design

Preimplementation qualitative study using semistructured interviews.

Setting

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

Participants

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Results

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

Conclusions

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

Can topical coconut oil reduce late-onset sepsis in extremely preterm infants? A pragmatic cluster-randomised controlled trial protocol

Por: Strunk · T. · Mountain · J. · Gordon · A. · Deshpande · G. · van den Boom · J. · DePaoli · A. G. · Jacobs · S. · Giannoutsos · N. · Doherty · D. A. · Patole · S.
Introduction

Infants born before 28 weeks’ gestation account for approximately 75% of neonatal morbidity and mortality. Late-onset sepsis (LOS) affects around 25% of these infants and is associated with an increased risk of adverse long-term outcomes. The topical application of coconut oil has been used for centuries in newborn care. Coconut oil is rich in saturated fatty acids, several of which have demonstrated antimicrobial properties. It is considered safe for extremely preterm infants, improves skin condition and may reduce the incidence of LOS.

Methods and analysis

This is a pragmatic, cluster-randomised, two-arm, parallel-group, multicentre, phase III clinical trial evaluating the effect of topical coconut oil versus routine skin care on the incidence of LOS in extremely preterm infants. Participating neonatal units will be cluster-randomised, and all infants born at

Ethics and dissemination

Following ethical approval, patients will be recruited at participating sites under a waiver of consent with opt-out framework. The trial results will be disseminated through conferences, media sources and publication in relevant peer-reviewed journals.

Trial registration number

ACTRN12620001332910.

Incorporation of social medicine curriculum in academic and community health centres: a scoping review protocol

Por: Cydis · M. · Hudson · E. · Shipper · A. G. · Lane · A. · Salzman · M.
Introduction

In the field of medicine, there has been a growing understanding of the impact of social and economic inequities on patients’ health outcomes. Social medicine was established with the intention of addressing these social and economic drivers of health when caring for patients. Physicians who practise social medicine aim to take an interdisciplinary and interprofessional approach to patient care with an emphasis on the promotion of health equity and patient advocacy. As the effects of social determinants of health (SDOH) on health outcomes have become more widely appreciated, medical professional organisations and accrediting bodies have advocated for formal education on the impact of SDOH in undergraduate and graduate medical curricula. The goal of this scoping review is to examine how undergraduate and graduate medical education programmes in the USA have implemented social medicine concepts into their curricula.

Methods and analysis

The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The review team worked with a medical librarian, who created a unique search for five databases (PubMed, Embase, Cochrane CENTRAL Register of Controlled Trials, ERIC and the Web of Science Core Collection). Additionally, we will conduct a grey literature search that includes medical school and residency programme websites, as well as Association of American Medical Colleges (AAMC), Council of Residency Directors in Emergency Medicine (CORD), Alliance for Academic Internal Medicine (AAIM) and Society for Academic Emergency Medicine (SAEM) conference abstracts. Two independent reviewers will assess all articles for eligibility. Data will be extracted using the Covidence data extraction tool. We will present the results of the extraction in tabular form. Themes identified during the full-text review and data extraction process will be discussed.

Ethics and dissemination

Data will be gathered from publicly accessible sources, so ethics approval is not necessary. The results will be disseminated through a peer-reviewed journal and reported at conferences related to medical education and social medicine.

Trial registration number

This protocol is registered on OSF (https://doi.org/10.17605/OSF.IO/7PZ8U).

Feasibility of a phase 3 partially randomised clinical trial to assess the safety and efficacy of paediatric praziquantel for schistosomiasis treatment in children aged 3 months to 6 years in endemic regions of Brazil: a pilot study

Objective

This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.

Design

Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.

Setting

Conde, Bahia, Brazil, from December 2024 to January 2025.

Participants

Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.

Primary and secondary outcome measures

The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.

Results

A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.

Conclusions

This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.

Trial registration number

Brazilian Clinical Trials Registry; RBR-86kcy37.

Agreement testing of AMSTAR-PF, a tool for quality appraisal of systematic reviews of prognostic factor studies

Por: Henry · M. L. · OConnell · N. E. · Riley · R. D. · Moons · K. G. M. · Shea · B. J. · Hooft · L. · Wallwork · S. B. · Damen · J. A. A. G. · Skoetz · N. · Appiah · R. P. · Berryman · C. · Crouch · S. M. · Ferencz · G. A. · Grant · A. R. · Henry · K. M. · Herman · A. M. · Karran · E. L. · K
Objectives

To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).

Design

Observational study.

Participants

14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.

Study procedure

Eight systematic reviews were rated by all reviewers using AMSTAR-PF.

Outcome measures

Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.

Results

Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.

Conclusions

Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.

Rationale and design of the REMECHOQUE multicentre registry protocol: evaluating therapeutic trends in cardiogenic shock

Introduction

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

Methods and analysis

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethics and dissemination

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Por: Oommen · A. M. · Ashfaq · M. · Tonsing · M. V. · Cherian · A. G. · Singarayar · P. · Viswanathan · V. · Muniswamy · V. · Hawkes · D. · Abraham · P. · Pricilla · R. A. · Manoharan · R. · Zomawia · E. · Oldenburg · B. · Saville · M. · Krishnaraj · K. · T S · S. · Basu · P. · Brotherton · J.
Background

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

Methods

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

Analysis

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics and dissemination

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

Trial registration number

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Development and validation of a risk prediction model for chronic kidney disease among adult hypertensive patients having follow-up at University of Gondar Comprehensive Specialised Hospital, Ethiopia: a retrospective cohort study

Por: Tilahun · A. D. · Limenih · M. A. · Muluneh · A. G. · Hailu · W. · Anlay · D. Z. · Liyew · B. · Muche · A. A.
Objective

Chronic kidney disease (CKD) arises due to uncontrolled hypertension (HTN). HTN significantly increases the risk of complications in vital organs, mainly the kidneys. If hypertensive individuals receive early intervention, the majority of these complications and deaths from CKD can be avoided. Having a clinically applicable tool to predict the future risk of those complications can prevent early disability and premature mortality. However, to this day, there is a lack of a validated risk prediction model specifically designed for CKD of hypertensive patients in Ethiopia. We aimed to develop a risk prediction model for CKD among hypertensive patients at the University of Gondar Comprehensive Specialised Hospital (UoGCSH), Ethiopia.

Study design

A retrospective follow-up study was conducted from 1 January 2012 to 30 December 2021. The Least Absolute Shrinkage and Selection Operator regression methods were used to select predictors. The performance of the models was assessed using the Area Under the Curve and calibration plots. The internal validity of the model was evaluated using bootstrapping methods, and the model was presented as a nomogram. Decision curve analysis was conducted to assess the net benefit of the prediction model in clinical and public health contexts.

Setting

Data from patients’ medical records were collected via the Kobo Toolbox in the UoGCSH.

Participant

We followed a total of 1120 Patients diagnosed with HTN.

Results

The incidence of CKD among adult hypertensive patients was 19.82% (95% CI 17.59% to 22.26%). In the multivariable logistic regression analysis, age, residency, baseline blood pressure status, type of HTN, family history of HTN, baseline serum creatinine levels, proteinuria at baseline and dyslipidaemia were identified as statistically significant predictors of CKD. The nomogram demonstrated a discriminatory power of 91.98% (95% CI 90.09% to 93.88%) and a calibration p value of 0.327. The sensitivity and specificity of the prediction model were 80.63% (95% CI 74.81% to 85.61%) and 87.97% (95% CI 85.66% to 90.03%), respectively. The developed nomogram has a greater net benefit than using the treat-all or treat-none strategies when the threshold probability of the patient is increased.

Conclusion

The nomogram demonstrated excellent discrimination and calibration in identifying hypertensive patients at high risk of CKD. This predictive model offers clinicians a valuable tool for early identification of high-risk individuals, enabling timely interventions, personalised counselling and optimised management through close monitoring to prevent disease progression.

Preoperative anaemia and its impact on immediate surgical outcomes in elderly patients: a multicentre prospective cohort study in Ethiopia

Por: Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Mekuriaw · B. Y. · Abuhay · A. G. · Afework · W. A. · Siyoum · T. M. · Gedefaw · G. D. · Abate · A. T. · Demissie · B. · Demtie · D. G. · Asmare · T. B.
Objective

To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.

Design

Prospective cohort study.

Setting

Two comprehensive specialised hospitals in Ethiopia.

Participants

Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.

Primary and secondary outcome measures

Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.

Results

The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p

Conclusion and recommendation

Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.

Financial catastrophe and its associated factors among chronic kidney disease patients undergoing haemodialysis in Kathmandu, Nepal: a mixed-method study

Por: Poudel · S. · Yadav · D. K. · Khanal · V. K. · Nepal Gurung · G. · Pokhrel · S. · Pudasaini · A. · Amatya · A. G.
Objective

The study aimed to assess the prevalence of financial catastrophe and explore patients’ perceived effectiveness of the government support programme related to chronic kidney disease.

Design

Cross-sectional mixed-method study.

Participants

A total of 120 patients receiving free regular haemodialysis under the government’s Deprived Citizen Support Programme for at least 6 months were included in the quantitative study, and 9 patients participated in the qualitative study.

Main outcome measures

Prevalence of financial catastrophe and factors associated with financial catastrophe among chronic kidney disease patients undergoing haemodialysis.

Methods

A convergent parallel mixed-method approach was carried out from 15 June to 15 December 2024, among chronic kidney disease patients undergoing haemodialysis at the National Kidney Center. Quantitative data were collected through face-to-face interviews using a semi-structured questionnaire. Financial catastrophe was defined as out-of-pocket (OOP) healthcare payments ≥40% of a household’s disposable income, following the WHO-recommended threshold for severe financial burden. OOP expenditures were assessed over 6 months, and associations were tested using 2 and binary logistic regression at a 95% CI in SPSS V.25.0. For the qualitative arm, in-depth interviews were conducted with nine purposively selected patients, and inductive thematic analysis was applied to explore the perceived effectiveness of the government support programme. The quantitative and qualitative findings were then integrated to achieve convergence and divergence, allowing for a comprehensive understanding of the extent and context of financial hardship among patients.

Results

The prevalence of financial catastrophe was 72.5%. The factors associated with financial catastrophe were the presence of complications (adjusted OR (AOR): 3.67, 95% CI 1.019 to 13.27), patients without financial support (AOR: 2.77, 95% CI 1.016 to 7.56) and reduction in food expenses (AOR: 0.313, 95% CI 0.109 to 0.896). Qualitative findings on awareness regarding government subsidies, financial strain, barriers to receiving treatment and perceived effectiveness of the programme revealed key aspects of utilisation and effectiveness of the government support programme.

Conclusion

The prevalence of financial catastrophe was substantially high, which highlights the importance of addressing economic challenges in chronic kidney disease care. The study emphasised the need to strengthen financial protection through the expansion of government subsidies and improved insurance coverage.

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