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Ayer — Octubre 2nd 2025Tus fuentes RSS

Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P.
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

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From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Association between household food insecurity and underweight status among women in flood-prone regions of Bangladesh: a cross-sectional study

Por: Lotus · S. U. · Akash · S. M. · Salsabil · N. · Hossain · M. T. · Sarker · S. · Zaman · Z. I. · Kawnine · R. · Haque · K. S. · Ahmed · M. Z. E. M. N. U. · Hossain · A.
Objectives

Bangladesh is highly prone to recurrent flooding that disrupts all four pillars of food security. This study aimed to explore the effect of household food insecurity on the underweight status of women in flood-affected areas of Bangladesh, which remains underexplored.

Design

This is a cross-sectional analysis.

Setting

This study was conducted in eight sub-districts (upazilas) across eight districts in Bangladesh that experience severe to moderate river flooding, flash floods and substantial tidal surges.

Participants

A total of 532 women participated in the study. The inclusion criteria for participation were as follows: (1) being at least 18 years of age, (2) residing in the household for at least 1 year and (3) having experienced limited food access in the 4 weeks before data collection due to flood-related constraints.

Primary outcome measures

Household food insecurity was measured using the U.S. Agency for International Development Household Food Insecurity Access Scale questionnaire. An underweight status was evaluated through anthropometric measurements of women. Adjusted prevalence ratios (aPRs) were estimated using robust log-linear models.

Results

Moderate food insecurity was the most common (58.3%) among the participants. The prevalence of underweight was the highest (52.1%) in the severely food-insecure group and decreased significantly with improved food security. Severe household food insecurity was strongly associated with a higher prevalence of underweight individuals (aPR = 4.12; 95% CI, 1.60 to 10.60). An underweight status was also prevalent in women from moderately food-insecure households (aPR = 1.75; 95% CI, 0.68 to 4.55).

Conclusion

This study reveals a significant association between household food insecurity and underweight status, highlighting the major challenges faced by women living in flood-prone areas of Bangladesh. These findings emphasise the urgent need to address household food insecurity to improve nutritional outcomes for women in vulnerable communities.

International guidelines for the imaging investigation of suspected child physical abuse (IGISPA): a protocol for a modified Delphi consensus study

Por: Sidpra · J. · Kemp · A. M. · Nour · A. S. · Christian · C. W. · Robinson · C. · Mirsky · D. M. · Holmes · H. · Chesters · H. · Nurmatov · U. · Pizzo · E. · Kan · E. Y. · Wawrzkowicz · E. · Bliss · H. · Knight · L. · Lucato · L. T. · Kvist · O. · Kelly · P. · Servaes · S. · Rosendahl · K. · A
Introduction

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

Methods and analysis

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

Ethics and dissemination

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Comparison of cardiovascular risk profiles of patients with type A aortic dissection and thoracic aortic aneurysm: a retrospective multicentre study

Por: Tirpan · A. U. · Dolmaci · O. B. · Jansen · E. K. · Twisk · J. W. R. · Klautz · R. J. M. · Grewal · N.
Objective

A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.

Design

A multicentre retrospective study.

Setting

The data were collected from electronic health records of two academic hospitals located in the Netherlands.

Participants

Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.

Results

Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p

Conclusion

This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.

Social support and multifactorial predictors of perinatal depression: insights from a hospital-based cross-sectional survey in Karachi, Pakistan

Por: Shoaib · N. · Abbasi · H. U. B. · Rizvi · S. A. · Ali · S. T.
Objectives

This study aimed to estimate the frequency of depression in mothers during the antepartum and postpartum periods and identify predictors of perinatal depression in the tertiary care hospital of Karachi, Pakistan.

Design

Analytical cross-sectional study.

Setting

Public Tertiary Care Hospital, Civil Hospital, Karachi, Sindh, Pakistan.

Participants

The study involved 262 mothers for the assessment of frequency and predictors of perinatal depression in Pakistan.

Main outcome measures

The Edinburgh Postpartum Depression Scale (EPDS) was used as the tool to screen for depression. The data were collected through a structured questionnaire encompassing the sociodemographic factors, pregnancy and birth-related information, newborn characteristics sections, family relationship and marital status and psychosocial and psychological history. Mean and SD were computed for continuous data, whereas frequencies and percentages were determined for categorical data. Pearson 2 test was applied to determine the association between categorical variables. Predictors of perinatal depression were identified through multivariate logistic regression.

Results

Out of 262 enrolled mothers, 198 screened positive for depressive symptoms using EPDS with a cut-off value ≥10. The mean age of participating mothers was 27.4±5.95 years. Approximately 39.7% of the mothers were illiterate, 75% were housewives and about 42% had a family income of less than US$126. Women with access to a healthcare facility had higher odds of antepartum depression symptoms, possibly due to poor healthcare experiences during antenatal visits. Emotional support by husband reduces the odds by 45.8% while experiencing abuse increases odds by three times. Significant predictors of postpartum depression symptoms included decision-making power, which reduced the odds of postpartum depression symptoms by 72.5% and emotional support by 80%.

Conclusions

The study concluded that maternal decision-making power is a significant protective factor against postpartum depression. Strikingly, access to health facilities by the mother was associated with higher odds of antepartum depression. Other factors, including household income, husband’s employment status, domestic violence, emotional support and family abuse, did not show significant associations with either antepartum or postpartum depression. These findings emphasise the importance of routine screening to identify women at risk during the perinatal period.

Management and outcomes of fractures over cranial venous sinuses: a scoping review protocol

Por: Takoutsing · B. · Wunde Njineck · U. · Wah · P. S. · Sebopelo · L. · Ngouanfo Tchoffo · J. · Bah · E. S. · Esene · I. N.
Introduction

Fractures over venous sinuses (FOVSs) are associated with difficulties in diagnosis and treatment resulting in a high level of morbidity and mortality. Despite its importance, there are limited aggregate data to guide the management of these fractures ultimately inflicting a major callenge to neurosurgeons. This protocol describes the methodology of a scoping review that aims to synthesise contemporary evidence on the management and outcomes of FOVSs.

Methods and analysis

The proposed study will be conducted in accordance with the Arksey and O’Malley’s framework for scoping reviews. The research question, eligibility criteria and search strategy were developed based on the population, intervention, comparator and outcome strategy. The following electronic bibliographic databases will be searched without restrictions on language and date of publication: PubMed, WHO Global Index Medicus, African Journals Online, SCOPUS, Embase, Cochrane and ProQuest Central. All peer-reviewed studies of primary data reporting on the management and outcomes of FOVSs will be included. The data extracted from included articles will be presented through descriptive statistics, pooled statistics and a narrative description.

Ethics and dissemination

Because this study did not directly involve human individuals, ethical approval was not necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at local, regional, national and international conferences and promotion over social media.

Human papillomavirus, sexually transmitted infections, and antimicrobial resistance in West Africa: Estimating population burden and understanding exposures to accelerate vaccine impact and drive new interventions: The PHASE survey protocol

by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke

Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.

Evaluating a population-based screening programme for early detection of liver fibrosis and cirrhosis in primary care in Germany: a cost assessment study

Por: Ortner · J. · Van Ewijk · R. · Velthuis · L. · Labenz · C. · Arslanow · A. · Nguyen-Tat · M. · Wörns · M.-A. · Reichert · M. C. · Farin-Glattacker · E. · Binder · H. · Fichtner · U. A. · Graf · E. · Stelzer · D. · Galle · P. R. · Lammert · F.
Objectives

Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.

Design

This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.

Setting

SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.

Participants

Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.

Interventions

Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.

Primary and secondary outcome measures

Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.

Results

Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.

Conclusions

SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.

Registration number

The SEAL registration number is DRKS00013460. This study relates to its results.

Development of intersectoral medical care for patients with 'chronic critical illness: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC{superscript 2})

Por: Edel · A. · Jöbges · S. · Weiss · B. · Paul · N. · Lyall · M. L. · Hoffmann · C. · Schüürhuis · S. · Piper · S. K. K. · Konietschke · F. · Berger · E. · Busse · R. · Marschall · U. · Kraufmann · B. · Witzenrath · M. · Eckardt · K.-U. · Spies · C.
Introduction

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

Method and analysis

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

Ethics and dissemination

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

Trial registration number

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

Impact of diabetes mellitus and body mass index on long-term survival in chronic total occlusion patients: a nationwide cohort study from the SCAAR registry

Por: Mohammed · M. · Sundström · J. · Louca · A. · Hellsen · G. · Rawshani · A. · Olivecrona · G. K. · Mohammad · M. A. · Ioanes · D. · Jensen · U. · Erlinge · D. · Angeras · O. · Petursson · P. · Myredal · A. · Völz · S. · Dworeck · C. · Odenstedt · J. · Rawshani · A. · Ramunddal · T.
Objectives

To evaluate the effects of diabetes mellitus (DM) and body mass index (BMI) on long-term all-cause mortality in chronic total occlusion (CTO) patients.

Design

Retrospective, nationwide cohort study.

Setting

Swedish Coronary Angiography and Angioplasty Registry, between June 2015 and December 2021.

Participants

24 284 patients with angiographically confirmed CTO. Prior coronary artery bypass graft surgery excluded. Subgroups were defined by DM status and BMI categories (underweight, healthy weight, overweight, obesity).

Primary outcome measures

Long-term all-cause mortality, assessed by Kaplan-Meier analysis and multivariable Cox proportional hazards regression.

Results

DM was present in 30.3% of patients and conferred a 31% higher risk of mortality (HR: 1.31, 95% CI: 1.20 to 1.42; p2, lowest risk (nadir) at 32 kg/m2 and modest rise above 35 kg/m2.

Conclusions

In this nationwide CTO cohort, DM independently predicted higher long-term mortality, accompanied by more severe comorbidities and greater CTO complexity, and insulin therapy further elevated hazard. Overweight and obese patients had better survival, while underweight individuals had the poorest prognosis. These findings underscore the importance of individualised risk assessment and management strategies in CTO patients, particularly those with DM or low BMI.

Association between womens empowerment and mental health help-seeking behaviour in Bangladesh: findings from a nationally representative survey

Por: Rafi · M. A. · Anika · U. S. · Hasan · M. T. · Hossain · M. G.
Background

Despite a high disease burden, care-seeking for mental health symptoms is low in Bangladesh, particularly among women.

Objective

To evaluate help-seeking behaviours for anxiety and depression symptoms among Bangladeshi women aged 15–49 and its association with women’s empowerment.

Methods

Data from the Bangladesh Demographic and Health Survey 2022 including 2881 women reporting anxiety or depression symptoms were analysed. Help-seeking behaviours, sociodemographics and women’s empowerment using the Survey-based Women’s Empowerment (SWPER) index were assessed. Logistic regression models were used to explore associations.

Results

The mean age of participants was 33.3 years (SD 8.7); two-thirds lived in rural areas. In the SWPER index, 83% of women had high empowerment in the attitude to violence domain, 16% in social independence and 60% in decision-making. Among women with anxiety or depression symptoms, 18.7% sought help, mainly from spouses (43%) or family (52%), and 15% consulted doctors. Women aged >30 years (adjusted OR, aOR 1.25, 95% CI 1.02 to 1.53), from rich households (aOR 1.49, 95% CI 1.09 to 1.89), and with secondary (aOR 1.47, 95% CI 1.08 to 2.01) or higher education (aOR 1.56, 95% CI 1.03 to 2.36) were more likely to seek help. High empowerment in attitude to violence (aOR 0.54, 95% CI 0.37 to 0.81) and decision-making (aOR 0.53, 95% CI 0.41 to 0.68) correlated negatively with help-seeking.

Conclusions

Few Bangladeshi women seek help for mental health symptoms, relying on informal sources. Age, education, wealth and employment predict help-seeking, while high empowerment level in attitude to violence and decision-making domain of SWPER index shows an inverse relationship.

Assessing health system preparedness from trends and time delays in the management of myocardial infarctions during the COVID-19 pandemic in India: a multicentre retrospective cohort study

Por: Menon · J. C. · MS · A. · S · H. · Janakiram · C. · James · A. · Sreedevi · A. · Menon · G. R. · John · D. · Cherian · J. J. · V · V. · Abhaichand · R. K. · Punnoose · E. P. · BS · A. · Abraham · M. · Thomas · P. · Pedada · C. · Govindan · U. · Mohan · B. · Pisharody · S. · Devasia · T. · Seba
Objectives

This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.

Design

Multicentre retrospective cohort study

Setting

Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.

Participants

All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.

Primary outcomes

Number of MI admissions, median O2D, D2B and D2N times.

Secondary outcomes

30-day outcomes including death, reinfarction and revascularisation.

Results

MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.

Conclusion

Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.

Diabetes self-management observational study investigating how CGM use impacts diabetes distress, glycaemia and functions as a technological substitute for hypoglycaemia awareness: a study protocol

Por: Nitschke · M. J. · Demir · C. · Brosen · J. M. B. · Tapager · I. W. · Norgaard · K. · Kristensen · P. L. · Pedersen-Bjergaard · U.
Introduction

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

Methods and analysis

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.

The collected data will be used in two substudies with the overall aims of:

Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.

Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.

Endpoints will include CGM metrics, alarm data and PROs.

Ethics and dissemination

The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.

Trial registration number

ClinicalTrials.gov (NCT06453434).

Comparative effectiveness of alternative initial doses of opioid agonist treatment for individuals with opioid use disorder: a protocol for a retrospective population-based study using target trial emulation in British Columbia, Canada

Por: Yan · R. · Hossain · M. B. · Min · J. E. · Kurz · M. · Smith · K. · Piske · M. · Seaman · S. · Bach · P. · Karim · E. · Platt · R. W. · Siebert · U. · Socias · M. E. · Xie · H. · Nosyk · B.
Introduction

Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

Methods and analysis

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

Ethics and dissemination

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Postnatal care utilisation and health beliefs among mothers in the Jazan region of Saudi Arabia: a cross-sectional study

Por: Altraifi · A. A. · Albasheer · O. · Abdelwahab · S. I. · Chourasia · U. · Abdelmageed · M. M. · Hakami · A. M. · Khormi · A. H. · Medani · I. E. · Ali · S. A. · Habeeb · S. A. · Shebaly · G. A. · Somaily · M. M. · Harshan · S. M. · Ali · S. M. · Hukma · S. H.
Background

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

Objectives

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

Design

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Setting

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

Participants

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

Primary and secondary outcome measures

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

Results

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

Conclusions

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

Depression among medical students in Bangladesh: a systematic review and meta-analysis protocol on prevalence and associated factors

Por: Rahman · M. M. · Sultana · S. · Alam · U. K. · Abdullah · I. · Shimu · A. T. · Fatema · N.
Introduction

Depression, affecting 350 million people globally, is notably prevalent among medical students, particularly in South Asia, including Bangladesh. Despite several studies, no meta-analysis has systematically examined the prevalence and contributing factors of depression to address the mental health burden. This systematic review and meta-analysis protocol aims to consolidate findings on the regional prevalence and key risk factors among Bangladeshi medical students.

Methods and analysis

The research team will search the Medline (Pubmed), Scopus, Web of science, Embase, PsycInfo, BanglaJOL and Google Scholar electronic databases following the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines for published studies from their inception till 1St March 2025, using truncated and phrase-searched keywords and relevant Medical Subject Headings (MeSHs). Observational studies, including cross-sectional, cohort and case-control studies published within the timeframe and following any validated depression assessment tools, with no language restriction, reporting bangladeshi medical students, will be included for the review. Review papers, intervention studies, commentaries, preprints, meeting abstracts, protocols, unpublished studies and letters will be excluded. Two independent reviewers (SS, IA) will screen the retrieved papers using Rayyan, a web-based application, while any disagreements between them will be resolved by a third reviewer (ATS). Exposure will refer to different factors associated with depression among Bangladeshi medical students. Prevalence of depression and associated factors will be extracted. Narrative synthesis (Qualitative information) and meta-analysis (Quantitative data) will be conducted to assess the pooled prevalence using the random-effects meta-analysis (REML) model. For enhanced visualisation of the included studies, forest and funnel plots will be constructed. Heterogeneity among the studies will be assessed using the I 2 statistic, sensitivity,and subgroup analyses will be conducted, if necessary, based on study heterogeneity. The quality of the included studies will be assessed using the modified Newcastle-Ottawa Scale (mNOS) tool developed for observational study designs. All statistical analyses and visualization will be conducted using the R studio v.4.3.2 with built-in "meta"-packages and GraphPad Prism v.9.0.2.

Ethics and dissemination

This review will analyse existing published evidence. Findings will be submitted to a peer-reviewed journal and disseminated through conferences, policy forums and stakeholders to guide future research and interventions.

PROSPERO registration number

CRD 420251006480.

The OPTION trial: outpatient induction of labour - study protocol for a prospective, non-inferiority, multicentre randomised controlled trial

Por: Sengpiel · V. · Sangskär · H. · Wennerholm · U.-B. · Elden · H. · Gemzell-Danielsson · K. · Graner · S. · Wallström · T. · Hesselman · S. · Domellöf · M. · Jonsson · M. · Brismar Wendel · S. · Herbst · A. · Kopp-Kallner · H. · Carlsson · Y.
Introduction

Sweden, as many other high-income countries, has adopted guidelines to offer induction of labour at 41+0 gestational weeks to decrease the risk for perinatal death. As more than 20% of the pregnant population reach this gestational age, and along with other contributing factors, induction rates have increased up to 30% in many countries. Both women and care providers have raised the question if outpatient induction could be a convenient, safe and economic alternative, reducing the burden on inpatient care in maternity hospitals. Before introducing outpatient induction into clinical routine, studies need to assure safety for the child and woman as well as efficacy of the method.

Method and analysis

A register-based randomised controlled multicentre non-inferiority trial to study if outpatient induction in low-risk inductions is (1) as safe for the child (perinatal composite of mortality and morbidity) and (2) as effective (proportion of vaginal deliveries) as inpatient induction at the hospital. Secondary outcomes are further health outcomes, experiences of pregnant women, partners and care providers, health economics and future pregnancy outcome. Participating women with a singleton pregnancy and unripe cervix between 37+0 and 41+6 gestational weeks planned for low-risk induction will undergo induction of labour with either a balloon catheter or oral misoprostol according to clinical practice at the study site and the woman’s informed choice. Randomisation will allocate women to either outpatient (home or patient hotel) or inpatient induction (standard care). Women undergoing outpatient induction can remain at home for up to 2 days, with an assessment after 24 hours including cardiotocography. Once active labour ensues, all women will receive standard care in the hospital.

The assessment of non-inferiority will involve a two-sided 95% CI and 80% power, requiring randomisation of 8891 women to ensure a probability of at least 0.80 that the upper limit of a two-sided 95.7% CI for a difference in the primary safety outcome is below the non-inferiority margin of 1.5%. 31 of the 45 delivery units in Sweden are currently recruiting. Data will be collected from the electronic case report form and Swedish healthcare registers. Questionnaire and qualitative interview-based studies will be performed to explore experiences of pregnant women, partners and care providers. Additionally, a health economic evaluation will be performed.

Ethics and dissemination

The Swedish Ethical Review Authority approved the study (3 June 2020; 2020-02675 with amendments 2021-03045, 2022-00865-02, 2023-01252-02, 2024-00560-02, 2024-2024-04597-02). The Swedish Medical Products Agency approved the study for the medication arm (25 August 2020, EudraCT number: 2020-000233-41; 5.1-2020-60240 with amendments 5.1-2022-73500, 5.1-2023-630). Due to changed regulation, in 2023, the study medication arm was transferred and approved by the European Medicines Agency (23 October 2023, EU CT Number: 2023-507164-39-00; CTIS 5.1.2-2023-099775 with amendments 5.1.2-2024-081916, 5.1.2-2025-036291). The Swedish Medical Products Agency approved the study for the medical device arm (6 April 2021, CIV-ID: CIV-20-09-034712; 5.1-2021-14812 with amendments 5.1-2022-14252, 5.1-2023-596, 5.1-2024-8886, 5.1-2024-55554). The medical device arm was transferred to Regulation (EU) 2017/745 (23 December 2024, 5.1-2025-24242 and amendment 5.1-2025-6050). The study will involve more than 80% of all delivery units in Sweden, which will allow for a smooth implementation of any new routine after the study’s conclusion. Results will be published in relevant scientific journals, presented at national and international conferences, and communicated to participants and relevant institutions through the Outpatient Induction study homepage (www.optionstudien.se), the webinars of the Swedish Network for National Clinical Studies in Obstetrics and Gynecology (www.snaks.se) as well as social and public media.

Trial registration number

EudraCT No: 2020-000233-41, after transfer to the European Medicines Agency EU CT Number: 2023-507164-39-00; CIV-ID 20-09-034712.

Proximal and distal middle cerebral artery diameter ratio and lenticulostriate artery infarction

by Jun Sang Yoo, Jae Hyun Choi, Jae Young Park, Jeong Yun Song, Jun Young Chang, Dong-Wha Kang, Sun U. Kwon, Hang Jin Jo, Bum Joon Kim

Background

Lipohyalinotic degeneration (LD) and branch atheromatous disease (BAD) can contribute to subcortical infarctions in the lenticulostriate artery (LSA) territory. This study aimed to identify the association between the proximal and distal middle cerebral artery (MCA) diameter ratio and the two different pathomechanisms of LSA infarction.

Methods

Patients with acute LSA infarctions categorized as small vessel occlusive disease were included. Demographic and clinical data, along with MCA geometrical variables, were collected. LD and BAD were differentiated based on the length of the infarction diameter and number of axial slices. The proximal/distal M1 diameter ratio was calculated. MCA geometrics between LD and BAD were compared. Independent factors associated with LD were investigated. Computational fluid dynamics (CFD) analysis was used to evaluate hemodynamic parameters.

Results

A total of 117 patients were included, of whom 64 (54.7%) and 53 (45.3%) were classified as BAD and LD, respectively. LD was associated with hypertension and favorable prognosis. MCA geometric variables revealed that LD had a higher proximal/distal M1 diameter ratio, indicating a potential distinguishing factor. Multivariate analysis confirmed the independent association between LD and the proximal/distal M1 diameter ratio. The proximal/distal M1 diameter ratio also showed a positive correlation with the number of ipsilesional lacunes. CFD analysis showed that the LD model had faster, greater blood influx into LSAs and higher wall shear stress and pressure gradient compared with the BAD model.

Conclusions

This study suggests MCA geometry, particularly the proximal/distal M1 diameter ratio, may serve as an independent factor for identifying LD.

Hospital discharge planning in cardiac care: study protocol for a mixed-methods study on the implementation, influencing factors and quality of care in Germany

Por: Imhof · L. · Bartels · R. · Blum · K. · Blume · K. S. · Fleischer · S. · Gottschalk · S. · Heber · R. · Horenkamp-Sonntag · D. · Meyer · G. · Remppis · B. A. · Schneider · U. · Schreyoegg · J. · Winter · V.
Introduction

Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.

Methods and analysis

A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.

Ethics and dissemination

This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.

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