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Systemic inflammation and malaria co-infection in irritable bowel syndrome: a cross-sectional study of 142 Yemeni patients

Por: Ali · N. T. · Mehdi · M. A. H. · Abdullah · R. S. · Gubran · A. N. M. · Al-Abd · N. M. · Ali · G. S. · Mohsen Ali · H.
Objective

To determine the prevalence of malaria co-infection among patients with irritable bowel syndrome (IBS) in Yemen and to evaluate the association of systemic inflammatory biomarkers (neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV) and platelet-to-lymphocyte ratio (PLR)) with this co-infection.

Design

Multicentre, cross-sectional observational study conducted between April and December 2024.

Setting

Primary and secondary healthcare facilities across 21 governorates in Yemen.

Participants

142 consecutive adult patients (aged 18–70 years) diagnosed with IBS according to the Rome IV criteria.

Outcome measures

The primary outcome was the prevalence of malaria infection, confirmed by a rapid diagnostic test . Secondary outcomes included differences in NLR, MPV and PLR between groups, assessed using independent t-tests, and the diagnostic performance of these biomarkers evaluated by receiver operating characteristic curve analysis with AUC calculation. Multivariate binary logistic regression was used to identify independent predictors of malaria co-infection, adjusting for potential confounders.

Results

The mean age was 42.3 years (SD 11.7) with an equal gender distribution. The prevalence of malaria co-infection was 45.1% (64/142). Patients with malaria positivity had significantly higher NLR (mean difference 0.56, 95% CI 0.40 to 0.72; p

Conclusions

Nearly half of the Yemeni patients with IBS in this study had malaria co-infection, with the highest burden in diarrhoea-predominant and mixed subtypes. Elevated NLR and PLR were strongly associated with co-infection, suggesting these readily available biomarkers could aid targeted screening in resource-limited, endemic settings.

EMPOWHPVR: exploring the factors that impact HPV self-sampling uptake amongst Black women and people with a cervix in Peel region, Ontario - a qualitative study protocol

Por: Lee-Foon · N. K. · Lofters · A. · Dias · K. · Ogilvie · G. S. · Massaquoi · N. · Kuluski · K. · Reid · R. J.
Introduction

Every 2 minutes, a woman dies from cervical cancer, resulting in over 300 000 preventable deaths globally. Nearly all cervical cancers are caused by human papillomavirus (HPV) and are preventable with HPV vaccination and screening through Papanicolaou (Pap) and HPV tests. In Canada, cervical cancer mortality rates have declined in recent decades with more accessible cervical cancer screening programmes. However, screening rates remain low, particularly among Black women and people with a cervix (WPC).

Cervical cancer screening studies of Black WPC in Ontario—Canada’s most populous province—are limited. These studies indicate Black WPCs are at elevated risk for under-screening, with many overdue for screening.

An innovative approach to begin addressing delays is HPV self-sampling (HPVSS). Self-sampling is a cost-effective and more accurate test for detecting high-risk HPV infections associated with precancerous changes versus the Pap test. Self-sampling supports Canada’s action plan—a response to WHO’s global strategy—to eliminate cervical cancer by 2040.

Despite Canada’s plan, research on the state of Black WPCs’ HPV knowledge and self-sampling interventions tailored to them is scant. These scarcities are concerning as Ontario plans to implement HPV primary screening and offer HPVSS soon.

The study objective is to codevelop an HPVSS intervention tailored for and made by Black WPC in Peel region, Ontario. This protocol focuses on phase one of a two-phased study.

Methods and analysis

In phase one, a qualitative, community-informed approach, co-led by community research assistants, will be used to purposively recruit 10 service providers (eg, clinicians, social workers, community care workers) and 40 Black WPC who will undergo one-on-one semistructured interviews and sociodemographic surveys to explore the state of: (1) Black WPC’s level of HPV, cervical cancer and cervical cancer screening knowledge; (2) Black WPC’s motivators, beliefs, attitudes and misconceptions towards HPVSS; (3) Black WPC’s perceived barriers and facilitators to HPVSS and (4) service providers’ perspectives on Black WPC’s barriers and facilitators to HPVSS. Charmaz’s grounded theory approach and intersectionality will guide data collection and analysis.

Ethics and dissemination

Ethical approval has been obtained from the Trillium Health Partners Research Ethics Board (ID#1207). Study findings will be disseminated through community healthcare events, conference presentations, peer-reviewed publications and virtual and physical pamphlets. Additionally, summaries of the findings will be shared and tailored to collaborators, healthcare leadership and researchers and community health centres. Wide dissemination will help enhance understanding of the state of cervical cancer screening, HPV and HPVSS among Black WPC. Given Canada’s commitment to eliminating cervical cancer, study findings will be used to begin developing an HPVSS intervention for Black communities.

Cost-effectiveness of osteoporotic fracture risk assessment in people with intellectual disabilities: a UK NHS modelling study

Por: Png · M. E. · Frighi · V. · Holt · T. A. · Achana · F. · Smith · M. C. · Collins · G. S. · Roast · J. · Petrou · S.
Objectives

We compared the cost-effectiveness of alternative fracture risk assessment strategies for people with intellectual disabilities (ID) aged ≥40 years from a UK National Health Services perspective over a lifetime horizon.

Design

Cost-effectiveness analysis using a lifetime decision-analytical model.

Setting

UK primary care, with data from literature and national databases.

Participants

People with ID.

Interventions

Three strategies were assessed: (S1) Risk assessment using the UK QFracture score; (S2) use of IDFracture (a fracture risk prediction tool specifically developed for adults with ID); and (S3) conducting a one-time dual-energy X-ray absorptiometry (DXA) scan in all. S1 and S2 were followed by DXA scan for those at risk. At-risk individuals received treatment according to UK practice (bisphosphonates plus vitamin D and calcium for osteoporosis, and vitamin D and calcium alone for osteopenia).

Primary outcome measures

Direct healthcare costs and quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

Results

In the base case, S2 (ICER: –£2568/QALY) was dominant (ie, less costly and more effective) and S3 (ICER: £1678/QALY) was cost-effective relative to S1 for major osteoporotic fracture (MOF). For hip fracture, S2 (ICER: £32 116/QALY) and S3 (ICER: £49 536/QALY) were not cost-effective relative to S1 under the National Institute for Health and Care Excellence-recommended cost-effectiveness thresholds. Findings from the sensitivity analyses were predominantly consistent with the base-case results. Subgroup analyses showed that age-specific and gender-specific strategies could be used.

Conclusion

For people with ID aged ≥40 years, a proactive approach to risk assessment for MOF is not only clinically beneficial, but also cost-effective.

Effectiveness of Virtual Baithak, an mHealth intervention to improve eye health literacy for the older adults in India: a protocol for a randomised controlled trial

Por: Rastogi · H. · Sarkar · D. · Rohilla · L. · Kumar · S. · Goyal · A. · Rana · G. S. · Singh · R. · Goyal · A. · Saini · S. K. · Gupta · V. · Pandav · S. · Duggal · M.
Introduction

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

Methods and analysis

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

Ethics and dissemination

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

Trial registration number

CTRI/2023/02/049383, dated 1 February 2023.

Perceived stress and coping strategies impact functional status and symptom severity in patients with carpal tunnel syndrome

Por: Bergeron · D. · Deli · G. S.

Commentary on: Asal MGR, Atta MHR, Abdelaliem SMF, et al. Perceived stress, coping strategies, symptoms severity and function status among carpal tunnel syndrome patients: a nurse-led correlational study. BMC Nurs 2024; 23: 83.

Implications for practice and research

  • Healthcare professionals should address stress management and coping skills in patients with carpal tunnel syndrome (CTS), as they impact symptom severity and functional status.

  • Research should examine the role of nurses in managing stress and developing coping skills in patients with CTS, as limited knowledge about chronic pain and psychosocial issues may limit their impact.

  • Context

    Carpal tunnel syndrome (CTS) has become one of the most prevalent occupational health problems1 and represents a major burden for individuals, employers1 2 and healthcare systems.1 The need to consider psychosocial factors such as stress and coping strategies is increasingly recognised...

    Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

    Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
    Introduction

    Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

    Methods and analysis

    This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

    A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

    Ethics and dissemination

    This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

    Trial registration number

    NCT06093217.

    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.

    Multiarm multistage randomised controlled trial of inflammatory signal inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic

    Por: Hazell · L. · Pillay · C. · Cornelius · V. · Phillips · R. · Charania · A. · Wason · J. · Cherlin · S. · Savic · S. · Whittington · A. · Neelakantan · P. · Collini · P. · Cook · L. · Willicome · M. · Milojkovic · D. · Kon · O. M. · Youngstein · T. · Innes · A. · Thursz · M. · Cooke · G. S.
    Objectives

    To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.

    Design

    Adaptive multiarm, multistage, randomised, open-label trial (three arm, two stage).

    Setting

    Five hospitals in England between October 2020 and September 2022.

    Participants

    Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified WHO COVID-19 severity grade of 3 or 4.

    Interventions

    Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day for 7 days) or SOC.

    Main outcome measures

    Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAEs).

    Results

    At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX progressed to stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, n=62) developed severe COVID-19 pneumonia in the RUX arm compared with 15 (24.6%, n=61) in the SOC arm (aOR: 0.63; 95% CI 0.25 to 1.57; p=0.161). Four (7.4%) participants in the FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only.

    Conclusions

    We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.

    Trial registration number

    NCT04581954; EUDRA-CT: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001750-22/GB.

    Determinants of treatment decisions in advanced dementia: a protocol for a cross-cultural mixed-methods study

    Por: Lima · J. P. · Mbuagbaw · L. · Prasad · M. · Kumar · A. · Wafeu · G. S. · Bonnet · R. · Agoritsas · T. · Li · S. · Liu · Z. · Alonso-Coello · P. · Akio Nishijuka · F. · Mirza · R. · Matos Silva · C. · Alshanketi · R. · Alsahafi · I. · Alnuaimi · A. · Heen · A. F. · Schwartz · L. · Guyatt
    Introduction

    Values and preferences are key determinants of optimal care, and variability in patient values and preferences often dictates differences in patient management. Clinicians’ views of patients’ values and preferences may differ across cultural aspects and stage of training, but the extent to which this is the case remains uncertain. One key value and preference issue is the trade-off between quantity and quality of life, and this issue is particularly prominent among patients with dementia. We therefore propose to investigate the extent to which physicians’ perceptions of optimal management for patients living with advanced dementia may differ due to cross-cultural factors and stage of medical training.

    Methods and analysis

    We will conduct a sequential explanatory mixed-methods study (QUAN -> qual). First, we will administer paper-based or electronic surveys during educational sessions, conferences and rounds to medical students, residents and physicians in ten countries, either in person or online. Following that, a qualitative inquiry, guided by the findings of the quantitative study and the principles of the interpretive description design, will inform an in-depth exploration of the predictive factors identified in the quantitative data analysis.

    Ethics and dissemination

    The Hamilton Integrated Research Ethics Board at McMaster University has approved this study (approval number 2024-17651). We will disseminate our findings in peer-reviewed publications and present results at conferences as oral and poster presentations.

    Effect size and event rate estimation in neurocritical care randomised clinical trials: a protocol for a systematic review

    Por: Shrestha · G. S. · Kitisin · N. · Talbot · P. · Linke · N. · Taylor · J. D. · Battistuzzo · C. R. · Serpa Neto · A. · Higgins · A. · Jeffcote · T. · Cooper · D. J. · Udy · A. A.
    Introduction

    Effect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.

    Methods and analysis

    We will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.

    Ethics and dissemination

    As this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.

    PROSPERO registration number

    CRD420251106394.

    Translation and content validity of the Arabic Communication and Symbolic Behaviour Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist

    Por: Al-Bluwi · G. S. M. · Masuadi · E. · Marquis · A. · Al-Rifai · R. H. · Elbarazi · I. · Ahmed · L. A.
    Objective

    The Communication and Symbolic Behaviour Scales Developmental Profile Infant–Toddler Checklist (CSBS DP ITC) is a screening tool designed to identify early deficits in social communication, expressive speech/language and symbolic functioning in children aged 6–24 months. This study aimed to translate and content validate the CSBS DP ITC into Modern Standard Arabic.

    Design

    Methodological study involving translation and content validation.

    Setting

    The study was conducted in the United Arab Emirates.

    Participants

    The translation process involved five bilingual translators and one monolingual Arabic language expert. Ten experts participated in the content validation phase, and 10 parents of young children participated in the face validity assessment.

    Outcome measures

    Content Validity Indices (CVIs), including the Item-level CVI (I-CVI), the Scale-level CVI by Average (S-CVI/Ave) and the S-CVI by Universal Agreement (S-CVI/UA), along with modified kappa statistics, were calculated to assess item-level and scale-level clarity, relevance and comprehensiveness.

    Results

    Expert panel ratings showed high clarity (I-CVI: 0.8–1, S-CVI/Ave: 0.98, S-CVI/UA: 0.88) and similar relevance scores. Face validity assessments yielded clarity I-CVI scores of 0.9–1, with S-CVI/Ave at 0.98 and S-CVI/UA at 0.8. The modified kappa statistic ranged from 0.89 to 1, indicating strong agreement among parents.

    Conclusions

    The CSBS DP ITC was effectively translated and content validated into Modern Standard Arabic. The calculated CVI values ranged from excellent to acceptable. This step establishes a foundation before proceeding to full psychometric testing of the instrument, paving the way for a reliable and culturally appropriate tool to identify early communication delays for use across the Arab-speaking population.

    Burden and predictors of age-related macular degeneration among old age patients with diabetes attending comprehensive specialised hospitals in Northwest Ethiopia: a multicentre cross-sectional prospective study

    Por: Shumye · A. F. · Desalegn · G. K. · Tegegn · M. T. · Worku · E. M. · Lorato · M. M. · Bogale · Z. M. · Tegegne · M. M. · Alimaw · Y. A. · Mengistu · H. G. · Bekele · M. M. · Bayabil · A. Z. · Birhan · G. S. · Eticha · B. L.
    Objective

    This study aims to assess the burden and predictors of age-related macular degeneration (AMD) among older age patients with diabetes attending comprehensive specialised hospitals in Northwest Ethiopia.

    Design

    A multicentre cross-sectional study was conducted among older patients with diabetes using a systematic random sampling technique.

    Setting

    The study was conducted at five comprehensive specialised hospitals in Northwest Ethiopia from 8 May to 8 June 2023.

    Participants

    The study included 832 diabetic individuals aged 40 years and above.

    Main outcome measures

    Data were collected using a pretested structured questionnaire and physical examinations.

    Result

    In this study, a total of 832 participants were involved, with a response rate of 96.85%. The burden of AMD was 15.4% (95% CI 13.0% to 18.0%). Male sex (adjusted OR (AOR) 2.04, 95% CI 1.17 to 3.56), older age (AOR 6.91, 95% CI 3.17 to 15.08), diabetes duration of 10 and more years (AOR 3.00, 95% CI 1.91 to 4.69), higher body mass index (AOR 2.56, 95% CI 1.15 to 5.71), presence of hypertension (AOR 2.45, 95% CI 1.56 to 3.85) and family history of diabetes mellitus (DM) (AOR 2.29, 95% CI 1.40 to 3.76) were positively associated with AMD.

    Conclusions

    This study found that the prevalence of AMD among patients with diabetes was 15.4%. Older age, male sex, longer DM duration, higher body mass index, presence of hypertension and family history of DM were significantly associated with AMD. Targeted screening of at-risk individuals for AMD, public health awareness campaigns focusing on these factors and further research to understand the burden and underlying mechanisms of these associations with AMD are recommended.

    Automatic uterus segmentation in transvaginal ultrasound using U-Net and nnU-Net

    by Dilara Tank, Bianca G. S. Schor, Lisa M. Trommelen, Judith A. F. Huirne, Iacer Calixto, Robert A. de Leeuw

    Purpose

    Transvaginal ultrasound (TVUS) is pivotal for diagnosing reproductive pathologies in individuals assigned female at birth, often serving as the primary imaging method for gynecologic evaluation. Despite recent advancements in AI-driven segmentation, its application to gynecological ultrasound still needs further attention. Our study aims to bridge this gap by training and evaluating two state-of-the-art deep learning (DL) segmentation models on TVUS data.

    Materials and methods

    An experienced gynecological expert manually segmented the uterus in our TVUS dataset of 124 patients with adenomyosis, comprising still images (n = 122), video screenshots (n = 472), and 3D volume screenshots (n = 452). Two popular DL segmentation models, U-Net and nnU-Net, were trained on the entire dataset, and each imaging type was trained separately. Optimization for U-Net included varying batch size, image resolution, pre-processing, and augmentation. Model performance was measured using the Dice score (DSC).

    Results

    U-Net and nnU-Net had good mean segmentation performances on the TVUS uterus segmentation dataset (0.75 to 0.97 DSC). We observed that training on specific imaging types (still images, video screenshots, 3D volume screenshots) tended to yield better segmentation performance than training on the complete dataset for both models. Furthermore, nnU-Net outperformed the U-Net across all imaging types. Lastly, we report the best results using the U-Net model with limited pre-processing and augmentations.

    Conclusions

    TVUS datasets are well-suited for DL-based segmentation. nnU-Net training was faster and yielded higher segmentation performance; thus, it is recommended over manual U-Net tuning. We also recommend creating TVUS datasets that include only one imaging type and are as clutter-free as possible. The nnU-Net strongly benefited from being trained on 3D volume screenshots in our dataset, likely due to their lack of clutter. Further validation is needed to confirm the robustness of these models on TVUS datasets. Our code is available on https://github.com/dilaratank/UtiSeg.

    Relationship between modifiable factors and late pregnancy physical activity on infant motor development at 12 months of age: findings from a rural city in the Mid-Southern USA

    Por: Tinius · R. · Perera · M. · Hawk · G. S. · Powell · L. · Rajendran · N. · Blankenship · M. M. · Furgal · K.
    Objectives

    To assess the relationship of infant growth, feeding practices and tummy time to their motor development at 12 months, with a special focus on how maternal physical activity during late pregnancy relates to infants’ motor skills.

    Design

    Longitudinal study.

    Setting

    Rural city in the Mid-Southern USA.

    Participants

    16 singleton pregnant women in the third trimester and their term infants were recruited, excluding mother–infant pairs with health issues that impact infants’ motor development and restrict mothers’ physical activity.

    Primary and secondary outcome measures

    Maternal physical activity and sedentary time during the third trimester were measured using Actigraph activity monitors. Labour nurses measured neonatal birth weight and length using standard procedures. Infants’ motor percentiles at 4 and 12 months were measured respectively using the Alberta Infant Motor Scale and Peabody Developmental Motor Scales II test by a licensed paediatric physical therapist. Feeding practices, infants’ time spent in different positions and family composition were evaluated separately at 4 and 12 months using a study-specific survey.

    Results

    Infant motor percentiles at 4 months were positively associated with their 12-month motor percentiles (r=0.649, p=0.009). For each additional percentile at 4 months, the mean 12-month percentile increased by 0.4. Motor percentiles at 12 months were also positively associated with infants’ birth weight (r=0.553, p=0.026) and length (r=0.637, p=0.008), but not significantly associated with tummy time (r=–0.069, p=0.840). Infant motor percentiles at 12 months were not associated with time spent sedentary (r=–0.134, p=0.634), light activity (r=0.213, p=0.447) or moderate activity (r=–0.050, p=0.858) during the third trimester. At 12 months, breastfeeding status (p=0.576) and having siblings (p=0.230) were not related to motor scores.

    Conclusions

    Motor percentiles at 4 months, birth weight and length correlated with motor skills at 12 months, whereas tummy time, siblings, and breastfeeding were not significant predictors. Physical activity during pregnancy did not significantly correlate to motor skills at 12 months.

    Head-to-head comparison of the RMI and ADNEX models to estimate the risk of ovarian malignancy: a systematic review and meta-analysis of external validation studies

    Por: Barrenada · L. · Ledger · A. · Kotlarz · A. · Dhiman · P. · Collins · G. S. · Wynants · L. · Verbakel · J. Y. J. · Valentin · L. · Timmerman · D. · Van Calster · B.
    Objectives

    Assessment of Different NEoplasias in the adneXa (ADNEX) and Risk of Malignancy Index (RMI) are models that estimate the risk of malignancy in ovarian masses based on clinical and ultrasound information. The aim is to perform a meta-analysis of studies that compared the performance of the two models in the same patients (‘head-to-head comparison’).

    Design

    Systematic review and meta-analysis.

    Data sources

    Systematic literature search from publication of ADNEX model (15/10/2014) up to 31/07/2024 in Embase, Web of Science, Scopus, Medline (via PubMed) and EuropePMC.

    Eligibility criteria for selecting studies

    We included all studies that externally validated the performance of ADNEX (with or without CA125) and RMI on the same data.

    Data extraction and synthesis

    Two independent reviewers extracted data using a standardised extraction sheet. We assessed risk of bias using PROBAST. We performed random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and clinical utility (net benefit, relative utility and probability of being useful in a hypothetical new centre) at thresholds commonly used clinically (10% risk of malignancy for ADNEX, 200 for RMI).

    Results

    We included 11 studies comprising 8271 tumours. Most studies were at high risk of bias. The summary AUC to distinguish benign from malignant tumours in operated patients for ADNEX with CA125 was 0.92 (95% CI 0.90 to 0.94) and for RMI it was 0.85 (0.81 to 0.89). Sensitivity and specificity for ADNEX with CA125 were 0.93 (0.90 to 0.96) and 0.77 (0.71 to 0.81) and for RMI, they were 0.61 (0.56 to 0.67) and 0.92 (0.89 to 0.94). The probability of the test being useful in a hypothetical new centre in operated patients was 96% for ADNEX with CA125 and 15% for RMI at the selected thresholds.

    Conclusions

    ADNEX has better discrimination and clinical utility than RMI.

    Eye check-up practice and its associated factors among adult diabetic patients attending primary hospitals of Central Gondar Zone, Northwest Ethiopia, 2024: a cross-sectional multicentre study

    Por: Desalegn · G. K. · Birhan · G. S. · Bogale · Z. M. · Assefa · A. L.
    Objectives

    This study aimed to assess eye check-up practice and associated factors among patients with diabetes attending primary hospitals in the Central Gondar Zone, Northwest Ethiopia.

    Design

    A multicentre hospital-based cross-sectional study.

    Setting

    This study was conducted at primary hospitals in Central Gondar Zone, Northwest Ethiopia, from 10 June 2024 to 10 July 2024.

    Participants

    The study included 689 consecutive adult patients with diabetes who met the inclusion criteria.

    Primary and secondary outcome measures

    Participants were diagnosed with diabetes mellitus by a general practitioner. Optometrists conducted interviews, reviewed medical records and administered a pretested, structured questionnaire. Binary logistic regression was performed to identify associated factors, with significance considered at a p

    Results

    A total of 689 participants were involved in this study, with a response rate of 98.4%. The proportion of good eye check-up practice was 20.6% (95% CI: 17.6% to 23.8%). Factors associated with good eye check-up practice included urban residence (adjusted OR, AOR=4.10, 95% CI: 1.72 to 9.82), diabetes duration of 12+ years (AOR=4.98, 95% CI: 1.43 to 17.38), previous eye disease (AOR=3.78, 95% CI: 1.79 to 7.95), good knowledge of diabetic retinopathy (AOR=3.22, 95% CI: 1.42 to 7.29), higher family income (AOR=3.80, 95% CI: 1.27 to 11.36), referral from a diabetic clinic (AOR=3.48, 95% CI: 1.58 to 7.67) and a favourable attitude (AOR=3.75, 95% CI: 1.46 to 9.65).

    Conclusions

    This study revealed a low proportion of good eye check-up practices among patients with diabetes. Urban residency, longer duration of diabetes, higher income, clinic referrals, history of eye disease, knowledge of diabetic retinopathy and a favourable attitude were significantly associated with good eye check-up practices. Therefore, targeted health education and strengthened referral systems are recommended to improve regular eye check-up practices among individuals with diabetes.

    Comorbidity prevalence and healthcare costs in people living with HIV compared with the general population: a 19-year retrospective cohort study in British Columbia, Canada

    Por: Magee · C. · Nathani · H. · Chan · M. · Takeh · B. · Budu · M. · Kooij · K. W. · Hogg · R. S. · Guillemi · S. · Montaner · J. G. S. · Lima · V. D.
    Objectives

    Our objectives were (1) to characterise the age-sex-standardised prevalence of comorbidities among people living with HIV (PLWH) and people not living with HIV (PnLWH) between 2001 and 2019 and (2) to examine the effect of comorbidities on direct healthcare costs among PLWH and PnLWH.

    Design

    This was a retrospective, matched cohort study conducted with the Comparative Outcomes and Service Utilisation Trends (COAST) cohort, which contained all known PLWH in British Columbia (BC), Canada and a general population sample.

    Setting

    BC, Canada.

    Participants

    A total of 9554 PLWH and 47 770 PnLWH from the COAST cohort were followed between 2001 and 2019. Participants were at least 19 years old and 82% male in both groups.

    Outcome measures

    The primary outcomes were the age-sex-standardised prevalence of 16 comorbidities, calculated annually, among PLWH and PnLWH. Secondary outcomes included direct healthcare costs associated with each comorbidity among PLWH and PnLWH. Outcomes were ascertained from administrative health databases.

    Results

    PLWH exhibited a higher age-sex-standardised prevalence of most comorbidities compared with PnLWH over the study period. Relative disparities in liver and kidney diseases markedly decreased since 2008. Disparities in the prevalence of mental health disorders and substance use disorder (SUD) were consistently large throughout the study period. Comorbidities were associated with high healthcare costs, especially among PLWH.

    Conclusions

    This study underscores the persistent and evolving burden of non-AIDS-defining comorbidities among PLWH, even in the context of improved HIV management. The high prevalence of mental health disorders and SUD, coupled with the substantial healthcare costs associated with these conditions, emphasises the need for holistic and integrated care models that address the full spectrum of health challenges faced by PLWH.

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