EClinicalMedicine最新文献

{"title":"Reimagining global health architecture for a sustainable future.","authors":"eClinicalMedicine","doi":"10.1016/j.eclinm.2025.103532","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103532","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103532"},"PeriodicalIF":10.0,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of focused lung ultrasound on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice (PLUS-FLUS): a pragmatic, randomised controlled, post-market trial.","authors":"Julie Jepsen Strøm, Camilla Aakjær Andersen, Martin Bach Jensen, Janus Laust Thomsen, Christian B Laursen, Søren Helbo Skaarup, Hans Henrik Lawaetz Schultz, Malene Plejdrup Hansen","doi":"10.1016/j.eclinm.2025.103518","DOIUrl":"10.1016/j.eclinm.2025.103518","url":null,"abstract":"<p><strong>Background: </strong>Antimicrobial resistance is a growing global concern. Antibiotic use is the main driver and rational use is essential. General practitioners (GPs) prescribe most antibiotics for patients with acute lower respiratory tract infections (LRTI). This trial assessed whether focused lung ultrasound (FLUS) added to usual care in general practice could reduce antibiotic prescribing at the index consultation.</p><p><strong>Methods: </strong>In this pragmatic, randomised, post-market, superiority trial, adults presenting with acute cough and at least one other symptom of acute LRTI, in whom the GP suspected pneumonia, were invited to participate. 34 GPs across 28 Danish office-based general practice clinics recruited participants. Patients were randomly assigned 1:1, stratified by GP, to receive either usual care (controls), reflecting current standard examination and care, or usual care supplemented with FLUS. The primary outcome was the proportion and relative risk (RR) of patients having antibiotics prescribed at the index consultation. Outcome assessors were blinded to group allocation. All patients were included in the intention-to-treat analyses. The trial was registered at ClinicalTrials.gov (NCT06210282).</p><p><strong>Findings: </strong>Between November 1, 2023, and July 10, 2024, 390 patients were enrolled and analysed; 192 were assigned to the FLUS group. In the usual care group (n = 198), 81 patients (41%) were prescribed antibiotics at the index consultation compared with 69 (36%) in the FLUS group (n = 192; RR 0·88, 95% CI: 0·68-1·14). No evidence of harm was identified with the addition of FLUS to usual care.</p><p><strong>Interpretation: </strong>Addition of FLUS did not lead to a 15% or larger reduction in antibiotic prescribing at the index consultation. Routine implementation of FLUS in this patient population is not supported by the findings. However, no evidence of harm was observed with the addition of FLUS.</p><p><strong>Funding: </strong>The Health Foundation, The Foundation for General Practice, The Lung Association's Research Fund, and regional committees for Quality and Education.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103518"},"PeriodicalIF":10.0,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Luvometinib in patients with Langerhans cell histiocytosis, Erdheim-Chester disease, and other histiocytic neoplasms: a single-arm, multicentre, phase 2 study.","authors":"Xin-Xin Cao, Qi Zhu, Zhen Cai, Jie Ma, Hui Zhou, Long Chang, Lai-Ping Zhong, Zhu-Li Wu, Xingli Wang, Pu Han, Hong-Mei Lin, Zhen Wei, Jia-Yan Guo, Yang Zheng, Jian Li","doi":"10.1016/j.eclinm.2025.103486","DOIUrl":"10.1016/j.eclinm.2025.103486","url":null,"abstract":"<p><strong>Background: </strong>Histiocytic neoplasms are a heterogeneous group of haematologic disorders marked by a high frequency of mutations in the somatic mitogen-activated protein kinase pathway. This single-arm, multicentre, phase 2 study evaluated the efficacy and safety of the selective MEK1/2 inhibitor luvometinib in adult patients with histiocytic neoplasms.</p><p><strong>Methods: </strong>Patients (aged >16 years), regardless of tumour genotype and who were either treatment-naïve or relapse/refractory, were enrolled and received oral luvometinib, 8 mg, once daily in 28-day cycles until disease progression, death, unacceptable toxicity, withdrawal of consent, or end of the study. The primary end point was overall response rate (ORR) assessed by an independent review committee according to positron emission tomography response criteria. This trial was registered with chinadrugtrials.org.cn (CTR20221069) and chictr.org.cn (ChiCTR2300067955).</p><p><strong>Findings: </strong>Between June 27, 2022 and February 2, 2024, 30 patients were enrolled; they were followed up for a median duration of 16.2 months (range, 1.5-19.3). In 29 evaluable patients, 22 (75.9%) had Langerhans cell histiocytosis, 3 (10.3%) had Erdheim-Chester disease, and 4 (13.8%) had other subtypes. Most (86.2%) patients had previously received systemic therapy and 27.6% had received ≥3 lines. With a median follow-up of 16.2 months, the ORR was 82.8% (95% CI, 64.2-94.2), with a median time to response of 2.9 months (range, 2.6-6.0) and median duration of response not reached. The 12-month progression-free survival rate was 74.4% (95% CI, 49.8-88.2). Grade ≥3 treatment-emergent adverse events occurred in 13 (43.3%) patients, with folliculitis (10.0%), hypertriglyceridemia (10.0%), and blood creatine phosphokinase increased (6.7%) occurring in more than one patient. No treatment-emergent adverse events led to treatment discontinuation.</p><p><strong>Interpretation: </strong>Luvometinib demonstrated high and durable responses and a manageable safety profile in patients with histiocytic neoplasms.</p><p><strong>Funding: </strong>Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103486"},"PeriodicalIF":10.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antitubercular therapy for uveitis of undetermined cause with positive interferon-gamma release assay: a single-blind, single-centre, phase 2 randomised controlled trial.","authors":"Rina La Distia Nora, Ikhwanuliman Putera, Mei Riasanti, Ratna Sitompul, Lukman Edwar, Made Susiyanti, Yulia Aziza, Muhammad Zakiy Waliyuddin, Erica Widodo, Ulifna Alfiya Sifyana, Priscilla Jessica, Rachel Ethelind, Gurmeet Singh, Willem A Dik, Saskia M Rombach, P Martin van Hagen","doi":"10.1016/j.eclinm.2025.103511","DOIUrl":"10.1016/j.eclinm.2025.103511","url":null,"abstract":"<p><strong>Background: </strong>No randomised controlled trial (RCT) has previously evaluated the effect of antitubercular therapy (ATT) in patients with uveitis of undetermined cause who tested positive on interferon-gamma release assays (IGRA), despite the absence of other identifiable causes of uveitis. We aimed to assess the efficacy and safety of treatment involving ATT compared to treatment without ATT in these patients, with respect to uveitis resolution and reduction in the risk of relapse.</p><p><strong>Methods: </strong>We conducted a single-blind, single-centre, phase 2 RCT at the uveitis clinic of Cipto Mangunkusumo Hospital in Jakarta, Indonesia, from August 16, 2021, to February 5, 2024. Seventy-six adults with newly diagnosed, active uveitis of undetermined cause and a positive IGRA were randomised 1:1 using block randomisation (block size 4) into two groups. Participants in the ATT group received an additional full course of ATT in addition to systemic corticosteroids. The control group received systemic corticosteroids without ATT. Investigators were masked to group assignment. The primary endpoint was the complete resolution of uveitis six months after randomisation. The trial is registered at ClinicalTrials.gov (NCT05005637).</p><p><strong>Findings: </strong>Seventy-six participants were randomly assigned to either ATT (n = 37) or control (n = 39) group. At primary end point, more participants assigned to the ATT group achieved the primary outcome of complete uveitis resolution compared to the control group (30/37, 81.1% vs. 20/39 participants; 51.3%, relative risk [RR] 1.58, 95% CI 1.12-2.23, <i>p</i> = 0.0060). Over the subsequent follow-up period, complete uveitis resolution was observed in 34 and 24 participants assigned to the ATT and the control groups, respectively. Additionally, uveitis relapse occurred in fewer participants assigned to the ATT group compared to those assigned to the control group (2/34 participants, 5.9% vs. 7/24 participants, 29.2%; HR 0.20, 95% CI 0.05-0.89, <i>p</i> = 0.0210). The findings regarding uveitis resolution and relapse rates were consistent in the per-protocol analysis.</p><p><strong>Interpretation: </strong>In IGRA-positive patients with uveitis of undetermined cause, initial treatment with ATT resulted in a significant benefit over those not receiving ATT.</p><p><strong>Funding: </strong>This work was supported by RISPRO-LPDP (Riset Inovatif Produktif-Lembaga Pengelola Dana Pendidikan).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103511"},"PeriodicalIF":10.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12475421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promoting motor recovery after stroke using cortico-cortical paired associative stimulation.","authors":"Domiziana Falaschi, Charlotte Stagg, Alejandra Sel","doi":"10.1016/j.eclinm.2025.103473","DOIUrl":"10.1016/j.eclinm.2025.103473","url":null,"abstract":"<p><p>Stroke is the most prevalent neurological disorder, the primary cause of long-term disability, and the second leading cause of mortality. Post-stroke motor symptoms critically impact and limit stroke survivors' quality of life. Rehabilitation aims to restore motor function by promoting neuroplasticity and neuronal reorganisation. A promising therapeutic approach involves combining non-invasive brain stimulation (NIBS) with activity-based training to enhance neuroplasticity. NIBS are thought to promote the innate neuronal reorganisation of the functionally relevant networks after a stroke. Amongst NIBS techniques, a pioneering method, often referred to as cortico-cortical paired associative stimulation (ccPAS), allows to enhance neuroplasticity in cortical networks. Unlike traditional approaches, ccPAS enables the manipulation of interregional connectivity within specific cortical pathways. In particular, ccPAS can promote synaptic plasticity and connectivity in a functionally relevant cortico-cortical route tailoring the interventions to individual lesion-specific network alterations. In this viewpoint, we propose and critically evaluate the use of ccPAS as a therapeutic tool using upper-limb motor rehabilitation as a primary example, highlighting its potential for post-stroke recovery. We summarise the limited and contrasting evidence supporting the use of ccPAS after a stroke and make suggestions to overcome the current limitations emphasising the need for further future research.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103473"},"PeriodicalIF":10.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing differences in country-level estimates of maternal mortality: a comparison of GMatH, UN, and GBD model results for 2020.","authors":"Zachary J Ward, Rifat Atun, Gary King, Brenda Sequeira Dmello, Sue J Goldie","doi":"10.1016/j.eclinm.2025.103505","DOIUrl":"10.1016/j.eclinm.2025.103505","url":null,"abstract":"<p><strong>Background: </strong>Estimates of maternal mortality are important for informing policy and resource allocation, both globally and for individual countries, and to track progress towards Sustainable Development Goals. The Global Maternal Health (GMatH) model was developed for policy analysis and produces global and country-level estimates of maternal mortality. Estimates are also produced by models from the United Nations (UN) and Global Burden of Disease (GBD).</p><p><strong>Methods: </strong>We compared country-level estimates for 2020 of maternal deaths and the maternal mortality ratio (MMR) across the UN (v2023), GBD (v2021), and GMatH (v2023) models. We summarized the differences, assessed model convergence, and characterized the available empirical mortality data for countries with large differences to shed light on potential reasons for these differences.</p><p><strong>Findings: </strong>On average, the GMatH estimates of country-level maternal deaths in 2020 were 272 larger (43% higher) than the UN estimates, and 728 larger (49% higher) than the GBD estimates. Country-level MMRs were on average 22.3 higher (19% higher) than the UN estimates and 48.1 higher (22% higher) than the GBD estimates. Overall, 87.9% of the UN country-level MMR estimates were convergent with the GMatH model, and 82.8% of the GBD MMR estimates were convergent, but large differences were found for some countries. Among countries with the largest differences across models, survey-based estimates of the pregnancy mortality ratio were usually the only empirical mortality data available.</p><p><strong>Interpretation: </strong>Although estimates of maternal mortality are similar across the GMatH, UN, and GBD models for most countries, there are also large differences. Our structural modelling approach leverages multiple types of data across the reproductive life course, including pregnancy mortality ratios, allowing for more robust estimation of maternal health indicators. Comparing results across models helps to build confidence in estimates where they are similar and sheds light on potential reasons for differences where they diverge to help refine estimates and guide policies to reduce maternal mortality.</p><p><strong>Funding: </strong>John D. and Catherine T. MacArthur Foundation, 10-97002-000-INP.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103505"},"PeriodicalIF":10.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12475481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic performance of HIV risk assessment tools for identifying pre-exposure prophylaxis candidates: a systematic review and meta-analysis.","authors":"Myo Minn Oo, Monica Rudd, Caley Shukalek, Teruko Kishibe, Mark Hull, Darrell H S Tan","doi":"10.1016/j.eclinm.2025.103487","DOIUrl":"10.1016/j.eclinm.2025.103487","url":null,"abstract":"<p><strong>Background: </strong>To support the implementation of HIV pre-exposure prophylaxis (PrEP), we conducted a systematic review and meta-analysis evaluating the diagnostic performance of HIV risk assessment tools in predicting HIV infection.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, and CINAHL for observational studies published between January 1, 1998, and May 13, 2024 that reported on the diagnostic performance of HIV risk assessment tools. We calculated pooled area under the curve (pAUC) values using inverse variance methods, with sensitivity and specificity reported at common cutoffs (PROSPERO registration number: CRD42024543975).</p><p><strong>Findings: </strong>Of 3704 publications, 27 met our criteria. Twelve studies on men who have sex with men (MSM) assessed nine tools, with four extensively validated, predominantly in U.S. populations. SexPro exhibited the highest performance (pAUC: 0.75), while HIRI-MSM (pAUC: 0.69), Menza (pAUC: 0.63), and SDET (pAUC: 0.66) demonstrated moderate predictive ability, with considerable heterogeneity. For cisgender women, twelve African studies evaluated six tools, with VOICE being the only extensively validated tool (pAUC: 0.65 for adult females; 0.62 for adolescent and young women). Although additional tools were available for subgroups within Africa, there were no tools for cisgender women outside Africa. Among other populations, DHRS demonstrated good discrimination for general U.S. adults (pAUC: 0.80), as did the HIV Prevalence Risk Score for African mixed populations (AUC: 0.70), Kahle for heterosexual serodiscordant couples in Africa (pAUC: 0.73), and ARCH-IDU for people who use drugs in the U.S. (pAUC: 0.72). Sensitivity and specificity varied by cutoffs. Tool items fell into six domains: sexual activities, substance use, clinical factors, demographics, reproductive health, and other factors, with complexity differing by population and context.</p><p><strong>Interpretation: </strong>Validated tools can help identify HIV risk in some populations, but tools are still needed to promote equitable PrEP access for subpopulations such as cisgender women outside Africa. Public health programs and clinicians should consider incorporating up-to-date, local data to enhance the relevance and effectiveness of existing tools.</p><p><strong>Funding: </strong>This work was supported by the Canadian Institutes of Health Research (Grant number PCS - 183410). DHST is supported by a Tier 2 Canada Research Chair in Biomedical HIV/STI Prevention.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"88 ","pages":"103487"},"PeriodicalIF":10.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12475485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term safety of mid-urethral sling for stress urinary incontinence in women: an emulated trial using French national health data system.","authors":"Cyrille Guillot-Tantay, Sylvie Guillo, Minh Hoang Thuy Diep Tran, Yann de Rycke, Agnès Dechartres, Pierre Mozer, Emmanuel Chartier-Kastler, Florence Tubach","doi":"10.1016/j.eclinm.2025.103411","DOIUrl":"10.1016/j.eclinm.2025.103411","url":null,"abstract":"<p><strong>Background: </strong>Mid-urethral sling (MUS) is the most-indicated therapy for treating stress urinary incontinence (SUI) in women. However, serious long-term side effects have escaped post-marketing studies. We aimed to compare two different MUS types, tension-free vaginal tape (TVT) and trans-obturator tape (TOT), in terms of incidence of MUS removal or section after implantation.</p><p><strong>Methods: </strong>We emulated a hypothetical target trial using French national healthcare data (SNDS) and included women who had undergone a first MUS implantation from 2011 to 2018 (Health Data Hub registration no. T16166982020061). The primary outcome was the cumulative incidence of MUS removal or section. Secondary outcomes were the cumulative incidence of MUS removal and section, hospitalization for urinary retention and MUS erosion and infection, and any of these outcomes, as well as reoperation for SUI. We used propensity score-weighted Cox models.</p><p><strong>Findings: </strong>In all, 215,141 women underwent implantation: 170,781 (79.4%) with TOT and 44,360 (20.6%) with TVT. At 5 years, the weighted cumulative incidence of MUS removal or section was lower in the TOT than TVT group (3.25%, 95% confidence interval CI 3.16-3.34 versus 4.13%, 95% CI 3.94-4.33). We observed a time-varying effect ([0-3 months] after implantation [hazard ratio 1.65, 95% CI 1.52-1.78], [3-12 months] after implantation [1.19, 95% CI 1.06-1.32], [1-5 years] after implantation [0.98, 95% CI 0.88-1.1] and ≥5 years after implantation [1.44, 95% CI 1.13-1.85]). MUS removal and section and hospitalization for urinary retention and MUS erosion and infection were significantly more frequent in women with TVT than TOT but second MUS implantation for SUI recurrence was less frequent.</p><p><strong>Interpretation: </strong>The risk of MUS removal or section was higher after TVT than TOT, with a time-varying effect, in this hypothetical target trial.</p><p><strong>Funding: </strong>This study was funded by a grant from the French Ministry of Health.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103411"},"PeriodicalIF":10.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analyzing caesarean sections through the Robson classification in Nigeria: a prospective nationwide study in referral level facilities.","authors":"Tina Lavin, Amaka N Ocheke, Ana Pilar Betran, Abiodun S Adeniran, Eziamaka Ezenkwele, Duum C Nwachukwu, Luz Gibbons, Aisha Abdurrahman, Sulaiman Muhammad Deneji, Akpanika Chinyere, Adewale Ashimi, Rais Ibraheem, Odward Elusoji Jagun, Innocent Anayochukwu Ugwu, Olufemi Aworinde, Agada Egwu, Sunday Ochigbo, Timothy A O Oluwasola, Aniekan Abasiattai, Anthonia Inibokun Njoku, Lawal Magaji, Peter Aboyeji, Hadiza Galadanci, Calvin Chama, Saturday Etuk, Joseph Ikechebelu, Olubukola Adesina, Jamilu Tukur","doi":"10.1016/j.eclinm.2025.103427","DOIUrl":"10.1016/j.eclinm.2025.103427","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Over the past 30 years, there has been increased concern on rising caesarean section rates. However, the absence of reliable data on appropriateness of caesarean section for women in many countries, including Nigeria, poses a significant obstacle to understanding the use of caesarean and the quality of care surrounding caesarean section. The objective of this study was to analyse the caesarean section rates in specific obstetric populations to better understand the appropriateness of caesarean section by Robson Group in 56 referral-level facilities across Nigeria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Data from 179,463 women who gave birth in 56 referral-level facilities across Nigeria between 1 September 2019 and 31 August 2022 were analysed using the Robson classification and interpreted using the WHO Implementation Manual.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Of the 158,246 women classified by Robson, 52,221 (33%) had caesarean section. Women with previous caesarean section (Group 5) were the largest contributors to overall caesarean section rate, accounting for 27.1% of all caesarean sections. This was followed by women with preterm birth (Group 10-17.1%). Women with term induced labour or those who had a pre-labour caesarean section also made substantial contributions to overall caesarean section rate (Group 2 (nullipara women)-12.8%; Group 4 (multipara women)-12.0%). When examining caesarean section rate within specific obstetric populations, Group 2 and Group 4 (nullipara and multipara women without previous caesarean section) had particularly high caesarean section rates-84.0% and 77.7%, respectively. Most of these were pre-labour caesarean sections: 83.9% (5620/6702) in Group 2 and 90.6% (5676/6263) in Group 4, few women in these obstetric populations had labour induction (16.1% in Group 2; 9.4% in Group 4). Among nulliparous women undergoing pre-labour caesarean section the main indications were hypertensive disorders (18.9%) and suspected contracted/inadequate pelvis (13.2%). For multiparous women, hypertensive disorders (15.0%) and placental conditions (11.9%) were the leading indications. Group 2a and Group 4a (women who had induction of labour) also had high caesarean section rates-45.9% and 24.6%, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;This nationwide programme shows a high caesarean section rate among women with a previous caesarean section, highlighting the importance of appropriate caesarean section use in nulliparous women to prevent caesarean section in future pregnancies. Women with term pregnancies without previous caesarean section had a high rate of caesarean section while the rate of labour induction in the same population of women was low. Among women who had an induction of labour, a substantial proportion had a caesarean section. There may be an opportunity to reduce caesarean rate by strengthening strategies to identify women who are good candidates for induction of labour and by fo","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103427"},"PeriodicalIF":10.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12424238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity.","authors":"Raghavendran Kulasegaran-Shylini, Abbie Bown, Tom Collinge, Alex Sienkiewicz, David W Eyre, Derrick Crook, Ann Sarah Walker, John Bell, Deborah A Williamson, Isabel Oliver, Mark Wilcox, Sue Hill, Tim Peto, Richard Vipond, Susan Hopkins, Tom Fowler","doi":"10.1016/j.eclinm.2025.103454","DOIUrl":"10.1016/j.eclinm.2025.103454","url":null,"abstract":"<p><strong>Background: </strong>Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data.</p><p><strong>Methods: </strong>The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID₅₀]/mL]) from LFD instructions for use (IFU).</p><p><strong>Findings: </strong>UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers' IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity.</p><p><strong>Interpretation: </strong>Laboratory evaluation found no evidence of correlation between manufacturer-reported SARS-CoV-2 LFD sensitivity data and UKHSA laboratory-determined sensitivity, supporting previous reports of discrepancies. Our findings suggest that manufacturer-reported performance data and claims for SARS-CoV-2 LFDs should be interpreted with caution and support the need for independent monitoring and testing, and standardisation of analysis methodologies.</p><p><strong>Funding: </strong>This study was funded by UK Department of Health and Social Care; UK Health Security Agency (formerly Public Health England and the National Health Service Test and Trace); and the University of Oxford NIHR Biomedical Research Centre.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103454"},"PeriodicalIF":10.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}