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Evolving trends in lung cancer risk factors in the ten most populous countries: an analysis of data from the 2019 Global Burden of Disease Study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-09 eCollection Date: 2025-01-01 DOI: 10.1016/j.eclinm.2024.103033
Chinmay T Jani, Samuel A Kareff, Dan Morgenstern-Kaplan, Ana S Salazar, Georgina Hanbury, Justin D Salciccioli, Dominic C Marshall, Joseph Shalhoub, Harpreet Singh, Estelamari Rodriguez, Gilberto Lopes
{"title":"Evolving trends in lung cancer risk factors in the ten most populous countries: an analysis of data from the 2019 Global Burden of Disease Study.","authors":"Chinmay T Jani, Samuel A Kareff, Dan Morgenstern-Kaplan, Ana S Salazar, Georgina Hanbury, Justin D Salciccioli, Dominic C Marshall, Joseph Shalhoub, Harpreet Singh, Estelamari Rodriguez, Gilberto Lopes","doi":"10.1016/j.eclinm.2024.103033","DOIUrl":"10.1016/j.eclinm.2024.103033","url":null,"abstract":"<p><strong>Background: </strong>Amid shifting tobacco policies and escalating air pollution levels, Lung Cancer (LC) risk factors have changed notably. Continuous assessment of these risk factors is necessary. This study compares trends in tobacco, air pollution, and asbestos-associated Age-Standardized Mortality Rates (ASMR) from Trachea, Bronchus, and Lung (TBL) Cancer across the top ten most populated countries (2023 censuses) and globally.</p><p><strong>Methods: </strong>We extracted overall and risk-factor-associated TBL cancer ASMR of the ten most populated countries for 1990-2019 from the Global Burden of Disease (GBD) database using the dedicated results tool (http://ghdx.healthdata.org/gbd-results-tool). GBD mapped the mortality data related to ICD codes (C33-C34, D02.1-D02.2, D38.1, 162-162.9, 231.1, 231.2, 231.8, 235.7 from ICD10 and B101 from ICD9). Tobacco, occupational exposure to asbestos and air pollution (ambient particulate matter and household air pollution) associated TBL cancer mortality data were extracted to evaluate the trends based on risk factors. We calculated relative changes in ASMRs between 1990 and 2019 for each sex in each country for each risk factor. Joinpoint regression analysis was performed to calculate the Estimated Annual Percentage Change (EAPC) and its corresponding 95% confidence interval (CI) for each line segment, allowing for trend assessment.</p><p><strong>Findings: </strong>Globally, TBL Cancer mortality has decreased by 8%, with a decrease for males but an increase for females. Globally, both tobacco and air pollution-associated TBL cancer ASMR have decreased. While tobacco-associated ASMR has increased in China and Indonesia, air pollution-associated ASMR has also increased in China, India, Pakistan, and Nigeria. On stratification, while PM-associated mortality increased by 25% globally, household-associated TBL cancer ASMR decreased by 62%. China had the highest PM-associated TBL Cancer in 2019 (8.8/100,000), twice higher than the global average. Despite a decline in asbestos-associated TBL cancer ASMR from 8.91/100,000 to 6.0/100,000, the rate in the United States remained twice higher than the global average for the entire study period.</p><p><strong>Interpretation: </strong>Tobacco-associated TBL cancer mortality is declining but still predominant. Ambient particulate matter-associated TBL cancer mortality is rising, requiring policy and awareness efforts. Expanding access to preventive services and addressing underlying risk factors are essential steps required toward reducing lung cancer mortality at the global level.</p><p><strong>Funding: </strong>This study did not receive any funding support.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103033"},"PeriodicalIF":9.6,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11833020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448590","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}
引用次数: 0
Expression of concern-Effectiveness of strategies for implementing guideline-concordant care in low back pain: a systematic review and meta-analysis of randomised controlled trials.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-08 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103064
The Editors For eClinicalMedicine
{"title":"Expression of concern-Effectiveness of strategies for implementing guideline-concordant care in low back pain: a systematic review and meta-analysis of randomised controlled trials.","authors":"The Editors For eClinicalMedicine","doi":"10.1016/j.eclinm.2024.103064","DOIUrl":"10.1016/j.eclinm.2024.103064","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103064"},"PeriodicalIF":9.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045985","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}
引用次数: 0
Preoperative and intraoperative neuromonitoring and mapping techniques impact oncological and functional outcomes in supratentorial function-eloquent brain tumours: a systematic review and meta-analysis.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-08 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103055
Asfand Baig Mirza, Amisha Vastani, Rishabh Suvarna, Sami Rashed, Aws Al-Omari, Engelbert Mthunzi, Feras Fayez, Nicala Rampersad, Josephine Jung, Alba Díaz Baamonde, José Siado Mosquera, Ali Elhag, Francesco Marchi, Richard Gullan, Keyoumars Ashkan, Ranjeev Bhangoo, Francesco Vergani, Ana Mirallave-Pescador, José Pedro Lavrador
{"title":"Preoperative and intraoperative neuromonitoring and mapping techniques impact oncological and functional outcomes in supratentorial function-eloquent brain tumours: a systematic review and meta-analysis.","authors":"Asfand Baig Mirza, Amisha Vastani, Rishabh Suvarna, Sami Rashed, Aws Al-Omari, Engelbert Mthunzi, Feras Fayez, Nicala Rampersad, Josephine Jung, Alba Díaz Baamonde, José Siado Mosquera, Ali Elhag, Francesco Marchi, Richard Gullan, Keyoumars Ashkan, Ranjeev Bhangoo, Francesco Vergani, Ana Mirallave-Pescador, José Pedro Lavrador","doi":"10.1016/j.eclinm.2024.103055","DOIUrl":"10.1016/j.eclinm.2024.103055","url":null,"abstract":"<p><strong>Background: </strong>Supratentorial function-eloquent brain tumour surgeries challenge the balance between maximal tumour resection and preservation of neurological function. This study aims to evaluate the efficacy of preoperative and intraoperative mapping techniques on resection outcomes and post-operative deficits.</p><p><strong>Methods: </strong>This systematic review and meta-analysis examined literature up to March 2023, sourced from PubMed, Embase, and Medline. Criteria for inclusion were studies on patients undergoing surgery for supratentorial brain tumours, comparing preoperative mapping only (POM), intraoperative neuromonitoring and mapping (IONM), and combined techniques (POM&IONM), excluding non-randomized controlled trials. Data extraction focused on rates of gross total resection (GTR) and focal neurological deficits (FNDs). The main outcomes, assessed through a random-effects model and Cochran's Q-test for subgroup analysis. The study protocol is published on PROSPERO CRD42024512306.</p><p><strong>Findings: </strong>19 studies involving 992 patients were included. Systematic review with meta-analysis revealed a non-significantly higher average GTR rates for POM&IONM (49.13%) and POM (50.79%) compared to IONM alone (41.23%). Highest rates of GTR were achieved with tractography-guided resection in POM group (66.59% versus fMRI-20.00%, <i>p</i> = 0.0004), multimodal stimulation in IONM group (54.16% versus low frequency stimulation (LFS)-13.29%, <i>p</i> < 0.0001) and in POM&IONM group (65.88% versus LFS-37.77%, <i>p</i> = 0.0036). Within the same tumour histology-metastasis, high grade and low grade glioma-there are no differences in the GTR rates achieved in the different groups (<i>p</i> > 0.05). In language-eloquent tumours and in awake craniotomy techniques regardless of tumour functional eloquence, POM&IONM group had higher GTR when compared to IONM groups (language eloquent tumours-POM&IONM 43.31% versus IONM-15.09%, <i>p</i> = 0.022; awake craniotomy technique-POM&IONM-41.22% versus IONM-12.08%, <i>p</i> = 0.0006). Permanent FNDs were higher in the IONM group (IONM-73.0%; POM-29.6%; POM&IONM-33.7% of immediate postoperative deficits, <i>p</i> = 0.0010).</p><p><strong>Interpretation: </strong>A combined POM&IONM approach is responsible for higher rates of GTR in patients with language eloquent tumours and in both awake and asleep craniotomy techniques regardless of the tumour functional eloquence. The tumour histology is not relevant for differences in GTR rates among different mapping and monitoring strategies. Permanent postoperative FNDs are more likely with standalone utilization of IONM.</p><p><strong>Funding: </strong>Not applicable.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103055"},"PeriodicalIF":9.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045988","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}
引用次数: 0
Roads to remission: evolving treatment concepts in type 2 inflammatory diseases.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-08 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103050
Marek Lommatzsch, Katharina Blumchen, Lisa A Beck, Jean Bousquet, Guy G Brusselle, Wytske J Fokkens, Eckard Hamelmann, Susanne Lau, Hagen Ott, Oliver Pfaar, Hugh A Sampson, Josef S Smolen, Christian Taube, Ingo H Tarner, Martin Wagenmann, Thomas Werfel, Margitta Worm, Harald Renz
{"title":"Roads to remission: evolving treatment concepts in type 2 inflammatory diseases.","authors":"Marek Lommatzsch, Katharina Blumchen, Lisa A Beck, Jean Bousquet, Guy G Brusselle, Wytske J Fokkens, Eckard Hamelmann, Susanne Lau, Hagen Ott, Oliver Pfaar, Hugh A Sampson, Josef S Smolen, Christian Taube, Ingo H Tarner, Martin Wagenmann, Thomas Werfel, Margitta Worm, Harald Renz","doi":"10.1016/j.eclinm.2024.103050","DOIUrl":"10.1016/j.eclinm.2024.103050","url":null,"abstract":"<p><p>Non-communicable diseases (NCDs) characterised by type 2 inflammation, including asthma, allergic rhinitis, chronic rhinosinusitis with nasal polyps, atopic dermatitis, food allergies and eosinophilic esophagitis, are increasing in prevalence worldwide. Currently, there is a major paradigm shift in the management of these diseases, towards the concept of disease modification and the treatment goal remission, regardless of severity and age. Remission as a treatment goal in chronic inflammatory NCDs was first introduced in rheumatoid arthritis, and then adopted in other non-type 2 inflammatory diseases. Among diseases with type 2 Inflammation, this concept is novel and currently most advanced in asthma. This new paradigm has been developed based on a better understanding of the pathophysiology of type 2 inflammation and the advent of highly effective drugs selectively interfering with type 2 pathways. Here, we review the evolution of the new remission concepts in type 2 inflammatory diseases and discuss associated challenges and future research needs.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103050"},"PeriodicalIF":9.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045989","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}
引用次数: 0
O' testosterone, where is thy sting? A Urologist's reflection on testosterone and prostate cancer.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-08 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103061
Abraham Morgentaler
{"title":"O' testosterone, where is thy sting? A Urologist's reflection on testosterone and prostate cancer.","authors":"Abraham Morgentaler","doi":"10.1016/j.eclinm.2024.103061","DOIUrl":"10.1016/j.eclinm.2024.103061","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103061"},"PeriodicalIF":9.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045987","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}
引用次数: 0
Alcohol use and HIV suppression after completion of financial incentives for alcohol abstinence and isoniazid adherence: a randomized controlled trial.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-08 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103045
Winnie R Muyindike, Robin Fatch, Sara Lodi, Nneka I Emenyonu, Allen Kekibiina, Julian Adong, Brian Beesiga, Kara Marson, Harsha Thirumurthy, Michael G McDonell, Moses R Kamya, Gabriel Chamie, Judith A Hahn
{"title":"Alcohol use and HIV suppression after completion of financial incentives for alcohol abstinence and isoniazid adherence: a randomized controlled trial.","authors":"Winnie R Muyindike, Robin Fatch, Sara Lodi, Nneka I Emenyonu, Allen Kekibiina, Julian Adong, Brian Beesiga, Kara Marson, Harsha Thirumurthy, Michael G McDonell, Moses R Kamya, Gabriel Chamie, Judith A Hahn","doi":"10.1016/j.eclinm.2024.103045","DOIUrl":"10.1016/j.eclinm.2024.103045","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In a recent randomized trial, six months of financial incentives contingent for recent alcohol abstinence led to lower levels of hazardous drinking, while incentives for recent isoniazid (INH) ingestion had no impact on INH adherence, during TB preventive therapy among persons with HIV (PWH). Whether the short-term incentives influence long-term alcohol use and HIV viral suppression post-intervention is unknown.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We analyzed twelve-month HIV viral suppression and alcohol use in the Drinkers' Intervention to Prevent Tuberculosis study, a randomized controlled trial among PWH with latent TB and unhealthy alcohol use in south-western Uganda. We randomly assigned 680 participants (1:1:1:1) initiating six months of INH to: Arm 1, no incentives (control); Arm 2, financial incentives contingent on recent alcohol abstinence; Arm 3, incentives contingent on recent INH use; and Arm 4, incentives for recent alcohol abstinence and INH use, rewarded separately. The 6 months post-intervention outcomes evaluated were pre-specified and included: HIV viral suppression (&lt;200 copies/mL) and no/low alcohol use, defined as Alcohol Use Disorders Identification Test-Consumption negative (&lt;3: women, &lt;4: men) and phosphatidylethanol, an alcohol biomarker, &lt;35 ng/mL. We estimated adjusted risk differences (aRD) for alcohol reduction and INH adherence interventions using multivariable logistic regression adjusting for randomization stratification factors (sex and study site), and baseline alcohol use (alcohol intervention model only). Clinicaltrials.gov registration: NCT03492216, Registered 04/10/2018.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Of 600 participants with 12-month viral load results, 556/585 (95%) with baseline results were virally suppressed, and 583/600 (97%) were virally suppressed at 12-months. Twelve-month viral suppression did not differ significantly between either intervention group versus control (alcohol reduction incentives versus control aRD = -0.9% (95% CI: -3.6 to 1.7); INH adherence incentives versus control aRD = 2.2% (95% CI: -0.4 to 4.9)). Of the 617 participants with 12-month alcohol use measures, alcohol reduction incentives led to a significantly greater proportion with no/low alcohol use at 12-months (20.2% [64/317]) versus no alcohol reduction incentives (11.0% [33/300]); aRD = 8.4%, (95% CI: 3.3-13.4), p = 0.001.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Viral suppression was high (&gt;95%) at baseline and at 12 months: we found no effect of either 6-month alcohol reduction or INH adherence incentives on long-term viral suppression. Six months of alcohol reduction incentives were effective at promoting no/low alcohol use at 12 months, demonstrating persistent effects post-intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Funding: &lt;/strong&gt;National Institutes of Health (NIH/NIAAA) U01AA026223 (PI: Hahn) and U01AA026221 (PI: Chamie), NIH/NIAAAK24 AA022586 (PI: Hahn), NIH/NIAAAK24 AA031211 (PI: Chamie), Providence","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103045"},"PeriodicalIF":9.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045983","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}
引用次数: 0
Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-07 eCollection Date: 2025-01-01 DOI: 10.1016/j.eclinm.2024.103016
Gabriela Tapia-Calle, Gloria Aguilar, Nathalie Vaissiere, Carla Truyers, Pedro Ylisastigui, Erik Buntinx, Mathieu Le Gars, Frank Struyf, Gert Scheper, Macaya Douoguih, Javier Ruiz-Guiñazú
{"title":"Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial.","authors":"Gabriela Tapia-Calle, Gloria Aguilar, Nathalie Vaissiere, Carla Truyers, Pedro Ylisastigui, Erik Buntinx, Mathieu Le Gars, Frank Struyf, Gert Scheper, Macaya Douoguih, Javier Ruiz-Guiñazú","doi":"10.1016/j.eclinm.2024.103016","DOIUrl":"10.1016/j.eclinm.2024.103016","url":null,"abstract":"<p><strong>Background: </strong>Vaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines.</p><p><strong>Methods: </strong>This non-inferiority, Phase 3, randomised, double-blind study enrolled 859 healthy adults and was conducted between 02 November 2021 and 28 November 2022. Participants aged ≥18-64 years were randomised to receive a seasonal quadrivalent standard dose (SD) influenza vaccine (<i>Afluria</i> Quadrivalent, Seqirus) concomitantly with Ad26.COV2.S (Coad_SD) or placebo (0.9% NaCl; Control_SD) on Day 1 and placebo or Ad26.COV2.S on Day 29. Participants aged ≥65-years were randomised to the Coad_SD or Control_SD groups, or to Coad_HD or Control_HD groups that received a seasonal quadrivalent HD (high-dose) influenza vaccine (<i>Fluzone</i> High-Dose Quadrivalent, Sanofi Pasteur Inc) in the same schedules. The primary outcomes were haemagglutinin inhibition titres against the four influenza vaccine strains at Day 29, and SARS-CoV-2 Spike-specific antibodies at Day 29 in the Coad_SD group and Day 57 in the Control-SD group, with a non-inferiority margin (Control-SD group/Coad_SD group) of 1.5. Reactogenicity and safety were assessed in all participants (NCT05091307).</p><p><strong>Findings: </strong>Non-inferiority criteria for concomitant administration in the SD groups were met for SARS-CoV-2 Spike-specific antibodies (ratio 1.11, 95% CI 0.97-1.26) and haemagglutinin inhibition titres for all influenza strains (A/H3N2 1.23, 95% CI 1.05-1.45; B/Victoria 0.99, 95% CI 0.84-1.19; B/Yamagata, 1.03, 95% CI 0.88-1.21) except A/H1N1 (1.28, 95% CI 1.09-1.53) for which the upper limit of the 95% CI was >1.5. Concomitant administration of Ad26.COV2.S and SD influenza vaccine induced robust immune responses in terms of SARS-CoV-2 Spike-specific antibodies and haemagglutinin inhibition to all four influenza strains. Seroconversion and seroprotection rates against all influenza vaccine strains were comparable in the Coad and Control groups. Anti-Spike antibodies 28 days after receiving Ad26.COV2.S were similar whether administered with influenza vaccine or alone. Antibody responses persisted at least 6 months post-vaccination in all groups. The reactogenicity and safety profile following co-administration was consistent with the known safety profiles of the study vaccines. No safety concerns were identified. Coadministration was immunogenic and well tolerated in adults aged ≥65 years who received HD influenza vaccine.</p><p><strong>Interpretation: </strong>Co-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines.</p><p><strong>Funding: </strong>Janssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103016"},"PeriodicalIF":9.6,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045981","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}
引用次数: 0
A reproducible framework for monitoring the impact of randomized clinical trials on clinical practice using large-scale real-world data: application to gynaecological surgical trials using the French national healthcare database.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-07 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103053
Floriane Jochum, Madeleine Doll, Anne-Sophie Hamy, Lou Donval, Paul Gougis, Élise Dumas, Lise Lecointre, Thomas Gaillard, Fabien Reyal, Fabrice Lecuru, Cherif Akladios, Enora Laas
{"title":"A reproducible framework for monitoring the impact of randomized clinical trials on clinical practice using large-scale real-world data: application to gynaecological surgical trials using the French national healthcare database.","authors":"Floriane Jochum, Madeleine Doll, Anne-Sophie Hamy, Lou Donval, Paul Gougis, Élise Dumas, Lise Lecointre, Thomas Gaillard, Fabien Reyal, Fabrice Lecuru, Cherif Akladios, Enora Laas","doi":"10.1016/j.eclinm.2024.103053","DOIUrl":"10.1016/j.eclinm.2024.103053","url":null,"abstract":"<p><strong>Background: </strong>Randomized clinical trials (RCTs) are fundamental to evidence-based medicine, but their real-world impact on clinical practice often remains unmonitored. Leveraging large-scale real-world data can enable systematic monitoring of RCT effects. We aimed to develop a reproducible framework using real-world data to assess how major RCTs influence medical practice, using two pivotal surgical RCTs in gynaecologic oncology as an example-the LACC (Laparoscopic Approach to Cervical Cancer) and LION (Lymphadenectomy in Ovarian Neoplasms) trials.</p><p><strong>Methods: </strong>We utilized data from the French National Health Insurance Database (SNDS), covering 98.8% of France's population. We analysed patients who underwent radical hysterectomy for cervical cancer (2013-2022) and patients who underwent cytoreductive surgery for ovarian cancer (2014-2022). Bayesian structural time series analysis assessed the causal effects of the LACC and LION trials on the discontinuation of minimally invasive surgery (MIS) and lymphadenectomy, respectively. Analyses were stratified by hospital type, academic status, research mission, domain expertise, human resources, and financial condition.</p><p><strong>Findings: </strong>Our nationwide cohorts included 7108 cervical cancer and 23,090 ovarian cancer patients treated across 596 centres. The LACC trial led to a 14.1% reduction in radical hysterectomies by MIS (275 fewer surgeries; 95% CI: -407 to -140), with academic centres showing 27.9% reduction compared to 2.5% increase in nonacademic centres. The LION trial resulted in a 22.6% reduction in lymphadenectomies (2358 fewer surgeries; 95% CI: -2708 to -2003), with academic centres achieving 31.1% reduction versus 15% in nonacademic centres. Significant variation was observed across medical settings. Centres with academic status, high research missions, substantial expertise, and robust resources were more responsive to trial outcomes, highlighting the influence of institutional and human factors on adopting new practices.</p><p><strong>Interpretation: </strong>This study demonstrates that large-scale real-world data can effectively monitor the impact of RCTs on clinical practice. While validated here using surgical trials, this reproducible framework is adaptable to various health domains and can be implemented in any country with national electronic health databases. Systematic monitoring is essential to ensure effective implementation of RCT findings and to address disparities in the adoption of evidence-based practices.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103053"},"PeriodicalIF":9.6,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11764352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045982","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}
引用次数: 0
Efficacy of brain stimulation therapies across psychiatric, movement, and cognitive disorders: an umbrella review synthesizing meta-analyses of randomized controlled trials.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-07 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103046
Zhenyue Zu, Fenglan Chen, Linxi Yang, Wenzhuo Wei, Mi Zhang, Limin Huang, Ni Li, Zihan Lv, He Du, Xinrong Xue, Lijun Ma, Huixue Wang, Kai Wang, Xiaoming Li
{"title":"Efficacy of brain stimulation therapies across psychiatric, movement, and cognitive disorders: an umbrella review synthesizing meta-analyses of randomized controlled trials.","authors":"Zhenyue Zu, Fenglan Chen, Linxi Yang, Wenzhuo Wei, Mi Zhang, Limin Huang, Ni Li, Zihan Lv, He Du, Xinrong Xue, Lijun Ma, Huixue Wang, Kai Wang, Xiaoming Li","doi":"10.1016/j.eclinm.2024.103046","DOIUrl":"10.1016/j.eclinm.2024.103046","url":null,"abstract":"<p><strong>Background: </strong>Brain stimulation therapy (BST) has significant potential in treating psychiatric, movement, and cognitive disorders. Given the high prevalence of comorbidities among these disorders, we conducted an umbrella review to comprehensively assess the efficacy of BSTs in treating the core symptoms across these three categories of disorders.</p><p><strong>Methods: </strong>We systematically searched for meta-analyses and network meta-analyses of randomized controlled trials with sham controls up to September 25, 2024, from databases including PubMed, PsycINFO, Embase, and the Cochrane Library. Our primary outcome was improvements in core symptoms. We evaluated quality using 11 criteria. We calculated pooled effect estimates for core symptoms based on the largest meta-analyses, then conducted sensitivity and subgroup analyses, and assessed heterogeneity, publication bias, and small-study effects. Finally, we synthesized effect sizes from all meta-analyses to provide a comprehensive overview of BSTs' efficacy. PROSPERO registration: CRD42023439090.</p><p><strong>Findings: </strong>We included 198 articles with 108,377 patients evaluating 14 BSTs across 21 disorders. The largest meta-analysis showed a moderate standardized mean difference (SMD) of 0.56 (95% CI: 0.49, 0.64; I<sup>2</sup> = 70%). Subgroup analyses revealed significant SMDs for psychiatric disorders (0.60; 95% CI: 0.49, 0.71; I<sup>2</sup> = 66%), movement disorders (0.56; 95% CI: 0.42, 0.69; I<sup>2</sup> = 79%), and cognitive disorders (0.46; 95% CI: 0.32, 0.61; I<sup>2</sup> = 48%). SMDs were 0.44 (95% CI: 0.23, 0.65; I<sup>2</sup> = 70%) for follow-up ≤1 month and 0.69 (95% CI: 0.43, 0.94; I<sup>2</sup> = 84%) for follow-up >1 month. Compared to other conditions, BSTs show better therapeutic effects in treating depression, post-traumatic stress disorder, obsessive-compulsive disorder, pain, fibromyalgia, and post-stroke motor recovery.</p><p><strong>Interpretation: </strong>This review explored the potential of BSTs for comorbidities of the three disorders from a disorder-specific perspective, providing a roadmap for their clinical application and future research.</p><p><strong>Funding: </strong>This work was supported by the Anhui Natural Science Foundation (2023AH040086), Key Laboratory of Philosophy and Social Science of Anhui Province on Adolescent Mental Health and Crisis Intelligence Intervention (SYS2023B08), and the Joint Funds of the National Natural Science Foundation of China (U23A20424).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103046"},"PeriodicalIF":9.6,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760298/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045984","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}
引用次数: 0
Development and validation of a model to predict cognitive impairment in traumatic brain injury patients: a prospective observational study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-01-02 eCollection Date: 2025-02-01 DOI: 10.1016/j.eclinm.2024.103023
Xiaofang Yuan, Qingrong Xu, Fengxia Du, Xiaoxia Gao, Jing Guo, Jianan Zhang, Yehuan Wu, Zhongkai Zhou, Youjia Yu, Yi Zhang
{"title":"Development and validation of a model to predict cognitive impairment in traumatic brain injury patients: a prospective observational study.","authors":"Xiaofang Yuan, Qingrong Xu, Fengxia Du, Xiaoxia Gao, Jing Guo, Jianan Zhang, Yehuan Wu, Zhongkai Zhou, Youjia Yu, Yi Zhang","doi":"10.1016/j.eclinm.2024.103023","DOIUrl":"10.1016/j.eclinm.2024.103023","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Traumatic brain injury (TBI) is a significant public health issue worldwide that affects millions of people every year. Cognitive impairment is one of the most common long-term consequences of TBI, seriously affect the quality of life. We aimed to develop and validate a predictive model for cognitive impairment in TBI patients, with the goal of early identification and support for those at risk of developing cognitive impairment at the time of hospital admission.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The training cohort included 234 TBI patients, all of whom were admitted to the Department of Neurosurgery at the Third Affiliated Hospital of Soochow University from May 2017 to April 2020. These patients were selected from our previously published studies. Baseline characteristics, medical history, clinical TBI characteristics, treatment details, and vital signs during hospitalization were screened via least absolute shrinkage and selection operator (LASSO) and logistic regression to construct a predictive net risk score. The derived score represents an estimate of the risk of developing cognitive impairment in patients with TBI. A nomogram was constructed, and its accuracy and predictive performance were evaluated with the area under the receiver operating characteristic curve (AUC), calibration curves, and clinical decision curves. For the validation cohort, data were prospectively collected from TBI patients admitted to the Department of Neurosurgery at the Third Affiliated Hospital of Soochow University from March 1, 2024 to August 30, 2024, according to the inclusion and exclusion criteria. This study is registered with the Chinese Clinical Trial Registry (ChiCTR) at http://www.chictr.org.cn/ (registration number: ChiCTR2400083495).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;The training cohort included 234 patients. The mean (standard deviation, SD) age of the patients in the cohort was 47.74 (17.89) years, and 184 patients (78.63%) were men. The validation cohort included 84 patients with a mean (SD) age of 48.44 (14.42) years, and 68 patients (80.95%) were men. Among the 48 potential predictors, the following 6 variables were significant independent predictive factors and were included in the net risk score: age (odds ratio (OR) = 1.06, 95% confidence interval (CI): 1.03-1.08, P = 0.00), years of education (OR = 0.80, 95% CI: 0.70-0.93, P = 0.00), pulmonary infection status (OR = 4.64, 95% CI: 1.41-15.27, P = 0.01), epilepsy status (OR = 4.79, 95% CI: 1.09-21.13, P = 0.04), cerebrospinal fluid leakage status (OR = 5.57, 95% CI: 1.08-28.75, P = 0.04), and the Helsinki score (OR = 1.53, 95% CI: 1.28-1.83, P = 0.00). The AUC in the training cohort was 0.90, and the cut-off value was 0.71. The AUC in the validation cohort was 0.87, and the cut-off value was 0.63. The score was translated into an online risk calculator that is freely available to the public (https://yuanxiaofang.shinyapps.io/Predict_cognitive_impairment_in_TBI/).","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103023"},"PeriodicalIF":9.6,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028322","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}
引用次数: 0
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