EClinicalMedicine最新文献

{"title":"Corrigendum for \"Development of a machine learning-based model to predict hepatic inflammation in chronic hepatitis B patients with concurrent hepatic steatosis: a cohort study\".","authors":"Fajuan Rui, Jie Li","doi":"10.1016/j.eclinm.2025.103119","DOIUrl":"10.1016/j.eclinm.2025.103119","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.eclinm.2023.102419.][This corrects the article DOI: 10.1016/j.eclinm.2025.103117.].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103119"},"PeriodicalIF":9.6,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11850148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499833","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":"Risk of aortic aneurysm or dissection following use of fluoroquinolones: a retrospective multinational network cohort study.","authors":"Jack L Janetzki, Jung Ho Kim, Evan Minty, Jung Ah Lee, Daniel R Morales, Rohan Khera, Chungsoo Kim, Thamir M Alshammari, Scott L DuVall, Michael E Matheny, Thomas Falconer, Seonji Kim, Thanh-Phuc Phan, Phung-Anh Nguyen, Min-Huei Hsu, Jason C Hsu, Rae Woong Park, Kenneth K C Man, Sarah Seager, Mui Van Zandt, James P Gilbert, Patrick B Ryan, Martijn J Schuemie, Marc A Suchard, George Hripcsak, Nicole Pratt, Seng Chan You","doi":"10.1016/j.eclinm.2025.103096","DOIUrl":"10.1016/j.eclinm.2025.103096","url":null,"abstract":"<p><strong>Background: </strong>Fluoroquinolones (FQs) are commonly used to treat urinary tract infections (UTIs), but some studies have suggested they may increase the risk of aortic aneurysm or dissection (AA/AD). However, no large-scale international study has thoroughly assessed this risk.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using a large, distributed network analysis across 14 databases from 5 countries (United States, South Korea, Japan, Taiwan, and Australia). The study included 13,588,837 patients aged 35 or older who initiated systemic fluoroquinolones (FQs) or comparable antibiotics (trimethoprim with or without sulfamethoxazole [TMP] or cephalosporins [CPHs]) for UTI treatment in the outpatient setting between JAN 01, 2010 and DEC 31, 2019. Patients were included if at the index date they had at least 365 days of prior observation and were not hospitalised for any reason on or within 7 days prior to the index date. The primary outcome was AA/AD occurrence within 60 days of exposure, with secondary outcomes examining AA and AD separately. Cox proportional hazards models with 1:1 propensity score (PS) matching were used to estimate the risk, with results calibrated using negative control outcomes. Analyses were subjected to pre-defined study diagnostics, and only those passing all diagnostics were reported. Hazard ratios (HRs) were pooled using Bayesian random-effects meta-analysis.</p><p><strong>Findings: </strong>Among analyses that passed diagnostics there were 1,954,798 and 1,195,962 propensity-matched pairs for the FQ versus TMP and FQ versus CPH comparisons respectively. For the 60-day follow-up there was no difference in risk of AA/AD between FQ and TMP (absolute rate difference [ARD], 0.21 per 1000 person-year; calibrated HR, 0.91 [95% CI 0.73-1.10]). There was no significant difference in risk for FQ versus CPH (ARD, 0.11 per 1000 person-year; calibrated HR, 1.01 [95% CI 0.82-1.25]).</p><p><strong>Interpretation: </strong>This large-scale study used a rigorous design with objective diagnostics to address bias and confounding. There was no increased risk of AA/AD associated with FQ compared to TMP or CPH in patients treated for UTI in the outpatient setting. As we only examined FQ used to treat UTIs in the outpatient setting, the results may not be generalisable to other indications with different severity.</p><p><strong>Funding: </strong>Yonsei University College of Medicine, Government-wide R&D Fund project for infectious disease research (GFID), Republic of Korea, National Health and Medical Research Council (NHMRC) Australian Government. Department of Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI), Department of Veterans Affairs, the United States Government.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103096"},"PeriodicalIF":9.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11836508/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457154","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":"Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone combined with high-dose methotrexate plus intrathecal chemotherapy for newly diagnosed intravascular large B-cell lymphoma (PRIMEUR-IVL): long-term results of a multicentre, single-arm, phase 2 trial.","authors":"Kazuyuki Shimada, Motoko Yamaguchi, Yachiyo Kuwatsuka, Kosei Matsue, Keijiro Sato, Shigeru Kusumoto, Hirokazu Nagai, Jun Takizawa, Noriko Fukuhara, Koji Nagafuji, Kana Miyazaki, Eiichi Ohtsuka, Akinao Okamoto, Yasumasa Sugita, Toshiki Uchida, Satoshi Kayukawa, Atsushi Wake, Daisuke Ennishi, Yukio Kondo, Akiko Meguro, Yoshihiro Kin, Yosuke Minami, Daigo Hashimoto, Takahiro Nishiyama, Satoko Shimada, Yasufumi Masaki, Masataka Okamoto, Yoshiko Atsuta, Hitoshi Kiyoi, Ritsuro Suzuki, Shigeo Nakamura, Tomohiro Kinoshita","doi":"10.1016/j.eclinm.2025.103078","DOIUrl":"10.1016/j.eclinm.2025.103078","url":null,"abstract":"<p><strong>Background: </strong>Intravascular large B-cell lymphoma (IVLBCL) is a rare type of extranodal large B-cell lymphoma for which prognosis is typically poor without a timely diagnosis. To explore the safety and efficacy of standard chemotherapy combined with central nervous system (CNS)-directed therapy, we conducted a multicentre, single-arm, phase 2 trial in untreated IVLBCL patients without CNS involvement at diagnosis (PRIMEUR-IVL). In the primary analysis, the PRIMEUR-IVL study demonstrated 2-year progression-free survival (PFS) of 76% and 2-year overall survival (OS) of 92% with a low incidence (3%) of secondary CNS involvement (sCNSi).</p><p><strong>Methods: </strong>We present a prespecified final analysis of the PRIMEUR-IVL study including 5-year PFS, OS and cumulative incidence of sCNSi. Participants were enrolled between June 2011 and July 2016, and the data cutoff date for the final analysis was 16 November 2021. The trial was registered in the UMIN Clinical Trial Registry (UMIN000005707) and the Japan Registry of Clinical Trials (jRCTs041180165).</p><p><strong>Findings: </strong>With a median follow-up of 7.1 years (interquartile range 5.6-8.7), 5-year PFS in all 37 eligible patients was 68% (95% confidence interval [CI] 50%-80%) and OS was 78% (95% CI 61%-89%). No additional sCNSi was observed after the primary analysis. Severe adverse events after the primary analysis were grade 4 neutropenia (n = 1) and grade 4 myelodysplastic syndrome that did not require specific treatment (n = 1). Eight deaths occurred during the observation period after enrolment, due to primary disease (n = 6), sepsis (n = 1) and unknown sudden death (n = 1).</p><p><strong>Interpretation: </strong>Long-term follow-up data demonstrated durable response for PFS and OS, and low cumulative incidence of sCNSi, indicating the efficacy of standard chemotherapy combined with CNS-directed therapy for untreated IVLBCL patients.</p><p><strong>Funding: </strong>This study received financial support from the Japan Agency for Medical Research and Development, Center for Supporting Hematology-Oncology Studies, and National Cancer Center.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103078"},"PeriodicalIF":9.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11833343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447882","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 impact of weight loss interventions on disordered eating symptoms in people with overweight and obesity: a systematic review & meta-analysis.","authors":"Elena Tsompanaki, Dimitrios A Koutoukidis, Gina Wren, Heather Tong, Annika Theodoulou, Danni Wang, Rebecca J Park, Susan A Jebb, Paul Aveyard","doi":"10.1016/j.eclinm.2024.103049","DOIUrl":"10.1016/j.eclinm.2024.103049","url":null,"abstract":"<p><strong>Background: </strong>It is unclear whether weight loss interventions worsen disordered eating in people living with overweight/obesity. We aimed to systematically evaluate the association between weight loss interventions and disordered eating.</p><p><strong>Methods: </strong>Six databases were searched from inception until September 2024. Trials of weight loss interventions in people with overweight/obesity were included if they reported a validated score for disordered eating on either the Eating Disorder Examination Interview or the Eating Disorder Examination Questionnaire pre- and post-intervention. Interventions included behavioural weight loss programmes (BWL) and pharmacotherapy licenced for weight loss, with or without concurrent psychological support, provided for at least 4 weeks. Pooled standardised mean differences (SMD) in scores of disordered eating were calculated using random effects meta-analyses. Risk of bias (RoB) was assessed using the Cochrane RoB 2 tool and the Newcastle-Ottawa scale for randomised and single-arm trials, respectively (PROSPERO ID: CRD42023404792).</p><p><strong>Findings: </strong>Thirty-eight studies with 66 eligible arms (61 interventions: 29 BWL, 11 BWL + pharmacotherapy, 20 BWL + psychological intervention, 1 pharmacotherapy + psychological intervention) and 3364 participants in total were included. The mean weight change was -4.7 kg (95% CI: -5.7, -3.7). Compared with baseline, disordered eating scores improved by -1.47 SMD units (95% CI: -1.67, -1.27, p < 0.001, I² = 94%) at intervention completion (median of 4 months). Seven randomised trials that directly compared a weight loss intervention to no/minimal intervention reported an improvement of -0.49 SMD units (95% CI, -0.93, -0.04, p = 0.0035, I² = 73%). Sub-group analyses showed: (a) disordered eating scores improved more in people with an eating disorder at baseline compared with people without high scores, (b) no clear evidence that the association depended upon intervention type, and (c) disordered eating scores improved more in trials rated at low overall RoB.</p><p><strong>Interpretation: </strong>Despite heterogeneity in effect size, weight loss interventions consistently improved disordered eating scores. These findings provide reassurance that weight loss interventions might not worsen disordered eating and may improve it.</p><p><strong>Funding: </strong>Novo Nordisk UK Research Foundation Doctoral Fellowship in Clinical Diabetes.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103049"},"PeriodicalIF":9.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11841075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467321","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":"R-index: a standardized representativeness metric for benchmarking diversity, equity, and inclusion in biopharmaceutical clinical trial development.","authors":"Spencer L James, Max Bourgognon, Patricia Pinto Vieira, Bruno Jolain, Sarah Bentouati, Emma Kipps, Assaf P Oron, Catherine W Gillespie, Ruma Bhagat, Altovise Ewing, Shalini Hede, Keith Dawson, Nicole Richie","doi":"10.1016/j.eclinm.2025.103079","DOIUrl":"10.1016/j.eclinm.2025.103079","url":null,"abstract":"<p><strong>Background: </strong>Diversity, equity, and inclusion pertaining to race, ethnicity, and related concepts have historically been underrepresented in clinical trials for pharmaceutical drug development, although this is an increasing topic for regulators, payers, and patient advocacy groups. We aimed to develop a summary statistical measure to assess such representativeness.</p><p><strong>Methods: </strong>A statistical measure using population demographic parameters derived from performance metrics through verbal autopsy research was proposed for using population frameworks in the UK. The summary measure, R-index, was demonstrated using simulation data with population frameworks from the UK (116 Roche UK clinical trials 2013-2022) and then using published clinical trial results (NCT02366143 [March 1, 2015-September 15, 2017], NCT04368728 [July 27, 2020-October 9, 2020], and NCT04470427 [July 27, 2020-November 25, 2020]). R-index was further proposed for use with benchmarking performance in representative trial development for internal processes, external benchmarking, and performance tracking in clinical trial development.</p><p><strong>Findings: </strong>R-index was derived from a standardized statistical measure called the L1 norm, or Manhattan distance, and then normalized to the maximum theoretical error observed in some populations using population framework or ontology for reporting concepts such as race, ethnicity, and other dimensions of diversity used to characterize patient cohorts. R-index demonstrated desirable qualities in demonstration simulations, including a range of 0-1, ease of calculation and use, and interpretability and flexibility, as data standards in the space of inclusive research continue to develop.</p><p><strong>Interpretation: </strong>R-index is an interpretable, accessible summary statistic that may be useful for tracking and benchmarking representativeness in inclusive research and related domains. R-index is adaptable to different population frameworks and ontologies across different settings and considerations in terms of underlying population variables.</p><p><strong>Funding: </strong>F. Hoffmann-La Roche Ltd/Genentech, Inc.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103079"},"PeriodicalIF":9.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11833413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447652","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":"Head-to-head comparisons of risk discrimination by questionnaire-based lung cancer risk prediction models: a systematic review and meta-analysis.","authors":"Clara Frick, Teresa Seum, Megha Bhardwaj, Tim Holland-Letz, Ben Schöttker, Hermann Brenner","doi":"10.1016/j.eclinm.2025.103075","DOIUrl":"10.1016/j.eclinm.2025.103075","url":null,"abstract":"<p><strong>Background: </strong>While different lung cancer risk prediction models have been established as essential tools to identify high-risk participants for lung cancer screening programs, evaluations of their risk discriminatory performances have reported heterogenous findings in different research cohorts. We therefore aimed to summarise results of head-to-head comparisons of the predictive performance of various lung cancer risk models performed within the same study population.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, we performed a systematic search of PubMed and Web of Science databases for primary studies published from inception to Oct 16, 2024. Articles comparing the performance of questionnaire-based lung cancer risk models in an independent, external validation cohort of participants with previous or current smoking exposure were included. The main reasons for exclusion of studies were if only one model was assessed in the external population or risk discrimination was not evaluated. Random-effects meta-analyses were conducted to synthesize differences in the area under the curve (AUC) of two models compared in multiple populations. To assess the risk of bias, PROBAST (the Prediction model Risk of Bias Assessment Tool) was used. The study was registered with PROSPERO, CRD42023427911.</p><p><strong>Findings: </strong>The systematic search yielded 5568 records. In total, 15 eligible studies were included in the meta-analysis, comprising 4,134,648 individuals with previous or current smoking exposure, of whom 45,448 (1.10%) developed LC within 5-7 years. Among the nine models that were compared, AUC differences reached up to 0.050 between two models. The Lung Cancer Risk Assessment Tool (LCRAT), Bach model and PLCOm2012 model consistently had a higher AUC when compared to any other model, with AUC differences ranging between 0.018 (95% CI 0.011, 0.026) and 0.044 (95% CI 0.038, 0.049). The risk of bias and applicability concerns were deemed low in eight, and high in seven of the included studies. Results excluding studies with high risk of bias were mostly consistent. Among eight of the 24 model pairs that were compared, there was notable between-study heterogeneity (I² ≥50%).</p><p><strong>Interpretation: </strong>Our systematic review and meta-analyses of head-to-head comparisons disclose major differences in predictive performance of widely used lung cancer risk models. Although our review is limited to the availability of head-to-head comparisons, evidence from current cohort-based model comparisons indicates that the LCRAT, Bach and PLCOm2012 consistently outperformed alternative questionnaire-based risk prediction tools.</p><p><strong>Funding: </strong>Funded by the European Union.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103075"},"PeriodicalIF":9.6,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11833416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448602","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":"Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre, phase 2 trial.","authors":"Niels A D Guchelaar, Ron H J Mathijssen, Maaike de Boer, Marlies L van Bekkum, Joan B Heijns, Birgit E P J Vriens, Mandy M van Rosmalen, Lonneke W Kessels, Lisanne Hamming, Karin J Beelen, Peter Nieboer, Susan M van den Berg, Esther Oomen-de Hoop, Rhodé M Bijlsma, Monique E M M Bos","doi":"10.1016/j.eclinm.2024.103065","DOIUrl":"10.1016/j.eclinm.2024.103065","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Effective later-line chemotherapy treatment options are scarce for patients with metastatic breast cancer (MBC). Trifluridine-tipiracil has shown survival benefit in heavily pre-treated patients with metastatic colorectal and in gastric cancer refractory to a fluoropyrimidine. This study aimed to investigate the efficacy of trifluridine-tipiracil in a Western population of previously treated patients with oestrogen receptor (ER+), HER2- MBC to facilitate further optimization of this treatment strategy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Adult patients at least 18 years old diagnosed with hormone receptor positive, HER2- receptor negative MBC with a performance status of 0 or 1 who have been treated with capecitabine in the metastatic setting and up to two other lines of chemotherapy, including a taxane, were enrolled in this single-arm, multicentre, phase 2 study in the Netherlands. The participants received trifluridine-tipiracil 35 mg/m&lt;sup&gt;2&lt;/sup&gt; orally twice a day on days 1-5 and days 8-12 during a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the disease control rate (DCR) at 8 weeks, defined as the percentage of patients that had stable disease, partial response or complete response according to RECIST 1.1, in all patients that received at least one dose of trifluridine-tipiracil and met the key eligibility criteria defined &lt;i&gt;a priori&lt;/i&gt;. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life and were performed in all patients that received at least one dose of trifluridine-tipiracil. The primary endpoint was considered met, justifying further research of this treatment regimen, if the lower boundary of the 80% confidence interval (CI) exceeded 30%. The study was registered within ClinicalTrials.gov (NCT04489173) and is closed for inclusion.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Fifty female patients were enrolled from September 2020 to July 2023, with a median of 3 (IQR, 2-3) previous endocrine therapy lines and 2 (IQR, 2-3) chemotherapy lines for MBC. The DCR rate at 8 weeks was 64.0% (&lt;i&gt;n&lt;/i&gt; = 32, 95% CI: 50.1-75.9%; 80% CI: 55.0-72.1%), thereby meeting the primary endpoint of this study. At data cutoff (January 8, 2024), the median follow-up time was 18.2 months (IQR, 13.1-25.1 months). The median PFS was 5.4 months (95% CI: 2.0-7.2 months) and the median OS 14.0 months (95% CI: 8.8-17.8 months). The safety profile of trifluridine-tipiracil aligned with expected toxicities and included leukopenia (n = 36, 69%), neutropenia (n = 43, 83%), and fatigue (n = 43, 83%). The most common grade 3-4 AEs were primarily haematological disorders and included neutropenia (n = 38, 73%), leukopenia (n = 15, 29%) and anaemia (n = 6, 12%). The most common SAEs (any grade) with a possible relationship with trifluridine-tipiracil included anaemia (n = 2) and vomiting (n = 2). No treatment-related deaths ","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103065"},"PeriodicalIF":9.6,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522898","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":"Corrigendum for \"The global birth prevalence of clubfoot: a systematic review and meta-analysis\".","authors":"Tracey Smythe, Sara Rotenberg, Chris Lavy","doi":"10.1016/j.eclinm.2025.103087","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103087","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.eclinm.2023.102178.].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103087"},"PeriodicalIF":9.6,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11803256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381850","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":"Perinatal mortality and other severe adverse outcomes following planned birth at 39 weeks versus expectant management in low-risk women: a population based cohort study.","authors":"Kylie Crawford, Waldemar A Carlo, Anthony Odibo, Aris Papageorghiou, William Tarnow-Mordi, Sailesh Kumar","doi":"10.1016/j.eclinm.2025.103076","DOIUrl":"10.1016/j.eclinm.2025.103076","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Planned birth by induction of labour in low-risk, nulliparous women at 39&lt;sup&gt;+0&lt;/sup&gt;-39&lt;sup&gt;+6&lt;/sup&gt; weeks gestation is associated with fewer caesarean sections, adverse maternal and neonatal outcomes and perinatal deaths compared with expectant management. However, the consequences of scheduled caesarean section in these women at this gestation are unclear. We compared outcomes following planned birth at 39&lt;sup&gt;+0&lt;/sup&gt;-39&lt;sup&gt;+6&lt;/sup&gt; weeks gestation (either by induction of labour or scheduled caesarean section) to expectant management.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The population included low-risk, singleton pregnancies between 2000 and 2021 in Queensland, Australia. Study outcomes were perinatal mortality (antepartum or intrapartum stillbirth and neonatal death), severe neonatal neurological morbidity and non-neurological morbidity, severe maternal outcome, maternal-infant separation, perineal trauma, shoulder dystocia, and caesarean birth. Multivariable models were built to determine risks of adverse outcomes for planned birth compared to expectant management. Subgroup analyses according to parity and birthweight were also performed. We calculated the number of planned births required that were associated with one less adverse outcome.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;In 472,520 low-risk pregnancies, planned birth at 39&lt;sup&gt;+0&lt;/sup&gt;-39&lt;sup&gt;+6&lt;/sup&gt; weeks occurred in 97,438 (20.6%) women, of whom 39,697 (40.7%) underwent induction of labour and 57,741 (59.3%) had scheduled caesarean delivery. Planned birth was associated with 52% lower odds of perinatal mortality (adjusted Odds Ratio (aOR) 0.48; 95% CI 0.30, 0.76, p = 0.002), 62% lower odds of antepartum stillbirth (aOR 0.38; 95% CI 0.15, 0.97, p = 0.04), and 84% lower odds of intrapartum stillbirth by (aOR 0.16; 95% CI 0.04, 0.66, p = 0.01). It was also associated with reduction in the odds of severe neurological morbidity (aOR 0.46; 95% CI 0.39, 0.53, p = 0.00004), severe non-neurological morbidity (aOR 0.65; 95% CI 0.62, 0.68, p = 0.00004), and severe maternal outcome (aOR 0.95; 95% CI 0.92, 0.99, p = 0.008) but not maternal-infant separation (aOR 1.04; 95% CI 1.00, 1.08, p = 0.08). The reduction in odds for perinatal mortality, severe neurological, and non-neurological morbidity was greatest for birth by scheduled caesarean section. Compared to expectant management, planned birth by induction of labour was associated with reduced odds of caesarean delivery (aOR 0.54; 95% CI 0.51, 0.58, p = 0.00004), severe perineal trauma (aOR 0.53; 95% CI 0.45, 0.63, p = 0.00004), and shoulder dystocia (aOR 0.73; 95% CI 0.64, 0.84, p = 0.00004). Planned delivery of 2278 (95% CI 1760, 3231) women is associated with a reduction in one case of perinatal death, however significantly lower numbers are required for the other outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Planned birth at 39&lt;sup&gt;+0&lt;/sup&gt;-39&lt;sup&gt;+6&lt;/sup&gt; weeks in low-risk women was associated with lower odds","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103076"},"PeriodicalIF":9.6,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11803212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381855","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":"Monitoring of prostate cancer screening in the European Union: development of key performance indicators through the PRAISE-U project.","authors":"Deependra Singh, Andre L Carvalho, Isabel Mosquera, Josep Vilaseca, Ausvydas Patasius, Gintare Miksiene, Krzysztof Tupikowski, Ángel Gómez Amorín, Marina Tarrazo Antelo, Montserrat Corujo Quinteiro, David Galvin, Brian Sheridan, Eveline Heijnsdijk, Roderick C N van den Bergh, Monique J Roobol, Lionne D F Venderbos, Sarah Collen, Hendrik van Poppel, Partha Basu, Arunah Chandran","doi":"10.1016/j.eclinm.2024.103022","DOIUrl":"10.1016/j.eclinm.2024.103022","url":null,"abstract":"<p><strong>Background: </strong>Monitoring and evaluation of prostate cancer (PCa) screening is key to ensure that the programme achieves the desired objectives. Utilizing a set of prioritized, feasible and harmonized key performance indicators (KPIs) is crucial for this purpose. We describe the methodology used to identify the PCa screening KPIs and the outcome of this process within the scope of the EU-funded PRostate cancer Awareness and Initiative for Screening in the EU (PRAISE-U) project. Feasibility of implementing these KPIs will be evaluated in the five pilots set up at multiple sites in the EU (Spain-2 sites, Poland, Ireland, Lithuania).</p><p><strong>Methods: </strong>The indicators were developed following a structured methodology involving the following steps: (i) Development of a specific conceptual framework for PCa screening is adapted from the existing risk-based algorithms and modified to guide the selection and mapping of indicators (from identification of population eligible for screening to the decision for treatment or follow-up), (ii) Scoping review of literature (coverage from 1971 to June 2023) to identify existing performance indicators for PCa screening to adapt to the new framework with redefining the indicators, where necessary, (iii) Survey among experts (October-November 2023) to select the indicators fulfilling pre-determined criteria such as accuracy of definition and calculation, importance, and feasibility, and (iv) Deliberations among experts to list the finalized set of indicators, held in December 2023.</p><p><strong>Findings: </strong>A total of 63 KPIs were selected for review using the step-wise methodology as described earlier. Following the review, survey, and deliberations, 21 KPIs were finalized to be piloted in the PRAISE-U project. The resulting 21 KPIs cover the different phases of the screening programme, including invitation, screening test, risk stratification, diagnosis, and also on treatment, harms, and impact. Each KPI has been defined with agreed numerator and denominator.</p><p><strong>Interpretation: </strong>Continuous monitoring of PCa screening programmes using the KPIs will serve as a powerful tool for optimizing service delivery, programme improvement, comparison per screening site, and ultimately contributing to a better benefit to harm ratio. The KPIs will be implemented in five pilot sites identified to be included in the PRAISE-U project aiming to identify an evidence-based scalable model for risk adapted PCa screening for Europe.</p><p><strong>Funding: </strong>This project has received funding from the EU4Health program under grant agreement 101101217, co-funded by the European Union.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103022"},"PeriodicalIF":9.6,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11804572/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381852","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}