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281. Effectiveness of a comprehensive package based on electronic medication monitors at improving treatment outcomes among tuberculosis patients in Tibet: a multicentre randomised controlled trial.
作者: Xiaolin Wei.;Joseph Paul Hicks.;Zhitong Zhang.;Victoria Haldane.;Pande Pasang.;Linhua Li.;Tingting Yin.;Bei Zhang.;Yinlong Li.;Qiuyu Pan.;Xiaoqiu Liu.;John Walley.;Jun Hu.
来源: Lancet. 2024年403卷10430期913-923页
WHO recommends that electronic medication monitors, a form of digital adherence technology, be used as a complement to directly observed treatment (DOT) for tuberculosis, as DOT is inconvenient and costly. However, existing evidence about the effectiveness of these monitors is inconclusive. Therefore, we evaluated the effectiveness of a comprehensive package based on electronic medication monitors among patients with tuberculosis in Tibet Autonomous Region (hereafter Tibet), China.
282. Efficacy of typhoid conjugate vaccine: final analysis of a 4-year, phase 3, randomised controlled trial in Malawian children.
作者: Priyanka D Patel.;Yuanyuan Liang.;James E Meiring.;Nedson Chasweka.;Pratiksha Patel.;Theresa Misiri.;Felistas Mwakiseghile.;Richard Wachepa.;Happy C Banda.;Florence Shumba.;Gift Kawalazira.;Queen Dube.;Nginache Nampota-Nkomba.;Osward M Nyirenda.;Tsion Girmay.;Shrimati Datta.;Leslie P Jamka.;J Kathleen Tracy.;Matthew B Laurens.;Robert S Heyderman.;Kathleen M Neuzil.;Melita A Gordon.; .
来源: Lancet. 2024年403卷10425期459-468页
Randomised controlled trials of typhoid conjugate vaccines among children in Africa and Asia have shown high short-term efficacy. Data on the durability of protection beyond 2 years are sparse. We present the final analysis of a randomised controlled trial in Malawi, encompassing more than 4 years of follow-up, with the aim of investigating vaccine efficacy over time and by age group.
283. The effect of computerised decision support alerts tailored to intensive care on the administration of high-risk drug combinations, and their monitoring: a cluster randomised stepped-wedge trial.
作者: Tinka Bakker.;Joanna E Klopotowska.;Dave A Dongelmans.;Saeid Eslami.;Wytze J Vermeijden.;Stefaan Hendriks.;Julia Ten Cate.;Attila Karakus.;Ilse M Purmer.;Sjoerd H W van Bree.;Peter E Spronk.;Martijn Hoeksema.;Evert de Jonge.;Nicolette F de Keizer.;Ameen Abu-Hanna.; .
来源: Lancet. 2024年403卷10425期439-449页
Drug-drug interactions (DDIs) can harm patients admitted to the intensive care unit (ICU). Yet, clinical decision support systems (CDSSs) aimed at helping physicians prevent DDIs are plagued by low-yield alerts, causing alert fatigue and compromising patient safety. The aim of this multicentre study was to evaluate the effect of tailoring potential DDI alerts to the ICU setting on the frequency of administered high-risk drug combinations.
284. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study.
作者: Jeffrey S Weber.;Matteo S Carlino.;Adnan Khattak.;Tarek Meniawy.;George Ansstas.;Matthew H Taylor.;Kevin B Kim.;Meredith McKean.;Georgina V Long.;Ryan J Sullivan.;Mark Faries.;Thuy T Tran.;C Lance Cowey.;Andrew Pecora.;Montaser Shaheen.;Jennifer Segar.;Theresa Medina.;Victoria Atkinson.;Geoffrey T Gibney.;Jason J Luke.;Sajeve Thomas.;Elizabeth I Buchbinder.;Jane A Healy.;Mo Huang.;Manju Morrissey.;Igor Feldman.;Vasudha Sehgal.;Celine Robert-Tissot.;Peijie Hou.;Lili Zhu.;Michelle Brown.;Praveen Aanur.;Robert S Meehan.;Tal Zaks.
来源: Lancet. 2024年403卷10427期632-644页
Checkpoint inhibitors are standard adjuvant treatment for stage IIB-IV resected melanoma, but many patients recur. Our study aimed to evaluate whether mRNA-4157 (V940), a novel mRNA-based individualised neoantigen therapy, combined with pembrolizumab, improved recurrence-free survival and distant metastasis-free survival versus pembrolizumab monotherapy in resected high-risk melanoma.
285. Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.
作者: Hellen C Barsosio.;Mwayiwawo Madanitsa.;Everlyne D Ondieki.;James Dodd.;Eric D Onyango.;Kephas Otieno.;Duolao Wang.;Jenny Hill.;Victor Mwapasa.;Kamija S Phiri.;Kenneth Maleta.;Miriam Taegtmeyer.;Simon Kariuki.;Christentze Schmiegelow.;Julie R Gutman.;Feiko O Ter Kuile.
来源: Lancet. 2024年403卷10424期365-378页
The efficacy of daily co-trimoxazole, an antifolate used for malaria chemoprevention in pregnant women living with HIV, is threatened by cross-resistance of Plasmodium falciparum to the antifolate sulfadoxine-pyrimethamine. We assessed whether addition of monthly dihydroartemisinin-piperaquine to daily co-trimoxazole is more effective at preventing malaria infection than monthly placebo plus daily co-trimoxazole in pregnant women living with HIV.
286. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial.
作者: Marta Rial-Crestelo.;Marek Lubusky.;Mauro Parra-Cordero.;Ladislav Krofta.;Anna Kajdy.;Eyal Zohav.;Elena Ferriols-Perez.;Rogelio Cruz-Martinez.;Marian Kacerovsky.;Elena Scazzocchio.;Lucie Roubalova.;Pamela Socias.;Lubomir Hašlík.;Jan Modzelewski.;Eran Ashwal.;Julia Castellá-Cesari.;Monica Cruz-Lemini.;Eduard Gratacos.;Francesc Figueras.; .
来源: Lancet. 2024年403卷10426期545-553页
The cerebroplacental ratio is associated with perinatal mortality and morbidity, but it is unknown whether routine measurement improves pregnancy outcomes. We aimed to evaluate whether the addition of cerebroplacental ratio measurement to the standard ultrasound growth assessment near term reduces perinatal mortality and severe neonatal morbidity, compared with growth assessment alone.
287. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.
作者: B Joseph Elmunzer.;Lydia D Foster.;Jose Serrano.;Gregory A Coté.;Steven A Edmundowicz.;Sachin Wani.;Raj Shah.;Ji Young Bang.;Shyam Varadarajulu.;Vikesh K Singh.;Mouen Khashab.;Richard S Kwon.;James M Scheiman.;Field F Willingham.;Steven A Keilin.;Georgios I Papachristou.;Amitabh Chak.;Adam Slivka.;Daniel Mullady.;Vladimir Kushnir.;James Buxbaum.;Rajesh Keswani.;Timothy B Gardner.;Nauzer Forbes.;Amit Rastogi.;Andrew Ross.;Joanna Law.;Patrick Yachimski.;Yen-I Chen.;Alan Barkun.;Zachary L Smith.;Bret Petersen.;Andrew Y Wang.;John R Saltzman.;Rebecca L Spitzer.;Collins Ordiah.;Cathie Spino.;Valerie Durkalski-Mauldin.; .
来源: Lancet. 2024年403卷10425期450-458页
The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.
288. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial.
作者: Katherine R Tuttle.;Sibylle J Hauske.;Maria Eugenia Canziani.;Maria Luiza Caramori.;David Cherney.;Lisa Cronin.;Hiddo J L Heerspink.;Christian Hugo.;Masaomi Nangaku.;Ricardo Correa Rotter.;Arnold Silva.;Shimoli V Shah.;Zhichao Sun.;Dorothea Urbach.;Dick de Zeeuw.;Peter Rossing.; .
来源: Lancet. 2024年403卷10424期379-390页
Excess aldosterone accelerates chronic kidney disease progression. This phase 2 clinical trial assessed BI 690517, an aldosterone synthase inhibitor, for efficacy, safety, and dose selection.
289. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study.
作者: Chiaojung Jillian Tsai.;Jonathan T Yang.;Narek Shaverdian.;Juber Patel.;Annemarie F Shepherd.;Juliana Eng.;David Guttmann.;Randy Yeh.;Daphna Y Gelblum.;Azadeh Namakydoust.;Isabel Preeshagul.;Shanu Modi.;Andrew Seidman.;Tiffany Traina.;Pamela Drullinsky.;Jessica Flynn.;Zhigang Zhang.;Andreas Rimner.;Erin F Gillespie.;Daniel R Gomez.;Nancy Y Lee.;Michael Berger.;Mark E Robson.;Jorge S Reis-Filho.;Nadeem Riaz.;Charles M Rudin.;Simon N Powell.; .
来源: Lancet. 2024年403卷10422期171-182页
Most patients with metastatic cancer eventually develop resistance to systemic therapy, with some having limited disease progression (ie, oligoprogression). We aimed to assess whether stereotactic body radiotherapy (SBRT) targeting oligoprogressive sites could improve patient outcomes.
290. Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.
作者: Inder Kaul.;Sharon Sawchak.;Christoph U Correll.;Rishi Kakar.;Alan Breier.;Haiyuan Zhu.;Andrew C Miller.;Steven M Paul.;Stephen K Brannan.
来源: Lancet. 2024年403卷10422期160-170页
New treatments with new mechanisms are urgently needed for people with schizophrenia. Xanomeline is a dual M1 and M4-preferring muscarinic receptor agonist that does not block D2 dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors. The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.
291. Perinatal morbidity among women with a previous caesarean delivery (PRISMA trial): a cluster-randomised trial.
作者: Nils Chaillet.;Benoît Mâsse.;William A Grobman.;Allison Shorten.;Robert Gauthier.;Patrick Rozenberg.;Marylène Dugas.;Jean-Charles Pasquier.;François Audibert.;Haim A Abenhaim.;Suzanne Demers.;Bruno Piedboeuf.;William D Fraser.;Robert Gagnon.;Guy-Paul Gagné.;Diane Francoeur.;Isabelle Girard.;Louise Duperron.;Marie-Josée Bédard.;Mira Johri.;Eric Dubé.;Simon Blouin.;Thierry Ducruet.;Mario Girard.;Emmanuel Bujold.; .
来源: Lancet. 2024年403卷10421期44-54页
Women with a previous caesarean delivery face a difficult choice in their next pregnancy: planning another caesarean or attempting vaginal delivery, both of which are associated with potential maternal and perinatal complications. This trial aimed to assess whether a multifaceted intervention, which promoted person-centred decision making and best practices, would reduce the risk of major perinatal morbidity among women with one previous caesarean delivery.
292. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study.
作者: David J Jackson.;Liam G Heaney.;Marc Humbert.;Brian D Kent.;Anat Shavit.;Lina Hiljemark.;Lynda Olinger.;David Cohen.;Andrew Menzies-Gow.;Stephanie Korn.; .
来源: Lancet. 2024年403卷10423期271-281页
Stepwise intensification of inhaled corticosteroids (ICS) is routine for severe eosinophilic asthma, despite some poor responses to high-dose ICS. Dose reductions are recommended in patients responding to biologics, but little supporting safety evidence exists.
293. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial.
作者: Ana Oaknin.;Laurence Gladieff.;Jerónimo Martínez-García.;Guillermo Villacampa.;Munetaka Takekuma.;Ugo De Giorgi.;Kristina Lindemann.;Linn Woelber.;Nicoletta Colombo.;Linda Duska.;Alexandra Leary.;Ana Godoy-Ortiz.;Shin Nishio.;Antoine Angelergues.;Maria Jesús Rubio.;Lorena Fariñas-Madrid.;Satoshi Yamaguchi.;Domenica Lorusso.;Isabelle Ray-Coquard.;Luis Manso.;Florence Joly.;Jesús Alarcón.;Philippe Follana.;Ignacio Romero.;Coriolan Lebreton.;J Alejandro Pérez-Fidalgo.;Mayu Yunokawa.;Hanna Dahlstrand.;Véronique D'Hondt.;Leslie M Randall.; .
来源: Lancet. 2024年403卷10421期31-43页
The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone.
294. Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial.
作者: Mark J Peters.;Doug W Gould.;Samiran Ray.;Karen Thomas.;Irene Chang.;Marzena Orzol.;Lauran O'Neill.;Rachel Agbeko.;Carly Au.;Elizabeth Draper.;Lee Elliot-Major.;Elisa Giallongo.;Gareth A L Jones.;Lamprini Lampro.;Jon Lillie.;Jon Pappachan.;Sam Peters.;Padmanabhan Ramnarayan.;Zia Sadique.;Kathryn M Rowan.;David A Harrison.;Paul R Mouncey.; .
来源: Lancet. 2024年403卷10424期355-364页
The optimal target for systemic oxygenation in critically ill children is unknown. Liberal oxygenation is widely practiced, but has been associated with harm in paediatric patients. We aimed to evaluate whether conservative oxygenation would reduce duration of organ support or incidence of death compared to standard care.
295. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Uwe Platzbecker.;Valeria Santini.;Pierre Fenaux.;Mikkael A Sekeres.;Michael R Savona.;Yazan F Madanat.;Maria Díez-Campelo.;David Valcárcel.;Thomas Illmer.;Anna Jonášová.;Petra Bělohlávková.;Laurie J Sherman.;Tymara Berry.;Souria Dougherty.;Sheetal Shah.;Qi Xia.;Libo Sun.;Ying Wan.;Fei Huang.;Annat Ikin.;Shyamala Navada.;Faye Feller.;Rami S Komrokji.;Amer M Zeidan.
来源: Lancet. 2024年403卷10423期249-260页
Unmet medical needs remain in patients with red blood cell transfusion-dependent (RBC-TD) lower-risk myelodysplastic syndromes (LR-MDS) who are not responding to or are ineligible for erythropoiesis-stimulating agents (ESAs). Imetelstat, a competitive telomerase inhibitor, showed promising results in a phase 2 trial. We aimed to compare the RBC transfusion independence (RBC-TI) rate with imetelstat versus placebo in patients with RBC-TD LR-MDS.
296. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.
作者: Marcus Maurer.;Luis Felipe Ensina.;Ana Maria Gimenez-Arnau.;Gordon Sussman.;Michihiro Hide.;Sarbjit Saini.;Clive Grattan.;Daria Fomina.;Dimitrios Rigopoulos.;Frederic Berard.;Giorgio Walter Canonica.;Heike Rockmann.;Carla Irani.;Jacek C Szepietowski.;Jeffrey Leflein.;Jonathan A Bernstein.;Jonny G Peter.;Kanokvalai Kulthanan.;Kiran Godse.;Ledit Ardusso.;Olga Ukhanova.;Petra Staubach.;Rodney Sinclair.;Shaila Gogate.;Simon Francis Thomsen.;Tonny Tanus.;Young Min Ye.;Alis Burciu.;Avantika Barve.;Darshna Modi.;Emil Scosyrev.;Eva Hua.;Kerstin Letzelter.;Vineeth Varanasi.;Manmath Patekar.;Thomas Severin.; .
来源: Lancet. 2024年403卷10422期147-159页
Many patients with chronic spontaneous urticaria (CSU) do not achieve complete control of their symptoms with current available treatments. In a dose-finding phase 2b study, ligelizumab improved urticaria symptoms in patients with H1-antihistamine (H1-AH) refractory CSU. Here, we report the efficacy and safety outcomes from two ligelizumab phase 3 studies.
297. Type of goals set and progress towards these goals, as part of a behaviour change intervention, in people with mild cognitive impairment: a secondary analysis.
作者: Tasmin Rookes.;Rachael Frost.;Yolanda Barrado-Martin.;Louise Marston.;Claudia Cooper.;Benjamin Gardner.;Megan Armstrong.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S80页
Mild cognitive impairment (MCI) affects 5-20% of older people in the UK, but often goes undiagnosed and is associated with increased risk of dementia. Targeting risk factors such as physical inactivity and social isolation through behaviour-change interventions could reduce this risk. However, it is unclear how MCI impacts engagement with these interventions. We aimed to explore how MCI affects goal-setting priorities and progress towards these goals in a behaviour-change intervention (HomeHealth).
298. A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.
作者: Marie H Murphy.;S Maria O'Kane.;Angela Carlin.;Ian M Lahart.;Leanne C Doherty.;Russell Jago.;Gary McDermott.;Maria Faulkner.;Alison M Gallagher.
来源: Lancet. 2023年402 Suppl 1卷S72页
Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls.
299. Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.
作者: Rachael Frost.;Christina Avgerinou.;Sarah Kalwarowsky.;Farah Mahmood.;Claire Goodman.;Andrew Clegg.;Jane Hopkins.;Rebecca Gould.;Benjamin Gardner.;Louise Marston.;Rachael Hunter.;Kalpa Kharicha.;Claudia Cooper.;Dawn A Skelton.;Vari Drennan.;Pip Logan.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S42页
NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual.
300. Lessons from the Gateway programme, aimed at improving health and life chances for young people committing low-level offences: a qualitative evaluation.
Young people who commit criminal offences are often affected by mental health issues, including drug and alcohol misuse, with many leading chaotic lifestyles. Gateway was a pioneering court-diversion programme aimed to reduce reoffending and improve the health and wellbeing of people aged 18-24 years who had been questioned for a low-level offence. The Gateway Study consisted of a pragmatic, parallel-group, superiority randomised controlled trial (RCT) of the programme's effectiveness, and its qualitative evaluation. We aimed to determine barriers and enablers for implementation of Gateway and recruitment into the RCT.
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