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Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial 电子健康记录促进肿瘤症状监测和协作护理干预(E2C2):一项群体随机、人群水平、楔形步进式实用试验
Pub Date : 2025-12-01 DOI: 10.1016/s1470-2045(25)00526-1
Andrea L Cheville, Jeph Herrin, Deirdre R Pachman, Veronica Grzegorczyk, Kurt Kroenke, Jennifer L Ridgeway, Sarah A Minteer, Jessica D Austin, Joan M Griffin, Linda Chlan, Cindy Tofthagen, Sandra A Mitchell, Ashley Smith, Kathryn J Ruddy
<h3>Background</h3>Patient-reported outcome measure (PROM) surveillance and collaborative care improve cancer symptom control. However, human resource requirements constrain their implementation and reach. Electronic health record (EHR) facilitation reduces resource needs and might allow population-level scaling. We aimed to assess the effect of EHR facilitation of PROM-directed collaborative care on clinical and health services outcomes.<h3>Methods</h3>E2C2 was a cohort cluster-randomised, unblinded, stepped-wedge, pragmatic trial, in which we randomly assigned 15 clusters of medical oncology and haematology clinics in the USA sharing a common EHR, Epic, to five sequences to compare an intervention of remotely delivered electronic PROM (ePROM) symptom surveillance and EHR-facilitated collaborative care (ECC) management with a usual care (UC) control of ePROM surveillance alone. Sequences transitioned from the UC control to the ECC intervention state at 8-month intervals. All adult (aged ≥18 years) patients who received medical oncology or haematology care in a US multi-state health system were enrolled. All cancer stages, cancer types, and treatment phases were included, except for patients enrolled in hospice or with acute leukaemia. SPPADE symptoms (sleep interference, pain, impaired physical function, anxiety, depression, and energy deficit or fatigue) were assessed with 0–10-point numerical rating scales linked to clinical encounters. The prespecified co-primary outcomes were all post-baseline SPPADE scores, and clinically actionable scores (≥4/10), among participants who completed at least two ePROMs. The outcomes were assessed using multivariate regression of cluster-period mean SPPADE symptom scores against intervention exposure, baseline SPPADE scores, fixed-cluster, and secular time effects. The trial is registered at <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> (<span><span>NCT03892967</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>) and is now closed to recruitment.<h3>Findings</h3>From March 28, 2019, to Jan 31, 2023, 50 207 patients were enrolled and administered ePROMs in association with oncology or haematology visits. In the analytical cohort of 24 874 participants, 10 390 (42%) were assigned ePROMS in both the ECC and UC periods. Of the 19 084 [77%] in the ECC group, 11 138 (58%) were female, 7946 (42%) were male, and 18189 (95%) were White; and of the 16 180 (65%) in the UC group, 9621 (60%) were female, 6559 (40%) were male, and 15468 (96%) were White. 21 153 (85%) participants reported one or more clinically actionable symptoms (defined as SPPADE score ≥4/10). In multiva
背景:患者报告的预后指标(PROM)监测和协同护理改善了癌症症状控制。然而,人力资源需求限制了它们的实施和范围。电子健康记录(EHR)的便利减少了资源需求,并可能允许在人群层面进行扩展。我们的目的是评估电子病历促进prom指导的协作护理对临床和卫生服务结果的影响。方法se2c2是一项队列随机、非盲、楔形步进式实用试验,在该试验中,我们随机分配了15个美国医学肿瘤学和血化学诊所集群,共享一个共同的电子病历Epic,并将其分配到5个序列中,以比较远程提供电子PROM (ePROM)症状监测和EHR促进协同护理(ECC)管理的干预与常规护理(UC)控制单独的ePROM监测。序列以8个月的间隔从UC控制状态过渡到ECC干预状态。所有在美国多州卫生系统接受肿瘤医学或血液学治疗的成人(年龄≥18岁)患者被纳入研究。所有癌症分期、癌症类型和治疗阶段都包括在内,但临终关怀或急性白血病患者除外。SPPADE症状(睡眠干扰、疼痛、身体功能受损、焦虑、抑郁、能量不足或疲劳)采用与临床遭遇相关的0- 10分数值评定量表进行评估。预先指定的共同主要结局是完成至少两个eprom的参与者的所有基线后SPPADE评分和临床可操作评分(≥4/10)。使用多变量回归对干预暴露、基线SPPADE评分、固定聚类和长期时间效应的聚类期SPPADE平均症状评分进行评估。该试验已在ClinicalTrials.gov注册(NCT03892967),目前已结束招募。从2019年3月28日至2023年1月31日,共有50207名患者入组,并在肿瘤或血液科就诊时接受了eprom治疗。在24874名参与者的分析队列中,10390名(42%)在ECC和UC期间都被分配了eprom。在ECC组19 084只[77%]中,女性11 138只(58%),男性7946只(42%),白种18189只(95%);在UC组的16180例(65%)中,9621例(60%)为女性,6559例(40%)为男性,15468例(96%)为白人。215153例(85%)参与者报告了一个或多个临床可操作症状(定义为SPPADE评分≥4/10)。在多变量分析中,平均人群关节sppad症状负担倾向于ECC期(p= 0.0055),调整后的平均差异为:焦虑期- 0.12 (95% CI为- 0.19至- 0.05),抑郁期- 0.08 (95% CI为- 0.15至- 0.01),疲劳期- 0.06 (95% CI为- 0.016至0.03),疼痛期- 0.04 (95% CI为- 0.014至0.07),身体功能期- 0.03 (95% CI为- 0.07至0.02),睡眠期- 0.07 (95% CI为- 0.016至0.02)。根据可操作评分(p< 0.0001),也注意到ECC益处,调整后的平均差异为焦虑- 0.10(- 0.17至- 0.03),抑郁- 0.09(- 0.16至- 0.02),疲劳- 0.09(- 0.18至- 0.01),疼痛- 0.04(- 0.05至0.12),身体功能- 0.07(- 0.03至0.17),睡眠- 0.02(- 0.010至0.07)。在减轻肿瘤患者spade症状的人群负担方面,集中的电子病历促进、症状监测和协作护理管理比单独的症状监测更有益。资助美国国立卫生研究院。
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引用次数: 0
The promise of scalable symptom surveillance with stepped collaborative care in oncology 可扩展的症状监测与肿瘤阶梯协作护理的承诺
Pub Date : 2025-12-01 DOI: 10.1016/s1470-2045(25)00564-9
Kelly M Shaffer, Roger Anderson
No Abstract
没有抽象的
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引用次数: 0
Gavi hits HPV vaccine milestone early but concerns surround future funding 全球疫苗免疫联盟提前达到了HPV疫苗的里程碑,但对未来资金的担忧
Pub Date : 2025-11-27 DOI: 10.1016/s1470-2045(25)00712-0
Tony Kirby
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引用次数: 0
New South Wales expands cancer coverage for firefighters 新南威尔士州扩大了消防员的癌症覆盖范围
Pub Date : 2025-11-27 DOI: 10.1016/s1470-2045(25)00713-2
Kark Gruber
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引用次数: 0
Europe is falling behind on targets to address AMR 欧洲正在落后于解决抗生素耐药性的目标
Pub Date : 2025-11-27 DOI: 10.1016/s1470-2045(25)00711-9
Sharmila Devi
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引用次数: 0
The Lucerne Toolbox 3: digital health and artificial intelligence to optimise the patient journey in early breast cancer—a multidisciplinary consensus 卢塞恩工具箱3:数字健康和人工智能优化早期乳腺癌患者的旅程-多学科共识
Pub Date : 2025-11-25 DOI: 10.1016/s1470-2045(25)00463-2
André Pfob, Katja Pinker, Ines Vaz-Luis, Antonio Di Meglio, Maria João Cardoso, Giuseppe Curigliano, Oreste Davide Gentilini, Günther Gruber, Nik Hauser, Jörg Heil, Orit Kaidar-Person, Michael Knauer, Han-Byoel Lee, Sae Byul Lee, Sherene Loi, Meinrad Mannhart, Stella Mastora, Icro Meattini, Rosa Di Micco, Aurelia Noske, Fedro Alessandro Peccatori, Fiorita Poulakaki, Mattea Reinisch, Isabel T Rubio, Charlie Swanton, Christoph Tausch, Marie-Jeanne Vrancken Peeters, Jong Han Yu, Walter Paul Weber, Norman Zerbe, Philip Poortmans, Carsten Denkert, Ritse Mann, Suzette Delaloge, Peter Dubsky, Alexandra Athanasiou, Marianne Aznar, Thomas Bachelot, Zsuzsanna Bago-Horvath, Maggie Banys-Paluchowski, Sophia Belouka, Almir Bitencourt, Liesbeth Boersma, Kimberly Bowles, Roswitha Britz, Samantha Brunsden, Carmela Caballero, Julia Camps-Herrero, Giuseppe F Catanuto, Effimia Chatzinikolaou, Charlotte Coles, Stefanie Corradini, Terri Coutee, Jana de Boniface, Antonio Di Meglio, Joachim Diebold, Susanne Dieroff Hay, Nina Ditsch, David Dodwell, Ian Ellis, Sarah Eskreis-Winkler, Pierfrancesco Franco, Maria Alice Franzoi, Helen Frazer, Thomas frederic-moreau, Michael Fuchsjäger, Dorota Gabryś, Ursula Ganz-Blättler, Maria Luisa Gasparri, Mami Iima, Eva Karamitopoulou, Maria Katapodi, Marietta Kirchner, Antigoni Kretsi, Randi Krogsgaard, David Krug, Thorsten Kuehn, Christiane Kuhl, Kristina Lång, Kyung-Hun Lee, Sae Byul Lee, Hee Jin Lee, Vincenzo L'Imperio, Mairead MacKenzie, Maja Vestmø Maraldo, Stuart A McIntosh, Ingvil Mjaaland, Angel Montero, Linda Moy, Rosine Mucklow, Sudeshen Naidoo, Anu Niemi, Federica Pediconi, Frederique Penault-Llorca, Marlen Pfeiffer, André Pfob, Katja Pinker, Niklas Prenissl, Nina Radosevic-Robin, Duvern Ramiah, Ivica Ratosa, Tilman Rau, Evangelia Razis, Peter Regitnig, Nicola Rocco, Patrizia Sager, Pedro F Saint-Maurice, Anja Sander, Francesco Sardanelli, Elisabet Schesny, Simone Schiaffino, Alexander Schipf, Maximilian Schuessler, Jane Shaw, Davide Soldato, Stamatis Stamatelopoulos, Petra Steyerova, Philipp Ströbel, Laura Testa, Thiemo J A van Nijnatten, Ines Vaz, Ines Vaz Luis, Sara E Vazquez-Manjarrez, Maria Vidal, Jose Volders, Markus Wallwiener, Lynda Wyld, Nicholas Zdenkowski
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引用次数: 0
Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial Fuzuloparib联合或不联合apatinib治疗her2阴性转移性乳腺癌伴种系BRCA1/2突变(FABULOUS):一项多中心、三组、开放标签、随机、3期试验的中期分析
Pub Date : 2025-11-25 DOI: 10.1016/s1470-2045(25)00523-6
Huiping Li, Jieqiong Liu, Quchang Ouyang, Shusen Wang, Yaxin Liu, Yuee Teng, Xiaojia Wang, Jing Cheng, Zhongsheng Tong, Tao Sun, Min Yan, Xin Zhou, Fanfan Li, Jianyun Nie, Zhi-Ming Shao, Changsheng Ye, Yongsheng Wang, Xiaohong Wu, Zhihua Li, Yudong Wu, Huihua Xiong, Hui Li, Lu Gan, Zhaofeng Niu, Juliang Zhang, Qingyuan Zhang, Yueyin Pan, Xinhong Wu, Yi Zhang, Weimin Xie, Yu Xiao, Jinnan Gao, Huadong Zhao, Yongmei Yin, Zhiying Qian, Sanyuan Sun, Hongwei Zhang, Kun Wang, Jinsong Lu, Yong Li, Xinshuai Wang, Xinfeng Yang, Yuting Wang, Quanren Wang, Erwei Song
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引用次数: 0
Neurocognitive outcomes in patients with brain metastases: a systematic review 脑转移患者的神经认知预后:一项系统综述
Pub Date : 2025-11-25 DOI: 10.1016/s1470-2045(25)00525-x
Tarek Bou Dargham, Sebastian F Winter, Kristen Batich, Karin Gehring, Michael W Parsons, Jorg Dietrich, Trey Mullikin, Zachary J Reitman, Scott R Floyd, John P Kirkpatrick, Paul W Sperduto, Jona Hattangadi-Gluth, Helen A Shih, Paul D Brown, Minesh Mehta, Erik P Sulman, Katherine B Peters, Eugene J Vaios
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引用次数: 0
Total neoadjuvant therapy followed by non-operative management or surgery in stage II–III rectal cancer (NO-CUT): a multicentre, single-arm, phase 2 trial II-III期直肠癌(NO-CUT)的完全新辅助治疗后非手术治疗或手术:一项多中心、单臂、2期试验
Pub Date : 2025-11-25 DOI: 10.1016/s1470-2045(25)00542-x
Alessio Amatu, Giorgio Patelli, Maria Giulia Zampino, Francesca Bergamo, Stefania Mosconi, Federica Tosi, Davide Ciardiello, Sara Lonardi, Giorgia Negrini, Daniela Sibio, Marianna Alessandra Gerardi, Sara Galuppo, Francesco Romeo Filippone, Pietro Carnevali, Simona Borin, Pierluigi Pilati, Elia Poiasina, Erica Bonazzina, Lorenzo Gervaso, Enzo Mammano, Francesco Bracco, Luca Bergamaschi, Gaya Spolverato, Matteo Origi, Uberto Fumagalli Romario, Gianluca Mauri, Nicola Fazio, Edoardo Forti, Giuseppe De Roberto, Chiara Cristofori, Cesare Burti, Luigi Asmundo, Luigi Funicelli, Gaetano Ramondo, Pietro Andrea Bonaffini, Sara Mariano, Luca Lazzari, Silvia Ghezzi, Claudio Isella, Daniela Cantarella, Maria Costanza Aquilano, Luca Bottiglieri, Emanuela Bonoldi, Massimiliano Mutignani, Valter Torri, Enzo Medico, Alberto Bardelli, Silvia Marsoni, Angelo Vanzulli, Mauro Filippo Palazzi, Giovanni Carlo Ferrari, Katia Bencardino, Andrea Sartore-Bianchi, Salvatore Siena
{"title":"Total neoadjuvant therapy followed by non-operative management or surgery in stage II–III rectal cancer (NO-CUT): a multicentre, single-arm, phase 2 trial","authors":"Alessio Amatu, Giorgio Patelli, Maria Giulia Zampino, Francesca Bergamo, Stefania Mosconi, Federica Tosi, Davide Ciardiello, Sara Lonardi, Giorgia Negrini, Daniela Sibio, Marianna Alessandra Gerardi, Sara Galuppo, Francesco Romeo Filippone, Pietro Carnevali, Simona Borin, Pierluigi Pilati, Elia Poiasina, Erica Bonazzina, Lorenzo Gervaso, Enzo Mammano, Francesco Bracco, Luca Bergamaschi, Gaya Spolverato, Matteo Origi, Uberto Fumagalli Romario, Gianluca Mauri, Nicola Fazio, Edoardo Forti, Giuseppe De Roberto, Chiara Cristofori, Cesare Burti, Luigi Asmundo, Luigi Funicelli, Gaetano Ramondo, Pietro Andrea Bonaffini, Sara Mariano, Luca Lazzari, Silvia Ghezzi, Claudio Isella, Daniela Cantarella, Maria Costanza Aquilano, Luca Bottiglieri, Emanuela Bonoldi, Massimiliano Mutignani, Valter Torri, Enzo Medico, Alberto Bardelli, Silvia Marsoni, Angelo Vanzulli, Mauro Filippo Palazzi, Giovanni Carlo Ferrari, Katia Bencardino, Andrea Sartore-Bianchi, Salvatore Siena","doi":"10.1016/s1470-2045(25)00542-x","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00542-x","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145593402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Of surrogate endpoints, shortcuts, and safety 代理端点、快捷方式和安全性
Pub Date : 2025-11-25 DOI: 10.1016/s1470-2045(25)00663-1
Clifford A Hudis, Elizabeth Garrett-Mayer
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引用次数: 0
期刊
The Lancet Oncology
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