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Author Correction: Subclassification of obesity for precision prediction of cardiometabolic diseases

Nature medicine 2025年第2期31卷 695页

作者： Daniel E Coral Femke Smit Ali Farzaneh Alexander Gieswinkel Juan Fernandez Tajes Thomas Sparsø Carl Delfin Pierre Bauvin Kan Wang Marinella Temprosa Diederik De Cock Jordi Blanch José Manuel Fernández-Real Rafael Ramos M Kamran Ikram Maria F Gomez Maryam Kavousi Marina Panova-Noeva Philipp S Wild Carla van der Kallen Michiel Adriaens Marleen van Greevenbroek Ilja Arts Carel Le Roux Fariba Ahmadizar Timothy M Frayling Giuseppe N Giordano Ewan R Pearson Paul W Franks Genetic and Molecular Epidemiology Unit Lund University Diabetes Centre Department of Clinical Science Lund University Helsingborg Sweden. daniel.coral@med.lu.se. Maastricht Centre for Systems Biology (MaCSBio) Maastricht University Maastricht The Netherlands. f.smit@maastrichtuniversity.nl. Department of Epidemiology Erasmus MC University Medical Center Rotterdam The Netherlands. Preventive Cardiology and Preventive Medicine Center for Cardiology University Medical Center of the Johannes Gutenberg-University Mainz Mainz Germany. Genetic and Molecular Epidemiology Unit Lund University Diabetes Centre Department of Clinical Science Lund University Helsingborg Sweden. Department of Pharmacometrics Novo Nordisk A/S Søborg Denmark. Université de Lille Inserm CHU Lille Institut Pasteur de Lille U1190-EGID Lille France. Biostatistics and Bioinformatics Milken Institute School of Public Health George Washington University Rockville MD USA. Biostatistics and Medical Informatics Research Group Department of Public Health Vrije Universiteit Brussel Brussels Belgium. Nutrition Eumetabolism and Health Group Institut d'Investigació Biomèdica de Girona (IDIBGI-CERCA) Girona Spain. Department of Medical Sciences University of Girona Girona Spain. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN) Instituto de Salud Carlos III Madrid Spain. Department of Diabetes Endocrinology and Nutrition Dr. Josep Trueta University Hospital Girona Spain. Departments of Epidemiology Erasmus MC University Medical Center Rotterdam The Netherlands. Diabetic Complications Unit Lund University Diabetes Centre Department of Clinical Science Lund University Malmö Sweden. Translational Medicine and Clinical Pharmacology Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim am Rhein Germany. Center for Thrombosis and Haemostasis University Medical Center of the Johannes Gutenberg-University Mainz Mainz Germany. DZHK (German Center for Cardiovascular Research) Partner Site Rhine-Ma

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Donor-Derived CAR T Cells Engineered with Sleeping Beauty Achieve Anti-Leukemic Activity without Severe Toxicity

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BLOOD 2020年 136卷 34-34页

作者： Magnani, Chiara F. Gaipa, Giuseppe Lussana, Federico Belotti, Daniela Gritti, Giuseppe Napolitano, Sara Buracchi, Chiara Borleri, Gian Maria Zaninelli, Silvia Rizzuto, Giuliana Tettamanti, Sarah Colombo, Valentina Cazzaniga, Giovanni Cabiati, Benedetta Rovelli, Attilio Biagi, Ettore Galimberti, Stefania Benedicenti, Fabrizio Montini, Eugenio Ferrari, Silvia Introna, Martino Balduzzi, Adriana Valsecchi, Maria Grazia Dastoli, Giuseppe Rambaldi, Alessandro Biondi, Andrea Tettamanti Research Center Department of Pediatrics University of Milano-Bicoc Monza Italy Tettamanti Research Center Department of Pediatrics University of Milano - Bicocca/Fondazione MBBM Monza Italy Laboratorio di Terapia Cellulare e Genica Stefano Verri ASST-Monza Ospedale San Gerardo Monza Italy Hematology and Bone Marrow Transplant Unit ASST Papa Giovanni XXIII Bergamo Italy Department of Pediatrics University of Milano - Bicocca Milan Italy Clinica Pediatrica Università Milano - Bicocca/Fondazione MBBM Monza Italy USS Centro di Terapia Cellulare “G. Lanzani” Bergamo Italy Bicocca Bioinformatics Biostatistics and Bioimaging Centre Department of Medicine and Surgery University of Milano - Bicocca Monza Italy San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) / IRCCS San Raffaele Scientific Institute Milan Italy

Background Significant efforts over the past few years led Chimeric Antigen Receptor (CAR) T cell therapy to success in relapsed and refractory (r/r) B-cell malignancies. Still logistical complexity, high costs and toxicities are currently the main barriers to the use of CAR T cell therapy. We therefore propose non-viral engineering of an allogeneic T cell population according to cytokine induced killer (CIK) cell protocol of differentiation. Methods We reported the updated results of our phase I/II trial in B-cell acute lymphoblastic leukemia (B-ALL) patients relapsed after allogeneic hematopoietic stem cell transplantation (HSCT) using donor-derived CD19 CAR T cells generated with the Sleeping Beauty (SB) transposon and differentiated into CIK (CARCIK-CD19) according to the method enclosed in the filed patent EP20140192371. After lymphodepletion with Fludarabine (30 mg/m 2 /day) x 4 days and Cyclophosphamide (500 mg/m 2 /day) x 2 days, CARCIK-CD19 were infused following a four-dose escalation scheme (1x10 6 , 3x10 6 , 7.5x10 6 and 15x10 6 transduced CAR+ T cells/kg) according to the Bayesian Optimal Interval Design (BOIN). During the cell manufacturing period, bridging anti leukemic therapy from patient registration to the beginning of the lymphodepletion, was allowed. The primary endpoint was to define the Maximum Tolerated Dose (MTD) and the safety assessment. Key secondary endpoints included the assessment of complete hematologic response (CR), defined as < 5% bone marrow (BM) blasts, circulating blasts < 1%, no clinical evidence of extramedullary disease, as well as the characterization of CARCIK-CD19 persistence in PB and BM (NCT03389035). Results The cellular product was produced successfully for all patients starting from the donor-derived peripheral blood (PB) and consisted mostly of CD3+ lymphocytes (mean 98.85% ±SD 1.19%) with a mean of 38.6% CAR expression (range 15.10%-73.17%). From January 2018 to July 2020, a total of 24 patients were screened, and 1

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Author Correction: Multi-ancestry genome-wide association analyses improve resolution of genes and pathways influencing lung function and chronic obstructive pulmonary disease risk

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Nature genetics 2023年第10期55卷 1778-1779页

作者： Nick Shrine Abril G Izquierdo Jing Chen Richard Packer Robert J Hall Anna L Guyatt Chiara Batini Rebecca J Thompson Chandan Pavuluri Vidhi Malik Brian D Hobbs Matthew Moll Wonji Kim Ruth Tal-Singer Per Bakke Katherine A Fawcett Catherine John Kayesha Coley Noemi Nicole Piga Alfred Pozarickij Kuang Lin Iona Y Millwood Zhengming Chen Liming Li Sara R A Wijnant Lies Lahousse Guy Brusselle Andre G Uitterlinden Ani Manichaikul Elizabeth C Oelsner Stephen S Rich R Graham Barr Shona M Kerr Veronique Vitart Michael R Brown Matthias Wielscher Medea Imboden Ayoung Jeong Traci M Bartz Sina A Gharib Claudia Flexeder Stefan Karrasch Christian Gieger Annette Peters Beate Stubbe Xiaowei Hu Victor E Ortega Deborah A Meyers Eugene R Bleecker Stacey B Gabriel Namrata Gupta Albert Vernon Smith Jian'an Luan Jing-Hua Zhao Ailin F Hansen Arnulf Langhammer Cristen Willer Laxmi Bhatta David Porteous Blair H Smith Archie Campbell Tamar Sofer Jiwon Lee Martha L Daviglus Bing Yu Elise Lim Hanfei Xu George T O'Connor Gaurav Thareja Omar M E Albagha Karsten Suhre Raquel Granell Tariq O Faquih Pieter S Hiemstra Annelies M Slats Benjamin H Mullin Jennie Hui Alan James John Beilby Karina Patasova Pirro Hysi Jukka T Koskela Annah B Wyss Jianping Jin Sinjini Sikdar Mikyeong Lee Sebastian May-Wilson Nicola Pirastu Katherine A Kentistou Peter K Joshi Paul R H J Timmers Alexander T Williams Robert C Free Xueyang Wang John L Morrison Frank D Gilliland Zhanghua Chen Carol A Wang Rachel E Foong Sarah E Harris Adele Taylor Paul Redmond James P Cook Anubha Mahajan Lars Lind Teemu Palviainen Terho Lehtimäki Olli T Raitakari Jaakko Kaprio Taina Rantanen Kirsi H Pietiläinen Simon R Cox Craig E Pennell Graham L Hall W James Gauderman Chris Brightling James F Wilson Tuula Vasankari Tarja Laitinen Veikko Salomaa Dennis O Mook-Kanamori Nicholas J Timpson Eleftheria Zeggini Josée Dupuis Caroline Hayward Ben Brumpton Claudia Langenberg Stefan Weiss Georg Homuth Carsten Oliver Schmidt Nicole Probst-Hensch Marjo-Riitta Jarvelin Alanna C Morrison Ozren Polasek Igor Department of Population Health Sciences University of Leicester Leicester UK. nick.shrine@leicester.ac.uk. Department of Population Health Sciences University of Leicester Leicester UK. Division of Respiratory Medicine and NIHR Nottingham Biomedical Research Centre University of Nottingham Nottingham UK. Leicester National Institute for Health and Care Research Biomedical Research Centre Glenfield Hospital Leicester UK. Channing Division of Network Medicine Division of Pulmonary and Critical Care Medicine Department of Medicine Brigham and Women's Hospital Boston MA USA. Harvard Medical School Boston MA USA. COPD Foundation Washington DC USA. Department of Clinical Science Unversity of Bergen Bergen Norway. Nuffield Department of Population Health University of Oxford Oxford UK. MRC Population Health Research Unit University of Oxford Oxford UK. Department of Epidemiology and Biostatistics School of Public Health Peking University Health Science Center Beijing China. Department of Respiratory Diseases Ghent Universital Hospital Ghent Belgium. Department of Bioanalysis Faculty of Pharmaceutical Sciences Ghent University Ghent Belgium. Department of Epidemiology Eramus Medical Center Rotterdam The Netherlands. Department of Internal Medicine Eramus Medical Center Rotterdam The Netherlands. Center for Public Health Genomics University of Virginia Charlottesville VA USA. Department of Medicine Columbia University Medical Center New York NY USA. Medical Research Council Human Genetics Unit Institute of Genetics and Cancer University of Edinburgh Edinburgh UK. Human Genetics Center Department of Epidemiology Human Genetics and Environmental Sciences School of Public Health The University of Texas Health Science Center at Houston Houston TX USA. MRC Centre for Environment and Health Department of Epidemiology and Biostatistics School of Public Health Imperial College London London UK. Department of Epidemiology and Public Health Swiss Tropical

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#241 Improving endometrial cancer assessment by combining the new technique of GENomic profiling with surgical extra uterine disease assessment (EUGENIE). Results of the first 90 enrolled patients

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International Journal of Gynecological Cancer 2023年 33卷 A421-A422页

作者： Rita Trozzi Luigi Congedo Emanuele Perrone Camilla Nero Emilia Palmieri Aniello Foresta Jenneke C Kasius Johanna Pijnenborg Thaïs Baert Annouschka Laenen Anne-Sophie Van Rompuy Ignacio Zapardiel Giuseppe Vizzielli Jure Knez Giovanni Scambia Francesco Fanfani Frédéric Amant Department of Women Children and Public Health Sciences Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Facoltà di Medicina e Chirurgia Università Cattolica del Sacro Cuore Rome Italy Department of Gynecological Oncology Amsterdam University Medical Centres Centre for Gynecological Oncology Amsterdam (CGOA) 22660 1100 DD Amsterdam The Netherlands Department of Obstetrics and Gynecology Radboudumc Nijmegen The Netherlands Division of Gynecologic Oncology； Department of Obstetrics and gynecology KU Leuven University Hospitals Leuven Leuven Belgium Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat) KULeuven Leuven Belgium Department of Pathology University Hospitals Leuven Leuven Belgium Laboratory of Translational Cell and Tissue Research Department of Imaging and Pathology KU Leuven – University of Leuven Leuven Belgium Gynecologic Oncology Unit La Paz University Hospital Madrid Spain Department of Medical Area (DAME) University of Udine Udine Italy Clinic of Obstetrics and Gynecology Udine Italy Department for Gynaecological Oncology University Medical Centre Maribor Maribor Slovenia Center for Gynaecologic Oncology Netherlands Cancer Institute Amsterdam The Netherlands

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Population-Specific Immunogenomic Alterations in Gallbladder Cancer and Prognostic Significance

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Modern Pathology 2025年

作者： Yan Zhu Luisa Maren Solis Soto Shubham Pant Eduardo A. Vega Eduardo Vinuela Behnaz Bozorgui Jean-Nicolas Vauthey Gloria Aguayo Zhonglin Wang Wei Lu Xinyue Chen Barbara Mino Lakshmi Kakarala Jianliang Dai Suyu Liu Khalida M. Wani Alexander J. Lazar Fernando Carapeto Sunyoung Lee Ignacio Wistuba Lawrence N. Kwong Department of Translational Molecular Pathology The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA Cancer Biology Program The University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences Houston TX77030 USA Bioinformatics and Computational Biology The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA Department of Digestive Surgery Hepato-Pancreato-Biliary Surgery Unit Surgery Service Sotero del Rio Hospital Santiago Chile Department of Surgical Oncology The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA Department of Surgery St. Elizabeth's Medical Center Boston University School of Medicine 11 Nevins St. Suite 201 Brighton Boston MA 02135 USA Department of Digestive Surgery Faculty of Medicine Catholic University of Chile Santiago Chile Department of Gastrointestinal Medical Oncology The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA Social Science Research Institute Duke University NC 27708 USA Department of Biostatistics The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA Department of Genomic Medicine The University of Texas MD Anderson Cancer Center Houston Texas 77030 USA

Gallbladder carcinoma is a deadly disease with a poor prognosis, and recent clinical data suggest only a modest benefit of PD1/PDL1 inhibitors in this disease. Optimizing immunotherapeutic approaches will require a detailed understanding of the immunogenomic landscape of this disease worldwide. We combined targeted next generation sequencing and immunohistochemistry to create detailed immunogenomic landscapes from two cohorts of gallbladder cancer cases from the united States (n=60) and Chile (n=62). Mutations in TP53, SMAD4, KRAS, PIK3CA, ARID2, ARID1A, ATM, FBXW7, ERBB2, and NF1 were found in both the US and Chilean primary cohorts, as well as amplifications in ERBB2, CCNE1, MDM2/CDK4, and CCND1. Despite similar mutation profiles, the immune profiles were distinct, with the Latin American cohort having higher densities of biomarkers associated with CD4+ T cells and PD-1, but lower densities of CD68+ macrophages compared to the North American cohort. Clustering and correlation analyses suggest novel immune subgroups and clinical associations independently of any specific mutations. Additionally, supported by multiplexed single-cell imaging technology, we identified low CD4 and high VISTA as a candidate biomarker pair of poor outcomes. In summary, our findings highlight the importance of sensitivity to geographic location when considering therapeutic developments and paves a path for further immune investigations of this understudied disease.

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Publisher Correction: Ancient origin and constrained evolution of the division and cell wall gene cluster in Bacteria

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Nature microbiology 2023年第2期8卷 361页

作者： Daniela Megrian Najwa Taib Alexander L Jaffe Jillian F Banfield Simonetta Gribaldo Evolutionary Biology of the Microbial Cell Institut Pasteur Université Paris Cité Paris France. Collège Doctoral Sorbonne Université Paris France. Unité de Microbiologie Structurale Institut Pasteur CNRS UMR 3528 Université Paris Paris France. Evolutionary Biology of the Microbial Cell Institut Pasteur Université Paris Cité Paris France. najwa.taib@pasteur.fr. Bioinformatics and Biostatistics Hub Institut Pasteur Université Paris Cité Paris France. najwa.taib@pasteur.fr. Department of Plant and Microbial Biology University of California Berkeley Berkeley CA USA. Innovative Genomics Institute University of California Berkeley Berkeley CA USA. Department of Earth and Planetary Science University of California Berkeley Berkeley CA USA. Department of Environmental Science Policy and Management University of California Berkeley Berkeley CA USA. Evolutionary Biology of the Microbial Cell Institut Pasteur Université Paris Cité Paris France. simonetta.gribaldo@pasteur.fr.

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Metastatic-niche labelling reveals parenchymal cells with stem features (vol 572, pg 603, 2019)

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NATURE 2019年第7784期575卷 E8-E8页

作者： Ombrato, Luigi Nolan, Emma Kurelac, Ivana Mavousian, Antranik Bridgeman, Victoria Louise Heinze, Ivonne Chakravarty, Probir Horswell, Stuart Gonzalez-Gualda, Estela Matacchione, Giulia Weston, Anne Kirkpatrick, Joanna Husain, Ehab Speirs, Valerie Collinson, Lucy Ori, Alessandro Lee, Joo-Hyeon Malanchi, Ilaria Tumour-Host Interaction Laboratory The Francis Crick Institute London UK Dipartimento di Scienze Mediche e Chirurgiche Università di Bologna Bologna Italy Wellcome—MRC Cambridge Stem Cell Institute University of Cambridge Cambridge UK Proteomics of Aging Leibniz Institute on Aging Fritz Lipmann Institute (FLI) Jena Germany Bioinformatics and Biostatistics Unit The Francis Crick Institute London UK Electron Microscopy Unit The Francis Crick Institute London UK Department of Pathology Aberdeen Royal Infirmary Aberdeen UK Institute of Medical Sciences University of Aberdeen Aberdeen UK Department of Physiology Development and Neuroscience University of Cambridge Cambridge UK

An Amendment to this paper has been published and can be accessed via a link at the top of the paper.

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Genome instability drives epistatic adaptation in the human pathogen Leishmania

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Proceedings of the National Academy of Sciences of the united States of America 2021年第51期118卷 e2113744118页

作者： Bussotti, Giovanni Piel, Laura Pescher, Pascale Domagalska, Malgorzata A. Shanmugha Rajan, K. Cohen-Chalamish, Smadar Doniger, Tirza Hiregange, Disha-Gajanan Myler, Peter J. Unger, Ron Michaeli, Shulamit Spath, Gerald F. Bioinformatics and Biostatistics Hub C3BI Institut Pasteur Universite de Paris Unite de Service et de Recherche (USR) 3756 Institut Pasteur CNRS Paris 75015 France Unite de Parasitologie moleculaire et Signalisation Institut Pasteur Universite de Paris INSERM U1201 Paris 75015 France Molecular Parasitology Unit Institute of Tropical Medicine B-2000 Antwerp Belgium The Mina and Everard Goodman Faculty of Life Sciences Advanced Materials and Nanotechnology Institute Bar-Ilan University Ramat-Gan 52900 Israel Department of Chemical and Structural Biology Weizmann Institute of Science Rehovot 7610001 Israel Seattle Structural Genomics Center for Infectious Disease Seattle 98195 WA United States Department of Biomedical Informatics and Medical Education University of Washington Seattle 98195 WA United States Department of Pediatrics University of Washington Seattle 98195 WA United States Department of Global Health University of Washington Seattle 98195 WA United States Center for Global Infectious Disease Research Seattle Children's Research Institute Seattle 98195 WA United States

How genome instability is harnessed for fitness gain despite its potential deleterious effects is largely elusive. An ideal system to address this important open question is provided by the protozoan pathogen Leishmania, which exploits frequent variations in chromosome and gene copy number to regulate expression levels. Using ecological genomics and experimental evolution approaches, we provide evidence that Leishmania adaptation relies on epistatic interactions between functionally associated gene copy number variations in pathways driving fitness gain in a given environment. We further uncover posttranscriptional regulation as a key mechanism that compensates for deleterious gene dosage effects and provides phenotypic robustness to genetically heterogenous parasite populations. Finally, we correlate dynamic variations in small nucleolar RNA (snoRNA) gene dosage with changes in ribosomal RNA 2⁰-O-methylation and pseudouridylation, suggesting translational control as an additional layer of parasite adaptation. Leishmania genome instability is thus harnessed for fitness gain by genome-dependent variations in gene expression and genome-independent compensatory mechanisms. This allows for polyclonal adaptation and maintenance of genetic heterogeneity despite strong selective pressure. The epistatic adaptation described here needs to be considered in Leishmania epidemiology and biomarker discovery and may be relevant to other fast-evolving eukaryotic cells that exploit genome instability for adaptation, such as fungal pathogens or cancer. © 2021 National Academy of Sciences. All rights reserved.

关键词： Epistatic interactions Evolutionary adaptation Fitness gain Genome instability Posttranscriptional regulation

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Correction to: Comprehensive genomic profiling on metastatic Melanoma: results from a network screening from 7 Italian Cancer Centres

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Journal of translational medicine 2024年第1期22卷 958页

作者： Matteo Pallocca Ivan Molineris Enrico Berrino Benedetta Marcozzi Martina Betti Lauretta Levati Stefania D'Atri Chiara Menin Gabriele Madonna Paola Ghiorzo Jenny Bulgarelli Virgina Ferraresi Tiziana Venesio Monica Rodolfo Licia Rivoltini Luisa Lanfrancone Paolo Antonio Ascierto Luca Mazzarella Pier Giuseppe Pelicci Ruggero De Maria Gennaro Ciliberto Enzo Medico Giandomenico Russo Institute of Experimental Endocrinology and Oncology National Research Council Naples Italy. matteo.pallocca@cnr.it. Department of Life Science and System Biology University of Turin Via Accademia Albertina 13 10123 Naples Italy. Candiolo Cancer Institute FPO-IRCCS Candiolo Italy. University of Turin Turin Italy. Biostatistics Bioinformatics and Clinical Trial Center IRCCS Regina Elena National Cancer Institute Rome Italy. Laboratory of Molecular Oncology IDI-IRCCS Rome Italy. Immunology and Oncological Molecular Diagnostics Oncological Institute IOV IRCCS UOC Padua Italy. Melanoma Cancer Immunotherapy and Development Therapeutics Istituto Nazionale Tumori IRCCS Fondazione G. Pascale 80131 Naples Italy. Genetics of Rare Cancers IRCCS Ospedale Policlinico San Martino 16132 Genoa Italy. Department of Internal Medicine and Medical Specialties University of Genova 16132 Genoa Italy. Immunotherapy Cell Therapy and Biobank Unit IRCCS Istituto Romagnolo Per lo Studio dei Tumori (IRST) "Dino Amadori" 47014 Meldola Italy. Sarcoma and Rare Tumours Departmental Unit- IRCCS Regina Elena National Cancer Institute-Rome Rome Italy. Unit of Translational Immunology Department of Experimental Oncology IRCCS Foundation National Cancer Institute Milan Italy. Department of Experimental Oncology European Institute of Oncology IRCCS (IEO) Milan Italy. Department of Oncology and Hemato-Oncology University of Milan Milan Italy. Institute of General Pathology Catholic University "Sacro Cuore" Rome Italy. Scientific Direction IRCCS Regina Elena National Cancer Institute Rome Italy. Istituto Dermopatico dell'Immacolata IDI-IRCCS Rome Italy.

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Using a personalized decision support algorithm for dosing in warfarin treatment: A randomised controlled trial

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Clinical Trials and Regulatory Science in Cardiology 2017年 25卷 1-6页

作者： Nielsen, Peter Brønnum Lundbye-Christensen, Søren van der Male, Meriam Larsen, Torben Bjerregaard Aalborg Thrombosis Research Unit Department of Clinical Medicine Faculty of Medicine Aalborg University Aalborg Denmark Department of Cardiology Aalborg University Hospital Aalborg Denmark Unit of Clinical Biostatistics and Bioinformatics Aalborg University Hospital Aalborg Denmark Department of Cardiology Aalborg University Hospital Denmark

Background Vitamin K-antagonists such as warfarin treatment remain the mainstay to prevent thromboembolic events in various conditions. The quality of the treatment is reflected through time in therapeutic (INR) range (TTR) with a threshold at ≥ 70% indicating ‘good quality’;achieving this quality is not trivial. We conducted a randomised controlled trial to assess the impact of decision aiding model on treatment quality in a high quality vitamin K-antagonist treatment setting. Methods We investigated if algorithm-suggested warfarin dosing was superior to standard dosing in a high-quality setting involving self-managing warfarin patients. Patients were initially allocated to either algorithm-suggested warfarin dosing or to standard care treatment, and were crossed over after three months. The trial period was a total of six months, and the primary endpoint was TTR;we also investigated a secondary endpoint of log-transformed INR variability. Results A total of 191 patients contributed to the main analysis with a mean follow-up time of 140 days;75% were males and the mean age was 65 years old. The intervention arm achieved a TTR of 81.6, while the placebo arm attained a TTR of 80.9 (difference [intervention arm minus placebo arm]: 0.67 (95% confidence interval − 2.93 to 4.27). The difference in INR variability was 0.30 (0.14 to 0.47), favouring the placebo arm in terms of lower log transformed variability. Conclusions We found no difference between the two trial-arms in a high-quality warfarin treatment setup. However in general, the model performed similarly as to routine patient self-management care. (*** number: NCT02705976) © 2016 The Authors

关键词： Anticoagulants Clinical decision support systems Randomised controlled clinical trial Therapeutic drug monitoring

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