Sökning: WFRF:(Rubin E) > IOIBD Recommendatio...
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001 | oai:DiVA.org:oru-97625 | |
003 | SwePub | |
008 | 220222s2022 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-976252 URI |
024 | 7 | a https://doi.org/10.1016/j.cgh.2022.02.0322 DOI |
040 | a (SwePub)oru | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Caron, Bénédicteu Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France4 aut |
245 | 1 0 | a IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis :b the PROCTRIAL Consensus |
264 | 1 | b Elsevier,c 2022 |
338 | a print2 rdacarrier | |
500 | a Funding agencies:Prometheus Takeda Pharmaceutical Company Ltd AbbVie Johnson & Johnson USA Janssen Biotech Inc Amgen Arena Pharmaceuticals BiogenBoehringer IngelheimBristol-Myers Squibb Celgene Corporation Celltrion Cosmos Pharmaceuticals Eisai Co Ltd Elan Eli Lilly Ferring Pharmaceuticals Galapagos NV Fresenius Kabi Roche Holding Genentech Gilead Sciences GlaxoSmithKline Merck & Company Mylan Dexcel Pharma ProgenityProtagonist TherapeuticsRoche Holding Novartis Satisfai HealthSublimity TherapeuticsJanssen OrthoLLCPrometheus BiosciencesMicrobaBristol-Myers Squibb Focus MedicalTheravance Biopharma RDCalibrCapella BioscienceCelltrion HealthcareClostraBioEntheraHoffmann-La Roche Gilead Sciences GlaxoSmithKline GossamerBioImmunicIndex PharmaceuticalsInnovation PharmaceuticalsIronwood PharmaceuticalsKaleidoKallyopeMiroBioMorphic TherapeuticOSE ImmunotherapeuticsOtsuka Pharmaceutical Palatin TechnologiesPrometheus LaboratoriesPharmaceuticalsSeres TherapeuticsSienna BiopharmaceuticalsSun PharmaSurrozenLLC (HCP Live Institutional Perspectives in GI)Teva Pharmaceutical Industries TheliumTheravance Biopharma RDTLL PharmaUSWM EnterprisesVentyx BiosciencesViela BioVivante HealthVivelix PharmaceuticalsBacainn TherapeuticsBoehringer Ingelheim Boston PharmaceuticalsQ32 BioRedhill BiopharmaRheos MedicinesSalix PharmaceuticalsCambridge HealthcareFood Industries OrganiszationJanssen NestleRandox Laboratories Roche Holding Genentech Sublimity Wild Bio Innate Pharma MSD Astelas Nestle SA Aesca Centocor Falk Pharma GmbH Immundiagnostik Ardeypharm Augurix Calypso | |
520 | a BACKGROUND AND AIMS: Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the PROCTRIAL (Definition and endpoints for ulcerative PROCtitis in clinical TRIALs) initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults.METHODS: Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.RESULTS: The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity is proposed. Secondary endpoints which should be evaluated include endoscopic remission, histological remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.CONCLUSION: In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the PROCTRIAL consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Gastroenterologi0 (SwePub)302132 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Gastroenterology and Hepatology0 (SwePub)302132 hsv//eng |
653 | a Consensus | |
653 | a definition | |
653 | a endpoint | |
653 | a ulcerative proctitis | |
700 | 1 | a Abreu, Maria T.u Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA4 aut |
700 | 1 | a Siegel, Corey A.u Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA4 aut |
700 | 1 | a Panaccione, Remou Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada4 aut |
700 | 1 | a Sands, Bruce E.u Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA4 aut |
700 | 1 | a Dignass, Axelu Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany4 aut |
700 | 1 | a Turner, Danu Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel4 aut |
700 | 1 | a Dotan, Irisu Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel4 aut |
700 | 1 | a Hart, Ailsa L.u Inflammatory Bowel Disease Unit, St. Mark's Hospital, Harrow, UK4 aut |
700 | 1 | a Ahuja, Vineetu Department of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, India4 aut |
700 | 1 | a Allez, Matthieuu Department of Gastroenterology, Hôpital Saint-Louis, APHP, INSERM U1160, Université de Paris, Paris, Île-de-France, France4 aut |
700 | 1 | a Ananthakrishnan, Ashwin N.u Division of Gastroenterology, Massachusetts General Hospital & Harvard Medical School, Boston, MA, USA4 aut |
700 | 1 | a Ghosh, Subratau College of Medicine and Health, University College Cork, Cork, Ireland4 aut |
700 | 1 | a Griffiths, Anne M.u SickKids Inflammatory Bowel Disease Center, Division of Gastroenterology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada4 aut |
700 | 1 | a Halfvarson, Jonas,d 1970-u Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology4 aut0 (Swepub:oru)jshn |
700 | 1 | a Kaser, Arthuru University of Cambridge and Cambridge University Hospitals - Addenbrooke's Hospital, Cambridge, UK4 aut |
700 | 1 | a Kotze, Paulo G.u IBD outpatient clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil4 aut |
700 | 1 | a Koutroubakis, Ioannis E.u Department of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, Greece4 aut |
700 | 1 | a Lakatos, Peter L.u Department of Medicine and Oncology, Semmelweis University, Budapest, Hungary; McGill University Health Center, Montreal General Hospital, Canada4 aut |
700 | 1 | a Levine, Arieu Pediatric Gastroenterology Unit, PIBD research center, Wolfson Medical Center, Holon, Israel4 aut |
700 | 1 | a Lewis, James D.u Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania4 aut |
700 | 1 | a Magro, Fernandou Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Clinical Pharmacology, São João University Hospital Center (CHUSJ), Porto, Portugal; Faculty of Medicine, University of Porto, Portugal; Center for Health Technology and Services Research (CINTESIS), Porto, Portugal4 aut |
700 | 1 | a Mantzaris, Gerassimos J.u Department of Gastroenterology, Evangelismos-Polykliniki General Hospital of Athens, Greece4 aut |
700 | 1 | a O'Morain, Colmu Faculty of Health Sciences, University of Dublin, Trinity College, Dublin, Ireland4 aut |
700 | 1 | a Ran, Zhihuau Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Inflammatory Bowel Disease Research Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China4 aut |
700 | 1 | a Reinisch, Walteru Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria4 aut |
700 | 1 | a Rogler, Gerhardu Department of Gastroenterology and Hepatology, University Hospital Zurich and University of Zurich, Zurich, Switzerland4 aut |
700 | 1 | a Sachar, David B.u Icahn School of Medicine at Mount Sinai, New York, New York, USA4 aut |
700 | 1 | a Siegmund, Brittau Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Department of Gastroenterology, Rheumatology and Infectious Disease, Campus Benjamin Franklin, Berlin, Germany4 aut |
700 | 1 | a Silverberg, Mark S.u Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, ON, Canada4 aut |
700 | 1 | a Sood, Ajitu Department of Gastroenterology, Dayanand Medical College & Hospital, Ludhiāna, Punjab, India4 aut |
700 | 1 | a Spinelli, Antoninou Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy4 aut |
700 | 1 | a Steinwurz, Flaviou Department of Gastroenterology, Albert Einstein Israelite Hospital, São Paulo, Brazil4 aut |
700 | 1 | a Tysk, Curtu Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden4 aut |
700 | 1 | a Yamamoto-Furusho, Jesus K.u Inflammatory Bowel Disease Clinic, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico4 aut |
700 | 1 | a Schreiber, Stefanu Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany4 aut |
700 | 1 | a Rubin, David T.u University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA4 aut |
700 | 1 | a Sandborn, William J.u Division of Gastroenterology, University of California San Diego, La Jolla, California, USA4 aut |
700 | 1 | a Danese, Silviou Humanitas Research Hospital and University Vita-Salute San Raffaele, Milano, Italy4 aut |
700 | 1 | a Peyrin-Biroulet, Laurentu Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France4 aut |
710 | 2 | a Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, Franceb Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA4 org |
773 | 0 | t Clinical Gastroenterology and Hepatologyd : Elsevierg 20:11, s. 2169-2627.e1q 20:11<2169-2627.e1x 1542-3565x 1542-7714 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-97625 |
856 | 4 8 | u https://doi.org/10.1016/j.cgh.2022.02.032 |
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