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FältnamnIndikatorerMetadata
00011577naa a2200805 4500
001oai:DiVA.org:oru-97625
003SwePub
008220222s2022 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-976252 URI
0247 a https://doi.org/10.1016/j.cgh.2022.02.0322 DOI
040 a (SwePub)oru
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Caron, Bénédicteu Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France4 aut
2451 0a IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis :b the PROCTRIAL Consensus
264 1b 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 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Gastroenterologi0 (SwePub)302132 hsv//swe
650 7a 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
7001 a Abreu, Maria T.u Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA4 aut
7001 a Siegel, Corey A.u Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA4 aut
7001 a Panaccione, Remou Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada4 aut
7001 a Sands, Bruce E.u Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA4 aut
7001 a Dignass, Axelu Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany4 aut
7001 a Turner, Danu Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel4 aut
7001 a Dotan, Irisu Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel4 aut
7001 a Hart, Ailsa L.u Inflammatory Bowel Disease Unit, St. Mark's Hospital, Harrow, UK4 aut
7001 a Ahuja, Vineetu Department of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, India4 aut
7001 a Allez, Matthieuu Department of Gastroenterology, Hôpital Saint-Louis, APHP, INSERM U1160, Université de Paris, Paris, Île-de-France, France4 aut
7001 a Ananthakrishnan, Ashwin N.u Division of Gastroenterology, Massachusetts General Hospital & Harvard Medical School, Boston, MA, USA4 aut
7001 a Ghosh, Subratau College of Medicine and Health, University College Cork, Cork, Ireland4 aut
7001 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
7001 a Halfvarson, Jonas,d 1970-u Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology4 aut0 (Swepub:oru)jshn
7001 a Kaser, Arthuru University of Cambridge and Cambridge University Hospitals - Addenbrooke's Hospital, Cambridge, UK4 aut
7001 a Kotze, Paulo G.u IBD outpatient clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil4 aut
7001 a Koutroubakis, Ioannis E.u Department of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, Greece4 aut
7001 a Lakatos, Peter L.u Department of Medicine and Oncology, Semmelweis University, Budapest, Hungary; McGill University Health Center, Montreal General Hospital, Canada4 aut
7001 a Levine, Arieu Pediatric Gastroenterology Unit, PIBD research center, Wolfson Medical Center, Holon, Israel4 aut
7001 a Lewis, James D.u Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania4 aut
7001 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
7001 a Mantzaris, Gerassimos J.u Department of Gastroenterology, Evangelismos-Polykliniki General Hospital of Athens, Greece4 aut
7001 a O'Morain, Colmu Faculty of Health Sciences, University of Dublin, Trinity College, Dublin, Ireland4 aut
7001 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
7001 a Reinisch, Walteru Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria4 aut
7001 a Rogler, Gerhardu Department of Gastroenterology and Hepatology, University Hospital Zurich and University of Zurich, Zurich, Switzerland4 aut
7001 a Sachar, David B.u Icahn School of Medicine at Mount Sinai, New York, New York, USA4 aut
7001 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
7001 a Silverberg, Mark S.u Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, ON, Canada4 aut
7001 a Sood, Ajitu Department of Gastroenterology, Dayanand Medical College & Hospital, Ludhiāna, Punjab, India4 aut
7001 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
7001 a Steinwurz, Flaviou Department of Gastroenterology, Albert Einstein Israelite Hospital, São Paulo, Brazil4 aut
7001 a Tysk, Curtu Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden4 aut
7001 a Yamamoto-Furusho, Jesus K.u Inflammatory Bowel Disease Clinic, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico4 aut
7001 a Schreiber, Stefanu Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany4 aut
7001 a Rubin, David T.u University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA4 aut
7001 a Sandborn, William J.u Division of Gastroenterology, University of California San Diego, La Jolla, California, USA4 aut
7001 a Danese, Silviou Humanitas Research Hospital and University Vita-Salute San Raffaele, Milano, Italy4 aut
7001 a Peyrin-Biroulet, Laurentu Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France4 aut
7102 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
7730 t Clinical Gastroenterology and Hepatologyd : Elsevierg 20:11, s. 2169-2627.e1q 20:11<2169-2627.e1x 1542-3565x 1542-7714
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-97625
8564 8u https://doi.org/10.1016/j.cgh.2022.02.032

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