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IOIBD Recommendatio...
IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis : the PROCTRIAL Consensus
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- Caron, Bénédicte (författare)
- Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France
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- Abreu, Maria T. (författare)
- Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA
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- Siegel, Corey A. (författare)
- Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
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- Panaccione, Remo (författare)
- Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
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- Sands, Bruce E. (författare)
- Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
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- Dignass, Axel (författare)
- Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany
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- Turner, Dan (författare)
- Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel
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- Dotan, Iris (författare)
- Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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- Hart, Ailsa L. (författare)
- Inflammatory Bowel Disease Unit, St. Mark's Hospital, Harrow, UK
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- Ahuja, Vineet (författare)
- Department of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
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- Allez, Matthieu (författare)
- Department of Gastroenterology, Hôpital Saint-Louis, APHP, INSERM U1160, Université de Paris, Paris, Île-de-France, France
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- Ananthakrishnan, Ashwin N. (författare)
- Division of Gastroenterology, Massachusetts General Hospital & Harvard Medical School, Boston, MA, USA
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- Ghosh, Subrata (författare)
- College of Medicine and Health, University College Cork, Cork, Ireland
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- Griffiths, Anne M. (författare)
- SickKids Inflammatory Bowel Disease Center, Division of Gastroenterology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
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- Halfvarson, Jonas, 1970- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology
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- Kaser, Arthur (författare)
- University of Cambridge and Cambridge University Hospitals - Addenbrooke's Hospital, Cambridge, UK
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- Kotze, Paulo G. (författare)
- IBD outpatient clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil
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- Koutroubakis, Ioannis E. (författare)
- Department of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, Greece
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- Lakatos, Peter L. (författare)
- Department of Medicine and Oncology, Semmelweis University, Budapest, Hungary; McGill University Health Center, Montreal General Hospital, Canada
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- Levine, Arie (författare)
- Pediatric Gastroenterology Unit, PIBD research center, Wolfson Medical Center, Holon, Israel
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- Lewis, James D. (författare)
- Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
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- Magro, Fernando (författare)
- 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, Portugal
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- Mantzaris, Gerassimos J. (författare)
- Department of Gastroenterology, Evangelismos-Polykliniki General Hospital of Athens, Greece
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- O'Morain, Colm (författare)
- Faculty of Health Sciences, University of Dublin, Trinity College, Dublin, Ireland
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- Ran, Zhihua (författare)
- 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, China
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- Reinisch, Walter (författare)
- Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
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- Rogler, Gerhard (författare)
- Department of Gastroenterology and Hepatology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
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- Sachar, David B. (författare)
- Icahn School of Medicine at Mount Sinai, New York, New York, USA
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- Siegmund, Britta (författare)
- 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, Germany
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- Silverberg, Mark S. (författare)
- Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, ON, Canada
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- Sood, Ajit (författare)
- Department of Gastroenterology, Dayanand Medical College & Hospital, Ludhiāna, Punjab, India
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- Spinelli, Antonino (författare)
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
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- Steinwurz, Flavio (författare)
- Department of Gastroenterology, Albert Einstein Israelite Hospital, São Paulo, Brazil
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- Tysk, Curt (författare)
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Yamamoto-Furusho, Jesus K. (författare)
- Inflammatory Bowel Disease Clinic, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico
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- Schreiber, Stefan (författare)
- Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany
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- Rubin, David T. (författare)
- University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA
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- Sandborn, William J. (författare)
- Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
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- Danese, Silvio (författare)
- Humanitas Research Hospital and University Vita-Salute San Raffaele, Milano, Italy
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- Peyrin-Biroulet, Laurent (författare)
- Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France
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(creator_code:org_t)
- Elsevier, 2022
- 2022
- Engelska.
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Ingår i: Clinical Gastroenterology and Hepatology. - : Elsevier. - 1542-3565 .- 1542-7714. ; 20:11, s. 2169-2627.e1
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- Consensus
- definition
- endpoint
- ulcerative proctitis
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- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Caron, Bénédicte
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Abreu, Maria T.
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Siegel, Corey A.
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Panaccione, Remo
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Sands, Bruce E.
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Dignass, Axel
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visa fler...
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Turner, Dan
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Dotan, Iris
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Hart, Ailsa L.
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Ahuja, Vineet
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Allez, Matthieu
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Ananthakrishnan, ...
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Ghosh, Subrata
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Griffiths, Anne ...
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Halfvarson, Jona ...
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Kaser, Arthur
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Kotze, Paulo G.
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Koutroubakis, Io ...
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Lakatos, Peter L ...
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Levine, Arie
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Lewis, James D.
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Magro, Fernando
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Mantzaris, Geras ...
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O'Morain, Colm
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Ran, Zhihua
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Reinisch, Walter
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Rogler, Gerhard
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Sachar, David B.
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Siegmund, Britta
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Silverberg, Mark ...
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Sood, Ajit
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Spinelli, Antoni ...
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Steinwurz, Flavi ...
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Tysk, Curt
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Yamamoto-Furusho ...
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Schreiber, Stefa ...
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Rubin, David T.
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Sandborn, Willia ...
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Danese, Silvio
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Peyrin-Biroulet, ...
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Örebro universitet