- Title
- Outcome measures in coeliac disease trials: The Tampere recommendations
- Creator
- Ludvigsson, Jonas F.; Ciacci, Carolina; Reilly, Norelle R.; Rodriguez-Herrera, Alfonso; Sanders, David S.; Schuppan, Detlef; Sleet, Sarah; Taavela, Juha; Voorhees, Kristin; Walker, Marjorie M.; Leffler, Daniel A.; Green, Peter H. R.; Kaukinen, Katri; Korponay-Szabo, Ilma R.; Kurppa, Kalle; Murray, Joseph A.; Lundin, Knut Erik Aslaksen; Maki, Markku J.; Popp, Alina
- Relation
- Gut Vol. 67, Issue 8, p. 1410-1424
- Publisher Link
- http://dx.doi.org/10.1136/gutjnl-2017-314853
- Publisher
- British Medical Journal (BMJ)
- Resource Type
- journal article
- Date
- 2018
- Description
- Objective A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Design Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. Results We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Conclusion Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.
- Subject
- celiac disease; clinical trials; gluten; gluten free diet
- Identifier
- http://hdl.handle.net/1959.13/1466320
- Identifier
- uon:47509
- Identifier
- ISSN:0017-5749
- Rights
- © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
- Language
- eng
- Full Text
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