TY - JOUR T1 - Outcome measures in coeliac disease trials: the Tampere recommendations JF - Gut JO - Gut DO - 10.1136/gutjnl-2017-314853 SP - gutjnl-2017-314853 AU - Jonas F Ludvigsson AU - Carolina Ciacci AU - Peter HR Green AU - Katri Kaukinen AU - Ilma R Korponay-Szabo AU - Kalle Kurppa AU - Joseph A Murray AU - Knut Erik Aslaksen Lundin AU - Markku J Maki AU - Alina Popp AU - Norelle R Reilly AU - Alfonso Rodriguez-Herrera AU - David S Sanders AU - Detlef Schuppan AU - Sarah Sleet AU - Juha Taavela AU - Kristin Voorhees AU - Marjorie M Walker AU - Daniel A Leffler Y1 - 2018/02/13 UR - http://gut.bmj.com/content/early/2018/02/13/gutjnl-2017-314853.abstract N2 - 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. ER -