RT Journal Article
SR Electronic
T1 Outcome measures in coeliac disease trials: the Tampere recommendations
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 1410
OP 1424
DO 10.1136/gutjnl-2017-314853
VO 67
IS 8
A1 Jonas F Ludvigsson
A1 Carolina Ciacci
A1 Peter HR Green
A1 Katri Kaukinen
A1 Ilma R Korponay-Szabo
A1 Kalle Kurppa
A1 Joseph A Murray
A1 Knut Erik Aslaksen Lundin
A1 Markku J Maki
A1 Alina Popp
A1 Norelle R Reilly
A1 Alfonso Rodriguez-Herrera
A1 David S Sanders
A1 Detlef Schuppan
A1 Sarah Sleet
A1 Juha Taavela
A1 Kristin Voorhees
A1 Marjorie M Walker
A1 Daniel A Leffler
YR 2018
UL http://gut.bmj.com/content/67/8/1410.abstract
AB 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.