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Outcome measures in coeliac disease trials: the Tampere recommendations. 2018
Jonas F Ludvigsson, and
Carolina Ciacci, and
Peter Hr Green, and
Katri Kaukinen, and
Ilma R Korponay-Szabo, and
Kalle Kurppa, and
Joseph A Murray, and
Knut Erik Aslaksen Lundin, and
Markku J Maki, and
Alina Popp, and
Norelle R Reilly, and
Alfonso Rodriguez-Herrera, and
David S Sanders, and
Detlef Schuppan, and
Sarah Sleet, and
Juha Taavela, and
Kristin Voorhees, and
Marjorie M Walker, and
Daniel A Leffler
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
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. 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. 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. 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.
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