@article{331774cd033a4a76b03796b63a9a4330,
title = "Outcome measures in coeliac disease trials: The Tampere recommendations",
abstract = "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.",
keywords = "celiac disease, clinical trials, gluten, gluten free diet",
author = "Ludvigsson, {Jonas F.} and Carolina Ciacci and Green, {Peter H.R.} and Katri Kaukinen and Korponay-Szabo, {Ilma R.} and Kalle Kurppa and Murray, {Joseph A.} and Lundin, {Knut Erik Aslaksen} and Maki, {Markku J.} and Alina Popp and Reilly, {Norelle R.} and Alfonso Rodriguez-Herrera and Sanders, {David S.} and Detlef Schuppan and Sarah Sleet and Juha Taavela and Kristin Voorhees and Walker, {Marjorie M.} and Leffler, {Daniel A.}",
note = "Funding Information: Funding JFl was supported by the Swedish research council (522-2a09-195) and the Swedish Society of Medicine while writing the draft of this paper. DS received research support from the german research Foundation (DFg), the Ministry of research and Development (BMBF) and the leibniz Foundation. DSS received an educational grant from Biocard and Simtomax to undertake an investigator-led research study on point-of-care tests and an educational grant from Dr Sch{\"a}r (a gluten-free food manufacturer) to undertake an investigator-led research study on gluten sensitivity. KKa was supported by the academy of Finland, the competitive research Funding of the tampere University Hospital and the Sigrid Juselius Foundation. irK-S was supported by the Hungarian research Fund (grant nKFi 120392). MJM was supported by the competitive State research Financing of the tampere University Hospital (grant 9U038). Publisher Copyright: {\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018.",
year = "2018",
month = aug,
day = "1",
doi = "10.1136/gutjnl-2017-314853",
language = "English (US)",
volume = "67",
pages = "1410--1424",
journal = "Gut",
issn = "0017-5749",
publisher = "BMJ Publishing Group",
number = "8",
}