Outcome measures in coeliac disease trials: the Tampere recommendations

ObjectiveA 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.Desi...

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Bibliographic Details
Published in:Gut 2018-08, Vol.67 (8), p.1410-1424
Main Authors: Ludvigsson, Jonas F, Ciacci, Carolina, Green, Peter HR, Kaukinen, Katri, Korponay-Szabo, Ilma R, Kurppa, Kalle, Murray, Joseph A, Lundin, Knut Erik Aslaksen, Maki, Markku J, Popp, Alina, Reilly, Norelle R, Rodriguez-Herrera, Alfonso, Sanders, David S, Schuppan, Detlef, Sleet, Sarah, Taavela, Juha, Voorhees, Kristin, Walker, Marjorie M, Leffler, Daniel A
Format: Article
Language:English
Subjects:
Celiac disease
Celiac Disease - therapy
Clinical trials
Clinical Trials as Topic
Coeliac Disease
Gluten
Histology
Humans
Immunogenicity
Immunology
Literature reviews
Medical research
Medicin och hälsovetenskap
Outcome Assessment, Health Care
Patient Preference
Patients
Pharmaceutical industry
Quality of Life
Questionnaires
Researchers
Serology
Small intestine
Systematic review
Teenagers
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Summary:ObjectiveA 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.DesignBased 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.ResultsWe 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.ConclusionCareful 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.
ISSN:0017-5749
1468-3288
1468-3288
DOI:10.1136/gutjnl-2017-314853