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Outcome measures in coeliac disease trials: the Tampere recommendations
Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Medical epidemiology and Biostatistics, Karolinska institutet, Stockholm, Sweden; Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.ORCID iD: 0000-0003-1024-5602
Coeliac Center at Department of Medicine and Surgery, Scuola Medica Salernitana, University of Salerno, Salerno, Italy.ORCID iD: 0000-0002-7426-1145
Celiac Disease Center at Columbia University, New York, USA.
Celiac Disease Research Center, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland; Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.
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2018 (English)In: Gut, ISSN 0017-5749, E-ISSN 1468-3288, Vol. 67, no 8, p. 1410-1424Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2018. Vol. 67, no 8, p. 1410-1424
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-68770DOI: 10.1136/gutjnl-2017-314853ISI: 000442465300008PubMedID: 29440464Scopus ID: 2-s2.0-85047308664OAI: oai:DiVA.org:oru-68770DiVA, id: diva2:1246264
Funder
Swedish Research Council, 522-2A09-195Swedish Society of Medicine
Note

Funding Agencies:

German Research Foundation (DFG)  

Ministry of Research and Development (BMBF)  

Leibniz Foundation  

Biocard  

Simtomax  

Academy of Finland  

Competitive Research Funding of the Tampere University Hospital  

Sigrid Juselius Foundation   Hungarian Research Fund  NKFI 120392 

Competitive State Research Financing of the Tampere University Hospital  9U038 

Available from: 2018-09-07 Created: 2018-09-07 Last updated: 2018-09-07Bibliographically approved

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Ludvigsson, Jonas F.

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