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

SUBMITTER: Ludvigsson JF 

PROVIDER: S-EPMC6204961 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature