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      Outcome measures in coeliac disease trials: the Tampere recommendations

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          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.

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          Most cited references180

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          Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994.

          The Sydney System for the classification of gastritis emphasized the importance of combining topographical, morphological, and etiological information into a schema that would help to generate reproducible and clinically useful diagnoses. To reappraise the Sydney System 4 years after its introduction, a group of gastrointestinal pathologists from various parts of the world met in Houston, Texas, in September 1994. The aims of the workshop were (a) to establish an agreed terminology of gastritis; (b) to identify, define, and attempt to resolve some of the problems associated with the Sydney System. This article introduces the Sydney System as it was revised at the Houston Gastritis Workshop and represents the consensus of the participants. Overall, the principles and grading of the Sydney System were only slightly modified, the grading being aided by the provision of a visual analogue scale. The terminology of the final classification has been improved to emphasize the distinction between the atrophic and nonatrophic stomach; the names used for each entity were selected because they are generally acceptable to both pathologists and gastroenterologists. In addition to the main categories and atrophic and nonatrophic gastritis, the special or distinctive forms are described and their respective diagnostic criteria are provided. The article includes practical guidelines for optimal biopsy sampling of the stomach, for the use of the visual analogue scales for grading the histopathologic features, and for the formulation of a comprehensive standardized diagnosis. A glossary of gastritis-related terms as used in this article is provided.
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            Development and validation of a multidimensional eating disorder inventory for anorexia nervosa and bulimia

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              The assessment of binge eating severity among obese persons

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                Author and article information

                Journal
                Gut
                Gut
                gutjnl
                gut
                Gut
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0017-5749
                1468-3288
                August 2018
                13 February 2018
                : 67
                : 8
                : 1410-1424
                Affiliations
                [1 ] departmentDepartment of Medical Epidemiology and Biostatistics , Karolinska Institutet , Stockholm, Sweden
                [2 ] departmentDepartment of Pediatrics , Örebro University Hospital , Örebro, Sweden
                [3 ] departmentCoeliac Center at Department of Medicine and Surgery, Scuola Medica Salernitana , University of Salerno , Salerno, Italy
                [4 ] Celiac Disease Center at Columbia University , New York, USA
                [5 ] departmentCeliac Disease Research Center, Faculty of Medicine and Life Sciences , University of Tampere , Tampere, Finland
                [6 ] departmentDepartment of Internal Medicine , Tampere University Hospital , Tampere, Finland
                [7 ] departmentCoeliac Disease Centre , Heim Pál Children’s Hospital , Budapest, Hungary
                [8 ] departmentDepartment of Paediatrics, Faculty of Medicine , University of Debrecen , Debrecen, Hungary
                [9 ] departmentCeliac Disease Research Center, Faculty of Medicine and Life Sciences , University of Tampere , Tampere, Finland
                [10 ] departmentDepartment of Paediatrics , Tampere University Hospital , Tampere, Finland
                [11 ] The Mayo Clinic , Rochester, Minnesota, USA
                [12 ] departmentInstitute of Clinical Medicine and K.G. Jebsen Coeliac Disease Research Centre, Faculty of Medicine , University of Oslo , Oslo, Norway
                [13 ] departmentDepartment of Gastroenterology , Oslo University Hospital , Oslo, Norway
                [14 ] departmentScience Center , Tampere University Hospital , Tampere, Finland
                [15 ] departmentTampere Centre for Child Health Research, Faculty of Medicine and Life Sciences , University of Tampere , Tampere, Finland
                [16 ] departmentInstitute for Mother and Child Health Bucharest , University of Medicine and Pharmacy ’Carol Davila' , Bucharest, Romania
                [17 ] departmentTampere Centre for Child Health Research , University of Tampere, Tampere University Hospital , Tampere, Finland
                [18 ] departmentDivision of Pediatric Gastroenterology , Columbia University Medical Center , New York, USA
                [19 ] departmentCeliac Disease Center, Department of Medicine , Columbia University Medical Center , New York, USA
                [20 ] Grupo IHP Pediatria , Sevilla, Spain
                [21 ] departmentAcademic Unit of Gastroenterology , Royal Hallamshire Hospital, University of Sheffield , Sheffield, UK
                [22 ] departmentCeliac Center , University Medical Center, Johannes-Gutenberg University , Mainz, Germany
                [23 ] departmentDivision of Gastroenterology , Beth Israel Deaconess Medical Center , Boston, Massachusetts, USA
                [24 ] Coeliac UK , Buckinghamshire, UK
                [25 ] departmentTampere Centre for Child Health Research , University of Tampere, Tampere University Hospital , Tampere, Finland
                [26 ] Continuum Clinical , Northbrook, Illinois, USA
                [27 ] departmentFaculty of Health and Medicine, School of Medicine and Public Health , University of Newcastle , Newcastle, New South Wales, Australia
                [28 ] departmentCeliac Center , Beth Israel Deaconess Medical Center, Harvard Medical School , Boston, Massachusetts, USA
                Author notes
                [Correspondence to ] Dr Jonas F Ludvigsson, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm 171 77, Sweden; jonasludvigsson@ 123456yahoo.com
                Author information
                http://orcid.org/0000-0003-1024-5602
                Article
                gutjnl-2017-314853
                10.1136/gutjnl-2017-314853
                6204961
                29440464
                bc28f436-33b1-40d7-9f0e-069c58f5f56f
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 14 July 2017
                : 19 December 2017
                : 08 January 2018
                Funding
                Funded by: Competitive Research Funding of the Tampere University Hospital;
                Funded by: Leibniz Foundation;
                Funded by: Ministry of Research and Development (BMBF), Germany;
                Funded by: FundRef http://dx.doi.org/10.13039/501100007687, Svenska Läkaresällskapet;
                Funded by: Hungarian Research Fund;
                Funded by: FundRef http://dx.doi.org/10.13039/501100001659, Deutsche Forschungsgemeinschaft;
                Funded by: FundRef http://dx.doi.org/10.13039/501100004359, Vetenskapsrådet;
                Funded by: itive State Research Financing of the Tampere University;
                Funded by: FundRef http://dx.doi.org/10.13039/501100002341, Suomen Akatemia;
                Funded by: The Sigrid Juselius Foundation;
                Categories
                Coeliac Disease
                1506
                2312
                1507
                Original article
                Custom metadata
                unlocked
                editors-choice

                Gastroenterology & Hepatology
                celiac disease,gluten,gluten free diet,clinical trials
                Gastroenterology & Hepatology
                celiac disease, gluten, gluten free diet, clinical trials

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