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Cited by 100Celiac Disease Research and ManagementGastrointestinal motility and disordersInflammatory Bowel Disease

Outcome measures in coeliac disease trials: the Tampere recommendations

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Ludvigsson, Jonas F, Ciacci, Carolina, Green, Peter HR, Kaukinen, Katri, Korponay-Szabo, Ilma R, Kurppa, Kalle, Murray, Joseph A, Lundin, Knut Erik Aslaksen +11 more·2018·Gut
DOI 10.1136/gutjnl-2017-314853PMC PMC6204961
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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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  • There is general consensus about the need to assess adherence to the gluten-free diet during follow-up of celiac disease patients.

    “There is general consensus about the need to assess adherence to the GFD during the follow up of CD patients (48-50).”

    From ESPGHAN Position Paper on Management and Follow-up of Children and Adolescents With Celiac Disease. (2022) · cites this paper as [49]

    The Results section, “Gluten immunogenic peptides as a compliance measure” (page unavailable), discusses assessing gluten-free-diet adherence and records strong agreement on considering GIP testing in future coeliac disease trials. That supports the importance of assessing adherence, but the recommendation concerns trial participants, not a general consensus that adherence must be assessed during routine patient follow-up. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • Repeated GIP positivity over a span of multiple days correlates with intestinal mucosa damage.

    “Repeated GIP positivity over a span of multiple days has been reported to correlate with intestinal mucosa damage (49, 54).”

    From ESPGHAN Position Paper on Management and Follow-up of Children and Adolescents With Celiac Disease. (2022) · cites this paper as [49]

    The Results section, under “Gluten immunogenic peptides as a compliance measure” (page unavailable), reports a strong correlation between absence of urinary GIPs and healing of the intestinal epithelium. It does not report whether repeated GIP positivity across multiple days correlates with mucosal damage; that timing and positivity-specific finding are unsupported by this copy. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

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Authors
Ludvigsson, J. F., Ciacci, C., Green, P. H., Kaukinen, K., Korponay-Szabo, I. R., Kurppa, K., Murray, J. A., Lundin, K. E. A., Maki, M. J., Popp, A., Reilly, N. R., Rodriguez-Herrera, A., Sanders, D. S., Schuppan, D., Sleet, S., Taavela, J., Voorhees, K., Walker, M. M., & Leffler, D. A.
Affiliations
  • Karolinska Institutet (SE)
  • University of Salerno (IT)
  • Columbia University (US)
  • Tampere University (FI)
  • University of Debrecen (HU)
  • Mayo Clinic (US)
  • Oslo University Hospital (NO)
  • Science Center, Tampere University Hospital, Tampere, Finland
  • Carol Davila University of Medicine and Pharmacy (RO)
  • Columbia University Irving Medical Center (US)
  • Grupo IHP Pediatria, Sevilla, Spain
  • Royal Hallamshire Hospital (GB)
  • Beth Israel Deaconess Medical Center (US)
  • Coeliac UK (GB)
  • Tampere University Hospital (FI)
  • Continuum Clinical, Northbrook, Illinois, USA
  • University of Newcastle Australia (AU)
Corresponding author
Ludvigsson, Jonas F
ORCID
Venue
Gut
Publisher
BMJ
Published
2018-02-13
Volume
67
Issue
8
Pages
1410-1424
ISSN
  • 0017-5749 (ISSN-L)
  • 1468-3288
DOI
10.1136/gutjnl-2017-314853
PMC
PMC6204961
OpenAlex
W2787260016
Cited by
100
References
9
Citations by year
2026: 4 · 2025: 7 · 2024: 8 · 2023: 7 · 2022: 13 · 2021: 21 · 2020: 12 · 2019: 19 · 2018: 9
FWCI
14.53
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Gut (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Tampere University Institutional Repository (Tampere University) (publishedVersion, cc-by-nc)
  • University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
  • University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, cc-by-nc)
  • University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion)
  • Figshare (submittedVersion, cc-by-nc)
  • HighWire Press Open Archive (submittedVersion)
  • Tampere University Institutional Repository (Tampere University) (submittedVersion, cc-by-nc)
  • NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc)
  • NOVA (University of Newcastle Australia) (submittedVersion, cc-by-nc)
Funders
  • Competitive Research Funding of the Tampere University Hospital
  • Leibniz Foundation
  • Ministry of Research and Development (BMBF), Germany
  • Svenska Läkaresällskapet
  • Hungarian Research Fund
  • Deutsche Forschungsgemeinschaft
  • Vetenskapsrådet
  • itive State Research Financing of the Tampere University
  • Suomen Akatemia
  • The Sigrid Juselius Foundation
Topics
  • Health Sciences › Medicine › Gastroenterology › Celiac Disease Research and Management
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
Keywords
celiac disease, outcome measures, clinical trial design, gluten-free diet, histology, serology, patient-reported outcomes, quality of life, gluten immunogenic peptides
MeSH terms
Celiac Disease, Clinical Trials as Topic, Humans, Quality of Life, Outcome Assessment, Health Care, Patient Preference

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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