Evidence map›Paper›PMID 29440464›Full record

ArticleGut2018

Outcome measures in coeliac disease trials: the Tampere recommendations.

Jonas F Ludvigsson, Carolina Ciacci, Peter Hr Green, Katri Kaukinen, Ilma R Korponay-Szabo, Kalle Kurppa, Joseph A Murray, Knut Erik Aslaksen Lundin, Markku J Maki, Alina Popp and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in Gut, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03462979 (GlPs Improve Practice), which is not on this map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03462979 nasuspendednot on this map

GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

TypeinterventionalSponsorBoston Children's HospitalRan2018 to 2023Enrolled120ConditionsCeliac Disease, Gluten Sensitivity, Gluten Enteropathy, Gastrointestinal DiseaseArmsImmunochromatographic lateral flow test
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. 'What' and 'How' to Measure in Allergy and Clinical Immunology: A Systematic Review of Core Outcome Sets and Outcome Harmonisation Processes.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Pooled it
  2. Guideline
  3. Tools Used to Measure the Physical State of Women with Celiac Disease: A Review with a Systematic Approach.International journal of environmental research and public health · 2020
    Pooled it
  4. Trial
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Development of the celiac disease symptom diary version 2.1Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Article
  11. Article
  12. Evolution in coeliac disease diagnosis and management.JGH open : an open access journal of gastroenterology and hepatology · 2024
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review article: Follow-up of coeliac disease.Alimentary pharmacology & therapeutics · 2022
    Review
  18. Evaluation of Celiac Disease by Minimally Invasive Biomarkers in a Spanish Pediatric Population.International journal of environmental research and public health · 2022
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Jonas F LudvigssonDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0003-1024-5602
Carolina CiacciCoeliac Center at Department of Medicine and Surgery, Scuola Medica Salernitana, University of Salerno, Salerno, Italy.
Peter Hr GreenCeliac Disease Center at Columbia University, New York, USA.
Katri KaukinenCeliac Disease Research Center, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
Ilma R Korponay-SzaboCoeliac Disease Centre, Heim Pál Children's Hospital, Budapest, Hungary.
Kalle KurppaCeliac Disease Research Center, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
Joseph A MurrayThe Mayo Clinic, Rochester, Minnesota, USA.
Knut Erik Aslaksen LundinInstitute of Clinical Medicine and K.G. Jebsen Coeliac Disease Research Centre, Faculty of Medicine, University of Oslo, Oslo, Norway.
Markku J MakiScience Center, Tampere University Hospital, Tampere, Finland.
Alina PoppInstitute for Mother and Child Health Bucharest, University of Medicine and Pharmacy 'Carol Davila', Bucharest, Romania.
Norelle R ReillyDivision of Pediatric Gastroenterology, Columbia University Medical Center, New York, USA.
Alfonso Rodriguez-HerreraGrupo IHP Pediatria, Sevilla, Spain.
David S SandersAcademic Unit of Gastroenterology, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK.
Detlef SchuppanCeliac Center, University Medical Center, Johannes-Gutenberg University, Mainz, Germany.
Sarah SleetCoeliac UK, Buckinghamshire, UK.
Juha TaavelaTampere Centre for Child Health Research, University of Tampere, Tampere University Hospital, Tampere, Finland.
Kristin VoorheesContinuum Clinical, Northbrook, Illinois, USA.
Marjorie M WalkerFaculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.
Daniel A LefflerCeliac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Outcome Assessment, Health CareCeliac DiseaseClinical Trials as TopicHumansPatient PreferenceQuality of Lifeceliac diseaseclinical trialsglutengluten free diet

Identifiers

PMID29440464
PMCPMC6204961

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.