Evidence map›Paper›PMID 37704112›Full record

ArticleGastroenterology2024

Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study.

Benjamin Lebwohl, Christopher Ma, Stephen M Lagana, Rish K Pai, K Adam Baker, Alexa Zayadi, Malcolm Hogan, Gerd Bouma, Christophe Cellier, Jeffrey D Goldsmith and 15 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Evolution in coeliac disease diagnosis and management.JGH open : an open access journal of gastroenterology and hepatology · 2024
    Review
  6. Review
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 15 institutions in 6 countries.

Benjamin LebwohlCeliac Disease Center, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York. Electronic address: bl114@cumc.columbia.edu.
Christopher MaDivision of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc, London, Ontario, Canada. Electronic address: christopher.ma@ucalgary.ca.
Stephen M LaganaDepartment of Pathology and Cell Biology, Columbia University, New York, New York.
Rish K PaiDepartment of Pathology and Laboratory Medicine, Mayo Clinic Arizona, Scottsdale, Arizona.
K Adam BakerAlimentiv Inc, London, Ontario, Canada.
Alexa ZayadiAlimentiv Inc, London, Ontario, Canada.
Malcolm HoganAlimentiv Inc, London, Ontario, Canada.
Gerd BoumaDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam, The Netherlands.
Christophe CellierDepartment of Gastroenterology, University of Paris-Cité, Georges-Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France.
Jeffrey D GoldsmithDepartment of Pathology, Boston Children's Hospital, Boston, Massachusetts.
Knut E A LundinNorwegian Coeliac Disease Research Centre, University of Oslo Faculty of Medicine, Oslo, Norway; Department of Gastroenterology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Maria I Pinto-SanchezDepartment of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Marie E RobertDepartment of Pathology, Yale University School of Medicine, New Haven, Connecticut.
Alberto Rubio-TapiaCeliac Disease Program, Division of Gastroenterology, Hepatology, and Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio.
David S SandersAcademic Unit of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom.
David F SchaefferDepartment of Pathology and Laboratory Medicine, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Carol E SemradDepartment of Gastroenterology, University of Chicago, Chicago, Illinois.
Jocelyn A SilvesterHarvard Celiac Research Program, Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts; Celiac Disease Center, Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Elena F VerdúDepartment of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Ritu VermaDepartment of Pediatrics, Section of Gastroenterology, Hepatology and Nutrition, The University of Chicago, Chicago, Illinois.
Tsung-Teh WuDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Brian G FeaganAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Eileen CrowleyAlimentiv Inc, London, Ontario, Canada; Division of Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital Western Ontario, London Health Sciences Centre, Western University, London, Ontario, Canada.
Vipul JairathAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Joseph A MurrayDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Western University · CABoston Children's Hospital · USColumbia University · USMayo Clinic · USPopulation Health Research Institute · CAUniversity of Chicago · USCleveland Clinic · USMayo Clinic in Arizona · USOslo University Hospital · NORoyal Hallamshire Hospital · GBUniversité Paris Cité · FRUniversity of Calgary · CAVancouver General Hospital · CAVrije Universiteit Amsterdam · NLYale University · US

Funding

Mechanisms and Markers of Small Intestinal Epithelial Injury and Villous AtrophyK23DK119584 · NIDDK · BOSTON CHILDREN'S HOSPITAL · PI SILVESTER, JOCELYN ANNE · 2019 to 2023
$971k
NIDDK NIH HHS K23 DK119584
6 · The paper itself

Abstract

BACKGROUND &

aimsThere is a need to develop safe and effective pharmacologic options for the treatment of celiac disease (CeD); however, consensus on the appropriate design and configuration of randomized controlled trials (RCTs) in this population is lacking.

methodsA 2-round modified Research and Development/University of California Los Angeles Appropriateness Method study was conducted. Eighteen gastroenterologists (adult and pediatric) and gastrointestinal pathologists voted on statements pertaining to the configuration of CeD RCTs, inclusion and exclusion criteria, gluten challenge, and trial outcomes. Two RCT designs were considered, representing the following distinct clinical scenarios for which pharmacotherapy may be used: trials incorporating a gluten challenge to simulate exposure; and trials evaluating reversal of histologic changes, despite attempted adherence to a gluten-free diet. Each statement was rated as appropriate, uncertain, or inappropriate, using a 9-point Likert scale.

resultsFor trials evaluating prevention of relapse after gluten challenge, participants adherent to a gluten-free diet for 12 months or more with normal or near-normal-sized villi should be enrolled. Gluten challenge should be FODMAPS (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) free, and efficacy evaluated using histology with a secondary patient-reported outcome measure. For trials evaluating reversal of villus atrophy, the panel voted it appropriate to enroll participants with a baseline villus height to crypt depth ratio ≤2 and measure efficacy using a primary histologic end point. Guidance for measuring histologic, endoscopic, and patient-reported outcomes in adult and pediatric patients with CeD are provided, along with recommendations regarding the merits and limitations of different end points.

conclusionsWe developed standardized recommendations for clinical trial design, eligibility criteria, outcome measures, gluten challenge, and disease evaluations for RCTs in patients with CeD.

Indexed as

Celiac DiseaseAdultChildDiet, Gluten-FreeGlutensHumansNeoplasm Recurrence, LocalRandomized Controlled Trials as TopicGlutensCeliacGlutenHistologyPatient-Reported Outcomes

Identifiers

PMID37704112
PMCPMC12055257
OpenAlexW4386600918

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.