Evidence map›Paper›PMID 36757156›Full record

SynthesisThe American journal of gastroenterology2023

Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review.

Sudheer K Vuyyuru, Florian Rieder, Virginia Solitano, Tran M Nguyen, Eileen Crowley, Neeraj Narula, Siddharth Singh, Christopher Ma, Vipul Jairath

Open access · greenAbstract readSystematic Review
In one paragraph

Synthesis in The American journal of gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 7% 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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. 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

9 authors at 5 institutions in 2 countries.

Sudheer K VuyyuruDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, Ontario, Canada.
Florian RiederDepartment of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Virginia SolitanoDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, Ontario, Canada.
Tran M NguyenLawson Health Research Institute, Western University, London, Ontario, Canada.
Eileen CrowleyDivision of Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital Western Ontario, London Health Sciences Centre, Western University, London, Ontario, Canada.
Neeraj NarulaDepartment of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Siddharth SinghDivision of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California, USA.
Christopher MaDepartments of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, Ontario, Canada.
Western University · CACleveland Clinic · USPopulation Health Research Institute · CAUniversity of Calgary · CAUniversity of California San Diego · US

Funding

Septins in intestinal fibrosisR01DK132038 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Andrei Ivanovich Ivanov, Florian Rieder · 2023 to 2026
$2.5M
Creeping fat and Crohn's disease associated stricturesR01DK123233 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI RIEDER, FLORIAN · 2020 to 2024
$1.9M
NIDDK NIH HHS R01 DK123233NIDDK NIH HHS R01 DK132038
6 · The paper itself

Abstract

introductionWe performed a systematic review to investigate whether patients with Crohn's disease (CD) and permanent ileostomy (PI) have been included in clinical trials evaluating biologics and small molecules.

methodsMEDLINE, Embase and Cochrane library (CENTRAL) data bases were searched from inception to May 16, 2022 for placebo controlled induction and/or maintenance randomized controlled trials assessing biologics and oral small molecules in adult patients with active CD.

resultsOf the 81 induction and maintenance trials assessing biologics and oral small molecules in CD, none permitted the enrollment of patients with PI. Patients with CD and PI have been universally excluded from pharmaceutical trials of biologics and small molecules to date. DISCUSSION: There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures enabling the inclusion of patients with CD and PI into clinical trials.

Indexed as

Biological ProductsCrohn DiseaseAdultHumansIleostomyRemission InductionBiological Products

Identifiers

PMID36757156
PMCPMC10958372
OpenAlexW4319656222

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.