Evidence map›Paper›PMID 28259484›Full record

Trial reportLancet (London, England)2017

Prediction of complicated disease course for children newly diagnosed with Crohn's disease: a multicentre inception cohort study.

Subra Kugathasan, Lee A Denson, Thomas D Walters, Mi-Ok Kim, Urko M Marigorta, Melanie Schirmer, Kajari Mondal, Chunyan Liu, Anne Griffiths, Joshua D Noe and 33 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Lancet (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06457035 (Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease), which is not on this map. Cited by 332 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
332citing papers in PubMed, 8 pooled it
56.2field-weighted citation impact, top 1% 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.

NCT06457035 completednot on this map

Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study

TypeobservationalSponsorFirst Affiliated Hospital, Sun Yat-Sen UniversityRan2005 to 2023Enrolled490ConditionsNewly-diagnosed Crohn's DiseaseArmsimmunosuppressant
3 · Its place in the literature

Who cites it

332 citing papers in PubMed, 8 syntheses or guidelines pooled it, 633 citations in OpenAlex.

  1. Guideline
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  3. Pooled it
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  7. Biomarkers for the Prediction and Diagnosis of Fibrostenosing Crohn's Disease: A Systematic Review.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Pooled it
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  9. Trial
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  13. Article
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  17. Recent advances in the management of small bowel Crohn's disease.The Korean journal of internal medicine · 2026
    Review
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  19. Article
  20. Review

272 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

43 authors at 20 institutions in 2 countries.

Subra KugathasanDivision of Pediatric Gastroenterology, Emory University School of Medicine, Atlanta, GA, USA; Children's Healthcare of Atlanta, Atlanta, GA, USA. Electronic address: skugath@emory.edu.
Lee A DensonDivision of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Thomas D WaltersDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Mi-Ok KimDivision of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Urko M MarigortaCenter for Integrative Genomics, Georgia Institute of Technology, Atlanta, GA, USA.
Melanie SchirmerThe Broad Institute of MIT and Harvard, Cambridge, MA, USA; Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.
Kajari MondalDivision of Pediatric Gastroenterology, Emory University School of Medicine, Atlanta, GA, USA.
Chunyan LiuDivision of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Anne GriffithsDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Joshua D NoeDepartment of Pediatric Gastroenterology, Hepatology, and Nutrition, Medical College of Wisconsin, Milwaukee, WI, USA.
Wallace V CrandallDepartment of Pediatric Gastroenterology, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus, OH, USA.
Scott SnapperDepartment of Gastroenterology and Nutrition, Boston Children's Hospital, Boston, MA, USA.
Shervin RabizadehDepartment of Pediatrics, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Joel R RoshDepartment of Pediatrics, Goryeb Children's Hospital, Morristown, NJ, USA.
Jason M ShapiroDepartment of Pediatrics, Hasbro Children's Hospital, Providence, RI, USA.
Stephen GutheryDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA.
David R MackDepartment of Pediatrics, Children's Hospital of Eastern Ontario IBD Centre and University of Ottawa, ON, Canada.
Richard KellermayerSection of Pediatric Gastroenterology, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.
Michael D KappelmanDepartment of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Steven SteinerDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Dedrick E MoultonDepartment of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.
David KeljoDepartment of Gastroenterology, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.
Stanley CohenChildren's Healthcare of Atlanta, Atlanta, GA, USA; Children's Center for Digestive Health Care, Atlanta, GA, USA.
Maria Oliva-HemkerDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Melvin B HeymanDepartment of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.
Anthony R OtleyDepartment of Pediatrics, Dalhousie University, Halifax, NS, Canada.
Susan S BakerDepartment of Digestive Diseases and Nutrition Center, University at Buffalo, Buffalo, NY, USA.
Jonathan S EvansDepartment of Pediatrics, Nemours Children's Specialty Care, Jacksonville, FL, USA.
Barbara S KirschnerDepartment of Pediatrics, University of Chicago, Chicago, IL, USA.
Ashish S PatelDepartment of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
David ZiringDepartment of Pediatrics, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.
Bruce C TrapnellDivision of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Francisco A SylvesterDepartment of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Michael C StephensDepartment of Pediatric Gastroenterology, Mayo Clinic, Rochester, MN, USA.
Robert N BaldassanoDepartment of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA.
James F MarkowitzDepartment of Pediatrics, Northwell Health, New York, NY, USA.
Judy ChoDepartment of Pediatrics, Mount Sinai Hospital, New York, NY, USA.
Ramnik J XavierThe Broad Institute of MIT and Harvard, Cambridge, MA, USA; Center for Computational and Integrative Biology, Gastrointestinal Unit and Center for the Study of Inflammatory Bowel Disease, Massachusetts General Hospital, Boston, MA, USA; Center for Microbiome Informatics and Therapeutics, Massachusetts Institute of Technology, Cambridge, MA, USA.
Curtis HuttenhowerThe Broad Institute of MIT and Harvard, Cambridge, MA, USA; Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.
Bruce J AronowDivision of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Greg GibsonCenter for Integrative Genomics, Georgia Institute of Technology, Atlanta, GA, USA.
Jeffrey S HyamsDivision of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, Hartford, CT, USA.
Marla C DubinskyDepartment of Pediatrics, Mount Sinai Hospital, New York, NY, USA.
Cincinnati Children's Hospital Medical Center · USChildren's Healthcare of Atlanta · USGeorgia Institute of Technology · USHarvard University · USMount Sinai Hospital · USUniversity of North Carolina at Chapel Hill · USBoston Children's Hospital · USBroad Institute · USCedars-Sinai Medical Center · USChildren's Hospital of Eastern Ontario · CAChildren's Hospital of Pittsburgh · USConnecticut Children's Medical Center · USDalhousie University · CAEmory University · USGoryeb Children's Hospital · USHospital for Sick Children · CAIndiana University – Purdue University Indianapolis · USJohns Hopkins Medicine · USMayo Clinic in Arizona · USMedical College of Wisconsin · US

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI RAYMOND T CHUNG · 1991 to 2026
$35.3M
Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Alexander Miethke · 2007 to 2026
$24.4M
Statistical Methods for X-Chromosome Genetic DataP01GM099568 · NIGMS · UNIVERSITY OF WASHINGTON · PI WEIR, BRUCE S. · 2012 to 2016
$7.3M
Role of GM-CSF in Myeloid Cell Function and Innate ImmunityR01HL085453 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI TRAPNELL, BRUCE C · 2007 to 2023
$6.5M
Pulmonary Macrophage Transplantation for Pulmonary Alveolar ProteinosisR01HL118342 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI TRAPNELL, BRUCE C, TRAPNELL, BRUCE COLSTON · 2014 to 2021
$4.5M
RLDC: Molecular Pathway-Driven Diagnostics & Therapeutics for Rare Lung DiseasesU54HL127672 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI TRAPNELL, BRUCE C · 2014 to 2018
$3.7M
NHLBI NIH HHS R01 HL085453NHLBI NIH HHS R01 HL118342NHLBI NIH HHS U54 HL127672NIDDK NIH HHS P30 DK043351NIDDK NIH HHS P30 DK078392NIGMS NIH HHS P01 GM099568
6 · The paper itself

Abstract

backgroundStricturing and penetrating complications account for substantial morbidity and health-care costs in paediatric and adult onset Crohn's disease. Validated models to predict risk for complications are not available, and the effect of treatment on risk is unknown.

methodsWe did a prospective inception cohort study of paediatric patients with newly diagnosed Crohn's disease at 28 sites in the USA and Canada. Genotypes, antimicrobial serologies, ileal gene expression, and ileal, rectal, and faecal microbiota were assessed. A competing-risk model for disease complications was derived and validated in independent groups. Propensity-score matching tested the effect of anti-tumour necrosis factor α (TNFα) therapy exposure within 90 days of diagnosis on complication risk.

findingsBetween Nov 1, 2008, and June 30, 2012, we enrolled 913 patients, 78 (9%) of whom experienced Crohn's disease complications. The validated competing-risk model included age, race, disease location, and antimicrobial serologies and provided a sensitivity of 66% (95% CI 51-82) and specificity of 63% (55-71), with a negative predictive value of 95% (94-97). Patients who received early anti-TNFα therapy were less likely to have penetrating complications (hazard ratio [HR] 0·30, 95% CI 0·10-0·89; p=0·0296) but not stricturing complication (1·13, 0·51-2·51; 0·76) than were those who did not receive early anti-TNFα therapy. Ruminococcus was implicated in stricturing complications and Veillonella in penetrating complications. Ileal genes controlling extracellular matrix production were upregulated at diagnosis, and this gene signature was associated with stricturing in the risk model (HR 1·70, 95% CI 1·12-2·57; p=0·0120). When this gene signature was included, the model's specificity improved to 71%.

interpretationOur findings support the usefulness of risk stratification of paediatric patients with Crohn's disease at diagnosis, and selection of anti-TNFα therapy.

fundingCrohn's and Colitis Foundation of America, Cincinnati Children's Hospital Research Foundation Digestive Health Center.

Indexed as

AdalimumabAdolescentAnti-Inflammatory Agents, Non-SteroidalChildCohort StudiesCrohn DiseaseDisease ProgressionFemaleGastrointestinal MicrobiomeHumansInfliximabIntestinal ObstructionMalePrognosisPropensity ScoreProspective StudiesAdalimumabAnti-Inflammatory Agents, Non-SteroidalInfliximabTumor Necrosis Factor-alpha

Identifiers

PMID28259484
PMCPMC5719489
OpenAlexW2593695507

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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.