Evidence map›Paper›PMID 39883071›Full record

ArticleInflammatory bowel diseases2025

Generalizability of Randomized Controlled Trials to Routine Clinical Care in Ulcerative Colitis.

Tarun Chhibba, Alexandra Frolkis, Levi R Stein, Sangmin Lee, Kaela Schill, Elena Mitevska, Allap K Judge, Marie-Louise Martin, Meaghan Martin, Kerri L Novak and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Tarun ChhibbaDivision of Gastroenterology, Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON M5S 3H2, Canada.ORCID 0000-0003-3122-5678
Alexandra FrolkisDivision of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 6th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Levi R SteinInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Sangmin LeeDepartment of Medicine, Western University, 1151 Richmond Street, London, ON N6A 5C1, Canada.ORCID 0000-0001-5512-7197
Kaela SchillCumming School of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, AB T2N 2T8, Canada.ORCID 0000-0003-4411-3579
Elena MitevskaDepartment of Pediatrics, University of Alberta, Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB T6G 1C9, Canada.
Allap K JudgeCumming School of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, AB T2N 2T8, Canada.
Marie-Louise MartinInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Meaghan MartinInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Kerri L NovakInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Cathy LuInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.ORCID 0000-0003-3004-7048
Richard J M IngramInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Melissa M ChanInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Tushar ShuklaInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Cynthia H SeowInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Gilaad G KaplanInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.
Ashwin N AnanthakrishnanDivision of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, 275 Cambridge Street, Boston, MA 02114, USA.ORCID 0000-0002-9436-1821
Remo PanaccioneInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.ORCID 0000-0002-5247-940X
Christopher MaInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 5th Floor Cal Wenzel Precision Health Building, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.ORCID 0000-0002-4698-9948

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHistorically, randomized controlled trials (RCTs) have been criticized for being poorly generalizable to patients with ulcerative colitis (UC) evaluated in routine care. We aimed to evaluate the proportion of patients with UC starting an advanced therapy who would be eligible to participate in phase 3 registrational UC RCTs.

methodsWe conducted a retrospective cohort analysis of UC patients starting vedolizumab, ustekinumab, or tofacitinib at 2 IBD clinics at the University of Calgary. Patient charts, endoscopy reports, and laboratory results were reviewed, and compared against the inclusion and exclusion criteria from 5 RCTs (GEMINI-I, UNIFI, OCTAVE, ELEVATE, and LUCENT). The proportion of patients who would have been deemed eligible versus ineligible for trial participation at the time of starting a new advanced therapy was determined.

resultsA total of 125 patients with UC were included: 78 (62.4%) would have been eligible for at least one of the considered RCTs. Trial-eligible patients were younger, less likely to be exposed to prior immunosuppressants, and had higher C-reactive protein and fecal calprotectin. The most common reason for trial ineligibility was having inadequate disease activity at baseline (Mayo endoscopy subscore <2 or absence of rectal bleeding). A significantly greater proportion of patients would have been eligible for LUCENT (45.6%) compared to GEMINI-I (24.8%), OCTAVE (35.2%), or ELEVATE (35.2%) (P < .01 for all comparisons).

conclusionsHalf of patients with UC starting advanced therapy in routine care may be eligible for participation in phase 3 RCTs. Disease activity is the primary reason for trial exclusion.

Indexed as

Colitis, UlcerativeGastrointestinal AgentsPatient SelectionRandomized Controlled Trials as TopicAdultAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicFemaleHumansMaleMiddle AgedPiperidinesPyrimidinesPyrrolesRetrospective StudiesUstekinumabAntibodies, Monoclonal, HumanizedGastrointestinal AgentsPiperidinesPyrimidinesPyrrolestofacitinibUstekinumabvedolizumabbiologicinclusionmoleculetrialsulcerative colitis

Identifiers

PMID39883071
PMCPMC12342827

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.