Evidence map›Paper›PMID 32384283›Full record

ArticleThe American journal of gastroenterology2020

Incorporating Fecal Calprotectin Into Clinical Practice for Patients With Moderate-to-Severely Active Ulcerative Colitis Treated With Biologics or Small-Molecule Inhibitors.

Parambir S Dulai, Robert Battat, Maria Barsky, Nghia H Nguyen, Christopher Ma, Neeraj Narula, Mahmoud Mosli, Niels Vande Casteele, Brigid S Boland, Larry Prokop and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The American journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. LIAISONUnited European gastroenterology journal · 2022
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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

16 authors.

Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Robert BattatDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Maria BarskyDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Nghia H NguyenDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Christopher MaUniversity of Calgary, Calgary, Alberta, Canada.
Neeraj NarulaMcMaster University, Hamilton, Ontario, Canada.
Mahmoud MosliDivision of Gastroenterology, King Abdulaziz University, Jeddah, Saudi Arabia.
Niels Vande CasteeleDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Brigid S BolandDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Larry ProkopEvidence-Based Practice Center, Mayo Clinic, Rochester, Minnesota, USA.
M Hassan MuradEvidence-Based Practice Center, Mayo Clinic, Rochester, Minnesota, USA.
Geert D'HaensDivision of Gastroenterology, Academic Medical Center, Amsterdam, the Netherlands.
Brian G FeaganDivision of Gastroenterology, University of Western Ontario, London, Ontario, Canada.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.
Vipul JairathDivision of Gastroenterology, University of Western Ontario, London, Ontario, Canada.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, San Diego, California, USA.

Funding

Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
NIDDK NIH HHS K23 DK117058NIDDK NIH HHS T32 DK007202
6 · The paper itself

Abstract

introductionWe applied the Grading of Recommendations, Assessment, Development, and Evaluation framework to evaluate the performance of fecal calprotectin (FC) as an alternative to endoscopy in patients with moderate-to-severe ulcerative colitis (UC) treated with a biologic agent or tofacitinib.

methodsIndividual participant data from the trials of infliximab, golimumab, vedolizumab, and tofacitinib for UC were pooled to generate prevalence of endoscopic activity (Mayo endoscopy score) across different combinations of the rectal bleeding score (RBS) and stool frequency score (SFS). These estimates were then combined with the data from an updated systematic review of the operating properties of FC to generate clinical scenario-specific assessments of the performance of FC as a predictor of endoscopic disease activity. A prespecified threshold of acceptability for false-negative (FN) and false-positive (FP) test results was set at 5%.

resultsFor patients with UC achieving RBS 0 + SFS 0/1, FC ≤ 50 μg/g may avoid endoscopy in 50% patients with a FN rate <5%. Similarly, for patients with RBS 2/3 + SFS 2/3, FC ≥ 250 μg/g potentially avoids endoscopy in approximately 50% patients with an FP rate <5%. The greatest uncertainty in the diagnostic performance for FC was observed in patients with UC achieving RBS 0 but having SFS 2/3, where FN and FP rates were consistently >10%, and endoscopic evaluation may be warranted. DISCUSSION: Two clinical scenarios were identified where FC can be used with confidence for monitoring treatment response to biologics or tofacitinib in patients with UC without the requirement for endoscopy.

Indexed as

ColonoscopyAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiological ProductsColitis, UlcerativeFecesGastrointestinal AgentsHumansInfliximabLeukocyte L1 Antigen ComplexOutcome Assessment, Health CarePatient Reported Outcome MeasuresPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiological ProductsGastrointestinal AgentsgolimumabInfliximabLeukocyte L1 Antigen ComplexPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibvedolizumab

Identifiers

PMID32384283
PMCPMC7274901

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Registered trials

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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.