Evidence map›Paper›PMID 33974994›Full record

ArticleContemporary clinical trials2021

Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.

Barcey T Levy, Jeanette M Daly, Yinghui Xu, Seth D Crockett, Richard M Hoffman, Jeffrey D Dawson, Kim Parang, Navkiran K Shokar, Daniel S Reuland, Marc J Zuckerman and 1 more

Open access · greenAbstract read
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Prevalence of enterotoxigenicFrontiers in cellular and infection microbiology · 2025
    Pooled it
  2. Article
  3. Is Cognitive Impairment Associated with Inadequate Bowel Preparation for Colonoscopy?Journal of the American Board of Family Medicine : JABFM · 2025
    Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. 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

11 authors at 1 institution in 1 country.

Barcey T LevyDepartment of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, United States of America; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, United States of America. Electronic address: barcey-levy@uiowa.edu.
Jeanette M DalyDepartment of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.
Yinghui XuDepartment of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.
Seth D CrockettDepartment of Gastroenterology and Hepatology, North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
Richard M HoffmanHolden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, United States of America; Department of Gastroenterology and Hepatology, North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
Jeffrey D DawsonDepartment of Biostatistics and Dean's Office, College of Public Health, University of Iowa, Iowa City, IA, United States of America.
Kim ParangDepartment of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.
Navkiran K ShokarDepartment of Family and Community Medicine, Texas Tech University Health Sciences Center, El Paso, TX, United States of America.
Daniel S ReulandDepartment of Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill, NC, United States of America.
Marc J ZuckermanDivision of Gastroenterology, Department of Internal Medicine, Texas Tech University Health Sciences Center, El Paso, TX, United States of America.
Avraham LevinDepartment of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.
University of Iowa · US

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
The University of Iowa Clinical and Translational Science AwardUL1TR002537 · NCATS · UNIVERSITY OF IOWA · PI HANSEN, MARLAN R, WINOKUR, PATRICIA · 2018 to 2022
$20.0M
Comparative Effectiveness of Fecal Immunochemical Tests with Optical ColonoscopyR01CA215034 · NCI · UNIVERSITY OF IOWA · PI LEVY, BARCEY THURSTON · 2017 to 2021
$4.5M
NCATS NIH HHS UL1 TR002537NCI NIH HHS P30 CA086862NCI NIH HHS R01 CA215034
6 · The paper itself

Abstract

backgroundThere are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings.

methodsA total of 3600 racially and ethnically diverse individuals aged 50 to 85 years having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard.

resultsWe have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed.

conclusionsOur focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.

Indexed as

Colorectal NeoplasmsOccult BloodColonoscopyEarly Detection of CancerFecesHumansClinical trialColorectal cancer screeningComparative effectiveness studyFecal immunochemical testProtocolTest characteristics

Identifiers

PMID33974994
PMCPMC8227954
OpenAlexW3163298822

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.