Evidence map›Paper›PMID 37490150›Full record

ArticleInternational journal of colorectal disease2023

FIT for purpose: study protocol for a randomized controlled trial to personalize surveillance colonoscopy for individuals at elevated risk of colorectal cancer.

Jean M Winter, Kathryn J Cornthwaite, Graeme P Young, Carlene Wilson, Gang Chen, Richard Woodman, Michelle Coats, Robert Fraser, Charles Cock, Peter Bampton and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in International journal of colorectal disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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.

Jean M WinterCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia. jean.winter@flinders.edu.au.
Kathryn J CornthwaiteCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Graeme P YoungCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Carlene WilsonCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Gang ChenCentre for Health Economics, Monash University, Caulfield East, VIC, Australia.
Richard WoodmanCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Michelle CoatsDepartment of Gastroenterology & Hepatology, Flinders Medical Centre, Bedford Park, SA, Australia.
Robert FraserCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Charles CockCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Peter BamptonCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Erin L SymondsCancer Research, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Funding

National Health and Medical Research Council APP1160443
6 · The paper itself

Abstract

purposeThere is increasing demand for colorectal cancer (CRC) surveillance, but healthcare capacity is limited. The burden on colonoscopy resources could be reduced by personalizing surveillance frequency using the fecal immunochemical test (FIT). This study will determine the safety, cost-effectiveness, and patient acceptance of using FIT to extend surveillance colonoscopy intervals for individuals at elevated risk of CRC.

methodsThis multicenter, prospective, randomized controlled trial will invite participants who are scheduled for surveillance colonoscopy (due to a personal history of adenomas or a family history of CRC) and who have returned a low fecal hemoglobin (< 2 μg Hb/g feces; F-Hb) using a two-sample FIT (OC Sensor, Eiken Chemical Company) in the prior 3 years. A total of 1344 individuals will be randomized to either surveillance colonoscopy as scheduled or delayed by 1 or 2 years for individuals originally recommended a 3- or 5-year surveillance interval, respectively. The primary endpoint is incidence of advanced neoplasia (advanced adenoma and/or CRC). Secondary endpoints include cost-effectiveness and consumer acceptability of extending surveillance intervals, determined using surveys and discrete choice experiments.

conclusionThis study will establish the safety, cost-effectiveness, and acceptability of utilizing a low FIT Hb result to extend colonoscopy surveillance intervals in a cohort at elevated risk for CRC. This personalized approach to CRC surveillance will lead to a reduction in unnecessary colonoscopies, increases in healthcare savings, and a better patient experience. 

trial registrationRegistration was approved on December 9, 2019 with the Australian New Zealand Clinical Trials Registry ANZCTR 12619001743156.

Indexed as

ColonoscopyColorectal NeoplasmsAustraliaFecesHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicColonoscopy surveillanceColorectal cancerFecal hemoglobinFIT

Identifiers

PMID37490150
PMCPMC10368549

What OpenQuestion holds

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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.