Evidence map›Paper›PMID 25117129›Full record

Trial reportJAMA2014

Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.

Øyvind Holme, Magnus Løberg, Mette Kalager, Michael Bretthauer, Miguel A Hernán, Eline Aas, Tor J Eide, Eva Skovlund, Jørn Schneede, Kjell Magne Tveit and 1 more

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 193 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
193citing papers in PubMed, 15 pooled it
22.2field-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.

NCT00119912 naactive not recruitingnot on this map

Norwegian Colorectal Cancer Prevention Trial

TypeinterventionalSponsorNorwegian Institute of Public HealthRan1999 to 2036Enrolled100,000ConditionsColorectal Cancer, AdenomaArmsA 1 Intervention arm Flex Sig, A 2 Intervention arm Flex Sig + iFOBT
NCT04482452 unknown statusnot on this mapstarted 2020, after this paper: background citation

Percentage Visualized Mucosa as a Marker for the Quality of Colonoscopy

TypeobservationalSponsorInsel Gruppe AG, University Hospital BernRan2020 to 2022Enrolled500ConditionsColonoscopyArmsColonoscopy
3 · Its place in the literature

Who cites it

193 citing papers in PubMed, 15 syntheses or guidelines pooled it, 428 citations in OpenAlex.

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  8. Systematic Review of Prevalence, Risk Factors, and Risk for Metachronous Advanced Neoplasia in Patients With Young-Onset Colorectal Adenoma.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
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  12. Guideline
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  14. Colorectal Cancer Screening in Average Risk Populations: Evidence Summary.Canadian journal of gastroenterology & hepatology · 2016
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133 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

Øyvind HolmeDepartment of Medicine, Sorlandet Hospital Kristiansand, Kristiansand, Norway2Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics Harvard School of Public Health, Boston, Massachusetts.
Magnus LøbergInstitute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Mette KalagerInstitute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Telemark Hospital Skien, Skien, Norway.
Michael BretthauerDepartment of Medicine, Sorlandet Hospital Kristiansand, Kristiansand, Norway2Institute of Health and Society, University of Oslo, Oslo, Norway3Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Miguel A HernánDepartment of Epidemiology, Harvard School of Public Health, Boston, Massachusetts4Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts5Harvard-MIT Division of Health Sciences and Technology, Boston, Boston, Massachusetts.
Eline AasInstitute of Health and Society, University of Oslo, Oslo, Norway.
Tor J EideDepartment of Pathology, Oslo University Hospital, Oslo, Norway.
Eva SkovlundSchool of Pharmacy, University of Oslo, Norway.
Jørn SchneedeDepartment of Pharmacology and Clinical Neuroscience, Clinical Pharmacology Unit, Umeå University, Umeå, Sweden.
Kjell Magne TveitDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Geir HoffInstitute of Health and Society, University of Oslo, Oslo, Norway7Telemark Hospital Skien, Skien, Norway13Cancer Registry of Norway, Oslo, Norway.
University of Oslo · NOOslo University Hospital · NOCancer Registry of Norway · NOHarvard University · USSørlandet Sykehus · NOUmeå University · SE

Funding

Statistical Methods for Analysis of Massive Genetic and Genomic Data in Cancer ResearchR35CA197449 · NCI · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI XIHONG LIN · 2015 to 2026
$10.9M
Statistical Methods for the Spatio-Temporal Assessment of Social Disparities in CancerP01CA134294 · NCI · HARVARD SCHOOL OF PUBLIC HEALTH · PI HANEUSE, SEBASTIEN, HERNAN, MIGUEL · 2008 to 2017
$6.8M
NCI NIH HHS P01 CA134294NCI NIH HHS R35 CA197449
6 · The paper itself

Abstract

importanceColorectal cancer is a major health burden. Screening is recommended in many countries.

objectiveTo estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. DESIGN, SETTING, AND

participantsRandomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry.

interventionsParticipants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. MAIN OUTCOMES AND MEASURES: Colorectal cancer incidence and mortality.

resultsA total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups. CONCLUSIONS AND RELEVANCE: In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups.

trial registrationclinicaltrials.gov Identifier: NCT00119912.

Indexed as

Early Detection of CancerSigmoidoscopyColorectal NeoplasmsFemaleHumansIncidenceIntention to Treat AnalysisMaleMiddle AgedNorwayOccult Blood

Identifiers

PMID25117129
PMCPMC4495882
OpenAlexW2087147904

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.