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Variability in Adenoma Detection Rate in Control Groups of Randomized Colonoscopy Trials

  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ,
    Author Footnotes
    ∗ these authors equally contributed to this work
    Cesare Hassan
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ∗ these authors equally contributed to this work
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  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ,
    Author Footnotes
    ∗ these authors equally contributed to this work
    Daniele Piovani
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ∗ these authors equally contributed to this work
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  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ,
    Author Footnotes
    ∗ these authors equally contributed to this work
    Marco Spadaccini
    Correspondence
    Corresponding author: Marco Spadaccini, MD, Humanitas Research Hospital and University, Via Manzoni 56, 20089 Rozzano Milano Italy, Tel: +39 (0)282242595, Fax: +390282242595
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    ∗ these authors equally contributed to this work
    Search for articles by this author
  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    Tommaso Parigi
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
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  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    Kareem Khalaf
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    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
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  • Author Footnotes
    3 University of Foggia, Department of Medical Sciences, Section of Gastroenterology, Foggia, Italy.
    Antonio Facciorusso
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    3 University of Foggia, Department of Medical Sciences, Section of Gastroenterology, Foggia, Italy.
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  • Alessandro Fugazza
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    4 Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    Thomas Rösch
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    4 Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
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    5 Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
    Michael Bretthauer
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    5 Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
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    5 Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
    ,
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    6 Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.
    Yuichi Mori
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    5 Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
    6 Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.
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    7 Kansas City VA Medical Center, Gastroenterology and Hepatology, Kansas City, United States.
    Prateek Sharma
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    7 Kansas City VA Medical Center, Gastroenterology and Hepatology, Kansas City, United States.
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  • Author Footnotes
    8 Indiana University School of Medicine, Division of Gastroenterology/Hepatology Indianapolis, Indiana, United States
    Douglas K. Rex
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    8 Indiana University School of Medicine, Division of Gastroenterology/Hepatology Indianapolis, Indiana, United States
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  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    Stefanos Bonovas
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
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  • Author Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    ,
    Author Footnotes
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    Alessandro Repici
    Footnotes
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    Search for articles by this author
  • Author Footnotes
    ∗ these authors equally contributed to this work
    1 Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
    2 Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
    3 University of Foggia, Department of Medical Sciences, Section of Gastroenterology, Foggia, Italy.
    4 Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    5 Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
    6 Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.
    7 Kansas City VA Medical Center, Gastroenterology and Hepatology, Kansas City, United States.
    8 Indiana University School of Medicine, Division of Gastroenterology/Hepatology Indianapolis, Indiana, United States
Published:October 12, 2022DOI:https://doi.org/10.1016/j.gie.2022.10.009
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      ABSTRACT

      Background and Aims

      Adenoma Detection Rate (ADR) is still the main surrogate outcome parameter of screening colonoscopy, but most of the studies included mixed indications and basic ADR is quite variable. We therefore looked at the control groups in randomized ADR trials using advanced imaging or mechanical methods to find out whether indications or other factors influence ADR levels.

      Methods

      Patients in the control groups of randomized controlled trials (RCTs) on ADR increase using various methods were collected based on a systematic review; this control group had to use high-definition (HD) white-light endoscopy performed between 2008 and 2021. Random-effects meta-analysis was used to pool ADR in control groups and its 95% confidence interval (CI) according to the following parameters: clinical (indication and demographic), study setting (tandem/parallel, N° centers, sample size), and technical (type of intervention, withdrawal time). Inter-study heterogeneity was reported with I-squared statistic. Multivariable mixed-effects meta-regression was performed for potentially relevant variables.

      Results

      25,304 patients from 80 studies in the respective control groups were included. ADR in control arms varied between 8.2% and 68.1% with a high degree of heterogeneity (I2 = 95.1%; random-effect pooled value: 37.5% [34.6‒40.5]). There was no difference in ADR levels between primary colonoscopy screening (12 RCTs, 15%), and mixed indications including screening/surveillance and diagnostic colonoscopy; however, FIT as an indication for colonoscopy was an independent predictor of ADR (OR: 1.6 [1.1‒2.4]). Other well-known parameters were confirmed by our analysis such as age (OR: 1.038 [1.004‒1.074]) and sex (male sex: OR: 1.02 [1.01‒1.03) as well withdrawal time (OR: 1.1 [1.0‒1.1). The type of intervention (imaging vs. mechanical) had no influence, but methodological factors did: more recent year of publication and smaller sample size were associated with higher ADR.

      Conclusions

      A high level of variability was found in the level of ADR in the controls of RCTs. With regards to indications, only FIT-based colonoscopy studies influenced basic ADR, primary colonoscopy screening appeared to be similar to other indications. Standardization for variables related to clinical, methodological, and technical parameters is required to achieve generalizability and reproducibility.

      Key-words

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