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Research ArticleOriginal Research

An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review

Alison N. Huffstetler, Joseph Fraiman, Shannon Brownlee, Michael A. Stoto and Kenneth W. Lin
The Journal of the American Board of Family Medicine May 2023, jabfm.2022.220320R2; DOI: https://doi.org/10.3122/jabfm.2022.220320R2
Alison N. Huffstetler
From Virginia Commonwealth University, Richmond, VA (ANH); Thibodaux Regional Medical Center, Department of Emergency Medicine, Thibodaux, LA (JF); Lown Institute, Boston, MA (SB); Georgetown University, Department of Health Systems Administration, Washington, DC (MAS); Georgetown University School of Medicine, Department of Family Medicine, Washington, DC (KWL).
MD
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Joseph Fraiman
From Virginia Commonwealth University, Richmond, VA (ANH); Thibodaux Regional Medical Center, Department of Emergency Medicine, Thibodaux, LA (JF); Lown Institute, Boston, MA (SB); Georgetown University, Department of Health Systems Administration, Washington, DC (MAS); Georgetown University School of Medicine, Department of Family Medicine, Washington, DC (KWL).
MD
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Shannon Brownlee
From Virginia Commonwealth University, Richmond, VA (ANH); Thibodaux Regional Medical Center, Department of Emergency Medicine, Thibodaux, LA (JF); Lown Institute, Boston, MA (SB); Georgetown University, Department of Health Systems Administration, Washington, DC (MAS); Georgetown University School of Medicine, Department of Family Medicine, Washington, DC (KWL).
MSc
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Michael A. Stoto
From Virginia Commonwealth University, Richmond, VA (ANH); Thibodaux Regional Medical Center, Department of Emergency Medicine, Thibodaux, LA (JF); Lown Institute, Boston, MA (SB); Georgetown University, Department of Health Systems Administration, Washington, DC (MAS); Georgetown University School of Medicine, Department of Family Medicine, Washington, DC (KWL).
PhD
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Kenneth W. Lin
From Virginia Commonwealth University, Richmond, VA (ANH); Thibodaux Regional Medical Center, Department of Emergency Medicine, Thibodaux, LA (JF); Lown Institute, Boston, MA (SB); Georgetown University, Department of Health Systems Administration, Washington, DC (MAS); Georgetown University School of Medicine, Department of Family Medicine, Washington, DC (KWL).
MD, MPH
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    Figure 1.

    PRISMA 2020 flow diagram for new systematic reviews which included searches of databases and registers only.

Tables

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    Table 1.

    Harms Study Characteristics

    Study IDYearStudy TypeMean Age/Age MinimumType of ColonoscopyPercent Polypectomy (If Reported)Perforations /10,000 ColonoscopiesSevere Bleeding/10,000 ColonoscopiesCardiovascular Adverse Events/10,000 Colonoscopies
    Bokemeyer442009Prospective>55ScreeningNot reported2.0416.4212.0
    Bretthauer232016Retrospective60Screening48.10%0.8014.32Not reported
    Causado-Calo262020Retrospective>50ScreeningNot reported5.040.070.0
    Rabeneck252008Retrospective60.9Screening24%5.5614.11Not reported
    Zwink292017Prospective61Screening12%19.0489.49Not reported
    Zafar262014Retrospective76.7ScreeningNot reported12.13165.61113.0
    • View popup
    Table 2.

    Adapted McMaster Harms Evaluation with Best Practice Evaluation

    BokemeyerBretthauerCausada-CaloRabeneckZwinkZafar
    Were there harms PRE-DEFINED using standardized or precise definitions?YesNoYesYesYesYes
    Were SERIOUS events precisely defined?YesNoNoNoYesNo
    Were SEVERE events precisely defined?YesNoNoNoNoNo
    Were the number of DEATHS in each study group specified OR were the reason(s) for not specifying them given?YesYesYesYesYesYes
    Was the mode of harms collection specified as ACTIVE?NoNoNoNoYesNo
    Was the mode of harms collection specified as PASSIVE?YesYesYesYesNoYes
    Did the study specify WHO collected the harms?NoNoYesNoYesNo
    Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?NoNoNoNoNoNo
    Did the study specify the TIMING and FREQUENCY of collection of the harms?YesYesYesYesYesYes
    Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?YesNoYesYesNoNo
    Did the authors specify if the harms reported encompass ALL the events collected or a selected SAMPLE?AllAllAllAllAllAll
    Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?N/AYesN/AN/AYesN/A
    Was the TOTAL NUMBER of participants affected by harms specified for each study arm?YesYesYesYesYesYes
    Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?YesYesYesYesYesYes
    Did the author(s) specify the type of analyses undertaken for harms data?NoNoYesYesYesYes
    • View popup
    Table 3.

    McMaster Tool for Assessing Quality of Harms Assessment and Reporting in Study Reports (McHarm)

    1.Were the harms PRE-DEFINED using standardized or precise definitions?
    2.Were SERIOUS events precisely defined?
    3.Were SEVERE events precisely defined?
    4.Were the number of DEATHS in each study group specified OR were the reason(s) for not specifying them given?
    5.Was the mode of harms collection specified as ACTIVE?
    6.Was the mode of harms collection specified as PASSIVE?
    7.Did the study specify WHO collected the harms?
    8.Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?
    9.Did the study specify the TIMING and FREQUENCY of collection of the harms?
    10.Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?
    11.Did the authors specify if the harms reported encompass ALL the events collected or a selected SAMPLE?
    12.Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?
    13.Was the TOTAL NUMBER of participants affected by harms specified for each study arm?
    14.Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
    15.Did the author(s) specify the type of analyses undertaken for harms data?
    • Source: Santaguida PL, Raina P. The development of the McHarm quality assessment scale for adverse events: Delphi consensus on important criteria for evaluating harms. Available at: http://hiru.mcmaster.ca/epc/mcharm.pdf. Accessed May 14, 2008.

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The Journal of the American Board of Family     Medicine: 38 (1)
The Journal of the American Board of Family Medicine
Vol. 38, Issue 1
January-February 2025
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An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review
Alison N. Huffstetler, Joseph Fraiman, Shannon Brownlee, Michael A. Stoto, Kenneth W. Lin
The Journal of the American Board of Family Medicine May 2023, jabfm.2022.220320R2; DOI: 10.3122/jabfm.2022.220320R2

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An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review
Alison N. Huffstetler, Joseph Fraiman, Shannon Brownlee, Michael A. Stoto, Kenneth W. Lin
The Journal of the American Board of Family Medicine May 2023, jabfm.2022.220320R2; DOI: 10.3122/jabfm.2022.220320R2
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Keywords

  • Colonoscopy
  • Colorectal Cancer
  • Early Detection of Cancer
  • Long Term Adverse Effects
  • Patient Harm
  • Preventive Medicine, Systematic Review

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