TY - JOUR
T1 - The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening
T2 - A systematic review and meta-analyses
AU - Kindt, Isabella Skaarup
AU - Martiny, Frederik Handberg Juul
AU - Gram, Emma Grundtvig
AU - Bie, Anne Katrine Lykke
AU - Jauernik, Christian Patrick
AU - Rahbek, Or Joseph
AU - Nielsen, Sigrid Brisson
AU - Siersma, Volkert
AU - Bang, Christine Winther
AU - Brodersen, John Brandt
N1 - Copyright: © 2023 Kindt et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023
Y1 - 2023
N2 - INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening.DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses.METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses.RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy.DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies.TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.
AB - INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening.DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses.METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses.RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy.DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies.TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.
KW - Humans
KW - Sigmoidoscopy/adverse effects
KW - Early Detection of Cancer/methods
KW - Colorectal Neoplasms/diagnosis
KW - Colonoscopy/adverse effects
KW - Mass Screening/methods
KW - Hemorrhage/diagnosis
KW - Occult Blood
U2 - 10.1371/journal.pone.0292797
DO - 10.1371/journal.pone.0292797
M3 - Journal article
C2 - 37906565
VL - 18
JO - PLoS ONE
JF - PLoS ONE
SN - 1932-6203
IS - 10
M1 - e0292797
ER -