The Centre of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Department of Social Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
PLoS One. 2023 Oct 31;18(10):e0292797. doi: 10.1371/journal.pone.0292797. eCollection 2023.
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.
Systematic review with descriptive statistics and random-effects meta-analyses.
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.
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.
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.
PROSPERO registration number: CRD42017058844.
结直肠癌筛查造成的身体伤害在临床试验中往往被低估和漏报。此外，对正在进行的结直肠癌筛查项目的研究发现，筛查程序造成的身体伤害更为频繁和严重，例如出血和穿孔，比之前的试验报告的更为严重。因此，本研究的目的是系统地回顾与结直肠癌筛查相关的出血和穿孔风险的证据。
系统评价，采用描述性统计和随机效应荟萃分析。
我们系统地在五个数据库中搜索了调查与结直肠癌筛查相关的身体伤害的研究。我们使用 ROBINS-I 工具和 GRADE 方法评估内部和外部有效性。使用混合泊松回归模型在随机效应荟萃分析中计算危害估计值。
我们纳入了 89 项研究。大多数研究对危害的报告和测量都不充分。实际上，97.3%的研究存在严重的偏倚风险，98.3%的研究存在关键的偏倚风险。所有 GRADE 评级均为极低。基于严重发现、非关键偏倚风险和 30 天随访，每 10 万人筛查的出血风险为：乙状结肠镜检查为 8 [2;24]，粪便免疫化学试验后结肠镜检查为 229 [129;408]，一次性结肠镜检查为 68 [39;118]，任何筛查试验后结肠镜检查为 698 [443;1045]。粪便免疫化学试验后结肠镜检查的穿孔风险为 88 [56;138]，一次性结肠镜检查的穿孔风险为 53 [25;112]。在任何筛查试验和乙状结肠镜检查的长期随访中，都没有发现严重穿孔的亚组数据。
危害估计值在研究之间差异很大，危害的报告和测量大多不充分，偏倚风险和 GRADE 评级都非常差，这共同导致了对危害的低估。实际上，我们认为我们的穿孔和出血估计值是保守的，这突出表明未来的研究需要更好的报告和测量。
PROSPERO 注册号：CRD42017058844。
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