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Screening for Colorectal Cancer: an Evidence Update for the U.S

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Screening for Colorectal Cancer: an Evidence Update for the U.S Evidence Synthesis Number 202 Screening for Colorectal Cancer: An Evidence Update for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 6 Prepared by: Kaiser Permanente Evidence-based Practice Center Kaiser Permanente Center for Health Research Portland, OR Investigators: Jennifer S. Lin, MD, MCR Leslie A. Perdue, MPH Nora B. Henrikson, PhD, MPH Sarah I. Bean, MPH Paula R. Blasi, MPH AHRQ Publication No. 20-05271-EF-1 May 2021 This report is based on research conducted by the Kaiser Permanente Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 6). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Tina Fan, MD, MPH, at AHRQ; current and former members of the U.S. Preventive Services Task Force who contributed to topic deliberations; the CISNET Colorectal Working Group; Samir Gupta, MD, and Carolyn Rutter, PhD, for their content expertise and review of the draft report; Rebecca Siegal, MPH, for providing incidence data; Douglas A. Corley, MD, PhD, MPH, Desmond Leddin MB, MSc, FRCPC, FRCPI, David Lieberman, MD, Dawn Provenzale, MD, MS, Paul Pinksy, PhD, and Carrie Klabunde, PhD, who provided expert review of the draft report; the National Cancer Institute for providing federal partner review of our draft report; and Todd Hannon and Katherine Essick, BS, at the Kaiser Permanente Center for Health Research for technical and editorial assistance. Suggested Citation Lin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Evidence Synthesis No. 202. AHRQ Publication No. 20-05271-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2021. Screening for Colorectal Cancer ii Kaiser Permanente EPC Structured Abstract Objective: We conducted this systematic review to support the U.S. Preventive Services Task Force in updating its recommendation on screening for colorectal cancer (CRC). Our review addresses the effectiveness of CRC screening, the test accuracy of CRC screening modalities, and the harms of CRC screening. Data Sources: We updated our prior systematic review and searched MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials to locate relevant studies for all key questions, from the end of our prior review through December 4, 2019. Study Selection: We reviewed 11,306 newly identified abstracts and 502 articles against the specified inclusion criteria. We carried an additional 126 studies forward from our prior review. Eligible studies included English-language studies conducted in asymptomatic screening populations age 40 years and older at average risk or unselected for risk factors. We evaluated direct visualization screening tests and currently available stool-, serum-, and urine-based screening tests. For effectiveness, we included trials or prospective cohort studies with contemporaneous controls; for test accuracy, we included diagnostic accuracy studies using a colonoscopy or cancer registry reference standard; and for harms, we included trials or observational studies reporting serious adverse events. Data Analysis: We conducted dual independent critical appraisal of all included studies and extracted all important study details and outcomes from fair- or good-quality studies. We narratively synthesized results by key question and type of screening test. When appropriate, we used random-effects meta-analyses. We graded the overall strength of evidence as high, moderate, low or insufficient based on criteria adapted from the EPC Program. Results: Effectiveness. We included 33 unique fair- to good-quality studies that assessed the effectiveness or comparative effectiveness of screening on CRC incidence and mortality. Based on four RCTs (n=458,002), a one- or two-time FS was consistently associated with a decrease in CRC incidence (IRR 0.78 (95% CI, 0.74 to 0.83) and CRC-specific mortality (IRR 0.74 (95% CI, 0.68 to 0.80) compared with no screening at 11 to 17 years of followup. Based on five RCTs (n=419,966), biennial screening with Hemoccult II was associated with a reduction of CRC- specific mortality compared with no screening after two to nine rounds of screening at 11 to 30 years of followup (RR 0.91 [95% CI, 0.84 to 0.98] at 19.5 years; RR 0.78 [95% CI, 0.65 to 0.93] at 30 years). Two prospective observational studies evaluated screening colonoscopy on CRC incidence or mortality. In one study (n=88,902), after 24 years of followup, the CRC-specific mortality rate was lower in people who self-reported at least one screening colonoscopy compared with those who had never had a screening colonoscopy (adjusted HR, 0.32 [95% CI, 0.24 to 0.45]). Results were no longer statistically significant after 5 years in people with a first- degree relative with CRC, as opposed to a sustained association beyond 5 years in people without a family history. Another study (n=348,025) with much shorter followup found that people ages 70 to 74 years who underwent a screening colonoscopy had a lower 8-year standardized risk for CRC (-0.42 percent; 95% CI, -0.24 to -0.63) than those who did not undergo the test. The magnitude of benefit was lower and no longer statistically significant for Screening for Colorectal Cancer iii Kaiser Permanente EPC people ages 75 to 79 years, and this study did not report any mortality outcomes. One prospective study (n=5,417,699) evaluating a national FIT screening program found that one to three rounds of screening with a biennial FIT were associated with lower CRC mortality than no screening (adj RR 0.90, 95% CI, 0.84, 0.95). While 3 Hemoccult II studies include adults under age 50 years, none of these studies conducted subgroup analyses in adults who initiated screening before age 50. Although we included 21 studies comparing different screening tests in average-risk populations, most of the studies were not true comparative effectiveness studies. Because most of these studies are limited to the evaluation of a single round of screening, report a low CRC yield (number of cancers detected), and do not report interval cancers, they do not provide robust direct evidence of comparative benefit on CRC incidence or mortality outcomes. Several ongoing comparative effectiveness trials that are powered to detect a difference in CRC incidence and/or mortality have not yet reported outcomes. Test accuracy. We included 59 fair- to good-quality studies evaluating the one-time test accuracy of various screening tests compared to an adequate reference standard. Direct visualization tests. Only 4 studies (n=4,821) reported the test accuracy of colonoscopy generalizable to community practice. The sensitivity to detect CRC was imprecise because of the limited number of cancers in these studies; the per-person sensitivity ranged from 0.18 to 1.0 (95% CI range 0.01, 1.0). For the detection of adenomas ≥10mm, the sensitivity ranged from 0.89 to 0.95 (95% CI range, 0.70 to 0.99) and the specificity from one study was 0.89 (95% CI, 0.86 to 0.91). For the detection of adenomas ≥6mm, the sensitivity ranged from 0.75 to 0.93 (95% CI range, 0.63 to 0.96) and the specificity was 0.94 (95% CI, 0.92 to 0.96) from one study. Based on 7 studies (n=5,328) of computed tomographic colonography (CTC) with bowel preparation, the per-person sensitivity to detect CRC was again imprecise and the per-person sensitivity ranged from 0.86 to 1.0 (95% CI range, 0.21 to 1.0). For the detection of adenomas ≥10mm, the sensitivity was 0.89 (95% CI, 0.83 to 0.96) and the specificity was 0.94 (95% CI, 0.89 to 1.0). For the detection of adenomas ≥6mm, the sensitivity was 0.86 (95% CI, 0.78 to 0.95) and the specificity was 0.88 (95% CI, 0.83 to 0.95). Based on two studies (n=920) evaluating screening capsule endoscopy, the sensitivity to detect adenomas 10 mm or larger ranged from 0.92 to 1.0 (95% CI range, 0.70 to 1.0) and specificity ranged from 0.95 to 0.98 (95% CI range, 0.93 to 0.99).
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