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Appendix Table 1. Eligibility Criteria for Studies, by Key Question

Key Question Population Study Design Setting Outcomes Other
KQ1: Impact of screening on mortality (for any screening test) Age ≥40 y, average risk; recruited from primary care or primary care–comparable population Systematic evidence review; RCT; cluster RCT; or well-designed CCT, cohort, and case—control studies Primary care or other setting with primary care—comparable population Mortality (all-cause or CRC-specific) For guaiac FOBT, only updates for the trials included in the previous review were considered
KQ2a: Accuracy of flexible sigmoidoscopy and colonoscopy (community setting) Age ≥40 y, average risk; recruited from primary care or primary care—comparable population Systematic evidence review; RCT; cohort studies; systematically selected case series; screening registry Community primary care or other setting with primary care—comparable population Sensitivity and specificity (per person) or miss rates (per polyp); yield for CRC, advanced neoplasia, or adenomas by size Colonoscopy as reference standard; full spectrum of disease represented; indeterminate results not excluded
KQ2b: Accuracy of newer screening tests (CT colonography, high-sensitivity FOBT, FIT, fecal DNA) Age ≥40 y, average risk; recruited from primary care or primary care—comparable population Systematic evidence review; RCT; diagnostic cohort studies; systematically selected case series; screening registry Any Sensitivity and specificity (per person) or miss rates (per polyp); yield for CRC, advanced neoplasia, or adenomas by size Colonoscopy (or registry follow-up) as reference standard; full spectrum of disease represented; indeterminate results not excluded
KQ3a: Harms of flexible sigmoidoscopy and colonoscopy (community setting) Age ≥40 y, average risk; recruited from primary care or primary care—comparable population Systematic evidence review; RCT/CCT; registries; large-database observational studies, cohort studies; cross-sectional studies; systematically selected case series Community primary care or other setting with primary care—comparable population Adverse events requiring hospitalization, including perforation, major bleeding, severe abdominal symptoms, cardiovascular events, and/or resulting in death Harms due to bowel preparation and sedation considered separate from serious adverse events
KQ3b: Harms of newer screening tests (CT colonography, high-sensitivity FOBT, FIT, fecal DNA) Age ≥40 y, average risk Systematic evidence review; RCT/CCT; registries; large-database observational studies, cohort studies; cross-sectional studies; systematically selected case series Any Adverse events requiring hospitalization, including perforation, major bleeding, severe abdominal symptoms, cardiovascular events, and/or resulting in death Potential harms due to radiation and extracolonic findings considered separate from serious adverse events

CCT = controlled clinical trial; CRC = colorectal cancer; CT = computed tomography; FIT . fecal immunochemical test; FOBT = fecal occult blood test; KQ = key question; RCT = randomized, controlled trial.

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