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Exhibit 4-1. Inclusion/Exclusion Criteria for the Systematic Review

Category Inclusion Criteria Exclusion Criteria
Study populationHumans, all races, ethnicities, cultural groups.

Asymptomatic for colorectal cancer (CRC) and not at increased risk for CRC OR at increased risk for CRC because of a family history of CRC or polyps, or because of a history of polyps at prior colonoscopy.

Studies that exclusively focus on CRC screening for patients with a family history.

Patients with diagnosis of any of the following:

  • Genetic diagnosis of familial adenomatous polyposis (FAP) or suspected FAP without genetic testing evidence
  • Genetic or clinical diagnosis of hereditary nonpolyposis colorectal cancer (HNPCC, also known as Lynch syndrome) or individuals at increased risk of HNPCC
  • Inflammatory bowel disease, chronic ulcerative colitis (UC), or Crohn's disease
  • Colon and/or rectal cancer
  • Other hereditary polyposis syndromes
Studies that assess whether certain groups are at greater risk for CRC than others (e.g., people with comorbidities like diabetes, liver transplant patients).
Study outcomes1

KQ 1, 2, and 3: trends in CRC screening rates by test type, discussions between patients and providers about testing, appropriate utilization, quality of testing, factors influencing testing (e.g., predisposing patient and physician characteristics, health system factors, interventions), harms from included screening procedures, extracolonic findings, patient discomfort during included procedures.

KQ 4: available number of screening providers and related equipment/facilities and support personnel to conduct the tests (e.g., nurses).

KQ 5: existence and adequacy of surveillance system.

KQ 3: Changes in attitudes, beliefs, or intentions to obtain screening.

Any articles that do not directly address at least one key question.

Studies that assess the cost-effectiveness, cost/benefit, or cost-utility of CRC screening for both included or excluded procedures.

Studies that assess whether a procedure (usually two procedures compared to each other) is better at diagnosing/more effective than other procedures (usually retrospective).

Studies that assess different risk factors for CRC (e.g., diet in relation to diagnosis of CRC, calcium supplements, women taking hormone replacement therapy) and relation to incidence and/or mortality.

Study on the treatment of complications (e.g., perforation).

Any articles about CRC treatment.

Study geographyUnited StatesAll other countries
Time period1/1/1998-10/1/2009Prior to 1/1/1998
SettingsAll other settingsOncology
InterventionsColonoscopy.

Sigmoidoscopy (or flexible sigmoidoscopy).

Computed tomographic colonography (CTC) (or virtual colonoscopy with only CT) stool tests:

  • DNA stool
  • Fecal immunochemical testing (FIT)
  • Guaiac-based fecal occult blood test (gFOBT, includes Hemoccult II and Hemoccult SENSA)

Studies testing the differences in sedation, dyes, and bowel cleansing methods during included procedures.

Office FOBT (unless described/tested along with one of the included interventions).

Magnetic resonance (MR) colonoscopy (or virtual colonoscopy with MRI).

Genetic testing.

Ultrasound.

Any other unapproved tests, including the following:

  • Included procedures combined with others (CTC with stool tagging, CTC with computer-aided detection [CAD] technology)
  • Carbon dioxide insufflation during colonoscopy
  • Whole colonic imaging (WCI)
  • Chromoendoscopy
  • Tomography (PET) and/or PET in combination with CTC, etc.
  • Bidirectional endoscopy
  • Laparoscopy with colonoscopy
  • Molecular screening
  • Submucosal injection polypectomy (SIP)
  • Upper GI scope/gastroscope

Studies examining the use of any of the included tests for the monitoring or assessment of a condition or disorder (e.g., diverticulitis) and therefore not for screening or surveillance of abnormal screenings for CRC.

Studies reporting on the use of included procedures in the surveillance of CRC.

Use of any included procedures to stage cancer (e.g., CTC).

Publication languageEnglish All other languages
Admissible evidence (study design and other criteria)Original research studies that provide sufficient detail regarding methods and results to enable use and adjustment of the data and results; relevant outcomes must be able to be abstracted from data presented in the papers.

Original research studies that provide sufficient detail regarding methods and results to enable use and adjustment of the data and results; relevant outcomes must be able to be abstracted from data presented in the papers.

Eligible study designs include:

  • Randomized controlled trials (RCTs).
  • Nonrandomized controlled trials.
  • Observation studies: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies.

Sample sizes must be appropriate for the study question addressed in the paper. RCTs: 30 or more participants; observational studies and nonrandomized controlled trials: 100 or more participants.

Studies of poor quality2 and/or insufficient sample sizes.

Single case reports or small case series.

1. Refer to document "CRC Screening Systematic Review Project: Draft Indicators of Use and Quality" (Appendix A).
2. Studies deemed "poor quality" will have to be appraised formally and rated with the template developed by EPC.

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