1. D EPARTMENT of F AMILY M EDICINE Colorectal Cancer Screening: Update on Guidelines and Projects Barcey T. Levy, PhD, MD Professor, Department of Family Medicine 2011 Iowa Dialogue on Colorectal Cancer September 16, 2011

2. D EPARTMENT of F AMILY M EDICINE Objectives 1. Provide review of colon cancer screening guidelines. 2. Share information from several studies concerning colon cancer screening conducted in the University of Iowa Department of Family Medicine.

3. D EPARTMENT of F AMILY M EDICINE United States Preventive Services Task Force Guidelines  Recommends screening for CRC using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults beginning at age 50 and continuing until age 75.  Recommends AGAINST routine screening in those 76 to 85 years.  Recommends AGAINST screening in those older than 85 years. Ann Intern Med 2008;149:627-637

4. D EPARTMENT of F AMILY M EDICINE Appropriate Intervals for CRC Testing for Average Risk Individuals ANY of the following:  Annual sensitive fecal test for occult blood (Hemoccult Sensa or a fecal immunochemical test (FIT)).  Flexible sigmoidoscopy every 5 years.  Colonoscopy every 10 years. Consistent with ACS/American Gastroenterological Association/USPSTF guidelines

5. D EPARTMENT of F AMILY M EDICINE Comparison of Tests for CRC TestSensitivitySpecificityPositivity rate Serious harms Cost Fecal immuno chemic al test 61 to 91%91 to 98%5 to 19%Very low$40 Colonos copy 95%90%40% adenoma bx; 3 to 5% for cancer 2.8/1000 procedures $4,000

6. D EPARTMENT of F AMILY M EDICINE Key Point  A decision analysis found no difference in life-years gained using any of the following strategies:  Colonoscopy every 10 years  Annual screening with a sensitive FOBT or FIT  Sensitive FOBT every two to three years with flexible sigmoidoscopy every 5 years  Thus, a sensitive stool test for occult blood done annually is perfectly acceptable! Zauber, et al, Ann Intern Med 2008;149(659-669)

7. D EPARTMENT of F AMILY M EDICINE CRC Mortality – Iowa SEER Data

8. D EPARTMENT of F AMILY M EDICINE Projects  AHRQ funded study to examine CRC screening among rural Iowans.  Factors predicting screening  Doctor’s reasons for not screening specific patients  IDPH contract to screen underserved Iowans.  American Cancer Society funded randomized clinical trial, testing four interventions of increasing intensity to improve CRC screening.

9. D EPARTMENT of F AMILY M EDICINE

10. AHRQ Study

11. D EPARTMENT of F AMILY M EDICINE Patients with CRC tests

12. D EPARTMENT of F AMILY M EDICINE Predictors of Being Up-To-Date: Univariate Odds Ratios VariableOR (95% CI)p-value Patient recalls MD recommendation* 6.4 (4.2, 9.6)<.001 MD documented CRC discussion* 14.1 (8.5, 23.3)<.001 * Not considered in multivariate model

13. D EPARTMENT of F AMILY M EDICINE Physicians’ Reasons for Specific Patients Not Being Up to Date with CRC Guidelines When CRC screening was not discussed  Lack of opportunity to discuss screening Patients came in only for acute visits or problems Patients came in sporadically or saw other providers for health maintenance care No tracking system Not enough time during appointments  Physician forgetfulness  Assessment that cost or lack of insurance would be prohibitive to patient  Patient had life issues or other health problems that distracted from screening  Expected patient refusal or lack of interest

14. D EPARTMENT of F AMILY M EDICINE Physicians’ Reasons for Specific Patients Not Being Up to Date with CRC Guidelines When CRC screening was discussed, but patient declined  Cost of screening  Lack of interest in screening  Patient autonomy  Patients had life issues or other health problems  Fear of screening test procedure  No symptoms or family history of CRC

15. D EPARTMENT of F AMILY M EDICINE IDPH Contract

16. D EPARTMENT of F AMILY M EDICINE IDPH Contract  Implemented a screening program for uninsured or underinsured Iowans.  Used a fecal immunochemical test (FIT) kit that required a small sample from a single stool.  The FIT is a very sensitive test for small amounts of human blood and does not require the dietary restrictions of the hemoccult test.

17. D EPARTMENT of F AMILY M EDICINE FIT results  Of 449 who indicated an interest (23% of study population), 297 were given an FIT kit.  Return rate on FITs was 79% (235 returned).  Of the 235 kits returned, 186 tested negative (79%) and 49 (21%) tested positive.  Each individual with a positive result was telephoned and their result explained to them.  Colonoscopies were strongly encouraged for those with positive results.

18. D EPARTMENT of F AMILY M EDICINE Colonoscopy Results  30 of the 49 (61%) individuals had a colonoscopy  20 individuals had at least 1 polyp biopsied  13 individuals had at least 1 tubular adenoma  2 had adenomas more than 1 cm in diameter  No colon cancers were identified  No complications from any of the colonoscopies

19. D EPARTMENT of F AMILY M EDICINE Conclusions from IDPH  Underinsured patients had a 79% return rate for the FIT kits.  The rate of positive tests was much higher than anticipated, leading to many more colonoscopies than originally anticipated.  Population-based strategies for offering FIT could significantly increase CRC screening among disadvantaged individuals.  Programs will have to develop sustainable mechanisms to include the necessary organization and address substantial costs of providing mass screening, as well as facilitating and providing colonoscopies for those who test positive.

20. D EPARTMENT of F AMILY M EDICINE American Cancer Society Study

21. D EPARTMENT of F AMILY M EDICINE Interventions to Improve Colon Cancer Screening in Poor, Rural Iowa Counties

22. D EPARTMENT of F AMILY M EDICINE Educational mailings – overall 47% screened by FIT

23. D EPARTMENT of F AMILY M EDICINE Final Outcome

24. D EPARTMENT of F AMILY M EDICINE Colonoscopy Reports (ACS) Colonoscopy reports were examined to assess several quality indicators, including: 1) presence of a colonoscopy report on the medical record, if the medical record indicated a colonoscopy had been completed 2) cecal intubation rate 3) adenoma detection rate 4) the content of the colonoscopy report.

25. D EPARTMENT of F AMILY M EDICINE Results Colonoscopy Reports (ACS)  581 colonoscopies reported as completed in 14 offices.  492 (85%) had a report on the medical record  Main reasons for colonoscopy:  236 (48%) for screening  98 (20%) obvious blood in stool  90 (18%) family history colon cancer  70 (14%) history of colon polyp  66 (13%) change in bowel habit

26. D EPARTMENT of F AMILY M EDICINE Results of Screening Colonoscopies (n=236)  Polyp detection rate was 34%  Adenoma detection rate was 24%  Men 31% (expected 25% based on national norms)  Women 19% (expected 15% based on national norms)

27. D EPARTMENT of F AMILY M EDICINE Results (continued) Items Provided on Colonoscopy Report (N = 492) All Subjects N (%) Depth of insertion 491 (100) How the patient tolerated procedure287 (58) Name of anesthetic drug provided268 (55) Informed consent obtained220 (45) Follow-up interval for next colonoscopy223 (45) Ileocecal valve landmark mentioned159 (33) Bowel preparation quality164 (33) Appendiceal orifice landmark mentioned103 (21)

28. D EPARTMENT of F AMILY M EDICINE Take Home Points  There is wide variation in screening rates across Iowa.  There is wide variation in CRC mortality across Iowa.  Simple interventions such as direct-to-patient mailings with FIT can work.  Colonoscopy reports should be standardized.  Screening programs need to allow for significant resources for organization and follow-up.

29. D EPARTMENT of F AMILY M EDICINE References 1. Levy, et al. Colorectal cancer testing among patients cared for by Iowa family physicians. Am J Prev Med 2006;21:193-201. 2. Levy BT, et al. Why hasn’t this patient been screened for colon cancer? An Iowa Research Network Study. J Am Board Fam Med. 2007;20(5):458-468 3. Levy, et al. The “Iowa Get Screened” Colon Cancer Screening Program. J of Primary Care & Comm Health 2010;1(1):43-49. 4. http://www.uiowa.edu/iowacancermaps/colorectal_mortality.ht ml http://www.uiowa.edu/iowacancermaps/colorectal_mortality.ht ml 5. Zauber, et al. Evaluating and testing strategies for CRC screening. Ann Intern Med 2008;149(9):659-669. 6. USPSTF. Screening for CRC. Ann Intern Med 2008;149:627- 637.

30. D EPARTMENT of F AMILY M EDICINE References (cont’d) 7. Levy BT, Daly JM, Schmidt EJ, Xu Y. The need for office systems to improve colorectal cancer screening. Journal of Primary Care and Community Health 2011 (In press). 8. Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunohistochemical tests plus education materials to improve colon cancer: screening rates in Iowa Research Network (IRENE) practices. Journal of the American Board of Family Medicine 2011 (In press). 9. Daly JM, Xu, Y, Ely J, Levy BT. A Colorectal Cancer Screening Intervention Trial in the Iowa Research Network: Study Recruitment Methods and Baseline Results. Journal of the American Board of Family Medicine 2011 (In press).