Screening for Colorectal Cancer: A Largely Preventable Disease
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Screening for Colorectal Cancer:
A Largely Preventable Disease
Barcey T. Levy, PhD, MD
Professor
Department of Family Medicine
Department of Epidemiology
University of Iowa, Iowa City, Iowa, U.S.
Sao Paulo, Brazil
June 14, 2012
DEPARTMENT of FAMILY MEDICINE
Objectives
Describe the epidemiology of colon cancer.
Discuss current U.S. colorectal cancer screening
guidelines.
Describe our Iowa Research Network (IRENE), a
practice-based research network (PBRN).
Describe the results of a study to screen low-income
Iowans.
Describe the results of our randomized controlled trial
(RCT) to improve CRC screening in 16 Iowa Research
Network Practices.
DEPARTMENT of FAMILY MEDICINE
Why CRC screening?
World-wide, colorectal cancer is the 3rd most common
cancer in men (663,000 cases; 10% of the total) and 2nd in
women (571,000; 9.4% of the total).
In the United States
CRC is the 2nd leading cause of cancer death men and
women.
Cases each year: 96,830 (colon); 40,000 (rectum)
Estimated deaths: 50,310 (combined)
Individuals of lower SES are consistently less likely to be
tested for CRC and have higher late-stage rates of CRC.
DEPARTMENT of FAMILY MEDICINE
1What about Iowa?
Iowa has one of the highest rates of CRC being
diagnosed at a late stage among the SEER
(Surveillance, Epidemiology, and End Results)
registries
We rank 3rd in late-stage incidence (133.3/100,000).
Only Louisiana and Kentucky rank higher.
Utah’s rates are 87.4/100,000
DEPARTMENT of FAMILY MEDICINE
Iowa Cancer Maps 2.0
http://www.uiowa.edu/iowacancermaps2/
These have been created for breast, prostate,
colorectal, lung, and cervical cancer.
DEPARTMENT of FAMILY MEDICINE
Colorectal Cancer Screening
Identification and removal of adenomatous polyps
(adenomas) will prevent cancer from developing.
With regular screening, 50 to 80% of cases can be
prevented or cured if caught early.
Many countries have population-based screening
programs.
The United States has several organizations that
have written and disseminated CRC screening
guidelines, but we still have many Americans who
remain unscreened.
DEPARTMENT of FAMILY MEDICINE
2Tubular adenoma
DEPARTMENT of FAMILY MEDICINE
DEPARTMENT of FAMILY MEDICINE
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 with
sensitive FOBT every 3 yrs
Colonoscopy every 10 years.
Consistent with ACS/American Gastroenterological
Association/USPSTF guidelines
DEPARTMENT of FAMILY MEDICINE
3United 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
DEPARTMENT of FAMILY MEDICINE
Key Point
A recent 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)
DEPARTMENT of FAMILY MEDICINE
Iowa Research Network (IRENE)
A primary care practice-based
research network (PBRN)
DEPARTMENT of FAMILY MEDICINE
4Iowa Research Network: IRENE
Practice-based research network
297 physicians
176 primary care practices
71 Iowa counties
71 practices have participated in IRENE studies
91 physicians have completed Human Subjects
protection education
DEPARTMENT of FAMILY MEDICINE
What is practice-based
research?
Practice-based research is grounded in, informed
by, and intended to improve practice.
Practice-based research is based on real patients
in real doctor’s offices, not the generally select
group that participates in clinical trials.
DEPARTMENT of FAMILY MEDICINE
IRENE’s Mission
IRENE – Iowa Research Network
The mission of IRENE is to create new knowledge
and improve clinical practice, especially in rural
communities.
IRENE will accomplish its mission through the
systematic evaluation of current practice.
A collaboration between the academic medical center
and primary care physicians throughout the state of
Iowa, with a particular focus on improving rural
health.
DEPARTMENT of FAMILY MEDICINE
5DEPARTMENT of FAMILY MEDICINE
IRENE Practices Rural/Urban
Counties
DEPARTMENT of FAMILY MEDICINE
Translational Research: T1, T2, T3
BENCH T1 BEDSIDE
T2
Basic science Human clinical Clinical Practice
Delivery of recommended
Pre-clinical research
care to the right patient
Animal Controlled observational
at the right time
studies
Identification of new
Phase 3 trials
clinical questions and
TRANSLATION TO HUMANS gaps in care
Case series
Phase 1 and 2 trials
T2 Practice-based Research
T3
Phase 3 and 4 Clinical Trials
Observational Studies
Guidelines
Survey Research Dissemination
Meta-analyses Research
Systematic Implementation
reviews Research
TRANSLATION TO PATIENTS TRANSLATION
Westfall JM, Mold J, Fagnan L. Practice-based research – “Blue TO PRACTICE
Highways” on the NIH Roadmap. JAMA 2007;297:403-6
DEPARTMENT of FAMILY MEDICINE
6Iowa Department of Public Health
Contract
Implemented a screening program for uninsured or
underinsured (low-income) 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 (guaiac) test.
DEPARTMENT of FAMILY MEDICINE
FIT results
Of 449 who completed eligibility forms (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.
DEPARTMENT of FAMILY MEDICINE
Colonoscopy Results for those
with a positive FIT
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
DEPARTMENT of FAMILY MEDICINE
7Conclusions 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.
DEPARTMENT of FAMILY MEDICINE
RCT in 16 IRENE Practices
(funded by the
American Cancer Society)
DEPARTMENT of FAMILY MEDICINE
Research Question
What practice-based intervention leads to the best CRC
screening rates in unscreened individuals?
DEPARTMENT of FAMILY MEDICINE
8Study Design
Randomized clinical trial
16 practices were randomly chosen from rural
counties with a median income below the state
average, to increase the chance of enrolling
individuals of low SES status.
DEPARTMENT of FAMILY MEDICINE
Study Design (cont’d)
Each practice identified a “CRC study coordinator”
who became certified in Human Subjects.
All study sites completed paperwork for FWA
approval.
One of the two lead investigators visited each
practice and provided a 50 minute training session.
Each site was paid a participation fee of $1000 per
year for three years.
DEPARTMENT of FAMILY MEDICINE
Study Design (cont’d)
During the study training session visit, we
Explained the study design
Obtained Informed Consent from each participating
clinician
Reviewed the current CRC screening guidelines
Provided written materials regarding the guidelines
Requested each clinician to complete a questionnaire
regarding their clinical practice regarding screening.
DEPARTMENT of FAMILY MEDICINE
9Study Design (cont’d)
Each practice provided a list of active patients aged
52 to 79 years.
Randomly selected 530 individuals from each
practice, half men and half women.
All but four practices had 530 individuals; in those
with fewer, all patients were invited.
Invited patients completed a baseline survey and an
informed consent document and agreed to be
randomized to one of four groups.
DEPARTMENT of FAMILY MEDICINE
Randomized Controlled Trial
• Recruited and enrolled 16 IRENE practices. All site
coordinators received Human Subjects training.
• Oriented physicians and site coordinators to the study.
• Obtained lists of patients 52 to 79 years of age.
• Invited 8,372 patients to participate.
2,008 (24%) returned baseline
survey
1,265 (63%) ineligible
Randomized 743 (37%) patients due for screening
within practices with equal chance to one of 4 groups
Usual care Chart Chart reminder + Mailed Chart reminder + Mailed
n = 185 reminder patient education/FIT/ patient education/FIT/
n = 185 Preference Sheet Preference Sheet +
n = 186 Telephone Reminder
n = 187
Main Outcome:
Rates of CRC testing as determined by medical record review in the 15 month interval
following the intervention.
DEPARTMENT of FAMILY MEDICINE
Physician Chart Reminder
DEPARTMENT of FAMILY MEDICINE
10Educational Materials
Standard materials available from the American
Cancer Society and the Centers for Disease Control
were used, including an 8 minute DVD
Websites:
http://www.cancer.org/acs/groups/content/@healthpr
omotions/documents/document/acsq-020998.pdf
http://www.cdc.gov/cancer/colorectal/sfl/print_materia
ls.htm
DEPARTMENT of FAMILY MEDICINE
Baseline Results (for the n=743)
Mean age (years) 61
Percentage female 52%
Percentage white 99%
Percentage married 77%
Percentage with income below $40K 39%
Percentage with high school education or less 37%
Percentage with no insurance 6.9%
DEPARTMENT of FAMILY MEDICINE
Baseline Results (cont’d) – for
the n=743
Family history:
Immediate family member 10.5%
More distant relative 11.2%
Health care provider (MD or nurse)
Discussed having a test for CRC 62.1%
Recommended CRC screening 50.2%
MD recommendation for CRC testing due to symptoms 7.7%
My doctor has discussed CRC screening with me 44.4%
DEPARTMENT of FAMILY MEDICINE
11Baseline Results (cont’d)
for the n=373 who had a recommendation for CRC screening
Tests recommended by patient’s physician %
Colonoscopy 58.5%
Fecal occult blood test x 3 29.8%
Flexible sigmoidoscopy 13.4%
Barium enema 5.6%
Fecal immunochemical test 7.8%
DEPARTMENT of FAMILY MEDICINE
Baseline Results (cont’d) –
for the n=743
Quality of CRC screening discussions (very or
(for the n =330 who had a discussion) extremely)
(%)
Comfort with asking questions 71.2%
Satisfaction with doctor’s discussion of screening 63.9%
importance
Input into the screening decision 56.4%
Satisfaction with doctor’s discussion of screening options 51.8%
DEPARTMENT of FAMILY MEDICINE
Baseline Results (cont’d) – for the n=743
Mean scores for
Scale Results
baseline
Attitude towards 1 to 5
screening Higher score = more 3.2 ± 0.6
favorable attitude
Readiness for CRC 0 to 10
screening Higher score = greater 6.9 ± 2.3
readiness for screening
Barriers to screening 0 to 5
Higher score = more barriers 1.3 ± 0.8
to screening
DEPARTMENT of FAMILY MEDICINE
12Chart Review
(selected variables)
Mean annual exam visits in past 2.2 years – 0.8 ± 1.0
Mean BMI – 30.9 ± 6.8
Percentage who had %
Mammogram in past 2.2 years 47.2%
Bone density in past 2.2 years (female 65+) 18.7%
PSA level in past 2.2 years (if male) 44.0%
Cholesterol in past 5 years (both genders) 66.1%
DEPARTMENT of FAMILY MEDICINE
CRC Testing Rates by Different Methods
(some subjects screened by more than one method) – based on
return of FIT and medical record review
80
56.5 57.2
70
Percentage Screened
60
50
FS
40 CS
20.5 Hx3
30
17.8 FIT
20
10
0
Usual Care Chart Rem CR+Mailed Edu CR+Mailed Edu+Call
DEPARTMENT of FAMILY MEDICINE
Educational mailings – overall 47%
screened by FIT
FIT Returned and Test Readiness
60
50 Group 3 Group 4
Percen ta g e
40
30
P < .0001
20
10
0
Returned FIT Ready for a test Not Ready
DEPARTMENT of FAMILY MEDICINE
13Any CRC Screening (Usual Care as
Reference Group)
Outcome Odds Ratio 95% CI p-values
variable (any test
completed)
Chart reminder 1.2 0.7, 2.0 0.5092
Chart reminder + 6.0 3.7, 9.6 < 0.0001
mailed education
Chart reminder + 6.2 3.8, 9.9 < 0.0001
mailed education
+ telephone call
DEPARTMENT of FAMILY MEDICINE
CRC Cases Among Iowa Medicare
Beneficiaries (2002-2009)
There were 9,432 confirmed CRC cases in Iowa among
those aged 65 +
After exclusions, 5,959 with continuous Medicare
coverage who had a colonoscopy.
Two-thirds of these individuals were diagnosed with late-
stage CRC
Those having a diagnostic as compared with a screening
colonoscopy were significantly more likely to be diagnosed
with late-stage CRC (OR 2.02)
Those who traveled outside of their zip code for colonoscopy
were significantly more likely to have late-stage CRC (OR 1.15)
DEPARTMENT of FAMILY MEDICINE
Take Home Points
CRC screening should occur regularly between ages
50 and 75 for average risk individuals.
Screening programs need to allow for significant
resources for organization and follow-up.
Simple interventions can work.
In our study, a telephone call had no added effect
over mailed educational materials.
DEPARTMENT of FAMILY MEDICINE
14Questions?
DEPARTMENT of FAMILY MEDICINE
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. Zauber, et al. Evaluating and testing strategies for CRC screening.
Ann Intern Med 2008;149(9):659-669.
5. USPSTF. Screening for CRC. Ann Intern Med 2008;149:627-637.
6. Levy, et al. Mailed fecal immunochemical tests plus educational
materials to improve colon cancer screening rates in Iowa Research
Network (IRENE) practices. J Am Board Fam Med, 2012;25(1):73-82.
7. Daly, et al. A randomized colorectal cancer screening intervention trial
in the Iowa Research Network: Study recruitment methods and
baseline results. J Am Board Fam Med, 2012;25(1):63-72.
DEPARTMENT of FAMILY MEDICINE
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