Implementing Colorectal Cancer Screening: Workshop Summary

INTRODUCTION

In 2003, the National Cancer Policy Board estimated that modest efforts to implement what is known from social sciences and biomedical research on cancer prevention and early detection could result in a 29 percent reduction in cancer deaths in about 20 years (NRC, 2003). With consideration to the gravity of that finding, the National Cancer Policy Forum1 sought to outline ways to increase the use of screening services in the United States. To maximize the impact of such a discussion, the NCPF chose to focus on colorectal cancer screening. Despite the strong evidence that screening is effective in preventing deaths and that there are effective health systems and community interventions to increase screening, use of colorectal cancer screening remains low. Therefore, the purpose of the workshop was to identify the next steps that need to be taken to fully implement recommended colorectal cancer screening, including steps to be taken at clinic, community, and health system levels.

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The Institute of Medicine (IOM) established the National Cancer Policy Forum (NCPF), effective on May 1, 2005, to succeed the National Cancer Policy Board (NCPB), which existed from 1996 to 2005. IOM forums are designed to allow government, industry, academic, and other representatives to meet and confer privately on subject areas of mutual interest. NCPF is the successor to NCPB in providing a focus within The National Academies for the consideration of issues in science, clinical medicine, public health, and public policy relevant to the goals of preventing, palliating, and curing cancer.



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Implementing Colorectal Cancer Screening: Workshop Summary INTRODUCTION In 2003, the National Cancer Policy Board estimated that modest efforts to implement what is known from social sciences and biomedical research on cancer prevention and early detection could result in a 29 percent reduction in cancer deaths in about 20 years (NRC, 2003). With consideration to the gravity of that finding, the National Cancer Policy Forum1 sought to outline ways to increase the use of screening services in the United States. To maximize the impact of such a discussion, the NCPF chose to focus on colorectal cancer screening. Despite the strong evidence that screening is effective in preventing deaths and that there are effec- tive health systems and community interventions to increase screening, use of colorectal cancer screening remains low. Therefore, the purpose of the workshop was to identify the next steps that need to be taken to fully implement recommended colorectal cancer screening, including steps to be taken at clinic, community, and health system levels. 1 The Institute of Medicine (IOM) established the National Cancer Policy Forum (NCPF), effective on May 1, 2005, to succeed the National Cancer Policy Board (NCPB), which existed from 1996 to 2005. IOM forums are designed to allow government, industry, academic, and other representatives to meet and confer privately on subject areas of mutual interest. NCPF is the successor to NCPB in providing a focus within The National Academies for the con- sideration of issues in science, clinical medicine, public health, and public policy relevant to the goals of preventing, palliating, and curing cancer. 

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 IMPLEMENTING COLORECTAL CANCER SCREENING The first U.S. Preventive Services Task Force (USPSTF)2 guidelines recommending colorectal cancer screening were made in 1996, based on research documenting that colorectal cancer screening using fecal occult blood tests (FOBTs) and sigmoidoscopy effectively reduced the numbers of deaths from this cancer (USPSTF, 1996). In 2002, colonoscopy and double-contrast barium enema were added to the USPSTF-recommended colorectal cancer screening arsenal (USPSTF, 2002). Researchers also found a number of interventions in medical practices/health systems and in communities that were effective in increasing screening rates, including client reminders and recalls, provider reminders, reduced structural bar- riers, provider assessment and feedback, and small media. Yet colorectal cancer screening rates remain relatively low in the United States. Encouraged by the Centers for Disease Control and Prevention (CDC) to recognize the need to make colorectal cancer screening more wide- spread, the NCPF convened the workshop “Implementing Colorectal Cancer Screening,” which was held February 25 and 26, 2008, in Wash- ington, DC. After the natural history and epidemiology of colorectal can- cer were described, speakers identified major barriers to implementa- tion of screening and described effective strategies to increase screening, based on available research and on their own experience as leaders in the field. These strategies included not only interventions to increase rates of screening, but also analysis of current screening technologies that could be used to increase screening effectiveness. The speakers represented a broad spectrum of contexts in which issues of implementation are encountered, from primary care or gastrointestinal (GI) specialty practices to community-, state-, or national-based programs. Health insurers and providers of employment-based programs also gave their perspective, as well as health economists and epidemiologists. The presentations were followed by a session in which participants discussed the relative value of actions needed to increase recommended colorectal cancer screening services. This document is a summary of the workshop proceedings. Moving Evidence-Based Recommendations into Practice Dr. Ralph Coates, associate director for science in the National Office of Public Health Genomics at the CDC, began the morning presentations by summarizing the purpose of the workshop and detailing how colorec- 2Across the complete range of clinical preventive health services, the U.S. Preventive Ser- vices Task Force (USPSTF) provides the gold standard in evidence-based recommendations. USPSTF recommendations are equally respected by physicians, patients, payers, and policy makers; because of this, the USPSTF has been instrumental in establishing the standard of care for preventive health services in the United States since its creation in 1984 (Eisenberg and Kamerow, 2001).

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 WORKSHOP SUMMARY tal cancer screening often is “lost in translation” on the continuum from discovery of benefit to clinical implementation in communities through- out the United States. He noted that the genesis of the workshop stemmed from the 2003 NCPB report, Fulfilling the Potential of Cancer Preention and Early Detection (NRC, 2003).3 The report concluded that because evidence-based prevention and screening interventions are not widely implemented, thousands of avoidable deaths occur each year. Although the 2003 report made several recommendations related to colorectal cancer—such as providing resources for state-based comprehen- sive cancer control programs, conducting timely reviews of cancer preven- tion interventions, providing insurance coverage of preventive services recommended by the USPSTF, and supporting a public health colorectal cancer screening program for low-income, uninsured populations—its broad focus precluded outlining detailed suggestions for how to boost implementation of cancer preventive services for specific cancers, Dr. Coates said. Consequently, the NCPF decided to take this report further by focusing on one cancer—colorectal cancer—and discern what steps need to be taken to improve screening implementation. As Dr. William Lawrence of the Agency for Healthcare Research and Quality (AHRQ) and the CDC added later, both agencies recently prioritized clinical pre- ventive services. Colorectal cancer screening was ranked number four on the list of all preventive services, and number two for the screening services, mainly because of the preventable disease burden linked to such screening, and the fact that optimal colon cancer prevention is not being achieved with current levels of screening (Maciosek et al., 2006). Until recently, fewer than half of Americans aged 50 and older received recommended colorectal cancer screening (Seeff et al., 2004). The limited implementation of this screening in the face of such strong evidence that it is effective is a conundrum. One reason that might explain this puzzling finding is that there is limited research on implementation that might indicate effective ways to improve it. Dr. Coates showed in a slide that as candidate clinical applications proceed on the continuum from discov- ery to clinical practice, there is a significant drop in funding beginning just before the development of evidence-based guidelines for using the intervention and continuing through all subsequent steps (Figure 1). The paucity of funding for relevant research on how to implement new clini- cal interventions may help explain why so many effective interventions are not more widely used in the clinic. “The bench-to-bedside continuum 3A subsequent NCPB workshop addressed cost-effectiveness of colorectal cancer screening. The workshop is summarized in Economic Models of Colorectal Cancer Screening in Aerage-Risk Adults: Workshop Summary (IOM, 2005b).

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 IMPLEMENTING COLORECTAL CANCER SCREENING T1 T2 T3 T4 Amount of Funding, Interest, and Activities Discovery to Application Guideline to Practice to clinical to evidence- clinical and health application based public health impact in guideline practice practice communities Bench to bedside continuum covers early Lost in translation phases only I----------------------------I FIGURE 1 The research community’s interest in implementation processes wanes along the continuum of cancer translational research. SOURCES: Coates presenta- tion (February 25, 2008) and IOM (2002), Khoury et al. (2007), Sung et al. (2003), and Woolf (2008). Adapted from Khoury, M. J., M. Gwinn, P. W. Yoon, N. Dowling, Figure 1, R01298. C. A. Moore, and L. Bradley. 2007. The continuum of translation research in ge- nomic medicine: How can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genetics in Medicine 9(10):665–674. Copyright 2007 by the American College of Medical Genetics. Re- printed with permission of Lippincott Williams & Wilkins. covers only the early phases of this continuum, and therefore some appli- cations are lost in translation,” Dr. Coates said. This seems to be especially true for colorectal cancer screening, Dr. Coates noted. Good biomedical research findings support the USPSTF evidence-based recommendations for such screening, and social science and health services research supports guideline recommendations of the Task Force on Community Preventive Services (TFCPS). But there is lim- ited research on implementation of screening services, and even less on implementing Guide to Community Preentie Serices (Community Guide) recommendations (TFCPS, 2008a). There also is limited assessment of what the health benefits are when those guidelines and services are effec- tively in the general population. The IOM tried to bridge that gap with its 2001 report Crossing the Quality Chasm: A New Health System for the st Century (IOM, 2001) and its 2005 report Building a Better Deliery System: A New Engineering/Health Care Partnership (IOM, 2005a). In those reports, the IOM recommended increasing the use of systems tools, such as tracking and reminder systems, and information technologies to increase quality and delivery of recommended services. But questions remain on how to

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 WORKSHOP SUMMARY implement those recommendations, and colorectal cancer was not specifi- cally addressed in either report. Consequently, in addition to presentations related to the natural his- tory and epidemiology of colorectal cancer, as well as evidence-based guidelines for screening for this cancer, the workshop was planned to bring together the expertise of workshop participants with presenta- tions on strategies for improving the implementation of colorectal cancer screening in health care settings, including both primary care practice and gastrointestinal specialty practices, Dr. Coates noted. But recogniz- ing that the health care delivery system does not operate in isolation, the workshop planners also aimed to gather expert advice on ways that other sectors of society, such as employers, health insurers, and state and federal public health agencies, have fostered successful implementation of colorectal cancer screening. Thus, the workshop includes presentations on those topics, as well as on the costs of implementation and performance monitoring. NATURAL HISTORY AND EPIDEMIOLOGY Dr. Bernard Levin, professor emeritus of the M.D. Anderson Cancer Center and chair of the American Cancer Society’s (ACS’s) National Advi- sory Task Force on Colorectal Cancer, and Dr. Michael Pignone, associ- ate professor of medicine and chief of the Division of General Internal Medicine at the University of North Carolina at Chapel Hill, presented the natural history and epidemiology of colorectal cancer. Dr. Levin revealed the latest trends in colorectal cancer incidence, mortality, and screening, and he discussed the natural history of the cancer and how screening can affect it. Dr. Pignone mainly focused on factors that influence the imple- mentation of colorectal cancer screening. Dr. Levin reported that colorectal cancer is the third most common cause of cancer in men and women, and the second leading cause of cancer death in the United States (ACS, 2007a). African Americans have higher incidence and death rates, as can be seen in Figure 2, and are more likely to develop colon cancer at an earlier age than white people (NCI, 2007). Remarkably, Japan, which previously had a low incidence of the cancer, is now the country with the highest incidence in men (Parkin et al., 2005), and Japanese who have emigrated to Hawaii have the highest incidence in the world (Sakamoto et al., 2006), Dr. Levin noted. This prob- ably reflects, at least in part, the environmental influences on the develop- ment of colorectal cancer. The incidence in China and Hong Kong is also increasing rapidly, perhaps due to the adoption of a Western lifestyle and diet (Hospital Authority, 2008; Sung et al., 2005; Vainio and Miller, 2003). Environmental factors linked to colorectal cancer include obesity, physi-

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 IMPLEMENTING COLORECTAL CANCER SCREENING 80 Incidence: 70 black 60 Rate per 100,000 50 Incidence: white 40 30 Death: black 20 Death: white 10 0 1975 1978 1981 1984 1987 1990 1993 1996 1999 2002 Year FIGURE 2 U.S. incidence and death rates by race from invasive colon and rectal cancers from 1975 to 2004. Rates are per 100,000 and are age-adjusted to the 2000 U.S. standard population. SOURCES: Levin/Pignone presentation (February 25, 2008) and SEER Cancer Statistics Reiew, 97–00 (NCI, 2007). cal inactivity, intake of red and processed meat, tobacco use, and heavy Figure 2, R01298. alcohol intake, Dr. Levin pointed out (Koushik et al., 2007; Wolin et al., 2007). In contrast to what is being seen in Asian countries, colorectal cancer incidence and mortality are declining in many Western nations. In the United States between 1973 and 1995, incidence declined by 7 percent and continued to decline between 1995 and 2003, while mortality declined by 20 percent (NCI, 2004) between 1985 and 2002 and even more steeply from 2002 to 2004, Dr. Levin reported (NCI, 2007). He attributed this decline to increased screening, detection, and removal of adenomas. As he noted, it is now well known that colorectal cancers begin as adenomas that may progress to invasive cancer over 5 to 15 years (Rozen et al., 2002). This slow progression enables physicians to identify and remove adenomas before they progress to invasive cancers. Colorectal adenomas are found in up to 40 percent of people by age 60, he indicated in the background paper he and Dr. Pignone provided (Appendix C; Eide, 1986; Kim and Lance, 1997; Peipins and Sandler, 1994). Although hereditary factors can heighten the risk of developing colorectal cancer, about 70 percent of

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7 WORKSHOP SUMMARY these cancers arise sporadically (Pignone et al., 2002). Consequently, colon cancer screening strategies cannot be directed solely to high-risk patients, Dr. Levin said. Colorectal cancer screening not only enables the detection and removal of adenomas before they progress to invasive cancers, but also fosters the detection of colorectal cancer at an earlier stage when it is more curable. Survival rates at 5 years are more than 80 percent for patients diagnosed with local disease, and higher than 60 percent for regional dis- ease (Appendix C; NCI, 2004). Encouragingly, comparing data collected between 1975 and 1979 with data collected between 1998 and 2003, reveal that people are being diagnosed at an earlier stage, with an increasing fraction of them being diagnosed with localized disease (Table 1; NCI, 2004). Data from the most recent Cancer Statistics Reiew, produced by the Surveillance Epidemiology and End Results (SEER) group of the National Cancer Institute (NCI), indicated that 40 percent of colorectal cancers in this country are localized when diagnosed, about 37 percent have spread regionally, and 19 percent have metastasized to distant sites, Dr. Levin reported (NCI, 2004).4 Dr. Pignone noted that the improvement in the stage of diagnosis might be attributable to the heightened amount of screening that has occurred recently, as two national studies reveal (CDC, 2008; Meissner et al., 2006). One study conducted by the CDC found that in 2007, more than 60 percent of age-eligible adults reported being up to date with screening, which compares with only 40 percent in 1997 (CDC, 2006). The recent increases in screening rates are due predominantly to increasing use of colonoscopy (Meissner et al., 2006). Dr. Pignone also reported what factors appear to increase a per- son’s likelihood to undergo colorectal cancer screening. These factors include being between 65 and 85 years of age, having a higher educational achievement or income, belonging to a health maintenance organization (HMO), having a belief that cancer is preventable, and lacking a strong fear of cancer. Receiving a physician recommendation for screening has 4 The TNM classification system is used to stage colorectal cancer (ACS, 2008; NCI, 2008). T refers to the characteristics of the primary tumor, N refers to the involvement of regional lymph nodes, and M refers to the extent of metastasis, if any. The TNM stages are then grouped into familiar numbered stages, 0–4. Stage 0 refers to highly localized cancers that have not grown beyond the inner layers of the colon or rectum. Stage 1 refers to cancers that have penetrated the inner layers of the colon or rectum, but not to the outer lay- ers. Stage 2 refers to cancers that have penetrated all layers of the colon or rectum, may or may not have reached adjacent tissues, but have not reached lymph nodes or distant sites. Stage 3 refers to cancers that have spread to one or a few nearby lymph nodes, and they may or may not have spread to nearby organs. Stage 4 refers to cancers that have spread to distant sites. For more information, see http://www.cancer.org/docroot/CRI/ content/CRI_2_4_3X_How_is_colon_and_rectum_cancer_staged.asp or http://www.cancer .gov/cancertopics/pdq/treatment/colon/HealthProfessional/page4.

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 TABLE 1 Stage at Diagnosis Improving Over Time 1975–1979 1985–1989 1996–2003 All White Black All White Black All White Black Percent localized 33% 33% 30% 38% 38% 33% 40% 40% 35% Percent regional 37% 37% 35% 37% 37% 36% 37% 37% 35% Percent distant 22% 22% 26% 19% 19% 24% 19% 18% 24% Percent unstaged 8% 8% 9% 6% 6% 7% 4% 4% 6% SOURCE: Levin presentation (February 25, 2008).

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9 WORKSHOP SUMMARY been one of the strongest factors linked to screening that has been identi- fied across studies, Dr. Pignone observed. Access variables, such as hav- ing a usual source of care, and the number of physician visits have been consistently linked to higher screening rates (Meissner et al., 2006). Dr. Pignone stressed that there is nearly a 30 percentage point difference in colorectal cancer screening rates between those who are insured and those who lack insurance, recent data show (Meissner et al., 2006). “I want to highlight that colorectal cancer screening is becoming a health disparity and an access issue, and our efforts need to be thought of in that context,” Dr. Pignone said. He summarized both his and Dr. Levin’s presentation by noting that although screening is an effective means of reducing colorectal cancer incidence and mortality, it is underused. “Things are getting better, but we are still not doing quite as well as we would like,” he said. Following Dr. Pignone’s presentation, a discussion focused on the disparities between black and white people in the incidence and mortal- ity statistics that Dr. Levin presented. Due to its complexity, Dr. Levin was not willing to ascribe the differences to one specific factor, but noted several factors that may contribute to those differences in incidence and outcome. These factors include access to treatment and obesity, he said. Dr. Patricia Ganz of the University of California, Los Angeles, Schools of Medicine and Public Health asked whether any studies had been con- ducted to examine the lower incidence of colorectal cancer among black Africans; she noted that comparisons between black Africans and black North Americans or Europeans could provide valuable information.5 Dr. Levin responded that he was unaware of any such studies, but that there was some evidence of an increasing prevalence of adenomas in Southern Africa (Angelo and Dreyer, 2001; Walker and Segal, 2002). Dr. Edward Benz of Harvard Medical School suggested that lower levels of vitamin D circulating metabolites in several of these groups may explain the increased incidence of colorectal cancer, which, several studies suggest, protect people from developing various cancers. Although Dr. Levin said he has seen data to support the notion that black North Americans have lower levels of Vitamin D circulating metabolites, he was not aware of convincing data that this was causally related to the increased incidence of colon cancer they experience compared to white people. Dr. Robert Fletcher of Harvard Medical School and the University of North Carolina at Chapel Hill School of Medicine added that environmental risk factors, such as smoking, diet, or obesity, may not individually account for the dif- ferences seen between black and white people. However, collectively the risk factors might explain much of the disparity in the colorectal cancer incidence statistics seen between these two populations. 5 For example, see O’Keefe et al. (2007).

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0 IMPLEMENTING COLORECTAL CANCER SCREENING Referring to Dr. Levin’s report that black people tend to develop colorectal cancer at an earlier age than white people, Dr. Ann Zauber of the Memorial Sloan-Kettering Cancer Center mentioned a microsimula- tion model she used that showed screening black people at age 45 rather than 50 would generate a 15 to 20 percent increase in life-years saved, assuming it did not decrease current adherence to screening. Dr. Coates pointed out that, in addition to racial variations in incidence, “it is also important to keep in mind that if we plotted variations in incidence by age for any risk factor, those groups at higher risk, that is those who are physically inactive or overweight or have a poor diet, would have higher incidence at an earlier age. So any potential recommendation for screen- ing one group early could also apply to those who are physically inactive, overweight, have a poor diet, etc.” EFFECTIvENESS OF COLORECTAL CANCER SCREENING The next presenter, Dr. Evelyn Whitlock, senior investigator at The Center for Health Research at Kaiser Permanente Northwest and associ- ate director of the Oregon Evidence-based Practice Center (OEPC), sum- marized the findings from the 2007–2008 updated evidence synthesis on colorectal cancer screening that the OEPC did for the USPSTF. The syn- thesis is the basis for the USPSTF’s updated recommendations on colon cancer screening (Whitlock et al., 2008).6 She began her talk by noting that in 2002, based on the evidence review done at that time, the USPSTF strongly recommended that clinicians screen men and women 50 years of age or older for colorectal cancer, but gave no preference for the type of screening done—whether it was home FOBT, flexible sigmoidoscopy, colonoscopy, double-contrast barium enema, or some combination of these options. The updated review Dr. Whitlock and her colleagues con- ducted focused on assessing the following factors: • ortality impact of colorectal cancer screening; M • ffectiveness of optical colonoscopy and flexible sigmoidoscopy in E community practice; • fficacy of newer screening technologies such as high-sensitivity E FOBTs (Hemoccult SENSA), fecal immunochemical tests (FITs), fecal DNA, and computed tomography (CT) colonography; and • Harms of screening tests. For this review, the OEPC researchers combed the literature for studies of the use of the various colorectal cancer screening technologies on people 6 See also http://www.ahrq.gov/clinic/uspstfix.htm.

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 WORKSHOP SUMMARY aged 40 and older who had average risk for developing the cancer. The OEPC review focused on evidence that was not available at the time of the 2002 recommendation and evidence that might justify changes to the 2002 recommendation. One review published after 2002 found that biennial FOBT was linked to a 15 percent reduction in colorectal cancer mortality in four randomized controlled trials (Kerr et al., 2007), but there was no additional evidence since the previous recommendation on the effects of other fecal screening tests, flexible sigmoidoscopy, optical colonoscopy, or CT colonography on mortality, Dr. Whitlock reported. The OEPC researchers used three studies to assess the effectiveness of optical colonoscopy in community practice (Johnson et al., 2007; Kim et al., 2007; Pickhardt et al., 2003). But estimates from these studies were hampered, to some degree, by the small number of colorectal cancers that occurred during the study interval. Although one study showed only 50 percent sensitivity in detecting colon cancer, only two colon cancers in total occurred in the study population (Pickhardt et al., 2003). No colon cancers occurred in the second study (Kim et al., 2007), while in the third study (Johnson et al., 2007), 20 percent of colon cancers were detected. Sensitivity for detecting adenomas 10 mm or larger ranged from 88 to 100 percent. Only one study documented its sensitivity for detecting adenomas 6 mm or larger (Pickhardt et al., 2003). This sensitivity was 92 percent. Another meta-analysis found miss rates in tandem colonoscopy in non-screening populations to be only 2 percent for larger lesions, and 13 percent for lesions 5 to 10 mm (van Rijn et al., 2006). The OEPC researchers used four studies, including an American College of Radiology Imaging Network (ACRIN) study (Johnson, 2007), whose results are not yet published, to assess the efficacy of CT colo- nography in comparison to optical colonoscopy (Johnson, 2007; Johnson et al., 2007; Kim et al., 2007; Pickhardt et al., 2003). They found that the sensitivities of the two tests were comparable, although CT colonography appeared to be less sensitive at detecting adenomas 6 mm or greater. The specificity was either lacking or ranged substantially in the studies reviewed, which made comparisons difficult, Dr. Whitlock noted. “In general, although not completely true, the specificity of CT colonogra- phy worsens as the lesions are smaller,” she said. Her group used three studies to estimate that between 1 in 10 and 1 in 13 patients who received CT colonography would subsequently receive optical colonoscopy if the threshold for referral was presence of a 10-mm or larger lesion. With a lower threshold of 6 mm or greater, between one in three and one in five persons would need to have optical colonoscopy. The OEPC researchers assessed the efficacy of newer fecal tests, such as high-sensitivity FOBTs, FITs, and fecal DNA tests, by comparing them

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 IMPLEMENTING COLORECTAL CANCER SCREENING 100 90 Percentage of Start-Up Expenditures 80 70 60 50 40 30 20 10 0 1 2 3 4 5 Program Other activities Administrative/overhead Patient support Data collection and tracking Partnership development and maintenance Quality assurance and professional development Public education and outreach Program management FIGURE 15 Distribution of start-up costs by activity for each of the five awardees. NOTES: Each of the CRCSDP awardees has different program structures/models. This graph includes costs from all funding sources (CRCSDP, in-kind, and oth- er). CRCSDP = Colorectal Cancer Screening Demonstration Program. SOURCES: Tangka presentation (February 26, 2008) R01298. et al. (2008). Figure 15, and Tangka be used for assessing efficiency, setting priorities, and accounting, she concluded. In the discussion following Dr. Tangka’s presentation, Dr. Ganz pointed out that it can be burdensome for staff to report their time by separating it into different activity bins. Although she applauded the

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9 WORKSHOP SUMMARY CDC awardees’ efforts in this regard, she added that getting staff to comply with providing such detailed records can be difficult. Dr. Tangka responded, “to get high-quality data, there are always tradeoffs. You do this and get high-quality data or you end up with estimates. If we are going to be using this for any expanded effort on colorectal cancer screen- ing, we must try to get as close as possible to the real costs of running this program.” She added, in response to another question, that much of this detailed cost information was lacking when the CDC’s National Breast and Cervical Cancer Early Detection Program31 started, although it has been collected for the past 3 years. “What I commend the colorectal cancer team for doing is starting to track the economic costs from the beginning as this really helped inform the program,” she said. GENERAL DISCUSSION AND WRAP-UP Following the workshop presentations, Mr. Tom Kean, executive director of C-Change, led a discussion among workshop participants on priority actions needed to increase recommended colorectal cancer screen- ing. Mr. Kean first reviewed the workshop by enumerating 10 topics that together encompassed the breadth of issues impacting implementation of screening, as highlighted by workshop presentations and discussions. After Mr. Kean’s summary, participants discussed their points of view on methods for increasing screening and how the workshop influenced their opinions on the topic. Mr. Kean recognized the wide variety of perspectives presented at the workshop, and noted that even so, “there were some threads and themes that wove through many of the conversations during the meeting that I think bear some further attention.” The 10 themes highlighted by Mr. Kean were as follows: • olorectal cancer: The incidence of colorectal cancer has declined C since screening was first recommended in 1980. Even so, too many colorectal cancer diagnoses are for late-state disease, and screen- ing rates are still too low. “Every year people are dying from this disease or suffering through more extensive treatment than they might otherwise need,” Mr. Kean said. • creening tests: A fair amount of consensus exists on the current S guidelines for colorectal cancer screening. However, the message is complicated by the different tests and intervals at which the tests are performed. Mr. Kean mentioned that even though there seems to be movement toward colonoscopy as the preferred test, 31 See http://www.cdc.gov/cancer/NBCCEDP/.

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70 IMPLEMENTING COLORECTAL CANCER SCREENING this is not necessarily based on evidence of better test sensitivity or specificity. Additional concerns arise as new tests are developed that provide only incremental benefit, but confuse the message to the public about colorectal cancer screening. • uality of screening: For colonoscopy, in particular, screening Q often takes place outside the primary care physician’s practice. Improving the referral process so that patients are not lost would improve screening rates. Regarding the quality of the testing itself, speakers discussed variability in test results due to different readers for multiple test types and quality of bowel preparation for endo- scopic screening. Nonadherence to screening guidelines results in inadequate promotion of screening or the use of non-evidence- based screening tests. • rimary care system: Mr. Kean observed that primary care physi- P cians and their staff are critical to the implementation of colorectal cancer screening. However, the primary care system is under enor- mous pressure. These physicians deal with significant time con- straints due to a large preventive, chronic, and acute care agenda. Financial stability of the practices and incentives for preventive care in primary care practices are also important considerations. • orkforce capacity: It is unclear whether the capacity to fully W implement colorectal cancer screening is currently available. On one hand, primary care physicians do not have time to fully imple- ment preventive care in their practices, and there may be long waits for colonoscopy appointments. On the other hand, there may be overuse of colonoscopy. The medical home concept was introduced as a possible route to address workforce issues. • etrics and measurements: Mr. Kean reiterated a plea from Ms. M Skye of Quintiles that “we often hear from community programs and organizations, which is for some advice on what we should be measuring to know whether we are getting where we want to be.” Datasets such as HEDIS are helpful in addressing these concerns. Errors and quality of measurements, data standards, and reporting methods were discussed, as well as the apparent spectrum between privacy protections and transparent systems. • osts: Mr. Kean reported that cost of screening and cost-effectiveness C were common themes throughout the workshop: not only the mon- etary costs of the testing itself, but also the time costs of staff, par- ticularly for small practices. Financial incentives and disincentives to physicians were also seen as affecting colorectal cancer screening implementation. • overage: Colorectal cancer screening is generally covered by C traditional health insurance plans and Medicare. Beyond lack of

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7 WORKSHOP SUMMARY coverage for uninsured and underinsured individuals, however, “we seem to be hearing more and more about the affordability of insurance and the trend to shift more of the cost burden on the employee,” Mr. Kean said. This may result in lack of coverage for colonoscopy for more people. “This is at the same time we are seeing increased interest in referrals to colonoscopy,” Mr. Kean said. Also, a great deal of variability in screening offerings was highlighted on a state-to-state level, among practice types, and on practice-to-practice and even physician-to-physician levels. • ommunications: The content of the message to the public was C discussed, as was its place in the general preventive care agenda. Communications between health plans and providers can be improved, as can communications to providers about screening guidelines. Community- and practice-based interventions were shown to be successful, although the data focused on interventions to increase FOBT screening. Data from state and federal demon- stration programs showed that large screening initiatives are use- ful in increasing screening rates and decreasing the incidence of colorectal cancer. • isparities: During the workshop, several issues of disparities D were discussed, including race, gender, age, and insurance cover- age. For example, African Americans experience earlier onset of colorectal cancer, suggesting that different screening guidelines might better serve this group. Another topic covered was differ- ence between genders: depending on the setting and types of inter- vention, there are different screening rates and disease outcomes to be addressed. After Mr. Kean reviewed the themes that arose from the workshop presentations, he opened the discussion to everyone by posing the ques- tion, what are the main ideas that conference particpants had that would help to improve colorectal cancer screening in the United States? Four main topics were discussed: screening implementation, communications, costs and coverage, and the primary care system. Screening Implementation The purpose of this workshop was to discuss progress on and how to improve the implementation of colorectal cancer screening. It became evident that, unlike other cancer screening, one of the major barriers is awareness of the need to get screened. Dr. Vernon pointed to the 2005 NHIS (NCHS, 2005) finding that more than 70 percent of the people who have not been screened reported it was due to lack of awareness of the

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7 IMPLEMENTING COLORECTAL CANCER SCREENING importance of such screening. “There is a lot of low-hanging fruit out there. I don’t think we are going to need a cannon to get a significantly greater number of people into screening,” she said. Dr. Ferrell agreed on the importance of paying attention to that finding. “This is strikingly different from other health care concerns I deal with, which are always divided amongst professional, patient, and system barriers. So I don’t think we should ignore that,” she said. She added that what made cervi- cal cancer screening so effective was the increased awareness of the need for it by patients, which led to them demanding the testing from their providers. “The need is to get the public message out that you should request screening, and that might be a greater return on our investment overall,” she said. Dr. Lieberman reinforced the importance of increasing patient aware- ness about colorectal cancer screening. He and his colleagues documented the important effect Katie Couric had on boosting screening rates by having a televised colonoscopy (Cram et al., 2003). But Dr. Fletcher and Dr. Seeff pointed out that there already are public campaigns to increase awareness of the importance of colorectal cancer screening. They won- dered whether the message needs refinement, but said they believed there was not a lack of awareness efforts. “I think maybe there is just a part of the population that is not hearing the message,” Dr. Seeff said. Dr. Ganz noted that there are two different communities that have to receive messages about colorectal cancer screening—the public and the physicians. For the public, the message should be simple: You should get screened to prevent cancer. The message for physicians as to which test to pursue depends on what might be best in their community. A local organization that has the infrastructure to track FOBTs might do better with that option, for example. “We may not necessarily have the same message to the public as we do to the provider community,” she said. Dr. Durado Brooks of the American Cancer Society added that it is important to improve the messaging to the provider community because the second most common reason people give for not undergoing screening is that their doctor never told them they needed it. “We need to try to figure out our messaging to physicians, and also the avenues for providing those messages—we need to know who primary care physicians are listening to and who influences them. Providing incentives is one way to think about it, but some of it is simply raising their awareness of the fact that they have probably got patients who are going to die because they didn’t offer this test,” he said. Mr. Kean then pointed out the fair amount of agreement on the impor- tance of boosting the awareness effort aimed at the public that encourages a demand for certain preventive health services, including colorectal can- cer screening. There also was agreement, he said, that screening should

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7 WORKSHOP SUMMARY be promoted and that there should be integration of all the public mes- sages about preventive health measures. Some segments of the population should not be too difficult to reach, he said, and “we ought to be thinking about identifying these people and how we might reach them. We may be able to get some fairly quick incremental gains, perhaps as much as a 20 percentage point increase in screening with minimal effort.” Communications Effective interventions to increase screening focus on communication to patients and providers about the need for screening. During the work- shop, speakers described screening efforts at many levels, and the discus- sion led to several common themes. Ms. Skye said, “We are overlooking a fantastic resource, which is an educated and empowered patient base.” She noted that it takes six exposures to a message before someone will act on it, on average, “so going to the doctor and hearing it once isn’t going to be enough. You have to put it in an e-mail, on a poster, etc.” Although she endorsed the idea of a preventive care reminder checklist, she added that to be effective, use of a checklist will require a cultural shift that makes patients take responsibility for their own preventive health. She suggested simplifying current template checklists that are based on gender and age and tailoring them more to the individual. Mr. Kean added that the public is getting multiple messages about preventive care measures from mul- tiple sources, and that messaging must be consistent. “We need to look for ways to make this a more integrated national push. We are out there with our colorectal cancer screening message, but so are the diabetes people and everybody else, not to mention the nonhealth people. Consequently, the public is very confused,” he said. Dr. Coates commented on the conflicting messages about which colorectal cancer screening practices to recommend to the public. “If the U.S. Preventive Services Task Force and the ACS and other groups are coming out with conflicting recommendations, we should focus on where there is agreement, not where there is disagreement,” he said. Openness and flexibility are needed when recommending screening tests to accom- modate the preferences and capacities of different communities, he said. Dr. Seeff agreed that there needs to be test choice tailored to the commu- nity. Dr. Wender noted that his practice changed from recommending all screening modalities to only recommending colonoscopies because “we felt we had a far greater capacity in our community to deliver something that had a longer interval than annually,” he said. But not all people have access to and can afford colonoscopies, Dr. Seeff pointed out. Dr. Levin added, “We are dealing with an imperfect menu, and restricting the choices is unwise at this point. It is likely that colonoscopy will continue

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7 IMPLEMENTING COLORECTAL CANCER SCREENING to dominate, but excluding the others excludes a significant segment of our population, and that seems unwise and unfair.” Dr. Seeff added that the colorectal cancer screening message to the public does need to be simplified. “This battery of tests has been a persis- tent barrier, and the test list, which is continuing to grow, is going to fur- ther complicate things,” she said. Dr. Ferrell agreed that a clear message about colorectal cancer screening is needed. “There’s a clear message in saying you need a mammogram—the public and the professional get it. I’m not sure we have a clear message for colorectal cancer screening, and we have all learned over the last 30 years that without the clear message, everything else is not going to work. So I would want to make that the top priority,” she said. Yet there was discussion of the shortcomings of the breast cancer screening message. Several participants brought up the need for clinical breast exam in addition to mammography. Dr. Ganz said, “Once a certain level of compliance or adherence to a recommendation is reached, you then have to backfill if there are ways to enhance the sensitivity of your strategy.” Participants discussed ways to apply this lesson to colorectal cancer, to make the message more specific and more effective without sacrificing clarity. Dr. Wender noted that because of the concern about an inconsistent message, the National Colorectal Cancer Roundtable hired a firm to come up with a single message, which was to get screened for colorectal cancer. But this message was not effective because it did not give a specific message about what action to take to get the screening, behavioral experts pointed out. There was discussion about whether or not it would be helpful to con- vey that screening can prevent colon cancer. Dr. Lieberman commented that if the message is extended to include the prevention message, there is a potential conflict: a situation where a patient goes to their provider for a test that will prevent colorectal cancer but then are told they are receiv- ing a test to detect early cancer. Mr. Kean added that focus groups have shown that many people do not believe cancer is preventable, but they do believe you can reduce the risk of cancer. “If you talk with them in terms of reducing your risk instead of prevention, they are more likely to listen to exactly the same message,” he said. Dr. Vernon said there is enough evidence that sending patient and provider reminders and reducing non-financial structural barriers to screening can improve screening rates, and pursuing those measures should be a high priority. However, Dr. Fletcher cautioned against try- ing to do too many interventions at once, and urged considering local issues and doing a few interventions well rather than carrying out mul- tiple interventions poorly. He also suggested publishing the details of interventions that do work. “There are a number of us who are talking

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7 WORKSHOP SUMMARY to journal editors and others to try to find ways to allow space to include information on interventions,” he said. Dr. Mercer suggested using the Internet to publish this information. Another suggestion from Dr. Fletcher was for researchers to use consistent metrics so there is enough evidence to recommend various interventions or to convince Congress that these interventions are cost-effective. Costs and Coverage Costs of screening are important to patients, practices, and payers. Insurance coverage facilitates screening, as do state and federal screening programs. Issues of costs and cost-effectiveness of screening in national screening programs, national health plans such as Medicare, and proposed national health care were also discussed. Dr. Levin observed that Dr. Seeff and others have preliminary data that screening in the pre-Medicare age groups would potentially save billions of dollars in the Medicare popula- tion. Dr. Seeff concurred that much of the cost would be deferred or pre- vented because cancer is prevented. Dr. Levin added that there is a huge differential in cost between treatment of early disease and late disease, with the cost of treating advanced colorectal cancer over one year being about $300,000. But Dr. Thorson added, “We all know that the older we get, the more expensive we get—ultimately we are going to have more expense, so from the entire system standpoint, we may not have as much savings as we anticipate up front.” Dr. Vernon added that until there is universal health care, there also should be some system-wide measures to improve screening within HMOs, the Veterans Administration, or other major health care systems. Dr. Coates suggested improving insurance coverage of screening by having insurers fully cover recommended screening services and making such coverage clear in their plans, and by supporting state and federal community-based programs that pay for such screening in the uninsured and low-income populations. Dr. Byers agreed with the suggestion to provide funding for colorectal cancer screening among the underinsured, and added that when funding a CDC program to address that, such fund- ing should be adequate and not done “in a small token way that takes the heat off the problem but doesn’t solve it. We should not repeat the mistake we have made in breast and cervical cancer programs of chroni- cally underfunding the effort.” He also suggested creating a single-payer system for clinical preventive services in the United States by lowering the age eligibility requirement for Medicare’s clinical preventive services package to age 50 because starting it at 65 is too late. “It would be more efficient, and we would have healthier people going into Medicare where the treatment side is picked up,” he said.

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7 IMPLEMENTING COLORECTAL CANCER SCREENING Dr. Lieberman endorsed Dr. Byers’s suggestion for lowering the age eligibility requirement for Medicare recipients. That suggestion might be supported by a cost argument, he pointed out, because so much of cancer care is deferred to the Medicare-aged population. “If we can develop pre- ventive strategies at a younger age, we end up averting those Medicare costs,” he said. Mr. Kean noted some agreement that there should be a national pro- gram to address the uninsured and underinsured, and that this program should be sufficiently funded and evidence based. He mentioned the divergent opinions on whether the program should involve a switch to a national health care system that provides preventive services or more incremental changes that support colorectal cancer screening alone, but added there was agreement that “we need to find some way to provide universal access to screening.” Associated with the issue of universal health care is the need to show that colorectal cancer screening has some cost-effectiveness benefits, Dr. Seeff added. “To make this an acceptable priority, we need to show that there actually is some cost relief,” she said. Dr. Zauber added the need to know not only cost-effectiveness, but also actual costs of the various screening measures, including the costs of complications. Dr. Pignone added that updated models are needed that reflect the current costs of colorectal cancer treatment because there will be cost avoidance as a benefit of screening. Dr. Fletcher added that doing a cost–benefit analysis is difficult in the current context of having multiple payers, including private health insurers up to age 65 and Medicare thereafter, because Medicare and not the private insurer benefits from preventive health measures for younger patients covered by private insurers. “If there were a single payer, then all the screening tests have more or less the same cost- effectiveness from society’s perspective,” he said. Primary Care System In addition to the discussion of a national colorectal cancer screening program and the potential benefits of universal health care, there were discussions of changes to the current primary care system that could help improve colorectal cancer screening. Dr. Coates suggested more financial support and incentives for primary care physicians to conduct preventive health counseling and tracking, or hire ancillary staff to perform those activities in their practices. Dr. Thorson built on that by suggesting the development of a system for preventive care that relies less on higher paid primary care physicians, who are trained to be diagnosticians, and more on less expensive nondiagnosticians. “We are talking about telling people to get a colonoscopy and get their blood pressure and blood sugar

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77 WORKSHOP SUMMARY checked at a defined frequency. Do we need a diagnostician, who is a very expensive person, to do that? I don’t think we do,” he said. Dr. Coates suggested improving, expanding, and making more trans- parent a system for tracking screening performance. Such a system would operate at the patient/physician level with screening reminders, at the practice level in the form of feedback of screening rates, and at the popu- lation level to ascertain demographic characteristics and disparities in screening. This tracking could help to identify individuals to act as cham- pions to increase screening in practices that are at low levels of screening, lead to a culture of improvement, and help to provide incentives for prac- tices with insufficient screening rates that might be motivated to undergo more education and training, Dr. Coates said. Dr. Vernon agreed with Dr. Coates that more integrated systems are needed that allow surveillance of screening and identify those who need screening. Regarding the use of patient and provider reminders, Dr. Wender pointed out that practices with EMRs that provide regular reminders quickly learn to ignore all those reminders because there are too many of them to monitor, and not enough time to address all of them. Dr. Pignone concurred and said, “There is not just one way to do reminder systems: there are good ways and bad ways.” Reducing the number of reminders by prioritizing may be helpful, he said. Dr. Lieberman advocated for increasing colorectal cancer screening rates by fostering better connections between primary care physicians and gastrointestinal specialists, including more communications and elec- tronic interoperability between the two groups, and improved patient access and navigation so that a primary care physician’s recommendation for screening is more likely to be carried out. “These are quite doable, and there are some models for doing them,” he said. He also advocated that colonoscopists provide good reports with clear recommendations for how to proceed in the future with surveillance. Dr. Pignone added that gastro- enterologists should have a registry for those patients on whom they have done a colonoscopy and be responsible for surveillance reminders, even if those reminders are also being given out by the primary care physician. “If there was dual responsibility there wouldn’t be a problem. Both belt and suspenders would probably work pretty well there,” he said. Dr. Wender stressed the importance of developing high-quality colonoscopy- based screening strategies, which would include patient navigation, ade- quate bowel preparation, and quality colonoscopy procedures, reports, and tracking. Mr. Kean cited the numerous suggestions for supporting primary care, “attempting to shore up the system,” as well as connecting the gas- trointestinal community with primary care providers in a more integrated fashion that results in good navigation, good communications, and high-

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7 IMPLEMENTING COLORECTAL CANCER SCREENING quality reporting. He also reiterated the suggestion that the components of a good system be delineated, beginning with primary care, moving through specialty care and subsequent follow-up. He ended his summary by noting the concern of many for more standardized information about interventions reported in a consistent manner, and more cost data col- lected and considered in cost-effectiveness analyses. Final Words Many workshop presenters and participants believe the implementa- tion of colorectal cancer screening faces several challenges that need to be addressed: awareness of the need for screening, the messages received by patients and providers, costs and coverage of screening, and facilitation of screening within the primary care system. Likewise, many workshop presenters and participants believe that increased screening will save lives through prevention of colorectal cancer, and it will decrease treatment costs and intensity through earlier diagnosis of cancers that do occur. There is reason to move quickly to determine the best paths forward: Dr. Seeff commented that although the general perception has been that systems to encourage and implement colorectal cancer screening were not yet well defined, in reality the field is evolving rapidly. “I think that may have been the case, but I think we are moving fast and furious. There are something like 15-plus states that are now moving toward organizing screening. So I think that makes it all the more important that we help keep the agenda moving forward,” she said.