Cervical Cancer: Opportunities and challenges for decreasing incidence and mortality

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Cervical Cancer: Opportunities and challenges for decreasing incidence and mortality

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1. Cervical Cancer: Opportunities and challenges for decreasing incidence and mortality developed by Herschel W. Lawson, MD Medical Advisor, Program Services Branch Division of Cancer Prevention and Control Final Version 10.1 (10/29/01) Introduce yourself. Welcome participants/audience members and thank them for taking the time to attend this slide presentation.Introduce yourself. Welcome participants/audience members and thank them for taking the time to attend this slide presentation.

2. Goals: Provide an overview of CDC’s policy for cervical cancer screening within the NBCCEDP Review the evidence supporting the policy Discuss what you and CDC can do to implement the policy The goals of this presentation are to— Provide an overview of CDC’s policy for cervical cancer screening for the NBCCEDP; Review the evidence supporting the policy; and Discuss what you and CDC can do to implement the policy. The goals of this presentation are to— Provide an overview of CDC’s policy for cervical cancer screening for the NBCCEDP; Review the evidence supporting the policy; and Discuss what you and CDC can do to implement the policy.

3. Incidence and mortality for cervical cancer, United States, 1973–1997 (SEER) This graph shows incidence and mortality patterns of cervical cancer since 1973, when the SEER cancer registry began. In the late 1940s and 1950s there was a noticeable decrease in mortality from cervical cancer even before the Pap test was widely available, but the Pap test has contributed largely to the decrease noted in the incidence of disease. However, since the 1980s, the rate of decline has slowed, and has become essentially flat line. Although cervical cancer rates have fallen a great deal, the incidence rate currently remains 8.3 per 100,000 women in the United States. Source: Ries, A.G.; Eisner, M.P.; Kosary, C.L.; Hankey, B.F.; Miller, B.A.; Clegg, L.; Edwards, B.K. (eds.). SEER cancer statistics review, 1973–1997. Bethesda, MD: National Cancer Institute; 2000. This graph shows incidence and mortality patterns of cervical cancer since 1973, when the SEER cancer registry began. In the late 1940s and 1950s there was a noticeable decrease in mortality from cervical cancer even before the Pap test was widely available, but the Pap test has contributed largely to the decrease noted in the incidence of disease. However, since the 1980s, the rate of decline has slowed, and has become essentially flat line. Although cervical cancer rates have fallen a great deal, the incidence rate currently remains 8.3 per 100,000 women in the United States. Source: Ries, A.G.; Eisner, M.P.; Kosary, C.L.; Hankey, B.F.; Miller, B.A.; Clegg, L.; Edwards, B.K. (eds.). SEER cancer statistics review, 1973–1997. Bethesda, MD: National Cancer Institute; 2000.

4. Incidence and mortality for cervical cancer, United States, 2000 (ACS) As can be seen in the graph, compared with breast cancer, new cases of and deaths from cervical cancer in the U.S. population are relatively low. However, there are important differences between cervical cancer and other cancers. The Pap test, in contrast to mammography, detects cervical changes before they become cancerous to a high degree, when they are still highly curable. Cervical cancer, unlike many other kinds of cancer, including breast cancer, can in most instances be prevented. Treating high-grade preinvasive cervical lesions appropriately will lead to fewer new cases and deaths from cervical cancer. Source: American Cancer Society (ACS). Cancer facts and figures—2000. Atlanta, GA: ACS; 2000.As can be seen in the graph, compared with breast cancer, new cases of and deaths from cervical cancer in the U.S. population are relatively low. However, there are important differences between cervical cancer and other cancers. The Pap test, in contrast to mammography, detects cervical changes before they become cancerous to a high degree, when they are still highly curable. Cervical cancer, unlike many other kinds of cancer, including breast cancer, can in most instances be prevented. Treating high-grade preinvasive cervical lesions appropriately will lead to fewer new cases and deaths from cervical cancer. Source: American Cancer Society (ACS). Cancer facts and figures—2000. Atlanta, GA: ACS; 2000.

5. The Public Health Approach The public health approach focuses on entire populations rather than individual clients/patients. The public health approach focuses primarily on the health needs of populations, whereas medicine, focuses on individual health needs. Public health interventions address the question, “What approach will have the maximum benefit for the largest population?” Source: Association of Schools of Public Health (ASPH). http:www.asph.org/aa_section.cfm/3/87. [Accessed June 29, 2001]The public health approach focuses primarily on the health needs of populations, whereas medicine, focuses on individual health needs. Public health interventions address the question, “What approach will have the maximum benefit for the largest population?” Source: Association of Schools of Public Health (ASPH). http:www.asph.org/aa_section.cfm/3/87. [Accessed June 29, 2001]

6. Healthy People 2010 Objective 3.4: reduce the death rate from cancer of the uterine cervix Baseline: 3.0 deaths per 100,000 females in 1998 Target: 2.0 deaths per 100,000 females in 2010 Healthy People 2010, using the public health approach as its foundation, has specific health objectives for priority populations most at risk. Reducing mortality from cervical cancer is one of its objectives: Objective 3.4 is to reduce the mortality rate from cervical cancer from the 1998 baseline of 3.0 per 100,000 to 2.0 per 100,000 in 2010. Healthy People 2010 has also recognized the value of cervical cancer screening, “…almost all cervical cancer deaths could be avoided” with routine screening and rescreening. Source: U.S. Department of Health and Human Services. Healthy people 2010: understanding and improving health, 2nd ed. Washington, DC: U.S. Government Printing Office; 2000.Healthy People 2010, using the public health approach as its foundation, has specific health objectives for priority populations most at risk. Reducing mortality from cervical cancer is one of its objectives: Objective 3.4 is to reduce the mortality rate from cervical cancer from the 1998 baseline of 3.0 per 100,000 to 2.0 per 100,000 in 2010. Healthy People 2010 has also recognized the value of cervical cancer screening, “…almost all cervical cancer deaths could be avoided” with routine screening and rescreening. Source: U.S. Department of Health and Human Services. Healthy people 2010: understanding and improving health, 2nd ed. Washington, DC: U.S. Government Printing Office; 2000.

7. CDC’s Principles for Cancer Prevention and Control Based on science Focus on translating gains from research into public health benefits as quickly as possible to as many people as possible Provide long-term support for cancer control initiatives CDC’s principles for cancer prevention and control are: Based on science Focus on translating gains from research into public health benefits—as quickly as possible…to as many people as possible Provide long-term support for cancer control initiatives. CDC’s principles for cancer prevention and control are: Based on science Focus on translating gains from research into public health benefits—as quickly as possible…to as many people as possible Provide long-term support for cancer control initiatives.

8. DCPC Guiding Principle for Cancer Prevention and Control DCPC's efforts are guided by the conviction that our work should be grounded in science and regularly evaluated For the Division of Cancer Prevention and Control, our guiding principle is that our efforts will be guided by the conviction that our work should be grounded in science and regularly evaluated.For the Division of Cancer Prevention and Control, our guiding principle is that our efforts will be guided by the conviction that our work should be grounded in science and regularly evaluated.

9. Cervical Cancer Policy Increase screening of never- and rarely-screened NBCCEDP-eligible women Decrease overscreening of women in the NBCCEDP Provide appropriate follow up for abnormal Pap test results In keeping with CDC’s cancer prevention and control principles and using the public health approach, a new cervical cancer screening policy was developed. The policy has two major goals: To reach the women at greatest risk for cervical cancer—increase screening of those who are rarely or never screened To decrease overscreening of women in the NBCCEDP ? In addition, the policy reiterates existing CDC guidelines for the appropriate followup of abnormal Pap test results. In keeping with CDC’s cancer prevention and control principles and using the public health approach, a new cervical cancer screening policy was developed. The policy has two major goals: To reach the women at greatest risk for cervical cancer—increase screening of those who are rarely or never screened To decrease overscreening of women in the NBCCEDP ? In addition, the policy reiterates existing CDC guidelines for the appropriate followup of abnormal Pap test results.

10. Cervical Cancer Policy: Other Issues Reducing Pap tests after hysterectomy Using new technologies Liquid-based Pap tests HPV testing In addition, the policy addresses— Pap tests after hysterectomy; and The use of new technologies, including liquid-based Pap testing methods and HPV testing. Let’s first cover information about the development of the policy. Then, let’s discuss each element of the policy with an emphasis on the populations to be screened and then on the use of new technologies.In addition, the policy addresses— Pap tests after hysterectomy; and The use of new technologies, including liquid-based Pap testing methods and HPV testing. Let’s first cover information about the development of the policy. Then, let’s discuss each element of the policy with an emphasis on the populations to be screened and then on the use of new technologies.

11. Development of the Policy Current science reviewed Existing cervical cancer screening policies/ guidelines reviewed NBCCEDP Pap screening outcomes reviewed External workgroup convened Input from NBCCEDP program directors considered Fiscal year 2001 congressional appropriations as in prior years allows the NBCCEDP to reach about 12 to 15 percent of NBCCEDP-eligible women nationally. Therefore, this policy was developed so that NBCCEDP resources would be targeted where they could have the greatest impact. To develop this policy, CDC used a thorough process to determine the best use of resources. The process included— In-depth review of the scientific literature; Review of professional organization guidelines related to cervical cancer; Review of NBCCEDP Pap test screening data and outcomes; External workgroup of cervical cancer screening experts*; and Input from NBCCEDP program directors. On the basis of these multiple sources of information, CDC issued a cervical cancer screening policy in 1999, which will be fully implemented by October 2001. Let’s now discuss the elements of the policy. This workgroup included clinical experts, epidemiologists, NBCCEDP program directors, researchers, and public health practitioners. Organizations represented at discussions of the workgroup included American Social Health Association; American Cancer Society; Arctic Slope Native Association Limited; Association of State and Territorial Chronic Disease Program Directors; Blues Technology Evaluation Center; Duke University; Emory University School of Medicine; National Cancer Institute; Native American Cancer Initiatives; and University of New Mexico. Fiscal year 2001 congressional appropriations as in prior years allows the NBCCEDP to reach about 12 to 15 percent of NBCCEDP-eligible women nationally. Therefore, this policy was developed so that NBCCEDP resources would be targeted where they could have the greatest impact. To develop this policy, CDC used a thorough process to determine the best use of resources. The process included— In-depth review of the scientific literature; Review of professional organization guidelines related to cervical cancer; Review of NBCCEDP Pap test screening data and outcomes; External workgroup of cervical cancer screening experts*; and Input from NBCCEDP program directors. On the basis of these multiple sources of information, CDC issued a cervical cancer screening policy in 1999, which will be fully implemented by October 2001. Let’s now discuss the elements of the policy. This workgroup included clinical experts, epidemiologists, NBCCEDP program directors, researchers, and public health practitioners. Organizations represented at discussions of the workgroup included American Social Health Association; American Cancer Society; Arctic Slope Native Association Limited; Association of State and Territorial Chronic Disease Program Directors; Blues Technology Evaluation Center; Duke University; Emory University School of Medicine; National Cancer Institute; Native American Cancer Initiatives; and University of New Mexico.

12. Policy Focus Reaching never- and rarely- screened women. The first major focus of the policy is reaching never- and rarely screened women to a higher degree. On this point, the policy states, “NBCCEDP resources need to be redirected toward identifying and screening never- and rarely screened women.” Women are considered “never screened” if they have never had a Pap test. Women are considered “rarely screened” if they have not had a Pap test in the last 5 years. CDC’s goal is that at least 20 percent of women screened for cervical cancer in the Breast and Cervical Cancer Early Detection Programs (BCCEDPs) have been never or rarely screened. CDC would like this portion of the policy to be the major emphasis for BCCEDPs. In other words, when implementing the policy, this is where CDC would like you to focus your efforts.The first major focus of the policy is reaching never- and rarely screened women to a higher degree. On this point, the policy states, “NBCCEDP resources need to be redirected toward identifying and screening never- and rarely screened women.” Women are considered “never screened” if they have never had a Pap test. Women are considered “rarely screened” if they have not had a Pap test in the last 5 years. CDC’s goal is that at least 20 percent of women screened for cervical cancer in the Breast and Cervical Cancer Early Detection Programs (BCCEDPs) have been never or rarely screened. CDC would like this portion of the policy to be the major emphasis for BCCEDPs. In other words, when implementing the policy, this is where CDC would like you to focus your efforts.

13. Unequal Burden of Disease Why do we want to identify and bring in never- and rarely screened women for cervical cancer screening? Even though never- and rarely screened women make up a small proportion of the overall population (10 to 15 percent), they have the greater burden of disease (60 percent).1 SEER data indicate that about half of women with newly diagnosed invasive cervical cancer have not had a Pap test within the past 5 years.2 Screening the same women repeatedly is not likely to highly impact the mortality rate from cervical cancer. However, increasing screening of those at greatest risk (i.e., never- and rarely screened women) should be effective in decreasing incidence and mortality from cervical cancer. Given these data, which clearly show that unscreened women have a disproportionate burden of cervical cancer, it makes public health sense to concentrate NBCCEDP’s resources where they can have the most impact. 1Shingleton, H.M.; Patrick, R.L.; Johnston, W.W.; Smith, R.A. The current status of the Papanicolaou smear. CA Cancer J. Clin. 45: 305–20; 1995. 2 Ries, A.G.; Eisner, M.P.; Kosary, C.L.; Hankey, B.F.; Miller, B.A.; Clegg, L.; Edwards, B.K. (eds.). SEER cancer statistics review, 1973–1997. Bethesda, MD: National Cancer Institute; 2000.Why do we want to identify and bring in never- and rarely screened women for cervical cancer screening? Even though never- and rarely screened women make up a small proportion of the overall population (10 to 15 percent), they have the greater burden of disease (60 percent).1 SEER data indicate that about half of women with newly diagnosed invasive cervical cancer have not had a Pap test within the past 5 years.2 Screening the same women repeatedly is not likely to highly impact the mortality rate from cervical cancer. However, increasing screening of those at greatest risk (i.e., never- and rarely screened women) should be effective in decreasing incidence and mortality from cervical cancer. Given these data, which clearly show that unscreened women have a disproportionate burden of cervical cancer, it makes public health sense to concentrate NBCCEDP’s resources where they can have the most impact. 1Shingleton, H.M.; Patrick, R.L.; Johnston, W.W.; Smith, R.A. The current status of the Papanicolaou smear. CA Cancer J. Clin. 45: 305–20; 1995. 2 Ries, A.G.; Eisner, M.P.; Kosary, C.L.; Hankey, B.F.; Miller, B.A.; Clegg, L.; Edwards, B.K. (eds.). SEER cancer statistics review, 1973–1997. Bethesda, MD: National Cancer Institute; 2000.

14. Unequal Burden of Disease

15. Reasons Women Aren’t Screened Access Provider knowledge/behavior Patient knowledge/behavior Research shows that, in general, women are less likely to be screened if— They lack access; that is, they lack insurance, do not have a regular provider, or do not participate in the health care system; A physician does not recommend screening; or They do not know about a particular screening test, its purpose, and the appropriate screening intervals. Sources: Centers for Disease Control and Prevention. An overview of population characteristics and strategies for reaching the hard to reach for cervical cancer screening. CDC Cervical Cancer Public Education and Outreach Workshop, Atlanta, GA; October 2000; and Centers for Disease Control and Prevention. Breast and cervical cancer messages for community health worker programs: a training packet, part 2. Atlanta, GA: CDC; 1998.Research shows that, in general, women are less likely to be screened if— They lack access; that is, they lack insurance, do not have a regular provider, or do not participate in the health care system; A physician does not recommend screening; or They do not know about a particular screening test, its purpose, and the appropriate screening intervals. Sources: Centers for Disease Control and Prevention. An overview of population characteristics and strategies for reaching the hard to reach for cervical cancer screening. CDC Cervical Cancer Public Education and Outreach Workshop, Atlanta, GA; October 2000; and Centers for Disease Control and Prevention. Breast and cervical cancer messages for community health worker programs: a training packet, part 2. Atlanta, GA: CDC; 1998.

16. Characteristics of women never or rarely screened for cervical cancer Older Low SES and/or lack of insurance or ability to pay for screening Less educated Racial or ethnic minority or new immigrant No regular health care provider Live in culturally-isolated urban neighborhoods or hard-to-reach rural areas We know that women at greatest risk for cervical cancer are those who are never or rarely screened. These women are likely to— Be older (i.e., past the normal reproductive years); Have a low income, not have health insurance or be underinsured, and/or be unable to pay for screening. Studies have shown that low socioeconomic status (SES) is correlated with a lower likelihood that a woman will be screened for cervical cancer; Be less educated and not fully aware of the risk factors for cervical cancer or the importance of screening to prevent cervical cancer; Be a member of a racial or ethnic minority or newly arrived immigrant. Hence, she may have beliefs or attitudes that discourage screening; Lack a regular health care provider and not participate in the mainstream health care system; or Live in culturally-isolated urban neighborhoods or isolated, hard-to-reach rural areas. Given these characteristics, our program has potential to impact this disease. However, after reviewing 10 years of data we have not seen the results we expected. Sources: Centers for Disease Control and Prevention. An overview of population characteristics and strategies for reaching the hard to reach for cervical cancer screening. CDC Cervical Cancer Public Education and Outreach Workshop, Atlanta, GA; October 2000; and Centers for Disease Control and Prevention. Breast and cervical cancer messages for community health worker programs: a training packet, part 2. Atlanta, GA: CDC; 1998. We know that women at greatest risk for cervical cancer are those who are never or rarely screened. These women are likely to— Be older (i.e., past the normal reproductive years); Have a low income, not have health insurance or be underinsured, and/or be unable to pay for screening. Studies have shown that low socioeconomic status (SES) is correlated with a lower likelihood that a woman will be screened for cervical cancer; Be less educated and not fully aware of the risk factors for cervical cancer or the importance of screening to prevent cervical cancer; Be a member of a racial or ethnic minority or newly arrived immigrant. Hence, she may have beliefs or attitudes that discourage screening; Lack a regular health care provider and not participate in the mainstream health care system; or Live in culturally-isolated urban neighborhoods or isolated, hard-to-reach rural areas. Given these characteristics, our program has potential to impact this disease. However, after reviewing 10 years of data we have not seen the results we expected. Sources: Centers for Disease Control and Prevention. An overview of population characteristics and strategies for reaching the hard to reach for cervical cancer screening. CDC Cervical Cancer Public Education and Outreach Workshop, Atlanta, GA; October 2000; and Centers for Disease Control and Prevention. Breast and cervical cancer messages for community health worker programs: a training packet, part 2. Atlanta, GA: CDC; 1998.

17. CDC Policy: Reducing over screening in the NBCCEDP After a woman has had three, consecutive, normal Pap tests within a 5-year (60-month) period documented in the program’s MDEs, the Pap test shall be performed every 3 years. The second major emphasis of the policy is on reducing overscreening. On this point, the policy states, “After a woman has had three, consecutive, normal Pap tests within a 5-year (60-month) period documented in the program’s MDEs, the Pap test shall be performed every 3 years.” CDC has set as its goal for BCCEDPs that at least 75 percent of NBCCEDP-enrolled women with three normal consecutive Pap tests within a 5-year (60-month) period should transition to a Pap test every 3 years.The second major emphasis of the policy is on reducing overscreening. On this point, the policy states, “After a woman has had three, consecutive, normal Pap tests within a 5-year (60-month) period documented in the program’s MDEs, the Pap test shall be performed every 3 years.” CDC has set as its goal for BCCEDPs that at least 75 percent of NBCCEDP-enrolled women with three normal consecutive Pap tests within a 5-year (60-month) period should transition to a Pap test every 3 years.

18. Evidence for need to reduce over-screening Natural history of cervical cancer The effectiveness of the Pap test as a screening tool Data analysis Policies/guidelines from other professional organizations Why do we want to reduce overscreening within the NBCCEDP? The evidence for this portion of the policy is drawn from several sources. They are: What we know about the natural history of cervical cancer What we know about the effectiveness of the Pap test as a screening tool Data analysis of screening outcomes from a study conducted with NBCCEDP enrollees Policies and guidelines from other professional organizations Let’s now talk about each of these sources of information and how they contributed to the policy. Why do we want to reduce overscreening within the NBCCEDP? The evidence for this portion of the policy is drawn from several sources. They are: What we know about the natural history of cervical cancer What we know about the effectiveness of the Pap test as a screening tool Data analysis of screening outcomes from a study conducted with NBCCEDP enrollees Policies and guidelines from other professional organizations Let’s now talk about each of these sources of information and how they contributed to the policy.

19. Natural history of cervical cancer In the majority of cervical cancers, the disease develops through a series of gradual, well-defined, precancerous lesions, usually beginning with human papillomavirus (HPV) infection and progressing through several stages over a long period of time. Precancerous lesions can persist, regress, or progress to an invasive malignancy. During this lengthy, steady progression, abnormal tissue can be detected by the Pap test and removed. On the left side of this continuum, we have infection with HPV. Although HPV appears to be necessary for the development of cervical cancer, not all HPV infections develop into cancer. It is not unusual for HPV to cause low-grade dysplasia within months of an infection. Low-grade cervical dysplasia is usually temporary and disappears over time. At least 70 percent of low-grade dysplasia regresses spontaneously or does not progress.1 Some cases, however, progress to high-grade dysplasia. High-grade cervical dysplasia, a precursor to cervical cancer, is much less common than low-grade cervical dysplasia. The development from high-grade dysplasia to invasive cancer usually occurs slowly, over a period of several years. Progression to detectable, precancerous lesions can take as long as 10 years or more. 1The ALTS Group. Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. J Natl Cancer Inst 92: 397–402; 2000. Overall source for graphic: Program for Applied Technology in Health (PATH). Natural history of cervical cancer: even infrequent screening of older women saves lives. Seattle, WA: PATH; 2001. In the majority of cervical cancers, the disease develops through a series of gradual, well-defined, precancerous lesions, usually beginning with human papillomavirus (HPV) infection and progressing through several stages over a long period of time. Precancerous lesions can persist, regress, or progress to an invasive malignancy. During this lengthy, steady progression, abnormal tissue can be detected by the Pap test and removed. On the left side of this continuum, we have infection with HPV. Although HPV appears to be necessary for the development of cervical cancer, not all HPV infections develop into cancer. It is not unusual for HPV to cause low-grade dysplasia within months of an infection. Low-grade cervical dysplasia is usually temporary and disappears over time. At least 70 percent of low-grade dysplasia regresses spontaneously or does not progress.1 Some cases, however, progress to high-grade dysplasia. High-grade cervical dysplasia, a precursor to cervical cancer, is much less common than low-grade cervical dysplasia. The development from high-grade dysplasia to invasive cancer usually occurs slowly, over a period of several years. Progression to detectable, precancerous lesions can take as long as 10 years or more. 1The ALTS Group. Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. J Natl Cancer Inst 92: 397–402; 2000. Overall source for graphic: Program for Applied Technology in Health (PATH). Natural history of cervical cancer: even infrequent screening of older women saves lives. Seattle, WA: PATH; 2001.

20. Screening Characteristics As noted earlier, during the lengthy progression to cervical cancer, abnormal tissue can be detected by the Pap test and removed. The ability to accurately detect cervical changes is dependent on how the Pap test performs as a screening tool. Ideally, a screening tool should have high sensitivity and specificity— “Do the results indicate the actual absence or presence of disease?” By “sensitivity,” we mean the probability of testing positive if the disease is truly present. As can be seen in the 2 by 2 table, “sensitivity” is equal to cell A—those people who have the disease and test positive, compared to all people who actually have the disease (cell A plus C). By “specificity,” we mean the probability of testing negative if the disease is truly absent. In this case, those people who do not test positive, nor actually have the disease (cell D), compared to all people who do not have the disease (cell B plus D). The test may be positive, even though the disease is not present in the person. This is called a “false-positive” result, and may cause unnecessary distress to patients, as well as additional costs in follow up diagnostic procedures. In addition, “false-negative” results—a situation where the test does not accurately reflect the presence of the disease. This may create an artificial sense of security and delay clinical diagnosis and treatment of the disease. Source: Morgan, J.W. Concise epidemiology: A practical text, 3rd ed. Bryn Mawr, CA.: MDM Consulting; 1994. As noted earlier, during the lengthy progression to cervical cancer, abnormal tissue can be detected by the Pap test and removed. The ability to accurately detect cervical changes is dependent on how the Pap test performs as a screening tool. Ideally, a screening tool should have high sensitivity and specificity— “Do the results indicate the actual absence or presence of disease?” By “sensitivity,” we mean the probability of testing positive if the disease is truly present. As can be seen in the 2 by 2 table, “sensitivity” is equal to cell A—those people who have the disease and test positive, compared to all people who actually have the disease (cell A plus C). By “specificity,” we mean the probability of testing negative if the disease is truly absent. In this case, those people who do not test positive, nor actually have the disease (cell D), compared to all people who do not have the disease (cell B plus D). The test may be positive, even though the disease is not present in the person. This is called a “false-positive” result, and may cause unnecessary distress to patients, as well as additional costs in follow up diagnostic procedures. In addition, “false-negative” results—a situation where the test does not accurately reflect the presence of the disease. This may create an artificial sense of security and delay clinical diagnosis and treatment of the disease. Source: Morgan, J.W. Concise epidemiology: A practical text, 3rd ed. Bryn Mawr, CA.: MDM Consulting; 1994.

21. Pap Test as a Screening Tool Sensitivity Moderate: 51–88% Specificity High: 95–98% The Pap test is considered moderately sensitive—51 to 88 percent.1 The wide range of reported sensitivity is due to differences in screening technique, such as sampling of cells, slide preparation, laboratory technique, and the way in which investigators define sensitivity.2 The Pap test is considered to be a very specific test for high-grade dysplasia—95 to 98 percent.1 Given the sensitivity and specificity of the Pap test, “...the major barrier to prevention of cervical cancer is not the accuracy of the Pap test, but the failure to be screened at all.”3 1Myers, E.R.; McCrory, D.C.; Subramanian, S.; McCall, N.; Nanda, K.; Datta, S.O.; Matchar, D.B. Setting the target for a better cervical screening test: characteristics of a cost-effective test for cervical neoplasia screening. Obstet Gynecol 96: 645–652; 2000. 2Eddy, D.M. Screening for cervical cancer. Ann Intern Med 113: 214–226; 1990. 3Brown, A.D.; Garber, A.M. Cost-effectiveness of three methods of enhancing the sensitivity of Papanicolau testing. JAMA 281: 347–353; 1999. The Pap test is considered moderately sensitive—51 to 88 percent.1 The wide range of reported sensitivity is due to differences in screening technique, such as sampling of cells, slide preparation, laboratory technique, and the way in which investigators define sensitivity.2 The Pap test is considered to be a very specific test for high-grade dysplasia—95 to 98 percent.1 Given the sensitivity and specificity of the Pap test, “...the major barrier to prevention of cervical cancer is not the accuracy of the Pap test, but the failure to be screened at all.”3 1Myers, E.R.; McCrory, D.C.; Subramanian, S.; McCall, N.; Nanda, K.; Datta, S.O.; Matchar, D.B. Setting the target for a better cervical screening test: characteristics of a cost-effective test for cervical neoplasia screening. Obstet Gynecol 96: 645–652; 2000. 2Eddy, D.M. Screening for cervical cancer. Ann Intern Med 113: 214–226; 1990. 3Brown, A.D.; Garber, A.M. Cost-effectiveness of three methods of enhancing the sensitivity of Papanicolau testing. JAMA 281: 347–353; 1999.

22. NBCCEDP Study Goal Design Study participants To help determine guidelines for effective screening, CDC researchers conducted a study to examine screening outcomes for women enrolled in the NBCCEDP. The goal of the study was to determine the incidence of cervical abnormalities following a Pap test preceded by a normal Pap test, by age and time from last normal test. The study was a prospective cohort study. The study included 128,805 women screened for cervical cancer within 3 years of a normal result from 1991 to 1998. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.To help determine guidelines for effective screening, CDC researchers conducted a study to examine screening outcomes for women enrolled in the NBCCEDP. The goal of the study was to determine the incidence of cervical abnormalities following a Pap test preceded by a normal Pap test, by age and time from last normal test. The study was a prospective cohort study. The study included 128,805 women screened for cervical cancer within 3 years of a normal result from 1991 to 1998. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

23. NBCCEDP Study (continued) Variables Outcomes The main variables for the study were— - Age at first Pap test; and - Time between negative and subsequent Pap tests. The main outcomes studied were Pap test cytological abnormalities: - Inflammation - Abnormal Squamous Cells (ASC) - Low-grade Squamous Intraepithelial Lesion (LSIL) - High-grade Squamous Intraepithelial Lesion (HSIL) - Squamous Cell Cancer Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000. The main variables for the study were— - Age at first Pap test; and - Time between negative and subsequent Pap tests. The main outcomes studied were Pap test cytological abnormalities: - Inflammation - Abnormal Squamous Cells (ASC) - Low-grade Squamous Intraepithelial Lesion (LSIL) - High-grade Squamous Intraepithelial Lesion (HSIL) - Squamous Cell Cancer Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

24. Overall NBCCEDP Rescreening Results Results of a 2nd Pap test following a normal Pap test— Benign Abnormal ASC LSIL HSIL Suggestive of squamous cell cancer The NBCCEDP study showed that once a woman has had a normal Pap test result, it is uncommon for her to have a high-grade abnormality on a subsequent test: Including tests with ASC results: only 4.6 percent of women had abnormal results only 0.2 percent were HSIL or worse Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000. The NBCCEDP study showed that once a woman has had a normal Pap test result, it is uncommon for her to have a high-grade abnormality on a subsequent test: Including tests with ASC results: only 4.6 percent of women had abnormal results only 0.2 percent were HSIL or worse Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

25. NBCCEDP Rescreening Results by Time Interval This graph shows screening results by time interval—that is, the time between the first and subsequent test. As you can see, the rate of abnormalities were similar for all time intervals. Including the small rise in the rate of HSIL over time, no increases were statistically significant. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.This graph shows screening results by time interval—that is, the time between the first and subsequent test. As you can see, the rate of abnormalities were similar for all time intervals. Including the small rise in the rate of HSIL over time, no increases were statistically significant. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

26. NBCCEDP Rescreening Results by Age This graph shows screening results by age group. As you can see, the incidence of all abnormalities decreases with age and only a small proportion are high-grade. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.This graph shows screening results by age group. As you can see, the incidence of all abnormalities decreases with age and only a small proportion are high-grade. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

27. NBCCEDP Study Conclusions Pap test abnormalities are uncommon False positive testing may increase morbidity from unnecessary diagnostic evaluations without decreasing mortality. This study yielded valuable information about Pap testing in the NBCCEDP and provided guidance for developing the screening frequency guidelines for the policy: Pap test abnormalities are uncommon in the 3 years following a normal smear, especially in women 50+. Based on these findings we could conclude that thefalse positive testing may increase morbidity from unnecessary diagnostic evaluations without decreasing cervical cancer morbidity or mortality. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.This study yielded valuable information about Pap testing in the NBCCEDP and provided guidance for developing the screening frequency guidelines for the policy: Pap test abnormalities are uncommon in the 3 years following a normal smear, especially in women 50+. Based on these findings we could conclude that thefalse positive testing may increase morbidity from unnecessary diagnostic evaluations without decreasing cervical cancer morbidity or mortality. Source: Sawaya, G.F.; Kerlikowske, K.; Lee, N.; Gildenhorn, G.; Washington, A.E. Frequency of cervical smear abnormalities within three years of normal cytology. Obstet Gynecol 96: 219–223; 2000.

28. Existing Screening Guidelines WHO (1992): Annual Pap tests are often unnecessary—“it is clear that it is more cost-effective to recruit a high proportion of the population and screen them infrequently, than to recruit a low proportion and screen them often.” As noted earlier, CDC looked to other national and international professional organizations for guidance in revising the policy, especially in the area of screening frequency recommendations. In a 1992 cervical cancer screening document, the World Health Organization (WHO) suggested that annual Pap tests are often unnecessary. The WHO noted that screening resources are often used on a small proportion of the population with minimal public health benefit. The WHO states, ... “it is clear that it is more cost-effective to recruit a high proportion of the population and screen them infrequently, than recruit a low proportion and screen them often.” Source: Miller, A.B. Cervical cancer screening programmes: managerial guidelines. Geneva: World Health Organization; 1992. As noted earlier, CDC looked to other national and international professional organizations for guidance in revising the policy, especially in the area of screening frequency recommendations. In a 1992 cervical cancer screening document, the World Health Organization (WHO) suggested that annual Pap tests are often unnecessary. The WHO noted that screening resources are often used on a small proportion of the population with minimal public health benefit. The WHO states, ... “it is clear that it is more cost-effective to recruit a high proportion of the population and screen them infrequently, than recruit a low proportion and screen them often.” Source: Miller, A.B. Cervical cancer screening programmes: managerial guidelines. Geneva: World Health Organization; 1992.

29. Existing Screening Guidelines (continued) USPSTF (1996): “There is little evidence that women who receive annual screening are at significantly lower risk for invasive cervical cancer than are women who are tested every 3–5 years.” In 1996, the U.S. Preventive Services Task Force (USPSTF) concluded, “There is little evidence that women who receive annual screening are at significantly lower risk for invasive cervical cancer than are women who are tested every 3–5 years.” Source: U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. 105–117; 1996. In 1996, the U.S. Preventive Services Task Force (USPSTF) concluded, “There is little evidence that women who receive annual screening are at significantly lower risk for invasive cervical cancer than are women who are tested every 3–5 years.” Source: U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. 105–117; 1996.

30. Existing Screening Guidelines (continued) ACPM (1996): “Estimates from mathematical models indicate that regular triennial screening would achieve 91-96% of the benefit of annual screening, while greatly reducing the cost, potential harms, and inconvenience.”

31. Existing Screening Guidelines (continued) ACOG (2000): “After a woman has had three or more consecutive, satisfactory, annual cytological examinations with normal findings, the Pap test may be performed less frequently on a low-risk woman at the discretion of her physician.” ACS (2001): “After three or more consecutive annual exams with normal findings, the Pap test may be performed less frequently at the discretion of the physician.”

32. CDC Policy: Pap Tests After Hysterectomy NBCCEDP funds not to be used to pay for cervical cancer screening in women after a hysterectomy unless the hysterectomy was for cervical neoplasia. Funds available once to determine presence or absence of cervix in otherwise eligible women Another policy statement related to overscreening covers Pap tests for women post hysterectomy. Here, the policy states that NBCCEDP funds are not to be used to pay for cervical cancer screening in women post hysterectomy unless the hysterectomy was performed for cervical neoplasia. However, funds can be used to pay for an initial pelvic exam to determine if the woman has a cervix. A woman who has had a supracervical hysterectomy—and therefore still has an intact cervix—may receive a Pap test with NBCCEDP funds according to policies stated earlier. Another policy statement related to overscreening covers Pap tests for women post hysterectomy. Here, the policy states that NBCCEDP funds are not to be used to pay for cervical cancer screening in women post hysterectomy unless the hysterectomy was performed for cervical neoplasia. However, funds can be used to pay for an initial pelvic exam to determine if the woman has a cervix. A woman who has had a supracervical hysterectomy—and therefore still has an intact cervix—may receive a Pap test with NBCCEDP funds according to policies stated earlier.

33. Pap Tests After Hysterectomy (continued) USPSTF (1996): “Women who have undergone hysterectomy in which the cervix was removed do not require Pap testing, unless it was performed because of cervical cancer or its precursors.” Based on a 1996 meta-analysis of published clinical research, the U.S. Preventive Services Task Force (USPSTF) concluded, “Women who have undergone hysterectomy in which the cervix was removed do not require Pap testing, unless it was performed because of cervical cancer or its precursors.” Source: U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. 105–117; 1996.Based on a 1996 meta-analysis of published clinical research, the U.S. Preventive Services Task Force (USPSTF) concluded, “Women who have undergone hysterectomy in which the cervix was removed do not require Pap testing, unless it was performed because of cervical cancer or its precursors.” Source: U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. 105–117; 1996.

34. CDC Policy: New Pap Testing Technologies NBCCEDP funds may not be used to reimburse for liquid-based technologies approved by FDA for primary screening unless the reimbursement rate for the new technology does not exceed the current reimbursement rate for a conventional Pap test. Use of new technologies to be re-evaluated when new data are available. Related to new Pap testing technologies, the new policy states, “NBCCEDP funds may not be used to reimburse for liquid-based technologies approved by FDA for primary screening unless the reimbursement rate for the new technology does not exceed the current reimbursement rate for a conventional Pap test.” This policy applies to— Liquid-based technologies, such as ThinPrep® and Autocyte. Reimbursement for use of these new technologies is currently being re-evaluated as new data become available.Related to new Pap testing technologies, the new policy states, “NBCCEDP funds may not be used to reimburse for liquid-based technologies approved by FDA for primary screening unless the reimbursement rate for the new technology does not exceed the current reimbursement rate for a conventional Pap test.” This policy applies to— Liquid-based technologies, such as ThinPrep® and Autocyte. Reimbursement for use of these new technologies is currently being re-evaluated as new data become available.

35. What We Know About Liquid-based Testing Technologies More sensitive, but not more specific, than conventional Pap tests (Austin, 1998) ACOG did not recommend routine use in 1998: Cost too high Insufficient data demonstrating reduction of disease incidence or cancer survival Currently silent on the issue On what evidence did CDC base the decision not to reimburse BCCEDPs for use of these new technologies? What we know today about the new liquid-based technologies is as follows: They are more sensitive, but not more specific, than conventional Pap tests.1 In 1998, ACOG did not recommend routine use of the new technologies because— Their cost is too high. There are insufficient data demonstrating reduction in new cases of cervical cancer or in survival among women diagnosed with cancer.2 Since late 2000, ACOG has been silent on the issue (i.e., they have no opinion or policy). The higher cost of these new technologies, which do not add any clear benefit, could risk reducing the number of women screened through the NBCCEDP. 1Austin, R.M. Implementing liquid-based gynecological cytology: balancing marketing, financial, and scientific issues. Cancer Cytopathol 84: 193–207; 1998. 2American College of Obstetricians and Gynecologists (ACOG). ACOG says new Pap technologies not standard of care. ACOG News Release; July 31, 1998. On what evidence did CDC base the decision not to reimburse BCCEDPs for use of these new technologies? What we know today about the new liquid-based technologies is as follows: They are more sensitive, but not more specific, than conventional Pap tests.1 In 1998, ACOG did not recommend routine use of the new technologies because— Their cost is too high. There are insufficient data demonstrating reduction in new cases of cervical cancer or in survival among women diagnosed with cancer.2 Since late 2000, ACOG has been silent on the issue (i.e., they have no opinion or policy). The higher cost of these new technologies, which do not add any clear benefit, could risk reducing the number of women screened through the NBCCEDP. 1Austin, R.M. Implementing liquid-based gynecological cytology: balancing marketing, financial, and scientific issues. Cancer Cytopathol 84: 193–207; 1998. 2American College of Obstetricians and Gynecologists (ACOG). ACOG says new Pap technologies not standard of care. ACOG News Release; July 31, 1998.

36. CDC Policy: HPV/DNA Testing Until further evidence is available, NBCCEDP funds may not be used to reimburse for HPV/DNA tests. Policy is being re-examined as new firm evidence becomes available. Related to HPV/DNA testing, the new CDC policy states, “Until further research results are available, NBCCEDP funds may not be used to reimburse for HPV/DNA tests.” This policy will be reexamined as new firm evidence becomes available.Related to HPV/DNA testing, the new CDC policy states, “Until further research results are available, NBCCEDP funds may not be used to reimburse for HPV/DNA tests.” This policy will be reexamined as new firm evidence becomes available.

37. HPV/DNA Testing ALTS Trials No benefit for women with LSIL results Probable benefit for women with ASC results A clinical trial was conducted to determine the most effective means of clinically managing ASC and LSIL Pap test results. The clinical trial utilized liquid-based Pap technology and the hybrid capture HPV testing technology. Results are as follows: In 2000, the ASC/LSIL Triage Study (ALTS) group at NCI published the LSIL results of the trial of the HPV/DNA test in conjunction with a liquid-based Pap test. Data showed that a large percentage of women with LSIL had positive HPV/DNA. Therefore, there was limited potential for the assay to aid in clinical management decisions of women with LSIL.1 In 2001, the ALTS group reported that HPV/DNA testing may be a viable triage tool for women with ASC who have an increased risk for developing ICC.2 1The ALTS Group. Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. J Natl Cancer Inst 92: 397–402; 2000. 2Solomon, D.; Schiffman, M.; Tarone, R. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 93: 293-299; 2001. Note: Additional citations continued on next slideA clinical trial was conducted to determine the most effective means of clinically managing ASC and LSIL Pap test results. The clinical trial utilized liquid-based Pap technology and the hybrid capture HPV testing technology. Results are as follows: In 2000, the ASC/LSIL Triage Study (ALTS) group at NCI published the LSIL results of the trial of the HPV/DNA test in conjunction with a liquid-based Pap test. Data showed that a large percentage of women with LSIL had positive HPV/DNA. Therefore, there was limited potential for the assay to aid in clinical management decisions of women with LSIL.1 In 2001, the ALTS group reported that HPV/DNA testing may be a viable triage tool for women with ASC who have an increased risk for developing ICC.2 1The ALTS Group. Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. J Natl Cancer Inst 92: 397–402; 2000. 2Solomon, D.; Schiffman, M.; Tarone, R. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 93: 293-299; 2001. Note: Additional citations continued on next slide

38. Review: Major Policy Emphasis Increase screening of never- and rarely- screened NBCCEDP-eligible women Decrease unnecessary over-screening of women in the NBCCEDP Now that we have gone through the highlights of the policy, let us review the two major points: The first major goal is to increase screening of never- and rarely screened NBCCEDP-eligible women. As noted earlier, this is the goal CDC would like states, territories, and tribes to focus on in their implementation of the policy. The second major goal is to decrease overscreening of women in the NBCCEDP. Additional information can be found in the policy, which is available as a handout. Now, let us talk about what programs can do to implement the policy. 3Manos, M.M.; Kinney, W.K.; Hurley, L.B.; Sherman, M.E.; Shieh-Ngai, J.; Kurman, R.J.; Ransley, J.E.; Fetterman, B.J.; Hartinger, J.S.; McIntosh, K.M.; Pawlick, G.F.; Hiatt, R.A. Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA 281: 1605–1610; 1999. 4van Ballegooijen, M., van den Akker-van Marle, M.E.; Warmerdam, P.G.; Meijer, C.J.L.M.; Walboomers, J.M.M.; Habbema, J.D.F. Present evidence on the value of HPV testing for cervical cancer screening: a model-based exploration of the (cost-) effectiveness. Br J Cancer 76: 651–657; 1997. Now that we have gone through the highlights of the policy, let us review the two major points: The first major goal is to increase screening of never- and rarely screened NBCCEDP-eligible women. As noted earlier, this is the goal CDC would like states, territories, and tribes to focus on in their implementation of the policy. The second major goal is to decrease overscreening of women in the NBCCEDP. Additional information can be found in the policy, which is available as a handout. Now, let us talk about what programs can do to implement the policy. 3Manos, M.M.; Kinney, W.K.; Hurley, L.B.; Sherman, M.E.; Shieh-Ngai, J.; Kurman, R.J.; Ransley, J.E.; Fetterman, B.J.; Hartinger, J.S.; McIntosh, K.M.; Pawlick, G.F.; Hiatt, R.A. Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA 281: 1605–1610; 1999. 4van Ballegooijen, M., van den Akker-van Marle, M.E.; Warmerdam, P.G.; Meijer, C.J.L.M.; Walboomers, J.M.M.; Habbema, J.D.F. Present evidence on the value of HPV testing for cervical cancer screening: a model-based exploration of the (cost-) effectiveness. Br J Cancer 76: 651–657; 1997.

39. NBCCEDP Expectations Implement the policy Assess current provider practice and provide professional education Expand case management activities Modify patient recall systems Develop interventions to reach the never- or rarely-screened As indicated in the new cervical cancer policy, NBCCEDP programs are expected to have an operational plan to implement the policy. As a part of implementation, programs are expected to— Assess current provider practices; Plan and implement professional education activities; Expand case management activities; Modify patient recall systems; Develop culturally competent and sensitive interventions that fit the intended audience; and increase efforts to reach the never or rarely screened.As indicated in the new cervical cancer policy, NBCCEDP programs are expected to have an operational plan to implement the policy. As a part of implementation, programs are expected to— Assess current provider practices; Plan and implement professional education activities; Expand case management activities; Modify patient recall systems; Develop culturally competent and sensitive interventions that fit the intended audience; and increase efforts to reach the never or rarely screened.

40. Policy Implementation Challenges Reaching never- and rarely-screened women Encouraging providers to reduce overscreening We hope that focusing NBCCEDP resources on screening women who are never or rarely screened will help eliminate unnecessary deaths due to cervical cancer. Several programs have expressed concerns about implementing the new cervical cancer screening policy. CDC appreciates this feedback and is working with programs and partners to address these issues. Concerns expressed by grantees are the challenges associated with: Recruiting women who are at greatest risk—never- or rarely screened women; and Providers continuing to overscreen. Let’s now discuss each of these challenges in more depth. We hope that focusing NBCCEDP resources on screening women who are never or rarely screened will help eliminate unnecessary deaths due to cervical cancer. Several programs have expressed concerns about implementing the new cervical cancer screening policy. CDC appreciates this feedback and is working with programs and partners to address these issues. Concerns expressed by grantees are the challenges associated with: Recruiting women who are at greatest risk—never- or rarely screened women; and Providers continuing to overscreen. Let’s now discuss each of these challenges in more depth.

41. Challenge: Encouraging changes in provider practice to reduce over-screening Concerns Potential for a two-tiered program Low SES is correlated with not being screened for cervical cancer. NBCCEDP has the opportunity to reduce the disparity between low and high SES. Providers will lose women if they do not come in for their yearly Pap test Eligible women can return annually for a CBE and mammogram (if age-appropriate). Concerns about working with providers to reduce overscreening have been voiced by several BCCEDPs. Some of the concerns expressed are as follows: Implementing the new policy may breed a two-tiered program. Studies have shown that low SES is correlated with not being screened for cervical cancer. NBCCEDP has the opportunity to equalize the disparity between low and high SES with respect to cervical cancer screening by focusing on those most in need of screening services: low-SES women who are rarely or never screened. A second concern is that if women are not seen annually for their Pap test, they may not return for other routine services. Women will still be able to return every year for a clinical breast exam and when appropriate a mammogram, as well as other prevention services. The overall message to clients may still focus on yearly screening. However, the types of tests performed will vary from visit to visit.Concerns about working with providers to reduce overscreening have been voiced by several BCCEDPs. Some of the concerns expressed are as follows: Implementing the new policy may breed a two-tiered program. Studies have shown that low SES is correlated with not being screened for cervical cancer. NBCCEDP has the opportunity to equalize the disparity between low and high SES with respect to cervical cancer screening by focusing on those most in need of screening services: low-SES women who are rarely or never screened. A second concern is that if women are not seen annually for their Pap test, they may not return for other routine services. Women will still be able to return every year for a clinical breast exam and when appropriate a mammogram, as well as other prevention services. The overall message to clients may still focus on yearly screening. However, the types of tests performed will vary from visit to visit.

42. Challenge: Encouraging changes in provider practice to reduce over screening (continued) Concerns (continued) Clinicians disagree about screening intervals Disagreement among clinicians about screening intervals is common. Programs can consult with Medical Advisory Committees to determine the screening frequency parameters. Screening interval for other preventable cancers not the same as for breast and cervical cancer A third concern is that clinicians do not agree or are confused about on screening intervals; this may result in mixed messages for BCCEDP clients. Disagreement among clinicians about screening intervals is true for other diseases as well (e.g., breast cancer). Programs can consult with their Medical Advisory Committee to determine the parameters for more frequent screening once a woman meets the eligibility requirement for less-frequent Pap testing. Several programs have already secured additional funding from which to provide more-frequent screening for women whose health histories indicate that need. Given limited funds in a public health program, a focused approach to screening is appropriate. Screening intervals for other cancers is not the same as for breast and cervical cancer . Take, for example, recommended screening for colo-rectal cancer. A third concern is that clinicians do not agree or are confused about on screening intervals; this may result in mixed messages for BCCEDP clients. Disagreement among clinicians about screening intervals is true for other diseases as well (e.g., breast cancer). Programs can consult with their Medical Advisory Committee to determine the parameters for more frequent screening once a woman meets the eligibility requirement for less-frequent Pap testing. Several programs have already secured additional funding from which to provide more-frequent screening for women whose health histories indicate that need. Given limited funds in a public health program, a focused approach to screening is appropriate. Screening intervals for other cancers is not the same as for breast and cervical cancer . Take, for example, recommended screening for colo-rectal cancer.

43. Next Steps Continued CDC support as programs implement the policy Provide technical assistance Help programs develop tools to communicate with providers and clients Identify effective client recruitment strategies Explore and evaluate impact of policy implementation Continue a national dialogue with guideline and policy developers To help with challenges in implementing the policy, CDC will offer support for programs through— Individual technical assistance; Development of tools, such as fact sheets, to assist programs with communicating to providers and clients about the new policy; and The identification of effective strategies to increase enrollment of never- and rarely screened women. While providing support to NBCCEDP programs, CDC will also work with a subset of programs to assess the potential impact of implementing the program over time. This will allow CDC to make decisions about potential revisions to the policy and to highlight “best practices” in implementing the policy. CDC will continue to work with other national organizations, such as the American Social Health Association, ACS, the National Cancer Institute, and others, to explore the current evidence related to cervical cancer screening and to achieve consensus on screening guidelines and policies. To help with challenges in implementing the policy, CDC will offer support for programs through— Individual technical assistance; Development of tools, such as fact sheets, to assist programs with communicating to providers and clients about the new policy; and The identification of effective strategies to increase enrollment of never- and rarely screened women. While providing support to NBCCEDP programs, CDC will also work with a subset of programs to assess the potential impact of implementing the program over time. This will allow CDC to make decisions about potential revisions to the policy and to highlight “best practices” in implementing the policy. CDC will continue to work with other national organizations, such as the American Social Health Association, ACS, the National Cancer Institute, and others, to explore the current evidence related to cervical cancer screening and to achieve consensus on screening guidelines and policies.

44. Key Messages Incidence and mortality rates for cervical cancer have leveled off. A decrease in cervical cancer incidence can be achieved by identifying and screening women never- or rarely-screened. The greatest risk for developing cervical cancer is not being screened. Some of the key messages we hope you will take away from this presentation are: Although incidence and mortality rates for cervical cancer have leveled off, a substantial decrease in cervical cancer incidence could be achieved by identifying and screening women never and rarely screened. The greatest risk for cervical cancer is not being screened. You play a significant role not only in getting these key messages to those who need to hear them, but also in doing what it takes to implement the cervical cancer policy. Some of the key messages we hope you will take away from this presentation are: Although incidence and mortality rates for cervical cancer have leveled off, a substantial decrease in cervical cancer incidence could be achieved by identifying and screening women never and rarely screened. The greatest risk for cervical cancer is not being screened. You play a significant role not only in getting these key messages to those who need to hear them, but also in doing what it takes to implement the cervical cancer policy.

45. What Can You Do? Educate your colleagues Talk to other programs Promote a simple message regarding overscreening Talk frequently with your CDC program consultant Although each program will have its own challenges in implementing the new cervical cancer screening policy, there are several things you can do to make it easier: Use this information to educate your colleagues. Talk to other programs that have found a way to reach out to those rarely or never screened. Promote a simple public education message to address overscreening. Talk with your CDC program consultant and ask him or her for assistance as you implement the policy.Although each program will have its own challenges in implementing the new cervical cancer screening policy, there are several things you can do to make it easier: Use this information to educate your colleagues. Talk to other programs that have found a way to reach out to those rarely or never screened. Promote a simple public education message to address overscreening. Talk with your CDC program consultant and ask him or her for assistance as you implement the policy.

46. Questions? Clinical or policy implications Implementation of the policy Ask participants/audience members for questions. As you answer questions, recognize that participants may still have concerns about the policy. You can help them “hear” your message by showing them that you appreciate their concerns and take them seriously. Let’s open up the conversation now to answer some of your questions. For the sake of organization, can we first focus on questions regarding either the clinical implications or the actual policy itself that may have surfaced as you listened to the presentation? Secondly, we will field questions about implementation of the policy itself.Ask participants/audience members for questions. As you answer questions, recognize that participants may still have concerns about the policy. You can help them “hear” your message by showing them that you appreciate their concerns and take them seriously. Let’s open up the conversation now to answer some of your questions. For the sake of organization, can we first focus on questions regarding either the clinical implications or the actual policy itself that may have surfaced as you listened to the presentation? Secondly, we will field questions about implementation of the policy itself.

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