Cervical Cancer Screening, Abnormal Cytology Management, and Counseling Practices.
Persistent infection with oncogenic types of human papillomavirus (HPV) causes cervical intraepithelial neoplasia (CIN) and invasive cancer. Recently, the Food and Drug Administration (FDA) approved a sensitive and specific test for oncogenic HPV genotypes (Hybrid Capture 2, Digene Diagnostics, Gaithersburg, MD), and several organizations released guidelines about its use.
In 1999, FDA approved this test to guide the management of the nearly 3 million American women each year with the borderline abnormal cervical cytology result, atypical squamous cells of undetermined significance (ASC-US). Clinicians can order HPV tests before and contingent upon an ASC-US result using residual cervical cells from liquid-based cytology media, a separate HPV specimen collected along with conventional cytology (“reflex testing”), or by recalling patients. By 2003, the American College of Obstetricians and Gynecologists (ACOG) and other organizations had endorsed HPV testing as one option to identify HPV-infected women with ASC-US results who were at highest risk of developing CIN and merited prompt colposcopy. The FDA did not approve HPV testing to guide colposcopy triage of women with abnormalities of higher grade than ASC-US. Because most of these women are infected with oncogenic HPV, testing adds little to stratifying risk for prevalent high-grade CIN and might delay colposcopy, diagnosis, and treatment.
In March 2003, FDA approved this HPV test as an adjunct to cytology for screening women aged 30 years and older (DNAwithPap test, Digene Diagnostics, Gaithersburg, MD). By 2004, several national organizations had endorsed this indication as an acceptable option, although one did not. Because HPV testing can distinguish persistently HPV-infected women at high risk of CIN from HPV-uninfected women at low risk of CIN, guidelines advise that women with normal cytology and positive HPV tests have repeat cytology within 6–12 months to determine whether HPV infection is transient, whereas women with normal cytology and negative HPV tests should be screened less frequently (eg, every 3 years). The test is not approved to replace cytology or as an adjunct to cytology for women under the age of 30 in whom most HPV infection is transient and benign. In mid-2004, we conducted the first national survey of clinician practices since the release of these guidelines.
DISCUSSION
This national survey demonstrates that the introduction of HPV tests and testing guidelines have transformed screening, abnormal cytology management, and counseling in the United States. Our findings allow clinicians to compare their practices with national patterns and can inform clinician, patient, and public education priorities; health care planning, reimbursement, and policy; and models of how HPV testing and HPV vaccines might influence cancer incidence and health care costs.
The large sample size, high response rate, adjustment for nonresponse, and inclusion of midlevel providers who provide a great deal of screening but are often overlooked in surveys make our data nationally representative of seven specialties that commonly offer screening. We enhanced survey validity by using established clinician survey metrics and extensive expert review and piloting. To discourage clinicians from reporting practices that were consistent with guidelines but not typical of their practice, the cover letter did not detail plans to compare reported practices with guidelines.
Most clinicians were aware that HPV infection causes cervical neoplasia and that HPV tests are available, but many were unaware of information useful for counseling; eg, most HPV infections clear spontaneously and wart- and cancer-related HPV genotypes usually differ. Most clinicians valued materials from organizations that issued recommendations about HPV testing, as other studies show. As expected, knowledge of obstetrician-gynecologists and nurse-midwives, who reported the highest cytology volume and most HPV test use, was most up-to-date. This knowledge will increase patient confidence in counseling and help answer patient questions raised by public education campaigns, HPV test consumer marketing, and news about HPV vaccines.
Liquid cytology was the dominant cytology method used in all specialties, as surveys of gynecologists and family physicians have shown. Although this method facilitates HPV testing, only 21% of clinicians used HPV tests as an adjunct to cytologic screening. Limited use may reflect the 14-month interval between FDA approval of this indication and the survey, the interim nature of current guidelines related to uncertainty about the effect on outcomes and cost, and limited reimbursement. It may also reflect concerns about how to counsel up to 13% of women with normal cytology and positive HPV tests or extending screening intervals of women with normal cytology and negative HPV tests. Guidelines advise longer intervals in these “double negative” patients because this test combination has a high-negative predictive value for incident CIN.
Although longer intervals may use medical resources more efficiently, reduce patient anxiety and follow-up, and free clinicians to focus on underscreened patients, they may also preclude interim visits for other care, reduce revenue from visits linked to screening, and be unacceptable to patients. Therefore, ACOG and ACS stressed regular gynecologic care when issuing their guidelines, and FDA approved this indication contingent on development of patient education materials. In one health plan, introducing HPV testing extended cytology intervals in HPV-negative women, increased CIN 2 detection, proved acceptable to patients, and overcame early clinician objections (Walter Kinney, written communication, December 6, 2004). Similar evaluations are needed in other health settings.
In all specialties except obstetrics-gynecology, HPV testing as an adjunct to cytology was more commonly used for women under 30 years of age (not recommended) than for older women (recommended). Misuse may stem from lack of awareness that most infections in young women are transient and benign and that testing may lead to unnecessary distress, colposcopy, invasive procedures, or costs; liberal reimbursement; or test demand fueled by mass media or consumer marketing.
Many clinicians in our survey, like less-representative ones, ordered HPV tests for ASC-US results, largely using reflex testing on liquid cytology specimens, and used test results for colposcopy triage. Solid clinical and cost evidence supports interest in this indication: HPV testing may speed the diagnosis or ruling out of CIN, reduce losses for follow-up cytology, prevent unnecessary visits, procedures, and treatment, and lower costs. Women can be spared the anxiety of delayed repeat cytology alternatives, and HPV-negative women can be returned to routine screening with confidence that they do not harbor high-grade CIN. The consensus of multiple guidelines, cost pressure to reduce colposcopy, test reimbursement by large public and commercial insurers, widespread use of liquid cytology, and standing orders or routine check boxes for reflex HPV testing may also foster test use. Although HPV testing for ASC-US results is now a mainstream practice in gynecologists, testing was least common among clinicians serving many patients without private insurance or on-site colposcopy access whose cancer risk may be elevated owing to irregular screening or poor colposcopic follow-up. Moreover, nearly 20% of clinicians noted that test reimbursement was problematic. Programs to expand access to this test indication would benefit medically underserved women if they improve colposcopy triage, outcomes, and patient satisfaction or reduce overtreatment and costs. In fact, our data on widespread HPV testing for ASC-US results supported continued federal funding of this indication for low-income women.
Although HPV testing is not recommended to guide colposcopy triage of abnormalities of higher grade than ACS-US, many clinicians, including obstetrician-gynecologists, reported such use. We may have overestimated inappropriate use if respondents confused HPV testing to guide initial colposcopy after screening with another recommended HPV test use, ie, secondary triage of patients with low- or high-grade squamous intraepithelial lesions after colposcopy, treatment, or an accelerated cytology program. However, this misclassification was probably minor because the survey posed all HPV testing questions in the screening section and did not cover posttreatment or postcolposcopy management and most clinicians who used HPV tests for higher-grade abnormalities practiced specialties that rarely treat these lesions. Moreover, a survey of obstetrician-gynecologists found similar patterns.
Test misuse may reflect confusion about newly marketed tests, liberal reimbursement, or patient demand for new technology prompted by consumer marketing; 58% of clinicians ordered tests at least partly on patient request. To enhance clinician knowledge about HPV and appropriate HPV testing, ACOG, CDC, and other organizations have developed training curricula, guideline summaries, and HPV test algorithms. Attention should first focus on physicians in family, adolescent, or internal medicine and physician assistants who screen many women but often reported inappropriate testing. Laboratory quality improvement organizations, health plans, insurers, and health care purchasers should also discourage reimbursement for reasons not approved by the FDA.
When clinicians ordered HPV tests, less than two thirds of clinicians notified patients of HPV testing, sought consent for HPV testing, or explained that the HPV test detects a sexually transmitted infection. Clinicians should consider that STD testing without consent may raise ethical and billing dilemmas; cause anger, discomfort, or stigma for patients; prolong counseling; or discourage needed follow-up or later screening, even if HPV test results are negative. Being notified of a sexually transmitted infection linked with cancer can be alarming, regardless of the cytology result, and can magnify the stress associated with abnormal cytology.Accordingly, some clinics have successfully introduced routine informed consent procedures for reflex HPV testing for ASC-US or cytology notification letters that explain HPV. Others are considering “shared decision making,” where clinicians and patients consider HPV testing along with other screening or ASC-US management options.
We found that, during checkups, screening, and notification of patients about abnormal cytology, the use of HPV tests has reinforced the message that a STD causes cervical cancer. Most clinicians noted that addressing HPV would encourage follow-up and not detract attention from cancer prevention. It may also provide entrées to discussing STD and human immunodeficiency virus (HIV) prevention, screening, vaccines, or barrier contraception. However, many clinicians noted that discussing HPV raises concerns about partner fidelity and causes patient distress, anger, or shame, as other studies show. Public knowledge about HPV is limited and fraught with misunderstanding. Many patients find it hard to grasp that most infections are transient, asymptomatic, and do not result in cancer and that HPV tests can be positive when cytology is normal. Even after counseling, patients may misinterpret test results, overestimate their cancer risk, or be unsure about follow-up. Effective counseling therefore takes skill, comfort, and time. Clinicians must balance positive and negative aspects of patient anxiety: motivation to adhere to follow-up advice versus difficulty in processing complex, sensitive information.
Written educational materials about HPV and abnormal cytology can reinforce counseling messages and reduce distress of patients who can digest information over time, but few clinicians in our survey used such materials. Fortunately, many counseling and education materials and hotlines have been recently developed in English and Spanish for all literacy levels. Many cover topics that might pre-empt anxiety, shame, and blaming: the high prevalence of benign HPV infection, the low absolute cancer risk of HPV-infected women, the value of regular cytologic screening, the likelihood that long-standing partners of HPV-infected women are already infected, and uncertainty about the timing of HPV acquisition. Studies of how these materials affect women's understanding and reactions, screening and follow-up, and sexual habits are especially important in high-risk, low-literacy women.
Many experts predict that HPV testing according to current guidelines will enhance the efficiency and cost-effectiveness of screening and follow-up of low-risk, regularly screened women. These are laudable goals, given that cytology is one of the nation's most costly screening programs and many women are overscreened. However, some experts caution that the current HPV test indications may not substantially reduce the bulk of U.S. cancer cases that are diagnosed in never or rarely screened women, most of whom are uninsured, rural, minority, or foreign-born, or that possibility of testing for HPV, a potentially stigmatized STD, may make such women less willing to seek screening. To meet the ultimate test of a new technology—to reduce cancer morbidity and mortality—HPV testing must be integrated into programs that enhance regular cytologic screening of underscreened women and ensure that STD-related stigma does not reduce screening participation.
In 1999, FDA approved this test to guide the management of the nearly 3 million American women each year with the borderline abnormal cervical cytology result, atypical squamous cells of undetermined significance (ASC-US). Clinicians can order HPV tests before and contingent upon an ASC-US result using residual cervical cells from liquid-based cytology media, a separate HPV specimen collected along with conventional cytology (“reflex testing”), or by recalling patients. By 2003, the American College of Obstetricians and Gynecologists (ACOG) and other organizations had endorsed HPV testing as one option to identify HPV-infected women with ASC-US results who were at highest risk of developing CIN and merited prompt colposcopy. The FDA did not approve HPV testing to guide colposcopy triage of women with abnormalities of higher grade than ASC-US. Because most of these women are infected with oncogenic HPV, testing adds little to stratifying risk for prevalent high-grade CIN and might delay colposcopy, diagnosis, and treatment.
In March 2003, FDA approved this HPV test as an adjunct to cytology for screening women aged 30 years and older (DNAwithPap test, Digene Diagnostics, Gaithersburg, MD). By 2004, several national organizations had endorsed this indication as an acceptable option, although one did not. Because HPV testing can distinguish persistently HPV-infected women at high risk of CIN from HPV-uninfected women at low risk of CIN, guidelines advise that women with normal cytology and positive HPV tests have repeat cytology within 6–12 months to determine whether HPV infection is transient, whereas women with normal cytology and negative HPV tests should be screened less frequently (eg, every 3 years). The test is not approved to replace cytology or as an adjunct to cytology for women under the age of 30 in whom most HPV infection is transient and benign. In mid-2004, we conducted the first national survey of clinician practices since the release of these guidelines.
DISCUSSION
This national survey demonstrates that the introduction of HPV tests and testing guidelines have transformed screening, abnormal cytology management, and counseling in the United States. Our findings allow clinicians to compare their practices with national patterns and can inform clinician, patient, and public education priorities; health care planning, reimbursement, and policy; and models of how HPV testing and HPV vaccines might influence cancer incidence and health care costs.
The large sample size, high response rate, adjustment for nonresponse, and inclusion of midlevel providers who provide a great deal of screening but are often overlooked in surveys make our data nationally representative of seven specialties that commonly offer screening. We enhanced survey validity by using established clinician survey metrics and extensive expert review and piloting. To discourage clinicians from reporting practices that were consistent with guidelines but not typical of their practice, the cover letter did not detail plans to compare reported practices with guidelines.
Most clinicians were aware that HPV infection causes cervical neoplasia and that HPV tests are available, but many were unaware of information useful for counseling; eg, most HPV infections clear spontaneously and wart- and cancer-related HPV genotypes usually differ. Most clinicians valued materials from organizations that issued recommendations about HPV testing, as other studies show. As expected, knowledge of obstetrician-gynecologists and nurse-midwives, who reported the highest cytology volume and most HPV test use, was most up-to-date. This knowledge will increase patient confidence in counseling and help answer patient questions raised by public education campaigns, HPV test consumer marketing, and news about HPV vaccines.
Liquid cytology was the dominant cytology method used in all specialties, as surveys of gynecologists and family physicians have shown. Although this method facilitates HPV testing, only 21% of clinicians used HPV tests as an adjunct to cytologic screening. Limited use may reflect the 14-month interval between FDA approval of this indication and the survey, the interim nature of current guidelines related to uncertainty about the effect on outcomes and cost, and limited reimbursement. It may also reflect concerns about how to counsel up to 13% of women with normal cytology and positive HPV tests or extending screening intervals of women with normal cytology and negative HPV tests. Guidelines advise longer intervals in these “double negative” patients because this test combination has a high-negative predictive value for incident CIN.
Although longer intervals may use medical resources more efficiently, reduce patient anxiety and follow-up, and free clinicians to focus on underscreened patients, they may also preclude interim visits for other care, reduce revenue from visits linked to screening, and be unacceptable to patients. Therefore, ACOG and ACS stressed regular gynecologic care when issuing their guidelines, and FDA approved this indication contingent on development of patient education materials. In one health plan, introducing HPV testing extended cytology intervals in HPV-negative women, increased CIN 2 detection, proved acceptable to patients, and overcame early clinician objections (Walter Kinney, written communication, December 6, 2004). Similar evaluations are needed in other health settings.
In all specialties except obstetrics-gynecology, HPV testing as an adjunct to cytology was more commonly used for women under 30 years of age (not recommended) than for older women (recommended). Misuse may stem from lack of awareness that most infections in young women are transient and benign and that testing may lead to unnecessary distress, colposcopy, invasive procedures, or costs; liberal reimbursement; or test demand fueled by mass media or consumer marketing.
Many clinicians in our survey, like less-representative ones, ordered HPV tests for ASC-US results, largely using reflex testing on liquid cytology specimens, and used test results for colposcopy triage. Solid clinical and cost evidence supports interest in this indication: HPV testing may speed the diagnosis or ruling out of CIN, reduce losses for follow-up cytology, prevent unnecessary visits, procedures, and treatment, and lower costs. Women can be spared the anxiety of delayed repeat cytology alternatives, and HPV-negative women can be returned to routine screening with confidence that they do not harbor high-grade CIN. The consensus of multiple guidelines, cost pressure to reduce colposcopy, test reimbursement by large public and commercial insurers, widespread use of liquid cytology, and standing orders or routine check boxes for reflex HPV testing may also foster test use. Although HPV testing for ASC-US results is now a mainstream practice in gynecologists, testing was least common among clinicians serving many patients without private insurance or on-site colposcopy access whose cancer risk may be elevated owing to irregular screening or poor colposcopic follow-up. Moreover, nearly 20% of clinicians noted that test reimbursement was problematic. Programs to expand access to this test indication would benefit medically underserved women if they improve colposcopy triage, outcomes, and patient satisfaction or reduce overtreatment and costs. In fact, our data on widespread HPV testing for ASC-US results supported continued federal funding of this indication for low-income women.
Although HPV testing is not recommended to guide colposcopy triage of abnormalities of higher grade than ACS-US, many clinicians, including obstetrician-gynecologists, reported such use. We may have overestimated inappropriate use if respondents confused HPV testing to guide initial colposcopy after screening with another recommended HPV test use, ie, secondary triage of patients with low- or high-grade squamous intraepithelial lesions after colposcopy, treatment, or an accelerated cytology program. However, this misclassification was probably minor because the survey posed all HPV testing questions in the screening section and did not cover posttreatment or postcolposcopy management and most clinicians who used HPV tests for higher-grade abnormalities practiced specialties that rarely treat these lesions. Moreover, a survey of obstetrician-gynecologists found similar patterns.
Test misuse may reflect confusion about newly marketed tests, liberal reimbursement, or patient demand for new technology prompted by consumer marketing; 58% of clinicians ordered tests at least partly on patient request. To enhance clinician knowledge about HPV and appropriate HPV testing, ACOG, CDC, and other organizations have developed training curricula, guideline summaries, and HPV test algorithms. Attention should first focus on physicians in family, adolescent, or internal medicine and physician assistants who screen many women but often reported inappropriate testing. Laboratory quality improvement organizations, health plans, insurers, and health care purchasers should also discourage reimbursement for reasons not approved by the FDA.
When clinicians ordered HPV tests, less than two thirds of clinicians notified patients of HPV testing, sought consent for HPV testing, or explained that the HPV test detects a sexually transmitted infection. Clinicians should consider that STD testing without consent may raise ethical and billing dilemmas; cause anger, discomfort, or stigma for patients; prolong counseling; or discourage needed follow-up or later screening, even if HPV test results are negative. Being notified of a sexually transmitted infection linked with cancer can be alarming, regardless of the cytology result, and can magnify the stress associated with abnormal cytology.Accordingly, some clinics have successfully introduced routine informed consent procedures for reflex HPV testing for ASC-US or cytology notification letters that explain HPV. Others are considering “shared decision making,” where clinicians and patients consider HPV testing along with other screening or ASC-US management options.
We found that, during checkups, screening, and notification of patients about abnormal cytology, the use of HPV tests has reinforced the message that a STD causes cervical cancer. Most clinicians noted that addressing HPV would encourage follow-up and not detract attention from cancer prevention. It may also provide entrées to discussing STD and human immunodeficiency virus (HIV) prevention, screening, vaccines, or barrier contraception. However, many clinicians noted that discussing HPV raises concerns about partner fidelity and causes patient distress, anger, or shame, as other studies show. Public knowledge about HPV is limited and fraught with misunderstanding. Many patients find it hard to grasp that most infections are transient, asymptomatic, and do not result in cancer and that HPV tests can be positive when cytology is normal. Even after counseling, patients may misinterpret test results, overestimate their cancer risk, or be unsure about follow-up. Effective counseling therefore takes skill, comfort, and time. Clinicians must balance positive and negative aspects of patient anxiety: motivation to adhere to follow-up advice versus difficulty in processing complex, sensitive information.
Written educational materials about HPV and abnormal cytology can reinforce counseling messages and reduce distress of patients who can digest information over time, but few clinicians in our survey used such materials. Fortunately, many counseling and education materials and hotlines have been recently developed in English and Spanish for all literacy levels. Many cover topics that might pre-empt anxiety, shame, and blaming: the high prevalence of benign HPV infection, the low absolute cancer risk of HPV-infected women, the value of regular cytologic screening, the likelihood that long-standing partners of HPV-infected women are already infected, and uncertainty about the timing of HPV acquisition. Studies of how these materials affect women's understanding and reactions, screening and follow-up, and sexual habits are especially important in high-risk, low-literacy women.
Many experts predict that HPV testing according to current guidelines will enhance the efficiency and cost-effectiveness of screening and follow-up of low-risk, regularly screened women. These are laudable goals, given that cytology is one of the nation's most costly screening programs and many women are overscreened. However, some experts caution that the current HPV test indications may not substantially reduce the bulk of U.S. cancer cases that are diagnosed in never or rarely screened women, most of whom are uninsured, rural, minority, or foreign-born, or that possibility of testing for HPV, a potentially stigmatized STD, may make such women less willing to seek screening. To meet the ultimate test of a new technology—to reduce cancer morbidity and mortality—HPV testing must be integrated into programs that enhance regular cytologic screening of underscreened women and ensure that STD-related stigma does not reduce screening participation.
posted by my-healthcare at 2:10 AM
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