Presentation on theme: "Cervical cancer screening practices in the U. S"— Presentation transcript:
1 Cervical cancer screening practices in the U. S Cervical cancer screening practices in the U. S. since the release of national guidelines on genital human papillomavirus (HPV) testing: Results of a national clinician survey, 20042005 AcademyHealth Annual Research MeetingKL Irwin1, D Montaño2, D Kasprzyk2, L Carlin2, C Freeman2, R Barnes1, N Jain11U.S. Centers for Disease Control and Prevention, Atlanta, Georgia USA2Battelle Memorial Institute, Seattle, Washington, USAGood morning. Today I will describe cervical cancer screening practices in the US since the release of national guidelines on genital human papillomavirus -- or HPV -- testing using results from a national clinician survey conducted in 2004 by CDC and Battelle Memorial Institute
2 Cervical cancer and genital human papillomaviruses (HPV) Genital HPV are very common sexually transmitted viruses~ 6 million new infections per year in US~ 20 million Americans are currently infectedMost infections are transient, asymptomatic, and clear without medical intervention.Persistent infection with oncogenic HPV types may cause:Cervical cancer precursor lesions or Cervical Intraepithelial Neoplasia (CIN)Invasive cervical cancerIn 2004, US women experienced:~ deaths from cervical cancer> 3 million abnormal Pap tests, most HPV-related> $1 billion in Pap test screening, follow up, and treatment costsFirst, a little background on HPV.Read first bulletsRead second bulletHowever, read third bulletRead 4th bullet
3 New tests for oncogenic types of HPV In the late 1990s, highly sensitive and specific DNA tests for oncogenic HPV were developed.Use of new liquid-based Pap test methods facilitates collection of HPV test specimens.FDA recently approved HPV tests for various reasons, includingmanaging patients with abnormal Pap testsan adjunct to Pap tests to screen women aged 30+ for cervical cancerRead first bulletALSO, read second bulletRead third bullet
4 Indication 1: HPV testing to manage patients with abnormal Pap results Women with abnormal Pap tests benefit from colposcopy = magnified visualization of cervixrequires a speculum-aided pelvic examination, special equipment, and trained colposcopistPermits cervical biopsy that provide pathologic diagnosis that determines treatmentColposcopy is a costly, painful procedure that is in short-supply in the U.S., especially in communities with highest cervical cancer incidence.Let me elaborate on the first FDA-approved indication – managing patients with abnormal Pap resultsRead first bulletRead second bullet
5 As you see here, this is a procedure most women would like to avoid if there are not important clinical benefits.
6 Indication 1 (continued) In 2000, FDA approved HPV tests to guide colposcopy triage of patients with the most common Pap test abnormality ASC-US (Atypical Squamous Cells, Undetermined Significance)In 2001, several organizations issued guidelines endorsing HPV tests as an option to guide such triage, including:American College of Obstetricians and GynecologistsCenters for Disease Control and PreventionAmerican Cancer SocietyWith this option, one orders HPV test if Pap result is ASC-US:HPV-infected women = high risk of developing CIN recommend prompt colposcopyHPV-uninfected women = low risk of developing CIN recommend repeat Pap testHPV tests not recommended for higher grade Pap results because colposcopy is advised regardless of HPV test resultsREAD First bulletOf which there are more than 3 million per yearRead second bulletRead third bulletRead 4th bullet
7 Indication 2: HPV test as Pap test adjunct to guide follow-up Pap interval In 2003, the FDA approved HPV tests as an adjunct to Pap tests to screen women aged 30+ to guide optimal follow up Pap test intervals because infection in women aged 30+ often represents persistent infection that increases risk of CIN.In 2003, two organizations issued guidelines that endorsed HPV tests as an option to screen women aged 30+:American Cancer SocietyAmerican College of Obstetricians and GynecologistsThis option would advise for women with normal Pap tests:If HPV test positive = high risk of progression to CIN repeat Pap test and HPV test in 6-12 monthsIf HPV test negative = low risk of progression to CIN less frequent follow up Pap screening intervals (every 3 years)This option could reduce frequent screening of women at low risk for developing HPV-related abnormalities and enhance follow up of women at high risk for these abnormalities.Under the second FDA-approved indication, HPV tests can be used as an adjunct to Pap tests to determine how often followup Pap test should be collected.The FDA approved HPV tests for this purpose to screen women aged 30 and older because infection in women of this age often represents persistent infection that increases risk of CINRead 2nd bulletRead 3rd bulletThe rationale for these guidelines was to reduce – read bulletAll intended to more effectively care for patients and more effectively use clinician time and health care dollars.
8 2004 national survey of US clinicians: Selected questions What guidelines are being used to guide cancer screening practices and management of abnormal Pap tests?How are HPV DNA tests being used for:managing patients with abnormal Pap testscervical cancer screeningHow are HPV test results influencing colposcopy and Pap test follow up practices?What are patient notification and consent when ordering HPV tests?How do HPV test use and test results influence patient counseling and education messages?To understand how these new HPV tests and new guidelines might influence practice, we conducted a national survey of clinicians in The survey addressed several questions, includingRead bulletsToday I will present data on the first 3 topics only.
9 Clinician survey methods Express mailed surveys to 5386 primary care clinicians in specialties that commonly provide Pap testing.Nationally-representative random samples (n= ) drawn from national clinician registries of:Physicians: Midlevel providers:Family/general practice Physician assistantsAdolescent medicine Certified nurse midwivesInternal medicine Nurse practitionersObstetrics/gynecologyCover letter noted results will inform new clinician training and decision supports tools and patient education materialsSurvey required minutes, $50 cash sent with first mailingAnalyses weighted to account for differences by clinical specialty in sampling and non-responseRead 1st bulletRead second bulllet – not specialitiesRead next 3 bulletsUsing fed ex mailing, cash incentives, and a credible source has yielded high response rates in past clinician surveys.Stratified sampling design used to ensure adequate sample in each specialty and comparisons across specialty because we thought specialty would be an important predictor of knowledge and practice.Postcards used to indicate if person ineligible due to death, retirement, or not practicing at least 8 hours per week in an outpatient setting.
10 Survey DispositionMore than 5300 surveys were mailed to primary care providers – with more than 3000 surveys were completed
11 Adjusted response rate by specialty Midlevel provider %Nurse midwivesNurse practitioners 96Physician assistant 865386 surveys mailedOverall response rate after adjusting for respondents who were deceased, retired, ineligible, or did not have current address = 82%Physician %Adolescent med 79Ob/GynFamily/Gen practice 68Internal med 59After we adjusted the response rate to exclude respondents who were ineligible, the overall response rate was 82%. Midlevel providers had higher response rates than physicians
12 Characteristics of Pap test providers (n=2980) Value Range (%)Clinician characteristics:Female (%) 46 (32-99)Mean years in practice 16 (11-21)Practice characteristics:Practice in private office setting (%) 74 (37-87)Use liquid-based Pap method (%) (58-92)Mean number Pap tests last yr 479 ( )Mean number abnormal Paps last yr 53 (10-158)Have on-site colposcopy (%) 46 (20-98)Patient characteristics:Mean % patients who are female 67 (59-100)Mean % patients who are white 68 (56-71)Mean % patients private insured 52 (33-67)Here you see the characteristics of the 2980 clinicians who provided Pap tests – the overall value and the range across different specialities. Most practiced in private settings, used liquid-based Pap tests that facilitate HPV test collection, provided a high volume of Paps, and had several patients with abnormal Paps. Nearly half had colposcopy equipment on site.
13 Sources used to guide cervical cancer screening or abnormal Pap management decisions among 2930 Pap test providers>50% reported using guidelines or materials of: %American College of Obstetrics/Gynecology 73Their clinical specialty organization 78Centers for Disease Control and Prevention 63American Cancer Society 58< 50% reported using guidelines or materials of: %US Preventive Services Task Force 46American Society for Colposcopy & Cervical PathologyHPV test manufacturerHealth plans or insurance companies 23When we asked respondents who provided Pap tests about what sources they used to guide their screening or abnormal Pap management practices, > 50% reported using guidelines of ACOG, CDC, and ACS – organizations that had issued guidelines on HPV test.READ BULLETSASCPP guidelines – most detailed, including how HPV test results should guide management of patients with ASCUS pap and normal Paps
14 Percent reporting ever using HPV tests for patients with Pap test abnormalities of any type We found that slightly more than half of Pap test providers reported ever using HPV test for patients with abnormal Pap tests – noted in the lavendar bar. Use of HPV tests for this reason was more common in ob/gyn and nurse midwives – noted here – than in other physician or midlevel provider specialites. Though not shown here, use of HPV tests for this reason was also more common in clinicians who provided a high volume of Pap tests, had a high volume of patients with abnormal Pap tests, and provided colposcopy on-site – characteristics typical of ob/gyns and nurse midwives.
15 HPV test use by type of screening Pap test abnormality* Pap test abnormality reporting usual/always use% range (%)*Borderline result “ASC-US” 98 (96-100)Higher grade results**:Atypical squamous cells of 79 (72-84)undetermined significance –cannot exclude high grade lesion**Low grade intraepithelial neoplasia** 63 (36-82)High grade intraepithelial neoplasia** 61 (31-78)* Among clinicians reporting HPV tests for any borderline or abnormal Pap test result. Range across 7 clinical specialties.**This use NOT approved by FDA or recommended by guidelines of U. S. clinical organizations. Internal and adolescent medicine physicians most commonly reported use for high grade lesions.
16 % who usually advise follow-up procedure Relation of HPV test results on colposcopy or followup Pap advice for women with ASC-US Pap results% who usually advise follow-up procedureTo determine if use of HPV tests influenced colposcopy triage decisions, we asked clinicians what followup procedures they would advise for patients with ASC-US Pap results and HPV positive (POINT) versus HPV negative tests (POINT)Respondents were more likely to recommend immediate colposcopy for patients with positive HPV test results than for patients with HPV negative results – just as the guidelines intended.ColposcopyPap testColposcopyPap testHPV test positiveHPV test negative
17 Percent who report ever using HPV tests as an adjunct to Pap tests by specialty Now turning to the second indication for HPV tests – use as an adjunct to Pap tests for cervical cancer screeningWe found this use to be less common – only about 20 percent had ever used it for this reason – in the lavendar bar. Again, this use was more common in ob/gyn and midwives, the specialties that provide the highest volume of Pap tests.
18 Percentage who reported usually/always using HPV tests as an adjunct to Pap tests by patient age When we asked those who used the test for this purpose for what patients they used it, we found that a higher percentage of respondents reported using the test to screen women under 30 – NOT recommended by guidelines – than women 30 and over – which is recommended by guidelines. Recall that most HPV infection in women under 30 is transient, asymptomatic, and will not result in cervical abnormalities whereas HPV infection in older women tends to represent persistent infection that may progress to CIN – so HPV testing is recommended as an option in this older age group.*Indication not endorsed by national guidelines
19 Percentage who reported usually/always using HPV tests as an adjunct to Pap tests by patient age When we asked how this test was used, we found that a higher percentage of respondents reported using the test to screen women under 30 – NOT recommended by guidelines – than 30 and over – which is recommended by guidelines. Recall that most HPV infection in women under 30 is transient, asymptomatic, and will not result in cervical abnormalities whereas HPV infection in older women tends to represent persistent infection that may progress to CIN.*Indication not endorsed by national guidelines
20 SummaryMost commonly cited guidelines are credible, non-commercial, and consistent with recent scientific evidenceMore than half of Pap test providers use HPV tests for ASC-US Pap results (a recommended option), especially:Obstetrician/gynecologists and nurse midwivesClinicians with high volume of Paps and abnormal Pap testsClinicians with on-site colposcopyColposcopy is more likely to be recommended to women with positive HPV tests as intended by guidelinesHowever, many report using HPV tests for patients with higher grade Pap abnormalities which is not recommendedFew report usually using HPV tests as adjunct to Pap tests in women 30+ (a recommended option)However, such HPV test use is more common in women < 30 (not-recommended) than women 30+ (recommended)So to sum up our key findings:Read 1st bulletRead 2nd bulletRead 3rd bulletAmong Pap providers who reported HPV test use, nearly all report using it to guide management of patients with ASCUS results as recommended by guidelines.However, many report using HPV tests for patients with higher grade lesions which is not recommneded because these patients are advised to have colposcopy regardless of their HPV test result because of their higher risk of CIN.Read final 2 bullets
21 Study strengths and limitations Large sample size with high overall response rate (82%)Stratified sampling design and weighting yielded more generalizable estimates within and across specialtyIncluded midlevel providers who provide much cervical cancer screening but are often overlooked in surveysLIMITATIONS:Reported practices may not reflect actual practicesSurvey did not determine:If use of HPV tests resulted in more appropriate use of colposcopy or follow up Pap intervalsreasons HPV tests used for non-recommended reasonsOur survey had several strengths, includingRead bulletsLike all surveys, this one was limited because
22 RecommendationsInterventions are needed to promote HPV testing practices that are consistent with national guidelines to avoid unnecessary:patient anxiety, stigma, or psychosocial burden due to STDcounseling burden by cliniciansHPV testing costsInterventions should be designed with input of key stakeholders:national organizations that issue screening guidelineslaboratorieshealth insurers, health plans, and health care purchasersHPV and Pap test manufacturerswomen eligible for cervical cancer screeningCDC, in collaboration with other organizations is:Updating clinical training and clinical decision support toolsDisseminating materials using print, web, and 2005 webcastUpdating patient and public education web and print materials to promote HPV test demand consistent with guidelinesOur findings yield several recommendationsRead first bullets
23 CDC sponsored webcast to train U. S CDC sponsored webcast to train U.S. clinicians about HPV and cervical cancerDate: August 9, 2005Time: 1-2 pm Eastern TimeAudience: Primary care cliniciansCME and CEU credits availableFor more information:
24 Patient counseling messages used by 2980 clinicians providing Pap tests Message % Range (%)When collecting Paps, I usually/always:Address methods to prevent cancer 49 (43-72)Discuss HPV as cancer risk factor 43 (32-66)Discuss HPV prevention 43 (30-79)For patients w/ HPV+ test or HPV-related Pap, I usually/always say:Virus is sexually transmitted 95 (88-99)Patient could transmit virus to partners 91 (83-97)HPV is common in sexually active persons 92 (76-93)Monogamy/↓ partner # can prevent transmission 79 (70-86)Condom use can prevent transmission 84 (81-95)Abstinence can prevent transmission (30-63)About half of respondents reported that when they collected Paps, they usually or alwaysRead bulletsThe majority of respondents said they usually or always included the following messages for patients with a positivei HPV test or HPV-related Pap result –READ FIRST FIVE BULLETSBut less than half discussed abstinence as a prevention measure. Tho this message was more common in adolescent providers – 62%
25 Key issues when addressing patients with positive HPV tests or HPV-related Pap results Addressing HPV would: %Increase likelihood patient would return for repeat Pap 87Assure patients they are getting complete information 83Raise patient concerns about partner fidelity 68It is somewhat or quite problematic to: %Indicate when/from whom infection was acquired 85Deal with emotional or relationship issues 73Get enough reimbursement to counsel patients 74Find time to counsel/educate patients 54We asked about facilitators and barriers to counseling patients with positive HPV test or HPV-related Pap result and found than most felt addressing was positive (FIRST TWO BULLETS). However, two thirds said addressing HPV would raise concerns about partner fidelity.Leading barriers to counseling these patients included READ BULLETS.These responses were highly consistent across all specialties.
26 Reported use of liquid-based cytology (LBC) and Conventional cytology Here is a graph of the percentages of respondents who reported ever using the HPV test for any reason, by specialty. Overall, 59% of respondents, indicated by the top light grey bar, reported ever using the HPV test. Ob/Gyn and nurse midwife providers, indicated by the bottom orange and light blue bars respectively, were more likely to report use of the test than other specialties.
27 Usual HPV test consent practices among 2680 Pap test providers When using to manage abnormal Pap results: %Seek patients consent for test 28Tell patients you are ordering 48Explain purpose of test as relates to Pap 58Explain HPV test detects STD 59When ordering test as adjunct to screening Pap test: %Seek patients consent for test 36Tell patients you are ordering 59Explain purpose of test in relation to Pap 63Explain HPV test detects STDWe asked clinicians using the HPV test what they said to patients when ordering or collecting the test for the two FDA approved indications – managing abnormal/borderline Paps and as adjunct to Pap for screening older womenBased on the subset of respondents whose data on this has been cleaned, about a third or more reported READ BULLETS
28 Summary: HPV test consent, notification, and counseling practices About one third explicitly report seeking consent for HPV testingAbout half report notifying patients when they are ordering HPV testsAbout two-thirds report telling patients that test detects sexually transmitted infectionHowever, more than half report telling patients about sexually transmitted HPV when:collecting Pap testsnotifying patients with positive HPV tests or HPV-related Pap abnormalitiesIn summary, the main survey findings include the following:About half of the providers in this survey reported HPV test use for any reason.OB/GYN and CNM providers, who see the largest percentage of women in their practices, were most likely to report HPV test use than other specialties.Among Pap providers who reported HPV test use, nearly all report using it to guide management of patients with ASCUS results as recommended by guidelines.However, many providers report using HPV tests non-recommended indications, including use for patients with anogenital warts, as an STD screening test, to test male sex partners, and for higher grade Pap test abnormalities