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Work Group Leader
Jeanne M. Anderson, MD, Family HealthServices Minnesota
Family Practice
Jeanne M. Anderson, MD, Family HealthServices Minnesota
Greg Angstman, MD, Mayo Clinic
Karen M. Granlund, MD, HealthSystem Minnesota
Jeff Meland, MD, HealthSystem Minnesota
Ob/Gyn
John LaFerla, MD, HealthPartners
Dale Akkerman, MD, HealthSystem Minnesota
Health Education
Janet Williams, HealthPartners
Internal Medicine
Cynthia Fay, MD, HealthPartners
Nursing
Adelaide J. Charlton, NP, HealthSystem Minnesota
Measurement Advisor
Jane Gendron, ICSI
Facilitator
Jane Erickson, MS, ICSI
Women age 18 through 64 or with the onset of sexual activity. Women with complaints secondary to the gynecologic system may lie outside the scope of this guideline.
Priority Aims For Medical Groups When Using This Guideline
1. Increase the percentage of women presenting for cervical Pap smear screening on a regular basis.
Possible measure of accomplishing this aim:
a. Percentage of continuously enrolled women having at least one cervical Pap smear during the past three years.
2. Improve the effectiveness of patient education by taking advantage of regular opportunities to inform women of the need for cervical Pap smear screening.
Possible measures of accomplishing this aim:
a. Percentage of women with normal Pap smears who received a mail communication stating normal results and information on the importance of regular cervical Pap smear screening.
b. Percentage of women with abnormal Pap smear who receive communication indicating the need for follow-up via a repeat Pap or scheduled diagnostic procedure.
c. Number of outreach initiatives by employers, schools, or communication education informing women of appropriate screening recommendations.
Clinical Algorithm Annotations
4
Initially all women should have annual Papanicolaou smear screening
beginning at age 18 or with the onset of sexual activity. After three consecutive
normal Pap smears and no dysplasia within the last 5 years, women may have
their screening performed less frequently at the discretion of the clinician
and patient. Screening for cervical cancer should be performed at least
every three years; it need not be performed for women who have had a hysterectomy
for benign disease. After age 65, there is no clear consensus on the need
for Pap smears in women who have had previous adequate screening. Pap smears
may be performed at the mutual consent of the patient and provider.
1. Prescreening
Educational and Counseling Activities
2. Initiation
of Screening
3. Prevention
Opportunity
4. Is Pap Smear Required?
5. If Present, Does Cervix Appear Normal?
6. Obtain Pap Smear
7. Is
Pap Smear Specimen Satisfactory for Lab Interpretation
8. Is Pap Smear to be Repeated?
9. Is Pap Smear Normal?
10. Evaluate
Patient Risk Factors/Define Needs/Respond to Questions and Concerns/Notify
of Results and Follow-up Recommendations
11. Conduct
Further Evaluation and Appropriate Treatment
Algorithm Annotations
1. Prescreening Educational and Counseling Activities
Employer, School and Community Education Activities
This group through this guideline acknowledges the crucial role played by education and outreach efforts in helping to increase the number of age-appropriate women who present themselves for regular cervical Pap smear screening, thereby reducing the incidence of cervical cancer mortality.
The following are some ideas for employers, school and community organizations.
Awareness initiative programming includes:
Educational initiative programming includes:
Behavioral change initiative programming includes:
Information on the importance of regular cervical Pap smear screening can be included as part of broader health promotion/disease prevention initiatives which includes not only cancer prevention education but addresses heart disease and appropriate health care utilization as well. Some employers and HMOs around the country have also launched successful Women's Health Campaigns which include cervical cancer screening along with other prominent health issues for women such as breast cancer detection, smoking, exercise and so on.
Provider Activities
Materials such as brochures, posters, "special message" prescription pads, chart reminders and so on can help support the provider in her/his role as patient counselor/educator. Face-to-face opportunities to encourage women - especially those who haven't had a Pap smear recently or ever - to take advantage of this important and potentially lifesaving procedure are instrumental in improving screening rates, thereby reducing cervical cancer mortality.
Suggested health care provider prescreening activities include:
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Cervical Pap smear screening should be initiated on all women greater than 18 years of age, or before the age of 18 years with the onset of sexual activity.
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In addition to the schedules described in the ICSI Preventive Services guidelines, some services will need to be obtained during routine visits or at other times. For example, a Pap smear should be obtained at least every three years for all patients. The screening of the patient chart should be incorporated into acute care visits, with appointments made for women who need Pap smears. For women, a brief intervening visit for clinical breast examination and mammography in an appropriate setting is recommended in addition to a regular preventive services visit.
The interval for females age 18 through 64 years old is flexible (i.e., 3-5 years) in order to permit care systems that are able to provide needed female exams at times other than at preventive visits to see females at the same frequency as males. In order to do this, however, systems will be needed to ensure preventive services delivery outside of preventive visits.
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Initially all women should have annual Pap smear screening beginning at age 18 or with the onset of sexual activity. After three consecutive normal Pap smears, women may have their screening performed less frequently at the discretion of the clinician and patient. Screening for cervical cancer should be performed at least every three years; it need not be performed for women who have had a hysterectomy for benign disease.
Patients with a history of dysplasia should have annual Pap smears until they no longer have a history of dysplasia within the last five years. At this point they need not be repeated more frequently than the standard recommendation.
Strength of the evidence for this recommendation: B.
Although the standard is three annual normal Pap smears, a wider time frame is acceptable as long as there are no intervening abnormal Pap smear results. This interval time frame should be three normal Pap smears in a period not to exceed five years.
Strength of the evidence for this recommendation: B.
After age 65, there is no clear consensus on the need for Pap smears in women who have had previous adequate screening. Pap smears may be performed at the mutual consent of the patient and provider.
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5. If Present, Does Cervix Appear Normal?
A normal looking cervix is defined in any standard medical text. The presence of eversion and/or Nabothian cysts does not constitute an abnormality in this context. If a lesion is grossly visible, Pap smear alone does not constitute adequate evaluation; biopsy with or without colposcopy should be strongly considered. There may be times in the care of a patient when a pelvic exam is performed, exclusive of a Pap, and when doing so, visualizing the cervix is a good idea.
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To enhance the likelihood of obtaining cells from the squamocolumnar junction, the following procedure is recommended:
Other devices such as the pointed Ayre spatula also sample the transformation zone. This device is gently inserted into the endocervix and rotated slowly one to two full turns.
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7. Is Pap Smear Specimen Satisfactory for Lab Interpretation?
It is suggested that providers implement some form of quality measurement in order to encourage adequate Pap specimens for accurate lab interpretation.
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8. Is Pap Smear to be Repeated?
The Bethesda system of nomenclature for Pap smear interpretation (see Annotation #9) includes an evaluative component describing the adequacy of the specimen. This component is further subdivided into three categories:
Because this guideline recommends that Pap smear screening may be performed on an every one to three year basis, this work group is also recommending that any Pap smear reported as "unsatisfactory for interpretation" or "satisfactory for interpretation, but limited by the absence of an endocervical component" be repeated when convenient within the next twelve months. If reasonable effort to obtain a Pap smear specimen results in continued "absence of endocervical" cells, the Pap smear should be considered normal and need not be repeated more frequently than the standard recommendation. In those patients who are postmenopausal and whose Pap smears are limited by the "absence of endocervical" cells, such Pap smears need not be repeated more frequently than the standard recommendation. If a Pap smear is categorized as "satisfactory but limited by inflammation, reparative and reactive changes or other benign condition," it should be considered normal in regard to cervical cancer screening and need not be repeated more frequently than the standard recommendation.
Women who are to have their Pap smear repeated due to an inadequate specimen should receive telephone or mail communication explaining the need for the repeat Pap smear within the next twelve months.
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In order to achieve a more consistent manner of Cervical Pap smear reporting within the HealthPartners network, it is highly recommended that all providers and their affiliated laboratories adopt the Bethesda system of nomenclature for Pap smear interpretation as their system of reporting Pap smear results.
Women whose Pap smear results are normal should receive a mailed communication stating that their Pap smear was normal and stressing the importance of continued regular, periodic cervical Pap smear screening.
Women whose Pap smear results were not normal should receive communication (e.g., mail or a telephone call) indicating their results and the need for follow-up via a repeat Pap smear or scheduled diagnostic procedure. Relevant educational materials could accompany this communication.
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10.
Evaluate Patient Risk Factors / Define Needs / Respond to Questions and
Concerns / Notify of Results and Follow-up
Recommendations:
Women who have many risk factors have a greater need to be screened, but do not need to be screened more frequently as long as their prior Pap smears have been normal. Below is a table of risk factors as summarized from research literature by Mendelblatt. Aside from HIV, the two highest risk factors are a history of dysplasia and no prior screening.
Risk Factors (Mandelblatt)
Relative Risks (Case Control Studies) for Cervical Cancer by Specific Risk Factor:
RR = relative risk
|
Moderate Dysplasia on |
|
|
Pap smear less than five years: |
RR = very high (?2000) |
|
No Prior Screening: |
RR = 10 |
|
HPV (depending on subtyping): |
RR = 2.5 - 30 |
|
Six or more lifetime sexual partners: |
RR = 5 |
|
Low socioeconomic class: |
RR = 5 |
|
Race (black vs. white): |
RR = 2.5 |
|
Smoking: |
RR = 2 |
|
Oral contraceptive use: |
RR = 1.2 - 1.5 |
|
Barrier Contraception: |
RR = 0.6 |
Note:
A relative risk of 1.0 would indicate no increased probability of negative outcome, whereas RR of less than 1.0 means an actual protective effect may be present. RR of 10 means a tenfold increase. Overall risk for reproductive age non-hysterectomized American women to develop cervical cancer is about one in 5200 per year, or 0.02%.
Patient Communication
Reminder post cards, letters and telephone calls are integral components of a cervical cancer screening initiative: Communication tools to inform women of Pap smear results, explanations of next steps necessary to further diagnose abnormalities, reminders regarding completing appropriate tests and/or examinations, and routine reminders for periodic Pap smears.
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11. Conduct Further Evaluation and Appropriate Treatment
Further cytologic examination is not required for women who have undergone a hysterectomy with removal of cervix for benign disease.
Women who have had a hysterectomy for carcinoma in situ or invasive cancer should be monitored clinically on at least an annual basis with pelvic exam and Pap smear from the vaginal apex. Immediately following hysterectomy for these indications, a Pap smear should be performed on a more frequent basis.
Women requiring further evaluation and treatment as a result of their cervical Pap smear results fall outside the purview of this guideline.
Brochures, booklets, teaching displays and videos are helpful educational tools for those women who need to undergo any follow-up or diagnostic procedures such as colposcopy, LEEP, and the like.
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Grade A: Conclusion based on a randomized, controlled trial that has been published in a peer-reviewed journal.
Grade B: Conclusion based on one of the following study types published in a peer-reviewed journal (but not on a randomized, controlled trial):
� a trial using historical or other non-randomized controls;
� a prospective cohort study;
� a case-control study; or
� a meta-analytic study.
Grade C: Conclusion based on one of the following (but not on any studies of the types mentioned above):
� an uncontrolled case series; or
� expert opinion.
Guidelines obtained from the Agency for Health Care Policy and Research (AHCPR) or other sources, position statements, panel consensus statements from the National Institutes of Health (NIH) or elsewhere, review articles, and textbook chapters that cite primary evidence are not assigned a grade because they are not primary evidence. The individual studies cited in such secondary sources can be graded according to the categories presented above.
Other Guidelines Referenced Within This Guideline
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