Management of initial abnormal Pap smear.

SOURCE(S):
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2001 Sep 1. 31 p.

RELEASE DATE:
1999 May (revised 2001 Jul)

MAJOR RECOMMENDATIONS:
The recommendations for the management of abnormal Pap smear are presented in the form of six algorithms, accompanied by detailed annotations. The major recommendations contained within these algorithms have been summarized by the National Guideline Clearinghouse (NGC). The reader is directed to the original guideline document for further discussion of each of the following topics.

Class of evidence (A-D, M, R, X) definitions are repeated at the end of the Major Recommendations field.

Health Education

Patients should be informed of an abnormal result by physicians or by other health care personnel who answer basic questions and have sufficient training to allay undue anxiety.

Following verbal notification of an abnormal result, patients should be mailed written material specific to the diagnosis and recommended procedures/follow-up.

Evidence supporting these conclusions is of classes: A, C

Pap Smear Test Result

Presence of benign endometrial cells (BEC):

· Some authors have recommended endometrial biopsy for patients with benign endometrial cells if outside the time frame of expected endometrial shedding to evaluate for endometrial cancer. Others have recommended biopsy only for women over the age of 40. Since there is no clear consensus on appropriate management of benign endometrial cells, no specific recommendation can be made in regards to management. Discussion with local expert opinion is recommended on a case by case basis.

Inflammation present:

· Inflammation: Mild inflammation is not considered an abnormal Pap result.

Evidence supporting these conclusions is of classes: A, D

· Evaluate and treat if clinically indicated: There is considerable evidence that persistent inflammatory smears have a 24 to 48% risk of harboring dysplasia, and it is recommended that if an initial Pap smear shows severe inflammation, consideration should be given to treatment and then repeat the Pap smear in 6 months.

Evidence supporting these conclusions is of classes: C, D

· Repeat Pap smear within 6 months: Performing a follow-up in 3 months or less risks finding the same abnormality.

· Resume routine screening: If a subsequent smear does not show evidence of inflammation and there are no other abnormalities detected.

· Perform colposcopy: If inflammation persists, colposcopy is recommended in view of the possibility of underlying dysplasia.

Atypical squamous cells of uncertain significance (ASCUS):

· See the Bethesda System (The Bethesda System for reporting cervical/vaginal cytologic diagnoses. Acta Cytol 1993;37:115-24) for reporting criteria of atypical squamous cells of uncertain significance. Some laboratories add a number of qualifiers to atypical squamous cells of uncertain significance results, blending the Bethesda system with other terms. Some laboratories do not qualify atypical squamous cells of uncertain significance further.

Evidence supporting these conclusions is of classes: C, D, X, R

· Atypical squamous cells of uncertain significance with inflammation: Evaluate and treat for infection. Treat chlamydia, gonorrhea, candida or Trichomonas if specifically diagnosed. Repeat Pap in 6 months until 3 consecutive normals. Resume routine screening, if Pap smear is normal. Perform colposcopy if any abnormal Pap tests on follow-up screening.

· Atypical squamous cells of uncertain significance with atrophic changes: Treat with estrogen. A 1992 National Cancer Institute Workshop recommended giving a course of estrogen for at least one month to women with atrophic changes and atypical squamous cells of uncertain significance. Repeat Pap in 6 months. Resume routine screening, if Pap smear is normal. Options for the patient with a contraindication to estrogen are re-screening or colposcopy. Colposcopy if any abnormal Pap tests on follow-up screening.

· Atypical squamous cells of uncertain significance without inflammation or atrophy: Repeat Pap 6 months until 3 consecutive normals. A 1992 National Cancer Institute Workshop recommended that patients who have atypical squamous cells of uncertain significance have a follow-up Pap test every 6 months for two years until there have been three consecutive negative smears. At this point, routine screening can be resumed. Colposcopy if any abnormal Pap tests on follow-up screening.

Note: See the original guideline document for a discussion of the utility of human papillomavirus testing.

· Colposcopy: Colposcopy is recommended for any woman who has atypical squamous cells of uncertain significance qualified by a statement that a neoplastic/dysplastic process is favored or who had a previous abnormal Pap smear or premalignant diagnosis within the past five years.

Evidence supporting these conclusions is of classes: C, R

Atypical glandular cells of uncertain significance (AGUS):

· See the Bethesda System for characteristics of atypical glandular cells of uncertain significance.

Evidence supporting these conclusions is of classes: C, D

· Perform colposcopy, endocervical curettage; consider endometrial biopsy: Consider an endometrial biopsy to rule out endometrial cancer or hyperplasia.

Evidence supporting these conclusions is of classes: C, D

· Treat findings appropriately.

· If evaluation is normal, repeat evaluation within 6 months. If the evaluation results are normal, repeat the Pap in 6 months. If the results continue to be normal, resume routine annual screening. If the subsequent Pap results are not normal, initiate individualized treatment.

Low-grade squamous intraepithelial lesion (LSIL):

· See the Bethesda System for reporting criteria of low-grade squamous intraepithelial lesion. Current clinical practice is usually to perform a colposcopy. An alternative is to repeat the Pap smear.

Evidence supporting these conclusions is of classes: R

· Perform colposcopy and treat appropriately. The most common management option is to perform a colposcopy. One must be cautious about over aggressive biopsy and treatment. Specifically, routine loop electro-excision procedure (LEEP) of the transformation zone as a method for evaluating a low-grade squamous intraepithelial lesion Pap smear is not recommended.

Evidence supporting these conclusions is of classes: C, D, R, X

· Repeat Pap within 3 months: As an alternative to colposcopy, an optional follow-up Pap smear in three months is proposed by a 1992 National Cancer Institute Work Group as a management option for carefully selected women considered reliable for follow-up. Women should be considered low risk (e.g., nonsmoker, no prior abnormal Pap smears, low risk behavior). If the result is abnormal, colposcopy is indicated. If the result is normal, repeat Pap every 6 months until 3 consecutive normals.

Evidence supporting these conclusions is of classes: D

High-grade squamous intraepithelial lesion (HSIL):

· See the Bethesda System for reporting criteria of high-grade squamous intraepithelial lesion.

Evidence supporting these conclusions is of classes: C, R

· Colposcopy with biopsy and/or loop-electro-excision procedure (LEEP): Colposcopic examination of the cervix with a directed biopsy is the established appropriate evaluation of women with high-grade squamous intraepithelial lesion Pap smear reports. ECC should be performed if no lesion can be visualized. At the discretion of the physician, a loop electro-excision procedure may be performed at the time of the initial colposcopy.

· Review with pathologist: If colposcopic histology reveals mild dysplasia or normal results, the clinician must not assume that such results are satisfactory. Discordance between the Pap report of high-grade squamous intraepithelial lesion and the histology report of normal or only mild abnormalities requires careful consideration and review of both pathology reports (Pap and biopsy) with the pathologist. The loop electro-excision procedure might still be the most appropriate management strategy, even in the face of normal or mild dysplasia reported on the colposcopic histology and colposcopic biopsy.

· Appropriate gynecologic therapy: Appropriate therapy depends on patient demographics, childbearing potential, the findings at pathology and the overall clinical situation. Therapies to be considered include: Loop electro-excision procedure, conization (with or without laser), cryotherapy (used less often since it does not result in tissue for confirmatory histologic examination) or hysterectomy.

If invasive cancer is discovered, then consultation with a gynecologic oncologist to assist with definitive staging and treatment is indicated.

Adenocarcinoma in situ (ASI)/Malignant cells present:

· Out of the scope of the current guideline

Definitions:

Rating Scheme for the Strength of the Evidence

Evidence Grading System: Classes of Research Reports:

A. Primary Reports of New Data Collection:

Class A:

· Randomized, controlled trial

Class B:

· Cohort study

Class C:

· Non-randomized trial with concurrent or historical controls

· Case-control study (except as above)

· Study of sensitivity and specificity of a diagnostic test

· Population-based descriptive study

Class D:

· Cross-sectional study

· Case series

· Case reports

B. Reports that Synthesize or Reflect upon Collections of Primary Reports

Class M:

· Meta-analysis

· Decision analysis

· Cost-benefit analysis

· Cost-effectiveness study

Class R:

· Review article

· Consensus statement

· Consensus report

Class X:

· Medical opinion

Edward E. Rylander, M.D.

Diplomat American Board of Family Practice.

Diplomat American Board of Palliative Medicine.