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.