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.