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A new solution to confusing Pap smear reports

Revised terminology aims to clarify which patients need follow-up care

From the November ACP-ASIM Observer, copyright 2001 by the American College of Physicians-American Society of Internal Medicine.

By Gina Rollins

In the coming months, physicians will notice some important changes in lab reports explaining Pap smears.

The good news is that changes to the Bethesda System terminology—which is used to grade and report cervical cytopathology—will eliminate some confusing terms and definitions and clarify findings that require further evaluation. The changes should also help physicians make decisions about appropriate follow-up care.

But while the new format may make lab results easier to interpret, there could be a slight downside for physicians. Experts caution that physicians will have to carefully read the comments section to learn about cellular characteristics.

The changes were approved in September, but it may take several months before all laboratories begin using the new nomenclature. Some labs, however, may have already started to implement the new terminology.

Here is an overview of the most significant updates and how they will affect your practice.

Specimen adequacy

The Bethesda System 2001 reflects new research findings and changes in practice related to cervical disease over the past decade. It also contains modifications designed to make the system less confusing to physicians.

For years, physicians have complained that the current system describing the adequacy of patient specimens as "satisfactory but limited by" is confusing. Does it mean you need to perform another Pap smear, or simply note that the sample had some obscuring elements like blood or inflammation?

Under the new system, all specimens will be ranked as either "satisfactory" or "unsatisfactory," with comments explaining the presence of any obscuring factors or reasons for rejecting a sample.

The goal of the new language is to clarify when physicians need to repeat a Pap smear. "The thought was, 'We won't bother you with satisfactory but limited by,' because basically, what do you do with it?" said Pamela Stratton, MD, chief of the gynecological consultation service at the National Institutes of Health Clinical Center in Bethesda, Md. The change is not expected to alter patient management, but it may force physicians to spend a little more time reading lab reports.

"Previously, the term 'satisfactory but limited by' provided a flag for specimens with inflammation or lots of endocervical cells," explained Thomas C. Wright, MD, director of gynecological pathology at Columbia University College of Physicians and Surgeons in New York. "Now, physicians will have to delve further into the report to find out about those things. I argued that eliminating that flag was not necessarily a good thing."

If a specimen is deemed unsatisfactory, it will now fall into one of two categories: rejected and not processed at all (due, for example, to a broken slide) or processed and found inadequate for other reasons (obscured by blood, for example).

Categorization changes

The Bethesda System 2001 also includes changes in how specimens are categorized. While both the old and the new system use three general categories to describe Pap smears, the new terminology uses clearer categories that should eliminate some confusion.

The new system will use three streamlined categories—"negative," "epithelial cell abnormality" and "other"—to clearly tell physicians whether a result is negative or positive. Whenever a Pap smear report indicates either "epithelial cell abnormality" or "other," it will offer additional interpretations and diagnoses.

The "other" category will be added to account for conditions such as non-epithelial malignancies and exfoliated endometrial cells in samples taken from women age 40 or older.

The new categories "reinforce what a Pap smear is really for," explained Pamela Charney, FACP, director of the internal medicine residency program at Norwalk Hospital in Norwalk, Conn., and clinical professor of medicine at the Albert Einstein College of Medicine in New York. "It's a test for cervical cancer, not something else. This just tells you there's no evidence of cancer." Dr. Charney is editor of the College's book series on women's health.

Because clinically significant changes will be described later in the report, Columbia's Dr. Wright noted, "Providers will have to read the report much more carefully."

Labs aren't required to use any of the three general categories under Bethesda System 2001, nor were they required to use the categories under the old system.

Interpretation and results

When a specimen reveals epithelial cell abnormalities, they will fall into one of two categories: squamous cell or glandular cell problems.

Squamous cells. When describing findings of atypical squamous cells, the old terminology used language that many physicians found subjective and inconsistent. To clarify findings, the new terminology will use two labels to describe atypical squamous cells: "undetermined significance" and "cannot exclude high-grade intraepithelial lesions."

Atypical squamous cells will be categorized as "of undetermined significance" when the specimen shows signs of cytologic changes that suggest a low-grade squamous intraepithelial lesion, but lacks criteria for a definitive interpretation.

The category incorporates research findings over the past decade showing that only a fairly small percentage of atypical squamous cells of undetermined significance ever progress to cervical intraepithelial neoplasia or show evidence of oncogenic human papillomavirus DNA. "We wanted to highlight those that are more likely to be abnormal and have evidence of precancer," explained Dr. Stratton from the NIH.

The modifier "cannot exclude high-grade intraepithelial lesions," on the other hand, will describe the estimated 5% to 10% of specimens that have cell changes that suggest—but do not absolutely indicate—a high-grade squamous intraepithelial lesion. A high proportion of these cells, perhaps 20%, is associated with high-grade intraepithelial lesions.

The latter modifier, experts say, should tell physicians that the patient needs more extensive diagnostic follow-up. "This change gives us more guidance about how to manage these results," according to Sandra Adamson Fryhofer, MACP, Immediate Past President of ACP-ASIM and a practicing internist in Atlanta. "Now it's clear that we should refer these patients for colposcopy now rather than wait six months, do another Pap and then refer for colposcopy only if the second Pap shows atypical squamous cells."

Glandular cells. The glandular cell interpretation results section of the new terminology will no longer use a modifier saying that an atypical glandular cell is of "undetermined significance." The acronym for this modifier, AGUS, was too similar to the acronym for atypical squamous cells of undetermined significance, ASCUS. As a result, experts decided to eliminate it.

Because recent research has indicated that atypical glandular cells are likely to be precancerous, experts emphasize that any findings noting atypical glandular cells require further evaluation.

Also in the glandular cell interpretation results section, the new terminology will add the term "endocervical adenocarcinoma in situ." Research conducted over the past decade suggests samples with this result need further evaluation.

More than 40 professional organizations took part in discussions about the new terminology and are expected to endorse the Bethesda System 2001 terminology. It will be published in various professional publications over the coming months and is available online at www.bethesda2001.cancer.gov.

In addition, the American Society for Colposcopy and Cervical Pathology plans to issue management guidelines based on the new terminology, probably by March 2002.

Gina Rollins is a freelance writer in Silver Spring, Md.

New Pap smear terminology: a look at the key changes

The Bethesda System 2001 terminology has eliminated much of the language that physicians found confusing. Here is an overview of the new language that will be used in Pap smear reports.

Specimen adequacy
- Satisfactory
- Unsatisfactory

General categories
- Negative for epithelial lesion or malignancy
- Epithelial cell abnormality
- Other

Interpretation/results
Atypical squamous cells (ASC)

- Undetermined significance (ASC-US)
- Cannot exclude high-grade intraepithelial lesions (ASC-H)

Atypical glandular cells
- Atypical glandular cells (no acronym will be used)
- Endocervical adnocarcinoma in-situ

The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of the ACP-ASIM.

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