Published: Jun 30, 2014
By Charles Bankhead, Staff Writer, MedPage Today

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Action Points

• Average-risk, asymptomatic women do not benefit from pelvic exams as part of routine care and face potential harms from false-positive results according to the American College of Physicians.
• Note that the ACP guidelines would seem to be at odds with recommendations released in 2012 by the American College of Obstetricians and Gynecologists that acknowledge the limitations of a routine pelvic exam but emphasize the potential benefits.

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Average-risk, asymptomatic women do not benefit from pelvic exams as part of routine care and face potential harms from false-positive results, according to a new clinical guideline.

When screening for cervical cancer, clinicians should limit the physical examination to visual inspection of the cervix and use of cervical swabs for cancer or human papillomavirus, said a panel of clinical specialists convened by the American College of Physicians (ACP).

A review of more than 60 years’ worth of medical literature did not produce compelling evidence that the benefits of routine pelvic exams outweigh the potential harms, the panel concluded in a statement published online in Annals of Internal Medicine. Instead, the authors of the guideline found that screening pelvic exams have a low diagnostic accuracy for both cancer and infections.

“Our guidelines really have to do with women who do not have symptoms, who do not have a discharge or bleeding or pain,” guideline panelist Russell Harris, MD, of the University of North Carolina in Chapel Hill, told MedPage Today. “Those women clearly need a pelvic examination, and that’s fine.”

“Our guidelines talk about screening of asymptomatic women who are not pregnant. Those women simply don’t need the exam. It’s not something that is useful for them.”

The guideline also does not apply to women who are due for cervical cancer screening, he added.

Preventive Care

Preventive gynecologic services cost the healthcare system an estimated $2.6 billion annually. In citing that figure, the ACP panel did not indicate how much of the total involves pelvic examinations. The authors did say that pelvic exams often are performed in women who are not due for cervical cancer screening and that “many women and clinicians believe that the pelvic examination should be part of annual wellness visits for women.”

In an effort to provide evidence-based recommendations for pelvic exams, the ACP convened a panel of clinical specialists representing primary care, obstetrics and gynecology, and gynecology oncology. The panel developed recommendations after reviewing the findings of a systematic evidence review and a background article (also published online in Annals).

The background article summarized results of a review of published literature from 1946 to 2014. The authors identified 52 studies, which formed the basis for the article, reported Hanna E. Bloomfield, MD, MPH, of the Minneapolis Veterans Affairs (VA) Health Care System, and colleagues.

In general, the studies provided little support for routine pelvic exams in average-risk, asymptomatic women who were not pregnant.

The data showed a positive predictive value for ovarian cancer of less than 4%, a figure based on two studies that reported the outcome. The authors found no studies that examined the morbidity or mortality benefits of screening pelvic exams for any condition.

Eight studies, involving a total of 4,576 women, showed that 11% to 60% (median 35%) of the patients reported pain or discomfort related to pelvic exams. Seven studies involving more than 10,000 patients showed that 10% to 80% (median 34%) of women said pelvic exams caused fear, embarrassment, and anxiety.

Lack of Data

“No data supporting the use of pelvic examination in asymptomatic, average-risk women were found,” the authors concluded. “Low-quality data suggest that pelvic examinations may cause pain, discomfort, fear, anxiety, or embarrassment in about 30% of women.”

After reviewing the background article and evidence review, the guideline panel offered a single but unequivocal recommendation: “ACP recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women.”

The panel delineated several points that led to the recommendation:

• Current evidence showed that harms outweigh any demonstrated benefits associated with screening pelvic exams.
• Indirect evidence showed that routine pelvic exams do not reduce morbidity or mortality from ovarian cancer.
• The addition of more sensitive tests, such as CA-125 and transvaginal ultrasound, did reduce morbidity or mortality from ovarian cancer.
• No study assessed the potential benefits of routine pelvic exams for other gynecologic conditions, including asymptomatic pelvic inflammatory disease, benign conditions, or gynecologic cancers other than cervical or ovarian cancer.
• Low-quality evidence suggests that screening pelvic exams can lead to harms, including fear, anxiety, embarrassment, pain, and discomfort, which may lead some women to avoid medical care.
• False-positive results may lead to unnecessary laparoscopies or laparotomies.

 

The authors emphasized that the guideline is limited to screening for average-risk, asymptomatic women.

“Full pelvic examination with bimanual examinations is indicated in some nonscreening clinical situations,” they stated. “This guideline does not address women who are due for cervical cancer screening.”

Competing Guidelines?

The ACP guidelines would seem to be at odds with recommendations released in 2012 by the American College of Obstetricians and Gynecologists (ACOG). The ACOG recommendations acknowledge the limitations of a routine pelvic exam but emphasize the potential benefits.

“The College guidelines recommend that a pelvic examination be performed on an annual basis in all patients aged 21 years and older. No evidence supports or refutes the annual pelvic examination or speculum and bimanual examination for the asymptomatic, low-risk patient.

“An annual pelvic examination seems logical, but also lacks data to support a specific time frame or frequency of such examinations. The decision whether or not to perform a complete pelvic examination at the time of the periodic health examination for the asymptomatic patient should be a shared decision after a discussion between the patient and her healthcare provider.”

In a prepared statement, ACOG officials described their recommendations and those of ACP as “complementary.”

“The College’s guidelines, which were detailed in our Committee Opinion on the Well-Woman Visit, acknowledge that no current evidence supports or refutes an annual pelvic exam for an asymptomatic, low-risk patient, instead suggesting that the decision about whether to perform a pelvic examination be a shared decision between healthcare provider and patient, based on her own individual needs, requests, and preferences.”

In the same statement, ACOG President John C. Jennings, MD, said, “”We continue to urge women to visit their healthcare providers for annual visits, which play an important role in patient care. An annual well-woman visit can help physicians to promote healthy living and preventive care, to evaluate patients for risk factors for medical conditions, and to identify existing medical conditions, thereby opening the door for treatment. Annual well-woman visits are essential for quality care of women and their continued health.”

Acknowledging the differing conclusions reached by the ACP and ACOG, a co-author of the ACP recommendation said guideline reflects the organization’s emphasis on evidence-based clinical practice.

“We’ve come to different conclusions, although I think everyone has the patient’s best interests at heart,” said Linda L. Humphrey, MD, of Oregon Health & Science University and the VA Medical Center, both in Portland.

Differing Opinions

Striking a balance between opposing views, the authors of an accompanying editorial said the long history of the annual pelvic exam “has come to be more of a ritual than an evidence-based practice.”

“With the current state of evidence, clinicians who continue to offer the examination should at least be cognizant about the uncertainty of its benefits and its potential to cause harm through false-positive testing and the cascade of events it prompts,” said George Sawaya, MD, and Vanessa Jacoby, MD, of the University of California San Francisco.

In general, clinicians contacted by MedPage Today gave a thumbs-down to the ACP recommendation.

“These guidelines, though well intended I’m sure, only serve to weaken the doctor-patient relationship,” said Marc Leavey, MD, of Mercy Health Services in Baltimore.

“I think they’re being penny wise and pound foolish with this one as part of a general scheme to remove the doctor from the relationship,” he added. “We’re no longer supposed to examine breasts or perform testicular examinations or other types of exams that go back to the old days of a physician who actually cared about his patients.”

Though understanding of the reasoning behind the guideline, medical oncologist Robert Morgan Jr., MD, of City of Hope in Duarte, Calif., said he’s concerned about the downstream effects of eliminating routine testing.

“If we take routine testing out of the usual practices of women in society, then other very important practices, particularly screening Pap smears for cervical cancer, will tend to be neglected,” Morgan said.

The guidelines won qualified support from Vanessa Barnabei, MD, of the University at Buffalo in Buffalo, N.Y.

“In general, I do agree,” Barnabei said. “The pelvic exam, which we always have done in screening for abnormalities, is not a very sensitive exam for that. I long ago stopped doing pelvic exams for women coming in just for contraception.”

However, the longstanding practice of annual pelvic exams, particularly with its historical association with the Pap test, will require a long time to change, she added.