USPSTF: Insufficient Evidence for Pelvic Exam Screening

Diana Swift

June 28, 2016

Draft recommendations from the US Preventive Services Task Force (USPSTF) say there is insufficient evidence to assess the balance of benefits and harms for the use of pelvic examinations to detect gynecologic conditions in asymptomatic, nonpregnant women aged 18 years and older.

The task force conducted its first-ever review of the evidence for this practice and issued its draft recommendation statement and draft evidence review on June 28. "Screening for Gynecologic Conditions With Pelvic Examination" ranks the evidentiary data as "I" (insufficient for making a recommendation either for or against such screening). The task force has posted the draft recommendations, as well as its first-ever evidence review on this practice, on its website, and is asking for public input through July 25.

In 2010, more than 60 million pelvic exams were performed in the United States, according to the statement, and although pelvic exams are frequently performed as part of general physical exams, their utility in asymptomatic women is unclear. In its systematic evidence review, the task force found no studies evaluating the benefit of pelvic exam screening on all-cause mortality, disease-specific morbidity or mortality, or quality of life.

"Women with gynecologic symptoms or concerns should discuss them with their clinicians," said Maureen G. Phipps, MD, MPH, a task force member and chair of the Department of Obstetrics and Gynecology, Brown University's Alpert Medical School, Providence, Rhode Island, in a USPSTF news release. "There is not enough evidence to make a determination on screening pelvic exam in asymptomatic women for conditions other than cervical cancer screening, gonorrhea, and chlamydia."

The task force has made separate recommendations on screening for these three diseases, using tests that are often administered during pelvic examines, such as the Papanicolaou test, the human papillomavirus test, and nucleic acid amplification tests. It stressed that the current statement exclusively targets the use of pelvic exams to screen for other gynecologic conditions.

As for screening-related harms, the synthesis found insufficient evidence across most gynecologic conditions. In ovarian cancer, four studies of diagnostic accuracy reported false-positive rates of 1.2% to 8.7%, and false-negative rates of 0% to 100%. Surgery rates resulting from abnormal pelvic exams were 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and a 1% complication rate within a year of abnormal ovarian findings on pelvic examination.

Furthermore, the low prevalence of ovarian cancer in the general population resulted in low positive predictive values: in more than 26,000 patients screened in the four studies, more than 96% of the positive test results were false positives, the authors report.

Very few studies reported on false-positive/false-negative rates for the broader range of gynecologic conditions, and none quantified patient anxiety or other psychological harms related to pelvic exam screening. Diagnostic accuracy was evaluated in three other conditions: bacterial vaginosis (two studies), trichomoniasis (one study), and genital herpes (one study). These studies were performed in high-prevalence populations with large proportions of symptomatic patients, which limited drawing conclusions about the value of screening.

"Evidence is lacking and of poor quality, and the balance of benefits and harms cannot be determined," the statement authors write.

They note some discrepancy in current practice guidelines between general practitioners and specialists. Although the recommendations of the American College of Physicians and the American Academy of Family Physicians advise against screening pelvic exams in asymptomatic, nonpregnant adult women, the American College of Obstetricians and Gynecologists supports annual pelvic examinations for all women, starting at age 21 years.

"The Task Force is calling for more research to better understand the benefits and harms of performing screening pelvic exams in women without any complaints or symptoms," said task force member Francisco García, MD, MPH, a professor of public health, obstetrics and gynecology at the University of Arizona in Tucson, Arizona, in the news release.

In a prepared statement, Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists (ACOG), said, "As the nation's leading group of physicians providing health care for women, ACOG stresses that women should see their ob-gyns at least once a year. In addition to the screenings, evaluations and counseling that clinicians can provide, the annual well-woman visit is an opportunity for the patient and her ob-gyn to discuss whether a pelvic examination is appropriate for her."

He continued, "ACOG is reviewing the USPSTF's draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination. ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized."

The authors have disclosed no relevant financial relationships.

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