Released July 1, 2016

Under the editorship of NAMS Executive Director JoAnn V. Pinkerton MD, NCMP, First to Know presents commentary on the latest, breaking scientific articles as suggested by members of The North American Menopause Society (NAMS), the leading nonprofit scientific organization dedicated to improving women’s health and quality of life through an understanding of menopause and healthy aging. Opinions expressed in the commentary are not necessarily endorsed by NAMS or by Dr. Pinkerton.

USPSTF looks for public comment on routine pelvic exams draft evidence review

“There is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice.”

Guirguis-Blake JM, Henderson JT, Perdue LA,
Whitlock EP. Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the US Preventive Services Task Force. Evidence Synthesis
No. 147. AHRQ Publication No. 15-05220-EF-1. June 2016.

Summary. The US Preventive Services Task Force (USPSTF) has opened for public comment a draft evidence review on the necessity of annual well-woman pelvic examinations. The final evidence review will be used to inform the first-ever USPSTF recom- mendation statement on pelvic exams.

The USPSTF has pointed out that although some 60 million pelvic exams are done each year, the practice has not been very well studied and said that the current evidence is “insufficient” to determine the balance of benefits and harms of the pelvic exam.

The systematic review was written to support the USPSTF in creating its recommendation on the periodic screening pelvic examination. The authors sought to discover direct evidence for the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease-specific morbidity and mortality, and improving quality of life.

The authors performed a search of the medical literature published over the past 60 years. They located just eight studies looking at the diagnostic accuracy of pelvic exams for only four medical conditions: ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes.

In the four ovarian cancer screening studies, with more than 26,000 women screened, more than 96% of the positive test results were false positives, and many patients had unnecessary follow-up procedures. Surgery rates resulting from an abnormal pelvic examination ranged from 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and 1% complication rate within 1 year.

In the end, the authors found no studies that assessed how effective the exams are for reducing death and disease or improving quality of life.

The draft recommendation does not apply to women who are pregnant or those with existing conditions that need to be evaluated and does not recommend changes to current guidelines for cervical cancer screening.

The American College of Obstetricians and Gynecologists (ACOG) said in a June 28, 2016, statement on the draft recommendations that it continues to recommend an annual pelvic examination for women aged 21 years and older but acknowledges that there is a lack of data. Its Well-Woman Task Force in 2015 recommended annual external exams but said that internal speculum and bimanual exams for women without specific complaints or symptoms should be “a shared, informed decision between the patient and provider.” ACOG is reviewing the draft recommendation to decide whether it needs to update its own pelvic-exam guidelines.

The opportunity for public comment on the draft review evidence expires on July 25, 2016, at 8:00 PM EST. To comment, go to USPSTF draft evidence review.

Commentary. The Executive Committee of The North American Menopause Society (NAMS) strongly disagrees with the conclusion of the USPSTF draft evidence review, particularly as it applies to postmenopausal women. The only four outcome measures available for inclusion in the review—ovarian cancer (for which there is NO good method of detection), bacterial vaginosis, genital herpes and vaginal trichomoniasis—represent a narrow fraction of the key medical conditions screened during the pelvic exam and disregards the many

benefits of the pelvic exam. Although it is perhaps reasonable to recommend against the pelvic exam for diagnosing those four conditions, there is no scientific basis for extrapolating beyond those four specific conditions to the myriad conditions that affect women.

The pelvic exam is needed to screen for conditions such as the genitourinary syndrome of menopause that affects more than 50% of postmenopausal women, neoplasias, fibroids, pelvic floor conditions, and dermatologic conditions associated with elevated disease risks (eg, lichen sclerosis). Broadly, the conclusion to discontinue the exam runs counter to the goals of improving women’s health through preventive care. The recommendation to perform pelvic exams only if women complain of problems will lead to missed opportunities to diagnose pelvic issues. Being asymptomatic is not the same as being healthy or not having a problem. The recommendation to discontinue routine pelvic exams runs the risk of further marginalizing postmenopausal women.

We strongly encourage a call to action to comment on this draft recommendation and to have your voices heard BEFORE women lose their right to routine screening pelvic exams.

The NAMS 2016 Executive Board

JoAnn V. Pinkerton, MD, NCMP, NAMS Executive Director
Peter F. Schnatz, DO, NCMP, NAMS President
Marla Shapiro, MD, NCMP, NAMS President-elect
Pauline M. Maki, PhD, NAMS Past-President
James Liu, MD, NCMP, NAMS Treasurer
Gloria Richard-Davis, MD, FACOG, NAMS Secretary
Sheryl Kingsberg, PhD, NAMS Board Member

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