The American College of Physicians (ACP) has issued a clinical practice guideline that strongly recommends against conducting pelvic examinations in asymptomatic, nonpregnant, adult women.
The recommendation, published in Annals of Internal Medicine, is based on a systematic review of relevant literature published from 1946 to 2014 that evaluated morbidity, mortality, and harms of the examination, which has long been considered a mainstay of the well-woman visit. The review by Bloomfield and colleagues concluded that there were no data to support the use of pelvic examinations in this patient population.
“Routine pelvic examination has not been shown to benefit asymptomatic, average risk, non-pregnant women,” Linda Humphrey, MD, MPH, a coauthor of the guideline and a member of ACP’s Clinical Practice Guidelines Committee, said in a press release. “It rarely detects important disease and does not reduce mortality and is associated with discomfort for many women, false positive and negative examinations, and extra cost.”
Pelvic examinations are traditionally used as a method to screen for pathologic conditions. The exam consists of a visualization of the external genitalia, speculum examination of the vagina and cervix, and bimanual examination of the uterus, cervix, and adnexa.
The American College of Obstetricians and Gynecologists currently recommends annual pelvic examinations be conducted in patients aged 21 years or older. Its most recent guideline, issued in 2012, states, “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 ACP guidelines states that when screening for cervical cancer, the recommended examination should be limited to visual inspection of the cervix and cervical swabs for cancer and, for some women, human papillomavirus (HPV), and the cancer screening exam does not need to include the bimanual examination.
Evidence for Recommendation
The review used as a basis for the ACP recommendation was a systematic review of 52 English-language studies that looked at the diagnostic accuracy, benefits, and harms of pelvic examinations in asymptomatic, nonpregnant, average-risk adult women.
The researchers found that pelvic exams had limited positive predictive value (about 3%) for ovarian cancer in the two studies identified that reported on this metric.
No studies were found that investigated the morbidity and mortality benefits of screening pelvic exams for the diagnosis of other types of cancer or benign gynecological conditions. In addition, no studies were found that investigated overdiagnosis, overtreatment, false reassurance, or diagnostic procedure-related harms that occurred from pelvic exams.
Results from eight studies indicated that pain or discomfort from a pelvic examination was reported in 11% to 60% of women. In addition, 10% to 80% of women experienced fear, embarrassment, or anxiety because of the exam.
In their discussion of the results, the researchers pointed out that the review had several limitations, including that only English-language studies were considered. In addition, there was an overall lack of data on diagnostic accuracy, morbidity, and mortality, and they admitted that “the studies reporting harms were generally low quality.”
Reaction to Recommendation
In an editorial published with the ACP recommendation, George F. Sawaya, MD, and Vanessa Jacoby, MD, MAS, of the University of California, San Francisco, predict that the recommendation is going to be controversial.
“Pelvic examination has long been considered a fundamental component of the well-woman visit, and 62.8 million were done in the United States in 2010,” they wrote. “Ending such a prevalent practice with widespread support among women’s health providers will be met with formidable challenges.”
Deborah Ottenheimer, MD, of New York Presbyterian Hospital, echoed this sentiment, pointing out that the study only looked at a small group of outcomes that are not the only relevant measures of the value of the pelvic examination.
“The thing that surprised me the most [about the recommendation] is that it is based on bad studies and on a lack of information,” Ottenheimer said. “Instead of putting out guidelines that may or may not limit care of women overall, they should have put out a call for research to specifically address these issues. I don’t have a problem with asking the question of whether they have value, but with the conclusion and with the basis for the conclusion.”
Addressing Women’s Health
This recommendation comes shortly after the U.S. Preventive Services Task Forces recommended in March 2012 to lengthen the interval of Pap smear screening from every year to every 3 years in women aged 21 to 65.
Both Ottenheimer and Adelaide G. Nardone, MD, a practicing obstetrician and gynecologist, worry that together, these two recommendations could change the face of the well-woman visit that has long been a mainstay of women’s health. Specifically, they worried that if women are told they do not need a Pap smear and they do not need a pelvic exam then they may begin to skip their annual visit to the ob/gyn.
“A lot of women view me as their primary care physician,” Nardone said. “These visits are very important. We get a reproductive history, domestic violence history, psychological history, substance abuse history, and they serve as valuable teaching moments for weight, diet, exercise, and other modifiable lifestyle behaviors.”
In addition, Nardone said that in her years of experience she has found a wide variety of health issues during a pelvic exam of women who are asymptomatic, including certain sexually transmitted diseases that present as skin infections, vulval intraepithelial neoplasia, vaginal warts, cervical warts, polyps, retained condoms or tampons and, in some cases, very large cysts that have the potential to rupture.
These changes to the well-woman visit are also of concern given that women have only just recently been guaranteed coverage of these preventive services through the Patient Protection and Affordable Care Act.
“I worry in today’s political climate that, as we chip away at these services, women’s health care will be degraded,” Ottenheimer said.
“During a basic physical examination, we still evaluate the eyes, ears, lymph nodes, heart, and lungs, even in patients who are asymptomatic,” Ottenheimer said. “Women’s bodies include the pelvis, and to begin to ignore that in a complete physical strikes me as odd.”
The ACP recommendation still advises to conduct pelvic examinations in women with symptoms, such as vaginal discharge, abnormal bleeding, pain, urinary problems, or sexual dysfunction.
In their editorial, Sawaya and Jacoby added that “the pelvic examination has held a prominent place in women’s health for many decades and 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.”
Bloomfield HE, Olson A, Greer N, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: an evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med.2014;161:46-53.
Oaseem A, Humphrey LL, Harris R, et al. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161:67-72.
Sawaya GF, Jacoby V. Screening pelvic examinations: right, wrong, or rite? Ann Intern Med. 2014;161:78-79.