Whither the annual bimanual pelvic examination?

Dr. Lockwood, Editor-in-Chief, is Dean of the Morsani College of Medicine and Senior Vice President of USF Health, University of South Florida, Tampa. He can be reached at DrLockwood@advanstar.com.

Recently, Qaseem and colleagues published an American College of Physicians (ACP) Clinical Guideline advising against pelvic examinations for the detection of pathological conditions in asymptomatic, nonpregnant, adult women.¹

This advisory has generated much commentary in the blogosphere and particularly among ob/gyns. Many women, upon hearing news reports concerning the ACP guidelines, will assume these recommendations are valid and that they no longer need annual pelvic exams. Moreover, some women may assume that since they no longer need such an exam, they also will not need to see their gynecologist annually.

When added to the confusion already rampant as to the need for mammograms and Pap smears, this ACP guideline will add yet another barrier to our ability to provide appropriate preventative care to our patients.

Are screening pelvic exams needed?

The Qaseem et al. study was a literature review conducted by the Minneapolis Veterans Affairs Health Care System’s Evidenced-based Synthesis Program center. The authors sought to assess the accuracy, benefits, and harms of screening pelvic examinations. They defined a pelvic exam as a “combination” of speculum and bimanual examination not including cervical cancer screening.

For this purpose, the authors conducted a MEDLINE search of relevant articles addressing these questions published from 1946 to 2014. Based on their findings, the ACP strongly recommended “against performing screening pelvic examinations in asymptomatic, non-pregnant, adult women” based on “moderate-quality evidence.” Potential harms cited included unnecessary laparoscopies or laparotomies, fear, embarrassment, anxiety, pain or discomfort and, ironically, avoidance of necessary care.

While I do believe there is a place for evidence-based medicine and I strongly support thoughtful, comprehensive, and data-rich analyses whose conclusions have robust statistical support, this study had none of those elements.

First the authors focused only on ovarian cancer and detection of bacterial vaginosis because those were the only conditions about which there were sufficient published data to draw tangential conclusions. (What is the old line about the inebriated fellow looking for his keys under the lamp post because that is where the light is shining?) As such, the authors failed to address the myriad of other reasons ob/gyns carry out bimanual exams, such as for detection of myomas, evidence of pelvic relaxation and stress incontinence, signs of endometriosis, chronic pelvic inflammatory disease, cervical polyps, vaginal cysts, etc.

Indeed the authors report that no studies directly address the utility of pelvic exams for any of these conditions. They also note that no studies have evaluated the potential indirect benefit of annual pelvic exams on non-ovarian and non-cervical cancer morbidity or mortality. Furthermore, they point out that no studies have evaluated the potential benefit of such exams as an incentive for women to access care and receive “recommended gynecological services, such as contraception, screening for sexually transmitted infections and other nongynecologcial care.”

The authors further admit that no studies actually address potential harms such as false reassurance, over-diagnosis, over-treatment, and diagnostic procedure-related harms even though these were the reasons they recommended against routine pelvic examinations! And they admit that studies examining pain, embarrassment, and fear are of low quality. Yet they confidently conclude that “current evidence shows that harms outweigh demonstrated benefits associated with the screening pelvic examination.”

The American College of Obstetricians and Gynecologists (ACOG) quickly responded to this ACP recommendation by directing providers to its “Well-Woman Visit” committee opinion.² This guideline recommends annual pelvic examinations for patients 21 years of age or older, noting that “this recommendation is based on expert opinion, and limitations of the internal pelvic examination should be recognized.”

ACOG also noted that “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 health care provider.” This is a far more reasonable position to hold since the absence of evidence for benefit is not the same as evidence of absence of benefit! I am frankly astonished at the certainty of the ACP conclusion.

Should a vaginal ultrasound be added to annual bimanual examination?

When faced with recommendations to change long-established practice based on preliminary, tentative, or frankly flimsy evidence, it is customary to recommend that large clinical trials be undertaken to permit a consensus. But in my opinion, in this case, that would be a waste of time.

My position is that the bimanual exam, while useful, is not sufficient to allow for an optimal contemporary assessment of reproductive tract pathology. Instead I would suggest that we ob/gyns double down on the utility of such exams by adding a vaginal ultrasound, performed at no cost, to annual bimanual exams.

How long did it take physicians to stop listening to patients’ hearts with their ear on the chest wall after René Laennec invented the stethoscope? Yet we are still performing this relatively crude bimanual evaluation when we can carefully assess the anatomy of the ovaries, tubes, myometrium, endometrium, and cervix in great detail and with astonishing clarity regardless of a patient’s body habitus. For two decades I have worked at institutions that have trained residents in both obstetrical and gynecological ultrasound. Multiple generations of practitioners are now extraordinarily adept at gynecological ultrasound. When cost is eliminated from the equation, the net potential benefit of this approach is substantial.

Evidence for the efficacy of gyn ultrasound

I am not the first to advocate for use of vaginal ultrasound as part of a routine gynecological examination. My colleague Dr. Steven Goldstein at New York University has been advocating for it for years.³ It has obvious utility in differentiating suspicious from benign cysts or myomas from ovarian pathology when a mass is suspected on bimanual examination.

The utility of ultrasound in assessment of abnormal endometrial bleeding is obvious. It can be used to longitudinally track the growth of myomas or identify early evidence of endometrial hyperplasia. Nevertheless, the pelvic exam still provides invaluable information about pelvic pathophysiology including the presence of pelvic organ prolapse. Detection of utero-sacral nodularity or a fixed retroverted uterus can help identify endometriosis. Vaginal pathology is also often better detected with a bimanual exam. As noted, because my proposal is not to charge the patient for such an ultrasound, cost would not be a factor. The only concern would be overdiagnosis and excessive interventions for benign lesions. The harm accruing such “false positives” would have to be weighed against the benefits of early detection of endometriosis, polyps, hyperplasia, myomas, adenomyosis, and incidentally detected endometrial and ovarian cancers. Thus, randomized trials would indeed be in order.

Take-home message

The ACP’s Clinical Guideline advising against pelvic examinations for the detection of pathological conditions in asymptomatic, nonpregnant, adult women is unfounded, ill timed, and ill considered. It is at best premature and non-evidence-based; at worst it will dissuade women from seeking appropriate preventative care and may be harmful. The ACOG guideline recommending annual pelvic examinations for patients 21 years of age or older should continue to be followed. Moreover, the utility of adding a no-cost vaginal ultrasound to such exams should be studied. Comparative effectiveness research is under assault from conservative members of Congress⁴ and studies such as that of Qaseem and colleagues will give these critics fresh ammunition.

References

1. Qaseem A, Humphrey LL, Harris R, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161(1):67–72.

2. Committee opinion No. 534: Well-woman visit. Committee on Gynecologic Practice. Obstet Gynecol. 2012;120(2 Pt 1):421–424. (Reaffirmed 2014)

3. Goldstein SR. routine use of office gynecologic ultrasound. J Ultrasound Med. 2002;21(5):489–492.

4. Iglehart JK. the political fight over comparative effectiveness research. Health Aff. 2010;29(10):1757–1560.