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ACP: Average-risk women should not undergo routine pelvic exams
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The harms of pelvic exams outweigh the benefits and therefore should not be used routinely in asymptomatic women at average-risk for ovarian cancer, according to an American College of Physicians guideline published today in Annals of Internal Medicine.
“Routine pelvic examination has not been shown to benefit asymptomatic, average risk, non-pregnant women,” Linda Humphrey, MD, guideline co-author and member of the American College of Physicians’ (ACP) Clinical Practice Guideline Committee, said in a press release. “It rarely detects important disease and does not reduce mortality, and [it] is associated with discomfort for many women, false positive and negative examinations and extra cost.”
The guideline also states pelvic examinations are not necessary before prescribing oral contraceptives, and urine testing or vaginal swabs may be used in lieu of pelvic examinations when screening for sexually transmitted diseases. Cervical examinations for cancer and HPV should be limited to visual examinations and cervical swabs, according to the guidelines.
However, pelvic examinations are warranted in women with symptoms such as vaginal discharge, abnormal bleeding, pain, urinary problems and sexual dysfunction.
The guideline was based on a report published by Bloomfield and colleagues, who reviewed data from three studies that evaluated the diagnostic accuracy of pelvic examinations for detecting ovarian cancer. The studies included 5,633 asymptomatic women who had an average risk for disease.
In one of the studies, researchers detected no cases of ovarian cancer by pelvic exam. In the other two studies, the positive predictive values of the exam for ovarian cancer were 1.2% and 3.6%. However, these studies were not powered to evaluate screening’s impact on ovarian cancer-related morbidity or mortality.
An additional analysis on the PLCO trial conducted by Humphrey and colleagues demonstrated pelvic exams or screening with CA-125 or transvaginal ultrasonography were not associated with reduced ovarian cancer mortality.
Bloomfield and colleagues then reviewed 14 surveys and one longitudinal cohort study that evaluated harms associated with screening. Data from one study indicated 31 (18%) of 2,000 women screened underwent surgery due to follow-up test results, leading to the detection of ovarian cancer in two women. Therefore, researchers calculated that 1.5% of the total population screened underwent unnecessary surgery.
Pain or discomfort from the pelvic examination occurred in a median 35% (range, 11% to 60%) of women in eight evaluable studies. A median 34% (range, 10% to 80%) of women from seven studies reported fear, embarrassment or anxiety associated with the exam.
One study found women who had not experienced pain during a previous pelvic exam were significantly more likely to undergo the exam again compared with women who had experienced pain (OR=1.73; 95% CI, 1.08-2.83).
Researchers estimated that the total annual cost associated with preventive gynecologic examinations was $2.6 billion.
“With the current evidence, we conclude the performing pelvic examination exposes women to unnecessary and avoidable harms with no benefit,” Humphrey and colleagues wrote. “In addition, these examinations add unnecessary costs to the health care system. These costs may be compounded by expenses incurred by additional follow-up tests, including follow-up tests as a result of false-positive screening results, increased medical visits and costs of keeping or obtaining health insurance.”
The guideline likely will be controversial, George F. Sawaya, MD and Vanessa Jacoby, MD, MAS, both of the department of obstetrics, gynecology and reproductive sciences at University of California, San Francisco, wrote in an accompanying editorial.
Detecting noncancerous masses is an important goal of the exams according to many obstetrician-gynecologists, yet the studies in the review did not assess this outcome, according to Sawaya and Jacoby.
“The pelvic examination has held a prominent place in women’s health for many decades and has become more of a ritual than an evidence-based practice,” they wrote. “Regardless of whether the ACP’s recommendation changes practice among obstetrician-gynecologists, it should prompt champions of this examination to clarify its goals and quantify its benefits and harms.”
For more information:
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Bloomfield HE. Ann Intern Med. 2014;doi:10.7326/M13-2881.
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Sawaya GF. Ann Intern Med. 2014;doi:10.7326/M14-1205.
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Qaseem A. Ann Intern Med. 2014;doi:10.7326/M14-0701.
Disclosure: Sawaya and Jacoby report no relevant financial disclosures. See the guideline for a full list of the researchers’ relevant financial disclosures.
Perspective
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David M. Gershenson, MD
The time-honored annual pelvic exam/Pap smear is a thing of the past. The national guidelines for Pap smear screening for cervical pathology have changed dramatically over the past few years, and we are currently in a transition period in which the Pap smear may soon become obsolete and completely replaced by HPV testing.Now the American College of Physicians has announced a clinical guideline that recommends against performing screening pelvic exams in asymptomatic, nonpregnant adult women. Their rationale principally relates to the harms/benefit ratio and unnecessary costs to the health care system. Importantly, this recommendation does not include pregnant women, those with gynecologic symptoms, or women undergoing cervical exams for cancer and HPV.
The authors admit that no studies surveyed addressed the diagnostic accuracy of pelvic exam for gynecologic cancers other than cervical or ovarian cancer or benign gynecologic conditions. Nor did this study evaluate the potential indirect benefit of annual pelvic exam to serve as an incentive for women to access health care for gynecologic services, such as contraception, STD screening or other gynecologic care.
Predictably, the gynecologic community has responded. Although admitting that no evidence supports or refutes the annual pelvic exam for asymptomatic, low-risk women, many gynecologists continue to urge women to have annual visits to their health care providers to promote healthy living and preventive care, for evaluation of risk factors for medical conditions, and to identify existing medical conditions. Furthermore, women see OB/GYNs for different issues than they visit internists. OB/GYNs perform pelvic exams not only to find pathology but also to confirm normalcy, explain anatomy, and to diagnose such conditions as urinary incontinence or sexual dysfunction. Also, a pelvic exam provides women with the opportunity to express concerns about potentially embarrassing issues they may not discuss with an internist.
In my view, this guideline’s most significant impact is that it will hopefully encourage women to discuss the pros and cons of having a routine pelvic exam with their health care providers. This story is far from resolved; it likely will prompt further studies and commentary, and it will be of interest to follow what influence the guideline has on CMS and other third-party payers.
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William J. Hoskins, MD
In its recent clinical practice guideline on pelvic examination, the American College of Physicians states that there is no scientific evidence to support routine bimanual examination of adult women in the absence of symptoms of abnormality. The new guideline is based on a systematic review of the English-language literature from 1964 to January 2014 by Bloomfield and colleagues.The guideline committee authors indicate the need for visualization of the cervix and the need to obtain a Pap smear for cervical cancer screening, and they indicate that it is appropriate to obtain a swab for the diagnosis of infectious diseases under certain circumstances. They state, however, that the bimanual palpation of the uterus and ovaries is not indicated in the absence of abnormal symptoms, and they explain that there are no good clinical trials in the medical literature that indicate this examination is effective. The authors provide limited evidence that false-positives from such examinations may actually be harmful.
The American College of Obstetricians and Gynecologists (ACOG), in a committee opinion published in August 2012, reiterated its recommendation for annual pelvic examination in adult well women (aged ≥21 years) to include inspection of the external genitalia; inspection of the vagina and cervix; and a bimanual palpation of the cervix, uterus, and adnexal area. It states, however, that this recommendation is based on expert opinion and not on evidence from clinical trials. The opinion also states that pelvic examination is only part of the general well-woman visit, which also includes a medical history and a physical examination, including breast exam.
In a June 2014 press release, ACOG again confirmed its recommendation for routine-screening pelvic examinations for well, adult women, emphasizing that the pelvic examination is only part of an annual well-woman visit, which also features health assessment and health care counseling.
Although there are no scientific data other than expert opinion to support bimanual pelvic examination, its use is clearly only part of a larger question of the role of periodic health assessments in healthy adults. The ACP clinical guideline on screening pelvic examination does not address this larger issue. The ACOG statement recommends an annual well-woman examination but offers no clinical trial data to support its opinion.
Clearly, there are indications for prospective clinical trials to address these issues, and any such trials should evaluate cost-effectiveness as a component of the larger analysis.
References:
Bloomfield HE. Ann Intern Med. 2014;161:46-53.
The American College of Obstetricians and Gynecologists. Committee opinion: Well-Woman Visit. Available at: www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Well-Woman-Visit. Accessed on Aug. 14, 2014.
The American Congress of Obstetricians and Gynecologists. ACOG Practice Advisory on Annual Pelvic Examination Recommendations. Available at: www.acog.org/About-ACOG/News-Room/College-Statements-and-Advisories/2014/ACOG-Practice-Advisory-on-Annual-Pelvic-Examination-Recommendations. Accessed on Aug. 14, 2014.
Qaseem A. Ann Intern Med. 2014;161:67-72.
Perspective
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Aparna Kamat, MD
The American College of Physicians (ACP) published new guidelines that state that healthy, asymptomatic, average-risk women do not need pelvic examinations as part of their annual examinations. Based on its review of the scientific evidence, the ACP concluded routine pelvic examinations have no demonstrated benefit and are not good screening tools for ovarian cancer, and expressed fear that the discomfort and anxiety associated with these examinations will deter women from accessing health care.In clinical practice, the utility of pelvic examinations — as with other aspects of a physical examination — is to assure normalcy of anatomy, to detect gynecologic conditions that may be asymptomatic, and to address issues such as sexual dysfunction and urinary incontinence, which many women think are a normal part of aging. In addition, many women with gynecologic problems have nonspecific symptoms that they fail to recognize as being important for further investigation.
In most cases, by the time a patient does become symptomatic enough to get a pelvic examination, they present with advanced-stage disease. Rather than asking women to forgo this essential part of their health care evaluation due to concerns of discomfort and embarrassment, it is our responsibility to make these examinations more comfortable for our patients. Finally, the American College of Obstetrics and Gynecology issued a statement in response to the ACP guidelines that continues to endorse pelvic examinations as an integral part of a woman’s annual health care evaluation.
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