Risa B. Burns, MD, MPH; Jennifer E. Potter, MD; Hope A. Ricciotti, MD; Eileen E. Reynolds, MD
Acknowledgment: The authors thank the patient for sharing her story.
Grant Support: Beyond the Guidelines receives no external support.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1220.
Requests for Single Reprints: Risa B. Burns, MD, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, E/Yamins 102, 330 Brookline Avenue, Boston, MA 02215; e-mail, email@example.com.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Current Author Addresses: Drs. Burns, Potter, and Reynolds: Division of General Medicine and Primary Healthcare, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215.
Dr. Ricciotti: Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215.
Burns RB, Potter JE, Ricciotti HA, Reynolds EE. Screening Pelvic Examinations in Adult Women: Grand Rounds Discussion From the Beth Israel Deaconess Medical Center. Ann Intern Med. 2015;163:537-547. doi: 10.7326/M15-1220
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Published: Ann Intern Med. 2015;163(7):537-547.
Appendix: Questions and Comments
Pelvic examinations have historically been a part of regular preventive care. However, because women can now be screened for cervical cancer at intervals up to every 5 years, the question of whether women need to be seen annually for routine pelvic examinations has arisen. In July 2014, the American College of Physicians (ACP) issued a guideline presenting the available evidence on screening for pathologic conditions using pelvic examination in adult, asymptomatic women at average risk. The American College of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice had previously issued a committee opinion in August 2012 on the need for annual examinations and provided guidelines on important elements of this procedure, including when to examine asymptomatic women. ACOG reaffirmed its initial position after publication of the ACP guideline. The guidelines differ—the ACP guideline recommends against and the ACOG committee opinion recommends
in favor of routine annual pelvic examination. This paper summarizes a discussion between an internist and a gynecologist on how they would balance these recommendations in general and what they would suggest for an individual patient.
Beyond the Guidelines is an educational feature based on recent guidelines. Each one considers a patient who “falls between the cracks” of available evidence and for whom the optimal clinical course in unclear. Presented at Beth Israel Deaconess Medical Center (BIDMC) Grand Rounds, each conference reviews the background evidence and 2 experts then discuss the patient and field audience questions. Videos of the patient and conference, slides, and a CME/MOC activity accompany each article. For more information, visit www.annals.org/GrandRounds.
Series Editor, Annals: Deborah Cotton, MD, MPH
Series Editor, BIDMC: Risa B. Burns, MD, MPH
Series Assistant Editors: Eileen E. Reynolds, MD; Gerald W. Smetana, MD
This article is based on the Department of Medicine Grand Rounds conference held on 12 March 2015.
Moderator: Eileen E. Reynolds, MD
Discussants: Jennifer E. Potter, MD; Hope A. Ricciotti, MD
Patient Interview and Grand Rounds videos
Questions and comments
Ms. C is a healthy, 41-year-old woman who recently visited her primary care physician for a periodic health examination. She has had annual mammograms since she was 40 years of age and has had Papanicolaou (Pap) tests every 3 years.
Her medical history includes gastroesophageal reflux, migraine headaches, and scoliosis. Her surgical history includes several procedures on her right knee. There is no family history of breast, cervical, ovarian, or colon cancer.
Ms. C receives norethindrone, 0.35 mg, once daily. Her only other medications are ibuprofen, 800 mg, as needed for pain; acetaminophen as needed for headaches; and calcium and vitamin D daily.
She lives with her son and works as an administrator. She does not smoke cigarettes and rarely drinks alcohol. She exercises regularly.
At the time of her visit, Ms. C's blood pressure was 124/81 and her body mass index was 25.2. On pelvic examination, she had normal external genitalia, vagina, and cervix. She had a Pap test but no bimanual examination (BME).
By 18, I was a senior in high school and had become sexually active, and that's when I felt like, “Oh, I guess it's time to go in and get checked.” I remember the doctor saying, “If you are going to be active you've crossed the line and you are a woman now. So you need to have an examination every year.” I know the examination includes the Pap test itself using the speculum, then the manual checkup, and usually when the speculum is in they do the swabbing and that's pretty much it.
The manual exam always felt funny. I can't imagine anyone doesn't think it feels funny, but in my mind, because they are medical professionals, I believed it was necessary. If something was wrong they would feel it, they would know it—even though I have no clue what they're doing. I figured that they could feel my ovaries—I don't know if that's true or not. I always assumed that the manual examination was to feel my ovaries, and they would be able to feel if there was a funny lump or if they were shaped wrong.
It is the biggest examination when you go for your yearly physical. That part of the body is sensitive and complicated, and it's not like you can look to see. I can't tell if something is wrong, so when I get that letter after my physical and it says everything came back normal, I'm usually relieved.
When I saw my doctor for my most recent Pap test, she mentioned that they were starting to recommend 5-year intervals for that test. I gave a look like, “Oh, no. This is not going to work.” So I started to ask questions—Won't they miss something? And she told me that a Pap smear only tests for cervical cancer, and that no one was sure even how helpful the manual examination is, and I am thinking of all the years that I had manual exams done that I could have done without.
I do want to see proof. I respect the professionals, so if you can provide proof from whatever studies have been done, then I think I would be more comfortable. Otherwise, I am going to think, “Oh, insurance companies are trying to save money; that's why they're doing that to us.” I don't want to believe that. I want to believe that your patients' health is foremost in your minds and that your research has proven that the exam is pointless. Then I would be okay with it.
See the Patient Interview video to view the patient telling her story.
Routine pelvic examinations have been a part of regular preventive care for decades—62.8 million were performed in the United States in 2010 (1). Historically, this examination was done in conjunction with annual cervical cancer screening. However, since cervical cancer screening can now be performed at intervals of up to every 5 years (2), depending on the patient, whether women need to see their physician annually for a routine pelvic examination is being questioned. Many women and providers continue to believe that routine examination should be a part of the well-woman visit (3). And yet, performing routine pelvic examinations places women at risk for unnecessary procedures and adds direct and indirect health care costs as well as opportunity costs (4).
It is helpful to review the 3 parts of a pelvic examination. First, the external genitalia, including the urethral meatus, vaginal introitus, and perianal region, are visually examined. Next, the speculum examination allows both visual examination of the vagina and cervix and specimen collection for cervical cancer screening. Third, the speculum is removed and the BME is done to palpate the uterus, ovaries, and adjacent structures.
In July 2014, the American College of Physicians (ACP) issued a guideline to present the available evidence regarding the screening pelvic examination for adult, asymptomatic, average-risk, nonpregnant women and recommended against it (5). The American College of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice had previously issued a committee opinion, in August 2012, supporting the need for annual screening and provided guidelines on important elements of the annual examination (3). It reaffirmed its position in a press release after publication of the ACP guideline (6).
The ACP guideline is based on a background article written by Bloomfield and colleagues (7) and a systematic evidence review sponsored by the Minneapolis Veterans Affairs Medical Center's Evidence-based Synthesis Program Center (8). The evidence was reviewed to address the following key questions with regard to routine pelvic examination in asymptomatic women: How accurate is the examination for detection of cancer (other than cervical), pelvic inflammatory disease, and other benign gynecologic conditions? What are the benefits and harms? What are the examination-related harms and indirect benefits? Do these harms vary by patient characteristics?
The evidence review, when examining the benefits of screening, found that the diagnostic accuracy of the screening pelvic examination for detecting ovarian cancer or bacterial vaginosis is low. In addition, the screening pelvic examination rarely detects noncervical cancer or other treatable conditions and was not associated with improved health outcomes. Lastly, no identified studies addressed the diagnostic accuracy of the pelvic examination for other gynecologic conditions, such as asymptomatic pelvic inflammatory disease, benign conditions, or gynecologic cancers other than cervical and ovarian.
The evidence review, when examining the harms of screening, found that false-positive findings are common, with attendant psychological and physical harms, including unnecessary laparoscopy and laparotomy. Other identified harms included fear, anxiety, embarrassment, pain, and discomfort. Finally, the review found that women with a history of sexual violence, especially those with posttraumatic stress disorder, may have increased pain, discomfort, fear, anxiety, and embarrassment.
Based on the evidence review, the ACP guideline recommends against routine screening pelvic examination in asymptomatic, nonpregnant, adult women (strong recommendation, moderate-quality evidence). It concluded that, according to current evidence, the harms of screening pelvic examination outweigh any demonstrated benefit in reducing mortality or morbidity in asymptomatic adult women.
Although the ACP guideline does not specifically address women who are due for cervical cancer screening, it recommends limiting the examination to visually inspecting the cervix and swabbing for cancer and human papillomavirus rather than including a full pelvic examination. To screen for chlamydia and gonorrhea, the guideline also recommends self-collection of vaginal swabs or urine, which do not require a pelvic examination. The guideline concluded that there is no indication that a pelvic examination is needed before oral contraceptives are prescribed. Thus, although many physicians include the pelvic examination as part of the well-woman visit, the ACP recommends that it be omitted from such visits because of its low value (5).
The ACOG Committee on Gynecologic Practice issued a committee opinion in August 2012 (3) reiterating the need for annual examinations and providing guidelines on important elements of this examination. According to the committee opinion, the annual visit is a fundamental part of medical care and provides an opportunity to promote prevention practices, recognize risk factors for disease, identify medical conditions, and establish a clinician–patient relationship. It stated that the annual visit should include screening, evaluation, counseling, and immunizations based on risk factors and age as well as a physical examination, although the components may vary depending on patient age, risk factors, and physician preferences.
The ACOG advocates including pelvic examination in the annual visit for all women aged 21 years or older. It acknowledges that no evidence supports or refutes the value of pelvic examination for asymptomatic, low-risk patients but states that performing the examination seems logical. It also acknowledges the dearth of data supporting the intervals at which such examinations should be done.
The ACOG opinion does state, however, that the decision on whether to perform routine pelvic examination at the time of the periodic health examination for asymptomatic patients should be based on a discussion between the patient and her health care provider. The ACOG opinion further states that the decision to receive an examination can be left to the patient if she is asymptomatic and has had a total abdominal hysterectomy and bilateral salpingo-oophorectomy for benign indications, has no history of vulvar or cervical neoplasia, is HIV negative, is not immunocompromised, and was not exposed to diethylstilbestrol. It further states that stopping pelvic examinations is reasonable when a woman's age or other health issues reach a point where she would not intervene on conditions detected during the examination.
To help us decide how to apply these divergent recommendations in Ms. C's case, we asked our discussants to answer the following questions:
1. Would you recommend an annual pelvic examination for this patient? Why or why not?
2. What are the pros and cons of performing an annual pelvic examination on this patient?
3. How do you think patient care would be affected if physicians stopped routinely performing pelvic examination on this and other patients?
As discussed in the review by Bloomfield and coworkers (7), few high-quality studies have specifically examined the benefits and harms of routine pelvic examination outside the context of cervical cancer screening (7); most have not considered the value of individual components of the pelvic examination (for example, speculum vs. BME). Nevertheless, sufficient evidence shows that neither screening BME alone nor screening speculum combined with BME has demonstrable benefits (Table 1); rather, routinely performing them misdirects health care resources and may cause harm (Table 2). Therefore, I would not recommend a BME for Ms. C.
Table 1. Routine Pelvic Examination in Asymptomatic, Average-Risk Women Who Are Up to Date With Cervical Cancer Screening: An Evidence-Based Appraisal of Proposed Benefits
Table 2. Routine Pelvic Examination in Asymptomatic, Average-Risk Women Who Are Up to Date With Cervical Cancer Screening: An Evidence-Based Appraisal of Potential Harms
Bimanual examination has been advocated as a screening test for noncervical cancers and benign conditions of the female upper genital tract and pelvic floor because it occasionally detects pathology (3). However, this observation does not necessarily mean that BME is the best way to detect such pathology or that routine performance enhances quality of life or survival. For a screening test to meet criteria for effectiveness, conclusive evidence must show that it accurately detects early-stage disease, is acceptable, is cost-effective, and reduces morbidity and mortality in a large-scale, randomized, controlled trial. BME simply does not meet these criteria.
Despite BME's limited accuracy in evaluating the female upper genital tract, this is a major indication cited by clinicians for performing a BME (22). For example, even when experienced gynecologists examined anesthetized women with known upper genital tract abnormalities undergoing surgery, the sensitivity of BME for detection of adnexal masses ≥5 cm was only 28% and the positive predictive value was 64% (9). Given these findings, it is not surprising that, in the 3 prospective cohort studies (combined n = 5633) that have examined this question, the positive predictive value of BME for detecting ovarian cancer was dismal (range, 0% to 3.6%) (Table 3) (10–12). In addition, BME was dropped from the screening protocol of 1 large ovarian cancer
screening trial (n = 78 216) (14) after 5 years when no cases of ovarian cancer were detected by adnexal palpation alone. Because of its poor diagnostic accuracy in detecting adnexal lesions, there is simply no basis for continuing to use BME to screen for ovarian cancer.
Table 3. Diagnostic Accuracy of Screening BME for Detection of Ovarian Cancer
With regard to screening for uterine abnormalities, the diagnostic accuracy of BME for detecting abnormal uterine size or contour under ideal circumstances (sensitivity 64% and 62%, respectively) has been shown to be better than that for adnexal abnormalities; however, corresponding positive predictive values were still disappointingly low (57% and 55%, respectively) (9). Given what is known about the biology of endometrial cancer, we would not expect pelvic examination to detect disease until late in its course (29). In fact, as a large proportion of women present at early stages because of symptoms (abnormal vaginal bleeding), patient education rather than screening pelvic examination is a key early-detection strategy (30). There is no evidence to support screening for benign uterine lesions (for example, fibroids) because treatment
for asymptomatic patients is not recommended (31).
In the era of nucleic acid amplification testing, BME has little value in screening for upper genital tract infection. For example, in a retrospective cohort study of asymptomatic, average-risk women presenting to a sexually transmitted infection (STI) clinic (1, 32), 26 of 2169 (1.2%) had upper genital tract findings; however, infection was confirmed in only a few (7 of 26) (13). Patient-collected vaginal swabs are now the specimens of choice when screening at-risk women for STIs (16, 33, 34); presumptive treatment is recommended only for patients with both symptoms and signs of pelvic inflammatory disease (35). One study showed that speculum examination and evaluation of vaginal discharge have value in diagnosing bacterial vaginosis (36); however, in light of the absence of evidence for benefit in treating asymptomatic, nonpregnant women, routine screening cannot be advocated.
Lastly, prevention of symptomatic pelvic floor dysfunction is a clinical priority, given the high prevalence (approximately 25%) of urinary and fecal incontinence or pelvic organ prolapse reported by nonpregnant women aged 20 years or older (n = 7924) participating in 3 National Health and Nutritional Examination Surveys done between 2005 and 2010 (37). The role of vaginal palpation in identifying at-risk women, motivating them to participate in pelvic floor muscle training, delaying or preventing onset of symptoms, or reducing the severity of later symptoms has not been established. A recent Cochrane analysis (5 trials; combined n = 673) found the likelihood of postpartum urinary incontinence among asymptomatic, pregnant women randomly assigned to prenatal pelvic floor muscle training to be approximately 30% lower than that in women receiving usual care (risk ratio, 0.71 [95%
CI, 0.54 to 0.95]) (38). Routine pelvic floor muscle training to prevent incontinence among asymptomatic, nonpregnant patients at other points across the reproductive health continuum (for example, during the menopausal transition) might also be worthy of study.
As discussed, there are no indications for performing BME on Ms. C. However, doing so could incur risks associated with downstream diagnostic procedures to evaluate apparent abnormalities detected during the examination (Table 2). For example, in a study by Adonakis and colleagues (10) (Table 3), 174 of 2000 (8.7%) asymptomatic, average-risk women had abnormal or ambiguous adnexal findings on BME; 31 of the 174 (18%) eventually had surgery because of those findings, and ovarian cancer was found in 2 of the 31 (6.5%). In other words, screening BME led to unnecessary surgery in 1.5% (29 of 2000) of patients (10). According to the National Ambulatory Medical Care Survey, 62.8 million screening pelvic examinations were done in 2010 (1); thus, the
number of false-positive results nationwide is probably substantial. False-positive results have been shown to be associated with significant harm: In the PLCO (Prostate, Lung, Colorectal, and Ovarian) cancer screening trial, 1080 of 3285 women (33%) with false-positive screening results had surgery, and 15% (163 of 1080) experienced at least 1 serious complication (14).
In her interview, Ms. C alludes to the awkwardness and discomfort patients frequently associate with pelvic examination. No studies have examined the degree of distress specifically attributable to BME; however, limited evidence from 15 low-quality studies (median, n = 409; range, 40 to 7168) shows that approximately 30% of patients experience psychological or physical distress (7). Low patient acceptability has consequences—women who have pain or discomfort are less likely to return for future care (7). Conversely, high patient acceptability and autonomy seem to be associated with enhanced sexual and reproductive health outcomes, as suggested by studies demonstrating greater utilization of hormonal contraceptives when receipt is uncoupled from pelvic examination (15). Patients were also found to prefer, and
superior performance characteristics were noted with, use of self- compared with provider-collected vaginal swabs for STI screening (16).
In addition to procedure-associated harms, unnecessary pelvic examinations misappropriate scarce health care resources. In a retrospective analysis of 8413 ambulatory visits made by U.S. adult women between 2002 and 2004, the total annual cost of preventive gynecologic examinations was $2.6 billion, with average per-visit diagnostic services costing $136 (4). Given the impact of inflation and the results of 2 national surveys showing that many clinicians continue to perform pelvic examinations more often than recommended for cervical cancer screening (23), these costs may be higher now. Reducing unnecessary pelvic examinations would result in significant savings with respect both to financial expenditures and provider and staff time that could be redirected toward provision of women's health services with proven benefits.
Embracing this evidence will revolutionize gynecologic care by refocusing clinicians' efforts on communicating more effectively with patients and increasing receipt of evidence-based care. Currently, most providers do not proactively ask patients about sexual function or incontinence (39, 40), and family history assessments for ovarian and uterine cancer, which can identify high-risk women who might benefit from referral to a genetics counselor to determine the potential benefit of various surveillance and prophylactic strategies (41), are often inaccurate (42). Moreover, the rate of unintended pregnancy in the United States remains high (24), whereas rates of human papillomavirus vaccination (43), screening for domestic violence (44) and chlamydia (45), and use of long-acting reversible contraception (24) among eligible women are disappointingly low. It is human nature to resist changing the status quo, but evidence shows that we must rise to the occasion to optimize female sexual and reproductive outcomes.
We will face challenges. Patients prefer to have a range of options to reveal sensitive information (17); research is needed to clarify effective screening questions and counseling techniques and the optimal method (for example, face-to-face, tablet computer) and timing (for example, age, reproductive life stage, context) for their delivery. Medical education for providers on topics related to sexual health is sorely lacking; targeted instruction is needed to enhance clinician competence in eliciting and addressing patient concerns (46). To ensure that trainees acquire pelvic examination skills in the face of reduced opportunities to perform these examinations routinely, genital teaching associates and simulation can be used to supplement the learning that occurs when performing evidence-based gynecologic procedures on actual patients (20, 47, 48). Finally, as women in the United States continue to experience disparities in obtaining needed medical care (49), clinicians can play a key role in advocating for enhanced access to and insurance coverage for all evidence-based female sexual and reproductive health services.
For a woman of Ms. C.'s age, body mass index, comorbidities, and stated risks, the periodic health visit provides an appropriate context to elicit symptoms (including a thorough sexual and urologic history) and respond to any concerns; carefully update her family history; screen for domestic violence; screen for STIs using patient-collected swabs if the sexual history suggests that she is at risk; discuss gynecologic “alarm” symptoms (for example, abnormal vaginal bleeding); provide counseling about highly effective contraception methods and healthy lifestyle behaviors; and offer same-day insertion of long-acting reversible contraception, if desired (25).
Yes. I believe this patient should have a pelvic examination. I do not agree with ACP's recommendation against pelvic examination for healthy, low-risk women. I agree with ACOG, which recommends annual pelvic examinations, including speculum and BME, for women older than 21 years. Although ACOG acknowledges that “no current scientific evidence supports or refutes an annual pelvic exam for an asymptomatic, low-risk patient, the College continues to firmly believe in the clinical value of pelvic examinations, through which gynecologists can recognize issues such as incontinence and sexual dysfunction” (3, 6) (Table 4).
Table 4. Summary of ACOG Recommendations* for Annual Pelvic Examination and Cervical Cancer Screening
Cervical cancer screening is not part of this debate, as there is consensus that cytology and human papillomavirus testing is very effective in prevention and early detection of cervical cancer (56). It is the BME that is at issue, as illustrated in this case. Adding to the controversy is that the recommended interval for cervical cancer screening has been lengthened to every 3 to 5 years (50), which may prompt women to question coming in to see their health provider in the years when a Pap test is not indicated.
It is also important to clarify that a pelvic examination is not necessary to screen for STIs or for initiating contraception. Urine or vaginal swab samples can be used to test for STIs with nucleic acid amplification and do not require a pelvic examination. Hormonal contraception can be initiated in healthy, asymptomatic women without a pelvic examination, because it would not identify contraindications to hormonal contraception (57).
The ACP guideline notes the absence of evidence for the effectiveness of pelvic examination in preventing ovarian cancer. I agree with this, as do most experts. There is consensus that the BME does not help with early detection of ovarian cancer. Indeed, there is no effective test for early detection of ovarian cancer in asymptomatic low-risk women—not the pelvic examination, ultrasonography, or CA-125 [serum cancer antigen 125] blood testing (58). Ovarian cancer is a disease for which an effective screening test has been elusive.
However, no studies in the review on which the ACP guideline was partially based addressed the diagnostic accuracy of the pelvic examination for benign conditions or gynecologic cancers other than cervical or ovarian cancer. It was not that any studies showed that the pelvic examination was ineffective for detecting these conditions; there have simply been no studies done. In addition, all of the women in the ovarian cancer studies were older than 45 years or were postmenopausal. Although ovarian cancer is most frequently diagnosed between the ages of 55 and 64 years, 18% of women are diagnosed between the ages 45 and 54, and 11% are younger than 45 (58).
Thus, I disagree with the ACP's conclusion that annual pelvic examinations should not be done in asymptomatic, nonpregnant, adult women because it was based on an absence of data as well as a limited age group. My conclusion is that we need more study, not that we need to stop doing pelvic examinations. Deciding when evidence is sufficient to make a broadly applied practice recommendation is a complex task. It should be feasible to perform studies that better define the pelvic examination's benefits and harms. So, I would have concluded that more study is needed to see if the pelvic examination has an effect on benign conditions or improves well-being among women of all ages, especially reproductive-aged women. There are currently no such studies under way.
Pelvic examination yields several benefits. It is a way to detect physical signs that can help direct communication with patients about what such signs may suggest. Basing the decision of whether to do a pelvic examination on a woman's report of abnormal symptoms or risk factors may not be universally effective because our ability to elicit accurate reports may vary. Some women are very in tune with their bodies and are able to communicate what may be bothering or worrying them. However, many are not, or may be too frightened or embarrassed to bring up a reproductive problem or may lack the education to understand what is normal or abnormal. Health care providers can ask questions about reproductive health, but physical findings, such as prolapse, vaginal discharge, atrophic changes, and fixed organs, might prompt a health care provider to ask additional pointed questions. For example, pelvic organ prolapse has been shown to adversely affect sexual function and
is associated with urinary incontinence, so identifying prolapse on pelvic examination would provide an opportunity for the clinician to raise these issues if the patient did not raise them herself (59). A pelvic examination is a tool that can enhance communication, informed decision making, and provider judgment; these are difficult outcomes to measure, and this aspect of pelvic examination has not yet been studied.
The cons of a pelvic examination include the potential harms of overdiagnosis and overtreatment, resulting in increased health care costs. Fourteen studies in the ACP analysis (deemed low quality) of potential harms from the pelvic examination found patient fear, anxiety, embarrassment, and pain, all of which may prompt patients to avoid care. I believe that the potential indirect benefits of enhanced communication and reproductive and sexual health outweigh these cons.
There are several important implications of not doing routine pelvic examinations. First, many women, especially reproductive-age and minority women, use their obstetrician/gynecologist (OB/GYN) as their primary caregiver (60). Data from the National Ambulatory Medical Care Survey showed that 57.8% of nonillness ambulatory visits for women aged 18 to 44 years and 34.7% for women aged 45 to 64 years were with an OB/GYN provider (61). One study showed that among women aged 18 to 40 years, 65% feel most comfortable with their OB/GYN, and women who use OB/GYNs for their primary care, either alone or in combination with a generalist physician, are more likely to receive reproductive preventive health services (60, 61). Women may stop coming in for preventive care for their reproductive health other than when their Pap is due and
miss regular screening for sexually transmitted infections, breast cancer, domestic violence, and substance abuse; contraceptive and dietary counseling; immunization updates; smoking cessation discussions; and mental health support. Second, I have concerns that this recommendation could be used to limit health insurance coverage for well-woman examinations. Finally, I worry about a decline in health care provider skill in performing comfortable, complete pelvic examinations, because physicians need to do a certain number of pelvic examinations to maintain competency. Residents need to be trained in pelvic examination by physicians who are skilled with the examinations. In obese patients, pelvic examinations are more challenging, and we may find ourselves unable to locate the cervix when doing cervical cancer screening every 3 to 5 years, because we've lost our skills.
Why is there so much more scrutiny of the pelvic examination than other parts of the physical examination? Is the pelvic examination being held to a standard higher than other parts of the physical examination? My goal as a women's health care provider is to ensure that the decision about whether to do a pelvic examination is made between a patient and her doctor; based on the best available evidence; tailored to the individual patient's personal history, family history, risk factors, and symptoms; and the pros and cons as they apply to a specific individual. It does not appear that the same scrutiny is being applied to other aspects of the “routine physical examination.” For example, a Cochrane review on screening for prostate cancer in men found no benefit using digital rectal examination and prostate-specific antigen. No studies examined the independent role of screening by digital rectal examination. The final recommendation was for clinicians to
adopt a shared approach to decision making by informing men of the lack of benefit and potential adverse effects of screening for prostate cancer. An analogous recommendation for the pelvic examination would be to encourage shared decision making between the physician and the patient (62). The pelvic examination should not be stigmatized.
A health care provider needs to weigh these pros and cons and understand their patient's values with respect to these tradeoffs of outcomes. A patient-centered approach should be to allow the patient to be the final arbiter of what tradeoffs they are willing to make to decrease their risk for a condition. The pelvic examination can also open the opportunity for patient education and identification of well-woman concerns that a patient may not bring up. More study is needed to determine if any indirect improvements to a woman's quality of life result from screening pelvic examinations.
Ms. C made a request: “I do want to see proof. I respect the professionals, so if you can provide proof from whatever studies have been done, then I think I would be more comfortable.” Our discussants agree on the available evidence, although they differ in how they would apply those data when making patient care decisions.
Dr. Potter agrees with the ACP guideline and would not recommend a pelvic examination based on current scientific evidence. Dr. Ricciotti concurs with the ACOG opinion and would recommend a pelvic examination, acknowledging that no current evidence supports annual pelvic examination for asymptomatic, average-risk women.
Both of our discussants agree that there are potential harms of performing screening pelvic examinations, including overdiagnosis and overtreatment as well as patient fear, anxiety, embarrassment, and pain. Our discussants disagree on what the effects of stopping routine pelvic examination would be. Dr. Potter suggested that providers could refocus their resources on communicating with patients more effectively and increasing receipt of evidence-based care. She acknowledged that physician training programs would need to enhance history-taking and counseling skills and supplement opportunities to practice pelvic examination on actual patients with simulation and use of genital teaching associates. Dr. Ricciotti had greater concerns about what would be lost. She was especially concerned that providers would lose the opportunity to initiate conversations about sexual and reproductive health or urinary symptoms that might indirectly improve quality of life, and that women
might present less often for care and miss regular screenings. She was also concerned that insurance coverage for routine care may become limited and that providers would be at risk for losing skills and training opportunities.
When thinking about high-value care considerations, our discussants agree that samples for gonorrhea and chlamydia screening can be self-collected and that there is no need for pelvic examination before prescribing birth control. However, they disagree about whether providers should perform BME at the time of a Pap test and whether there is a continued role for routine annual pelvic examination.
Ms. C asked us whether we could provide proof. Deciding whether there is sufficient-quality evidence to stop a broadly applied practice is difficult. Future research is needed to determine the optimal method and timing for sensitive conversations, the value of pelvic examination in detecting benign conditions, and whether diagnosis of these conditions via pelvic examination improves quality of life for such women. Each provider will need to decide whether the evidence is sufficient to stop performing routine pelvic examinations or whether patients and providers should engage in the process of shared decision making until more evidence is available. As Ms. C so aptly reminded us, for some women the pelvic examination is a barrier to care. For others, it's an avenue to beginning a difficult conversation about a woman's reproductive and sexual health.
A transcript of the audience question-and-answer period is available in the Appendix. View the entire Conference Video, including the question-and-answer session, online.
Dr. Burns is a member of the Division of General Medicine and Primary Care at Beth Israel Deaconess Medical Center and an Assistant Professor of Medicine at Harvard Medical School, Boston, Massachusetts.
Dr. Potter is Director of Women's Health Programs at Beth Israel Deaconess Medical Center and at Fenway Health and an Associate Professor of Medicine at the Harvard Medical School, Boston, Massachusetts.
Dr. Ricciotti is Chair and Residency Program Director in the Department of Obstetrics and Gynecology at Beth Israel Deaconess Medical Center, the Obstetrics and Gynecology Clerkship Committee Chair for Harvard Medical School, and an Associate Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, Boston, Massachusetts.
Dr. Reynolds is Vice Chair for Education in the Department of Medicine at Beth Israel Deaconess Medical Center and an Associate Professor of Medicine at Harvard Medical School, Boston, Massachusetts.
Dr. Reynolds: So let me start by fast-forwarding 10 years. I am thinking about the general internists or other primary care providers who aren't OB/GYN specialists and who now are not performing routine BMEs. I am wondering, Dr. Potter, if you can imagine whether we, as primary care doctors, can continue to be able to convince patients that we are competent providers in talking about reproductive issues; in dealing with issues of incontinence, prolapse, and vaginitis; and whether you believe that we will continue to be able to care for women's genitourinary health? Or do you think we will automatically refer our patients to OB/GYNs for all reproductive and vaginal concerns? How will the lack of “practicing” the physical exam impact our competence?
Dr. Potter: My belief is that we will be trained to be able to handle those issues very well. There is currently a movement in the whole country toward family medicine practice, which I think will rub off on internal medicine training as well. If we are going to be taking care of females in reproductive ages who may get pregnant, we really need to think about how to prevent unintended pregnancies. More and more people in training now are expressing a desire to learn how to insert long-acting reversible contraceptive methods. So I think that we will become actually more technically expert at doing the evidence-based procedures that need to be done and also better at communicating effectively with patients. We will take better care of women overall.
Dr. Reynolds: Dr. Ricciotti, I wonder if you could imagine what it would be like to see more patients for problems that previously were addressed by primary care doctors?
Dr. Ricciotti: I would definitely worry that this guideline is going to push us back. We have made a lot of progress with primary care doctors doing a lot of reproductive health and using OB/GYNs much more as specialists when problems are more complex. I worry that this guideline will make that progress go in the wrong direction.
Dr. Mark Zeidel: So—2 quick questions for both of you. First, if we decide that we are not going to do screening pelvic exams, when will pelvic exams need to be done? And second, is it is really justified to subject patients to a procedure because we have to maintain skills? I think that is an ethical problem. If there is no value and there may be harm, then should we not figure out another way to maintain the skills?
Dr. Potter: I really appreciate your raising the second point in particular. I do think that it is unethical to subject patients to an exam that has no demonstrable value. That really is the bottom line in this discussion.
Dr. Ricciotti: I agree that it is unethical to do a pelvic exam when there is not demonstrable value, but I do not believe we have shown that there is no demonstrable value.
Dr. Tom Delbanco: I think that over the years, for many understandable and also weird reasons, you have turned pregnancy into an illness, and I am worrying that you are going to turn the pelvis increasingly into an illness. The question is why do you have to have these discussions that sound elegant, terrific, and marvelous with a woman lying on her back? Why can't she sit in the chair next to you while you talk about it? Particularly, I think if the male is standing over her that way with a woman lying on her back that she might be much less receptive to hearing. People only remember 40% of what happened at all in the visit, and half of it they remember incorrectly.
Dr. Ricciotti: I think you do need to be thoughtful and really focused on making this a patient-centered exercise, but I would just reiterate some of this is about educating women about what is normal anatomy. I do not want to stigmatize the pelvis.
Dr. Kenneth Bauer: So the pelvic exam has been targeted, but if we turn to the whole general physical exam in terms of what are the data, what is the value of a general internal medicine physical exam? I am not going so far as to negate the value of routine health screening visits and good historical information and up-to-date immunizations.
Dr. Potter: That topic is certainly raised by the current debate, and I am sure that we will be hearing more about the value of the general physical examination as time goes by. All of the procedures that we have been doing routinely for many years are now subject to reexamination, and that is how it should be.
Dr. Ricciotti: And I would just reiterate that the outcomes that we are studying are not always things like cancer or heart disease, but quality-of-life issues, like comfortable sexuality, like incontinence, like prolapse. That is what I want to emphasize, and I do not think we have asked the right questions in this evaluation.
Dr. Karen Victor: So I have separate questions for each of you. Dr. Potter, do you think that there is a nonverbal communication benefit to doing more routine exams? Thinking analogously, when I, as a female physician, learned that testicular exams were not recommended, I felt that was a loss and that I did not demonstrate routinely to my male patients that that part of their body is indeed something that I can address concerns about and need to hear about. Dr. Ricciotti, my question to you is do you think that if we do get better at spending time in the history elucidating problems, that we will be doing enough bimanual exams to achieve some of the goals that you have concern about, acknowledging Dr. Zeidel's concerns that there is an ethical question about doing exams strictly to maintain skills?
Dr. Potter: There is no question that clinicians need regular practice in order to maintain their technical skills. If we follow the ACP guideline, we will still have ample opportunity to perform pelvic exams for women who present with genitourinary symptoms. Such symptoms are actually quite prevalent if we ask the right questions, as evidenced by the high rate (approximately 25%) of women who experience pelvic floor symptoms, as I discussed previously (37). In addition, a recent, large (n = 26 466 women aged 20 years and older; response rate, 54.5%), Danish, Web-based survey found that 15% of respondents reported pelvic pain and 10% reported dyspareunia in the past 4 weeks (63). Last but not least, women's health clinicians will have ongoing opportunities to maintain their pelvic exam skills during performance of evidence-based procedures,
such as IUD [intrauterine device] insertion and endometrial biopsy.
Dr. Ricciotti: I am going to tell a little story to answer your question. I love what you said about the nonverbal relationship that develops from the laying on of hands. Almost every time that maybe I have not done as good of a job as I should have at screening for issues of sexuality, after I have gone through my whole history and physical exam and the patient is on her way out with her hand on the door knob there is the statement, “Oh—by the way. My partner wanted me to ask you…” And I know that the next question is going to be about sexuality. So I think that you are absolutely right. We do, as providers, need to do a better job of asking questions in the history, but something happens as the visit evolves that creates trust. We have not studied it. I am not giving you evidence-based medicine. This is the art.
Dr. Potter: And for some people, there is no doubt that laying on hands in such a vulnerable type of exam will cause a rift in trust. We have to remember that we do not know exactly what percentage of patients experience the exam in this way. Patients are different, and we need to respect their individual preferences.
Dr. Ricciotti: One signal that is really helpful when I go to do a pelvic exam, and I find it extremely uncomfortable for the patient, that can be a cue to me that there may have been some violence in the past. I then do a better job trying to ask more questions in a more thoughtful way. So Dr. Potter's point is very well-taken.
Ms. C: I have been truly enjoying the conversation, and I feel like I am stuck in the middle. I think I agree that we can pull away from the BMEs; it does not sound like they are very useful at this point. For the pelvic exams, what I am thinking and what I keep hearing is the shared decisions and communicating more with the patient, which I think is huge. I am different. I do not wait for my doctor to ask all the questions. I offer information because I figure the more I share with her, the better she is going to serve me, but I know a lot of people are not that way. So I am thinking that with the pelvic exam, based on your conversation with the patient before they even get on their back, you will be able to figure out, do we need to do a pelvic exam? Maybe we don't, based on what they share with you. But the crucial thing is getting them to share. My parents are not from this country, and I am lucky that they believe in going to doctors. There are a
lot of immigrants who don't go until there is a problem, and those women are not going to tell you what they are doing in the bedroom. So I am thinking that's going to be extra work for all of you to actually figure out how you are going to communicate with patients, especially with patients for whom it is not normal to talk about what's going on in the bathroom and what's going in the bedroom.
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Patient Interview Video - Beyond the Guidelines: Screening Pelvic Examinations in Adult Women
Conference Video - Beyond the Guidelines: Screening Pelvic Examinations in Adult Women
Ain Shams university, Faculty of medicine
October 6, 2015
Shall we retire other "classical" signs in the clinical examination ?
I would like to touch on another point that wasn't thoroughly discussed in the talk , which is the issue of the other physical findings in general examination , Many signs have low sensitivity and specificity when put to evidence, yet they are marked as classical.And the eponymous rare clinical signs like Duroziez sign, Corrigan;s pulse, Quincke's pulse....etc or even the heart murmurs that was proved to have a wide range of variability as proved by books like that of Dr Steven Mcgee "Evidence Based Clinical Diagnosis" and studies like "Eponyms and the diagnosis of aortic regurgitation" by Babu AN published in the annals at 2003.We still need to auscultate every patient thoroughly and examine very patient scrupulously attaining those signs and others even if they may be nonspecific and the investigations can provide a final diagnosis anyway.So why not do the same in the issue of BME ?? Tell the patient what we know and let her decide if she wants to have it done or not .I am talking from being in a developing country where women don't seek medical care regularly even when symptomatic and it seems logical that BME may provide a benefit .References:1)Babu AN, Kymes SM, Carpenter Fryer SM. Eponyms and the Diagnosis of Aortic Regurgitation: What Says the Evidence?. Ann Intern Med. 2003;138:736-742. doi:10.7326/0003-4819-138-9-200305060-000102)https://books.google.com.eg/books/about/Evidence_based_Physical_Diagnosis.html?id=rG5rAAAAMAAJ&redir_esc=y
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