Draft Recommendation Statement
Gynecological Conditions: Periodic Screening With the Pelvic Examination
This opportunity for public comment expired on July 25, 2016 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Draft: Recommendation Summary
|Asymptomatic, nonpregnant adult women|
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic, nonpregnant adult women.
This statement does not apply to pelvic examinations performed for the purposes of screening for specific disorders for which the USPSTF has already issued a recommendation (i.e., cervical cancer, gonorrhea, and chlamydia).
Many conditions that can affect women’s health are often evaluated through pelvic examination. These conditions include but are not limited to: malignant diseases, such as ovarian, uterine, vaginal, and cervical cancer; infectious diseases, such as bacterial vaginosis, candidiasis, genital warts, genital herpes, trichomoniasis, and pelvic inflammatory disease; and other benign conditions, such as cervical polyps, endometriosis, ovarian cysts, dysfunction of the pelvic wall and floor, and uterine fibroids. Pelvic examination is a common part of the physical examination; in 2010, more than 60 million pelvic examinations were performed in the United States.1 Although it is a common part of the physical examination, it is unclear whether performing screening pelvic examinations in asymptomatic women has a significant effect on disease morbidity and mortality. The USPSTF has made separate recommendations on screening for cervical cancer, gonorrhea, and chlamydia using tests that are often performed during a pelvic examination (e.g., Papanicolaou test, human papillomavirus test, and nucleic acid amplification tests); in this recommendation statement, the USPSTF seeks to understand the utility of performing screening pelvic examinations for other gynecologic conditions.
The pelvic examination may include any of the following components, alone or in combination: assessment of the external genitalia, internal speculum examination, bimanual palpation, and rectovaginal examination. The USPSTF found inadequate evidence on the accuracy of pelvic examination to detect a range of gynecologic conditions. Limited evidence from studies evaluating the use of screening pelvic examination alone for ovarian cancer detection generally reported low positive predictive values (0% to 3.6%).2 Very few studies on screening for other gynecologic conditions with pelvic examination alone have been done,2 and the USPSTF found that these studies have limited generalizability to the current population of asymptomatic women seen in primary care settings in the United States.
Benefits of Screening
The USPSTF found inadequate evidence on the benefits of screening for a range of gynecologic conditions with pelvic examination. No studies were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.2
Harms of Screening
The USPSTF found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination. A few studies reported on false-positive rates for ovarian cancer, ranging from 1.2% to 8.6%, and false-negative rates, ranging from 0% to 100%. Among women who had abnormal findings on pelvic examination, 5% to 36% went on to surgery.2 Very few studies reported false-positive and false-negative rates for other gynecologic conditions.2 No studies quantified the amount of anxiety associated with screening pelvic examinations.2
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic women for the early detection and treatment of a range of gynecologic conditions. Evidence is lacking and of poor quality, and the balance of benefits and harms cannot be determined.
Draft: Clinical Considerations
Patient Population Under Consideration
This recommendation applies to asymptomatic women age 18 years and older who are not at increased risk for specific gynecologic conditions. It does not apply to pregnant women or adolescents.
Suggestions for Practice Regarding the I Statement
Potential Preventable Burden
Numerous gynecologic conditions may be detected during a screening pelvic examination. These include malignant diseases, such as ovarian, uterine, vaginal, and cervical cancer; infectious diseases, such as bacterial vaginosis, candidiasis, genital warts, genital herpes, trichomoniasis, and pelvic inflammatory disease; and other benign conditions, such as cervical polyps, endometriosis, ovarian cysts, dysfunction of the pelvic wall and floor, and uterine fibroids.
The accuracy of detecting and the benefit of treating some of these conditions early, while women are asymptomatic, is unknown. No studies evaluated the effectiveness of early diagnosis and treatment of screen-detected, asymptomatic gynecologic conditions compared to the diagnosis and treatment of symptomatic gynecologic conditions.2 It is also unknown whether performing screening pelvic examinations more frequently than every 3 to 5 years (the recommended screening interval for cervical cancer) is beneficial. Although it is common practice to perform a pelvic examination as part of an annual physical examination, the benefit of performing screening pelvic examinations at this interval is unclear. The benefit of using pelvic examination alone to screen for gynecologic conditions other than cervical cancer, gonorrhea, and chlamydia is also unknown.
The USPSTF found limited evidence on the harms of screening with pelvic examination. Harms reported in studies included false-positive and false-negative results. Available evidence reports false-positive rates for ovarian cancer of 1.2% to 8.6% and false-negative rates of 0% to 100%.2 Unnecessary diagnostic workup and treatment could also result from pelvic examination screening. In particular, there is a concern for potential invasive diagnostic procedures and treatment of ovarian cancer (such as surgery) that could result from evaluating abnormal findings on pelvic examination. In the reviewed studies, approximately 5% to 36% of women who had abnormal pelvic examination findings went on to surgery.2 The potential association between urinary tract infections and pelvic examinations was explored in a single study with inconclusive results. Additional theoretical harms of pelvic examination include psychological harms (anxiety), pain and discomfort from the examination, and the potential for these harms to serve as a barrier for women to receive medical care.
According to the National Ambulatory Medical Care Survey, 62.8 million pelvic examinations were performed in 2010.1 In a 2010–2011 nationally representative survey of obstetricians and gynecologists, almost all surveyed clinicians indicated that they would perform a bimanual examination on asymptomatic patients during routine visits.3 According to another survey performed in 2009, 79% of surveyed clinicians (including obstetricians/gynecologists, family/general practitioners, and internists) believed that pelvic examination is useful for screening for gynecologic cancer in asymptomatic women; approximately 50% to 60% reported believing that pelvic examination is useful for cervical cancer screening, 49% to 70% for ovarian cancer screening (70% of obstetrician/gynecologists vs. 49% to 50% of internists and family practitioners), 39% to 45% for uterine cancer, 57% to 62% for vaginal cancer, and 53% to 62% for vulvar cancer (estimates are based on graphic display of data, exact numbers were not provided).4 Nearly all surveyed clinicians (97%) believed that the pelvic examination included bimanual examination, while most (69%) believed that the pelvic examination included rectovaginal examination.4
Research Needs and Gaps
The USPSTF recognizes that research on the effectiveness of the screening pelvic examination is difficult given that multiple conditions could potentially be detected with this single preventive service. However, in reviewing the currently available evidence on the benefits and harms of performing screening pelvic examinations in asymptomatic adult women, the USPSTF identified the following critical evidence gaps. Studies evaluating the accuracy and effectiveness of screening pelvic examination to detect conditions other than ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis are lacking. Studies reporting on the harms of screening with pelvic examination (including quantified psychological harms) in asymptomatic women in primary care are also lacking.
Studies reporting the effects of performing routine screening pelvic examinations on health outcomes such as all-cause mortality, disease-specific morbidity and mortality, quality of life, and psychological benefits and harms could help fill the gaps in the existing evidence and inform future USPSTF recommendations. Studies evaluating and quantifying harms are needed, as well as studies evaluating the potential effectiveness of risk assessment tools to determine which women might benefit from a pelvic examination. Research is needed to clarify which indications primary care clinicians are currently using the screening pelvic examination for in asymptomatic patients and which components of the pelvic examination are performed most frequently. Studies exploring women’s attitudes toward pelvic examinations, the outcomes women value from these examinations, and how pelvic examinations affect women’s decisions to seek and obtain care are also needed to clarify the potential benefits and harms of providing this preventive service.
For the purposes of this recommendation, the term “pelvic examination” includes any of the following components, alone or in combination: assessment of the external genitalia, internal speculum examination, bimanual palpation, and rectovaginal examination.
Screening for cervical cancer, gonorrhea, and chlamydia are not included in this recommendation statement on screening pelvic examinations because they are already addressed in separate USPSTF recommendation statements (available at http://www.uspreventiveservicestaskforce.org/). Further information on screening for ovarian cancer with preventive services other than pelvic examination can also be found on the USPSTF Web site, as well as USPSTF recommendations on counseling to prevent sexually transmitted infections.
Burden of Disease
Given the range of gynecologic conditions that could be detected with pelvic examination, the burden of disease varies depending on the specific condition. Some conditions, such as vaginal cancer, may be rare, with an incidence rate of 0.7 cases per 100,000 women. Other conditions, such as candidiasis, are relatively common, with nearly 75% of adult women reporting at least one occurrence. Associated morbidity and mortality can also vary. Some conditions, such as ovarian cancer, may be associated with a high mortality rate (5-year survival rate of 45.6%), while other conditions, such as candidiasis, may have no known associated mortality. More information on the burden and epidemiology of the numerous gynecologic conditions potentially detected by pelvic examination is available in Table 1 of the accompanying systematic evidence review.2
Scope of Review
The USPSTF commissioned a systematic review to evaluate the evidence on the accuracy, benefits, and potential harms of performing screening pelvic examinations in asymptomatic, nonpregnant adult women age 18 years and older. The review focused on gynecologic conditions that are commonly identified by clinicians as a reason for performing the screening pelvic examination, conditions for which detection of early-stage disease in asymptomatic patients is biologically and clinically plausible, and conditions for which another method of screening is not already addressed by a current USPSTF recommendation. The review included the following components of the pelvic examination: inspection of the external genitalia, urethral meatus, vaginal introitus, and perianal region; speculum examination of the vagina and cervix; bimanual palpation of the uterus, cervix, and adnexa; and rectovaginal examination of the posterior wall of the vagina.
Accuracy of Screening Tests
The USPSTF found little evidence on the accuracy of screening pelvic examinations to detect various conditions; four studies (n=26,432) reported on ovarian cancer, two studies (n=930) on bacterial vaginosis, one study (n=770) on genital herpes, and one study (n=150) on trichomoniasis.
Of the four studies reporting on detection of ovarian cancer, the largest was the Prostate, Lung, Colorectal, and Ovarian Cancer Screening (PLCO) trial, which was conducted in the United States.5 The PLCO trial is a good-quality population-based, randomized trial that recruited women ages 55 to 74 years (mean age, 62.9 years) without a history of cancer. It evaluated screening for ovarian cancer with ultrasonography and blood testing (for the tumor marker CA-125) but originally included palpation of the ovaries in its screening protocol. The ovarian palpation component was discontinued 5 years into the study because no cases of ovarian cancer were detected solely with bimanual palpation of the ovaries.5 In a subanalysis of the trial that evaluated 20,872 participants who underwent ovarian palpation at least once, the yield of screening was 23 (0.1%) cancer cases detected over 1 year of followup and 72 (0.3%) cancer cases detected over 1 to 5 years of followup.6 Over multiple rounds of screening (mean number of screenings, 2.4 [range, 1 to 4]), 96.7% of the ovarian cancer cases identified during the trial were not detected by palpation.6 The reported sensitivity and specificity for detection of ovarian cancer over 1 to 5 years of followup in the PLCO trial was 2.8% (95% CI, 0.6 to 8.6) and 98.8% (95% CI, 98.7 to 99), respectively. The other three fair-quality studies were conducted in Greece, Australia, and the United Kingdom and were generally much smaller (n=1,010 to 2,550).2, 7-9 Outcomes were reported at 1 year of followup, and the range of sensitivity and specificity for detection of ovarian cancer was 0% to 100% and 91.4% to 98.4%, respectively.2
The four studies that reported on the accuracy of pelvic examination to detect various infectious diseases (bacterial vaginosis, genital herpes, and trichomoniasis) were all fair-quality and conducted in the United States.2 One study was conducted in a hospital setting,10 while the other three were conducted in sexually transmitted infection clinics.11-13 It is important to note that given the settings of these studies, participants were more likely to represent higher-risk, symptomatic populations compared to women who are generally seen in primary care. The reported yield of screening was 38.7% to 47% of bacterial vaginosis cases, 47.8% of genital herpes cases, and 15.2% of trichomoniasis cases.2 Depending on the specific clinical sign used in screening, the reported sensitivity of pelvic examination to detect bacterial vaginosis ranged from 2.6% to 78.8%,2, 10, 11 from 14.2% to 19.6% for genital herpes,12 and from 1.7% to 59.2% for trichomoniasis.13 The specificity of pelvic examination to detect bacterial vaginosis ranged from 48.4% to 100%,2, 10, 11 from 97.1% to 97.5% for genital herpes,12 and from 72.0% to 100% for trichomoniasis.13
Effectiveness of Early Detection
No good- or fair-quality studies directly evaluated the effectiveness of screening pelvic examinations in asymptomatic, nonpregnant adult women to improve quality of life, reduce disease-specific morbidity, or reduce disease-specific or all-cause mortality.
Potential Harms of Screening
The USPSTF found little evidence on the potential harms of screening pelvic examination. Studies reporting on the accuracy of screening pelvic examination to detect various gynecologic conditions also reported on false-positive and false-negative rates, which could lead to important harms due to missed diagnoses or unnecessary and potentially harmful procedures and treatment. The false-positive and false-negative rates in the PLCO trial subanalyses were 1.2% (95% CI, 1.0 to 1.3) and 97.2% (95% CI, 91.4 to 99.4), respectively.6 False-positive and false-negative rates in the three other ovarian cancer studies ranged from 1.6% to 8.6% and 0% to 100%, respectively.2 The four studies reporting on the accuracy of screening with pelvic examination for ovarian cancer also reported the percentage of patients with positive results who subsequently underwent surgery, which overall ranged from 5% to 36%. Based on the PLCO trial subanalyses, 11.2% of women who had any positive palpation examination over 0 to 3 years of followup but did not ultimately receive an ovarian cancer diagnosis underwent surgery.6 Depending on the specific clinical sign used to detect various infectious diseases, the false-positive rate for bacterial vaginosis ranged from 0% to 46.1%, from 2.5% to 3.0% for genital herpes, and from 0% to 28.0% for trichomoniasis. The false-negative rate for bacterial vaginosis ranged from 21.2% to 97.7%, from 80.4% to 85.8% for genital herpes, and from 40.8% to 98.3% for trichomoniasis. One small (n=150) exploratory, poor- to fair-quality study reported on urinary tract infections in patients undergoing pelvic examination; however, the study was underpowered to detect any significant difference. The USPSTF searched for but did not find any studies that quantified harms of anxiety or other psychological harms associated with screening pelvic examination.2
Estimate of Magnitude of Net Benefit
Overall, the USPSTF found inadequate evidence on screening pelvic examinations for the early detection and treatment of a range of gynecologic conditions in asymptomatic, nonpregnant adult women. No studies directly evaluated the effectiveness of screening pelvic examinations to improve health outcomes such as quality of life, morbidity, or mortality. Few studies reported on the accuracy of screening pelvic examination; out of the range of possible gynecologic conditions that could be detected with pelvic examination, only four were evaluated in published studies, often in only a single study. Although studies on detection of ovarian cancer often recruited participants from the community, participants in studies evaluating detection of infectious diseases came from sexually transmitted infection clinics, whose populations are likely more symptomatic and at higher risk for disease than the typical primary care population, thus making the applicability of this evidence to primary care populations unclear. Overall, the current available evidence is insufficient for the USPSTF to determine the net balance of benefits and harms of screening pelvic examinations, and the USPSTF cannot recommend for or against performing screening pelvic examinations in asymptomatic, nonpregnant adult women.
Draft: Recommendations of Others
Across various organizations, guidelines range from recommending against screening pelvic examination to performing them annually. The American College of Physicians recommends against performing screening pelvic examinations in asymptomatic, nonpregnant adult women.14 Based on the American College of Physicians review and recommendation, the American Academy of Family Physicians also concluded that performing screening pelvic examinations in asymptomatic, nonpregnant adult women is not recommended.15 The American College of Obstetricians and Gynecologists (ACOG) recommends performing pelvic examinations annually in all patients age 21 years and older.16 While ACOG found no evidence to support or refute the benefit of annual pelvic examination or speculum and bimanual examination in asymptomatic, low-risk patients, it concluded that the decision to perform a complete examination at the time of the periodic health examination should be a shared decision between the patient and provider. The Well-Woman Task Force convened by ACOG in 2013 recommends that for women age 21 years and older, external examination may be performed annually and that inclusion of speculum examination, bimanual examination, or both in otherwise healthy women should be a shared, informed decision between patient and provider. The Well-Woman Task Force also recommends speculum examination and/or bimanual examination for asymptomatic patients with specific indications (e.g., intrauterine device placement or cervical cancer screening).17
1. National Center for Health Statistics, Centers for Disease Control and Prevention. National Ambulatory Medical Care Survey: 2010 Summary Tables. http://www.cdc.gov/nchs/data/ahcd/namcs_summary/2011_namcs_web_tables.pdf. Accessed June 10, 2016.
2. Guirguis-Blake JM, Henderson JT, Perdue LA, Whitlock EP. Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the U.S. Preventive Servcies Task Force. Evidence Synthesis No. 147. AHRQ Publication No. 15-05220-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2016.
3. Henderson JT, Harper CC, Gutin S, et al. Routine bimanual pelvic examinations: practices and beliefs of US obstetrician-gynecologists. Am J Obstet Gynecol . 2013;208(2):109.e1-7.
4. Stormo AR, Cooper CP, Hawkins NA, et al. Physician characteristics and beliefs associated with use of pelvic examinations in asymptomatic women. Prev Med. 2012;54(6):415-21.
5. Buys SS, Partridge E, Greene MH, et al. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of randomized trial. Am J Obstet Gynecol. 2005;193(5):1630-9.
6. Personal communication with Dr. Paul Pinsky, National Cancer Institute. May 2016.
7. Jacobs I, Stabile I, Bridges J, et al. Multimodal approach to screening for ovarian cancer. Lancet. 1988;1(8580):268-71.
8. Adonakis GL, Paraskevaidis E, Tsiga S, et al. A combined approach for the early detection of ovarian cancer in asymptomatic women. Eur J Obstet Gynecol Reprod Biol. 1996;65(2):221-5.
9. Grover S, Quinn MA, Weideman P, et al. Screening for ovarian cancer using serum CA125 and vaginal examination: report on 2550 females. Int J Gynecol Cancer. 1995;5(4):291-5.
10. Gutman R, Peipert J, Weitzen S, et al. Evaluation of clinical methods for diagnosing bacterial vaginosis. Obstet Gynecol. 2005;105(3):551-6.
11. Eschenback DA, Hillier S, Critchlow C, et al. Diagnosis and clincial manifestations of bacterial vaginosis. Am J Obstet Gynecol. 1988;158(4):819-28.
12. Koutsky LA, Stevens CE, Homes KK, et al. Underdiagnosis of genital herpes by current clinical and viral-isolation procedures. N Engl J Med. 1992;326(23):1533-9.
13. Wolner-Hanssen P, Krieger J, Stevens C, et al. Clinical manifestations of vaginal trichomoniasis. JAMA. 1989;261(4):571-6.
14. Qaseem 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(1):67-72.
15. American Academy of Family Physicians. Clinical Practice Guideline: Screening Pelvic Examination in Adult Women. http://www.aafp.org/patient-care/clinical-recommendations/all/screeningpelvicexam.html. Accessed June 10, 2016.
16. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120(2 pt 1):421-4.
17. Conry JA, Brown H. Well-Woman Task Force: components of the well-woman visit. Obstet Gynecol. 2015;126(4):697-701.
Internet Citation: Draft Recommendation Statement: Gynecological Conditions: Periodic Screening With the Pelvic Examination. U.S. Preventive Services Task Force. June 2016.