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  • Guideline Synthesis

Screening for Gynecologic Conditions with Pelvic Examination

Guidelines Being Compared:

  • American College of Physicians (ACP)

    Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians.

    2014 Jul 01

    View Summary

A direct comparison of recommendations presented in the above guidelines for screening pelvic examination in asymptomatic, nonpregnant, adult women for the early detection of a range of gynecologic conditions is provided. The USPSTF guideline does not apply to specific disorders for which the USPSTF already recommends screening (i.e., Pap smear and HPV testing for cervical cancer; nucleic acid amplification test for gonorrhea and chlamydia). The USPSTF has issued separate recommendation statements for these topics, and ACP also has guidance on cervical cancer screening.

For the purposes of this Synthesis, the term "pelvic examination" consists of any of the following components, alone or in combination: assessment of the external genitalia; speculum examination of the vagina and cervix; bimanual palpation of the adnexa uterus, ovaries and bladder; and rectovaginal examination.

Areas of Agreement

Screening for Gynecologic Conditions with Pelvic Examination

Neither guideline developer recommends routine screening pelvic examination in asymptomatic, nonpregnant adult women. See Areas of Difference below for additional information.

Areas of Difference

Screening for Gynecologic Conditions with Pelvic Examination

The ACP identified no studies that addressed the diagnostic accuracy of the pelvic examination for asymptomatic pelvic inflammatory disease, gynecologic cancer other than cervical or ovarian cancer, or benign conditions. They found evidence that the diagnostic accuracy of pelvic examination for detecting ovarian cancer or bacterial vaginosis is low. Weighing the available evidence on the benefits and harms of the screening pelvic examination, the ACP makes a strong recommendation against the use of screening pelvic examination in asymptomatic, nonpregnant adult women. The guideline developer found no evidence that screening pelvic examination in this patient population provides any benefit and indirect evidence that it does not reduce morbidity or mortality rates. Moreover, the ACP cites limited low-quality evidence suggesting that screening pelvic examinations may be associated with pain, discomfort, fear, anxiety, or embarrassment in approximately 30% of women. Additionally, screening pelvic examinations can lead to unnecessary, invasive, and potentially harmful diagnostic procedures. As it is considered low-value care, the ACP further suggests that the pelvic examination be omitted from the well-woman visit.

Although the USPSTF sought evidence on the effectiveness of using pelvic examination to screen for all asymptomatic gynecologic conditions other than cervical cancer, chlamydia, and gonorrhea, it was only able to identify limited evidence on its accuracy to detect ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis. The USPSTF concludes that this currently available evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic, nonpregnant adult women for the early detection and treatment of a range of gynecologic conditions (an "I statement"). In the absence of clear evidence on the balance of benefits and harms, the USPSTF encourages clinicians to consider the patient's risk factors for various gynecologic conditions and the patient's values and preferences, and engage in shared decision making with the patient to determine whether to perform a pelvic examination.

Screening for Gynecologic Conditions with Pelvic Examination

ACP
(2014)

Recommendation: The American College of Physicians recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women (strong recommendation, moderate-quality evidence).

The current evidence shows that harms outweigh any demonstrated benefits associated with the screening pelvic examination. Indirect evidence showed that screening pelvic examination does not reduce mortality or morbidity rates in asymptomatic adult women, as 1 trial showed that screening for ovarian cancer with more sensitive tests (transvaginal ultrasonography and CA-125) also did not reduce mortality or morbidity rates. Because CA-125 and transvaginal ultrasonography found all cancer detected by the screening pelvic examination as well as additional cancer and this earlier detection did not lead to a reduction in morbidity or mortality rates, the guideline authors conclude that the screening pelvic examination alone would also not reduce morbidity or mortality rates. No studies assessed the benefit of pelvic examination for other gynecologic conditions, such as asymptomatic pelvic inflammatory disease, benign conditions, or gynecologic cancer other than cervical or ovarian cancer. Also, there is low-quality evidence that screening pelvic examination leads to harms, including fear, anxiety, embarrassment, pain, and discomfort, and possibly prevents women from receiving medical care. In addition, false-positive screening results can lead to unnecessary laparoscopies or laparotomies. Note that this guideline is focused on screening asymptomatic women; full pelvic examination with bimanual examinations is indicated in some nonscreening clinical situations. This guideline does not address women who are due for cervical cancer screening. However, the recommended cervical cancer screening examination should be limited to visual inspection of the cervix and cervical swabs for cancer and HPV and should not entail a full pelvic examination.

High-Value Care

Although screening for chlamydia and gonorrhea traditionally required a speculum examination, nucleic acid amplification tests on self-collected vaginal swabs or urine have been shown to be highly specific and sensitive, and this technique is supported by several organizations. ACP found no evidence that screening pelvic examination in asymptomatic, nonpregnant, adult women provides any benefit and indirect evidence that it does not reduce morbidity or mortality rates. However, many clinicians include pelvic examination as part of the well-woman visit, and because pelvic examination is low-value care, it should be omitted from the well-woman visit. Many clinicians also require pelvic examination before prescribing oral contraceptives, although this practice is low-value care and not supported by evidence. Many organizations also advise against screening pelvic examination before prescribing hormonal contraception for healthy asymptomatic women.

With the available evidence, the ACP concludes that screening pelvic examination exposes women to unnecessary and avoidable harms with no benefit (reduced mortality or morbidity rates). In addition, these examinations add unnecessary costs to the health care system ($2.6 billion in the United States). These costs may be amplified 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.

Summary

Pelvic examination is commonly used in asymptomatic, nonpregnant, adult women to screen for pathology. Evidence shows that the diagnostic accuracy of pelvic examination for detecting ovarian cancer or bacterial vaginosis is low. The PLCO trial and cohort studies suggest that the screening pelvic examination rarely detects noncervical cancer or other treatable conditions and was not associated with improved health outcomes. The PLCO trial found no reduction of ovarian cancer mortality rates by screening with pelvic examination or by screening with CA-125 or transvaginal ultrasonography, both of which are more sensitive for detecting ovarian cancer than the pelvic examination itself. Thus, there is indirect evidence that pelvic examination (as distinct from cervical cancer screening) in asymptomatic, adult women does not reduce morbidity or mortality rates. No studies were identified that addressed the diagnostic accuracy of the pelvic examination for other gynecologic conditions, such as asymptomatic pelvic inflammatory disease, benign conditions, or gynecologic cancer other than cervical or ovarian cancer. Many false-positive findings are associated with pelvic examination, with attendant psychological and physical harms, as well as harms associated with the examination itself. Harms of pelvic examination include unnecessary laparoscopies or laparotomies, fear, anxiety, embarrassment, pain, and discomfort. Women with a history of sexual violence, and particularly those with PTSD, may experience more pain, discomfort, fear, anxiety, or embarrassment during pelvic examination.

USPSTF
(2017)

Summary of Recommendation and Evidence

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 (I statement).

This statement does not apply to specific disorders for which the USPSTF already recommends screening (i.e., screening for cervical cancer with a Papanicolaou ["Pap"] smear, screening for gonorrhea and chlamydia).

Rationale

Importance

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., Pap smear, HPV 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. Although the USPSTF sought evidence on the effectiveness of using pelvic examination to screen for all asymptomatic gynecologic conditions other than cervical cancer, chlamydia, and gonorrhea, it was only able to identify limited evidence on its accuracy to detect ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis.

Detection

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%). Very few studies on screening for other gynecologic conditions with pelvic examination alone have been conducted, 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.

USPSTF Assessment

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.

Clinical Considerations

Patient Population Under Consideration

This recommendation applies to asymptomatic women 18 years and older who are not at increased risk for any specific gynecologic conditions, such as ovarian or cervical cancer. The recommendation does not apply to pregnant women or adolescents.

Suggestions for Practice Regarding the I Statement

In the absence of clear evidence on the balance of benefits and harms of using pelvic examination to screen for asymptomatic gynecologic conditions, clinicians are encouraged to consider the patient's risk factors for various gynecologic conditions and the patient's values and preferences, and engage in shared decision making with the patient to determine whether to perform a pelvic examination.

ACP
(2014)

Grading of Quality of Evidence

High-Quality Evidence: Evidence is considered high quality when it is obtained from 1 or more well-designed and well-executed randomized, controlled trials (RCTs) that yield consistent and directly applicable results. This also means that further research is very unlikely to change confidence in the estimate of effect.

Moderate-Quality Evidence: Evidence is considered moderate quality when it is obtained from RCTs with important limitations—for example, biased assessment of the treatment effect, large loss to follow-up, lack of blinding, unexplained heterogeneity (even if it is generated from rigorous RCTs), indirect evidence originating from similar (but not identical) populations of interest, and RCTs with a very small number of participants or observed events. In addition, evidence from well-designed controlled trials without randomization, well-designed cohort or case-control analytic studies, and multiple time series with or without intervention are in this category. Moderate-quality evidence also means that further research will probably have an important effect on confidence in the estimate of effect and may change the estimate.

Low-Quality Evidence: Evidence obtained from observational studies would typically be rated as low quality because of the risk for bias. Low-quality evidence means that further research is very likely to have an important effect on confidence in the estimate of effect and will probably change the estimate. However, the quality of evidence may be rated as moderate or even high, depending on circumstances under which evidence is obtained from observational studies. Factors that may contribute to upgrading the quality of evidence include a large magnitude of the observed effect, a dose-response association, or the presence of an observed effect when all plausible confounders would decrease the observed effect.

Insufficient Evidence to Determine Net Benefits or Risks: When the evidence is insufficient to determine for or against routinely providing a service, the recommendation was graded as "insufficient evidence to determine net benefits or risks." Evidence may be conflicting, of poor quality, or lacking, and hence the balance of benefits and harms cannot be determined. Any estimate of effect that is very uncertain as evidence is either unavailable or does not permit a conclusion.

The American College of Physicians Guideline Grading System*
Quality of Evidence Strength of Recommendation
Benefits Clearly Outweigh Risks and Burden or Risks and Burden Clearly Outweigh Benefits Benefits Finely Balanced with Risks and Burden
High Strong Weak
Moderate Strong Weak
Low Strong Weak
Insufficient evidence to determine net benefits or risks

*Adopted from the classification developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group.

USPSTF
(2017)

What the U.S. Preventive Services Task Force (USPSTF) Grades Mean and Suggestions for Practice

Grade Definition Suggestions for Practice
A The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service.
B The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service.
C The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small. Offer or provide this service for selected patients depending on individual circumstances.
D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service.
I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality or conflicting, and the balance of benefits and harms cannot be determined. Read the "Clinical Considerations" section of the USPSTF Recommendation Statement (see the "Major Recommendations" field). If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.

USPSTF Levels of Certainty Regarding Net Benefit

Definition: The USPSTF defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.

Level of Certainty Description
High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
  • The number, size, or quality of individual studies
  • Inconsistency of findings across individual studies
  • Limited generalizability of findings to routine primary care practice
  • Lack of coherence in the chain of evidence
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
  • The limited number or size of studies
  • Important flaws in study design or methods
  • Inconsistency of findings across individual studies
  • Gaps in the chain of evidence
  • Findings not generalizable to routine primary care practice
  • A lack of information on important health outcomes
More information may allow an estimation of effects on health outcomes.
Click on the links below for details of guideline development methodology

ACP
(2014)

USPSTF
(2017)

The ACP and USPSTF guidelines were developed from systematic reviews of the evidence conducted by the Minneapolis Department of Veterans Affairs Health Care System's Evidence-based Synthesis Program Center and the Kaiser Permanente Research Affiliates Evidence-based Practice Center (EPC), respectively. Both systematic reviews provide relevant details of the literature search and selection process, including the electronic databases that were searched, time period of the search, search terms used, and the inclusion and exclusion criteria applied. To assess the quality and strength of the selected evidence, the guideline developers weighted it according to a rating scheme and provide the scheme. Both the ACP and the USPSTF formulated the guideline recommendations using an expert consensus process based on evaluation of the evidence, and rate the strength of the individual recommendations according to a scheme. To validate the guidelines, ACP sought internal peer review and an independent peer review process via journal publication; the USPSTF sought internal and external peer review and compared its recommendations to those in guidelines developed by other groups, including the ACP.

Benefits

ACP
(2014)

None identified

USPSTF
(2017)

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.

Harms

ACP
(2014)

Unnecessary laparoscopies or laparotomies, fear, embarrassment, anxiety, pain or discomfort, avoidance of necessary care

USPSTF
(2017)

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 have surgery. Very few studies reported false-positive and false-negative rates for other gynecologic conditions. No studies quantified the amount of anxiety associated with screening pelvic examinations.

ACP, American College of Physicians

EPC, Evidence-based Practice Center

GRADE, Grading of Recommendations Assessment, Development and Evaluation

HPV, human papillomavirus

PLCO trial, Prostate, Lung, Colorectal, and Ovarian trial

PTSD, posttraumatic stress disorder

RCT, randomized controlled trial

USPSTF, U.S. Preventive Services Task Force

This synthesis was prepared by ECRI Institute on April 2, 2017. The information was verified by the USPSTF on April 12, 2017 and by ACP on April 28, 2017.

About NGC Guideline Syntheses

Syntheses are systematic comparisons of selected guidelines that address similar topics. For definitions of synthesis attributes, see the Guideline Synthesis Template.


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