A Systematic Review of the Bimanual Examination as a Test for Ovarian Cancer

doi:10.1016/j.amepre.2014.10.007

American Journal of Preventive Medicine

Volume 48, Issue 3, March 2015, Pages 350-356

https://doi.org/10.1016/j.amepre.2014.10.007 Get rights and content

Context

An annual bimanual pelvic examination remains widely recommended for healthy women, but its inclusion may discourage attendance. Our goal was to determine the accuracy of the pelvic examination as a screening test for ovarian cancer and to distinguish benign from malignant lesions.

Evidence acquisition

PubMed was searched to identify studies evaluating the accuracy of the bimanual pelvic examination for ovarian cancer diagnosis. Data regarding study design, study quality, and test accuracy were abstracted. Heterogeneity was evaluated and meta-analysis performed where appropriate, including bivariate receiver operating characteristic curves.

Evidence synthesis

Eight studies in screening populations (n=36,599) and seven studies in symptomatic patients (n=782) were identified. Search was completed in November 2013; included studies were published between 1988 and 2009. Screening studies were homogeneous; the summary estimates of sensitivity and specificity of the pelvic examination as a screening test for ovarian cancer were 0.44 and 0.98 (positive likelihood ratio, 24.7; negative likelihood ratio, 0.57). For distinguishing benign versus malignant lesions, there was considerable heterogeneity, with a range of sensitivity from 0.43 to 0.93 and specificity from 0.53 to 0.91.

Conclusions

The bimanual pelvic examination lacks accuracy as a screening test for ovarian cancer and as a way to distinguish benign from malignant lesions. In a typical screening population, the positive predictive value of an abnormal pelvic examination is only 1% (95% CI=0.67%, 3.0%). Its inclusion in a health maintenance examination cannot be justified on the basis of using it to screen for ovarian cancer.

Introduction

A pelvic examination is routinely performed on women as part of the “annual physical” or “periodic health exam.” It typically includes inspection of the external genitalia, a speculum examination of the vagina and cervix (almost always accompanied by a Pap test), and a bimanual examination to palpate the uterus and adnexa. The American College of Obstetrics and Gynecology¹ recently reiterated its support for performing a bimanual examination annually in otherwise healthy women aged ≥21 years, although they note that it may be omitted if desired for otherwise healthy women who have had a total hysterectomy and bilateral salpingo-oophorectomy for benign indications.

Reasons given by physicians for performing the bimanual pelvic examination include that it is a standard part of a well woman examination, to screen for ovarian cancer, to screen for other gynecologic cancers, to screen for sexually transmitted infections (STIs),² and as a requirement for hormonal contraception.³ A study⁴ surveyed physicians and found that 47% of obstetrician-gynecologists believed that the pelvic examination is an effective screening test for ovarian cancer. However, the bimanual examination is not needed to screen for STIs¹ and is not recommended as a screening test for gynecologic cancer by the American Cancer Society⁵ or the U.S. Preventive Services Task Force.6, 7 It is also no longer recommended as a requirement before receiving oral contraceptives.1, 8, 9 Although many women have had an annual pelvic examination in association with screening for cervical cancer, the interval for this screening has increased to 3–5 years for average-risk women, calling into question the need to perform an annual bimanual pelvic examination that is not accompanied by a Pap test.⁷

In fact, the knowledge that an annual health maintenance visit is likely to include a bimanual pelvic examination, which many women view as invasive and uncomfortable, can cause anxiety¹⁰ and may actually discourage attendance.¹¹ As a consequence, some women may not receive other important clinical preventive services. Perhaps even more important is the opportunity cost incurred by performing a pelvic during a periodic health examination, time that might be better spent delivering clinical preventive services that have been proven effective.¹² The objective of the current study is to systematically review the literature regarding the accuracy of the bimanual examination as a screening test for ovarian cancer. A secondary goal is to examine the ability of the pelvic examination to distinguish benign from malignant lesions in women with a known abnormality, the other reason for using the bimanual examination related to ovarian cancer.

Section snippets

Inclusion Criteria

Two types of studies were identified, screening studies and studies of symptomatic patients. In screening studies, the goal of the bimanual examination was to detect ovarian cancer in an asymptomatic woman. Screening studies that performed a bimanual pelvic examination in asymptomatic women and reported enough information to calculate the sensitivity, specificity, or both for the diagnosis of ovarian malignancy were included. Acceptable reference standards included ultrasound, cancer antigen

Results

The PubMed search returned a total of 303 articles, and previous systematic reviews and reference lists of included studies identified another 24 studies, for a total of 315 unique studies after elimination of duplicates. A total of 56 studies met the initial review and were examined in full. Forty-one studies were excluded because they did not meet the inclusion criteria, most often because of failure to report sensitivity or specificity, failure to address one of our study questions, or

Discussion

The bimanual pelvic examination has very low sensitivity for the diagnosis of ovarian cancer. Although the specificity of 0.98 appears high, it is important to remember that the examination is being used to detect a rare disease. The Prostate Lung Colon Ovary (PLCO) trial detected approximately 5 cases of ovarian cancer per 10,000 person-years of follow-up.³² Thus, if 10,000 women are screened, the 44% sensitivity means that approximately two of the five cancers would be detected. However, the

Acknowledgments

This study was not funded or sponsored. It was conceived, carried out, and written by the authors under the lead of Dr. Ebell. The authors do not have any relevant conflicts of interest, either financial or professional. Dr. Ebell is a member of the U.S. Preventive Services Task Force (USPSTF). This article does not necessarily represent the views and policies of the USPSTF.

No financial disclosures were reported by the authors of this paper.

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Both the ACOG and the RCOG recognize the limited pelvic examination ability to identify an adnexal mass with an estimated sensitivity of 15–51% (especially with patient body mass index >30). Indeed, A recent systematic review concluded that pelvic examination inclusion in a health maintenance examination cannot be justified on the basis of using it to screen for ovarian cancer [15]. Nonetheless, the SOGC (strong) and the ACOG (level of recommendations not mentioned), recommend pelvic examination for the evaluation of mass tenderness, mobility, nodularity, and ascites.
General gynecologists are often the first to face a newly diagnosed adnexal mass. Bothering mass symptoms, fertility issues, and the effect of a possible surgical intervention on fertility in term of mechanical factor and ovarian follicular reserve are all considerations that should be accounted for. This study summarizes and compares five different adnexal mass management guidelines, enabling clinicians to peruse consensus and controversy issues, thus choosing the optimal management method.
We retrieved, reviewed and compared the most recent national guidelines of adnexal mass management from the national societies of the United States (American College of Obstetricians and Gynecologists), England (the Royal College of Obstetricians and Gynecologists), Canada (the Society of Obstetricians and Gynaecologists of Canada), Australia (the Royal Australian College of General Practitioners), and France (French College of Gynaecologists and Obstetricians).
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Adnexal mass management national guidelines, though similar, had noticeable variations in the content, references cited, and recommendations made. While this variation might raise a concern as to the reproducibility of synthesizing literature, it can help practitioners present all spectra of recommendations and available data.
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Neither systematic review used current standards for the assessment of diagnostic study quality,7 the synthesis of data such as bivariate meta-analysis, or the reporting of CIs and predictive intervals around summary estimates. A previous study8 by this research team performed a systematic review of the bimanual pelvic exam for the diagnosis of ovarian cancer, finding that it lacked sensitivity. In the current systematic review, the results of a meta-analysis of individual symptoms and combinations of symptoms for the diagnosis of ovarian cancer are reported.
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Review and Special ArticlesA Systematic Review of the Bimanual Examination as a Test for Ovarian Cancer

Context

Evidence acquisition

Evidence synthesis

Conclusions

Introduction

Section snippets

Inclusion Criteria

Results

Discussion

Acknowledgments

Lancet

Eur J Obstet Gynecol Reprod Biol

Gynecol Oncol

Int J Gynaecol Obstet

Gynecol Oncol

Obstet Gynecol

Eur J Obstet Gynecol Reprod Biol

Committee opinion no. 534: well-woman visit

Obstet Gynecol

Routine pelvic examinations in asymptomatic young women

N Engl J Med

The pelvic examination as a screening tool: practices of US physicians

Arch Intern Med

Routine bimanual pelvic examinations: practices and beliefs of US obstetrician-gynecologists

Am J Obstet Gynecol

Screening for ovarian cancer: recommendation statement

Ann Fam Med

U.S. Preventive Services Task Force. Screening for ovarian cancer: USPSTF reaffirmation recommendation statement

Ann Intern Med

Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence

JAMA

Pelvic examinations and access to oral hormonal contraception

Obstet Gynecol

Patient anxiety during gynecologic examinations. Behavioral indicators

J Reprod Med

Review and Special Articles
A Systematic Review of the Bimanual Examination as a Test for Ovarian Cancer