Hanna E. Bloomfield, MD, MPH; Andrew Olson, MD; Nancy Greer, PhD; Amy Cantor, MD, MHS; Roderick MacDonald, MS; Indulis Rutks, BS; Timothy J. Wilt, MD, MPH
Acknowledgment: The authors thank the topic nominators and technical expert panel members: Michelle Berlin, MD, MPH; Navjit Goraya, MD; Sally G. Haskell, MD; Linda Humphrey, MD, MPH; Linda S. Kinsinger, MD, MPH; Terri Murphy, RN, MSN; Wanda Nicholson, MD, MPH; and Laurie C. Zephyrin, MD, MPH, MBA.
Financial Support: By the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative (project 09-009), and the American College of Physicians Clinical Guidelines Committee.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2881.
Requests for Single Reprints: Hanna E. Bloomfield, MD, MPH, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 151, Minneapolis, MN 55417; e-mail, Hanna.Bloomfield@va.gov.
Current Author Addresses: Dr. Bloomfield: Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 151, Minneapolis, MN 55417.
Dr. Olson: Division of General Internal Medicine, Department of Medicine, University of Minnesota, MMC 741, 420 Delaware Street SE, Minneapolis, MN 55455.
Drs. Greer and Wilt and Mr. MacDonald: Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 111-O, Minneapolis, MN 55417.
Dr. Cantor: Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, Mail Code BICC, 3181 SW Sam Jackson Park Road, Portland, OR 97239.
Mr. Rutks: Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 152, Minneapolis, MN 55417.
Author Contributions: Conception and design: H.E. Bloomfield, A. Olson, N. Greer, A. Cantor, T.J. Wilt.
Analysis and interpretation of the data: H.E. Bloomfield, A. Olson, N. Greer, A. Cantor, R. MacDonald, T.J. Wilt.
Drafting of the article: H.E. Bloomfield, A. Olson, A. Cantor.
Critical revision of the article for important intellectual content: A. Olson, N. Greer, A. Cantor, T.J. Wilt.
Final approval of the article: H.E. Bloomfield, A. Olson, N. Greer, A. Cantor, R. MacDonald, I. Rutks, T.J. Wilt.
Provision of study materials or patients: I. Rutks.
Obtaining of funding: T.J. Wilt.
Administrative, technical, or logistic support: N. Greer, I. Rutks, T.J. Wilt.
Collection and assembly of data: H.E. Bloomfield, A. Olson, N. Greer, A. Cantor, R. MacDonald, I. Rutks.
Pelvic examination is often included in well-woman visits even when cervical cancer screening is not required.
To evaluate the diagnostic accuracy, benefits, and harms of pelvic examination in asymptomatic, nonpregnant, average-risk adult women. Cervical cancer screening was not included.
MEDLINE and Cochrane databases through January 2014 and reference lists from identified studies.
52 English-language studies, 32 of which included primary data.
Data were extracted on study and sample characteristics, interventions, and outcomes. Quality of the diagnostic accuracy studies was evaluated using a published instrument, and quality of the survey studies was evaluated with metrics assessing population representativeness, instrument development, and response rates.
The positive predictive value of pelvic examination for detecting ovarian cancer was less than 4% in the 2 studies that reported this metric. No studies that investigated the morbidity or mortality benefits of screening pelvic examination for any condition were identified. The percentage of women reporting pelvic examination–related pain or discomfort ranged from 11% to 60% (median, 35%; 8 studies [n = 4576]). Corresponding figures for fear, embarrassment, or anxiety ranged from 10% to 80% (median, 34%; 7 studies [n = 10 702]).
Only English-language publications were included; the evidence on diagnostic accuracy, morbidity, and mortality was scant; and the studies reporting harms were generally low quality.
No data supporting the use of pelvic examination in asymptomatic, average-risk women were found. Low-quality data suggest that pelvic examinations may cause pain, discomfort, fear, anxiety, or embarrassment in about 30% of women.
Department of Veterans Affairs.
Summary of evidence search and selection
Appendix Table 1. Prospective Cohort Studies of Diagnostic Accuracy of the Screening Pelvic Examination for Detecting Ovarian Cancer in Asymptomatic, Average-Risk Women
Appendix Table 2. Pelvic Examination–Related Harms and the Effect on Return Visits
Appendix Table 3. History of SV as a Predictor of the Pelvic Examination Experience and Receipt of Pap Smears
Table. Summary of Screening Pelvic Examination Review
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Author Insight Video - Andrew Olson, MD
John C. Jennings, MD, Jennifer Blake, MD, MSC
American College of Obstetricians and Gynecologists, The Society of Obstetricians and Gynaecologists of Canada
July 31, 2014
Lack of Evidence Does Not Mean Lack of Value
As important as evidence-based decision-making is to medical practice, creating guidelines based on limited and low quality evidence is inappropriate. Lack of evidence does not mean lack of value. The ability of pelvic examinations to help gynecologists diagnose and treat patients for conditions such as vulvar disease, atrophy, prolapse, incontinence, and sexual dysfunction clearly justifies its role in gynecologic practice.
The evidence report conducted in conjunction with the American College of Physicians’ clinical practice guidelines about pelvic exams relied solely on evidence regarding use of pelvic exams to detect noncervical cancer or pelvic inflammatory disease and/or to reduce morbidity and mortality. We agree that the literature does not support this indication. We argue, however, that this is not the intent of pelvic exams. And while the clinical value of pelvic exams has not been subject to peer-reviewed, scientific scrutiny (and, realistically, how could it be?), it is proven daily in gynecologic exam rooms across the country.
We also disagree with the suggestion that pelvic exams cause harm to the patient. The authors of the evidence review acknowledge that any evidence to support this conclusion is of low quality, with “substantial methodological weaknesses, including unrepresentative populations, low response rates, and inadequately validated survey instruments.”
One of the primary sources, Adonakis et al, used data from women receiving care between 1991 and 1993 . With more than 20 years of diagnostic developments since these data were collected, we can assume that, given current management algorithms, many of the 1.5 percent of women who underwent surgery following screening pelvic exams would not require surgery today. Describing those surgeries as “unnecessary” is subjective. Many of the interventions, although ultimately treating benign disease, were likely medically indicated for management of ad nexal pathology.
The guidance to avoid routine pelvic examination assumes that patients presenting for well-woman care are asymptomatic. A woman who presents to a gynecologist for her well-woman visit has self-selected her provider, and although she may be labeled as asymptomatic, we often encounter patients who have difficult or embarrassing issues which they disclose only during the pelvic exam. By eliminating routine exams we lose an opportunity to identify and address key concerns.
We should not base care guidelines on the evidence from this methodologically limited study. Doing so could compromise the care of millions of women.
John C. Jennings, MD
American College of Obstetricians and Gynecologists
Jennifer Blake, MD, MSC
Chief Executive Officer
The Society of Obstetricians and Gynaecologists of Canada
Hanna E. Bloomfield, MD, MPH, Timothy Wilt, MD, MPH, Andrew Olson, MD
October 8, 2014
We thank Drs. Jennings and Blake for their comments and appreciate this opportunity to respond. First, our literature search included all gynecological conditions not just non-cervical cancer and pelvic inflammatory disease. Second, we agree that lack of evidence does not mean lack of value, but it does mean that value has not been empirically demonstrated. Value is defined as the magnitude of benefit relative to the cost. We found no evidence of benefit for the pelvic examination (excluding exams performed for cervical cancer screening) in the asymptomatic average risk woman (1). Without demonstrable benefit there cannot be value. Third, Drs. Jennings and Blake point out that the pelvic examination sometimes reveals abnormalities. The issue, however, is not whether the exam reveals abnormalities, but whether finding them in an asymptomatic woman improves her health, well-being, or longevity. We found no evidence that pre-symptomatic detection of any of the conditions listed by Drs. Jennings and Blake improves patient outcomes. Fourth, we disagree with the assertion that pelvic examinations do not cause harm. All procedures have the potential for harm, if not directly from the procedure itself then from downstream invasive interventions that follow abnormal or inconclusive results. In the large US ovarian cancer screening trial, 1080 women who did not have ovarian cancer underwent exploratory surgery to follow up on abnormal screening tests and 15% of these women experienced major surgical complications (2). We should not subject asymptomatic people to that level of risk in the absence of documented benefit. Fifth, we are perplexed by the comment that the pelvic examination is an important method for eliciting symptoms. Perhaps future studies should investigate how providers can effectively uncover sensitive concerns during history taking to avoid the need for an invasive examination. Finally, we take issue with the characterization of our study as methodologically limited. The review, conducted under the auspices of the VA Evidence-based Synthesis Program, conformed to commonly accepted standards for systematic reviews, was informed by a panel of experts in women’s health, and underwent external peer-review before publication. The limitation was that there were few studies evaluating the benefits and harms of the pelvic examination. As noted in the accompanying editorial, this lack of evidence will hopefully “prompt champions of this examination to clarify its goals and quantify its benefits and harms” (3) Hanna E. Bloomfield, MD, MPHAndrew P.J. Olson, MDTimothy J. Wilt, MD, MPH1. Bloomfield HE, Olson A, Greer N, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: An evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med 2014;161:46-53. 2. Buys SS, Partridge E, Black A et al. Effect of screening on ovarian cancer mortality: The prostate, lung, colorectal and ovarian (PLCO) cancer screening randomized controlled trial. JAMA 2011;305:2295-2303.
Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutks I, et al. Screening Pelvic Examinations in Asymptomatic, Average-Risk Adult Women: An Evidence Report for a Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2014;161:46-53. doi: 10.7326/M13-2881
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Published: Ann Intern Med. 2014;161(1):46-53.
Cancer Screening/Prevention, Hematology/Oncology, High Value Care, Infectious Disease, Prevention/Screening.
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