Editorial
Annals of Internal Medicine
Screening Pelvic Examinations: Right, Wrong, or Rite?
I
n the modern era, many routine practices are being reevaluated through a lens of not only evidence, but also value. In this issue, the American College of Physicians discusses the screening pelvic examination and gives a “strong” recommendation against it being done in asymptomatic, nonpregnant adult women (1). The recommendation is based on a systematic review (2) that found “no data in support of the examination” but did find evidence of harms ranging from distress to unnecessary surgery. This recommendation will be controversial. Pelvic examination has long been considered a fundamental component of the well-woman visit, and 62.8 million were done in the United States in 2010 (3). The examination has been closely linked with cervical cancer screening, but with current guidelines recommending less-than-annual testing, the need for asymptomatic women to return annually for this examination has been questioned. In 2012, the American College of Obstetricians and Gynecologists (ACOG) published a committee opinion describing the content of the well-woman visit and continued to recommend annual pelvic examinations, including speculum and bimanual examinations, in all women aged 21 years or older (4). According to a recent survey (5), obstetriciangynecologists in the United States universally conduct pelvic examinations across a lifespan in asymptomatic women and believe that lengthening the interval between examinations would decrease patient satisfaction and overall health and well-being (6). Ending such a prevalent practice with widespread support among women’s health providers will be met with formidable challenges. However, one essential question remains unanswered: What adverse health outcomes is the examination believed to prevent? The ACOG opinion acknowledges that “no evidence supports or refutes the annual pelvic examination or speculum and bimanual examination for the asymptomatic, low-risk patient,” which echoes the conclusion of the systematic review. The opinion further states that the examination “seems logical” but suggests that it is reasonable to discontinue “when a woman’s age or other health issues reach a point where the woman would not choose to intervene on conditions detected,” although these conditions are not defined. For women who have had surgical removal of the uterus, fallopian tubes, and ovaries, the ACOG opinion is somewhat puzzling and states that the decision to have a pelvic examination should be “left to the woman.” In the absence of guidance on the examination’s purpose, recent surveys have investigated what clinicians believe they are achieving by performing them (5– 8). The examination has been cited by obstetrician-gynecologists as being most important for detecting benign uterine and ovarian lesions (5). High importance has also been placed on detection of ovarian cancer, which is concerning in light 78 © 2014 American College of Physicians
of recommendations by the U.S. Preventive Services Task Force (9) and ACOG (10) that specifically discourage ovarian cancer screening by any method in low-risk women. Other reasons clinicians believed were important included accommodating patient expectations and reassuring them that they are healthy, both of which might be modifiable with patient education. The American College of Physicians points to the absence of evidence of benefit presented in a systematic review to justify its recommendation against pelvic examination. But all 3 studies in the review that assessed examination accuracy focused on older women (mean age of 51 to 58 years) enrolled in ovarian cancer screening programs; 2 studies enrolled women aged 45 years or older, and 1 excluded premenopausal women. Thus, it is reasonable to disagree with using these findings to recommend a major change in clinical practice for women of all ages attending well-woman visits. Many will ask, “Have all of the pertinent clinical questions been addressed?” None of the included studies evaluated the most important goal of the pelvic examination cited by obstetriciangynecologists— detecting noncancerous masses. Detection of these masses presumably has benefits (for example, preventing surgical emergencies due to ovarian torsion or rupture) and harms (for example, surgery for asymptomatic uterine leiomyomas), but little is known about the likelihood of either. Deciding when evidence is sufficient to conclude that an intervention should be promoted, discontinued, or submitted to further study is challenging (7). The determination relies largely on judgment about evidence quality and the likelihood that more evidence will tip the balance in making either a favorable or an unfavorable recommendation. Is it feasible to perform studies that better define the pelvic examination’s benefits and harms? Or is it simply too likely that the magnitude of credible potential benefits (whatever they may be) will never be large enough to outweigh the expected harms? The answers to these questions will be essential to the inevitable ensuing debate. The pelvic examination has held a prominent place in women’s health for many decades and has become more of a ritual than an evidence-based practice. Regardless of whether the American College of Physicians’ recommendation changes practice among obstetrician-gynecologists, it should prompt champions of this examination to clarify its goals and quantify its benefits and harms. Even if net benefit is ultimately shown, the question of value will need to be addressed to understand the resources required to achieve that benefit. With the current state of evidence, clinicians who continue to offer the examination should at least be cognizant of the uncertainty of benefit and the potential to cause harm through a positive test result and the cascade of events that follow.
Screening Pelvic Examinations: Right, Wrong, or Rite?
George F. Sawaya, MD Vanessa Jacoby, MD, MAS University of California, San Francisco San Francisco, California Disclosures: Authors have disclosed no conflicts of interest. Forms can
be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms .do?msNum⫽M14-1205. Requests for Single Reprints: George F. Sawaya, MD, Department of
Obstetrics, Gynecology and Reproductive Science, University of California, San Francisco, San Francisco, CA 94143. Current author addresses are available at www.annals.org. Ann Intern Med. 2014;161:78-79. doi:10.7326/M14-1205
References 1. Qaseem A, Humphrey LL, Harris R, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161:67-72. 2. Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutks I, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: an
www.annals.org
Editorial
evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161:46-53. 3. Ambulatory and Hospital Care Statistics Branch. National Ambulatory Medical Care Survey: 2010 Summary Tables. Atlanta, GA: Centers for Disease Control and Prevention; 2010. Accessed at www.cdc.gov/nchs/data/ahcd/namcs _summary/2010_namcs_web_tables.pdf on 18 May 2014. 4. Committee on Gynecologic Practice. Committee opinion no. 534: wellwoman visit. Obstet Gynecol. 2012;120:421-4. [PMID: 22825111] 5. Henderson JT, Harper CC, Gutin S, Saraiya M, Chapman J, Sawaya GF. Routine bimanual pelvic examinations: practices and beliefs of US obstetriciangynecologists. Am J Obstet Gynecol. 2013;208:109.e1-7. [PMID: 23159688] 6. Henderson JT, Yu JM, Harper CC, Sawaya GF. U.S. clinicians’ perspectives on less frequent routine gynecologic examinations. Prev Med. 2014;62:49-53. [PMID: 24518004] 7. Sawaya GF, Guirguis-Blake J, LeFevre M, Harris R, Petitti D; U.S. Preventive Services Task Force. Update on the methods of the U.S. Preventive Services Task Force: estimating certainty and magnitude of net benefit. Ann Intern Med. 2007;147:871-5. [PMID: 18087058] 8. Stormo AR, Cooper CP, Hawkins NA, Saraiya M. Physician characteristics and beliefs associated with use of pelvic examinations in asymptomatic women. Prev Med. 2012;54:415-21. [PMID: 22484240] 9. Moyer VA; U.S. Preventive Services Task Force. Screening for ovarian cancer: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med. 2012;157:900-4. [PMID: 22964825] 10. American College of Obstetricians anf Gynecologists. ACOG Committee Opinion: number 280, December 2002. The role of the generalist obstetriciangynecologist in the early detection of ovarian cancer. Obstet Gynecol. 2002;100: 1413-6. [PMID: 12468197]
1 July 2014 Annals of Internal Medicine Volume 161 • Number 1 79
Annals of Internal Medicine Current Author Addresses: Drs. Sawaya and Jacoby: Department of
Obstetrics, Gynecology and Reproductive Science, University of California, San Francisco, San Francisco, CA 94143.
www.annals.org
1 July 2014 Annals of Internal Medicine Volume 161 • Number 1
Copyright © American College of Physicians 2014.
Annals of Internal Medicine
Screening Pelvic Examinations: Right, Wrong, or Rite?
I
n the modern era, many routine practices are being reevaluated through a lens of not only evidence, but also value. In this issue, the American College of Physicians discusses the screening pelvic examination and gives a “strong” recommendation against it being done in asymptomatic, nonpregnant adult women (1). The recommendation is based on a systematic review (2) that found “no data in support of the examination” but did find evidence of harms ranging from distress to unnecessary surgery. This recommendation will be controversial. Pelvic examination has long been considered a fundamental component of the well-woman visit, and 62.8 million were done in the United States in 2010 (3). The examination has been closely linked with cervical cancer screening, but with current guidelines recommending less-than-annual testing, the need for asymptomatic women to return annually for this examination has been questioned. In 2012, the American College of Obstetricians and Gynecologists (ACOG) published a committee opinion describing the content of the well-woman visit and continued to recommend annual pelvic examinations, including speculum and bimanual examinations, in all women aged 21 years or older (4). According to a recent survey (5), obstetriciangynecologists in the United States universally conduct pelvic examinations across a lifespan in asymptomatic women and believe that lengthening the interval between examinations would decrease patient satisfaction and overall health and well-being (6). Ending such a prevalent practice with widespread support among women’s health providers will be met with formidable challenges. However, one essential question remains unanswered: What adverse health outcomes is the examination believed to prevent? The ACOG opinion acknowledges that “no evidence supports or refutes the annual pelvic examination or speculum and bimanual examination for the asymptomatic, low-risk patient,” which echoes the conclusion of the systematic review. The opinion further states that the examination “seems logical” but suggests that it is reasonable to discontinue “when a woman’s age or other health issues reach a point where the woman would not choose to intervene on conditions detected,” although these conditions are not defined. For women who have had surgical removal of the uterus, fallopian tubes, and ovaries, the ACOG opinion is somewhat puzzling and states that the decision to have a pelvic examination should be “left to the woman.” In the absence of guidance on the examination’s purpose, recent surveys have investigated what clinicians believe they are achieving by performing them (5– 8). The examination has been cited by obstetrician-gynecologists as being most important for detecting benign uterine and ovarian lesions (5). High importance has also been placed on detection of ovarian cancer, which is concerning in light 78 © 2014 American College of Physicians
of recommendations by the U.S. Preventive Services Task Force (9) and ACOG (10) that specifically discourage ovarian cancer screening by any method in low-risk women. Other reasons clinicians believed were important included accommodating patient expectations and reassuring them that they are healthy, both of which might be modifiable with patient education. The American College of Physicians points to the absence of evidence of benefit presented in a systematic review to justify its recommendation against pelvic examination. But all 3 studies in the review that assessed examination accuracy focused on older women (mean age of 51 to 58 years) enrolled in ovarian cancer screening programs; 2 studies enrolled women aged 45 years or older, and 1 excluded premenopausal women. Thus, it is reasonable to disagree with using these findings to recommend a major change in clinical practice for women of all ages attending well-woman visits. Many will ask, “Have all of the pertinent clinical questions been addressed?” None of the included studies evaluated the most important goal of the pelvic examination cited by obstetriciangynecologists— detecting noncancerous masses. Detection of these masses presumably has benefits (for example, preventing surgical emergencies due to ovarian torsion or rupture) and harms (for example, surgery for asymptomatic uterine leiomyomas), but little is known about the likelihood of either. Deciding when evidence is sufficient to conclude that an intervention should be promoted, discontinued, or submitted to further study is challenging (7). The determination relies largely on judgment about evidence quality and the likelihood that more evidence will tip the balance in making either a favorable or an unfavorable recommendation. Is it feasible to perform studies that better define the pelvic examination’s benefits and harms? Or is it simply too likely that the magnitude of credible potential benefits (whatever they may be) will never be large enough to outweigh the expected harms? The answers to these questions will be essential to the inevitable ensuing debate. The pelvic examination has held a prominent place in women’s health for many decades and has become more of a ritual than an evidence-based practice. Regardless of whether the American College of Physicians’ recommendation changes practice among obstetrician-gynecologists, it should prompt champions of this examination to clarify its goals and quantify its benefits and harms. Even if net benefit is ultimately shown, the question of value will need to be addressed to understand the resources required to achieve that benefit. With the current state of evidence, clinicians who continue to offer the examination should at least be cognizant of the uncertainty of benefit and the potential to cause harm through a positive test result and the cascade of events that follow.
Screening Pelvic Examinations: Right, Wrong, or Rite?
George F. Sawaya, MD Vanessa Jacoby, MD, MAS University of California, San Francisco San Francisco, California Disclosures: Authors have disclosed no conflicts of interest. Forms can
be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms .do?msNum⫽M14-1205. Requests for Single Reprints: George F. Sawaya, MD, Department of
Obstetrics, Gynecology and Reproductive Science, University of California, San Francisco, San Francisco, CA 94143. Current author addresses are available at www.annals.org. Ann Intern Med. 2014;161:78-79. doi:10.7326/M14-1205
References 1. Qaseem A, Humphrey LL, Harris R, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161:67-72. 2. Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutks I, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: an
www.annals.org
Editorial
evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014;161:46-53. 3. Ambulatory and Hospital Care Statistics Branch. National Ambulatory Medical Care Survey: 2010 Summary Tables. Atlanta, GA: Centers for Disease Control and Prevention; 2010. Accessed at www.cdc.gov/nchs/data/ahcd/namcs _summary/2010_namcs_web_tables.pdf on 18 May 2014. 4. Committee on Gynecologic Practice. Committee opinion no. 534: wellwoman visit. Obstet Gynecol. 2012;120:421-4. [PMID: 22825111] 5. Henderson JT, Harper CC, Gutin S, Saraiya M, Chapman J, Sawaya GF. Routine bimanual pelvic examinations: practices and beliefs of US obstetriciangynecologists. Am J Obstet Gynecol. 2013;208:109.e1-7. [PMID: 23159688] 6. Henderson JT, Yu JM, Harper CC, Sawaya GF. U.S. clinicians’ perspectives on less frequent routine gynecologic examinations. Prev Med. 2014;62:49-53. [PMID: 24518004] 7. Sawaya GF, Guirguis-Blake J, LeFevre M, Harris R, Petitti D; U.S. Preventive Services Task Force. Update on the methods of the U.S. Preventive Services Task Force: estimating certainty and magnitude of net benefit. Ann Intern Med. 2007;147:871-5. [PMID: 18087058] 8. Stormo AR, Cooper CP, Hawkins NA, Saraiya M. Physician characteristics and beliefs associated with use of pelvic examinations in asymptomatic women. Prev Med. 2012;54:415-21. [PMID: 22484240] 9. Moyer VA; U.S. Preventive Services Task Force. Screening for ovarian cancer: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med. 2012;157:900-4. [PMID: 22964825] 10. American College of Obstetricians anf Gynecologists. ACOG Committee Opinion: number 280, December 2002. The role of the generalist obstetriciangynecologist in the early detection of ovarian cancer. Obstet Gynecol. 2002;100: 1413-6. [PMID: 12468197]
1 July 2014 Annals of Internal Medicine Volume 161 • Number 1 79
Annals of Internal Medicine Current Author Addresses: Drs. Sawaya and Jacoby: Department of
Obstetrics, Gynecology and Reproductive Science, University of California, San Francisco, San Francisco, CA 94143.
www.annals.org
1 July 2014 Annals of Internal Medicine Volume 161 • Number 1
Copyright © American College of Physicians 2014.
