Expert Commentary

EXPERT COMMENTARY

Both the Centers for Disease Control and Prevention and the World Health Organization currently recommend that patients with trichomoniasis be treated with a single 2-g oral dose of metronidazole.¹ Following treatment, the reported rates of repeat infection or persistent infection range from 5% to 31%. Repeat infection rates may be even higher in HIV-infected patients.

Repeat infections presumably result from a failure to treat the patient’s sexual partner(s) or from the patient’s exposure to a new partner. Persistent infections, however, may be the result of inadequate primary therapy, even though inherent resistance of the organism to metronidazole is quite rare. To date, no single study has shown that single-dose therapy is inferior to multidose therapy, but most of these studies lack sufficient power to completely exclude the possibility of a type-2 statistical error.² To compare single-dose with multidose therapy for trichomoniasis in a more systematic manner, Howe and Kissinger conducted a meta-analysis, which was recently published in Sexually Transmitted Diseases.

Related article:
2016 Update on infectious disease

Details of the study

The investigators conducted a comprehensive literature search using Embase, Medline, and ClinicalTrials.gov; 6 articles were included in the final results, 4 of which were randomized controlled trials. Approximately 1,300 participants were included in the 6 trials. All of the patients in the single-dose treatment arms received a 2-g oral dose of metronidazole. In the multidose treatment arms for 2 studies the participants received metronidazole 250 mg orally 3 times daily for 7 days, and for 2 studies the dose was 200 mg 3 times daily for 7 days. The fifth study employed a 500-mg oral dose of metronidazole twice daily for 7 days. The final study used a 400-mg oral dose twice daily for 5 days. The key study end point was treatment failure.

Howe and Kissinger demonstrated that women who received the single 2-g dose were 1.87 times (95% CI, 1.23−2.82; P<.01) more likely to experience a treatment failure compared with women who received a multidose regimen. When the one study that focused only on HIV-infected women was excluded from analysis, the results were similar. The relative risk of treatment failure was 1.80 (95% CI, 1.07−3.02; P<.03).

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

Study limitations

The results of this meta-analysis are interesting and provocative. However, the analysis has several important limitations. Five of the 6 studies were published many years ago (1971, 1972, 1979, 1980, and 1982). The most recent study was published in 2010. The investigators used 4 different multidose regimens, with metronidazole doses ranging from 200 mg to 500 mg and duration of therapy ranging from 5 to 7 days. Four of the six investigations used saline microscopy as the definitive diagnostic test of treatment failure. Compared with culture or DNA testing, microscopy is not as accurate. Moreover, the timing of retesting varied in the studies, and some apparent treatment failures actually may have been due to reinfection. In addition, the studies did not consistently track the adequacy of treatment of the sexual partner.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Both the Centers for Disease Control and Prevention and the World Health Organization currently recommend that patients with trichomoniasis be treated with a single 2-g oral dose of metronidazole.¹ Following treatment, the reported rates of repeat infection or persistent infection range from 5% to 31%. Repeat infection rates may be even higher in HIV-infected patients.

Repeat infections presumably result from a failure to treat the patient’s sexual partner(s) or from the patient’s exposure to a new partner. Persistent infections, however, may be the result of inadequate primary therapy, even though inherent resistance of the organism to metronidazole is quite rare. To date, no single study has shown that single-dose therapy is inferior to multidose therapy, but most of these studies lack sufficient power to completely exclude the possibility of a type-2 statistical error.² To compare single-dose with multidose therapy for trichomoniasis in a more systematic manner, Howe and Kissinger conducted a meta-analysis, which was recently published in Sexually Transmitted Diseases.

Related article:
2016 Update on infectious disease

Details of the study

The investigators conducted a comprehensive literature search using Embase, Medline, and ClinicalTrials.gov; 6 articles were included in the final results, 4 of which were randomized controlled trials. Approximately 1,300 participants were included in the 6 trials. All of the patients in the single-dose treatment arms received a 2-g oral dose of metronidazole. In the multidose treatment arms for 2 studies the participants received metronidazole 250 mg orally 3 times daily for 7 days, and for 2 studies the dose was 200 mg 3 times daily for 7 days. The fifth study employed a 500-mg oral dose of metronidazole twice daily for 7 days. The final study used a 400-mg oral dose twice daily for 5 days. The key study end point was treatment failure.

Howe and Kissinger demonstrated that women who received the single 2-g dose were 1.87 times (95% CI, 1.23−2.82; P<.01) more likely to experience a treatment failure compared with women who received a multidose regimen. When the one study that focused only on HIV-infected women was excluded from analysis, the results were similar. The relative risk of treatment failure was 1.80 (95% CI, 1.07−3.02; P<.03).

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

Study limitations

The results of this meta-analysis are interesting and provocative. However, the analysis has several important limitations. Five of the 6 studies were published many years ago (1971, 1972, 1979, 1980, and 1982). The most recent study was published in 2010. The investigators used 4 different multidose regimens, with metronidazole doses ranging from 200 mg to 500 mg and duration of therapy ranging from 5 to 7 days. Four of the six investigations used saline microscopy as the definitive diagnostic test of treatment failure. Compared with culture or DNA testing, microscopy is not as accurate. Moreover, the timing of retesting varied in the studies, and some apparent treatment failures actually may have been due to reinfection. In addition, the studies did not consistently track the adequacy of treatment of the sexual partner.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Both the Centers for Disease Control and Prevention and the World Health Organization currently recommend that patients with trichomoniasis be treated with a single 2-g oral dose of metronidazole.¹ Following treatment, the reported rates of repeat infection or persistent infection range from 5% to 31%. Repeat infection rates may be even higher in HIV-infected patients.

Repeat infections presumably result from a failure to treat the patient’s sexual partner(s) or from the patient’s exposure to a new partner. Persistent infections, however, may be the result of inadequate primary therapy, even though inherent resistance of the organism to metronidazole is quite rare. To date, no single study has shown that single-dose therapy is inferior to multidose therapy, but most of these studies lack sufficient power to completely exclude the possibility of a type-2 statistical error.² To compare single-dose with multidose therapy for trichomoniasis in a more systematic manner, Howe and Kissinger conducted a meta-analysis, which was recently published in Sexually Transmitted Diseases.

Related article:
2016 Update on infectious disease

Details of the study

The investigators conducted a comprehensive literature search using Embase, Medline, and ClinicalTrials.gov; 6 articles were included in the final results, 4 of which were randomized controlled trials. Approximately 1,300 participants were included in the 6 trials. All of the patients in the single-dose treatment arms received a 2-g oral dose of metronidazole. In the multidose treatment arms for 2 studies the participants received metronidazole 250 mg orally 3 times daily for 7 days, and for 2 studies the dose was 200 mg 3 times daily for 7 days. The fifth study employed a 500-mg oral dose of metronidazole twice daily for 7 days. The final study used a 400-mg oral dose twice daily for 5 days. The key study end point was treatment failure.

Howe and Kissinger demonstrated that women who received the single 2-g dose were 1.87 times (95% CI, 1.23−2.82; P<.01) more likely to experience a treatment failure compared with women who received a multidose regimen. When the one study that focused only on HIV-infected women was excluded from analysis, the results were similar. The relative risk of treatment failure was 1.80 (95% CI, 1.07−3.02; P<.03).

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

Study limitations

The results of this meta-analysis are interesting and provocative. However, the analysis has several important limitations. Five of the 6 studies were published many years ago (1971, 1972, 1979, 1980, and 1982). The most recent study was published in 2010. The investigators used 4 different multidose regimens, with metronidazole doses ranging from 200 mg to 500 mg and duration of therapy ranging from 5 to 7 days. Four of the six investigations used saline microscopy as the definitive diagnostic test of treatment failure. Compared with culture or DNA testing, microscopy is not as accurate. Moreover, the timing of retesting varied in the studies, and some apparent treatment failures actually may have been due to reinfection. In addition, the studies did not consistently track the adequacy of treatment of the sexual partner.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Resources

• Essure permanent birth control (Bayer) instructions for use

• Essure patient information booklet

• US Food and Drug Administration. Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization: guidance for industry and Food and Drug Administration staff. October 31, 2016

• Visit the companion article

Resources

• Essure permanent birth control (Bayer) instructions for use

• Essure patient information booklet

• US Food and Drug Administration. Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization: guidance for industry and Food and Drug Administration staff. October 31, 2016

• Visit the companion article

Resources

• Essure permanent birth control (Bayer) instructions for use

• Essure patient information booklet

• US Food and Drug Administration. Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization: guidance for industry and Food and Drug Administration staff. October 31, 2016

• Visit the companion article

In November 2016, Bayer, the manufacturer of the permanent birth control tubal implant system (Essure), revised the Essure product labeling in accordance with a US Food and Drug Administration (FDA) guidance document.¹ The FDA developed its labeling guidance based on its examination of an increasing number of reported adverse events associated with the system’s use (such as persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions) and its evaluation of a trade complaint regarding allegations initially made in a Citizen Petition.

Changes to the new FDA-approved labeling for Essure include:

• the addition of a boxed warning listing adverse events that have been reported either in clinical studies or through postmarket surveillance (see Box)
• updated Instructions for Use document for clinicians and Patient Information Booklet, which contain additional information on safety (contraindications, warnings, and precautions), clinical data, and instructions^2,3
• a Patient-Doctor Discussion Checklist (included within the Patient Information Booklet), designed to support appropriate patient counseling, facilitate the patient’s understanding of birth control options, and explain the benefits and risks associated with the device and what to expect during and after the implantation procedure.³

How will these labeling changes impact clinicians and patients? OBG Managementasked Linda Bradley, MD, Professor of Surgery and Vice Chair of Obstetrics and Gynecology at the Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio, to share her expertise with readers.

OBG Management: What does the new product labeling mean for clinicians who offer tubal implants as an option for permanent sterilization?

Linda D. Bradley, MD: The FDA-approved revised labeling for the Essure system means that physicians should have a very detailed, in-depth conversation with their patients who are contemplating hysteroscopic tubal insert placement for permanent sterilization. This counseling really should not differ from what doctors were doing before the label was revised. However, physicians can now use the new Patient-Doctor Discussion Checklist as a guide in reviewing the benefits of the device, its known risks and potential risks, outcomes of the insertion procedure, and the possible need for future surgical intervention if device placement–related issues arise.

For clinicians, this counseling adds just a few more minutes to the visit. The Patient-Doctor Discussion Checklist will become an inherent part of the informed consent process, aiding in the review of the device’s benefits, potential risks, and more importantly its permanence.

In the past, there was some concern that perhaps patients did not receive enough guidance for informed consent, so one of the first things listed on the checklist is confirmation—in the form of a printed line where the patient can sign her initials—that she understands that Essure is a permanent form of birth control. The checklist covers additional important issues, including that the doctor has indeed shared with the patient other options for birth control or sterilization, such as laparoscopic sterilization, vasectomy for her male partner, an intrauterine device (IUD), and birth control pills. This is an opportunity to reinforce the fact that tubal implants are a permanent form of birth control, and if the patient is uncertain about ending her fertility, the clinician can inform her about reversible options. The checklist also includes for discussion the pregnancy risk with use of the device, what the patient can expect during the implant insertion procedure and for the days afterwards (such as cramping, mild to moderate pain, nausea and vomiting), and the need for a confirmation test 3 months after device placement.

Other discussion points covered include long-term risks and benefits of the device, the potential for complications, and the possibility (due to pelvic pain) that the hysteroscopically placed devices may need to be removed with a surgical procedure requiring general anesthesia.

Incorporating the checklist into our clinical practice shows that we have listened to patients and complied with recommendations made by the FDA review panel, and we can use this document to have a more complete discussion with our patients.

OBG Management: Do you agree with some clinicians who say that physicians who place the device also should have the skills required to remove it if necessary?

Dr. Bradley: Essure placement—which is a hysteroscopic procedure—is done very differently than a laparoscopic procedure. In the past, among women who needed to have the Essure system removed, most procedures would be done laparoscopically. Since we work collaboratively in teams, someone within the team or division would have the clinical expertise to remove the devices. An ObGyn who does laparoscopy with salpingectomy and/or cornual resection would best be able to remove the devices.

The clinician who does hysteroscopy is not always the same one who does laparoscopy. Someone within the division who is interested in removing the device will develop an expertise and algorithm that suits the practice, so that person in the practice becomes the expert. This is no different from many other things that physicians do. In our clinical practice, for example, we have a pelvic pain specialist, a sexual counselor, someone interested in menopause and management, and someone interested in alternatives to hysterectomies. Those who practice their craft and their art become proficient at it. So if you do not perform a particular procedure such as a tubal implant removal, know the expert to whom you can make a referral.

OBG Management: How do you now advise your colleagues to counsel patients on permanent sterilization?

Dr. Bradley: Hysteroscopic tubal implant sterilization, a minimally invasive procedure, is an excellent and viable option for women who meet the inclusion criteria and who do not have the exclusion criteria for placement. It is overall safe and extremely effective. If a patient has issues after undergoing implant placement—just like with any other surgery or procedure—for example, if she is not feeling better or is not doing as well as anticipated, we must not forget the patient. It is important for our patients to be listened to and to be heard. Postprocedure issues are generally transient and related to pain and discomfort or abnormal bleeding. If they are persistent, then further evaluation is needed.

Tell the patient to contact you if she has questions or issues, and have a tiered approach for working up any problems that she may present with. In addition, reiterate that the patient must use another form of birth control for 3 months until she undergoes the confirmation test and until the results verify that the implants can be relied on for contraception. I am still placing the device. Before I perform the procedure, I speak with my patients—as I did before the checklist was developed—about all of the informed consent issues, the risk−benefit profile, and ruling out contraindications to use. I think this is good medical and surgical practice. The new labeling means we need to have a critical conversation with our patients, and we should be doing that for all procedures.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In November 2016, Bayer, the manufacturer of the permanent birth control tubal implant system (Essure), revised the Essure product labeling in accordance with a US Food and Drug Administration (FDA) guidance document.¹ The FDA developed its labeling guidance based on its examination of an increasing number of reported adverse events associated with the system’s use (such as persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions) and its evaluation of a trade complaint regarding allegations initially made in a Citizen Petition.

Changes to the new FDA-approved labeling for Essure include:

• the addition of a boxed warning listing adverse events that have been reported either in clinical studies or through postmarket surveillance (see Box)
• updated Instructions for Use document for clinicians and Patient Information Booklet, which contain additional information on safety (contraindications, warnings, and precautions), clinical data, and instructions^2,3
• a Patient-Doctor Discussion Checklist (included within the Patient Information Booklet), designed to support appropriate patient counseling, facilitate the patient’s understanding of birth control options, and explain the benefits and risks associated with the device and what to expect during and after the implantation procedure.³

How will these labeling changes impact clinicians and patients? OBG Managementasked Linda Bradley, MD, Professor of Surgery and Vice Chair of Obstetrics and Gynecology at the Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio, to share her expertise with readers.

OBG Management: What does the new product labeling mean for clinicians who offer tubal implants as an option for permanent sterilization?

Linda D. Bradley, MD: The FDA-approved revised labeling for the Essure system means that physicians should have a very detailed, in-depth conversation with their patients who are contemplating hysteroscopic tubal insert placement for permanent sterilization. This counseling really should not differ from what doctors were doing before the label was revised. However, physicians can now use the new Patient-Doctor Discussion Checklist as a guide in reviewing the benefits of the device, its known risks and potential risks, outcomes of the insertion procedure, and the possible need for future surgical intervention if device placement–related issues arise.

For clinicians, this counseling adds just a few more minutes to the visit. The Patient-Doctor Discussion Checklist will become an inherent part of the informed consent process, aiding in the review of the device’s benefits, potential risks, and more importantly its permanence.

In the past, there was some concern that perhaps patients did not receive enough guidance for informed consent, so one of the first things listed on the checklist is confirmation—in the form of a printed line where the patient can sign her initials—that she understands that Essure is a permanent form of birth control. The checklist covers additional important issues, including that the doctor has indeed shared with the patient other options for birth control or sterilization, such as laparoscopic sterilization, vasectomy for her male partner, an intrauterine device (IUD), and birth control pills. This is an opportunity to reinforce the fact that tubal implants are a permanent form of birth control, and if the patient is uncertain about ending her fertility, the clinician can inform her about reversible options. The checklist also includes for discussion the pregnancy risk with use of the device, what the patient can expect during the implant insertion procedure and for the days afterwards (such as cramping, mild to moderate pain, nausea and vomiting), and the need for a confirmation test 3 months after device placement.

Other discussion points covered include long-term risks and benefits of the device, the potential for complications, and the possibility (due to pelvic pain) that the hysteroscopically placed devices may need to be removed with a surgical procedure requiring general anesthesia.

Incorporating the checklist into our clinical practice shows that we have listened to patients and complied with recommendations made by the FDA review panel, and we can use this document to have a more complete discussion with our patients.

OBG Management: Do you agree with some clinicians who say that physicians who place the device also should have the skills required to remove it if necessary?

Dr. Bradley: Essure placement—which is a hysteroscopic procedure—is done very differently than a laparoscopic procedure. In the past, among women who needed to have the Essure system removed, most procedures would be done laparoscopically. Since we work collaboratively in teams, someone within the team or division would have the clinical expertise to remove the devices. An ObGyn who does laparoscopy with salpingectomy and/or cornual resection would best be able to remove the devices.

The clinician who does hysteroscopy is not always the same one who does laparoscopy. Someone within the division who is interested in removing the device will develop an expertise and algorithm that suits the practice, so that person in the practice becomes the expert. This is no different from many other things that physicians do. In our clinical practice, for example, we have a pelvic pain specialist, a sexual counselor, someone interested in menopause and management, and someone interested in alternatives to hysterectomies. Those who practice their craft and their art become proficient at it. So if you do not perform a particular procedure such as a tubal implant removal, know the expert to whom you can make a referral.

OBG Management: How do you now advise your colleagues to counsel patients on permanent sterilization?

Dr. Bradley: Hysteroscopic tubal implant sterilization, a minimally invasive procedure, is an excellent and viable option for women who meet the inclusion criteria and who do not have the exclusion criteria for placement. It is overall safe and extremely effective. If a patient has issues after undergoing implant placement—just like with any other surgery or procedure—for example, if she is not feeling better or is not doing as well as anticipated, we must not forget the patient. It is important for our patients to be listened to and to be heard. Postprocedure issues are generally transient and related to pain and discomfort or abnormal bleeding. If they are persistent, then further evaluation is needed.

Tell the patient to contact you if she has questions or issues, and have a tiered approach for working up any problems that she may present with. In addition, reiterate that the patient must use another form of birth control for 3 months until she undergoes the confirmation test and until the results verify that the implants can be relied on for contraception. I am still placing the device. Before I perform the procedure, I speak with my patients—as I did before the checklist was developed—about all of the informed consent issues, the risk−benefit profile, and ruling out contraindications to use. I think this is good medical and surgical practice. The new labeling means we need to have a critical conversation with our patients, and we should be doing that for all procedures.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In November 2016, Bayer, the manufacturer of the permanent birth control tubal implant system (Essure), revised the Essure product labeling in accordance with a US Food and Drug Administration (FDA) guidance document.¹ The FDA developed its labeling guidance based on its examination of an increasing number of reported adverse events associated with the system’s use (such as persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions) and its evaluation of a trade complaint regarding allegations initially made in a Citizen Petition.

Changes to the new FDA-approved labeling for Essure include:

• the addition of a boxed warning listing adverse events that have been reported either in clinical studies or through postmarket surveillance (see Box)
• updated Instructions for Use document for clinicians and Patient Information Booklet, which contain additional information on safety (contraindications, warnings, and precautions), clinical data, and instructions^2,3
• a Patient-Doctor Discussion Checklist (included within the Patient Information Booklet), designed to support appropriate patient counseling, facilitate the patient’s understanding of birth control options, and explain the benefits and risks associated with the device and what to expect during and after the implantation procedure.³

How will these labeling changes impact clinicians and patients? OBG Managementasked Linda Bradley, MD, Professor of Surgery and Vice Chair of Obstetrics and Gynecology at the Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio, to share her expertise with readers.

OBG Management: What does the new product labeling mean for clinicians who offer tubal implants as an option for permanent sterilization?

Linda D. Bradley, MD: The FDA-approved revised labeling for the Essure system means that physicians should have a very detailed, in-depth conversation with their patients who are contemplating hysteroscopic tubal insert placement for permanent sterilization. This counseling really should not differ from what doctors were doing before the label was revised. However, physicians can now use the new Patient-Doctor Discussion Checklist as a guide in reviewing the benefits of the device, its known risks and potential risks, outcomes of the insertion procedure, and the possible need for future surgical intervention if device placement–related issues arise.

For clinicians, this counseling adds just a few more minutes to the visit. The Patient-Doctor Discussion Checklist will become an inherent part of the informed consent process, aiding in the review of the device’s benefits, potential risks, and more importantly its permanence.

In the past, there was some concern that perhaps patients did not receive enough guidance for informed consent, so one of the first things listed on the checklist is confirmation—in the form of a printed line where the patient can sign her initials—that she understands that Essure is a permanent form of birth control. The checklist covers additional important issues, including that the doctor has indeed shared with the patient other options for birth control or sterilization, such as laparoscopic sterilization, vasectomy for her male partner, an intrauterine device (IUD), and birth control pills. This is an opportunity to reinforce the fact that tubal implants are a permanent form of birth control, and if the patient is uncertain about ending her fertility, the clinician can inform her about reversible options. The checklist also includes for discussion the pregnancy risk with use of the device, what the patient can expect during the implant insertion procedure and for the days afterwards (such as cramping, mild to moderate pain, nausea and vomiting), and the need for a confirmation test 3 months after device placement.

Other discussion points covered include long-term risks and benefits of the device, the potential for complications, and the possibility (due to pelvic pain) that the hysteroscopically placed devices may need to be removed with a surgical procedure requiring general anesthesia.

Incorporating the checklist into our clinical practice shows that we have listened to patients and complied with recommendations made by the FDA review panel, and we can use this document to have a more complete discussion with our patients.

OBG Management: Do you agree with some clinicians who say that physicians who place the device also should have the skills required to remove it if necessary?

Dr. Bradley: Essure placement—which is a hysteroscopic procedure—is done very differently than a laparoscopic procedure. In the past, among women who needed to have the Essure system removed, most procedures would be done laparoscopically. Since we work collaboratively in teams, someone within the team or division would have the clinical expertise to remove the devices. An ObGyn who does laparoscopy with salpingectomy and/or cornual resection would best be able to remove the devices.

The clinician who does hysteroscopy is not always the same one who does laparoscopy. Someone within the division who is interested in removing the device will develop an expertise and algorithm that suits the practice, so that person in the practice becomes the expert. This is no different from many other things that physicians do. In our clinical practice, for example, we have a pelvic pain specialist, a sexual counselor, someone interested in menopause and management, and someone interested in alternatives to hysterectomies. Those who practice their craft and their art become proficient at it. So if you do not perform a particular procedure such as a tubal implant removal, know the expert to whom you can make a referral.

OBG Management: How do you now advise your colleagues to counsel patients on permanent sterilization?

Dr. Bradley: Hysteroscopic tubal implant sterilization, a minimally invasive procedure, is an excellent and viable option for women who meet the inclusion criteria and who do not have the exclusion criteria for placement. It is overall safe and extremely effective. If a patient has issues after undergoing implant placement—just like with any other surgery or procedure—for example, if she is not feeling better or is not doing as well as anticipated, we must not forget the patient. It is important for our patients to be listened to and to be heard. Postprocedure issues are generally transient and related to pain and discomfort or abnormal bleeding. If they are persistent, then further evaluation is needed.

Tell the patient to contact you if she has questions or issues, and have a tiered approach for working up any problems that she may present with. In addition, reiterate that the patient must use another form of birth control for 3 months until she undergoes the confirmation test and until the results verify that the implants can be relied on for contraception. I am still placing the device. Before I perform the procedure, I speak with my patients—as I did before the checklist was developed—about all of the informed consent issues, the risk−benefit profile, and ruling out contraindications to use. I think this is good medical and surgical practice. The new labeling means we need to have a critical conversation with our patients, and we should be doing that for all procedures.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The United States undoubtedly will undergo tremendous change under its new President and Congress. These branches of government are already indicating their determination to rewrite a vast array of health care laws. If carried out, proposals regarding the Affordable Care Act, Medicare, and Medicaid will dramatically alter the landscape of women’s health care and significantly affect ObGyns and their patients.

These shifts are coming as ACOG’s top leadership undergoes its annual transition. In May 2017, we will thank American College of Obstetricians and Gynecologists (ACOG) President Thomas Gellhaus, MD, for his tremendous service and welcome Haywood Brown, MD, as our new President.

With so much uncertainty ahead, I recently asked these 2 leaders for their reflections, predictions, hardest challenges, and plans to help our specialty surmount any new obstacles to move forward with positive initiatives.

What have we faced down in the past year; what faces us now?

Thomas Gellhaus, MD: When I took this position almost 1 year ago, our specialty and our ability to care for patients were challenged on 3 fronts: MACRA, workforce, and politics.

Through the efforts of a united American Medical Association, we saw MACRA, the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015, replace the sustainable growth rate formula, which would have drastically reduced provider payments under Medicare’s Physician Fee Schedule. With this change, a major challenge was crossed off our list and a major new one added. Now, we must ensure proper enactment of MACRA’s new payment system and be continually vigilant with respect to its implementation.

Second, we must ensure there are enough ObGyns to care for patients nationally, across all areas of the country. We must find new ways to recruit ObGyns and maintain and expand our workforce.

Third, we must stand firm against political interference. The future of our patients, our practices, and our specialty depend on it. Only 2 people are allowed in the exam room—the patient and her ObGyn—and we must close its door to politicians who want to make decisions about the kind of care our patients need and how we should provide it. We must defeat the many state efforts to decree or limit care. Patient’s access to care, including reproductive care, must not be subject to politics.

These challenges can be opportunities. For example, the more we make MACRA work for practicing ObGyns now, the brighter our future will be, as private payers likely will be following suit.

Ilustration: Paul Zwolak for OBG Management

We stand with patients on reproductive rights and access to care

Haywood Brown, MD: We face several challenges. First, when we become ObGyns, we join our patients in taking on the everyday challenges of women’s health care, reproduction, and reproductive rights. These will continue to be major issues for our specialty. In addition, in our continued efforts to address health care disparities, we must take the lead at ACOG as well as enlist other women’s health care providers as partners. Too often, access to high-quality perinatal, cancer, and other women’s health care is determined or influenced by a patient’s race, residence, or income. This must change.

A future for team-based care

Another challenge is to define clinical practice expectations for the newer generations of Fellows. We must impart to Junior Fellows that team-based care will:

• help them see obstetrics and gynecology as an immensely satisfying calling and career rather than as just a job
• contribute to the expansion of care to women in all communities
• allow for the maintenance of a good work–life balance for many years. (See “Steps to address ObGyn work–life balance” on page 30.)

It’s a new Washington. We are poised for new challenges.

Dr. Gellhaus: With the new US President, Congress, governors, and state legislators in office, a new challenge is to maintain the women’s health protections in the Affordable Care Act—particularly insurance coverage for maternity care and preventive and contraceptive services. We must guard against a resurgence in the number of the uninsured and underinsured, including patients whose health insurance is cut off once they become seriously ill or reach their annual or lifetime coverage limit.

We also must be ready to fight the anticipated onslaught of state and federal attempts to limit our patients’ access to reproductive health care. Many of us remember the days of illegal, unsafe abortions and their devastating effects on women’s health. No lawmaker should doubt that having access to contraceptives helps reduce the rates of unwanted pregnancies and abortions, improves maternal and infant outcomes, and decreases health care costs. It’s a win-win!

Groundwork has been laid, and opportunities will surface

Dr. Gellhaus: The best opportunities will emerge from our long-standing history of bipartisan political cooperation in this area, as we work with lawmakers from both parties on issues that benefit ObGyns and their patients. Over the years, ACOG has well positioned itself and developed important long-term relationships with Republican and Democratic lawmakers to focus on women’s health as a central issue. This position will give ACOG a voice in the new federal Administration, in Congress, and in state houses.

We also will have opportunities to educate elected officials, debunk many of the false or mistaken ideas surrounding contraceptive methods, and reinforce the need for politicians to stop interfering with the sacred physician–patient relationship and stay out of our exam rooms.

Our commitment to our patients is strong

Dr. Brown: It is more important than ever for ACOG to affirm its commitment to women’s reproductive choices and their access to contraceptives—especially with respect to programs funded by Medicaid and Title X. In the United States, Medicaid covers 48% of all births, as well as preventive and screening services provided by Planned Parenthood clinics. Over the next years, these programs will be challenged and could fall into jeopardy. We must remind our Fellows that both Title X contraception coverage and abortion choice have been the law of the land for almost 50 years. We cannot allow politicians to return us to an era that was far worse for our patients.

Steps to address ObGyn work-life balance

In my article, "ObGyn burnout: ACOG takes aim," published in the August 2016 issue of OBG Management, Thomas Gellhaus, MD, current President of the American Congress of Obstetricians and Gynecologists (ACOG), while recognizing that physician satisfaction is affected by increasing bureaucratic tasks that can be seen as obstacles to patient care, offered several strategies to maintain career satisfaction. Those strategies included mentorship, global volunteering, and advocacy.

I asked Haywood Brown, MD, the incoming ACOG President as of May 2017, how he views ACOG's role in addressing a main reason for ObGyn burnout--the increasing burden of compliance with required electronic documentation.

Haywood Brown, MD: We must develop new models of care that foster the ability of ObGyns to embrace practicing the depth and breadth of ObGyn long term, and maintain their enthusiasm about providing care to women throughout the life span. Compliance and electronic documentation requirements can enhance patient care by allowing us to better communicate with our practice partners and our patients, improve quality, safety, and patient satisfaction. It can also quickly wear us down.

Burnout can be reduced through shared practice models, development of niches within shared practices, and being creative with better incorporating advanced practice providers into team-based care. I sincerely believe that if we embrace new models of clinical practice, the satisfaction for what we are trained to do will improve and burnout will be less a threat to our specialty over time.

All-In for Advocacy tops presidential initiatives list

Dr. Gellhaus: With political legislative interference increasing across all of medicine, we need a unified, powerful, cohesive voice. Advocacy is at the top of my presidential initiatives list. The voice of our national organization can have a huge impact on maintaining and improving women’s health care in the United States. That is why All-In for Advocacy is vital. This initiative has significantly increased members’ involvement in ACOG. We will harness this power to pass vital legislation to help the women we serve and our specialty.

Addressing health disparities drives career and presidential focus

Dr. Brown: My presidential initiatives are rooted in my career decision to focus on health disparities, particularly race-based health disparities.

Maternal morbidity and mortality and infant mortality are complex issues shrouded in the social determinants of health. Access to care, fragmentation of care, and quality of care are other factors relevant in disparity. There is evidence of an implicit bias in health care delivery.

My telehealth initiative will focus on implementing Levels of Maternal Care (of which there are 4), the National Partnership for Maternal Safety (NPMS), and the Alliance for Innovation on Maternal Health (AIM) as well as redefining healthy pregnancies and postpartum periods as the gateway to women’s long-term health. The February 2015 Levels of Maternal Care Obstetric Care Consensus Statement, jointly issued by ACOG and the Society for Maternal–Fetal Medicine (SMFM),¹ proposes a classification system for birth centers, from basic to specialized regional perinatal health care centers. ACOG is working with hospitals throughout the country to designate the Levels of Maternal Care and thereby ensure each patient receives the appropriate level of care.

The AIM program, led by ACOG and funded by the Health Resources and Services Administration (HRSA), reduces obstetric complications by encouraging hospitals to adopt defined evidence-based patient safety measures. The goal is to prevent 100,000 severe labor and delivery complications and 1,000 maternal deaths over 4 years.

ACOG is committed to a “big tent” approach

Dr. Gellhaus: Like US citizens, ACOG represents members with many points of view. ACOG can best represent our members’ diversity in the future by remaining the moderate voice, and by opposing federal and state proposals that are inconsistent with facts and science. We need to bring to our membership’s attention the federal and state successes we have had, show how they have helped our patients and our specialty, and make it clear that our successes are due to our bipartisan work over the years, which we have achieved regardless of which political party has been in office.

For ACOG to continue to be a leader in women’s health care and our specialty, we must remain vigilant against political interference in the patient–physician relationship and be ready to counter with science, facts, and evidence.

Compassion and passion lie at the heart of member similarities

Dr. Brown: First and foremost, we ObGyns care about our patients and, regardless of personal politics, most of us understand the reproductive health challenges facing the women of this country as well as our history with respect to those challenges. All of us must be willing to provide counsel to patients when needed, and that counseling must be nonjudgmental. We also must be willing to protect confidentially and to refer patients whose decisions are at odds with our personal views.

ACOG recognizes that we are a melting pot of specialists and subspecialists and that we are all guided by our personal beliefs and values. Choosing to become an exclusive women’s health care physician requires our passion and compassion.

Let us use our collective voice!

Dr. Gellhaus: Our members must realize the power of our collective voice and that we must use it to deliver a unified, cohesive message. We cannot sit on the sidelines and expect others to speak for us. If we are not part of the solution, then we cede our future to others and have no right to complain about the result. Our members need to commit to advocating outside their exam rooms. A good first step is to see how ACOG makes advocacy easy. When thousands of ACOG members contact elected officials about important issues, officials listen.

Dr. Brown: Yes! We all need to get involved in ACOG and in our communities. Together, we will accomplish many important things.

[polldaddy:9703185]

The United States undoubtedly will undergo tremendous change under its new President and Congress. These branches of government are already indicating their determination to rewrite a vast array of health care laws. If carried out, proposals regarding the Affordable Care Act, Medicare, and Medicaid will dramatically alter the landscape of women’s health care and significantly affect ObGyns and their patients.

These shifts are coming as ACOG’s top leadership undergoes its annual transition. In May 2017, we will thank American College of Obstetricians and Gynecologists (ACOG) President Thomas Gellhaus, MD, for his tremendous service and welcome Haywood Brown, MD, as our new President.

With so much uncertainty ahead, I recently asked these 2 leaders for their reflections, predictions, hardest challenges, and plans to help our specialty surmount any new obstacles to move forward with positive initiatives.

What have we faced down in the past year; what faces us now?

Thomas Gellhaus, MD: When I took this position almost 1 year ago, our specialty and our ability to care for patients were challenged on 3 fronts: MACRA, workforce, and politics.

Through the efforts of a united American Medical Association, we saw MACRA, the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015, replace the sustainable growth rate formula, which would have drastically reduced provider payments under Medicare’s Physician Fee Schedule. With this change, a major challenge was crossed off our list and a major new one added. Now, we must ensure proper enactment of MACRA’s new payment system and be continually vigilant with respect to its implementation.

Second, we must ensure there are enough ObGyns to care for patients nationally, across all areas of the country. We must find new ways to recruit ObGyns and maintain and expand our workforce.

Third, we must stand firm against political interference. The future of our patients, our practices, and our specialty depend on it. Only 2 people are allowed in the exam room—the patient and her ObGyn—and we must close its door to politicians who want to make decisions about the kind of care our patients need and how we should provide it. We must defeat the many state efforts to decree or limit care. Patient’s access to care, including reproductive care, must not be subject to politics.

These challenges can be opportunities. For example, the more we make MACRA work for practicing ObGyns now, the brighter our future will be, as private payers likely will be following suit.

Ilustration: Paul Zwolak for OBG Management

We stand with patients on reproductive rights and access to care

Haywood Brown, MD: We face several challenges. First, when we become ObGyns, we join our patients in taking on the everyday challenges of women’s health care, reproduction, and reproductive rights. These will continue to be major issues for our specialty. In addition, in our continued efforts to address health care disparities, we must take the lead at ACOG as well as enlist other women’s health care providers as partners. Too often, access to high-quality perinatal, cancer, and other women’s health care is determined or influenced by a patient’s race, residence, or income. This must change.

A future for team-based care

Another challenge is to define clinical practice expectations for the newer generations of Fellows. We must impart to Junior Fellows that team-based care will:

• help them see obstetrics and gynecology as an immensely satisfying calling and career rather than as just a job
• contribute to the expansion of care to women in all communities
• allow for the maintenance of a good work–life balance for many years. (See “Steps to address ObGyn work–life balance” on page 30.)

It’s a new Washington. We are poised for new challenges.

Dr. Gellhaus: With the new US President, Congress, governors, and state legislators in office, a new challenge is to maintain the women’s health protections in the Affordable Care Act—particularly insurance coverage for maternity care and preventive and contraceptive services. We must guard against a resurgence in the number of the uninsured and underinsured, including patients whose health insurance is cut off once they become seriously ill or reach their annual or lifetime coverage limit.

We also must be ready to fight the anticipated onslaught of state and federal attempts to limit our patients’ access to reproductive health care. Many of us remember the days of illegal, unsafe abortions and their devastating effects on women’s health. No lawmaker should doubt that having access to contraceptives helps reduce the rates of unwanted pregnancies and abortions, improves maternal and infant outcomes, and decreases health care costs. It’s a win-win!

Groundwork has been laid, and opportunities will surface

Dr. Gellhaus: The best opportunities will emerge from our long-standing history of bipartisan political cooperation in this area, as we work with lawmakers from both parties on issues that benefit ObGyns and their patients. Over the years, ACOG has well positioned itself and developed important long-term relationships with Republican and Democratic lawmakers to focus on women’s health as a central issue. This position will give ACOG a voice in the new federal Administration, in Congress, and in state houses.

We also will have opportunities to educate elected officials, debunk many of the false or mistaken ideas surrounding contraceptive methods, and reinforce the need for politicians to stop interfering with the sacred physician–patient relationship and stay out of our exam rooms.

Our commitment to our patients is strong

Dr. Brown: It is more important than ever for ACOG to affirm its commitment to women’s reproductive choices and their access to contraceptives—especially with respect to programs funded by Medicaid and Title X. In the United States, Medicaid covers 48% of all births, as well as preventive and screening services provided by Planned Parenthood clinics. Over the next years, these programs will be challenged and could fall into jeopardy. We must remind our Fellows that both Title X contraception coverage and abortion choice have been the law of the land for almost 50 years. We cannot allow politicians to return us to an era that was far worse for our patients.

Steps to address ObGyn work-life balance

In my article, "ObGyn burnout: ACOG takes aim," published in the August 2016 issue of OBG Management, Thomas Gellhaus, MD, current President of the American Congress of Obstetricians and Gynecologists (ACOG), while recognizing that physician satisfaction is affected by increasing bureaucratic tasks that can be seen as obstacles to patient care, offered several strategies to maintain career satisfaction. Those strategies included mentorship, global volunteering, and advocacy.

I asked Haywood Brown, MD, the incoming ACOG President as of May 2017, how he views ACOG's role in addressing a main reason for ObGyn burnout--the increasing burden of compliance with required electronic documentation.

Haywood Brown, MD: We must develop new models of care that foster the ability of ObGyns to embrace practicing the depth and breadth of ObGyn long term, and maintain their enthusiasm about providing care to women throughout the life span. Compliance and electronic documentation requirements can enhance patient care by allowing us to better communicate with our practice partners and our patients, improve quality, safety, and patient satisfaction. It can also quickly wear us down.

Burnout can be reduced through shared practice models, development of niches within shared practices, and being creative with better incorporating advanced practice providers into team-based care. I sincerely believe that if we embrace new models of clinical practice, the satisfaction for what we are trained to do will improve and burnout will be less a threat to our specialty over time.

All-In for Advocacy tops presidential initiatives list

Dr. Gellhaus: With political legislative interference increasing across all of medicine, we need a unified, powerful, cohesive voice. Advocacy is at the top of my presidential initiatives list. The voice of our national organization can have a huge impact on maintaining and improving women’s health care in the United States. That is why All-In for Advocacy is vital. This initiative has significantly increased members’ involvement in ACOG. We will harness this power to pass vital legislation to help the women we serve and our specialty.

Addressing health disparities drives career and presidential focus

Dr. Brown: My presidential initiatives are rooted in my career decision to focus on health disparities, particularly race-based health disparities.

Maternal morbidity and mortality and infant mortality are complex issues shrouded in the social determinants of health. Access to care, fragmentation of care, and quality of care are other factors relevant in disparity. There is evidence of an implicit bias in health care delivery.

My telehealth initiative will focus on implementing Levels of Maternal Care (of which there are 4), the National Partnership for Maternal Safety (NPMS), and the Alliance for Innovation on Maternal Health (AIM) as well as redefining healthy pregnancies and postpartum periods as the gateway to women’s long-term health. The February 2015 Levels of Maternal Care Obstetric Care Consensus Statement, jointly issued by ACOG and the Society for Maternal–Fetal Medicine (SMFM),¹ proposes a classification system for birth centers, from basic to specialized regional perinatal health care centers. ACOG is working with hospitals throughout the country to designate the Levels of Maternal Care and thereby ensure each patient receives the appropriate level of care.

The AIM program, led by ACOG and funded by the Health Resources and Services Administration (HRSA), reduces obstetric complications by encouraging hospitals to adopt defined evidence-based patient safety measures. The goal is to prevent 100,000 severe labor and delivery complications and 1,000 maternal deaths over 4 years.

ACOG is committed to a “big tent” approach

Dr. Gellhaus: Like US citizens, ACOG represents members with many points of view. ACOG can best represent our members’ diversity in the future by remaining the moderate voice, and by opposing federal and state proposals that are inconsistent with facts and science. We need to bring to our membership’s attention the federal and state successes we have had, show how they have helped our patients and our specialty, and make it clear that our successes are due to our bipartisan work over the years, which we have achieved regardless of which political party has been in office.

For ACOG to continue to be a leader in women’s health care and our specialty, we must remain vigilant against political interference in the patient–physician relationship and be ready to counter with science, facts, and evidence.

Compassion and passion lie at the heart of member similarities

Dr. Brown: First and foremost, we ObGyns care about our patients and, regardless of personal politics, most of us understand the reproductive health challenges facing the women of this country as well as our history with respect to those challenges. All of us must be willing to provide counsel to patients when needed, and that counseling must be nonjudgmental. We also must be willing to protect confidentially and to refer patients whose decisions are at odds with our personal views.

ACOG recognizes that we are a melting pot of specialists and subspecialists and that we are all guided by our personal beliefs and values. Choosing to become an exclusive women’s health care physician requires our passion and compassion.

Let us use our collective voice!

Dr. Gellhaus: Our members must realize the power of our collective voice and that we must use it to deliver a unified, cohesive message. We cannot sit on the sidelines and expect others to speak for us. If we are not part of the solution, then we cede our future to others and have no right to complain about the result. Our members need to commit to advocating outside their exam rooms. A good first step is to see how ACOG makes advocacy easy. When thousands of ACOG members contact elected officials about important issues, officials listen.

Dr. Brown: Yes! We all need to get involved in ACOG and in our communities. Together, we will accomplish many important things.

[polldaddy:9703185]

The United States undoubtedly will undergo tremendous change under its new President and Congress. These branches of government are already indicating their determination to rewrite a vast array of health care laws. If carried out, proposals regarding the Affordable Care Act, Medicare, and Medicaid will dramatically alter the landscape of women’s health care and significantly affect ObGyns and their patients.

These shifts are coming as ACOG’s top leadership undergoes its annual transition. In May 2017, we will thank American College of Obstetricians and Gynecologists (ACOG) President Thomas Gellhaus, MD, for his tremendous service and welcome Haywood Brown, MD, as our new President.

With so much uncertainty ahead, I recently asked these 2 leaders for their reflections, predictions, hardest challenges, and plans to help our specialty surmount any new obstacles to move forward with positive initiatives.

What have we faced down in the past year; what faces us now?

Thomas Gellhaus, MD: When I took this position almost 1 year ago, our specialty and our ability to care for patients were challenged on 3 fronts: MACRA, workforce, and politics.

Through the efforts of a united American Medical Association, we saw MACRA, the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015, replace the sustainable growth rate formula, which would have drastically reduced provider payments under Medicare’s Physician Fee Schedule. With this change, a major challenge was crossed off our list and a major new one added. Now, we must ensure proper enactment of MACRA’s new payment system and be continually vigilant with respect to its implementation.

Second, we must ensure there are enough ObGyns to care for patients nationally, across all areas of the country. We must find new ways to recruit ObGyns and maintain and expand our workforce.

Third, we must stand firm against political interference. The future of our patients, our practices, and our specialty depend on it. Only 2 people are allowed in the exam room—the patient and her ObGyn—and we must close its door to politicians who want to make decisions about the kind of care our patients need and how we should provide it. We must defeat the many state efforts to decree or limit care. Patient’s access to care, including reproductive care, must not be subject to politics.

These challenges can be opportunities. For example, the more we make MACRA work for practicing ObGyns now, the brighter our future will be, as private payers likely will be following suit.

Ilustration: Paul Zwolak for OBG Management

We stand with patients on reproductive rights and access to care

Haywood Brown, MD: We face several challenges. First, when we become ObGyns, we join our patients in taking on the everyday challenges of women’s health care, reproduction, and reproductive rights. These will continue to be major issues for our specialty. In addition, in our continued efforts to address health care disparities, we must take the lead at ACOG as well as enlist other women’s health care providers as partners. Too often, access to high-quality perinatal, cancer, and other women’s health care is determined or influenced by a patient’s race, residence, or income. This must change.

A future for team-based care

Another challenge is to define clinical practice expectations for the newer generations of Fellows. We must impart to Junior Fellows that team-based care will:

• help them see obstetrics and gynecology as an immensely satisfying calling and career rather than as just a job
• contribute to the expansion of care to women in all communities
• allow for the maintenance of a good work–life balance for many years. (See “Steps to address ObGyn work–life balance” on page 30.)

It’s a new Washington. We are poised for new challenges.

Dr. Gellhaus: With the new US President, Congress, governors, and state legislators in office, a new challenge is to maintain the women’s health protections in the Affordable Care Act—particularly insurance coverage for maternity care and preventive and contraceptive services. We must guard against a resurgence in the number of the uninsured and underinsured, including patients whose health insurance is cut off once they become seriously ill or reach their annual or lifetime coverage limit.

We also must be ready to fight the anticipated onslaught of state and federal attempts to limit our patients’ access to reproductive health care. Many of us remember the days of illegal, unsafe abortions and their devastating effects on women’s health. No lawmaker should doubt that having access to contraceptives helps reduce the rates of unwanted pregnancies and abortions, improves maternal and infant outcomes, and decreases health care costs. It’s a win-win!

Groundwork has been laid, and opportunities will surface

Dr. Gellhaus: The best opportunities will emerge from our long-standing history of bipartisan political cooperation in this area, as we work with lawmakers from both parties on issues that benefit ObGyns and their patients. Over the years, ACOG has well positioned itself and developed important long-term relationships with Republican and Democratic lawmakers to focus on women’s health as a central issue. This position will give ACOG a voice in the new federal Administration, in Congress, and in state houses.

We also will have opportunities to educate elected officials, debunk many of the false or mistaken ideas surrounding contraceptive methods, and reinforce the need for politicians to stop interfering with the sacred physician–patient relationship and stay out of our exam rooms.

Our commitment to our patients is strong

Dr. Brown: It is more important than ever for ACOG to affirm its commitment to women’s reproductive choices and their access to contraceptives—especially with respect to programs funded by Medicaid and Title X. In the United States, Medicaid covers 48% of all births, as well as preventive and screening services provided by Planned Parenthood clinics. Over the next years, these programs will be challenged and could fall into jeopardy. We must remind our Fellows that both Title X contraception coverage and abortion choice have been the law of the land for almost 50 years. We cannot allow politicians to return us to an era that was far worse for our patients.

Steps to address ObGyn work-life balance

In my article, "ObGyn burnout: ACOG takes aim," published in the August 2016 issue of OBG Management, Thomas Gellhaus, MD, current President of the American Congress of Obstetricians and Gynecologists (ACOG), while recognizing that physician satisfaction is affected by increasing bureaucratic tasks that can be seen as obstacles to patient care, offered several strategies to maintain career satisfaction. Those strategies included mentorship, global volunteering, and advocacy.

I asked Haywood Brown, MD, the incoming ACOG President as of May 2017, how he views ACOG's role in addressing a main reason for ObGyn burnout--the increasing burden of compliance with required electronic documentation.

Haywood Brown, MD: We must develop new models of care that foster the ability of ObGyns to embrace practicing the depth and breadth of ObGyn long term, and maintain their enthusiasm about providing care to women throughout the life span. Compliance and electronic documentation requirements can enhance patient care by allowing us to better communicate with our practice partners and our patients, improve quality, safety, and patient satisfaction. It can also quickly wear us down.

Burnout can be reduced through shared practice models, development of niches within shared practices, and being creative with better incorporating advanced practice providers into team-based care. I sincerely believe that if we embrace new models of clinical practice, the satisfaction for what we are trained to do will improve and burnout will be less a threat to our specialty over time.

All-In for Advocacy tops presidential initiatives list

Dr. Gellhaus: With political legislative interference increasing across all of medicine, we need a unified, powerful, cohesive voice. Advocacy is at the top of my presidential initiatives list. The voice of our national organization can have a huge impact on maintaining and improving women’s health care in the United States. That is why All-In for Advocacy is vital. This initiative has significantly increased members’ involvement in ACOG. We will harness this power to pass vital legislation to help the women we serve and our specialty.

Addressing health disparities drives career and presidential focus

Dr. Brown: My presidential initiatives are rooted in my career decision to focus on health disparities, particularly race-based health disparities.

Maternal morbidity and mortality and infant mortality are complex issues shrouded in the social determinants of health. Access to care, fragmentation of care, and quality of care are other factors relevant in disparity. There is evidence of an implicit bias in health care delivery.

My telehealth initiative will focus on implementing Levels of Maternal Care (of which there are 4), the National Partnership for Maternal Safety (NPMS), and the Alliance for Innovation on Maternal Health (AIM) as well as redefining healthy pregnancies and postpartum periods as the gateway to women’s long-term health. The February 2015 Levels of Maternal Care Obstetric Care Consensus Statement, jointly issued by ACOG and the Society for Maternal–Fetal Medicine (SMFM),¹ proposes a classification system for birth centers, from basic to specialized regional perinatal health care centers. ACOG is working with hospitals throughout the country to designate the Levels of Maternal Care and thereby ensure each patient receives the appropriate level of care.

The AIM program, led by ACOG and funded by the Health Resources and Services Administration (HRSA), reduces obstetric complications by encouraging hospitals to adopt defined evidence-based patient safety measures. The goal is to prevent 100,000 severe labor and delivery complications and 1,000 maternal deaths over 4 years.

ACOG is committed to a “big tent” approach

Dr. Gellhaus: Like US citizens, ACOG represents members with many points of view. ACOG can best represent our members’ diversity in the future by remaining the moderate voice, and by opposing federal and state proposals that are inconsistent with facts and science. We need to bring to our membership’s attention the federal and state successes we have had, show how they have helped our patients and our specialty, and make it clear that our successes are due to our bipartisan work over the years, which we have achieved regardless of which political party has been in office.

For ACOG to continue to be a leader in women’s health care and our specialty, we must remain vigilant against political interference in the patient–physician relationship and be ready to counter with science, facts, and evidence.

Compassion and passion lie at the heart of member similarities

Dr. Brown: First and foremost, we ObGyns care about our patients and, regardless of personal politics, most of us understand the reproductive health challenges facing the women of this country as well as our history with respect to those challenges. All of us must be willing to provide counsel to patients when needed, and that counseling must be nonjudgmental. We also must be willing to protect confidentially and to refer patients whose decisions are at odds with our personal views.

ACOG recognizes that we are a melting pot of specialists and subspecialists and that we are all guided by our personal beliefs and values. Choosing to become an exclusive women’s health care physician requires our passion and compassion.

Let us use our collective voice!

Dr. Gellhaus: Our members must realize the power of our collective voice and that we must use it to deliver a unified, cohesive message. We cannot sit on the sidelines and expect others to speak for us. If we are not part of the solution, then we cede our future to others and have no right to complain about the result. Our members need to commit to advocating outside their exam rooms. A good first step is to see how ACOG makes advocacy easy. When thousands of ACOG members contact elected officials about important issues, officials listen.

Dr. Brown: Yes! We all need to get involved in ACOG and in our communities. Together, we will accomplish many important things.

[polldaddy:9703185]

EXPERT COMMENTARY

Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is  multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.¹ 

Details of the study

To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.

The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.

The results of this trial are consistent with prior study findings in colorectal surgery.² Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.

Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.

Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).³ Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.

The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.

Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.⁴ These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is  multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.¹ 

Details of the study

To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.

The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.

The results of this trial are consistent with prior study findings in colorectal surgery.² Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.

Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.

Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).³ Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.

The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.

Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.⁴ These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is  multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.¹ 

Details of the study

To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.

The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.

The results of this trial are consistent with prior study findings in colorectal surgery.² Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.

Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.

Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).³ Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.

The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.

Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.⁴ These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

• Visit PAGS

• Visit PAGS

• Visit PAGS

We all know these patients:

The young man who, when his name shows up on the ED board, everyone lets out a little groan, knowing his hospital stay will be long and tumultuous.

The middle-aged woman who seems to do want your care and attention and yet rebuffs your attempts to help her, meanwhile, making constant demands on nursing staff.

The older man who trusts no one and will not cooperate with any of his needed care, frustrating staff and physicians alike.

Caring for the patient is integral to the art of doctoring, and yet, there are some people for whom this is incredibly hard to do. They frustrate even the most seasoned professional and work their way under our skin. While their disruptive acts may feel volitional to those of us attempting to provide care, these individuals may suffer from a personality disorder.

Megan Riddle, MD, PhD, is based in the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

NOTES

1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Arlington, VA: American Psychiatric Association; 2013.

2. Riddle M, Meeks T, Alvarez C, Dubovsky A. When personality is the problem: Managing patients with difficult personalities on the acute care unit. J Hosp Med. 2016 Dec;11(12):873-878.

3. Bukh JD, Bock C, Kessing LV. Association between genetic polymorphisms in the serotonergic system and comorbid personality disorders among patients with first-episode depression. J Pers Disord. 2014 Jun;28(3):365-378.

4. Perez-Rodriguez MM, Weinstein S, New AS, et al. Tryptophan-hydroxylase 2 haplotype association with borderline personality disorder and aggression in a sample of patients with personality disorders and healthy controls. J Psychiatr Res. 2010 Nov; 44(15):1075-1081.

5. Checknita D, Maussion G, Labonte B, et al. Monoamine oxidase: A gene promoter methylation and transcriptional downregulation in an offender population with antisocial personality disorder. Br J Psychiatry. 2015 Mar;206(3):216-222.

6. Boen E, Westlye LT, Elvsashagen T, et al. Regional cortical thinning may be a biological marker for borderline personality disorder. Acta Psychiatr Scand. 2014 Sep;130(3):193-204.

7. Thoma P, Friedmann C, Suchan B. Empathy and social problem solving in alcohol dependence, mood disorders and selected personality disorders. Neurosci Biobehav Rev. 2013 Mar;37(3):448-470.

8. Liu H, Liao J, Jiang W, Wang W. Changes in low-frequency fluctuations in patients with antisocial personality disorder revealed by resting-state functional MRI. PLoS One. 2014 Mar 5;9(3):e89790.

9. Yang Y, Raine A. Prefrontal structural and functional brain imaging findings in antisocial, violent, and psychopathic individuals: A meta-analysis. Psychiatry Res. 2009 Nov 30;174(2):81-88.

10. Fok ML, Hayes RD, Chang CK, Stewart R, Callard FJ, Moran P. Life expectancy at birth and all-cause mortality among people with personality disorder. J Psychosom Res. 2012 Aug;73(2):104-107.

11. Tyrer P, Reed GM, Crawford MJ. Classification, assessment, prevalence, and effect of personality disorder. Lancet. 2015 Feb 21;385:717-726.

12. Groves JE. Taking care of the hateful patient. N Engl J Med. 1978 Apr 20; 298:883-887.

13. Groves JE. Management of the borderline patient on a medical or surgical ward: The psychiatric consultant’s role. Int J Psychiatry Med. 1975;6(3):337-348.

14. Bodner E, Cohen-Fridel S, Mashiah M, et al. The attitudes of psychiatric hospital staff toward hospitalization and treatment of patients with borderline personality disorder. BMC psychiatry. 2015 Jan 22;15:2.

15. Colli A, Tanzilli A, Dimaggio G, Lingiardi V. Patient personality and therapist response: An empirical investigation. Am J Psychiatry. 2014 Jan;171(1):102-108.

16. Ingenhoven T, Lafay P, Rinne T, Passchier J, Duivenvoorden H. Effectiveness of pharmacotherapy for severe personality disorders: Meta-analyses of randomized controlled trials. J Clin Psychiatry. 2010 Jan;71(1):14-25.

We all know these patients:

The young man who, when his name shows up on the ED board, everyone lets out a little groan, knowing his hospital stay will be long and tumultuous.

The middle-aged woman who seems to do want your care and attention and yet rebuffs your attempts to help her, meanwhile, making constant demands on nursing staff.

The older man who trusts no one and will not cooperate with any of his needed care, frustrating staff and physicians alike.

Caring for the patient is integral to the art of doctoring, and yet, there are some people for whom this is incredibly hard to do. They frustrate even the most seasoned professional and work their way under our skin. While their disruptive acts may feel volitional to those of us attempting to provide care, these individuals may suffer from a personality disorder.

Megan Riddle, MD, PhD, is based in the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

NOTES

1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Arlington, VA: American Psychiatric Association; 2013.

2. Riddle M, Meeks T, Alvarez C, Dubovsky A. When personality is the problem: Managing patients with difficult personalities on the acute care unit. J Hosp Med. 2016 Dec;11(12):873-878.

3. Bukh JD, Bock C, Kessing LV. Association between genetic polymorphisms in the serotonergic system and comorbid personality disorders among patients with first-episode depression. J Pers Disord. 2014 Jun;28(3):365-378.

4. Perez-Rodriguez MM, Weinstein S, New AS, et al. Tryptophan-hydroxylase 2 haplotype association with borderline personality disorder and aggression in a sample of patients with personality disorders and healthy controls. J Psychiatr Res. 2010 Nov; 44(15):1075-1081.

5. Checknita D, Maussion G, Labonte B, et al. Monoamine oxidase: A gene promoter methylation and transcriptional downregulation in an offender population with antisocial personality disorder. Br J Psychiatry. 2015 Mar;206(3):216-222.

6. Boen E, Westlye LT, Elvsashagen T, et al. Regional cortical thinning may be a biological marker for borderline personality disorder. Acta Psychiatr Scand. 2014 Sep;130(3):193-204.

7. Thoma P, Friedmann C, Suchan B. Empathy and social problem solving in alcohol dependence, mood disorders and selected personality disorders. Neurosci Biobehav Rev. 2013 Mar;37(3):448-470.

8. Liu H, Liao J, Jiang W, Wang W. Changes in low-frequency fluctuations in patients with antisocial personality disorder revealed by resting-state functional MRI. PLoS One. 2014 Mar 5;9(3):e89790.

9. Yang Y, Raine A. Prefrontal structural and functional brain imaging findings in antisocial, violent, and psychopathic individuals: A meta-analysis. Psychiatry Res. 2009 Nov 30;174(2):81-88.

10. Fok ML, Hayes RD, Chang CK, Stewart R, Callard FJ, Moran P. Life expectancy at birth and all-cause mortality among people with personality disorder. J Psychosom Res. 2012 Aug;73(2):104-107.

11. Tyrer P, Reed GM, Crawford MJ. Classification, assessment, prevalence, and effect of personality disorder. Lancet. 2015 Feb 21;385:717-726.

12. Groves JE. Taking care of the hateful patient. N Engl J Med. 1978 Apr 20; 298:883-887.

13. Groves JE. Management of the borderline patient on a medical or surgical ward: The psychiatric consultant’s role. Int J Psychiatry Med. 1975;6(3):337-348.

14. Bodner E, Cohen-Fridel S, Mashiah M, et al. The attitudes of psychiatric hospital staff toward hospitalization and treatment of patients with borderline personality disorder. BMC psychiatry. 2015 Jan 22;15:2.

15. Colli A, Tanzilli A, Dimaggio G, Lingiardi V. Patient personality and therapist response: An empirical investigation. Am J Psychiatry. 2014 Jan;171(1):102-108.

16. Ingenhoven T, Lafay P, Rinne T, Passchier J, Duivenvoorden H. Effectiveness of pharmacotherapy for severe personality disorders: Meta-analyses of randomized controlled trials. J Clin Psychiatry. 2010 Jan;71(1):14-25.

We all know these patients:

The young man who, when his name shows up on the ED board, everyone lets out a little groan, knowing his hospital stay will be long and tumultuous.

The middle-aged woman who seems to do want your care and attention and yet rebuffs your attempts to help her, meanwhile, making constant demands on nursing staff.

The older man who trusts no one and will not cooperate with any of his needed care, frustrating staff and physicians alike.

Caring for the patient is integral to the art of doctoring, and yet, there are some people for whom this is incredibly hard to do. They frustrate even the most seasoned professional and work their way under our skin. While their disruptive acts may feel volitional to those of us attempting to provide care, these individuals may suffer from a personality disorder.

Megan Riddle, MD, PhD, is based in the department of psychiatry and behavioral sciences at the University of Washington, Seattle.

NOTES

1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Arlington, VA: American Psychiatric Association; 2013.

2. Riddle M, Meeks T, Alvarez C, Dubovsky A. When personality is the problem: Managing patients with difficult personalities on the acute care unit. J Hosp Med. 2016 Dec;11(12):873-878.

3. Bukh JD, Bock C, Kessing LV. Association between genetic polymorphisms in the serotonergic system and comorbid personality disorders among patients with first-episode depression. J Pers Disord. 2014 Jun;28(3):365-378.

4. Perez-Rodriguez MM, Weinstein S, New AS, et al. Tryptophan-hydroxylase 2 haplotype association with borderline personality disorder and aggression in a sample of patients with personality disorders and healthy controls. J Psychiatr Res. 2010 Nov; 44(15):1075-1081.

5. Checknita D, Maussion G, Labonte B, et al. Monoamine oxidase: A gene promoter methylation and transcriptional downregulation in an offender population with antisocial personality disorder. Br J Psychiatry. 2015 Mar;206(3):216-222.

6. Boen E, Westlye LT, Elvsashagen T, et al. Regional cortical thinning may be a biological marker for borderline personality disorder. Acta Psychiatr Scand. 2014 Sep;130(3):193-204.

7. Thoma P, Friedmann C, Suchan B. Empathy and social problem solving in alcohol dependence, mood disorders and selected personality disorders. Neurosci Biobehav Rev. 2013 Mar;37(3):448-470.

8. Liu H, Liao J, Jiang W, Wang W. Changes in low-frequency fluctuations in patients with antisocial personality disorder revealed by resting-state functional MRI. PLoS One. 2014 Mar 5;9(3):e89790.

9. Yang Y, Raine A. Prefrontal structural and functional brain imaging findings in antisocial, violent, and psychopathic individuals: A meta-analysis. Psychiatry Res. 2009 Nov 30;174(2):81-88.

10. Fok ML, Hayes RD, Chang CK, Stewart R, Callard FJ, Moran P. Life expectancy at birth and all-cause mortality among people with personality disorder. J Psychosom Res. 2012 Aug;73(2):104-107.

11. Tyrer P, Reed GM, Crawford MJ. Classification, assessment, prevalence, and effect of personality disorder. Lancet. 2015 Feb 21;385:717-726.

12. Groves JE. Taking care of the hateful patient. N Engl J Med. 1978 Apr 20; 298:883-887.

13. Groves JE. Management of the borderline patient on a medical or surgical ward: The psychiatric consultant’s role. Int J Psychiatry Med. 1975;6(3):337-348.

14. Bodner E, Cohen-Fridel S, Mashiah M, et al. The attitudes of psychiatric hospital staff toward hospitalization and treatment of patients with borderline personality disorder. BMC psychiatry. 2015 Jan 22;15:2.

15. Colli A, Tanzilli A, Dimaggio G, Lingiardi V. Patient personality and therapist response: An empirical investigation. Am J Psychiatry. 2014 Jan;171(1):102-108.

16. Ingenhoven T, Lafay P, Rinne T, Passchier J, Duivenvoorden H. Effectiveness of pharmacotherapy for severe personality disorders: Meta-analyses of randomized controlled trials. J Clin Psychiatry. 2010 Jan;71(1):14-25.

The online rating business is proliferating in the medical industry. This should really come as no surprise as health care is a service industry and online ratings have long been a staple in most other service industries. It has become routine practice for most of us to search such online reviews when seeking a pair of shoes, a toaster, or a restaurant; we almost can’t help but scour these sites to help us make the best decision possible.

• Anticipated cost (is the physician or practice in or out of network?).
• Availability or access to the service (location of the practice and how long it will take to be seen).
• How good the services and care will be when they get there.

• They felt it was “tacky” and that the profession of medicine should not be relegated to oversimplified service ratings. They worried that they would feel pressured to please the patient rather than “do the right thing” for the patient. For example, they would be less likely to give difficult advice (such as lose weight or stop smoking) or to resist prescribing medications that they deemed unnecessary or frankly dangerous (for example, antibiotics or narcotics).

Although these are valid concerns, it is hard to ignore the proliferation and traffic of these online websites. For you and your team, I would recommend taking a look at what is online about the members of your group and thinking about online strategies to take control of the conversation.

I don’t think the controversy over online physician ratings will wane anytime soon, but there is no doubt that they are profitable for companies and are therefore highly likely to continue to multiply.

References

1.Hanauer DA, Zheng K, Singer DC, Gebremariam A, Davis MM. Public awareness, perception, and use of online physician rating sites. JAMA. 2014;311(7):734-735. 2. A to Z provider listing: find a U of U Health Care physician by last name. University of Utah website. Available at http://healthcare.utah.edu/fad. Accessed Nov. 16, 2016.

Danielle Scheurer, MD, MSc, SFHM, is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at scheured@musc.edu.

The online rating business is proliferating in the medical industry. This should really come as no surprise as health care is a service industry and online ratings have long been a staple in most other service industries. It has become routine practice for most of us to search such online reviews when seeking a pair of shoes, a toaster, or a restaurant; we almost can’t help but scour these sites to help us make the best decision possible.

• Anticipated cost (is the physician or practice in or out of network?).
• Availability or access to the service (location of the practice and how long it will take to be seen).
• How good the services and care will be when they get there.

• They felt it was “tacky” and that the profession of medicine should not be relegated to oversimplified service ratings. They worried that they would feel pressured to please the patient rather than “do the right thing” for the patient. For example, they would be less likely to give difficult advice (such as lose weight or stop smoking) or to resist prescribing medications that they deemed unnecessary or frankly dangerous (for example, antibiotics or narcotics).

Although these are valid concerns, it is hard to ignore the proliferation and traffic of these online websites. For you and your team, I would recommend taking a look at what is online about the members of your group and thinking about online strategies to take control of the conversation.

I don’t think the controversy over online physician ratings will wane anytime soon, but there is no doubt that they are profitable for companies and are therefore highly likely to continue to multiply.

References

1.Hanauer DA, Zheng K, Singer DC, Gebremariam A, Davis MM. Public awareness, perception, and use of online physician rating sites. JAMA. 2014;311(7):734-735. 2. A to Z provider listing: find a U of U Health Care physician by last name. University of Utah website. Available at http://healthcare.utah.edu/fad. Accessed Nov. 16, 2016.

Danielle Scheurer, MD, MSc, SFHM, is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at scheured@musc.edu.

The online rating business is proliferating in the medical industry. This should really come as no surprise as health care is a service industry and online ratings have long been a staple in most other service industries. It has become routine practice for most of us to search such online reviews when seeking a pair of shoes, a toaster, or a restaurant; we almost can’t help but scour these sites to help us make the best decision possible.

• Anticipated cost (is the physician or practice in or out of network?).
• Availability or access to the service (location of the practice and how long it will take to be seen).
• How good the services and care will be when they get there.

• They felt it was “tacky” and that the profession of medicine should not be relegated to oversimplified service ratings. They worried that they would feel pressured to please the patient rather than “do the right thing” for the patient. For example, they would be less likely to give difficult advice (such as lose weight or stop smoking) or to resist prescribing medications that they deemed unnecessary or frankly dangerous (for example, antibiotics or narcotics).

Although these are valid concerns, it is hard to ignore the proliferation and traffic of these online websites. For you and your team, I would recommend taking a look at what is online about the members of your group and thinking about online strategies to take control of the conversation.

I don’t think the controversy over online physician ratings will wane anytime soon, but there is no doubt that they are profitable for companies and are therefore highly likely to continue to multiply.

References

1.Hanauer DA, Zheng K, Singer DC, Gebremariam A, Davis MM. Public awareness, perception, and use of online physician rating sites. JAMA. 2014;311(7):734-735. 2. A to Z provider listing: find a U of U Health Care physician by last name. University of Utah website. Available at http://healthcare.utah.edu/fad. Accessed Nov. 16, 2016.

Danielle Scheurer, MD, MSc, SFHM, is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at scheured@musc.edu.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.