In this Update, I discuss important new study results regarding the cardiovascular safety of hormone therapy (HT) in early menopausal women. In addition, I review survey data that reveal a huge number of US women are using compounded HT preparations, which have unproven efficacy and safety.

Earlier initiation is better: ELITE trial provides strong support for the estrogen timing hypothesis
_{Hodis HN, Mack WJ, Henderson VW, et al; for the ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.}

_{Keaney JF, Solomon G. Postmenopausal hormone therapy and atherosclerosis--time is of the essence [editorial]. N Engl J Med. 2016;374(13):1279-1280.}

A substantial amount of published data, including from the Women's Health Initiative (WHI), supports the timing hypothesis, which proposes that HT slows the progression of atherosclerosis among recently menopausal women but has a neutral or adverse effect among women who are a decade or more past menopause onset.¹ To directly test this hypothesis, Hodis and colleagues randomly assigned healthy postmenopausal women (<6 years or ≥10 years past menopause) without cardiovascular disease (CVD) to oral estradiol 1 mg or placebo. Women with a uterus also were randomly assigned to receive either vaginal progesterone gel or placebo gel. The primary outcome was the rate of change in carotid artery intima-media thickness (CIMT), which was assessed at baseline and each 6 months of the study. (An earlier report had noted that baseline CIMT correlated well with CVD risk factors.²) Coronary artery atherosclerosis, a secondary outcome, was assessed at study completion using computed tomography (CT).

Details of the study
Among the 643 participants in the Early versus Late Intervention Trial with Estradiol (ELITE), the median years since menopause and the median age at enrollment were 3.5 and 55.4, respectively, in the early postmenopause group and 14.3 and 63.6, respectively, in the late postmenopause group.  

Among the younger women, after a median of 5 years of study medications, the estradiol group had less progression of CIMT than the placebo group (P = .008). By contrast, in the older group, rates of CIMT progression were similar in the HT and placebo groups (P = .29). The relationship between estrogen and CIMT progression differed significantly between the younger and older groups (P = .007). Use of progesterone did not change these trends. Coronary artery CT parameters did not differ significantly between the placebo and HT groups in the age group or in the time-since-menopause group.

What this evidence means for practice
In an editorial accompanying the published results of the ELITE trial, Keaney and Solomon concluded that, although estrogen had a favorable effect on atherosclerosis in early menopause, it would be premature to recommend HT for prevention of cardiovascular events. I agree with them, but I also would like to note that the use of HT for the treatment of menopausal symptoms has plummeted since the initial WHI findings in 2002, with infrequent HT use even among symptomatic women in early menopause.³ (And I refer you to the special inset featuring JoAnn E. Manson, MD, DrPH) The takeaway message is that this important new clinical trial provides additional reassurance regarding the cardiovascular safety of HT when initiated by recently menopausal women to treat bothersome vasomotor symptoms. This message represents welcome news for women with bothersome menopausal symptoms considering use of HT.

A word about the vaginal progesterone gel used in the ELITE trial in relation to clinical practice: Given the need for vaginal placement of progesterone gel, potential messiness, and high cost, few clinicians may prescribe this formulation, and few women probably would choose to use it. As an alternative, micronized progesterone 100-mg capsules are less expensive and well accepted by most patients. These capsules are formulated with peanut oil. Because they may cause women to feel drowsy, the capsules should be taken at bedtime. In women with an intact uterus who are taking oral estradiol 1-mg tablets, one appropriate progestogen regimen for endometrial suppression is a 100-mg micronized progesterone capsule each night, continuously.

WHI, ELITE and the timing hypothesis:
New evidence on HT in early menopause is reassuring

 

Q&A with JoAnn E. Manson, MD, DrPH
In this interview, Dr. JoAnn Manson discusses the reassuring results of recent hormone therapy (HT) trials in early versus later postmenopausal women, examines these outcomes in the context of the Women's Health Initiative (WHI) trial and ELITE trial, and debunks an enduring common misconception about the WHI.

Q You have said for several years that there has been a misconception about the WHI trial. What is that misconception, and what has been its impact on clinicians, women, and the use of HT?
A The WHI HT trial has been largely misunderstood. It was designed to address the balance of benefits and risks of long-term HT for the prevention of chronic disease in postmenopausal women across a broad range of ages (average age 63).^1,2 It was not intended to evaluate the clinical role of HT for managing menopausal symptoms in young and early menopausal women.³ Overall, the WHI study findings have been inappropriately extrapolated to women in their 40s and early 50s who report distressing hot flashes, night sweats, and other menopausal symptoms, and they are often used as a reason to deny therapy when in fact many of these women would be appropriate candidates for HT.

There is increasing evidence that younger women in early menopause who are taking HT have a lower risk of adverse outcomes and lower absolute risks of disease than older women.^2,3 In younger, early menopausal women with bothersome hot flashes, night sweats, or other menopausal symptoms and who have no contraindications to HT, the benefits of treatment are likely to outweigh the risks, and these patients derive quality-of-life benefits from treatment.

Q How do the results of the recent ELITE (Early versus Late Intervention Trial with Estradiol) trial build on cardiovascular safety, in particular, of HT and when HT is optimally initiated?
A The ELITE trial directly tested the "timing hypothesis" and the role of HT in slowing the progression of atherosclerosis in early menopause (defined as within 6 years of menopause onset) compared with the effect in women in later menopause (defined as at least 10 yearspast menopause).⁴ The investigators used carotid artery intima-media thickness (CIMT) as a surrogate end point. In this trial, 643 women were randomly assigned according to whether they were in early or later menopause to receive either placebo or estradiol 1 mg daily; women with a uterus also received progesterone 45 mg as a 4% vaginal gel or matching placebo gel. The median duration of intervention was 5 years.
 
The ELITE study results provide support for the "critical window hypothesis" in that the estradiol-treated younger women closer to onset of menopause had slowing of atherosclerosis compared with the placebo group, while the older women more distant from menopause did not have slowing of atherosclerosis with estradiol.
 
The ELITE trial was not large enough, however, to assess clinical end points--rates of heart attack, stroke, or other cardiovascular events. So it remains unclear whether the findings for the surrogate end point of CIMT would translate into a reduced risk of clinical events in the younger women. Nevertheless, ELITE does provide more reassurance about the use of HT in early menopause and supports the possibility that the overall results of the WHI among women enrolled at an average age of 63 years may not apply directly to younger women in early menopause.

Q What impact on clinical practice do you anticipate as a result of the ELITE trial results?
A The findings provide further support for the timing hypothesis and offer additional reassurance regarding the safety  of HT in early menopause for management of menopausal symptoms. However, the trial does not provide conclusive evidence to support recommendations to use HT for the express purpose of preventing cardiovascular disease (CVD), even if HT is started in early menopause. Using a surrogate end point for atherosclerosis (CIMT) is not the same as looking at clinical events. There are many biologic pathways for heart attacks, strokes, and other cardiovascular events. In addition to atherosclerosis, for example, there is thrombosis, clotting, thrombo-occlusion within a blood vessel, and plaque rupture. Again, we do not know whether the CIMT-based results would translate directly into a reduction in clinical heart attacks and stroke.

The main takeaway point from the ELITE trial results is further reassurance for use of HT for management of menopausal symptoms in early menopause, but not for long-term chronic disease prevention at any age.

Q Another recent study, published in the Journal of Clinical Endocrinology and Metabolism, addresses HT and the timing hypothesis but in this instance relating to glucose tolerance.⁵ What did these study authors find? 
A This study by Pereira and colleagues is very interesting and suggests that the window of opportunity for initiating estrogen therapy may apply not only to coronary events but also to glucose tolerance, insulin sensitivity, and diabetes risk.⁵

The authors investigated the effects of short-term high-dose transdermal estradiol on the insulin-mediated glucose disposal rate (GDR), which is a measure of insulin-stimulated glucose uptake. Participants in this randomized, crossover, placebo-controlled study included 22 women who were in early menopause (6 years or less since final menses) and 24 women who were in later menopause (10 years or longer since final menses). All of the women were naïve to hormone therapy, and baseline GDR did not differ between groups. After 1 week of treatment with transdermal estradiol (a high dose of 150 μg) or placebo, the participants' GDR was measured via a hyperinsulinemic-euglycemic clamp.
 
The investigators found that in the younger women, estradiol had a favorable effect on insulin sensitivity and GDR, whereas in the older women, there was no evidence of a favorable effect and, in fact, there was a signal for risk and more adverse findings in this group.

Several studies in the WHI also looked at glucose tolerance and at the risk of being diagnosed with diabetes. While the results of the WHI estrogen-alone trial revealed a reduction in diabetes and favorable effects across age groups, in the WHI estrogen-plus-progestin trial we did see a signal that the results for diabetes may have been more favorable in the younger than in the older women, somewhat consistent with the findings of Pereira and colleagues.^2,5
Overall this issue requires more research, but the Pereira study provides further support for the possibility that estrogen's metabolic effects may vary by age and time since menopause, and there is evidence that the estrogen receptors may be more functional and more sensitive in early rather than later menopause. These findings are very interesting and consistent with the overall hypothesis about the importance of age and time since menopause in relation to estrogen action. Again, they offer further support for use of HT for managing bothersome menopausal symptoms in early menopause, but they should not be interpreted as endorsing the use of HT to prevent either diabetes or CVD, due to the potential for other risks.

Q Where would you like to see future research conducted regarding the timing hypothesis?
A I would like to see more research on the role of oral versus transdermal estrogen in relation to insulin sensitivity, diabetes risk, and CVD risk, and more research on the role of estrogen dose, different types of progestogens, and the benefits and risks of novel formulations, including selective estrogen receptor modulators and tissue selective estrogen complexes.
 

 

---

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School and Chief of the Division of Preventive Medicine at Brigham and Women's Hospital, Boston, Massachusetts. She is a past President of the North American Menopause Society (NAMS) and a NAMS Certified Menopause Practitioner.

The author reports no financial relationships relevant to this article.

 

---

References

 

1. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
2. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013(13);310:1353-1368.
3. Manson JE, Kaunitz AM. Menopause management-- getting clinical care back on track. N Engl J Med. 2016;374(19):803-806.
4. Hodis HN, Mack WJ, Henderson VW, et al; ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.
5. Pereira RI, Casey BA, Swibas TA, Erickson CB, Wolfe P, Van Pelt RE. Timing of estradiol treatment after menopause may determine benefit or harm to insulin action. J Clin Endocrinol Metab. 2015;100(12):4456-4462.

FDA-approved HT is preferable to compounded HT formulations
_{Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. Menopause. 2015;22(9):926-936.}

_{Pinkerton JV, Constantine GD. Compounded non-FDA-approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. Menopause. 2016;23(4):359-367.}

_{Gass ML, Stuenkel CA, Utian WH, LaCroix A, Liu JH, Shifren JL.; North American Menopause Society (NAMS) Advisory Panel consisting of representatives of NAMS Board of Trustees and other experts in women's health. Use of compounded hormone therapy in the United States: report of The North American Menopause Society Survey. Menopause. 2015;22(12):1276-1284.}

Consider how you would manage this clinical scenario: During a well-woman visit, your 54-year-old patient mentions that, after seeing an advertisement on television, she visited a clinic that sells compounded hormones. There, she underwent some testing and received an estrogen-testosterone implant and a progesterone cream that she applies to her skin each night to treat her menopausal symptoms. Now what?

The use of HT for menopausal symptoms declined considerably following the 2002 publication of the initial findings from the WHI, and its use remains low.⁴ Symptomatic menopausal women often find that their physicians are reluctant to consider prescribing treatment for menopausal symptoms because of safety concerns regarding HT use. Further, confusion about HT safety has opened the door to the increasing use of compounded bioidentical HT formulations, which are not approved by the US Food and Drug Administration (FDA).³ Since the publication of my 2015 Update on menopause (OBG Manag. 2015;27(6):37−40,42−43), several reports have addressed the use of "custom compounded" bioidentical menopausal HT in US women.

Millions use compounded HT for menopausal symptoms
A recent study by Pinkerton and Santoro that analyzed data from 2 national surveys suggested that as many as 2.5 million US women currently use non−FDA-approved custom-compounded HT. The authors also found that more than three-quarters of women using compounded HT are unaware that these medications, which include oral, topical, injectable, and implantable (pellet) formulations, are not FDA approved. In a study by Pinkerton and Constantine, total annual sales of compounded HT were estimated at approximately $1.5 billion. The dramatic growth in the use of compounded HT appears to have stemmed from celebrity endorsements, aggressive and unregulated marketing, and beliefs about the safety of "natural" hormones.⁵

Spurious laboratory testing. Women seeking care from physicians and clinics that provide compounded HT are often advised to undergo saliva and serum testing to determine hormone levels. Many women are unaware, however, that saliva testing does not correlate with serum levels of hormones. Further, in contrast with conditions such as thyroid disease and diabetes, routine laboratory testing is neither indicated nor helpful in the management of menopausal symptoms.⁶ Of note, insurance companies often do not reimburse for the cost of saliva hormone testing or for non-FDA-approved hormones.⁵

Inadequate endometrial protection. Topical progesterone cream, which is not absorbed in sufficient quantities to generate therapeutic effects, is often prescribed by practitioners who sell bioidentical compounded hormones to their patients.7 According to a report by the North American Menopause Society, several cases of endometrial cancer have been reported among women using compounded HT. These cases may reflect use of systemic estrogen without adequate progesterone protection, as could occur when topical progesterone cream is prescribed to women with an intact uterus using systemic estrogen therapy. 

What this evidence means for practice
Clinicians should be alert to the growing prevalence of use of compounded HT and should educate themselves and their patients about the differences between non−FDA-approved HT and FDA-approved HT. Further, women interested in using "natural," "bioidentical," or "custom compounded" HT should be aware that FDA-approved estradiol (oral, transdermal, and vaginal) and progesterone (oral and vaginal) formulations are available.

Because the FDA does not test custom compounded hormones for efficacy or safety and the standardization and purity of these products are uncertain, the American College of Obstetricians and Gynecologists has stated that FDA-approved HT is preferred for management of menopausal symptoms.⁸ Similarly, the North American Menopause Society does not recommend the use of compounded HT for treatment of menopausal symptoms unless a patient is allergic to ingredients contained in FDA-approved HT formulations.⁹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this Update, I discuss important new study results regarding the cardiovascular safety of hormone therapy (HT) in early menopausal women. In addition, I review survey data that reveal a huge number of US women are using compounded HT preparations, which have unproven efficacy and safety.

Earlier initiation is better: ELITE trial provides strong support for the estrogen timing hypothesis
_{Hodis HN, Mack WJ, Henderson VW, et al; for the ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.}

_{Keaney JF, Solomon G. Postmenopausal hormone therapy and atherosclerosis--time is of the essence [editorial]. N Engl J Med. 2016;374(13):1279-1280.}

A substantial amount of published data, including from the Women's Health Initiative (WHI), supports the timing hypothesis, which proposes that HT slows the progression of atherosclerosis among recently menopausal women but has a neutral or adverse effect among women who are a decade or more past menopause onset.¹ To directly test this hypothesis, Hodis and colleagues randomly assigned healthy postmenopausal women (<6 years or ≥10 years past menopause) without cardiovascular disease (CVD) to oral estradiol 1 mg or placebo. Women with a uterus also were randomly assigned to receive either vaginal progesterone gel or placebo gel. The primary outcome was the rate of change in carotid artery intima-media thickness (CIMT), which was assessed at baseline and each 6 months of the study. (An earlier report had noted that baseline CIMT correlated well with CVD risk factors.²) Coronary artery atherosclerosis, a secondary outcome, was assessed at study completion using computed tomography (CT).

Details of the study
Among the 643 participants in the Early versus Late Intervention Trial with Estradiol (ELITE), the median years since menopause and the median age at enrollment were 3.5 and 55.4, respectively, in the early postmenopause group and 14.3 and 63.6, respectively, in the late postmenopause group.  

Among the younger women, after a median of 5 years of study medications, the estradiol group had less progression of CIMT than the placebo group (P = .008). By contrast, in the older group, rates of CIMT progression were similar in the HT and placebo groups (P = .29). The relationship between estrogen and CIMT progression differed significantly between the younger and older groups (P = .007). Use of progesterone did not change these trends. Coronary artery CT parameters did not differ significantly between the placebo and HT groups in the age group or in the time-since-menopause group.

What this evidence means for practice
In an editorial accompanying the published results of the ELITE trial, Keaney and Solomon concluded that, although estrogen had a favorable effect on atherosclerosis in early menopause, it would be premature to recommend HT for prevention of cardiovascular events. I agree with them, but I also would like to note that the use of HT for the treatment of menopausal symptoms has plummeted since the initial WHI findings in 2002, with infrequent HT use even among symptomatic women in early menopause.³ (And I refer you to the special inset featuring JoAnn E. Manson, MD, DrPH) The takeaway message is that this important new clinical trial provides additional reassurance regarding the cardiovascular safety of HT when initiated by recently menopausal women to treat bothersome vasomotor symptoms. This message represents welcome news for women with bothersome menopausal symptoms considering use of HT.

A word about the vaginal progesterone gel used in the ELITE trial in relation to clinical practice: Given the need for vaginal placement of progesterone gel, potential messiness, and high cost, few clinicians may prescribe this formulation, and few women probably would choose to use it. As an alternative, micronized progesterone 100-mg capsules are less expensive and well accepted by most patients. These capsules are formulated with peanut oil. Because they may cause women to feel drowsy, the capsules should be taken at bedtime. In women with an intact uterus who are taking oral estradiol 1-mg tablets, one appropriate progestogen regimen for endometrial suppression is a 100-mg micronized progesterone capsule each night, continuously.

WHI, ELITE and the timing hypothesis:
New evidence on HT in early menopause is reassuring

 

Q&A with JoAnn E. Manson, MD, DrPH
In this interview, Dr. JoAnn Manson discusses the reassuring results of recent hormone therapy (HT) trials in early versus later postmenopausal women, examines these outcomes in the context of the Women's Health Initiative (WHI) trial and ELITE trial, and debunks an enduring common misconception about the WHI.

Q You have said for several years that there has been a misconception about the WHI trial. What is that misconception, and what has been its impact on clinicians, women, and the use of HT?
A The WHI HT trial has been largely misunderstood. It was designed to address the balance of benefits and risks of long-term HT for the prevention of chronic disease in postmenopausal women across a broad range of ages (average age 63).^1,2 It was not intended to evaluate the clinical role of HT for managing menopausal symptoms in young and early menopausal women.³ Overall, the WHI study findings have been inappropriately extrapolated to women in their 40s and early 50s who report distressing hot flashes, night sweats, and other menopausal symptoms, and they are often used as a reason to deny therapy when in fact many of these women would be appropriate candidates for HT.

There is increasing evidence that younger women in early menopause who are taking HT have a lower risk of adverse outcomes and lower absolute risks of disease than older women.^2,3 In younger, early menopausal women with bothersome hot flashes, night sweats, or other menopausal symptoms and who have no contraindications to HT, the benefits of treatment are likely to outweigh the risks, and these patients derive quality-of-life benefits from treatment.

Q How do the results of the recent ELITE (Early versus Late Intervention Trial with Estradiol) trial build on cardiovascular safety, in particular, of HT and when HT is optimally initiated?
A The ELITE trial directly tested the "timing hypothesis" and the role of HT in slowing the progression of atherosclerosis in early menopause (defined as within 6 years of menopause onset) compared with the effect in women in later menopause (defined as at least 10 yearspast menopause).⁴ The investigators used carotid artery intima-media thickness (CIMT) as a surrogate end point. In this trial, 643 women were randomly assigned according to whether they were in early or later menopause to receive either placebo or estradiol 1 mg daily; women with a uterus also received progesterone 45 mg as a 4% vaginal gel or matching placebo gel. The median duration of intervention was 5 years.
 
The ELITE study results provide support for the "critical window hypothesis" in that the estradiol-treated younger women closer to onset of menopause had slowing of atherosclerosis compared with the placebo group, while the older women more distant from menopause did not have slowing of atherosclerosis with estradiol.
 
The ELITE trial was not large enough, however, to assess clinical end points--rates of heart attack, stroke, or other cardiovascular events. So it remains unclear whether the findings for the surrogate end point of CIMT would translate into a reduced risk of clinical events in the younger women. Nevertheless, ELITE does provide more reassurance about the use of HT in early menopause and supports the possibility that the overall results of the WHI among women enrolled at an average age of 63 years may not apply directly to younger women in early menopause.

Q What impact on clinical practice do you anticipate as a result of the ELITE trial results?
A The findings provide further support for the timing hypothesis and offer additional reassurance regarding the safety  of HT in early menopause for management of menopausal symptoms. However, the trial does not provide conclusive evidence to support recommendations to use HT for the express purpose of preventing cardiovascular disease (CVD), even if HT is started in early menopause. Using a surrogate end point for atherosclerosis (CIMT) is not the same as looking at clinical events. There are many biologic pathways for heart attacks, strokes, and other cardiovascular events. In addition to atherosclerosis, for example, there is thrombosis, clotting, thrombo-occlusion within a blood vessel, and plaque rupture. Again, we do not know whether the CIMT-based results would translate directly into a reduction in clinical heart attacks and stroke.

The main takeaway point from the ELITE trial results is further reassurance for use of HT for management of menopausal symptoms in early menopause, but not for long-term chronic disease prevention at any age.

Q Another recent study, published in the Journal of Clinical Endocrinology and Metabolism, addresses HT and the timing hypothesis but in this instance relating to glucose tolerance.⁵ What did these study authors find? 
A This study by Pereira and colleagues is very interesting and suggests that the window of opportunity for initiating estrogen therapy may apply not only to coronary events but also to glucose tolerance, insulin sensitivity, and diabetes risk.⁵

The authors investigated the effects of short-term high-dose transdermal estradiol on the insulin-mediated glucose disposal rate (GDR), which is a measure of insulin-stimulated glucose uptake. Participants in this randomized, crossover, placebo-controlled study included 22 women who were in early menopause (6 years or less since final menses) and 24 women who were in later menopause (10 years or longer since final menses). All of the women were naïve to hormone therapy, and baseline GDR did not differ between groups. After 1 week of treatment with transdermal estradiol (a high dose of 150 μg) or placebo, the participants' GDR was measured via a hyperinsulinemic-euglycemic clamp.
 
The investigators found that in the younger women, estradiol had a favorable effect on insulin sensitivity and GDR, whereas in the older women, there was no evidence of a favorable effect and, in fact, there was a signal for risk and more adverse findings in this group.

Several studies in the WHI also looked at glucose tolerance and at the risk of being diagnosed with diabetes. While the results of the WHI estrogen-alone trial revealed a reduction in diabetes and favorable effects across age groups, in the WHI estrogen-plus-progestin trial we did see a signal that the results for diabetes may have been more favorable in the younger than in the older women, somewhat consistent with the findings of Pereira and colleagues.^2,5
Overall this issue requires more research, but the Pereira study provides further support for the possibility that estrogen's metabolic effects may vary by age and time since menopause, and there is evidence that the estrogen receptors may be more functional and more sensitive in early rather than later menopause. These findings are very interesting and consistent with the overall hypothesis about the importance of age and time since menopause in relation to estrogen action. Again, they offer further support for use of HT for managing bothersome menopausal symptoms in early menopause, but they should not be interpreted as endorsing the use of HT to prevent either diabetes or CVD, due to the potential for other risks.

Q Where would you like to see future research conducted regarding the timing hypothesis?
A I would like to see more research on the role of oral versus transdermal estrogen in relation to insulin sensitivity, diabetes risk, and CVD risk, and more research on the role of estrogen dose, different types of progestogens, and the benefits and risks of novel formulations, including selective estrogen receptor modulators and tissue selective estrogen complexes.
 

 

---

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School and Chief of the Division of Preventive Medicine at Brigham and Women's Hospital, Boston, Massachusetts. She is a past President of the North American Menopause Society (NAMS) and a NAMS Certified Menopause Practitioner.

The author reports no financial relationships relevant to this article.

 

---

References

 

1. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
2. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013(13);310:1353-1368.
3. Manson JE, Kaunitz AM. Menopause management-- getting clinical care back on track. N Engl J Med. 2016;374(19):803-806.
4. Hodis HN, Mack WJ, Henderson VW, et al; ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.
5. Pereira RI, Casey BA, Swibas TA, Erickson CB, Wolfe P, Van Pelt RE. Timing of estradiol treatment after menopause may determine benefit or harm to insulin action. J Clin Endocrinol Metab. 2015;100(12):4456-4462.

FDA-approved HT is preferable to compounded HT formulations
_{Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. Menopause. 2015;22(9):926-936.}

_{Pinkerton JV, Constantine GD. Compounded non-FDA-approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. Menopause. 2016;23(4):359-367.}

_{Gass ML, Stuenkel CA, Utian WH, LaCroix A, Liu JH, Shifren JL.; North American Menopause Society (NAMS) Advisory Panel consisting of representatives of NAMS Board of Trustees and other experts in women's health. Use of compounded hormone therapy in the United States: report of The North American Menopause Society Survey. Menopause. 2015;22(12):1276-1284.}

Consider how you would manage this clinical scenario: During a well-woman visit, your 54-year-old patient mentions that, after seeing an advertisement on television, she visited a clinic that sells compounded hormones. There, she underwent some testing and received an estrogen-testosterone implant and a progesterone cream that she applies to her skin each night to treat her menopausal symptoms. Now what?

The use of HT for menopausal symptoms declined considerably following the 2002 publication of the initial findings from the WHI, and its use remains low.⁴ Symptomatic menopausal women often find that their physicians are reluctant to consider prescribing treatment for menopausal symptoms because of safety concerns regarding HT use. Further, confusion about HT safety has opened the door to the increasing use of compounded bioidentical HT formulations, which are not approved by the US Food and Drug Administration (FDA).³ Since the publication of my 2015 Update on menopause (OBG Manag. 2015;27(6):37−40,42−43), several reports have addressed the use of "custom compounded" bioidentical menopausal HT in US women.

Millions use compounded HT for menopausal symptoms
A recent study by Pinkerton and Santoro that analyzed data from 2 national surveys suggested that as many as 2.5 million US women currently use non−FDA-approved custom-compounded HT. The authors also found that more than three-quarters of women using compounded HT are unaware that these medications, which include oral, topical, injectable, and implantable (pellet) formulations, are not FDA approved. In a study by Pinkerton and Constantine, total annual sales of compounded HT were estimated at approximately $1.5 billion. The dramatic growth in the use of compounded HT appears to have stemmed from celebrity endorsements, aggressive and unregulated marketing, and beliefs about the safety of "natural" hormones.⁵

Spurious laboratory testing. Women seeking care from physicians and clinics that provide compounded HT are often advised to undergo saliva and serum testing to determine hormone levels. Many women are unaware, however, that saliva testing does not correlate with serum levels of hormones. Further, in contrast with conditions such as thyroid disease and diabetes, routine laboratory testing is neither indicated nor helpful in the management of menopausal symptoms.⁶ Of note, insurance companies often do not reimburse for the cost of saliva hormone testing or for non-FDA-approved hormones.⁵

Inadequate endometrial protection. Topical progesterone cream, which is not absorbed in sufficient quantities to generate therapeutic effects, is often prescribed by practitioners who sell bioidentical compounded hormones to their patients.7 According to a report by the North American Menopause Society, several cases of endometrial cancer have been reported among women using compounded HT. These cases may reflect use of systemic estrogen without adequate progesterone protection, as could occur when topical progesterone cream is prescribed to women with an intact uterus using systemic estrogen therapy. 

What this evidence means for practice
Clinicians should be alert to the growing prevalence of use of compounded HT and should educate themselves and their patients about the differences between non−FDA-approved HT and FDA-approved HT. Further, women interested in using "natural," "bioidentical," or "custom compounded" HT should be aware that FDA-approved estradiol (oral, transdermal, and vaginal) and progesterone (oral and vaginal) formulations are available.

Because the FDA does not test custom compounded hormones for efficacy or safety and the standardization and purity of these products are uncertain, the American College of Obstetricians and Gynecologists has stated that FDA-approved HT is preferred for management of menopausal symptoms.⁸ Similarly, the North American Menopause Society does not recommend the use of compounded HT for treatment of menopausal symptoms unless a patient is allergic to ingredients contained in FDA-approved HT formulations.⁹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this Update, I discuss important new study results regarding the cardiovascular safety of hormone therapy (HT) in early menopausal women. In addition, I review survey data that reveal a huge number of US women are using compounded HT preparations, which have unproven efficacy and safety.

Earlier initiation is better: ELITE trial provides strong support for the estrogen timing hypothesis
_{Hodis HN, Mack WJ, Henderson VW, et al; for the ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.}

_{Keaney JF, Solomon G. Postmenopausal hormone therapy and atherosclerosis--time is of the essence [editorial]. N Engl J Med. 2016;374(13):1279-1280.}

A substantial amount of published data, including from the Women's Health Initiative (WHI), supports the timing hypothesis, which proposes that HT slows the progression of atherosclerosis among recently menopausal women but has a neutral or adverse effect among women who are a decade or more past menopause onset.¹ To directly test this hypothesis, Hodis and colleagues randomly assigned healthy postmenopausal women (<6 years or ≥10 years past menopause) without cardiovascular disease (CVD) to oral estradiol 1 mg or placebo. Women with a uterus also were randomly assigned to receive either vaginal progesterone gel or placebo gel. The primary outcome was the rate of change in carotid artery intima-media thickness (CIMT), which was assessed at baseline and each 6 months of the study. (An earlier report had noted that baseline CIMT correlated well with CVD risk factors.²) Coronary artery atherosclerosis, a secondary outcome, was assessed at study completion using computed tomography (CT).

Details of the study
Among the 643 participants in the Early versus Late Intervention Trial with Estradiol (ELITE), the median years since menopause and the median age at enrollment were 3.5 and 55.4, respectively, in the early postmenopause group and 14.3 and 63.6, respectively, in the late postmenopause group.  

Among the younger women, after a median of 5 years of study medications, the estradiol group had less progression of CIMT than the placebo group (P = .008). By contrast, in the older group, rates of CIMT progression were similar in the HT and placebo groups (P = .29). The relationship between estrogen and CIMT progression differed significantly between the younger and older groups (P = .007). Use of progesterone did not change these trends. Coronary artery CT parameters did not differ significantly between the placebo and HT groups in the age group or in the time-since-menopause group.

What this evidence means for practice
In an editorial accompanying the published results of the ELITE trial, Keaney and Solomon concluded that, although estrogen had a favorable effect on atherosclerosis in early menopause, it would be premature to recommend HT for prevention of cardiovascular events. I agree with them, but I also would like to note that the use of HT for the treatment of menopausal symptoms has plummeted since the initial WHI findings in 2002, with infrequent HT use even among symptomatic women in early menopause.³ (And I refer you to the special inset featuring JoAnn E. Manson, MD, DrPH) The takeaway message is that this important new clinical trial provides additional reassurance regarding the cardiovascular safety of HT when initiated by recently menopausal women to treat bothersome vasomotor symptoms. This message represents welcome news for women with bothersome menopausal symptoms considering use of HT.

A word about the vaginal progesterone gel used in the ELITE trial in relation to clinical practice: Given the need for vaginal placement of progesterone gel, potential messiness, and high cost, few clinicians may prescribe this formulation, and few women probably would choose to use it. As an alternative, micronized progesterone 100-mg capsules are less expensive and well accepted by most patients. These capsules are formulated with peanut oil. Because they may cause women to feel drowsy, the capsules should be taken at bedtime. In women with an intact uterus who are taking oral estradiol 1-mg tablets, one appropriate progestogen regimen for endometrial suppression is a 100-mg micronized progesterone capsule each night, continuously.

WHI, ELITE and the timing hypothesis:
New evidence on HT in early menopause is reassuring

 

Q&A with JoAnn E. Manson, MD, DrPH
In this interview, Dr. JoAnn Manson discusses the reassuring results of recent hormone therapy (HT) trials in early versus later postmenopausal women, examines these outcomes in the context of the Women's Health Initiative (WHI) trial and ELITE trial, and debunks an enduring common misconception about the WHI.

Q You have said for several years that there has been a misconception about the WHI trial. What is that misconception, and what has been its impact on clinicians, women, and the use of HT?
A The WHI HT trial has been largely misunderstood. It was designed to address the balance of benefits and risks of long-term HT for the prevention of chronic disease in postmenopausal women across a broad range of ages (average age 63).^1,2 It was not intended to evaluate the clinical role of HT for managing menopausal symptoms in young and early menopausal women.³ Overall, the WHI study findings have been inappropriately extrapolated to women in their 40s and early 50s who report distressing hot flashes, night sweats, and other menopausal symptoms, and they are often used as a reason to deny therapy when in fact many of these women would be appropriate candidates for HT.

There is increasing evidence that younger women in early menopause who are taking HT have a lower risk of adverse outcomes and lower absolute risks of disease than older women.^2,3 In younger, early menopausal women with bothersome hot flashes, night sweats, or other menopausal symptoms and who have no contraindications to HT, the benefits of treatment are likely to outweigh the risks, and these patients derive quality-of-life benefits from treatment.

Q How do the results of the recent ELITE (Early versus Late Intervention Trial with Estradiol) trial build on cardiovascular safety, in particular, of HT and when HT is optimally initiated?
A The ELITE trial directly tested the "timing hypothesis" and the role of HT in slowing the progression of atherosclerosis in early menopause (defined as within 6 years of menopause onset) compared with the effect in women in later menopause (defined as at least 10 yearspast menopause).⁴ The investigators used carotid artery intima-media thickness (CIMT) as a surrogate end point. In this trial, 643 women were randomly assigned according to whether they were in early or later menopause to receive either placebo or estradiol 1 mg daily; women with a uterus also received progesterone 45 mg as a 4% vaginal gel or matching placebo gel. The median duration of intervention was 5 years.
 
The ELITE study results provide support for the "critical window hypothesis" in that the estradiol-treated younger women closer to onset of menopause had slowing of atherosclerosis compared with the placebo group, while the older women more distant from menopause did not have slowing of atherosclerosis with estradiol.
 
The ELITE trial was not large enough, however, to assess clinical end points--rates of heart attack, stroke, or other cardiovascular events. So it remains unclear whether the findings for the surrogate end point of CIMT would translate into a reduced risk of clinical events in the younger women. Nevertheless, ELITE does provide more reassurance about the use of HT in early menopause and supports the possibility that the overall results of the WHI among women enrolled at an average age of 63 years may not apply directly to younger women in early menopause.

Q What impact on clinical practice do you anticipate as a result of the ELITE trial results?
A The findings provide further support for the timing hypothesis and offer additional reassurance regarding the safety  of HT in early menopause for management of menopausal symptoms. However, the trial does not provide conclusive evidence to support recommendations to use HT for the express purpose of preventing cardiovascular disease (CVD), even if HT is started in early menopause. Using a surrogate end point for atherosclerosis (CIMT) is not the same as looking at clinical events. There are many biologic pathways for heart attacks, strokes, and other cardiovascular events. In addition to atherosclerosis, for example, there is thrombosis, clotting, thrombo-occlusion within a blood vessel, and plaque rupture. Again, we do not know whether the CIMT-based results would translate directly into a reduction in clinical heart attacks and stroke.

The main takeaway point from the ELITE trial results is further reassurance for use of HT for management of menopausal symptoms in early menopause, but not for long-term chronic disease prevention at any age.

Q Another recent study, published in the Journal of Clinical Endocrinology and Metabolism, addresses HT and the timing hypothesis but in this instance relating to glucose tolerance.⁵ What did these study authors find? 
A This study by Pereira and colleagues is very interesting and suggests that the window of opportunity for initiating estrogen therapy may apply not only to coronary events but also to glucose tolerance, insulin sensitivity, and diabetes risk.⁵

The authors investigated the effects of short-term high-dose transdermal estradiol on the insulin-mediated glucose disposal rate (GDR), which is a measure of insulin-stimulated glucose uptake. Participants in this randomized, crossover, placebo-controlled study included 22 women who were in early menopause (6 years or less since final menses) and 24 women who were in later menopause (10 years or longer since final menses). All of the women were naïve to hormone therapy, and baseline GDR did not differ between groups. After 1 week of treatment with transdermal estradiol (a high dose of 150 μg) or placebo, the participants' GDR was measured via a hyperinsulinemic-euglycemic clamp.
 
The investigators found that in the younger women, estradiol had a favorable effect on insulin sensitivity and GDR, whereas in the older women, there was no evidence of a favorable effect and, in fact, there was a signal for risk and more adverse findings in this group.

Several studies in the WHI also looked at glucose tolerance and at the risk of being diagnosed with diabetes. While the results of the WHI estrogen-alone trial revealed a reduction in diabetes and favorable effects across age groups, in the WHI estrogen-plus-progestin trial we did see a signal that the results for diabetes may have been more favorable in the younger than in the older women, somewhat consistent with the findings of Pereira and colleagues.^2,5
Overall this issue requires more research, but the Pereira study provides further support for the possibility that estrogen's metabolic effects may vary by age and time since menopause, and there is evidence that the estrogen receptors may be more functional and more sensitive in early rather than later menopause. These findings are very interesting and consistent with the overall hypothesis about the importance of age and time since menopause in relation to estrogen action. Again, they offer further support for use of HT for managing bothersome menopausal symptoms in early menopause, but they should not be interpreted as endorsing the use of HT to prevent either diabetes or CVD, due to the potential for other risks.

Q Where would you like to see future research conducted regarding the timing hypothesis?
A I would like to see more research on the role of oral versus transdermal estrogen in relation to insulin sensitivity, diabetes risk, and CVD risk, and more research on the role of estrogen dose, different types of progestogens, and the benefits and risks of novel formulations, including selective estrogen receptor modulators and tissue selective estrogen complexes.
 

 

---

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School and Chief of the Division of Preventive Medicine at Brigham and Women's Hospital, Boston, Massachusetts. She is a past President of the North American Menopause Society (NAMS) and a NAMS Certified Menopause Practitioner.

The author reports no financial relationships relevant to this article.

 

---

References

 

1. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
2. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013(13);310:1353-1368.
3. Manson JE, Kaunitz AM. Menopause management-- getting clinical care back on track. N Engl J Med. 2016;374(19):803-806.
4. Hodis HN, Mack WJ, Henderson VW, et al; ELITE Research Group. Vascular effects of early versus late postmenopausal treatment with estradiol. N Engl J Med. 2016;374(13):1221-1231.
5. Pereira RI, Casey BA, Swibas TA, Erickson CB, Wolfe P, Van Pelt RE. Timing of estradiol treatment after menopause may determine benefit or harm to insulin action. J Clin Endocrinol Metab. 2015;100(12):4456-4462.

FDA-approved HT is preferable to compounded HT formulations
_{Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. Menopause. 2015;22(9):926-936.}

_{Pinkerton JV, Constantine GD. Compounded non-FDA-approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. Menopause. 2016;23(4):359-367.}

_{Gass ML, Stuenkel CA, Utian WH, LaCroix A, Liu JH, Shifren JL.; North American Menopause Society (NAMS) Advisory Panel consisting of representatives of NAMS Board of Trustees and other experts in women's health. Use of compounded hormone therapy in the United States: report of The North American Menopause Society Survey. Menopause. 2015;22(12):1276-1284.}

Consider how you would manage this clinical scenario: During a well-woman visit, your 54-year-old patient mentions that, after seeing an advertisement on television, she visited a clinic that sells compounded hormones. There, she underwent some testing and received an estrogen-testosterone implant and a progesterone cream that she applies to her skin each night to treat her menopausal symptoms. Now what?

The use of HT for menopausal symptoms declined considerably following the 2002 publication of the initial findings from the WHI, and its use remains low.⁴ Symptomatic menopausal women often find that their physicians are reluctant to consider prescribing treatment for menopausal symptoms because of safety concerns regarding HT use. Further, confusion about HT safety has opened the door to the increasing use of compounded bioidentical HT formulations, which are not approved by the US Food and Drug Administration (FDA).³ Since the publication of my 2015 Update on menopause (OBG Manag. 2015;27(6):37−40,42−43), several reports have addressed the use of "custom compounded" bioidentical menopausal HT in US women.

Millions use compounded HT for menopausal symptoms
A recent study by Pinkerton and Santoro that analyzed data from 2 national surveys suggested that as many as 2.5 million US women currently use non−FDA-approved custom-compounded HT. The authors also found that more than three-quarters of women using compounded HT are unaware that these medications, which include oral, topical, injectable, and implantable (pellet) formulations, are not FDA approved. In a study by Pinkerton and Constantine, total annual sales of compounded HT were estimated at approximately $1.5 billion. The dramatic growth in the use of compounded HT appears to have stemmed from celebrity endorsements, aggressive and unregulated marketing, and beliefs about the safety of "natural" hormones.⁵

Spurious laboratory testing. Women seeking care from physicians and clinics that provide compounded HT are often advised to undergo saliva and serum testing to determine hormone levels. Many women are unaware, however, that saliva testing does not correlate with serum levels of hormones. Further, in contrast with conditions such as thyroid disease and diabetes, routine laboratory testing is neither indicated nor helpful in the management of menopausal symptoms.⁶ Of note, insurance companies often do not reimburse for the cost of saliva hormone testing or for non-FDA-approved hormones.⁵

Inadequate endometrial protection. Topical progesterone cream, which is not absorbed in sufficient quantities to generate therapeutic effects, is often prescribed by practitioners who sell bioidentical compounded hormones to their patients.7 According to a report by the North American Menopause Society, several cases of endometrial cancer have been reported among women using compounded HT. These cases may reflect use of systemic estrogen without adequate progesterone protection, as could occur when topical progesterone cream is prescribed to women with an intact uterus using systemic estrogen therapy. 

What this evidence means for practice
Clinicians should be alert to the growing prevalence of use of compounded HT and should educate themselves and their patients about the differences between non−FDA-approved HT and FDA-approved HT. Further, women interested in using "natural," "bioidentical," or "custom compounded" HT should be aware that FDA-approved estradiol (oral, transdermal, and vaginal) and progesterone (oral and vaginal) formulations are available.

Because the FDA does not test custom compounded hormones for efficacy or safety and the standardization and purity of these products are uncertain, the American College of Obstetricians and Gynecologists has stated that FDA-approved HT is preferred for management of menopausal symptoms.⁸ Similarly, the North American Menopause Society does not recommend the use of compounded HT for treatment of menopausal symptoms unless a patient is allergic to ingredients contained in FDA-approved HT formulations.⁹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Patient may benefit from treatment for dyspareuniaA 54-year-old woman has been in your care for more than 15 years. Three years ago, at her well-woman examination, she was not yet having symptoms of menopause. Now, during her current examination, she reports hot flashes, which she says are not bothersome. In passing, she also says, “I don’t want to take hormone therapy,” but then is not overly conversational or responsive to your questions. She does mention having had 3 urinary tract infections over the past 8 months. On physical examination, you note mildly atrophied vaginal tissue.

Your patient does not bring up any sexual concerns, and so far you have not directly asked about sexual health. However, the time remaining in this visit is limited, and your patient, whose daughter is sitting in the waiting area, seems anxious to finish and leave. Still, you want to broach the subject of your patient’s sexual health. What are your best options?

We learned a lot about women’s perceptions regarding their sexual health in the 2008 Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking study (PRESIDE). Approximately 43% of 31,581 questionnaire respondents reported dysfunction in sexual desire, arousal, or orgasm.¹ Results also showed that 11.5% of the respondents with any of these types of female sexual dysfunction (FSD) were distressed about it. For clinicians, knowing who these women are is key in recognizing and treating FSD.

Important to the opening case, in PRESIDE, Shifren and colleagues found that women in their midlife years (aged 45 to 64) had the highest rate of any distressing sexual problem: 14.8%. Younger women (aged 18 to 44 years) had a rate of 10.8%; older women (aged 65 years or older) had a rate of 8.9%.¹

The most prevalent FSD was hypoactive sexual desire disorder,¹ which in 2013 was renamed sexual interest and arousal disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.² As with any distressing FSD, reports of being distressed about low sexual desire were highest for midlife women (12.3%) relative to younger (8.9%) and older (7.4%) women.¹

Unfortunately, decreased desire can have a ripple effect that goes well beyond a patient’s sexual health. A less-than-satisfying sex life can have a significant negative impact on self-image, possibly leading to depression or overall mood instability, which in turn can put undue strain on personal relationships.^1,3 A patient’s entire quality of life can be affected negatively.

With so much at stake, it is important for physicians to take a more active role in addressing the sexual health of their patients. Emphasizing wellness can help reduce the stigma of sexual dysfunction, break the silence, and open up patient–physician communication.⁴ There is also much to be gained by helping patients realize that having positive and respectful relationships is protective for health, including sexual health.⁴ Likewise, patients benefit from acknowledging that sexual health is an element of overall health and contributes to it.⁴

Toward these ends, more discussion with patients is needed. According to a 2008 national study, although 63% of US ObGyns surveyed indicated that they routinely asked their patients about sexual activity, only 40% asked about sexual problems, and only 29% asked patients if their sex lives were satisfying.⁵

Without communication, information is missed, and clinicians easily can overlook their patients’ sexual dysfunction and need for intervention. For midlife women, who are disproportionately affected by dysfunction relative to younger and older women, and for whom the rate of menopausal symptoms increases over the transition years, the results of going undiagnosed and untreated can be especially troubling. As reported in one study, for example, the rate of bothersome vulvovaginal atrophy, which can be a source of sexual dysfunction, increased from less than 5% at premenopause to almost 50% at 3 years postmenopause.⁶ What is standing in our way, however, and how can we overcome the hurdles to an open-door approach and meaningful conversation?

Obstacles to taking a sexual historyInitiating a sexual history can be like opening Pandora’s box. How do clinicians deal with the problems that come out? Some clinicians worry about embarrassing a patient with the first few questions about sexual health. Male gynecologists may feel awkward asking a patient about sex—particularly an older, midlife patient. The problem with not starting the conversation is that the midlife patient is often the one in the most distress, and the one most in need of treatment. Only by having the sexual health discussion can clinicians identify any issues and begin to address them.

Icebreakers to jump-start the conversation
Asking open-ended questions works best. Here are some options for starting a conversation with a midlife patient:

Such tools as checklists are often needed to bridge the wide communication gap between patients and physicians. Of the 255 women who reported experiencing dyspareunia in the Revealing Vaginal Effects at Midlife (REVEAL) study, almost half (44%) indicated that they had not spoken with their health care clinician about it.⁷ Another 44% had spoken about the problem but on their own initiative. In only 10% of cases had a physician started the conversation.

Clinicians can and should do better. Many of us have known our patients for years—given them their annual examinations, delivered their babies, performed their surgeries, become familiar with their bodies and intimate medical histories. We are uniquely qualified to start conversations on sexual health. A clinician who examines tissues and sees a decrease in vaginal caliber and pallor must say something. In some cases, the vagina is dry, but the patient has not been having lubrication problems. In other cases, a more serious condition might be involved. The important thing is to open up a conversation and talk about treatments.

CASE Continued
As today’s office visit wraps up and your patient begins moving for the door, you say, “Your hot flashes aren’t bothering you, but some women start experiencing certain sexual problems around this time in life. Have you noticed any issues?”

“Well, I have been having more burning during intercourse,” your patient responds.

On hearing this, you say, “That’s very important, Mrs. X, and I am glad you told me about it. I would like to discuss your concern a bit more, so let’s make another appointment to do just that.”

At the next visit, as part of the discussion, you give your patient a 15-minute sexual status examination.

Sexual status examination
Performing this examination helps clinicians see patterns in both sexual behavior and sexual health, which in turn can make it easier to recognize any dysfunction that might subsequently develop. The key to this process is establishing trust with the patient and having her feel comfortable with the discussion.

The patient remains fully clothed during this 15-minute session, which takes place with guarantees of nonjudgmental listening, confidentiality, privacy, and no interruptions. With the topic of sex being so personal, it should be emphasized that she is simply giving the clinician information, as she does on other health-related matters.

Establish her sexual status. Begin by asking the patient to describe her most recent or typical sexual encounter, including details such as day, time, location, type of activity, thoughts and feelings, and responses.

Potential issues can become apparent immediately. A patient may not have had a sexual encounter recently, or ever. Another may want sex, or more sex, but sees obstacles or lack of opportunity. Each of these is an issue to be explored, if the patient allows.

A patient can be sexually active in a number of ways, as the definition varies among population groups (race and age) and individuals. Sex is not only intercourse or oral sex—it is also kissing, touching, and hugging. Some people have an expansive view of what it is to be sexually active. When the patient mentions an encounter, ask what day, what time, where (at home, in a hotel room, at the office), and what type of activity (foreplay, oral sex, manual stimulation, intercourse, and position). Following up, ask what the patient was thinking or feeling about the encounter. For example, were there distracting thoughts or feelings of guilt? How did the patient and her partner respond during the encounter?

Assess for sexual dysfunction. After assessing the patient’s sexual status, turn to dysfunction. Arousal, pain, orgasm, and satisfaction are 4 areas of interest. Did the patient have difficulty becoming aroused? Was there a problem with lubrication? Did she have an orgasm? Was sex painful? How did she feel in terms of overall satisfaction?

In general, patients are comfortable speaking about sexual function and health. Having this talk can help identify a pattern, which can be discussed further during another visit. Such a follow-up would not take long—a level 3 visit should suffice.

Differential diagnosis. Consider the effects of current medications.^8,9 The psychiatric illnesses and general health factors that may affect sexual function should be considered as well (FIGURE 2).^10–22

When is it important to refer?
There are many reasons to refer a patient to another physician, including:

• a recommended treatment is not working
• abuse is suspected
• the patient shows symptoms of depression, anxiety, or another psychiatric condition
• a chronic, generalized (vs situational) disorder may be involved
• physical pain issues must be addressed
• you simply do not feel comfortable with a particular problem or patient.

Given the range of potential issues associated with sexual function, it is important to be able to provide the patient with expert assistance from a multidisciplinary team of specialists. This team can include psychologists, psychiatrists, counselors, sex educators, and, for pain issues, pelvic floor specialists and pelvic floor physical therapists. These colleagues are thoroughly familiar with the kinds of issues that can arise, and can offer alternative and adjunctive therapies.

Referrals also can be made for the latest nonpharmacologic and FDA-approved pharmacologic treatment options. Specialists tend to be familiar with these options, some of which are available only recently.

It is important to ask patients about sexual function and, if necessary, give them access to the best treatment options.

CASE Resolved
During the sexual status examination, your patient describes her most recent sexual encounter with her husband. She is frustrated with her lack of sexual response and describes a dry, tearing sensation during intercourse. You recommend first-line treatment with vaginal lubricants, preferably iso-osmolar aqueous− or silicone/dimethicone−based lubricants during intercourse. You also can discuss topical estrogen therapy via estradiol cream, conjugated equine estrogen cream, estradiol tablets in the vagina, or the estrogen ring. She is reassured that topical estrogen use will not pose significant risk for cancer, stroke, heart disease, or blood clot and that progesterone treatment is not necessary.

For patients who are particularly concerned about vaginal estrogen use, 2 or 3 times weekly use of a vaginal moisturizer could be an alternative for genitourinary symptoms and dyspareunia.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Patient may benefit from treatment for dyspareuniaA 54-year-old woman has been in your care for more than 15 years. Three years ago, at her well-woman examination, she was not yet having symptoms of menopause. Now, during her current examination, she reports hot flashes, which she says are not bothersome. In passing, she also says, “I don’t want to take hormone therapy,” but then is not overly conversational or responsive to your questions. She does mention having had 3 urinary tract infections over the past 8 months. On physical examination, you note mildly atrophied vaginal tissue.

Your patient does not bring up any sexual concerns, and so far you have not directly asked about sexual health. However, the time remaining in this visit is limited, and your patient, whose daughter is sitting in the waiting area, seems anxious to finish and leave. Still, you want to broach the subject of your patient’s sexual health. What are your best options?

We learned a lot about women’s perceptions regarding their sexual health in the 2008 Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking study (PRESIDE). Approximately 43% of 31,581 questionnaire respondents reported dysfunction in sexual desire, arousal, or orgasm.¹ Results also showed that 11.5% of the respondents with any of these types of female sexual dysfunction (FSD) were distressed about it. For clinicians, knowing who these women are is key in recognizing and treating FSD.

Important to the opening case, in PRESIDE, Shifren and colleagues found that women in their midlife years (aged 45 to 64) had the highest rate of any distressing sexual problem: 14.8%. Younger women (aged 18 to 44 years) had a rate of 10.8%; older women (aged 65 years or older) had a rate of 8.9%.¹

The most prevalent FSD was hypoactive sexual desire disorder,¹ which in 2013 was renamed sexual interest and arousal disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.² As with any distressing FSD, reports of being distressed about low sexual desire were highest for midlife women (12.3%) relative to younger (8.9%) and older (7.4%) women.¹

Unfortunately, decreased desire can have a ripple effect that goes well beyond a patient’s sexual health. A less-than-satisfying sex life can have a significant negative impact on self-image, possibly leading to depression or overall mood instability, which in turn can put undue strain on personal relationships.^1,3 A patient’s entire quality of life can be affected negatively.

With so much at stake, it is important for physicians to take a more active role in addressing the sexual health of their patients. Emphasizing wellness can help reduce the stigma of sexual dysfunction, break the silence, and open up patient–physician communication.⁴ There is also much to be gained by helping patients realize that having positive and respectful relationships is protective for health, including sexual health.⁴ Likewise, patients benefit from acknowledging that sexual health is an element of overall health and contributes to it.⁴

Toward these ends, more discussion with patients is needed. According to a 2008 national study, although 63% of US ObGyns surveyed indicated that they routinely asked their patients about sexual activity, only 40% asked about sexual problems, and only 29% asked patients if their sex lives were satisfying.⁵

Without communication, information is missed, and clinicians easily can overlook their patients’ sexual dysfunction and need for intervention. For midlife women, who are disproportionately affected by dysfunction relative to younger and older women, and for whom the rate of menopausal symptoms increases over the transition years, the results of going undiagnosed and untreated can be especially troubling. As reported in one study, for example, the rate of bothersome vulvovaginal atrophy, which can be a source of sexual dysfunction, increased from less than 5% at premenopause to almost 50% at 3 years postmenopause.⁶ What is standing in our way, however, and how can we overcome the hurdles to an open-door approach and meaningful conversation?

Obstacles to taking a sexual historyInitiating a sexual history can be like opening Pandora’s box. How do clinicians deal with the problems that come out? Some clinicians worry about embarrassing a patient with the first few questions about sexual health. Male gynecologists may feel awkward asking a patient about sex—particularly an older, midlife patient. The problem with not starting the conversation is that the midlife patient is often the one in the most distress, and the one most in need of treatment. Only by having the sexual health discussion can clinicians identify any issues and begin to address them.

Icebreakers to jump-start the conversation
Asking open-ended questions works best. Here are some options for starting a conversation with a midlife patient:

Such tools as checklists are often needed to bridge the wide communication gap between patients and physicians. Of the 255 women who reported experiencing dyspareunia in the Revealing Vaginal Effects at Midlife (REVEAL) study, almost half (44%) indicated that they had not spoken with their health care clinician about it.⁷ Another 44% had spoken about the problem but on their own initiative. In only 10% of cases had a physician started the conversation.

Clinicians can and should do better. Many of us have known our patients for years—given them their annual examinations, delivered their babies, performed their surgeries, become familiar with their bodies and intimate medical histories. We are uniquely qualified to start conversations on sexual health. A clinician who examines tissues and sees a decrease in vaginal caliber and pallor must say something. In some cases, the vagina is dry, but the patient has not been having lubrication problems. In other cases, a more serious condition might be involved. The important thing is to open up a conversation and talk about treatments.

CASE Continued
As today’s office visit wraps up and your patient begins moving for the door, you say, “Your hot flashes aren’t bothering you, but some women start experiencing certain sexual problems around this time in life. Have you noticed any issues?”

“Well, I have been having more burning during intercourse,” your patient responds.

On hearing this, you say, “That’s very important, Mrs. X, and I am glad you told me about it. I would like to discuss your concern a bit more, so let’s make another appointment to do just that.”

At the next visit, as part of the discussion, you give your patient a 15-minute sexual status examination.

Sexual status examination
Performing this examination helps clinicians see patterns in both sexual behavior and sexual health, which in turn can make it easier to recognize any dysfunction that might subsequently develop. The key to this process is establishing trust with the patient and having her feel comfortable with the discussion.

The patient remains fully clothed during this 15-minute session, which takes place with guarantees of nonjudgmental listening, confidentiality, privacy, and no interruptions. With the topic of sex being so personal, it should be emphasized that she is simply giving the clinician information, as she does on other health-related matters.

Establish her sexual status. Begin by asking the patient to describe her most recent or typical sexual encounter, including details such as day, time, location, type of activity, thoughts and feelings, and responses.

Potential issues can become apparent immediately. A patient may not have had a sexual encounter recently, or ever. Another may want sex, or more sex, but sees obstacles or lack of opportunity. Each of these is an issue to be explored, if the patient allows.

A patient can be sexually active in a number of ways, as the definition varies among population groups (race and age) and individuals. Sex is not only intercourse or oral sex—it is also kissing, touching, and hugging. Some people have an expansive view of what it is to be sexually active. When the patient mentions an encounter, ask what day, what time, where (at home, in a hotel room, at the office), and what type of activity (foreplay, oral sex, manual stimulation, intercourse, and position). Following up, ask what the patient was thinking or feeling about the encounter. For example, were there distracting thoughts or feelings of guilt? How did the patient and her partner respond during the encounter?

Assess for sexual dysfunction. After assessing the patient’s sexual status, turn to dysfunction. Arousal, pain, orgasm, and satisfaction are 4 areas of interest. Did the patient have difficulty becoming aroused? Was there a problem with lubrication? Did she have an orgasm? Was sex painful? How did she feel in terms of overall satisfaction?

In general, patients are comfortable speaking about sexual function and health. Having this talk can help identify a pattern, which can be discussed further during another visit. Such a follow-up would not take long—a level 3 visit should suffice.

Differential diagnosis. Consider the effects of current medications.^8,9 The psychiatric illnesses and general health factors that may affect sexual function should be considered as well (FIGURE 2).^10–22

When is it important to refer?
There are many reasons to refer a patient to another physician, including:

• a recommended treatment is not working
• abuse is suspected
• the patient shows symptoms of depression, anxiety, or another psychiatric condition
• a chronic, generalized (vs situational) disorder may be involved
• physical pain issues must be addressed
• you simply do not feel comfortable with a particular problem or patient.

Given the range of potential issues associated with sexual function, it is important to be able to provide the patient with expert assistance from a multidisciplinary team of specialists. This team can include psychologists, psychiatrists, counselors, sex educators, and, for pain issues, pelvic floor specialists and pelvic floor physical therapists. These colleagues are thoroughly familiar with the kinds of issues that can arise, and can offer alternative and adjunctive therapies.

Referrals also can be made for the latest nonpharmacologic and FDA-approved pharmacologic treatment options. Specialists tend to be familiar with these options, some of which are available only recently.

It is important to ask patients about sexual function and, if necessary, give them access to the best treatment options.

CASE Resolved
During the sexual status examination, your patient describes her most recent sexual encounter with her husband. She is frustrated with her lack of sexual response and describes a dry, tearing sensation during intercourse. You recommend first-line treatment with vaginal lubricants, preferably iso-osmolar aqueous− or silicone/dimethicone−based lubricants during intercourse. You also can discuss topical estrogen therapy via estradiol cream, conjugated equine estrogen cream, estradiol tablets in the vagina, or the estrogen ring. She is reassured that topical estrogen use will not pose significant risk for cancer, stroke, heart disease, or blood clot and that progesterone treatment is not necessary.

For patients who are particularly concerned about vaginal estrogen use, 2 or 3 times weekly use of a vaginal moisturizer could be an alternative for genitourinary symptoms and dyspareunia.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Patient may benefit from treatment for dyspareuniaA 54-year-old woman has been in your care for more than 15 years. Three years ago, at her well-woman examination, she was not yet having symptoms of menopause. Now, during her current examination, she reports hot flashes, which she says are not bothersome. In passing, she also says, “I don’t want to take hormone therapy,” but then is not overly conversational or responsive to your questions. She does mention having had 3 urinary tract infections over the past 8 months. On physical examination, you note mildly atrophied vaginal tissue.

Your patient does not bring up any sexual concerns, and so far you have not directly asked about sexual health. However, the time remaining in this visit is limited, and your patient, whose daughter is sitting in the waiting area, seems anxious to finish and leave. Still, you want to broach the subject of your patient’s sexual health. What are your best options?

We learned a lot about women’s perceptions regarding their sexual health in the 2008 Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking study (PRESIDE). Approximately 43% of 31,581 questionnaire respondents reported dysfunction in sexual desire, arousal, or orgasm.¹ Results also showed that 11.5% of the respondents with any of these types of female sexual dysfunction (FSD) were distressed about it. For clinicians, knowing who these women are is key in recognizing and treating FSD.

Important to the opening case, in PRESIDE, Shifren and colleagues found that women in their midlife years (aged 45 to 64) had the highest rate of any distressing sexual problem: 14.8%. Younger women (aged 18 to 44 years) had a rate of 10.8%; older women (aged 65 years or older) had a rate of 8.9%.¹

The most prevalent FSD was hypoactive sexual desire disorder,¹ which in 2013 was renamed sexual interest and arousal disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.² As with any distressing FSD, reports of being distressed about low sexual desire were highest for midlife women (12.3%) relative to younger (8.9%) and older (7.4%) women.¹

Unfortunately, decreased desire can have a ripple effect that goes well beyond a patient’s sexual health. A less-than-satisfying sex life can have a significant negative impact on self-image, possibly leading to depression or overall mood instability, which in turn can put undue strain on personal relationships.^1,3 A patient’s entire quality of life can be affected negatively.

With so much at stake, it is important for physicians to take a more active role in addressing the sexual health of their patients. Emphasizing wellness can help reduce the stigma of sexual dysfunction, break the silence, and open up patient–physician communication.⁴ There is also much to be gained by helping patients realize that having positive and respectful relationships is protective for health, including sexual health.⁴ Likewise, patients benefit from acknowledging that sexual health is an element of overall health and contributes to it.⁴

Toward these ends, more discussion with patients is needed. According to a 2008 national study, although 63% of US ObGyns surveyed indicated that they routinely asked their patients about sexual activity, only 40% asked about sexual problems, and only 29% asked patients if their sex lives were satisfying.⁵

Without communication, information is missed, and clinicians easily can overlook their patients’ sexual dysfunction and need for intervention. For midlife women, who are disproportionately affected by dysfunction relative to younger and older women, and for whom the rate of menopausal symptoms increases over the transition years, the results of going undiagnosed and untreated can be especially troubling. As reported in one study, for example, the rate of bothersome vulvovaginal atrophy, which can be a source of sexual dysfunction, increased from less than 5% at premenopause to almost 50% at 3 years postmenopause.⁶ What is standing in our way, however, and how can we overcome the hurdles to an open-door approach and meaningful conversation?

Obstacles to taking a sexual historyInitiating a sexual history can be like opening Pandora’s box. How do clinicians deal with the problems that come out? Some clinicians worry about embarrassing a patient with the first few questions about sexual health. Male gynecologists may feel awkward asking a patient about sex—particularly an older, midlife patient. The problem with not starting the conversation is that the midlife patient is often the one in the most distress, and the one most in need of treatment. Only by having the sexual health discussion can clinicians identify any issues and begin to address them.

Icebreakers to jump-start the conversation
Asking open-ended questions works best. Here are some options for starting a conversation with a midlife patient:

Such tools as checklists are often needed to bridge the wide communication gap between patients and physicians. Of the 255 women who reported experiencing dyspareunia in the Revealing Vaginal Effects at Midlife (REVEAL) study, almost half (44%) indicated that they had not spoken with their health care clinician about it.⁷ Another 44% had spoken about the problem but on their own initiative. In only 10% of cases had a physician started the conversation.

Clinicians can and should do better. Many of us have known our patients for years—given them their annual examinations, delivered their babies, performed their surgeries, become familiar with their bodies and intimate medical histories. We are uniquely qualified to start conversations on sexual health. A clinician who examines tissues and sees a decrease in vaginal caliber and pallor must say something. In some cases, the vagina is dry, but the patient has not been having lubrication problems. In other cases, a more serious condition might be involved. The important thing is to open up a conversation and talk about treatments.

CASE Continued
As today’s office visit wraps up and your patient begins moving for the door, you say, “Your hot flashes aren’t bothering you, but some women start experiencing certain sexual problems around this time in life. Have you noticed any issues?”

“Well, I have been having more burning during intercourse,” your patient responds.

On hearing this, you say, “That’s very important, Mrs. X, and I am glad you told me about it. I would like to discuss your concern a bit more, so let’s make another appointment to do just that.”

At the next visit, as part of the discussion, you give your patient a 15-minute sexual status examination.

Sexual status examination
Performing this examination helps clinicians see patterns in both sexual behavior and sexual health, which in turn can make it easier to recognize any dysfunction that might subsequently develop. The key to this process is establishing trust with the patient and having her feel comfortable with the discussion.

The patient remains fully clothed during this 15-minute session, which takes place with guarantees of nonjudgmental listening, confidentiality, privacy, and no interruptions. With the topic of sex being so personal, it should be emphasized that she is simply giving the clinician information, as she does on other health-related matters.

Establish her sexual status. Begin by asking the patient to describe her most recent or typical sexual encounter, including details such as day, time, location, type of activity, thoughts and feelings, and responses.

Potential issues can become apparent immediately. A patient may not have had a sexual encounter recently, or ever. Another may want sex, or more sex, but sees obstacles or lack of opportunity. Each of these is an issue to be explored, if the patient allows.

A patient can be sexually active in a number of ways, as the definition varies among population groups (race and age) and individuals. Sex is not only intercourse or oral sex—it is also kissing, touching, and hugging. Some people have an expansive view of what it is to be sexually active. When the patient mentions an encounter, ask what day, what time, where (at home, in a hotel room, at the office), and what type of activity (foreplay, oral sex, manual stimulation, intercourse, and position). Following up, ask what the patient was thinking or feeling about the encounter. For example, were there distracting thoughts or feelings of guilt? How did the patient and her partner respond during the encounter?

Assess for sexual dysfunction. After assessing the patient’s sexual status, turn to dysfunction. Arousal, pain, orgasm, and satisfaction are 4 areas of interest. Did the patient have difficulty becoming aroused? Was there a problem with lubrication? Did she have an orgasm? Was sex painful? How did she feel in terms of overall satisfaction?

In general, patients are comfortable speaking about sexual function and health. Having this talk can help identify a pattern, which can be discussed further during another visit. Such a follow-up would not take long—a level 3 visit should suffice.

Differential diagnosis. Consider the effects of current medications.^8,9 The psychiatric illnesses and general health factors that may affect sexual function should be considered as well (FIGURE 2).^10–22

When is it important to refer?
There are many reasons to refer a patient to another physician, including:

• a recommended treatment is not working
• abuse is suspected
• the patient shows symptoms of depression, anxiety, or another psychiatric condition
• a chronic, generalized (vs situational) disorder may be involved
• physical pain issues must be addressed
• you simply do not feel comfortable with a particular problem or patient.

Given the range of potential issues associated with sexual function, it is important to be able to provide the patient with expert assistance from a multidisciplinary team of specialists. This team can include psychologists, psychiatrists, counselors, sex educators, and, for pain issues, pelvic floor specialists and pelvic floor physical therapists. These colleagues are thoroughly familiar with the kinds of issues that can arise, and can offer alternative and adjunctive therapies.

Referrals also can be made for the latest nonpharmacologic and FDA-approved pharmacologic treatment options. Specialists tend to be familiar with these options, some of which are available only recently.

It is important to ask patients about sexual function and, if necessary, give them access to the best treatment options.

CASE Resolved
During the sexual status examination, your patient describes her most recent sexual encounter with her husband. She is frustrated with her lack of sexual response and describes a dry, tearing sensation during intercourse. You recommend first-line treatment with vaginal lubricants, preferably iso-osmolar aqueous− or silicone/dimethicone−based lubricants during intercourse. You also can discuss topical estrogen therapy via estradiol cream, conjugated equine estrogen cream, estradiol tablets in the vagina, or the estrogen ring. She is reassured that topical estrogen use will not pose significant risk for cancer, stroke, heart disease, or blood clot and that progesterone treatment is not necessary.

For patients who are particularly concerned about vaginal estrogen use, 2 or 3 times weekly use of a vaginal moisturizer could be an alternative for genitourinary symptoms and dyspareunia.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

I am pleased to introduce this month’s video, from the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Penn State. Dr. Michelle Pacis addresses an increasingly important topic to MIGS surgeons: removal of previously hysteroscopically placed tubal occlusion devices. These devices offer a permanent alterative to laparoscopic sterilization. If women require their removal, however, whether desired or because of complications, gynecologic surgeons must be familiar with the steps involved.

The following video was produced in order to demonstrate a reproducible technique for laparoscopic removal of a device for women requesting this procedure. Key objectives of the video include:

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]

I am pleased to introduce this month’s video, from the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Penn State. Dr. Michelle Pacis addresses an increasingly important topic to MIGS surgeons: removal of previously hysteroscopically placed tubal occlusion devices. These devices offer a permanent alterative to laparoscopic sterilization. If women require their removal, however, whether desired or because of complications, gynecologic surgeons must be familiar with the steps involved.

The following video was produced in order to demonstrate a reproducible technique for laparoscopic removal of a device for women requesting this procedure. Key objectives of the video include:

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]

I am pleased to introduce this month’s video, from the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Penn State. Dr. Michelle Pacis addresses an increasingly important topic to MIGS surgeons: removal of previously hysteroscopically placed tubal occlusion devices. These devices offer a permanent alterative to laparoscopic sterilization. If women require their removal, however, whether desired or because of complications, gynecologic surgeons must be familiar with the steps involved.

The following video was produced in order to demonstrate a reproducible technique for laparoscopic removal of a device for women requesting this procedure. Key objectives of the video include:

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to [email protected]

The clerical work involved in managing the electronic health record (EHR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.

However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?

A recent study published by Misra-Hebert and colleagues reported on this issue.¹ It provides some insight—and reason for optimism, especially because the study authors found that outpatient notes from trained staff stack up quite well when compared to those of physicians. Having worked myself with this approach to documentation, I can attest to its benefits, as well.

Team documented notes compare well
There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EHR—including documentation.

Misra-Hebert and colleagues studied the second approach in a retrospective chart review of ambulatory progress notes written before and after 8 practice sites transitioned to using medical assistants as scribes. Comparing notes relating to diabetes encounters and same-day appointments, the study authors found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians. For diabetes encounters, scribed notes were rated higher in overall quality, as well as more up to date, thorough, useful, and comprehensible, than unscribed notes.¹

In my experience
This change in the way we approach EHRs involves commitment, as I have seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that has been our experience.)

How has the physician’s role changed? Prior to team-based care, I would try to enter information into the EHR in the room while seeing the patient. After the visit, I would go to the computer at my station and use voice recognition software to add information. Now, the CMA/LPN does the initial documentation and other EHR work, while I am able to focus on the patient without the distraction of the computer. When I leave the room, the CMA/LPN stays with the patient, arranging necessary tests or consults, scheduling future labs and appointments, and reviewing the chart, all before seeing the next patient.

We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone. And since the problems with burnout and all of the other reasons for making this transformation to team-based care applies to all office-based specialties, we plan to have our entire system adopt this model.

An ObGyn group was the first specialty group to pilot this model in our system. In fact, the American College of Obstetricians and Gynecologists’ interprofessional Task Force of Collaborative Practice published in March 2016 a strong recommendation that all practices across all specialties adopt team-based care.² Among the aims of this care are that it should “respond to emerging demands and reduce undue burdens on health care providers.”

In order for this transformation to teambased care to be successful and sustainable at Bellin Health, we realized that we had to achieve 3 wins:

A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since the physicians no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.

A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.

A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs, thanks to the additional team support.

Team documentation can help bring the joy back
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.” That is something that patients, and doctors alike, can feel good about.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice. 

The clerical work involved in managing the electronic health record (EHR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.

However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?

A recent study published by Misra-Hebert and colleagues reported on this issue.¹ It provides some insight—and reason for optimism, especially because the study authors found that outpatient notes from trained staff stack up quite well when compared to those of physicians. Having worked myself with this approach to documentation, I can attest to its benefits, as well.

Team documented notes compare well
There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EHR—including documentation.

Misra-Hebert and colleagues studied the second approach in a retrospective chart review of ambulatory progress notes written before and after 8 practice sites transitioned to using medical assistants as scribes. Comparing notes relating to diabetes encounters and same-day appointments, the study authors found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians. For diabetes encounters, scribed notes were rated higher in overall quality, as well as more up to date, thorough, useful, and comprehensible, than unscribed notes.¹

In my experience
This change in the way we approach EHRs involves commitment, as I have seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that has been our experience.)

How has the physician’s role changed? Prior to team-based care, I would try to enter information into the EHR in the room while seeing the patient. After the visit, I would go to the computer at my station and use voice recognition software to add information. Now, the CMA/LPN does the initial documentation and other EHR work, while I am able to focus on the patient without the distraction of the computer. When I leave the room, the CMA/LPN stays with the patient, arranging necessary tests or consults, scheduling future labs and appointments, and reviewing the chart, all before seeing the next patient.

We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone. And since the problems with burnout and all of the other reasons for making this transformation to team-based care applies to all office-based specialties, we plan to have our entire system adopt this model.

An ObGyn group was the first specialty group to pilot this model in our system. In fact, the American College of Obstetricians and Gynecologists’ interprofessional Task Force of Collaborative Practice published in March 2016 a strong recommendation that all practices across all specialties adopt team-based care.² Among the aims of this care are that it should “respond to emerging demands and reduce undue burdens on health care providers.”

In order for this transformation to teambased care to be successful and sustainable at Bellin Health, we realized that we had to achieve 3 wins:

A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since the physicians no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.

A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.

A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs, thanks to the additional team support.

Team documentation can help bring the joy back
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.” That is something that patients, and doctors alike, can feel good about.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice. 

The clerical work involved in managing the electronic health record (EHR) is clearly not at the top of the skill set for physicians, yet many office-based clinicians find themselves bogged down in this work with no easy way out.

However, practices that are adopting team-based care—where each team member works at the top of his or her skill set—are finding a solution in the form of scribing or team documentation. This approach can ease that burden and perhaps even help to curb physician burnout in the process. But many questions still surround this approach, notably: What do we know about the quality of this documentation?

A recent study published by Misra-Hebert and colleagues reported on this issue.¹ It provides some insight—and reason for optimism, especially because the study authors found that outpatient notes from trained staff stack up quite well when compared to those of physicians. Having worked myself with this approach to documentation, I can attest to its benefits, as well.

Team documented notes compare well
There are 2 different ways that physicians can get help with documentation. One involves the use of trained scribes, who come from a variety of backgrounds and are charged with writing down, or scribing, what the physician says. The other involves training staff, usually certified medical assistants (CMAs) or licensed practical nurses (LPNs), to take on a wide variety of additional duties including refill management, care gap closure, and most of the duties concerning the EHR—including documentation.

Misra-Hebert and colleagues studied the second approach in a retrospective chart review of ambulatory progress notes written before and after 8 practice sites transitioned to using medical assistants as scribes. Comparing notes relating to diabetes encounters and same-day appointments, the study authors found important evidence that using staff in this way does not adversely affect—and may even enhance—documentation previously done entirely by physicians. For diabetes encounters, scribed notes were rated higher in overall quality, as well as more up to date, thorough, useful, and comprehensible, than unscribed notes.¹

In my experience
This change in the way we approach EHRs involves commitment, as I have seen first hand. There needs to be significant training to make this work and there needs to be more staff, since physicians require 2 of these valuable team members to function effectively. (At least that has been our experience.)

How has the physician’s role changed? Prior to team-based care, I would try to enter information into the EHR in the room while seeing the patient. After the visit, I would go to the computer at my station and use voice recognition software to add information. Now, the CMA/LPN does the initial documentation and other EHR work, while I am able to focus on the patient without the distraction of the computer. When I leave the room, the CMA/LPN stays with the patient, arranging necessary tests or consults, scheduling future labs and appointments, and reviewing the chart, all before seeing the next patient.

We are in the process of implementing team-based care throughout our 32-location health care system and have found that using CMAs and LPNs to assist with documentation is a “win” for everyone. And since the problems with burnout and all of the other reasons for making this transformation to team-based care applies to all office-based specialties, we plan to have our entire system adopt this model.

An ObGyn group was the first specialty group to pilot this model in our system. In fact, the American College of Obstetricians and Gynecologists’ interprofessional Task Force of Collaborative Practice published in March 2016 a strong recommendation that all practices across all specialties adopt team-based care.² Among the aims of this care are that it should “respond to emerging demands and reduce undue burdens on health care providers.”

In order for this transformation to teambased care to be successful and sustainable at Bellin Health, we realized that we had to achieve 3 wins:

A win for the patient. Patients immediately notice that their physicians are now able to focus on them during the office visit, since the physicians no longer have to tend to the demands of the computer. In addition, since the CMAs/LPNs are with patients during the entire visit, the patients bond with them and feel the extra support from this relationship.

A win for the care team. Physician satisfaction has never been higher. Charts are usually closed at the end of each half-day. There is no need to take work home at night. CMAs/LPNs feel empowered and meaningfully involved in patient care. Their increase in satisfaction mirrors that of the physicians.

A win for the system. Not only are quality measures improving, but access improves since this team support increases efficiency. We are able to see more patients per day and are billing at a higher level of service, since there is more time to attend to more of the patient’s needs, thanks to the additional team support.

Team documentation can help bring the joy back
There is much talk about putting joy back into the practice of medicine. But the benchmark of any change needs to be whether it helps our patients. I believe that team documentation does. Happier, less burned-out physicians are able to better focus on patients during their visit. As one patient recently said to me at the end of a visit, “I feel like I’ve got my doctor back.” That is something that patients, and doctors alike, can feel good about.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice. 

Public speaking is one of the best ways to market and promote your skills as a physician. It is an ethical way of communicating and showcasing your areas of interest and expertise to professional or lay audiences. Most physicians and health care professionals take pride in their ability to communicate. After all, that is how we take a history, discuss our findings with patients, and educate individuals on restoring or maintaining their health. Public speaking, though, for the most part is a learned skill. Except for presentations to faculty at bedside or at grand rounds, we have received little training in public speaking.

Few of us are naturally comfortable in front of a live audience or a TV or video camera. But with a little practice and diligent preparation, we can become good or even excellent, confident public speakers. This article—the first in a series of 3—provides you with preparatory tips and techniques to enhance your public speaking skills.

First, know your audience
Whether you are presenting to a group of 20 or 200, you can do certain things in advance to ensure that your presentation achieves the desired response. Most important: Know your audience. Don’t assume the audience is like you. To connect with them, you need to understand why your topic is important to them. What do they expect to learn from the presentation? Each attendee will be asking, “What’s in it for me?”

To keep listeners interested and engaged, you also must know their level of knowledge about the topic. If you are speaking to a group of residents about pelvic organ prolapse, you would use different language and content than if you were speaking to practicing primary care doctors; and these elements would be different again if you were speaking to a group of practicing urogynecologists. It’s insulting to recite basic information to highly knowledgeable physicians, or to present sophisticated technical content and complicated slides to novice physicians or lay people.

When presenting in a foreign country, learn how the culture of the audience differs from yours. How do they dress? What style of humor do they favor? How do they typically communicate? What gestures are appropriate or inappropriate? Are there religious influences to consider?

Practical steps. Before the meeting or event, speak to the organizer or meeting planner and find out the audience’s level of knowledge on the topic. Ask about audience expectations as well as demographics (such as age and background). If you are speaking at an industry event, research the event’s website and familiarize yourself with the mission of the event and who are the typical attendees. If you are presenting to a corporation, learn as much as you can about it by visiting its website, reading news reports, and reviewing associated blogs.

In addition to knowing the needs of the audience, ask the meeting planner about the goals and objectives for the program to make certain you can deliver on the requests.

Know your talk stem to stern
Review your slide material thoroughly. Understand each slide in the presentation and be comfortable with its content.

Avoid reading from slides. Reciting content that viewers can read for themselves breeds boredom and makes them lose interest. Further, when you are looking at the slides, you are not making eye contact with the audience and risk losing their attention. Good speakers are so comfortable with their slides that they can discuss each one without having to look at it.

Rehearse. The best way to achieve the foregoing is to rehearse. Your audience will be able to tell if you took the slide deck directly from a CD and loaded it into a computer and are giving the talk for the first time. You’ll need to know how long the program is to last and how long you are to speak. We suggest you practice with a timer to be certain you do not exceed the allotted time. Rehearse your talk aloud several times with all the props and audiovisual equipment you plan to use. This practice will help to curb filler words such as “ah” and “um.” It is also helpful to practice slide transitions, pauses, and even your breathing.

Prepare for the unexpected, too. Dinner meetings, for instance, may not start on time due to office or hospital delays for attending physicians, possibly resulting in a need to shorten your presentation.

Ask about the meeting agenda. If a meal is to be served, will you be speaking beforehand? This is the least favorable time slot, as you are holding people hostage before they can eat. Our preference is to speak after the appetizer is served and the orders have been taken by the wait staff. This way, attendees are not starving and they have something to drink. You can assure the waiters they won’t be disturbing you, and you can ask them to avoid walking in front of the projector. Ideally, you should end your presentation before dessert arrives and use the remaining time to field questions.

We suggest that you prepare a handout to be distributed at the end of the program, not before. You want your audience focused on you and your slides as you are speaking. Tell the audience you will be providing a handout of your presentation, which will minimize note-taking during your talk.

Your speech opening
The first and last 30 seconds of any speech probably have the most impact.¹ Give extra thought, time, and effort to your opening and closing remarks. Do not open with “Good evening, it is a pleasure to be here tonight.” That wastes precious seconds.

While opening a speech with a joke or funny story is the conventional wisdom, ask yourself¹:

• Is my selection appropriate to the occasion and for this audience?
• Is it in good taste?
• Does it relate to me (my service) or to the event or the group? Does it support my topic or its key points?

A humorous story or inspirational vignette that relates to your topic or audience can grab the audience’s attention. If you feel that demands more presentation skill than you possess at the outset of your public-speaking career, give the audience what you know and what they most want to hear. You know the questions that you have heard most at cocktail receptions or professional society meetings. So, put the answers to those questions in your speech.

For example. A scientist working with a major corporation was preparing a speech for a lay audience. Since most of the audience did not know what scientists do, he offered the following analogy: “Being a scientist is like doing a jigsaw puzzle in a snowstorm at night...you don’t have all the pieces...and you don’t have the picture on the front of the box to work from.” You can say more with less.¹

Your closing
The closing is an important aspect of your speech. Summarize the key elements to your presentation. If you are going to take questions, a good approach is to say, “Before my closing remarks, are there any questions?” Following the questions, finish with a takeaway message that ties into your theme.¹

Prepare an autobiographical introduction
We suggest that you write your own introduction and e-mail it to the person who will be introducing you. Let them know it is a suggestion that they are welcome to modify. We have found that most emcees or meeting planners are delighted to have the introduction and will use it just as you have written it. Also bring hard copy with you; many emcees will have forgotten to download what you sent. The figure shows an example of the introduction that one of us (NHB) uses, and you are welcome to modify it for your own use.

Ask about and confirm audiovisual support
Ask the meeting planner ahead of time if they will be providing the computer, projector, and screen. And if, for instance, they will provide a projector but not a computer, make sure the computer you will bring is compatible with their projector. Also, you will probably not require a microphone for a small group, but if you are speaking in a loud restaurant, a portable microphone-speaker system may be helpful.

Arrive early at the program venue to make sure the computers, projector, screen placement, and seating arrangement are all in order. Nothing can sidetrack a speaker (even a seasoned one) like a problem with the computer or equipment setup—for example, your flash drive requiring a USB port cannot connect to the sponsor’s computer, or your program created on a Mac does not run on the sponsor’s PC. 

Show time: Getting ready
Another benefit in arriving early, besides being able to check on the equipment, is the chance to greet the audience members as they enter. It is easier to speak to a group of friends than strangers. And if you can remember their names, you can call on them and ask their opinion or how they might manage a patient who has the condition you are discussing. You also could suggest to the meeting planner that name tags for attendees would be helpful.

Warming up. A public speaker, like an athlete, needs to warm up physically before the event. If the facility has an anteroom available, use it for the following exercises suggested by public speaking coach Patricia Fripp¹:

• Stand on one leg and shake the other (remove high heels first). When you place your raised foot back on the floor, it will feel lighter than the other one. Repeat the exercise using the other leg. Imagine your energy going down through the floor and up out of your head. While this sounds quite comical, it is not. It is a practical technique used by actors.
• Shake your hands vigorously. Hold them above your head, bending your wrists and elbows, then return your arms to your sides. This will make your hand movements more natural.
• Warm up your facial muscles by chewing in a highly exaggerated way. Do shoulder and neck rolls. Imagine you are at eye level with a clock. As you look at 12 o’clock, pull as much of your face up to the 12 as you can; move your eyes to 3 and repeat, then down to 6, and finally over to 9.

Not only do these exercises warm you up but they also relax you. The exaggerated movements help your movements to flow more naturally.¹

This is just the start
Thorough preparation is key to making a solid presentation. But other factors are important too. Your goal is for the audience to take action or to implement suggestions from your presentation. In part 2 of this series, we will share tips on elements of the presentation itself that will encourage audience engagement and message retention. We will discuss how to make your message “stick” and how to make a dynamic, effective presentation that holds your audience’s attention for your entire talk.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Public speaking is one of the best ways to market and promote your skills as a physician. It is an ethical way of communicating and showcasing your areas of interest and expertise to professional or lay audiences. Most physicians and health care professionals take pride in their ability to communicate. After all, that is how we take a history, discuss our findings with patients, and educate individuals on restoring or maintaining their health. Public speaking, though, for the most part is a learned skill. Except for presentations to faculty at bedside or at grand rounds, we have received little training in public speaking.

Few of us are naturally comfortable in front of a live audience or a TV or video camera. But with a little practice and diligent preparation, we can become good or even excellent, confident public speakers. This article—the first in a series of 3—provides you with preparatory tips and techniques to enhance your public speaking skills.

First, know your audience
Whether you are presenting to a group of 20 or 200, you can do certain things in advance to ensure that your presentation achieves the desired response. Most important: Know your audience. Don’t assume the audience is like you. To connect with them, you need to understand why your topic is important to them. What do they expect to learn from the presentation? Each attendee will be asking, “What’s in it for me?”

To keep listeners interested and engaged, you also must know their level of knowledge about the topic. If you are speaking to a group of residents about pelvic organ prolapse, you would use different language and content than if you were speaking to practicing primary care doctors; and these elements would be different again if you were speaking to a group of practicing urogynecologists. It’s insulting to recite basic information to highly knowledgeable physicians, or to present sophisticated technical content and complicated slides to novice physicians or lay people.

When presenting in a foreign country, learn how the culture of the audience differs from yours. How do they dress? What style of humor do they favor? How do they typically communicate? What gestures are appropriate or inappropriate? Are there religious influences to consider?

Practical steps. Before the meeting or event, speak to the organizer or meeting planner and find out the audience’s level of knowledge on the topic. Ask about audience expectations as well as demographics (such as age and background). If you are speaking at an industry event, research the event’s website and familiarize yourself with the mission of the event and who are the typical attendees. If you are presenting to a corporation, learn as much as you can about it by visiting its website, reading news reports, and reviewing associated blogs.

In addition to knowing the needs of the audience, ask the meeting planner about the goals and objectives for the program to make certain you can deliver on the requests.

Know your talk stem to stern
Review your slide material thoroughly. Understand each slide in the presentation and be comfortable with its content.

Avoid reading from slides. Reciting content that viewers can read for themselves breeds boredom and makes them lose interest. Further, when you are looking at the slides, you are not making eye contact with the audience and risk losing their attention. Good speakers are so comfortable with their slides that they can discuss each one without having to look at it.

Rehearse. The best way to achieve the foregoing is to rehearse. Your audience will be able to tell if you took the slide deck directly from a CD and loaded it into a computer and are giving the talk for the first time. You’ll need to know how long the program is to last and how long you are to speak. We suggest you practice with a timer to be certain you do not exceed the allotted time. Rehearse your talk aloud several times with all the props and audiovisual equipment you plan to use. This practice will help to curb filler words such as “ah” and “um.” It is also helpful to practice slide transitions, pauses, and even your breathing.

Prepare for the unexpected, too. Dinner meetings, for instance, may not start on time due to office or hospital delays for attending physicians, possibly resulting in a need to shorten your presentation.

Ask about the meeting agenda. If a meal is to be served, will you be speaking beforehand? This is the least favorable time slot, as you are holding people hostage before they can eat. Our preference is to speak after the appetizer is served and the orders have been taken by the wait staff. This way, attendees are not starving and they have something to drink. You can assure the waiters they won’t be disturbing you, and you can ask them to avoid walking in front of the projector. Ideally, you should end your presentation before dessert arrives and use the remaining time to field questions.

We suggest that you prepare a handout to be distributed at the end of the program, not before. You want your audience focused on you and your slides as you are speaking. Tell the audience you will be providing a handout of your presentation, which will minimize note-taking during your talk.

Your speech opening
The first and last 30 seconds of any speech probably have the most impact.¹ Give extra thought, time, and effort to your opening and closing remarks. Do not open with “Good evening, it is a pleasure to be here tonight.” That wastes precious seconds.

While opening a speech with a joke or funny story is the conventional wisdom, ask yourself¹:

• Is my selection appropriate to the occasion and for this audience?
• Is it in good taste?
• Does it relate to me (my service) or to the event or the group? Does it support my topic or its key points?

A humorous story or inspirational vignette that relates to your topic or audience can grab the audience’s attention. If you feel that demands more presentation skill than you possess at the outset of your public-speaking career, give the audience what you know and what they most want to hear. You know the questions that you have heard most at cocktail receptions or professional society meetings. So, put the answers to those questions in your speech.

For example. A scientist working with a major corporation was preparing a speech for a lay audience. Since most of the audience did not know what scientists do, he offered the following analogy: “Being a scientist is like doing a jigsaw puzzle in a snowstorm at night...you don’t have all the pieces...and you don’t have the picture on the front of the box to work from.” You can say more with less.¹

Your closing
The closing is an important aspect of your speech. Summarize the key elements to your presentation. If you are going to take questions, a good approach is to say, “Before my closing remarks, are there any questions?” Following the questions, finish with a takeaway message that ties into your theme.¹

Prepare an autobiographical introduction
We suggest that you write your own introduction and e-mail it to the person who will be introducing you. Let them know it is a suggestion that they are welcome to modify. We have found that most emcees or meeting planners are delighted to have the introduction and will use it just as you have written it. Also bring hard copy with you; many emcees will have forgotten to download what you sent. The figure shows an example of the introduction that one of us (NHB) uses, and you are welcome to modify it for your own use.

Ask about and confirm audiovisual support
Ask the meeting planner ahead of time if they will be providing the computer, projector, and screen. And if, for instance, they will provide a projector but not a computer, make sure the computer you will bring is compatible with their projector. Also, you will probably not require a microphone for a small group, but if you are speaking in a loud restaurant, a portable microphone-speaker system may be helpful.

Arrive early at the program venue to make sure the computers, projector, screen placement, and seating arrangement are all in order. Nothing can sidetrack a speaker (even a seasoned one) like a problem with the computer or equipment setup—for example, your flash drive requiring a USB port cannot connect to the sponsor’s computer, or your program created on a Mac does not run on the sponsor’s PC. 

Show time: Getting ready
Another benefit in arriving early, besides being able to check on the equipment, is the chance to greet the audience members as they enter. It is easier to speak to a group of friends than strangers. And if you can remember their names, you can call on them and ask their opinion or how they might manage a patient who has the condition you are discussing. You also could suggest to the meeting planner that name tags for attendees would be helpful.

Warming up. A public speaker, like an athlete, needs to warm up physically before the event. If the facility has an anteroom available, use it for the following exercises suggested by public speaking coach Patricia Fripp¹:

• Stand on one leg and shake the other (remove high heels first). When you place your raised foot back on the floor, it will feel lighter than the other one. Repeat the exercise using the other leg. Imagine your energy going down through the floor and up out of your head. While this sounds quite comical, it is not. It is a practical technique used by actors.
• Shake your hands vigorously. Hold them above your head, bending your wrists and elbows, then return your arms to your sides. This will make your hand movements more natural.
• Warm up your facial muscles by chewing in a highly exaggerated way. Do shoulder and neck rolls. Imagine you are at eye level with a clock. As you look at 12 o’clock, pull as much of your face up to the 12 as you can; move your eyes to 3 and repeat, then down to 6, and finally over to 9.

Not only do these exercises warm you up but they also relax you. The exaggerated movements help your movements to flow more naturally.¹

This is just the start
Thorough preparation is key to making a solid presentation. But other factors are important too. Your goal is for the audience to take action or to implement suggestions from your presentation. In part 2 of this series, we will share tips on elements of the presentation itself that will encourage audience engagement and message retention. We will discuss how to make your message “stick” and how to make a dynamic, effective presentation that holds your audience’s attention for your entire talk.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Public speaking is one of the best ways to market and promote your skills as a physician. It is an ethical way of communicating and showcasing your areas of interest and expertise to professional or lay audiences. Most physicians and health care professionals take pride in their ability to communicate. After all, that is how we take a history, discuss our findings with patients, and educate individuals on restoring or maintaining their health. Public speaking, though, for the most part is a learned skill. Except for presentations to faculty at bedside or at grand rounds, we have received little training in public speaking.

Few of us are naturally comfortable in front of a live audience or a TV or video camera. But with a little practice and diligent preparation, we can become good or even excellent, confident public speakers. This article—the first in a series of 3—provides you with preparatory tips and techniques to enhance your public speaking skills.

First, know your audience
Whether you are presenting to a group of 20 or 200, you can do certain things in advance to ensure that your presentation achieves the desired response. Most important: Know your audience. Don’t assume the audience is like you. To connect with them, you need to understand why your topic is important to them. What do they expect to learn from the presentation? Each attendee will be asking, “What’s in it for me?”

To keep listeners interested and engaged, you also must know their level of knowledge about the topic. If you are speaking to a group of residents about pelvic organ prolapse, you would use different language and content than if you were speaking to practicing primary care doctors; and these elements would be different again if you were speaking to a group of practicing urogynecologists. It’s insulting to recite basic information to highly knowledgeable physicians, or to present sophisticated technical content and complicated slides to novice physicians or lay people.

When presenting in a foreign country, learn how the culture of the audience differs from yours. How do they dress? What style of humor do they favor? How do they typically communicate? What gestures are appropriate or inappropriate? Are there religious influences to consider?

Practical steps. Before the meeting or event, speak to the organizer or meeting planner and find out the audience’s level of knowledge on the topic. Ask about audience expectations as well as demographics (such as age and background). If you are speaking at an industry event, research the event’s website and familiarize yourself with the mission of the event and who are the typical attendees. If you are presenting to a corporation, learn as much as you can about it by visiting its website, reading news reports, and reviewing associated blogs.

In addition to knowing the needs of the audience, ask the meeting planner about the goals and objectives for the program to make certain you can deliver on the requests.

Know your talk stem to stern
Review your slide material thoroughly. Understand each slide in the presentation and be comfortable with its content.

Avoid reading from slides. Reciting content that viewers can read for themselves breeds boredom and makes them lose interest. Further, when you are looking at the slides, you are not making eye contact with the audience and risk losing their attention. Good speakers are so comfortable with their slides that they can discuss each one without having to look at it.

Rehearse. The best way to achieve the foregoing is to rehearse. Your audience will be able to tell if you took the slide deck directly from a CD and loaded it into a computer and are giving the talk for the first time. You’ll need to know how long the program is to last and how long you are to speak. We suggest you practice with a timer to be certain you do not exceed the allotted time. Rehearse your talk aloud several times with all the props and audiovisual equipment you plan to use. This practice will help to curb filler words such as “ah” and “um.” It is also helpful to practice slide transitions, pauses, and even your breathing.

Prepare for the unexpected, too. Dinner meetings, for instance, may not start on time due to office or hospital delays for attending physicians, possibly resulting in a need to shorten your presentation.

Ask about the meeting agenda. If a meal is to be served, will you be speaking beforehand? This is the least favorable time slot, as you are holding people hostage before they can eat. Our preference is to speak after the appetizer is served and the orders have been taken by the wait staff. This way, attendees are not starving and they have something to drink. You can assure the waiters they won’t be disturbing you, and you can ask them to avoid walking in front of the projector. Ideally, you should end your presentation before dessert arrives and use the remaining time to field questions.

We suggest that you prepare a handout to be distributed at the end of the program, not before. You want your audience focused on you and your slides as you are speaking. Tell the audience you will be providing a handout of your presentation, which will minimize note-taking during your talk.

Your speech opening
The first and last 30 seconds of any speech probably have the most impact.¹ Give extra thought, time, and effort to your opening and closing remarks. Do not open with “Good evening, it is a pleasure to be here tonight.” That wastes precious seconds.

While opening a speech with a joke or funny story is the conventional wisdom, ask yourself¹:

• Is my selection appropriate to the occasion and for this audience?
• Is it in good taste?
• Does it relate to me (my service) or to the event or the group? Does it support my topic or its key points?

A humorous story or inspirational vignette that relates to your topic or audience can grab the audience’s attention. If you feel that demands more presentation skill than you possess at the outset of your public-speaking career, give the audience what you know and what they most want to hear. You know the questions that you have heard most at cocktail receptions or professional society meetings. So, put the answers to those questions in your speech.

For example. A scientist working with a major corporation was preparing a speech for a lay audience. Since most of the audience did not know what scientists do, he offered the following analogy: “Being a scientist is like doing a jigsaw puzzle in a snowstorm at night...you don’t have all the pieces...and you don’t have the picture on the front of the box to work from.” You can say more with less.¹

Your closing
The closing is an important aspect of your speech. Summarize the key elements to your presentation. If you are going to take questions, a good approach is to say, “Before my closing remarks, are there any questions?” Following the questions, finish with a takeaway message that ties into your theme.¹

Prepare an autobiographical introduction
We suggest that you write your own introduction and e-mail it to the person who will be introducing you. Let them know it is a suggestion that they are welcome to modify. We have found that most emcees or meeting planners are delighted to have the introduction and will use it just as you have written it. Also bring hard copy with you; many emcees will have forgotten to download what you sent. The figure shows an example of the introduction that one of us (NHB) uses, and you are welcome to modify it for your own use.

Ask about and confirm audiovisual support
Ask the meeting planner ahead of time if they will be providing the computer, projector, and screen. And if, for instance, they will provide a projector but not a computer, make sure the computer you will bring is compatible with their projector. Also, you will probably not require a microphone for a small group, but if you are speaking in a loud restaurant, a portable microphone-speaker system may be helpful.

Arrive early at the program venue to make sure the computers, projector, screen placement, and seating arrangement are all in order. Nothing can sidetrack a speaker (even a seasoned one) like a problem with the computer or equipment setup—for example, your flash drive requiring a USB port cannot connect to the sponsor’s computer, or your program created on a Mac does not run on the sponsor’s PC. 

Show time: Getting ready
Another benefit in arriving early, besides being able to check on the equipment, is the chance to greet the audience members as they enter. It is easier to speak to a group of friends than strangers. And if you can remember their names, you can call on them and ask their opinion or how they might manage a patient who has the condition you are discussing. You also could suggest to the meeting planner that name tags for attendees would be helpful.

Warming up. A public speaker, like an athlete, needs to warm up physically before the event. If the facility has an anteroom available, use it for the following exercises suggested by public speaking coach Patricia Fripp¹:

• Stand on one leg and shake the other (remove high heels first). When you place your raised foot back on the floor, it will feel lighter than the other one. Repeat the exercise using the other leg. Imagine your energy going down through the floor and up out of your head. While this sounds quite comical, it is not. It is a practical technique used by actors.
• Shake your hands vigorously. Hold them above your head, bending your wrists and elbows, then return your arms to your sides. This will make your hand movements more natural.
• Warm up your facial muscles by chewing in a highly exaggerated way. Do shoulder and neck rolls. Imagine you are at eye level with a clock. As you look at 12 o’clock, pull as much of your face up to the 12 as you can; move your eyes to 3 and repeat, then down to 6, and finally over to 9.

Not only do these exercises warm you up but they also relax you. The exaggerated movements help your movements to flow more naturally.¹

This is just the start
Thorough preparation is key to making a solid presentation. But other factors are important too. Your goal is for the audience to take action or to implement suggestions from your presentation. In part 2 of this series, we will share tips on elements of the presentation itself that will encourage audience engagement and message retention. We will discuss how to make your message “stick” and how to make a dynamic, effective presentation that holds your audience’s attention for your entire talk.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The efficacy of an investigational malaria vaccine waned from 36% to 2.5% over a period of 7 years in Kenya, at which time it was even associated with an excess of cases in areas of high malaria transmission.

The overall vaccine efficacy during the entire follow-up period was 4.4%, Ally Olotu, PhD, and colleagues wrote in the June 29 issue of the New England Journal of Medicine (2016;374:2519-29. doi: 10.1056/NEJMoa1515257). But after 7 years, in areas of high malaria risk, the vaccine was associated with 141 excess cases per 1,000 vaccinated children.

©jarun011/Thinkstock

“We found that RTS,S/AS01 provided protective efficacy in the first year after vaccination but that the efficacy subsequently waned,” wrote Dr. Olotu of the Kenya Medical Research Institute in Africa and associates. “Efficacy was close to zero in the fourth year and may have been negative in the fifth year. This result eroded the benefits that were seen in early years.”

The rebound in cases probably occurred because the vaccine targets only a particular early-stage form of Plasmodium falciparum, they noted. “[It] protects against malaria sporozoites but does not induce clinical immunity against blood-stage parasites. We and others have previously found lower levels of antibodies against blood-stage parasites in children who have been immunized with the RTS,S/AS01 vaccine than in those given the control vaccine. The reduced exposure to blood-stage parasites among persons who have received the vaccine may lead to a slower acquisition of immunity to blood-stage parasites, leading to an increase in episodes of clinical malaria in later life.”

The phase II study comprised 447 children aged 5-17 months who were randomized to three doses of RTS,S/AS01 or a control rabies vaccine, administered at baseline and at 1 and 2 months. Children were followed for 7 years. The study had a large attrition rate, with 312 children completing all the follow-up visits.

In an intent-to-treat analysis, 150 incident cases of malaria developed among 223 children in the active group, and 157 cases among 224 in the control group. This equated to a vaccine efficacy of 27% against a first episode of malaria.

Overall, there were 1,002 episodes of malaria in the vaccine group and 992 in the control group. When the investigators grouped the children according to the endemic potential of their environment (high- vs. low-risk exposure), they observed that efficacy was consistently better in the low-risk group than the high-risk group (16.6% vs. –2.4%)

They then examined this finding year by year. Vaccine efficacy declined from 36% in year 1 to 3.6% in year 7. At year 5, there was significant negative efficacy in the high-risk exposure cohort (–56.8%, P = .008).

Overall, the vaccine averted 317 cases of clinical malaria per 1,000 children vaccinated, but the investigators noted that this finding was nonsignificant. In the low-exposure cohort, the vaccine did better, averting 718 cases per 1,000 vaccinated children. “However, in the high-exposure cohort … there were more cumulative cases among participants in the RTS,S/AS01 group than among those in the control group … which more than offset the cases that were averted in earlier years,” leading to an excess of 141 cases per 1,000 vaccinated children over baseline levels.

The rate of serious adverse events was similar between the vaccine and control groups (17.9% vs. 25.4%). No cases of meningitis occurred.

The investigators said a larger, phase III trial is being conducted in several areas with varying levels of transmission, and with different dosing schedules. “It will be essential to monitor efficacy in longer-term follow-up for year 5 and beyond to accurately measure the benefit and potential risk of vaccination with the RTS,S/AS01 vaccine,” they wrote.

The study was funded by grants from the PATH Malaria Vaccine Initiative, GlaxoSmithKline Biologicals, the Bill and Melinda Gates Foundation, and the Wellcome Trust. Two of the investigators, Amanda Leach and Marc Lievens, reported receiving personal fees and other support from GlaxoSmithKline Vaccines.

[email protected]

On Twitter @Alz_Gal

The efficacy of an investigational malaria vaccine waned from 36% to 2.5% over a period of 7 years in Kenya, at which time it was even associated with an excess of cases in areas of high malaria transmission.

The overall vaccine efficacy during the entire follow-up period was 4.4%, Ally Olotu, PhD, and colleagues wrote in the June 29 issue of the New England Journal of Medicine (2016;374:2519-29. doi: 10.1056/NEJMoa1515257). But after 7 years, in areas of high malaria risk, the vaccine was associated with 141 excess cases per 1,000 vaccinated children.

©jarun011/Thinkstock

“We found that RTS,S/AS01 provided protective efficacy in the first year after vaccination but that the efficacy subsequently waned,” wrote Dr. Olotu of the Kenya Medical Research Institute in Africa and associates. “Efficacy was close to zero in the fourth year and may have been negative in the fifth year. This result eroded the benefits that were seen in early years.”

The rebound in cases probably occurred because the vaccine targets only a particular early-stage form of Plasmodium falciparum, they noted. “[It] protects against malaria sporozoites but does not induce clinical immunity against blood-stage parasites. We and others have previously found lower levels of antibodies against blood-stage parasites in children who have been immunized with the RTS,S/AS01 vaccine than in those given the control vaccine. The reduced exposure to blood-stage parasites among persons who have received the vaccine may lead to a slower acquisition of immunity to blood-stage parasites, leading to an increase in episodes of clinical malaria in later life.”

The phase II study comprised 447 children aged 5-17 months who were randomized to three doses of RTS,S/AS01 or a control rabies vaccine, administered at baseline and at 1 and 2 months. Children were followed for 7 years. The study had a large attrition rate, with 312 children completing all the follow-up visits.

In an intent-to-treat analysis, 150 incident cases of malaria developed among 223 children in the active group, and 157 cases among 224 in the control group. This equated to a vaccine efficacy of 27% against a first episode of malaria.

Overall, there were 1,002 episodes of malaria in the vaccine group and 992 in the control group. When the investigators grouped the children according to the endemic potential of their environment (high- vs. low-risk exposure), they observed that efficacy was consistently better in the low-risk group than the high-risk group (16.6% vs. –2.4%)

They then examined this finding year by year. Vaccine efficacy declined from 36% in year 1 to 3.6% in year 7. At year 5, there was significant negative efficacy in the high-risk exposure cohort (–56.8%, P = .008).

Overall, the vaccine averted 317 cases of clinical malaria per 1,000 children vaccinated, but the investigators noted that this finding was nonsignificant. In the low-exposure cohort, the vaccine did better, averting 718 cases per 1,000 vaccinated children. “However, in the high-exposure cohort … there were more cumulative cases among participants in the RTS,S/AS01 group than among those in the control group … which more than offset the cases that were averted in earlier years,” leading to an excess of 141 cases per 1,000 vaccinated children over baseline levels.

The rate of serious adverse events was similar between the vaccine and control groups (17.9% vs. 25.4%). No cases of meningitis occurred.

The investigators said a larger, phase III trial is being conducted in several areas with varying levels of transmission, and with different dosing schedules. “It will be essential to monitor efficacy in longer-term follow-up for year 5 and beyond to accurately measure the benefit and potential risk of vaccination with the RTS,S/AS01 vaccine,” they wrote.

The study was funded by grants from the PATH Malaria Vaccine Initiative, GlaxoSmithKline Biologicals, the Bill and Melinda Gates Foundation, and the Wellcome Trust. Two of the investigators, Amanda Leach and Marc Lievens, reported receiving personal fees and other support from GlaxoSmithKline Vaccines.

[email protected]

On Twitter @Alz_Gal

The efficacy of an investigational malaria vaccine waned from 36% to 2.5% over a period of 7 years in Kenya, at which time it was even associated with an excess of cases in areas of high malaria transmission.

The overall vaccine efficacy during the entire follow-up period was 4.4%, Ally Olotu, PhD, and colleagues wrote in the June 29 issue of the New England Journal of Medicine (2016;374:2519-29. doi: 10.1056/NEJMoa1515257). But after 7 years, in areas of high malaria risk, the vaccine was associated with 141 excess cases per 1,000 vaccinated children.

©jarun011/Thinkstock

“We found that RTS,S/AS01 provided protective efficacy in the first year after vaccination but that the efficacy subsequently waned,” wrote Dr. Olotu of the Kenya Medical Research Institute in Africa and associates. “Efficacy was close to zero in the fourth year and may have been negative in the fifth year. This result eroded the benefits that were seen in early years.”

The rebound in cases probably occurred because the vaccine targets only a particular early-stage form of Plasmodium falciparum, they noted. “[It] protects against malaria sporozoites but does not induce clinical immunity against blood-stage parasites. We and others have previously found lower levels of antibodies against blood-stage parasites in children who have been immunized with the RTS,S/AS01 vaccine than in those given the control vaccine. The reduced exposure to blood-stage parasites among persons who have received the vaccine may lead to a slower acquisition of immunity to blood-stage parasites, leading to an increase in episodes of clinical malaria in later life.”

The phase II study comprised 447 children aged 5-17 months who were randomized to three doses of RTS,S/AS01 or a control rabies vaccine, administered at baseline and at 1 and 2 months. Children were followed for 7 years. The study had a large attrition rate, with 312 children completing all the follow-up visits.

In an intent-to-treat analysis, 150 incident cases of malaria developed among 223 children in the active group, and 157 cases among 224 in the control group. This equated to a vaccine efficacy of 27% against a first episode of malaria.

Overall, there were 1,002 episodes of malaria in the vaccine group and 992 in the control group. When the investigators grouped the children according to the endemic potential of their environment (high- vs. low-risk exposure), they observed that efficacy was consistently better in the low-risk group than the high-risk group (16.6% vs. –2.4%)

They then examined this finding year by year. Vaccine efficacy declined from 36% in year 1 to 3.6% in year 7. At year 5, there was significant negative efficacy in the high-risk exposure cohort (–56.8%, P = .008).

Overall, the vaccine averted 317 cases of clinical malaria per 1,000 children vaccinated, but the investigators noted that this finding was nonsignificant. In the low-exposure cohort, the vaccine did better, averting 718 cases per 1,000 vaccinated children. “However, in the high-exposure cohort … there were more cumulative cases among participants in the RTS,S/AS01 group than among those in the control group … which more than offset the cases that were averted in earlier years,” leading to an excess of 141 cases per 1,000 vaccinated children over baseline levels.

The rate of serious adverse events was similar between the vaccine and control groups (17.9% vs. 25.4%). No cases of meningitis occurred.

The investigators said a larger, phase III trial is being conducted in several areas with varying levels of transmission, and with different dosing schedules. “It will be essential to monitor efficacy in longer-term follow-up for year 5 and beyond to accurately measure the benefit and potential risk of vaccination with the RTS,S/AS01 vaccine,” they wrote.

The study was funded by grants from the PATH Malaria Vaccine Initiative, GlaxoSmithKline Biologicals, the Bill and Melinda Gates Foundation, and the Wellcome Trust. Two of the investigators, Amanda Leach and Marc Lievens, reported receiving personal fees and other support from GlaxoSmithKline Vaccines.

[email protected]

On Twitter @Alz_Gal

A recent report on data obtained from the Intermountain Healthcare facilities in Utah and Idaho suggests that maternal influenza vaccination, besides its maternal protective effect, also may benefit the newborn by protecting against influenza. I think that ObGyns generally accept the notion that influenza vaccination has defined maternal benefit. Notably, acceptance of influenza vaccine became much more widespread during and following the H1N1 flu pandemic of 2009. The fact that there may be neonatal and infant benefit as well is certainly not objectionable, especially since flu vaccine is not recommended for infants less than 6 months of age.

Details of the study
Shakib and colleagues’ goal was to compare influenza outcomes in infants younger than 6 months born to women who self-reported receiving or not receiving influenza vaccine during pregnancy. The study cohort included 245,386 women and 249,387 infants who were born between December 2005 and March 2014. The outcomes studied were influenza-like illness (ILI), laboratory-confirmed influenza, and influenza hospitalizations.

Of 866 infants younger than 6 months born to women who had received a flu shot, 32 had 1 or more ILI encounters, compared with 834 born to women who were not immunized (relative risk [RR], 0.36; 95% confidence interval [CI], 0.26–0.52; P<.001). Laboratory-confirmed influenza was identified in 658 infants; of these, 20 were born to women reporting immunization and 638 were born to unimmunized women (RR, 0.30; 95% CI, 0.19–0.46; P<.001). Finally, 151 infants with laboratory-confirmed influenza were hospitalized; 3 were born to immunized women and 148 to women who had not received a flu shot (RR, 0.19; 95% CI, 0.06–0.60; P = .005).

The authors calculated that infants born to women who reported influenza immunization during pregnancy had risk reductions of 64% for ILI, 70% for laboratory-confirmed influenza, and 81% for influenza hospitalizations.

Consider immunization benefits realistically
The authors state in their published report that “Protecting young infants from influenza through maternal immunization during pregnancy is a public health priority.” This may be overstating their case, for the following reasons. First, influenza vaccine has varying degrees of efficacy depending on the particular year and influenza strains that predominate, and it never has been shown to be entirely protective. Second, when looking only at this study’s laboratory-proven cases of influenza in newborns, infants whose mothers were vaccinated had a case rate of 0.84/1,000, while the case rate in newborns born to unvaccinated women was 2.83/1,000. While this shows a difference, the report provides no additional outcome data regarding morbidity or mortality.

In fact, although infant hospitalization rates differed (0.13/1,000 born to vaccinated women versus 0.66/1,000 born to unvaccinated women), there were no influenza-related mortalities in this cohort. The effect seems better when including “influenza-like illness,” but it is unclear why we should think that the influenza vaccine protects against infection that is not caused by influenza.

What this EVIDENCE means for practice
ObGyns should continue to promote influenza vaccination during pregnancy for the maternal protection it imparts. These new data on the potential for newborn protection, although not conclusive, may improve maternal acceptance of vaccination; from that perspective, these data are valuable.
— John T. Repke, MD

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A recent report on data obtained from the Intermountain Healthcare facilities in Utah and Idaho suggests that maternal influenza vaccination, besides its maternal protective effect, also may benefit the newborn by protecting against influenza. I think that ObGyns generally accept the notion that influenza vaccination has defined maternal benefit. Notably, acceptance of influenza vaccine became much more widespread during and following the H1N1 flu pandemic of 2009. The fact that there may be neonatal and infant benefit as well is certainly not objectionable, especially since flu vaccine is not recommended for infants less than 6 months of age.

Details of the study
Shakib and colleagues’ goal was to compare influenza outcomes in infants younger than 6 months born to women who self-reported receiving or not receiving influenza vaccine during pregnancy. The study cohort included 245,386 women and 249,387 infants who were born between December 2005 and March 2014. The outcomes studied were influenza-like illness (ILI), laboratory-confirmed influenza, and influenza hospitalizations.

Of 866 infants younger than 6 months born to women who had received a flu shot, 32 had 1 or more ILI encounters, compared with 834 born to women who were not immunized (relative risk [RR], 0.36; 95% confidence interval [CI], 0.26–0.52; P<.001). Laboratory-confirmed influenza was identified in 658 infants; of these, 20 were born to women reporting immunization and 638 were born to unimmunized women (RR, 0.30; 95% CI, 0.19–0.46; P<.001). Finally, 151 infants with laboratory-confirmed influenza were hospitalized; 3 were born to immunized women and 148 to women who had not received a flu shot (RR, 0.19; 95% CI, 0.06–0.60; P = .005).

The authors calculated that infants born to women who reported influenza immunization during pregnancy had risk reductions of 64% for ILI, 70% for laboratory-confirmed influenza, and 81% for influenza hospitalizations.

Consider immunization benefits realistically
The authors state in their published report that “Protecting young infants from influenza through maternal immunization during pregnancy is a public health priority.” This may be overstating their case, for the following reasons. First, influenza vaccine has varying degrees of efficacy depending on the particular year and influenza strains that predominate, and it never has been shown to be entirely protective. Second, when looking only at this study’s laboratory-proven cases of influenza in newborns, infants whose mothers were vaccinated had a case rate of 0.84/1,000, while the case rate in newborns born to unvaccinated women was 2.83/1,000. While this shows a difference, the report provides no additional outcome data regarding morbidity or mortality.

In fact, although infant hospitalization rates differed (0.13/1,000 born to vaccinated women versus 0.66/1,000 born to unvaccinated women), there were no influenza-related mortalities in this cohort. The effect seems better when including “influenza-like illness,” but it is unclear why we should think that the influenza vaccine protects against infection that is not caused by influenza.

What this EVIDENCE means for practice
ObGyns should continue to promote influenza vaccination during pregnancy for the maternal protection it imparts. These new data on the potential for newborn protection, although not conclusive, may improve maternal acceptance of vaccination; from that perspective, these data are valuable.
— John T. Repke, MD

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A recent report on data obtained from the Intermountain Healthcare facilities in Utah and Idaho suggests that maternal influenza vaccination, besides its maternal protective effect, also may benefit the newborn by protecting against influenza. I think that ObGyns generally accept the notion that influenza vaccination has defined maternal benefit. Notably, acceptance of influenza vaccine became much more widespread during and following the H1N1 flu pandemic of 2009. The fact that there may be neonatal and infant benefit as well is certainly not objectionable, especially since flu vaccine is not recommended for infants less than 6 months of age.

Details of the study
Shakib and colleagues’ goal was to compare influenza outcomes in infants younger than 6 months born to women who self-reported receiving or not receiving influenza vaccine during pregnancy. The study cohort included 245,386 women and 249,387 infants who were born between December 2005 and March 2014. The outcomes studied were influenza-like illness (ILI), laboratory-confirmed influenza, and influenza hospitalizations.

Of 866 infants younger than 6 months born to women who had received a flu shot, 32 had 1 or more ILI encounters, compared with 834 born to women who were not immunized (relative risk [RR], 0.36; 95% confidence interval [CI], 0.26–0.52; P<.001). Laboratory-confirmed influenza was identified in 658 infants; of these, 20 were born to women reporting immunization and 638 were born to unimmunized women (RR, 0.30; 95% CI, 0.19–0.46; P<.001). Finally, 151 infants with laboratory-confirmed influenza were hospitalized; 3 were born to immunized women and 148 to women who had not received a flu shot (RR, 0.19; 95% CI, 0.06–0.60; P = .005).

The authors calculated that infants born to women who reported influenza immunization during pregnancy had risk reductions of 64% for ILI, 70% for laboratory-confirmed influenza, and 81% for influenza hospitalizations.

Consider immunization benefits realistically
The authors state in their published report that “Protecting young infants from influenza through maternal immunization during pregnancy is a public health priority.” This may be overstating their case, for the following reasons. First, influenza vaccine has varying degrees of efficacy depending on the particular year and influenza strains that predominate, and it never has been shown to be entirely protective. Second, when looking only at this study’s laboratory-proven cases of influenza in newborns, infants whose mothers were vaccinated had a case rate of 0.84/1,000, while the case rate in newborns born to unvaccinated women was 2.83/1,000. While this shows a difference, the report provides no additional outcome data regarding morbidity or mortality.

In fact, although infant hospitalization rates differed (0.13/1,000 born to vaccinated women versus 0.66/1,000 born to unvaccinated women), there were no influenza-related mortalities in this cohort. The effect seems better when including “influenza-like illness,” but it is unclear why we should think that the influenza vaccine protects against infection that is not caused by influenza.

What this EVIDENCE means for practice
ObGyns should continue to promote influenza vaccination during pregnancy for the maternal protection it imparts. These new data on the potential for newborn protection, although not conclusive, may improve maternal acceptance of vaccination; from that perspective, these data are valuable.
— John T. Repke, MD

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The mean income for ObGyns rose by 10% in 2015 over 2014 ($277,000 compared with $249,000), according to a recent report from Medscape.¹ This jump follows a gradual increase over the last few years ($243,000 in 2013; $242,000 in 2012; $220,000 in 2011).¹⁻³ The report included responses from 19,183 physicians across 26 specialties, 5% (nearly 1,000) of whom were ObGyns.¹

The highest earners among all physician specialties were orthopedists ($443,000), cardiologists, and dermatologists. The lowest earners were pediatricians ($204,000), endocrinologists, and family physicians. The highest ObGyn earners lived in the Southwest ($307,000), the North Central region, and the West.¹

Merritt Hawkins & Associates, a national physician search and consulting firm, recently evaluated the annual starting salaries and year-over-year increases of 3,342 of its physician and advanced practitioner recruiting assignments. They found that ObGyns had the second greatest increase in starting salaries among specialties, at 16%. They also found obstetrics and gynecology to be among the top 5 specialties most in demand.⁴

The gender picture
As in past years, male ObGyns reported higher earnings than their female counterparts: full-time male ObGyns earned $304,000 while full-time female ObGyns earned $256,000.¹

According to a report published in the British Medical Journal in June 2016, there are drastic differences between the incomes of white and black male and female physicians in the United States.⁵ White male physicians had an adjusted median annual income of $253,042 (95% confidence interval [CI], $248,670−$257,413), compared with $188,230 ($170,844−$205,616) for black male physicians, $163,234 (95% CI, $159,912−$166,557) for white female physicians, and $152,784 (95% CI, $137,927−$167,641) for black female physicians.

How does employment status factor in? Of the self-employed, men earn $310,000 while women earn $285,000. Men who are employed report earning $293,000, with women reporting $244,000.⁵ (This includes full-time workers but does not control for the number of hours worked.) When Medscape evaluated full- versus part-time work (<40 hours per week), results indicated that, among primary care and most other specialties, more female physicians (25%) are part-timers than males (12%).⁶ However, among ObGyns, 13% of women report part-time employment versus 16% of men.¹

Time with patients. Medscape reports that, among all physicians, 41% of men spent 17 minutes or more with their patients, compared with 49% of women. For office-based ObGyns, 31% of men and 39% of women spent 17 minutes or more with patients.¹

Can disparity in leadership positions explain gender-related salary discrepancy?
In 2015, 48% of all medical students were female.⁷ In residency, the ratio of men to women is similar: For 2013−2014, the Association of American Medical Colleges (AAMC) reported that 46% of all residents were female.⁸ For ObGyn residency, however, the AMA’s FREIDA Online specialty training search (detailing 2014 general program information) indicates that, of the 5,018 active residents and fellows in ObGyn, 81.4% are female.⁹

Although the ObGyn field is becoming female-dominated, leadership within the specialty remains male dominated, points out Laura E. Baecher-Lind, MD, MPH, Director of the Division of General Obstetrics & Gynecology at Tufts Medical Center, Boston, Massachusetts. Dr. Baecher-Lind authored a study in 2012 in which she explored whether the proportions of ObGyn leadership positions held by women reflect the proportion of women who entered the field at the same time as current leaders.¹⁰ She found that very few academic department chair positions in ObGyn are held by women, although that number is gradually increasing.¹⁰ In addition, her study results indicated that women should hold 71 of the total of 194 ObGyn leadership positions. In actuality, 41 of the leadership positions were held by women (21.1%, P<.001) when based on the proportion of women entering residency programs. When considering only leaders who graduated during the years in which residency matching data were available, she found that women should hold 28 of 74 leadership positions, but they actually held 20 (27.0%, P = .05).¹⁰

Could the salary discrepancy disappear if more women held leadership positions? OBG <scaps>Management</scaps> posed this question to Dr. Baecher-Lind. “I suspect that the gender pay gap would persist,” she said. “Studies indicate that women hold implicit gender bias as strongly as men. This bias leads to devaluing women’s skills and accomplishments compared with men’s and is a strong contributor to the leadership and pay gaps in this country and in our specialty. We need to be mindful of this implicit bias and work against it with policies such as salary transparency and salary audits to encourage parity.”¹¹

What are ObGyns’ greatest practice concerns?
The Medicus Firm reported in its 2016 Physician Practice Preference and Relocation Survey that the top 3 major practice concerns for practicing physicians were compensation, work-life balance, and work-related burnout and stress.¹² They found that physicians in general were slightly more satisfied with their 2015 income than their 2014 income, but less optimistic about the future. Only 29% projected that their 2016 income would increase over their 2015 earnings.

With ObGyn salaries on the up in 2015, less than half (46%) of ObGyns reported to Medscape that they feel fairly compensated; these physicians made $62,000 more than those who believed their pay was unfair.¹ Fifty-four percent of employed male ObGyns and 64% of employed female ObGyns reported feeling fairly compensated, compared with 43% and 32%, respectively, who were self-employed.

ObGyns indicated in the 2016 Medscape report that the prime causes of stress were bureaucratic tasks and spending too many hours at work. More than half (52%) of ObGyns spend 30 to 45 hours per week seeing patients, and 40% spend more time than that.¹ According to employment status, 56% of those who are self-employed and 58% of those who are employed spend 10 hours or more per week on administrative tasks.¹

Lucia DiVenere, MA, Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists (ACOG) in Washington, DC, offers a brief look, with an in-depth focus to come in an upcoming issue, at the growing concern of burnout among physicians and how it can affect both ObGyns and their patients. She outlines ACOG’s efforts to help ObGyns maintain work-life balance in “ObGyn burnout: ACOG takes aim.”

ObGyn burnout: ACOG takes aim

Lucia DiVenere, MA

The good news: More women have access to coverage for health care than ever before--better insurance coverage for pregnancy, contraceptives, and well-woman care.

The bad news: America faces a shortage of ObGyns to provide that care, a shortage not likely to go away soon.

One of the imperatives of this dynamic is that we need to help every practicing ObGyn perform at his or her very best: your highest level of quality care, your best productivity, and your best ability to survive and thrive in an always changing and often challenging work environment.

This imperative is undermined when ObGyns are so stressed, overworked, overworried, and undersupported that you experience the very real effects of physician burnout.

Studies show that: 

 

• ObGyns experience high rates of burnout 
• rates of burnout are increasing over time
• women, the majority gender in obstetrics and gynecology, experience higher rates of burnout than their male counterparts. 

Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ Fifty-one percent of ObGyns reported experiencing burnout in 2015, with women reporting 55% compared to 46% for men.²

This insert is a quick look at this important issue, which can seriously erode an ObGyn's ability to provide high-quality care and continue enjoying practice. It can take a real toll on your personal health and well-being, too. In an upcoming issue of OBG Management, I will take a deeper dive, previewing the American College of Obstetricians and Gynecologists (ACOG) and American Medical Association resources to help you avoid burnout, plus highlighting ObGyns who provide insight and inspiration. I also will interview ACOG President Tom Gellhaus, MD, who is dedicating his presidency to providing you with opportunities to experience new and meaningful aspects of the ObGyn specialty. I will discuss ACOG's programs to help you combat burnout, as well as how you can:

 

• help underserved women around the globe through medical missions
• bring your leadership and passion for women's health to your state and national capitals
• explore your artistic side.

ObGyn burnout amounts to a public health challenge in women's health care. ACOG takes your well-being seriously, so that you can continue to ensure the well-being of women.

 

---

Lucia DiVenere, MA, is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.

Ms. DiVenere reports no financial relationships relevant to this article. .

 

---

References

 

1. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clinic Proceedings. 2015;90(12):1600-1613.
2. Peckham C. Medscape Lifestyle Report 2016: Bias and Burnout. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2016/public/overview. Published January 13, 2016. Accessed June 14, 2016.

Effects of the ACA on ObGyns
As of February 2016, 12.7 million Americans selected plans through the Health Insurance Marketplace of the Affordable Care Act (ACA).¹ Physicians often have no choice in whether or not they participate in Health Insurance Exchanges; however, in 2016, 24% of ObGyns said they plan to participate in exchanges, 25% do not, and the rest are unsure.¹

It is still unclear how the ACA affects physician income.¹ When ObGyns who participated in Health Insurance Exchanges in 2015 were asked whether their income was affected, approximately 60% reported no change, 30% reported a decrease, and 9% said it increased.¹

Medicus reported that physicians’ approval of the ACA has declined since last year. In their 2016 report, 71% of respondents gave the ACA a passing grade (A, B, C, or D), compared with 83% in 2015 and 77% in 2014. Fewer than 3% of 2016 respondents gave the ACA an “A.”¹²

Medscape reported that 36% of ObGyns have seen an increase in the number of patients due to the ACA.¹ A 2015 report from the Kaiser Family Foundation and The Commonwealth Fund assessing the experiences and attitudes of primary care providers after the first year of ACA coverage found no association with lower- and higher-quality care whether or not patient load had increased.¹³ Among those in the Medscape report who said that quality of care had worsened, 21% had a greater patient load; 18% reported no increase in patient load. Seventy-eight percent of physicians whose patient load increased said that quality had stayed the same or improved; 82% of those who experienced no increase in patient load reported that quality had stayed the same or improved.¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The mean income for ObGyns rose by 10% in 2015 over 2014 ($277,000 compared with $249,000), according to a recent report from Medscape.¹ This jump follows a gradual increase over the last few years ($243,000 in 2013; $242,000 in 2012; $220,000 in 2011).¹⁻³ The report included responses from 19,183 physicians across 26 specialties, 5% (nearly 1,000) of whom were ObGyns.¹

The highest earners among all physician specialties were orthopedists ($443,000), cardiologists, and dermatologists. The lowest earners were pediatricians ($204,000), endocrinologists, and family physicians. The highest ObGyn earners lived in the Southwest ($307,000), the North Central region, and the West.¹

Merritt Hawkins & Associates, a national physician search and consulting firm, recently evaluated the annual starting salaries and year-over-year increases of 3,342 of its physician and advanced practitioner recruiting assignments. They found that ObGyns had the second greatest increase in starting salaries among specialties, at 16%. They also found obstetrics and gynecology to be among the top 5 specialties most in demand.⁴

The gender picture
As in past years, male ObGyns reported higher earnings than their female counterparts: full-time male ObGyns earned $304,000 while full-time female ObGyns earned $256,000.¹

According to a report published in the British Medical Journal in June 2016, there are drastic differences between the incomes of white and black male and female physicians in the United States.⁵ White male physicians had an adjusted median annual income of $253,042 (95% confidence interval [CI], $248,670−$257,413), compared with $188,230 ($170,844−$205,616) for black male physicians, $163,234 (95% CI, $159,912−$166,557) for white female physicians, and $152,784 (95% CI, $137,927−$167,641) for black female physicians.

How does employment status factor in? Of the self-employed, men earn $310,000 while women earn $285,000. Men who are employed report earning $293,000, with women reporting $244,000.⁵ (This includes full-time workers but does not control for the number of hours worked.) When Medscape evaluated full- versus part-time work (<40 hours per week), results indicated that, among primary care and most other specialties, more female physicians (25%) are part-timers than males (12%).⁶ However, among ObGyns, 13% of women report part-time employment versus 16% of men.¹

Time with patients. Medscape reports that, among all physicians, 41% of men spent 17 minutes or more with their patients, compared with 49% of women. For office-based ObGyns, 31% of men and 39% of women spent 17 minutes or more with patients.¹

Can disparity in leadership positions explain gender-related salary discrepancy?
In 2015, 48% of all medical students were female.⁷ In residency, the ratio of men to women is similar: For 2013−2014, the Association of American Medical Colleges (AAMC) reported that 46% of all residents were female.⁸ For ObGyn residency, however, the AMA’s FREIDA Online specialty training search (detailing 2014 general program information) indicates that, of the 5,018 active residents and fellows in ObGyn, 81.4% are female.⁹

Although the ObGyn field is becoming female-dominated, leadership within the specialty remains male dominated, points out Laura E. Baecher-Lind, MD, MPH, Director of the Division of General Obstetrics & Gynecology at Tufts Medical Center, Boston, Massachusetts. Dr. Baecher-Lind authored a study in 2012 in which she explored whether the proportions of ObGyn leadership positions held by women reflect the proportion of women who entered the field at the same time as current leaders.¹⁰ She found that very few academic department chair positions in ObGyn are held by women, although that number is gradually increasing.¹⁰ In addition, her study results indicated that women should hold 71 of the total of 194 ObGyn leadership positions. In actuality, 41 of the leadership positions were held by women (21.1%, P<.001) when based on the proportion of women entering residency programs. When considering only leaders who graduated during the years in which residency matching data were available, she found that women should hold 28 of 74 leadership positions, but they actually held 20 (27.0%, P = .05).¹⁰

Could the salary discrepancy disappear if more women held leadership positions? OBG <scaps>Management</scaps> posed this question to Dr. Baecher-Lind. “I suspect that the gender pay gap would persist,” she said. “Studies indicate that women hold implicit gender bias as strongly as men. This bias leads to devaluing women’s skills and accomplishments compared with men’s and is a strong contributor to the leadership and pay gaps in this country and in our specialty. We need to be mindful of this implicit bias and work against it with policies such as salary transparency and salary audits to encourage parity.”¹¹

What are ObGyns’ greatest practice concerns?
The Medicus Firm reported in its 2016 Physician Practice Preference and Relocation Survey that the top 3 major practice concerns for practicing physicians were compensation, work-life balance, and work-related burnout and stress.¹² They found that physicians in general were slightly more satisfied with their 2015 income than their 2014 income, but less optimistic about the future. Only 29% projected that their 2016 income would increase over their 2015 earnings.

With ObGyn salaries on the up in 2015, less than half (46%) of ObGyns reported to Medscape that they feel fairly compensated; these physicians made $62,000 more than those who believed their pay was unfair.¹ Fifty-four percent of employed male ObGyns and 64% of employed female ObGyns reported feeling fairly compensated, compared with 43% and 32%, respectively, who were self-employed.

ObGyns indicated in the 2016 Medscape report that the prime causes of stress were bureaucratic tasks and spending too many hours at work. More than half (52%) of ObGyns spend 30 to 45 hours per week seeing patients, and 40% spend more time than that.¹ According to employment status, 56% of those who are self-employed and 58% of those who are employed spend 10 hours or more per week on administrative tasks.¹

Lucia DiVenere, MA, Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists (ACOG) in Washington, DC, offers a brief look, with an in-depth focus to come in an upcoming issue, at the growing concern of burnout among physicians and how it can affect both ObGyns and their patients. She outlines ACOG’s efforts to help ObGyns maintain work-life balance in “ObGyn burnout: ACOG takes aim.”

ObGyn burnout: ACOG takes aim

Lucia DiVenere, MA

The good news: More women have access to coverage for health care than ever before--better insurance coverage for pregnancy, contraceptives, and well-woman care.

The bad news: America faces a shortage of ObGyns to provide that care, a shortage not likely to go away soon.

One of the imperatives of this dynamic is that we need to help every practicing ObGyn perform at his or her very best: your highest level of quality care, your best productivity, and your best ability to survive and thrive in an always changing and often challenging work environment.

This imperative is undermined when ObGyns are so stressed, overworked, overworried, and undersupported that you experience the very real effects of physician burnout.

Studies show that: 

 

• ObGyns experience high rates of burnout 
• rates of burnout are increasing over time
• women, the majority gender in obstetrics and gynecology, experience higher rates of burnout than their male counterparts. 

Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ Fifty-one percent of ObGyns reported experiencing burnout in 2015, with women reporting 55% compared to 46% for men.²

This insert is a quick look at this important issue, which can seriously erode an ObGyn's ability to provide high-quality care and continue enjoying practice. It can take a real toll on your personal health and well-being, too. In an upcoming issue of OBG Management, I will take a deeper dive, previewing the American College of Obstetricians and Gynecologists (ACOG) and American Medical Association resources to help you avoid burnout, plus highlighting ObGyns who provide insight and inspiration. I also will interview ACOG President Tom Gellhaus, MD, who is dedicating his presidency to providing you with opportunities to experience new and meaningful aspects of the ObGyn specialty. I will discuss ACOG's programs to help you combat burnout, as well as how you can:

 

• help underserved women around the globe through medical missions
• bring your leadership and passion for women's health to your state and national capitals
• explore your artistic side.

ObGyn burnout amounts to a public health challenge in women's health care. ACOG takes your well-being seriously, so that you can continue to ensure the well-being of women.

 

---

Lucia DiVenere, MA, is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.

Ms. DiVenere reports no financial relationships relevant to this article. .

 

---

References

 

1. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clinic Proceedings. 2015;90(12):1600-1613.
2. Peckham C. Medscape Lifestyle Report 2016: Bias and Burnout. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2016/public/overview. Published January 13, 2016. Accessed June 14, 2016.

Effects of the ACA on ObGyns
As of February 2016, 12.7 million Americans selected plans through the Health Insurance Marketplace of the Affordable Care Act (ACA).¹ Physicians often have no choice in whether or not they participate in Health Insurance Exchanges; however, in 2016, 24% of ObGyns said they plan to participate in exchanges, 25% do not, and the rest are unsure.¹

It is still unclear how the ACA affects physician income.¹ When ObGyns who participated in Health Insurance Exchanges in 2015 were asked whether their income was affected, approximately 60% reported no change, 30% reported a decrease, and 9% said it increased.¹

Medicus reported that physicians’ approval of the ACA has declined since last year. In their 2016 report, 71% of respondents gave the ACA a passing grade (A, B, C, or D), compared with 83% in 2015 and 77% in 2014. Fewer than 3% of 2016 respondents gave the ACA an “A.”¹²

Medscape reported that 36% of ObGyns have seen an increase in the number of patients due to the ACA.¹ A 2015 report from the Kaiser Family Foundation and The Commonwealth Fund assessing the experiences and attitudes of primary care providers after the first year of ACA coverage found no association with lower- and higher-quality care whether or not patient load had increased.¹³ Among those in the Medscape report who said that quality of care had worsened, 21% had a greater patient load; 18% reported no increase in patient load. Seventy-eight percent of physicians whose patient load increased said that quality had stayed the same or improved; 82% of those who experienced no increase in patient load reported that quality had stayed the same or improved.¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The mean income for ObGyns rose by 10% in 2015 over 2014 ($277,000 compared with $249,000), according to a recent report from Medscape.¹ This jump follows a gradual increase over the last few years ($243,000 in 2013; $242,000 in 2012; $220,000 in 2011).¹⁻³ The report included responses from 19,183 physicians across 26 specialties, 5% (nearly 1,000) of whom were ObGyns.¹

The highest earners among all physician specialties were orthopedists ($443,000), cardiologists, and dermatologists. The lowest earners were pediatricians ($204,000), endocrinologists, and family physicians. The highest ObGyn earners lived in the Southwest ($307,000), the North Central region, and the West.¹

Merritt Hawkins & Associates, a national physician search and consulting firm, recently evaluated the annual starting salaries and year-over-year increases of 3,342 of its physician and advanced practitioner recruiting assignments. They found that ObGyns had the second greatest increase in starting salaries among specialties, at 16%. They also found obstetrics and gynecology to be among the top 5 specialties most in demand.⁴

The gender picture
As in past years, male ObGyns reported higher earnings than their female counterparts: full-time male ObGyns earned $304,000 while full-time female ObGyns earned $256,000.¹

According to a report published in the British Medical Journal in June 2016, there are drastic differences between the incomes of white and black male and female physicians in the United States.⁵ White male physicians had an adjusted median annual income of $253,042 (95% confidence interval [CI], $248,670−$257,413), compared with $188,230 ($170,844−$205,616) for black male physicians, $163,234 (95% CI, $159,912−$166,557) for white female physicians, and $152,784 (95% CI, $137,927−$167,641) for black female physicians.

How does employment status factor in? Of the self-employed, men earn $310,000 while women earn $285,000. Men who are employed report earning $293,000, with women reporting $244,000.⁵ (This includes full-time workers but does not control for the number of hours worked.) When Medscape evaluated full- versus part-time work (<40 hours per week), results indicated that, among primary care and most other specialties, more female physicians (25%) are part-timers than males (12%).⁶ However, among ObGyns, 13% of women report part-time employment versus 16% of men.¹

Time with patients. Medscape reports that, among all physicians, 41% of men spent 17 minutes or more with their patients, compared with 49% of women. For office-based ObGyns, 31% of men and 39% of women spent 17 minutes or more with patients.¹

Can disparity in leadership positions explain gender-related salary discrepancy?
In 2015, 48% of all medical students were female.⁷ In residency, the ratio of men to women is similar: For 2013−2014, the Association of American Medical Colleges (AAMC) reported that 46% of all residents were female.⁸ For ObGyn residency, however, the AMA’s FREIDA Online specialty training search (detailing 2014 general program information) indicates that, of the 5,018 active residents and fellows in ObGyn, 81.4% are female.⁹

Although the ObGyn field is becoming female-dominated, leadership within the specialty remains male dominated, points out Laura E. Baecher-Lind, MD, MPH, Director of the Division of General Obstetrics & Gynecology at Tufts Medical Center, Boston, Massachusetts. Dr. Baecher-Lind authored a study in 2012 in which she explored whether the proportions of ObGyn leadership positions held by women reflect the proportion of women who entered the field at the same time as current leaders.¹⁰ She found that very few academic department chair positions in ObGyn are held by women, although that number is gradually increasing.¹⁰ In addition, her study results indicated that women should hold 71 of the total of 194 ObGyn leadership positions. In actuality, 41 of the leadership positions were held by women (21.1%, P<.001) when based on the proportion of women entering residency programs. When considering only leaders who graduated during the years in which residency matching data were available, she found that women should hold 28 of 74 leadership positions, but they actually held 20 (27.0%, P = .05).¹⁰

Could the salary discrepancy disappear if more women held leadership positions? OBG <scaps>Management</scaps> posed this question to Dr. Baecher-Lind. “I suspect that the gender pay gap would persist,” she said. “Studies indicate that women hold implicit gender bias as strongly as men. This bias leads to devaluing women’s skills and accomplishments compared with men’s and is a strong contributor to the leadership and pay gaps in this country and in our specialty. We need to be mindful of this implicit bias and work against it with policies such as salary transparency and salary audits to encourage parity.”¹¹

What are ObGyns’ greatest practice concerns?
The Medicus Firm reported in its 2016 Physician Practice Preference and Relocation Survey that the top 3 major practice concerns for practicing physicians were compensation, work-life balance, and work-related burnout and stress.¹² They found that physicians in general were slightly more satisfied with their 2015 income than their 2014 income, but less optimistic about the future. Only 29% projected that their 2016 income would increase over their 2015 earnings.

With ObGyn salaries on the up in 2015, less than half (46%) of ObGyns reported to Medscape that they feel fairly compensated; these physicians made $62,000 more than those who believed their pay was unfair.¹ Fifty-four percent of employed male ObGyns and 64% of employed female ObGyns reported feeling fairly compensated, compared with 43% and 32%, respectively, who were self-employed.

ObGyns indicated in the 2016 Medscape report that the prime causes of stress were bureaucratic tasks and spending too many hours at work. More than half (52%) of ObGyns spend 30 to 45 hours per week seeing patients, and 40% spend more time than that.¹ According to employment status, 56% of those who are self-employed and 58% of those who are employed spend 10 hours or more per week on administrative tasks.¹

Lucia DiVenere, MA, Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists (ACOG) in Washington, DC, offers a brief look, with an in-depth focus to come in an upcoming issue, at the growing concern of burnout among physicians and how it can affect both ObGyns and their patients. She outlines ACOG’s efforts to help ObGyns maintain work-life balance in “ObGyn burnout: ACOG takes aim.”

ObGyn burnout: ACOG takes aim

Lucia DiVenere, MA

The good news: More women have access to coverage for health care than ever before--better insurance coverage for pregnancy, contraceptives, and well-woman care.

The bad news: America faces a shortage of ObGyns to provide that care, a shortage not likely to go away soon.

One of the imperatives of this dynamic is that we need to help every practicing ObGyn perform at his or her very best: your highest level of quality care, your best productivity, and your best ability to survive and thrive in an always changing and often challenging work environment.

This imperative is undermined when ObGyns are so stressed, overworked, overworried, and undersupported that you experience the very real effects of physician burnout.

Studies show that: 

 

• ObGyns experience high rates of burnout 
• rates of burnout are increasing over time
• women, the majority gender in obstetrics and gynecology, experience higher rates of burnout than their male counterparts. 

Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ Fifty-one percent of ObGyns reported experiencing burnout in 2015, with women reporting 55% compared to 46% for men.²

This insert is a quick look at this important issue, which can seriously erode an ObGyn's ability to provide high-quality care and continue enjoying practice. It can take a real toll on your personal health and well-being, too. In an upcoming issue of OBG Management, I will take a deeper dive, previewing the American College of Obstetricians and Gynecologists (ACOG) and American Medical Association resources to help you avoid burnout, plus highlighting ObGyns who provide insight and inspiration. I also will interview ACOG President Tom Gellhaus, MD, who is dedicating his presidency to providing you with opportunities to experience new and meaningful aspects of the ObGyn specialty. I will discuss ACOG's programs to help you combat burnout, as well as how you can:

 

• help underserved women around the globe through medical missions
• bring your leadership and passion for women's health to your state and national capitals
• explore your artistic side.

ObGyn burnout amounts to a public health challenge in women's health care. ACOG takes your well-being seriously, so that you can continue to ensure the well-being of women.

 

---

Lucia DiVenere, MA, is Officer, Government and Political Affairs, at the American Congress of Obstetricians and Gynecologists in Washington, DC.

Ms. DiVenere reports no financial relationships relevant to this article. .

 

---

References

 

1. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clinic Proceedings. 2015;90(12):1600-1613.
2. Peckham C. Medscape Lifestyle Report 2016: Bias and Burnout. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2016/public/overview. Published January 13, 2016. Accessed June 14, 2016.

Effects of the ACA on ObGyns
As of February 2016, 12.7 million Americans selected plans through the Health Insurance Marketplace of the Affordable Care Act (ACA).¹ Physicians often have no choice in whether or not they participate in Health Insurance Exchanges; however, in 2016, 24% of ObGyns said they plan to participate in exchanges, 25% do not, and the rest are unsure.¹

It is still unclear how the ACA affects physician income.¹ When ObGyns who participated in Health Insurance Exchanges in 2015 were asked whether their income was affected, approximately 60% reported no change, 30% reported a decrease, and 9% said it increased.¹

Medicus reported that physicians’ approval of the ACA has declined since last year. In their 2016 report, 71% of respondents gave the ACA a passing grade (A, B, C, or D), compared with 83% in 2015 and 77% in 2014. Fewer than 3% of 2016 respondents gave the ACA an “A.”¹²

Medscape reported that 36% of ObGyns have seen an increase in the number of patients due to the ACA.¹ A 2015 report from the Kaiser Family Foundation and The Commonwealth Fund assessing the experiences and attitudes of primary care providers after the first year of ACA coverage found no association with lower- and higher-quality care whether or not patient load had increased.¹³ Among those in the Medscape report who said that quality of care had worsened, 21% had a greater patient load; 18% reported no increase in patient load. Seventy-eight percent of physicians whose patient load increased said that quality had stayed the same or improved; 82% of those who experienced no increase in patient load reported that quality had stayed the same or improved.¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.