To improve patient care and outcomes, leading dermatologists offered their recommendations on bar soaps. Consideration must be given to:

• Avène Cold Cream Ultra-Rich Cleansing Bar
  Pierre Fabre Dermo-Cosmetique USA
  “This gentle cleansing bar is not only hypoallergenic, soap free, and lanolin free, it also has Avène’s soothing Thermal Spring Water, plus white beeswax and a noncomedogenic, pharmaceutical-grade paraffin oil to protect the skin.”—Jeannette Graf, MD, Great Neck, New York
   
• Hydrating Cleanser Bar
  CeraVe
  Recommended by Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Cleansing Bar
  Pharmaceutical Specialties, Inc
  “This is a great option for patients with eczema or dry, sensitive skin.”—Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Lip plumpers, shaving lotions for men, and night creams will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on bar soaps. Consideration must be given to:

• Avène Cold Cream Ultra-Rich Cleansing Bar
  Pierre Fabre Dermo-Cosmetique USA
  “This gentle cleansing bar is not only hypoallergenic, soap free, and lanolin free, it also has Avène’s soothing Thermal Spring Water, plus white beeswax and a noncomedogenic, pharmaceutical-grade paraffin oil to protect the skin.”—Jeannette Graf, MD, Great Neck, New York
   
• Hydrating Cleanser Bar
  CeraVe
  Recommended by Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Cleansing Bar
  Pharmaceutical Specialties, Inc
  “This is a great option for patients with eczema or dry, sensitive skin.”—Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Lip plumpers, shaving lotions for men, and night creams will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on bar soaps. Consideration must be given to:

• Avène Cold Cream Ultra-Rich Cleansing Bar
  Pierre Fabre Dermo-Cosmetique USA
  “This gentle cleansing bar is not only hypoallergenic, soap free, and lanolin free, it also has Avène’s soothing Thermal Spring Water, plus white beeswax and a noncomedogenic, pharmaceutical-grade paraffin oil to protect the skin.”—Jeannette Graf, MD, Great Neck, New York
   
• Hydrating Cleanser Bar
  CeraVe
  Recommended by Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Cleansing Bar
  Pharmaceutical Specialties, Inc
  “This is a great option for patients with eczema or dry, sensitive skin.”—Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Lip plumpers, shaving lotions for men, and night creams will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.

Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”

They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”

Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.

But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
 

Tom Miller, resident fellow, American Enterprise Institute:

“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.

“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
 

Stan Dorn, senior fellow, Families USA:

“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”

Bob Kocher, MD, partner, Venrock:

“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.

“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
 

Tracy Watts, senior partner, Mercer:

“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.

“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
 

John Rother, president and CEO, National Coalition on Health Care:

“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”

Suzanne Delbanco, executive director, Catalyst for Payment Reform:

“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.

“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
 

Brian Marcotte, president and CEO, National Business Group on Health:

“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.

“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.

“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
 

Joseph Antos, health economist, American Enterprise Institute:

“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”

Ceci Connolly, president and CEO, Alliance of Community Health Plans:

“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”

David Lansky, CEO, Pacific Business Group on Health:

“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.

“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.

“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
 

Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.

Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”

They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”

Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.

But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
 

Tom Miller, resident fellow, American Enterprise Institute:

“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.

“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
 

Stan Dorn, senior fellow, Families USA:

“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”

Bob Kocher, MD, partner, Venrock:

“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.

“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
 

Tracy Watts, senior partner, Mercer:

“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.

“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
 

John Rother, president and CEO, National Coalition on Health Care:

“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”

Suzanne Delbanco, executive director, Catalyst for Payment Reform:

“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.

“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
 

Brian Marcotte, president and CEO, National Business Group on Health:

“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.

“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.

“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
 

Joseph Antos, health economist, American Enterprise Institute:

“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”

Ceci Connolly, president and CEO, Alliance of Community Health Plans:

“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”

David Lansky, CEO, Pacific Business Group on Health:

“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.

“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.

“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
 

Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.

Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”

They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”

Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.

But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
 

Tom Miller, resident fellow, American Enterprise Institute:

“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.

“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
 

Stan Dorn, senior fellow, Families USA:

“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”

Bob Kocher, MD, partner, Venrock:

“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.

“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
 

Tracy Watts, senior partner, Mercer:

“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.

“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
 

John Rother, president and CEO, National Coalition on Health Care:

“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”

Suzanne Delbanco, executive director, Catalyst for Payment Reform:

“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.

“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
 

Brian Marcotte, president and CEO, National Business Group on Health:

“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.

“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.

“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
 

Joseph Antos, health economist, American Enterprise Institute:

“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”

Ceci Connolly, president and CEO, Alliance of Community Health Plans:

“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”

David Lansky, CEO, Pacific Business Group on Health:

“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.

“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.

“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
 

Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Janus kinase inhibitors look promising in the treatment of severe alopecia areata, particularly in adolescents, said Lucy Yichu Liu, MD, and Brett Andrew King, MD, of Yale University, New Haven, Conn.

Standard medical therapies for alopecia areata – usually topical or injected corticosteroids and allergic contact sensitization – are not very effective for severe disease, particularly alopecia totalis and alopecia universalis. The Janus kinase (JAK) pathway recently has been suggested as a target for treatment.

Dr. Liu and Dr. King reviewed several studies, including a retrospective cohort study of 13 patients aged 12-17 years, in which 7 patients had 100% hair loss and 6 had 20%-70% scalp hair loss. The adolescents were treated with the JAK1/3 inhibitor tofacitinib citrate 5 mg twice daily for 2-16 months (median, 5 months). That led to 93% median improvement in Severity of Alopecia Tool (SALT) score (range, 1%-100%) from baseline. Nine patients experienced hair regrowth. There were mild adverse effects, such as upper respiratory infections and headaches.

Courtesy RegionalDerm.com

SOURCE: Liu LY et al. J Investig Dermatol Symp Proc. 2018 Jan. doi: 10.1016/j.jisp.2017.10.003.

Janus kinase inhibitors look promising in the treatment of severe alopecia areata, particularly in adolescents, said Lucy Yichu Liu, MD, and Brett Andrew King, MD, of Yale University, New Haven, Conn.

Standard medical therapies for alopecia areata – usually topical or injected corticosteroids and allergic contact sensitization – are not very effective for severe disease, particularly alopecia totalis and alopecia universalis. The Janus kinase (JAK) pathway recently has been suggested as a target for treatment.

Dr. Liu and Dr. King reviewed several studies, including a retrospective cohort study of 13 patients aged 12-17 years, in which 7 patients had 100% hair loss and 6 had 20%-70% scalp hair loss. The adolescents were treated with the JAK1/3 inhibitor tofacitinib citrate 5 mg twice daily for 2-16 months (median, 5 months). That led to 93% median improvement in Severity of Alopecia Tool (SALT) score (range, 1%-100%) from baseline. Nine patients experienced hair regrowth. There were mild adverse effects, such as upper respiratory infections and headaches.

Courtesy RegionalDerm.com

SOURCE: Liu LY et al. J Investig Dermatol Symp Proc. 2018 Jan. doi: 10.1016/j.jisp.2017.10.003.

Janus kinase inhibitors look promising in the treatment of severe alopecia areata, particularly in adolescents, said Lucy Yichu Liu, MD, and Brett Andrew King, MD, of Yale University, New Haven, Conn.

Standard medical therapies for alopecia areata – usually topical or injected corticosteroids and allergic contact sensitization – are not very effective for severe disease, particularly alopecia totalis and alopecia universalis. The Janus kinase (JAK) pathway recently has been suggested as a target for treatment.

Dr. Liu and Dr. King reviewed several studies, including a retrospective cohort study of 13 patients aged 12-17 years, in which 7 patients had 100% hair loss and 6 had 20%-70% scalp hair loss. The adolescents were treated with the JAK1/3 inhibitor tofacitinib citrate 5 mg twice daily for 2-16 months (median, 5 months). That led to 93% median improvement in Severity of Alopecia Tool (SALT) score (range, 1%-100%) from baseline. Nine patients experienced hair regrowth. There were mild adverse effects, such as upper respiratory infections and headaches.

Courtesy RegionalDerm.com

SOURCE: Liu LY et al. J Investig Dermatol Symp Proc. 2018 Jan. doi: 10.1016/j.jisp.2017.10.003.

Brenda Fitzgerald, MD, director of the Centers for Disease Control and Prevention, resigned Jan. 31 after reports surfaced on the public affairs website Politico that she purchased shares of Japan Tobacco about 1 month after becoming the agency’s director.

Dr. Fitzgerald, an ob.gyn., also bought stock in Merck & Co., Bayer, and Humana after joining the Trump Administration in July 2017, according to the report. Financial disclosure records confirm that she sold the tobacco stock in October and “all of her stock holdings above $1,000 by Nov. 21, more than 4 months after she became CDC director,” according to the Politico report.

According to a spokesperson for the Health and Human Services department, “This morning Secretary Azar accepted Dr. Brenda Fitzgerald’s resignation as Director of the Centers for Disease Control and Prevention.

“Dr. Fitzgerald owns certain complex financial interests that have imposed a broad recusal limiting her ability to complete all of her duties as the CDC Director. Due to the nature of these financial interests, Dr. Fitzgerald could not divest from them in a definitive time period. After advising Secretary Azar of both the status of the financial interests and the scope of her recusal, Dr. Fitzgerald tendered, and the Secretary accepted, her resignation. The Secretary thanks Dr. Brenda Fitzgerald for her service and wishes her the best in all her endeavors,” according to a report on CNBC.
 

[email protected]

Brenda Fitzgerald, MD, director of the Centers for Disease Control and Prevention, resigned Jan. 31 after reports surfaced on the public affairs website Politico that she purchased shares of Japan Tobacco about 1 month after becoming the agency’s director.

Dr. Fitzgerald, an ob.gyn., also bought stock in Merck & Co., Bayer, and Humana after joining the Trump Administration in July 2017, according to the report. Financial disclosure records confirm that she sold the tobacco stock in October and “all of her stock holdings above $1,000 by Nov. 21, more than 4 months after she became CDC director,” according to the Politico report.

According to a spokesperson for the Health and Human Services department, “This morning Secretary Azar accepted Dr. Brenda Fitzgerald’s resignation as Director of the Centers for Disease Control and Prevention.

“Dr. Fitzgerald owns certain complex financial interests that have imposed a broad recusal limiting her ability to complete all of her duties as the CDC Director. Due to the nature of these financial interests, Dr. Fitzgerald could not divest from them in a definitive time period. After advising Secretary Azar of both the status of the financial interests and the scope of her recusal, Dr. Fitzgerald tendered, and the Secretary accepted, her resignation. The Secretary thanks Dr. Brenda Fitzgerald for her service and wishes her the best in all her endeavors,” according to a report on CNBC.
 

[email protected]

Brenda Fitzgerald, MD, director of the Centers for Disease Control and Prevention, resigned Jan. 31 after reports surfaced on the public affairs website Politico that she purchased shares of Japan Tobacco about 1 month after becoming the agency’s director.

Dr. Fitzgerald, an ob.gyn., also bought stock in Merck & Co., Bayer, and Humana after joining the Trump Administration in July 2017, according to the report. Financial disclosure records confirm that she sold the tobacco stock in October and “all of her stock holdings above $1,000 by Nov. 21, more than 4 months after she became CDC director,” according to the Politico report.

According to a spokesperson for the Health and Human Services department, “This morning Secretary Azar accepted Dr. Brenda Fitzgerald’s resignation as Director of the Centers for Disease Control and Prevention.

“Dr. Fitzgerald owns certain complex financial interests that have imposed a broad recusal limiting her ability to complete all of her duties as the CDC Director. Due to the nature of these financial interests, Dr. Fitzgerald could not divest from them in a definitive time period. After advising Secretary Azar of both the status of the financial interests and the scope of her recusal, Dr. Fitzgerald tendered, and the Secretary accepted, her resignation. The Secretary thanks Dr. Brenda Fitzgerald for her service and wishes her the best in all her endeavors,” according to a report on CNBC.
 

[email protected]

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

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.

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

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.

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

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.

President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.

“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”

Courtesy The White House

[email protected]

President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.

“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”

Courtesy The White House

[email protected]

President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.

“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”

Courtesy The White House

[email protected]

Newer disease-modifying therapies are often used in patients with pediatric-onset MS, and they appear to have short-term side effect profiles similar to those observed in adults, a study of data from multiple clinics demonstrated.

“There are limited studies of MS treatments in pediatric-onset MS (onset before 18 years) as the main trials used to approve disease-modifying therapies [DMTs] are performed in adults,” lead study author Kristen Krysko, MD, said in an interview prior to a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis in San Diego. “This makes it difficult to treat children with MS as there is limited high-quality evidence for safety and effectiveness of treatments.”

Dr. Krysko, a multiple sclerosis clinical research fellow at the University of California, San Francisco, and her associates reported findings from 749 pediatric patients with MS and 274 with clinically-isolated syndrome whose data had been entered into the network as of August 2017 and who were followed for a mean of 3.3 years. The majority of patients were female (65%) with a mean age at disease onset of 12.9 years. Over time, the researchers observed increasing overall and first-line use of newer oral and intravenous DMTs in those younger than and older than 12 years of age at the start of a DMT (P less than .001).

Of the 618 patients who received a DMT before 18 years of age, 259 (42%) received a newer DMT and 104 (17%) received a newer DMT as first-line therapy. Dimethyl fumarate was the newer DMT used most often (ever in 100, as a first-line therapy in 36), followed by natalizumab (ever in 101, as a first-line therapy in 30), rituximab (ever in 57, as a first-line therapy in 22), fingolimod (ever in 37, as a first-line therapy in 14), daclizumab (ever in 5, as a first-line therapy in none), and teriflunomide (ever in 3, as a first-line therapy in 2).

The overall side effect profiles of newer DMTs were not different from those reported with the same agents in adults. Specifically, the number of side effects was greatest for dimethyl fumarate (37.7 per 100 person-years), followed by rituximab (20.1 per 100 person-years), natalizumab (15.7 per 100 person-years), and daclizumab (9.6 per 100 person-years).

“We found that newer medications are being prescribed more often in children with MS over time,” Dr. Krysko said. “Even children who were quite young (younger than 12 years old) received newer MS treatments in some cases, although older children (12 years and older) were more likely to receive newer treatments than were the very young children. We did not find new safety concerns with these medications compared to adults.”

She acknowledged certain limitations of the study, including the “likely underestimate” of side effects and the lack of access to laboratory results of children while on these medications. “Thus, further investigation of the safety of these newer medications in children is needed,” she said.

The National MS Society funded the study. Dr. Krysko disclosed that she is funded by the society as a Sylvia Lawry Physician Fellow.

[email protected]

SOURCE: Krysko K et al. ACTRIMS Forum 2018 Poster 68.

Newer disease-modifying therapies are often used in patients with pediatric-onset MS, and they appear to have short-term side effect profiles similar to those observed in adults, a study of data from multiple clinics demonstrated.

“There are limited studies of MS treatments in pediatric-onset MS (onset before 18 years) as the main trials used to approve disease-modifying therapies [DMTs] are performed in adults,” lead study author Kristen Krysko, MD, said in an interview prior to a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis in San Diego. “This makes it difficult to treat children with MS as there is limited high-quality evidence for safety and effectiveness of treatments.”

Dr. Krysko, a multiple sclerosis clinical research fellow at the University of California, San Francisco, and her associates reported findings from 749 pediatric patients with MS and 274 with clinically-isolated syndrome whose data had been entered into the network as of August 2017 and who were followed for a mean of 3.3 years. The majority of patients were female (65%) with a mean age at disease onset of 12.9 years. Over time, the researchers observed increasing overall and first-line use of newer oral and intravenous DMTs in those younger than and older than 12 years of age at the start of a DMT (P less than .001).

Of the 618 patients who received a DMT before 18 years of age, 259 (42%) received a newer DMT and 104 (17%) received a newer DMT as first-line therapy. Dimethyl fumarate was the newer DMT used most often (ever in 100, as a first-line therapy in 36), followed by natalizumab (ever in 101, as a first-line therapy in 30), rituximab (ever in 57, as a first-line therapy in 22), fingolimod (ever in 37, as a first-line therapy in 14), daclizumab (ever in 5, as a first-line therapy in none), and teriflunomide (ever in 3, as a first-line therapy in 2).

The overall side effect profiles of newer DMTs were not different from those reported with the same agents in adults. Specifically, the number of side effects was greatest for dimethyl fumarate (37.7 per 100 person-years), followed by rituximab (20.1 per 100 person-years), natalizumab (15.7 per 100 person-years), and daclizumab (9.6 per 100 person-years).

“We found that newer medications are being prescribed more often in children with MS over time,” Dr. Krysko said. “Even children who were quite young (younger than 12 years old) received newer MS treatments in some cases, although older children (12 years and older) were more likely to receive newer treatments than were the very young children. We did not find new safety concerns with these medications compared to adults.”

She acknowledged certain limitations of the study, including the “likely underestimate” of side effects and the lack of access to laboratory results of children while on these medications. “Thus, further investigation of the safety of these newer medications in children is needed,” she said.

The National MS Society funded the study. Dr. Krysko disclosed that she is funded by the society as a Sylvia Lawry Physician Fellow.

[email protected]

SOURCE: Krysko K et al. ACTRIMS Forum 2018 Poster 68.

Newer disease-modifying therapies are often used in patients with pediatric-onset MS, and they appear to have short-term side effect profiles similar to those observed in adults, a study of data from multiple clinics demonstrated.

“There are limited studies of MS treatments in pediatric-onset MS (onset before 18 years) as the main trials used to approve disease-modifying therapies [DMTs] are performed in adults,” lead study author Kristen Krysko, MD, said in an interview prior to a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis in San Diego. “This makes it difficult to treat children with MS as there is limited high-quality evidence for safety and effectiveness of treatments.”

Dr. Krysko, a multiple sclerosis clinical research fellow at the University of California, San Francisco, and her associates reported findings from 749 pediatric patients with MS and 274 with clinically-isolated syndrome whose data had been entered into the network as of August 2017 and who were followed for a mean of 3.3 years. The majority of patients were female (65%) with a mean age at disease onset of 12.9 years. Over time, the researchers observed increasing overall and first-line use of newer oral and intravenous DMTs in those younger than and older than 12 years of age at the start of a DMT (P less than .001).

Of the 618 patients who received a DMT before 18 years of age, 259 (42%) received a newer DMT and 104 (17%) received a newer DMT as first-line therapy. Dimethyl fumarate was the newer DMT used most often (ever in 100, as a first-line therapy in 36), followed by natalizumab (ever in 101, as a first-line therapy in 30), rituximab (ever in 57, as a first-line therapy in 22), fingolimod (ever in 37, as a first-line therapy in 14), daclizumab (ever in 5, as a first-line therapy in none), and teriflunomide (ever in 3, as a first-line therapy in 2).

The overall side effect profiles of newer DMTs were not different from those reported with the same agents in adults. Specifically, the number of side effects was greatest for dimethyl fumarate (37.7 per 100 person-years), followed by rituximab (20.1 per 100 person-years), natalizumab (15.7 per 100 person-years), and daclizumab (9.6 per 100 person-years).

“We found that newer medications are being prescribed more often in children with MS over time,” Dr. Krysko said. “Even children who were quite young (younger than 12 years old) received newer MS treatments in some cases, although older children (12 years and older) were more likely to receive newer treatments than were the very young children. We did not find new safety concerns with these medications compared to adults.”

She acknowledged certain limitations of the study, including the “likely underestimate” of side effects and the lack of access to laboratory results of children while on these medications. “Thus, further investigation of the safety of these newer medications in children is needed,” she said.

The National MS Society funded the study. Dr. Krysko disclosed that she is funded by the society as a Sylvia Lawry Physician Fellow.

[email protected]

SOURCE: Krysko K et al. ACTRIMS Forum 2018 Poster 68.

The future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures

ACOG’s role in developing quality measures

In October 2016, the Centers for Medicare and Medicaid Services released the final Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under this rule, the Merit-based Incentive Payment System (MIPS) was created, which was intended to drive “value” rather than “volume” in payment incentives. Measures are critical to defining value-based care. However, the law has limited or no impact on providers who do not care for Medicare patients.

Clinicians eligible to participate in MACRA must bill more than $90,000 a year in Medicare Part B allowed charges and provide care for more than 200 Medicare patients per year.⁶ This means that the MIPS largely overlooks ObGyns, as the bulk of our patients are insured either by private insurance or by Medicaid. However, maternity care spending is a significant part of both Medicaid and private insurers’ outlay, and both payers are actively considering using value-based financial models that will need to be fed by quality metrics. ACOG wants to be at the forefront of measure development for quality metrics that affect members and has committed resources to formation of a measure development team.

ACOG wants providers to be in control of how their practices are evaluated. For this reason, ACOG is focusing on measures that are based on clinical data entered by providers into an EHR at the point of care. At the same time, ACOG is cognizant of not increasing the documentation burden for providers. Understanding the quality of the data, as opposed to the quality of care, will be a fundamental task for the maternity care registry that ACOG is launching in 2018.

What can ObGyns do?

Quality measures are about more than just money. Public reporting of these measures on government and payer websites may influence public perception of a practice.⁷ The focus on patient-centered care means that patients have a voice in their care, financially as well as literally, so expect to see increased scrutiny of provider performance by patients as well as payers. One way to measure patient experience of treatments, symptoms, and quality of life is through patient-reported outcome measures (PROMs). Assessing PROMs in routine care ensures that information only the patient can provide is collected and analyzed, thus further enhancing the delivery of care and evaluating how that care is impacting the lives of your patients.

The transition from fee-for-service to a value-based system will not happen overnight, but it will happen. This transition—from being paid for the quantity of documentation to the quality of documentation—will require some change management, rethinking of workflows, and better documentation tools (such as apps instead of EHR customization).

Many in the medical profession are actively exploring these changes and new developments. These changes are too important to leave to administrators, coders, scribes, app developers, and policy makers. Someone in your practice, hospital, or health system is working on these issues today. Tomorrow, you need to be at the table. The voices of practicing ObGyns are critical as we work to address the current challenging environment in which we spend more per capita than any other nation with far inferior results. Measures that matter to us and to our patients will help us provide better and more cost-effective care that payers and patients value.⁸

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 future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures

ACOG’s role in developing quality measures

In October 2016, the Centers for Medicare and Medicaid Services released the final Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under this rule, the Merit-based Incentive Payment System (MIPS) was created, which was intended to drive “value” rather than “volume” in payment incentives. Measures are critical to defining value-based care. However, the law has limited or no impact on providers who do not care for Medicare patients.

Clinicians eligible to participate in MACRA must bill more than $90,000 a year in Medicare Part B allowed charges and provide care for more than 200 Medicare patients per year.⁶ This means that the MIPS largely overlooks ObGyns, as the bulk of our patients are insured either by private insurance or by Medicaid. However, maternity care spending is a significant part of both Medicaid and private insurers’ outlay, and both payers are actively considering using value-based financial models that will need to be fed by quality metrics. ACOG wants to be at the forefront of measure development for quality metrics that affect members and has committed resources to formation of a measure development team.

ACOG wants providers to be in control of how their practices are evaluated. For this reason, ACOG is focusing on measures that are based on clinical data entered by providers into an EHR at the point of care. At the same time, ACOG is cognizant of not increasing the documentation burden for providers. Understanding the quality of the data, as opposed to the quality of care, will be a fundamental task for the maternity care registry that ACOG is launching in 2018.

What can ObGyns do?

Quality measures are about more than just money. Public reporting of these measures on government and payer websites may influence public perception of a practice.⁷ The focus on patient-centered care means that patients have a voice in their care, financially as well as literally, so expect to see increased scrutiny of provider performance by patients as well as payers. One way to measure patient experience of treatments, symptoms, and quality of life is through patient-reported outcome measures (PROMs). Assessing PROMs in routine care ensures that information only the patient can provide is collected and analyzed, thus further enhancing the delivery of care and evaluating how that care is impacting the lives of your patients.

The transition from fee-for-service to a value-based system will not happen overnight, but it will happen. This transition—from being paid for the quantity of documentation to the quality of documentation—will require some change management, rethinking of workflows, and better documentation tools (such as apps instead of EHR customization).

Many in the medical profession are actively exploring these changes and new developments. These changes are too important to leave to administrators, coders, scribes, app developers, and policy makers. Someone in your practice, hospital, or health system is working on these issues today. Tomorrow, you need to be at the table. The voices of practicing ObGyns are critical as we work to address the current challenging environment in which we spend more per capita than any other nation with far inferior results. Measures that matter to us and to our patients will help us provide better and more cost-effective care that payers and patients value.⁸

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 future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures

ACOG’s role in developing quality measures

In October 2016, the Centers for Medicare and Medicaid Services released the final Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under this rule, the Merit-based Incentive Payment System (MIPS) was created, which was intended to drive “value” rather than “volume” in payment incentives. Measures are critical to defining value-based care. However, the law has limited or no impact on providers who do not care for Medicare patients.

Clinicians eligible to participate in MACRA must bill more than $90,000 a year in Medicare Part B allowed charges and provide care for more than 200 Medicare patients per year.⁶ This means that the MIPS largely overlooks ObGyns, as the bulk of our patients are insured either by private insurance or by Medicaid. However, maternity care spending is a significant part of both Medicaid and private insurers’ outlay, and both payers are actively considering using value-based financial models that will need to be fed by quality metrics. ACOG wants to be at the forefront of measure development for quality metrics that affect members and has committed resources to formation of a measure development team.

ACOG wants providers to be in control of how their practices are evaluated. For this reason, ACOG is focusing on measures that are based on clinical data entered by providers into an EHR at the point of care. At the same time, ACOG is cognizant of not increasing the documentation burden for providers. Understanding the quality of the data, as opposed to the quality of care, will be a fundamental task for the maternity care registry that ACOG is launching in 2018.

What can ObGyns do?

Quality measures are about more than just money. Public reporting of these measures on government and payer websites may influence public perception of a practice.⁷ The focus on patient-centered care means that patients have a voice in their care, financially as well as literally, so expect to see increased scrutiny of provider performance by patients as well as payers. One way to measure patient experience of treatments, symptoms, and quality of life is through patient-reported outcome measures (PROMs). Assessing PROMs in routine care ensures that information only the patient can provide is collected and analyzed, thus further enhancing the delivery of care and evaluating how that care is impacting the lives of your patients.

The transition from fee-for-service to a value-based system will not happen overnight, but it will happen. This transition—from being paid for the quantity of documentation to the quality of documentation—will require some change management, rethinking of workflows, and better documentation tools (such as apps instead of EHR customization).

Many in the medical profession are actively exploring these changes and new developments. These changes are too important to leave to administrators, coders, scribes, app developers, and policy makers. Someone in your practice, hospital, or health system is working on these issues today. Tomorrow, you need to be at the table. The voices of practicing ObGyns are critical as we work to address the current challenging environment in which we spend more per capita than any other nation with far inferior results. Measures that matter to us and to our patients will help us provide better and more cost-effective care that payers and patients value.⁸

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.

Contents

Introduction
Barbara P. Yawn, MD, MSc, FAAFP

Dyspnea and Hyperinflation in Chronic Obstructive Pulmonary Disease: Impact on Physical Activity
Nathaniel Marchetti, DO, and Alan Kaplan, MD

Anxiety and Depression in Chronic Obstructive Pulmonary Disease: Recognition and Management
Abebaw Mengistu Yohannes, PhD; Alan Kaplan, MD; and Nicola A. Hanania, MD, MS

Considerations for Optimal Inhaler Device Selection in Chronic Obstructive Pulmonary Disease
Rajiv Dhand, MD; Tricia Cavanaugh, MD; and Neil Skolnik, MD

Treatment Options for Stable Chronic Obstructive Pulmonary Disease: Current Recommendations and Unmet Needs
Barbara Yawn, DM, MSc, FAAFP; and Victor Kim, MD

Contents

Introduction
Barbara P. Yawn, MD, MSc, FAAFP

Dyspnea and Hyperinflation in Chronic Obstructive Pulmonary Disease: Impact on Physical Activity
Nathaniel Marchetti, DO, and Alan Kaplan, MD

Anxiety and Depression in Chronic Obstructive Pulmonary Disease: Recognition and Management
Abebaw Mengistu Yohannes, PhD; Alan Kaplan, MD; and Nicola A. Hanania, MD, MS

Considerations for Optimal Inhaler Device Selection in Chronic Obstructive Pulmonary Disease
Rajiv Dhand, MD; Tricia Cavanaugh, MD; and Neil Skolnik, MD

Treatment Options for Stable Chronic Obstructive Pulmonary Disease: Current Recommendations and Unmet Needs
Barbara Yawn, DM, MSc, FAAFP; and Victor Kim, MD

Contents

Introduction
Barbara P. Yawn, MD, MSc, FAAFP

Dyspnea and Hyperinflation in Chronic Obstructive Pulmonary Disease: Impact on Physical Activity
Nathaniel Marchetti, DO, and Alan Kaplan, MD

Anxiety and Depression in Chronic Obstructive Pulmonary Disease: Recognition and Management
Abebaw Mengistu Yohannes, PhD; Alan Kaplan, MD; and Nicola A. Hanania, MD, MS

Considerations for Optimal Inhaler Device Selection in Chronic Obstructive Pulmonary Disease
Rajiv Dhand, MD; Tricia Cavanaugh, MD; and Neil Skolnik, MD

Treatment Options for Stable Chronic Obstructive Pulmonary Disease: Current Recommendations and Unmet Needs
Barbara Yawn, DM, MSc, FAAFP; and Victor Kim, MD

Chronic pelvic pain (CPP) is defined as noncyclic pain in the pelvis, anterior abdominal wall, back, or buttocks that has been present for at least 6 months and is severe enough to cause functional disability or require medical care.¹ CPP is very common, with an estimated prevalence of 15% to 20%. It accounts for 20% of gynecology visits and 15% of hysterectomies in the United States, and it is believed to account for $2.8 billion in direct health care spending annually.^2–5

Caring for patients with CPP can be very challenging. They often arrive at your office frustrated, having seen multiple providers or having undergone multiple surgeries. They may come to you whether you are a general ObGyn or subspecialize in maternal-fetal medicine, oncology, reproductive endocrinology, urogynecology, or adolescent gynecology. From interactions with other providers or their own family members, these patients may have received the message—either subtly or overtly—that their pain is “all in their head.” As such, some patients may resist any implication that their pain does not have an anatomic source. It is therefore critical to have appropriate tools for evaluating and managing the complex problem of CPP.

Perform a thorough and thoughtful assessment

Chronic pelvic pain often presents as a constellation of symptoms with contributions from multiple sources, as opposed to a single disease entity. Occasionally there is a single cause of pain, such as a large endometrioma or degenerating fibroid, where surgery can be curative. But more commonly the pain arises from multiple organ systems. In such cases, surgery may be unnecessary and, often, can worsen pain.

Thoughtful evaluation is critical in the CPP population. Take a thorough patient history to determine the characteristics of pain (cyclic or constant, widespread or localized), exacerbating factors, sleep disturbances, fatigue, and current coping strategies. Focus a comprehensive physical examination on identifying the maneuvers that reproduce the patient’s pain, and include an examination of the pelvic floor muscles.⁶ In most cases, pelvic ultrasonography provides adequate evaluation for anatomic sources of pain.

Chronic pain does not behave like acute injury or postsurgical pain. Continuous peripheral pain signals for a prolonged period can lead to changes in how the brain processes pain; specifically, the brain can begin to amplify pain signals. This “central pain amplification” is characterized clinically by widespread pain, fatigue, sleep disturbances, memory difficulties, and somatic symptoms. Central pain amplification occurs in many chronic pain conditions, including fibromyalgia, interstitial cystitis, irritable bowel syndrome, low back pain, chronic headaches, and temporomandibular joint disorder.^7,8 Recent clinical and functional magnetic resonance imaging (MRI) studies demonstrate central pain amplification in many patients with CPP.^9–12 Notably, these findings are independent of the presence or severity of endometriosis.

In this article we discuss many therapies that have not been specifically studied in patients with CPP, and treatment efficacy is extrapolated from other conditions with chronic pain amplification, such as fibromyalgia or interstitial cystitis. Additionally, many treatments for conditions associated with central pain amplification are used off-label, that is, the US Food and Drug Administration (FDA) has not approved the medication for treatment of these specific conditions. This should be disclosed to patients during counseling.

Discuss treatment expectations with patients

Educating patients regarding the pathophysiology of chronic pain and setting reasonable expectations is the cornerstone of providing patient-centered care for this complex condition. We start most of our discussions about treatment options by telling patients that while we may not cure their pain, we will provide them with medical, surgical, and behavioral strategies that will reduce their pain, improve their function, and enhance their quality of life.

Surprisingly, most patients say that a cure is not their goal. They just want to feel better so they can return to work or activities, fully participate in family life, or not feel exhausted all the time. As such, a multimodal treatment plan is generally the best strategy for achieving a satisfactory improvement in symptoms.

Read about treating a case of continued pain after endometriosis treatment.

CASE 1 Patient’s pain continues after endometriosis excision

A 32-year-old woman (G1P1) reports having CPP for 8 years. She underwent excision of stage 1 endometriosis last year, which resulted in a modest improvement in pain for 6 months. Her pain is worse during menses, at the end of the day, and with vaginal intercourse (both during and lasting for 1 to 2 days after). On examination, you find diffuse pelvic floor tenderness but no adnexal masses or rectovaginal nodularity on palpation.

What treatment options would you consider for this patient?

Multimodal treatment often needed to manage CPP symptoms

The patient described in Case 1 may benefit from a combination of therapies that include analgesics, hormone suppression agents, and physical therapy (PT) (TABLE).

Analgesics

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, work by inhibiting cyclooxygenase enzyme, which decreases assembly of peripheral prostaglandins and thromboxane. In a large Cochrane review, NSAIDs were associated with moderate or excellent pain relief for approximately 50% of patients with dysmenorrhea, and they have been shown to reduce menstrual flow due to decreased production of uterine prostaglandins.¹³ There is little evidence for use of NSAIDs in chronic pain conditions.

Acetaminophen’s mechanism of action is unclear, but the drug likely inhibits central prostaglandin synthesis, and it works synergistically with other analgesics.

Opioids act on μ and δ opioid receptors in the central and peripheral nervous systems as well as in the gastrointestinal system. No evidence supports opioid use in CPP or other chronic pain conditions. Long-term opioid use is associated with a multitude of adverse effects, risk for dependence, and the induction of opioid-induced hyperalgesia (in which patients develop greater sensitivity to pain stimuli).

Analgesics, specifically NSAIDs, can be considered for use in patients with dysmenorrhea, cyclic pain exacerbation, or a suspected inflammatory component of pain. Best practices include scheduling NSAID use before the onset of menses and continuing the drugs on a scheduled basis throughout. NSAIDs should be used for a brief period, and regular use on an empty stomach should be avoided.

Hormone suppression

Many types of hormone suppression therapy are available, including combined estrogen-progestin medications, progestin-only medications, and gonadotropin-releasing hormone (GnRH) agonists and antagonists.

Combined estrogen-progestin medications include oral contraceptive pills (OCPs), vaginal rings, and transdermal patches. Combined estrogen-progestin methods cause atrophy of eutopic and ectopic endometrium and suppress GnRH.

Progestin-only methods include oral formulations, the levonorgestrel intrauterine device, intramuscular and subcuticular injections, and subdermal implants. Progestin-only methods lead to atrophy of eutopic and ectopic endometrium.

A GnRH agonist, leuprolide depot works by downregulating luteinizing hormone and follicle stimulating hormone release from the pituitary, causing suppression of ovarian follicular development and ovulation, leading to a hypoestrogenic state.

Combined estrogen-progestin formulations and progestin-only options are often considered first-line therapy for dysmenorrhea and endometriosis.¹³ Continuous administration, with the goal of inducing amenorrhea, is effective in the treatment of dysmenorrhea. Several randomized controlled trials have shown that different types of hormone suppression agents are, essentially, equally effective.^13–15 Treatment recommendations therefore should focus on adverse effects, cost, and patient preference. GnRH agonists and norethindrone are not FDA approved for the treatment of endometriosis.

It may be appropriate to consider use of hormone suppression therapy in patients with menstrual exacerbation of pain symptoms, including those with a history of endometriosis. We generally advise patients that the goal is amenorrhea and that achieving it often involves a process of trying different formulations to find the best fit. Remember that GnRH agonists are dependent on a functional hypothalamic-pituitary-ovarian axis, and they are unlikely to be effective in women with suspected residual endometriosis who have had a bilateral oophorectomy.

Physical therapy

For CPP, PT typically targets musculoskeletal dysfunction in the pelvic floor, abdominal wall, hips, and back. Interventions include muscle control, mobilization, and biofeedback. Pelvic PT has been shown to improve pain and dyspareunia in patients with CPP, coccydynia, and vestibulodynia.^16–18 One large study found a significant, patient-directed decrease in pain medication use after pelvic floor PT.¹⁹ Pelvic PT for patients with interstitial cystitis and pelvic floor tenderness resulted in improved pain and bladder symptoms.²⁰

Pelvic PT can be considered for patients with pain reproducible with palpation of the pelvic floor, abdominal wall, paraspinal-lumbar muscles, or sacroiliac joints. Best practices include referral to a therapist who has specialized training in CPP, including pelvic floor therapy. It is important to clearly list the indication for referral, as many of these therapists also treat stress urinary incontinence. The wrong exercises can result in increased hypercontractility of pelvic floor muscles, which can worsen pelvic pain.

It is also critical to clarify expectations with your patient at the time of PT referral. Specifically, advise patients that when beginning therapy, it is common to experience a temporary increase in discomfort of the pelvic muscles. Inform patients also to expect that their therapist will perform internal manipulation of the pelvic floor muscles through the vagina, as this can be surprising for some patients. Finally, counsel patients that their adherence to daily home exercises improves their chance of a durable, long-term successful response.²¹

CASE 1 Treatment recommendations

For treatment of this patient’s CPP, consider scheduled naproxen therapy during menses, continuous OCPs, and referral for pelvic floor PT.

Read about treating a case of pain, sleep disturbance, and depression.

CASE 2 Patient with long-standing CPP, multiple diagnoses, and sleep problems

A 30-year-old woman (G2P2) reports having had CPP for 17 years. She is amenorrheic with continuous OCP treatment. She had experienced some improvement with pelvic PT. The patient reports that she has daily pain with intermittent pain flares and that she is exhausted and has poor sleep quality, which she attributes to pain. She has been diagnosed with interstitial cystitis, irritable bowel syndrome, and temporomandibular joint disorder. She has a history of depression, which she feels is well controlled with bupropion. Physical examination reveals that the patient has diffuse but mild pain in the pelvic floor and abdominal wall muscles.

What further pain management options can you offer for this patient?

Managing pain, sleep disturbance, and depression

This patient has been living with CPP for many years, and she has sleep difficulties that might be exacerbating pain or result from pain (or both). She is already on continuous OCPs and has had some relief with pelvic PT. Other options that may help with her multiple issues include antidepressants, cyclobenzaprine, and calcium channel blockers.

Antidepressants

Several classes of antidepressants have been used in the treatment of chronic pain conditions, specifically, tricyclic antidepressants (TCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Commonly used TCAs include amitriptyline, nortriptyline, desipramine, and doxepin. Commonly used SNRIs are duloxetine and milnacipran. Both TCAs and SNRIs increase the availability of norepinephrine and serotonin, which are thought to act on the descending pain inhibitory systems to decrease pain sensitivity. Of note, most selective serotonin reuptake inhibitors (SSRIs) at typical doses do not exert a significant enough impact on norepinephrine to be useful for chronic pain.²²

Evidence is limited on the use of antidepressants for treating CPP. Amitriptyline is the most extensively studied antidepressant. Amitriptyline treatment resulted in modest pain improvement in patients with CPP and fibromyalgia.^23,24 Bothersome anticholinergic effects, including fatigue, dry mouth, and constipation, often are reported with TCAs. Adverse effects tend to be less with nortriptyline or desipramine compared with amitriptyline, but possibly at the expense of efficacy.

While SNRIs have not yet been studied in CPP, several investigations have shown that they improve pain and quality of life in fibromyalgia patients.^22,25

Antidepressant therapy may be appropriate for patients with suspected central pain amplification, widespread pain, and sleep disturbances. Best practices include patient education and careful discussion of this option with your patient. We suggest that clinicians explain that antidepressant medications alter the function of neurotransmitters, which modulate pain signals. While neurotransmitters also are involved in mood modulation, this is not the therapeutic goal in this circumstance. In addition, the doses used for the effective treatment of chronic pain are significantly lower than those needed to treat depression effectively.

Patients often need to hear that you believe that their pain is real and is not a manifestation of depression or another mood disorder. If you suspect that the patient also has untreated depression, address this as its own issue and use medications that have greater efficacy for mood symptoms.

Because many antidepressants can cause sedation, they are best taken before bedtime. Also, slow dose titration over several weeks will reduce the chance of bothersome adverse effects. Counsel patients that efficacy is not generally seen until at goal dose for several weeks. Be aware of interactions with other medications that can cause serotonin syndrome.

Cyclobenzaprine

Cyclobenzaprine is a muscle relaxant that also has activity in the central nervous system. The drug’s precise mechanism of action is not known, but it appears to potentiate norepinephrine and bind to serotonin receptors. Thus, it also likely has some TCA-like activity.

Cyclobenzaprine has not been studied in patients with CPP. In fibromyalgia patients, however, it produced significant improvements in pain, sleep, fatigue, and tenderness.^26,27 In our anecdotal experience with CPP patients, cyclobenzaprine has been one of the most impactful therapies. It hits the “chronic pain triad,” meaning that it helps with myofascial pain, neuropathic pain, and sleep disturbances.

Cyclobenzaprine treatment may be considered for patients with myofascial pain, sleep disturbances, and clinical symptoms of central pain amplification. Best practices include starting with low (5 mg) scheduled doses at bedtime and slowly titrating the dose. Drowsiness is a very common side effect, so we try to use that to the patient’s advantage to help with sleep quality.

Notably, sleep disturbances are highly prevalent in patients with chronic pain.²⁸ The relationship appears to be bidirectional, meaning that chronic pain negatively impacts sleep quality, and poor sleep quality causes amplified perception of pain.^28–30 Interventions that improve sleep quality have been associated with improvements in pain, coping, mood, and functional status.³¹ Helping a patient to improve her sleep generally requires a multifaceted approach. It always involves “sleep hygiene” or a behavioral component, and pharmacologic assistance may be considered when improved sleep hygiene does not provide adequately improved sleep quality.

Calcium channel blockers

Gabapentin and pregabalin are calcium channel blockers that inhibit the reuptake of glutamate, norepinephrine, and substance P, which helps to decrease pain sensitivity. They also act as membrane stabilizers, reducing hyperexcitability of peripheral and central nerves. Studies have shown that in patients with CPP, gabapentin resulted in improved pain and mood symptoms with few adverse effects.^23,32 Patients with fibromyalgia had improvements in pain, sleep, quality of life, fatigue, and anxiety with both gabapentin and pregabalin.³³

It is appropriate to consider use of gabapentin or pregabalin in patients with central pain amplification and sleep disturbances. Best practices include starting with a low dose at bedtime. Traditionally, gabapentin is given in 3 equal doses throughout the day. In our experience, patients report less daytime drowsiness and better sleep quality if two-thirds of the daily dose is given at night, with the remaining daily dose broken up into 2 smaller daytime doses. Slow titration over several weeks will reduce risk of bothersome adverse effects. Patients should be counseled that efficacy is not generally seen until treatment is at goal dose for several weeks.

CASE 2 Treatment recommendations

For this patient with daily pelvic pain, multiple diagnoses that have a pain component, and poor sleep quality, consider a treatment plan that includes scheduled cyclobenzaprine, improved sleep hygiene, and, if needed, gabapentin.

Read about treating a case of focal pain.

CASE 3 Cesarean delivery, hysterectomy, and continued pelvic pain

A 38-year-old woman (G2P2) has had CPP for the past 10 years. She developed persistent left lower-quadrant pain after cesarean delivery of her son. She had a hysterectomy 2 years ago for CPP, after which her pain worsened. She describes daily pain with intermittent flares. On examination, the patient has focal left lower-quadrant pain lateral to the left apex of her Pfannenstiel incision.

What treatment approach would be appropriate for this patient?

Focal pain requires a precisely targeted treatment

This patient with focal left lower-quadrant pain is a candidate for anesthetic trigger point injections in the affected area near her Pfannenstiel incision.

Anesthetic injections

Consider the presence of trigger points and peripheral neuropathy in patients with focal abdominal wall pain. Trigger points are focal, palpable nodules within muscles. They are markedly painful to palpation and are associated with referred pain, motor dysfunction, and occasionally autonomic symptoms. They frequently are seen in abdominal wall or pelvic floor muscles in patients with CPP and are caused by abnormal neuromuscular depolarization.

The ilioinguinal, iliohypogastric, and genitofemoral nerves are in close proximity to Pfannenstiel and laparoscopic port site incisions. These nerves may be injured directly during surgery, but they also may be compressed by postoperative scarring.

Anesthetics, such as lidocaine and bupivacaine, which act as sodium channel blockers, can be injected into this area, and improvement often substantially outlasts the anesthetic’s duration of action. While these drugs’ mechanism of action is not clear, theories include altered function of sodium channels on sensory nerves with repeated anesthetic exposure, dry needling that occurs during injection, hydrodissection of tight connective tissue bands surrounding neuromuscular bundles, or depletion of substance P and neuropeptides as a result of injection.^34,35

In several studies, patients with CPP reported decreased pain with lidocaine injections in pelvic floor or abdominal wall trigger points.^36–38 Patients with fibromyalgia reported improvement in pain and a decreased need for NSAIDs with bupivacaine trigger point injections.³⁹ While abdominal wall nerve blocks have not been extensively studied in patients with chronic neuropathic pain following gynecologic surgery, they have been shown to substantially improve chronic neuropathic pain following inguinal hernia repair.⁴⁰

Anesthetic injections appropriately may be considered in patients with focal pain in a muscle or in the distribution of abdominal wall nerves, palpation of which reproduces pain symptoms. Patients with diffuse pain are less likely to benefit from anesthetic injections. Best practices include careful examination with attention to areas of prior abdominal incisions.

Our practice is to inject each affected area with a mix of 9 mL of 1% lidocaine and 1 mL of sodium bicarbonate. If a patient reports at least 24 hours of improvement, we repeat the injection in 2 to 4 weeks. The goal is for the patient to experience a progressively longer duration of benefit with subsequent injections. We perform repeat injections shortly after pain begins to recur at that site. The patient should eventually graduate from receiving regular injections and may return for a remedial injection if pain recurs.

CASE 3 Treatment recommendations

For this patient with persistent focal left-lower quadrant pain and a defined trigger point near her Pfannenstiel incision, consider anesthetic injection in the left lower quadrant.

Work toward realistic symptom improvement

Remember that living with chronic pain is exhausting, and empathy with a patient-centered approach is the most important ingredient for patient improvement and satisfaction. Discuss realistic expectations with patients. Remind them that there is no magic bullet for the complex problem of CPP, and that chronic conditions generally do not improve overnight. Focus on improving the patient’s function and quality of life, and applaud symptom improvement rather than focusing on complete pain resolution.

As these visits often require a good deal of patient education, budget more appointment time if feasible. We find that scheduling frequent return visits (approximately every 3 to 4 months) allows timely treatment follow-up so that changes may be made if needed. If you have maximized your available treatment options, referring the patient to a specialist with additional training in CPP is a sensible next step.

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.

Chronic pelvic pain (CPP) is defined as noncyclic pain in the pelvis, anterior abdominal wall, back, or buttocks that has been present for at least 6 months and is severe enough to cause functional disability or require medical care.¹ CPP is very common, with an estimated prevalence of 15% to 20%. It accounts for 20% of gynecology visits and 15% of hysterectomies in the United States, and it is believed to account for $2.8 billion in direct health care spending annually.^2–5

Caring for patients with CPP can be very challenging. They often arrive at your office frustrated, having seen multiple providers or having undergone multiple surgeries. They may come to you whether you are a general ObGyn or subspecialize in maternal-fetal medicine, oncology, reproductive endocrinology, urogynecology, or adolescent gynecology. From interactions with other providers or their own family members, these patients may have received the message—either subtly or overtly—that their pain is “all in their head.” As such, some patients may resist any implication that their pain does not have an anatomic source. It is therefore critical to have appropriate tools for evaluating and managing the complex problem of CPP.

Perform a thorough and thoughtful assessment

Chronic pelvic pain often presents as a constellation of symptoms with contributions from multiple sources, as opposed to a single disease entity. Occasionally there is a single cause of pain, such as a large endometrioma or degenerating fibroid, where surgery can be curative. But more commonly the pain arises from multiple organ systems. In such cases, surgery may be unnecessary and, often, can worsen pain.

Thoughtful evaluation is critical in the CPP population. Take a thorough patient history to determine the characteristics of pain (cyclic or constant, widespread or localized), exacerbating factors, sleep disturbances, fatigue, and current coping strategies. Focus a comprehensive physical examination on identifying the maneuvers that reproduce the patient’s pain, and include an examination of the pelvic floor muscles.⁶ In most cases, pelvic ultrasonography provides adequate evaluation for anatomic sources of pain.

Chronic pain does not behave like acute injury or postsurgical pain. Continuous peripheral pain signals for a prolonged period can lead to changes in how the brain processes pain; specifically, the brain can begin to amplify pain signals. This “central pain amplification” is characterized clinically by widespread pain, fatigue, sleep disturbances, memory difficulties, and somatic symptoms. Central pain amplification occurs in many chronic pain conditions, including fibromyalgia, interstitial cystitis, irritable bowel syndrome, low back pain, chronic headaches, and temporomandibular joint disorder.^7,8 Recent clinical and functional magnetic resonance imaging (MRI) studies demonstrate central pain amplification in many patients with CPP.^9–12 Notably, these findings are independent of the presence or severity of endometriosis.

In this article we discuss many therapies that have not been specifically studied in patients with CPP, and treatment efficacy is extrapolated from other conditions with chronic pain amplification, such as fibromyalgia or interstitial cystitis. Additionally, many treatments for conditions associated with central pain amplification are used off-label, that is, the US Food and Drug Administration (FDA) has not approved the medication for treatment of these specific conditions. This should be disclosed to patients during counseling.

Discuss treatment expectations with patients

Educating patients regarding the pathophysiology of chronic pain and setting reasonable expectations is the cornerstone of providing patient-centered care for this complex condition. We start most of our discussions about treatment options by telling patients that while we may not cure their pain, we will provide them with medical, surgical, and behavioral strategies that will reduce their pain, improve their function, and enhance their quality of life.

Surprisingly, most patients say that a cure is not their goal. They just want to feel better so they can return to work or activities, fully participate in family life, or not feel exhausted all the time. As such, a multimodal treatment plan is generally the best strategy for achieving a satisfactory improvement in symptoms.

Read about treating a case of continued pain after endometriosis treatment.

CASE 1 Patient’s pain continues after endometriosis excision

A 32-year-old woman (G1P1) reports having CPP for 8 years. She underwent excision of stage 1 endometriosis last year, which resulted in a modest improvement in pain for 6 months. Her pain is worse during menses, at the end of the day, and with vaginal intercourse (both during and lasting for 1 to 2 days after). On examination, you find diffuse pelvic floor tenderness but no adnexal masses or rectovaginal nodularity on palpation.

What treatment options would you consider for this patient?

Multimodal treatment often needed to manage CPP symptoms

The patient described in Case 1 may benefit from a combination of therapies that include analgesics, hormone suppression agents, and physical therapy (PT) (TABLE).

Analgesics

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, work by inhibiting cyclooxygenase enzyme, which decreases assembly of peripheral prostaglandins and thromboxane. In a large Cochrane review, NSAIDs were associated with moderate or excellent pain relief for approximately 50% of patients with dysmenorrhea, and they have been shown to reduce menstrual flow due to decreased production of uterine prostaglandins.¹³ There is little evidence for use of NSAIDs in chronic pain conditions.

Acetaminophen’s mechanism of action is unclear, but the drug likely inhibits central prostaglandin synthesis, and it works synergistically with other analgesics.

Opioids act on μ and δ opioid receptors in the central and peripheral nervous systems as well as in the gastrointestinal system. No evidence supports opioid use in CPP or other chronic pain conditions. Long-term opioid use is associated with a multitude of adverse effects, risk for dependence, and the induction of opioid-induced hyperalgesia (in which patients develop greater sensitivity to pain stimuli).

Analgesics, specifically NSAIDs, can be considered for use in patients with dysmenorrhea, cyclic pain exacerbation, or a suspected inflammatory component of pain. Best practices include scheduling NSAID use before the onset of menses and continuing the drugs on a scheduled basis throughout. NSAIDs should be used for a brief period, and regular use on an empty stomach should be avoided.

Hormone suppression

Many types of hormone suppression therapy are available, including combined estrogen-progestin medications, progestin-only medications, and gonadotropin-releasing hormone (GnRH) agonists and antagonists.

Combined estrogen-progestin medications include oral contraceptive pills (OCPs), vaginal rings, and transdermal patches. Combined estrogen-progestin methods cause atrophy of eutopic and ectopic endometrium and suppress GnRH.

Progestin-only methods include oral formulations, the levonorgestrel intrauterine device, intramuscular and subcuticular injections, and subdermal implants. Progestin-only methods lead to atrophy of eutopic and ectopic endometrium.

A GnRH agonist, leuprolide depot works by downregulating luteinizing hormone and follicle stimulating hormone release from the pituitary, causing suppression of ovarian follicular development and ovulation, leading to a hypoestrogenic state.

Combined estrogen-progestin formulations and progestin-only options are often considered first-line therapy for dysmenorrhea and endometriosis.¹³ Continuous administration, with the goal of inducing amenorrhea, is effective in the treatment of dysmenorrhea. Several randomized controlled trials have shown that different types of hormone suppression agents are, essentially, equally effective.^13–15 Treatment recommendations therefore should focus on adverse effects, cost, and patient preference. GnRH agonists and norethindrone are not FDA approved for the treatment of endometriosis.

It may be appropriate to consider use of hormone suppression therapy in patients with menstrual exacerbation of pain symptoms, including those with a history of endometriosis. We generally advise patients that the goal is amenorrhea and that achieving it often involves a process of trying different formulations to find the best fit. Remember that GnRH agonists are dependent on a functional hypothalamic-pituitary-ovarian axis, and they are unlikely to be effective in women with suspected residual endometriosis who have had a bilateral oophorectomy.

Physical therapy

For CPP, PT typically targets musculoskeletal dysfunction in the pelvic floor, abdominal wall, hips, and back. Interventions include muscle control, mobilization, and biofeedback. Pelvic PT has been shown to improve pain and dyspareunia in patients with CPP, coccydynia, and vestibulodynia.^16–18 One large study found a significant, patient-directed decrease in pain medication use after pelvic floor PT.¹⁹ Pelvic PT for patients with interstitial cystitis and pelvic floor tenderness resulted in improved pain and bladder symptoms.²⁰

Pelvic PT can be considered for patients with pain reproducible with palpation of the pelvic floor, abdominal wall, paraspinal-lumbar muscles, or sacroiliac joints. Best practices include referral to a therapist who has specialized training in CPP, including pelvic floor therapy. It is important to clearly list the indication for referral, as many of these therapists also treat stress urinary incontinence. The wrong exercises can result in increased hypercontractility of pelvic floor muscles, which can worsen pelvic pain.

It is also critical to clarify expectations with your patient at the time of PT referral. Specifically, advise patients that when beginning therapy, it is common to experience a temporary increase in discomfort of the pelvic muscles. Inform patients also to expect that their therapist will perform internal manipulation of the pelvic floor muscles through the vagina, as this can be surprising for some patients. Finally, counsel patients that their adherence to daily home exercises improves their chance of a durable, long-term successful response.²¹

CASE 1 Treatment recommendations

For treatment of this patient’s CPP, consider scheduled naproxen therapy during menses, continuous OCPs, and referral for pelvic floor PT.

Read about treating a case of pain, sleep disturbance, and depression.

CASE 2 Patient with long-standing CPP, multiple diagnoses, and sleep problems

A 30-year-old woman (G2P2) reports having had CPP for 17 years. She is amenorrheic with continuous OCP treatment. She had experienced some improvement with pelvic PT. The patient reports that she has daily pain with intermittent pain flares and that she is exhausted and has poor sleep quality, which she attributes to pain. She has been diagnosed with interstitial cystitis, irritable bowel syndrome, and temporomandibular joint disorder. She has a history of depression, which she feels is well controlled with bupropion. Physical examination reveals that the patient has diffuse but mild pain in the pelvic floor and abdominal wall muscles.

What further pain management options can you offer for this patient?

Managing pain, sleep disturbance, and depression

This patient has been living with CPP for many years, and she has sleep difficulties that might be exacerbating pain or result from pain (or both). She is already on continuous OCPs and has had some relief with pelvic PT. Other options that may help with her multiple issues include antidepressants, cyclobenzaprine, and calcium channel blockers.

Antidepressants

Several classes of antidepressants have been used in the treatment of chronic pain conditions, specifically, tricyclic antidepressants (TCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Commonly used TCAs include amitriptyline, nortriptyline, desipramine, and doxepin. Commonly used SNRIs are duloxetine and milnacipran. Both TCAs and SNRIs increase the availability of norepinephrine and serotonin, which are thought to act on the descending pain inhibitory systems to decrease pain sensitivity. Of note, most selective serotonin reuptake inhibitors (SSRIs) at typical doses do not exert a significant enough impact on norepinephrine to be useful for chronic pain.²²

Evidence is limited on the use of antidepressants for treating CPP. Amitriptyline is the most extensively studied antidepressant. Amitriptyline treatment resulted in modest pain improvement in patients with CPP and fibromyalgia.^23,24 Bothersome anticholinergic effects, including fatigue, dry mouth, and constipation, often are reported with TCAs. Adverse effects tend to be less with nortriptyline or desipramine compared with amitriptyline, but possibly at the expense of efficacy.

While SNRIs have not yet been studied in CPP, several investigations have shown that they improve pain and quality of life in fibromyalgia patients.^22,25

Antidepressant therapy may be appropriate for patients with suspected central pain amplification, widespread pain, and sleep disturbances. Best practices include patient education and careful discussion of this option with your patient. We suggest that clinicians explain that antidepressant medications alter the function of neurotransmitters, which modulate pain signals. While neurotransmitters also are involved in mood modulation, this is not the therapeutic goal in this circumstance. In addition, the doses used for the effective treatment of chronic pain are significantly lower than those needed to treat depression effectively.

Patients often need to hear that you believe that their pain is real and is not a manifestation of depression or another mood disorder. If you suspect that the patient also has untreated depression, address this as its own issue and use medications that have greater efficacy for mood symptoms.

Because many antidepressants can cause sedation, they are best taken before bedtime. Also, slow dose titration over several weeks will reduce the chance of bothersome adverse effects. Counsel patients that efficacy is not generally seen until at goal dose for several weeks. Be aware of interactions with other medications that can cause serotonin syndrome.

Cyclobenzaprine

Cyclobenzaprine is a muscle relaxant that also has activity in the central nervous system. The drug’s precise mechanism of action is not known, but it appears to potentiate norepinephrine and bind to serotonin receptors. Thus, it also likely has some TCA-like activity.

Cyclobenzaprine has not been studied in patients with CPP. In fibromyalgia patients, however, it produced significant improvements in pain, sleep, fatigue, and tenderness.^26,27 In our anecdotal experience with CPP patients, cyclobenzaprine has been one of the most impactful therapies. It hits the “chronic pain triad,” meaning that it helps with myofascial pain, neuropathic pain, and sleep disturbances.

Cyclobenzaprine treatment may be considered for patients with myofascial pain, sleep disturbances, and clinical symptoms of central pain amplification. Best practices include starting with low (5 mg) scheduled doses at bedtime and slowly titrating the dose. Drowsiness is a very common side effect, so we try to use that to the patient’s advantage to help with sleep quality.

Notably, sleep disturbances are highly prevalent in patients with chronic pain.²⁸ The relationship appears to be bidirectional, meaning that chronic pain negatively impacts sleep quality, and poor sleep quality causes amplified perception of pain.^28–30 Interventions that improve sleep quality have been associated with improvements in pain, coping, mood, and functional status.³¹ Helping a patient to improve her sleep generally requires a multifaceted approach. It always involves “sleep hygiene” or a behavioral component, and pharmacologic assistance may be considered when improved sleep hygiene does not provide adequately improved sleep quality.

Calcium channel blockers

Gabapentin and pregabalin are calcium channel blockers that inhibit the reuptake of glutamate, norepinephrine, and substance P, which helps to decrease pain sensitivity. They also act as membrane stabilizers, reducing hyperexcitability of peripheral and central nerves. Studies have shown that in patients with CPP, gabapentin resulted in improved pain and mood symptoms with few adverse effects.^23,32 Patients with fibromyalgia had improvements in pain, sleep, quality of life, fatigue, and anxiety with both gabapentin and pregabalin.³³

It is appropriate to consider use of gabapentin or pregabalin in patients with central pain amplification and sleep disturbances. Best practices include starting with a low dose at bedtime. Traditionally, gabapentin is given in 3 equal doses throughout the day. In our experience, patients report less daytime drowsiness and better sleep quality if two-thirds of the daily dose is given at night, with the remaining daily dose broken up into 2 smaller daytime doses. Slow titration over several weeks will reduce risk of bothersome adverse effects. Patients should be counseled that efficacy is not generally seen until treatment is at goal dose for several weeks.

CASE 2 Treatment recommendations

For this patient with daily pelvic pain, multiple diagnoses that have a pain component, and poor sleep quality, consider a treatment plan that includes scheduled cyclobenzaprine, improved sleep hygiene, and, if needed, gabapentin.

Read about treating a case of focal pain.

CASE 3 Cesarean delivery, hysterectomy, and continued pelvic pain

A 38-year-old woman (G2P2) has had CPP for the past 10 years. She developed persistent left lower-quadrant pain after cesarean delivery of her son. She had a hysterectomy 2 years ago for CPP, after which her pain worsened. She describes daily pain with intermittent flares. On examination, the patient has focal left lower-quadrant pain lateral to the left apex of her Pfannenstiel incision.

What treatment approach would be appropriate for this patient?

Focal pain requires a precisely targeted treatment

This patient with focal left lower-quadrant pain is a candidate for anesthetic trigger point injections in the affected area near her Pfannenstiel incision.

Anesthetic injections

Consider the presence of trigger points and peripheral neuropathy in patients with focal abdominal wall pain. Trigger points are focal, palpable nodules within muscles. They are markedly painful to palpation and are associated with referred pain, motor dysfunction, and occasionally autonomic symptoms. They frequently are seen in abdominal wall or pelvic floor muscles in patients with CPP and are caused by abnormal neuromuscular depolarization.

The ilioinguinal, iliohypogastric, and genitofemoral nerves are in close proximity to Pfannenstiel and laparoscopic port site incisions. These nerves may be injured directly during surgery, but they also may be compressed by postoperative scarring.

Anesthetics, such as lidocaine and bupivacaine, which act as sodium channel blockers, can be injected into this area, and improvement often substantially outlasts the anesthetic’s duration of action. While these drugs’ mechanism of action is not clear, theories include altered function of sodium channels on sensory nerves with repeated anesthetic exposure, dry needling that occurs during injection, hydrodissection of tight connective tissue bands surrounding neuromuscular bundles, or depletion of substance P and neuropeptides as a result of injection.^34,35

In several studies, patients with CPP reported decreased pain with lidocaine injections in pelvic floor or abdominal wall trigger points.^36–38 Patients with fibromyalgia reported improvement in pain and a decreased need for NSAIDs with bupivacaine trigger point injections.³⁹ While abdominal wall nerve blocks have not been extensively studied in patients with chronic neuropathic pain following gynecologic surgery, they have been shown to substantially improve chronic neuropathic pain following inguinal hernia repair.⁴⁰

Anesthetic injections appropriately may be considered in patients with focal pain in a muscle or in the distribution of abdominal wall nerves, palpation of which reproduces pain symptoms. Patients with diffuse pain are less likely to benefit from anesthetic injections. Best practices include careful examination with attention to areas of prior abdominal incisions.

Our practice is to inject each affected area with a mix of 9 mL of 1% lidocaine and 1 mL of sodium bicarbonate. If a patient reports at least 24 hours of improvement, we repeat the injection in 2 to 4 weeks. The goal is for the patient to experience a progressively longer duration of benefit with subsequent injections. We perform repeat injections shortly after pain begins to recur at that site. The patient should eventually graduate from receiving regular injections and may return for a remedial injection if pain recurs.

CASE 3 Treatment recommendations

For this patient with persistent focal left-lower quadrant pain and a defined trigger point near her Pfannenstiel incision, consider anesthetic injection in the left lower quadrant.

Work toward realistic symptom improvement

Remember that living with chronic pain is exhausting, and empathy with a patient-centered approach is the most important ingredient for patient improvement and satisfaction. Discuss realistic expectations with patients. Remind them that there is no magic bullet for the complex problem of CPP, and that chronic conditions generally do not improve overnight. Focus on improving the patient’s function and quality of life, and applaud symptom improvement rather than focusing on complete pain resolution.

As these visits often require a good deal of patient education, budget more appointment time if feasible. We find that scheduling frequent return visits (approximately every 3 to 4 months) allows timely treatment follow-up so that changes may be made if needed. If you have maximized your available treatment options, referring the patient to a specialist with additional training in CPP is a sensible next step.

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.

Chronic pelvic pain (CPP) is defined as noncyclic pain in the pelvis, anterior abdominal wall, back, or buttocks that has been present for at least 6 months and is severe enough to cause functional disability or require medical care.¹ CPP is very common, with an estimated prevalence of 15% to 20%. It accounts for 20% of gynecology visits and 15% of hysterectomies in the United States, and it is believed to account for $2.8 billion in direct health care spending annually.^2–5

Caring for patients with CPP can be very challenging. They often arrive at your office frustrated, having seen multiple providers or having undergone multiple surgeries. They may come to you whether you are a general ObGyn or subspecialize in maternal-fetal medicine, oncology, reproductive endocrinology, urogynecology, or adolescent gynecology. From interactions with other providers or their own family members, these patients may have received the message—either subtly or overtly—that their pain is “all in their head.” As such, some patients may resist any implication that their pain does not have an anatomic source. It is therefore critical to have appropriate tools for evaluating and managing the complex problem of CPP.

Perform a thorough and thoughtful assessment

Chronic pelvic pain often presents as a constellation of symptoms with contributions from multiple sources, as opposed to a single disease entity. Occasionally there is a single cause of pain, such as a large endometrioma or degenerating fibroid, where surgery can be curative. But more commonly the pain arises from multiple organ systems. In such cases, surgery may be unnecessary and, often, can worsen pain.

Thoughtful evaluation is critical in the CPP population. Take a thorough patient history to determine the characteristics of pain (cyclic or constant, widespread or localized), exacerbating factors, sleep disturbances, fatigue, and current coping strategies. Focus a comprehensive physical examination on identifying the maneuvers that reproduce the patient’s pain, and include an examination of the pelvic floor muscles.⁶ In most cases, pelvic ultrasonography provides adequate evaluation for anatomic sources of pain.

Chronic pain does not behave like acute injury or postsurgical pain. Continuous peripheral pain signals for a prolonged period can lead to changes in how the brain processes pain; specifically, the brain can begin to amplify pain signals. This “central pain amplification” is characterized clinically by widespread pain, fatigue, sleep disturbances, memory difficulties, and somatic symptoms. Central pain amplification occurs in many chronic pain conditions, including fibromyalgia, interstitial cystitis, irritable bowel syndrome, low back pain, chronic headaches, and temporomandibular joint disorder.^7,8 Recent clinical and functional magnetic resonance imaging (MRI) studies demonstrate central pain amplification in many patients with CPP.^9–12 Notably, these findings are independent of the presence or severity of endometriosis.

In this article we discuss many therapies that have not been specifically studied in patients with CPP, and treatment efficacy is extrapolated from other conditions with chronic pain amplification, such as fibromyalgia or interstitial cystitis. Additionally, many treatments for conditions associated with central pain amplification are used off-label, that is, the US Food and Drug Administration (FDA) has not approved the medication for treatment of these specific conditions. This should be disclosed to patients during counseling.

Discuss treatment expectations with patients

Educating patients regarding the pathophysiology of chronic pain and setting reasonable expectations is the cornerstone of providing patient-centered care for this complex condition. We start most of our discussions about treatment options by telling patients that while we may not cure their pain, we will provide them with medical, surgical, and behavioral strategies that will reduce their pain, improve their function, and enhance their quality of life.

Surprisingly, most patients say that a cure is not their goal. They just want to feel better so they can return to work or activities, fully participate in family life, or not feel exhausted all the time. As such, a multimodal treatment plan is generally the best strategy for achieving a satisfactory improvement in symptoms.

Read about treating a case of continued pain after endometriosis treatment.

CASE 1 Patient’s pain continues after endometriosis excision

A 32-year-old woman (G1P1) reports having CPP for 8 years. She underwent excision of stage 1 endometriosis last year, which resulted in a modest improvement in pain for 6 months. Her pain is worse during menses, at the end of the day, and with vaginal intercourse (both during and lasting for 1 to 2 days after). On examination, you find diffuse pelvic floor tenderness but no adnexal masses or rectovaginal nodularity on palpation.

What treatment options would you consider for this patient?

Multimodal treatment often needed to manage CPP symptoms

The patient described in Case 1 may benefit from a combination of therapies that include analgesics, hormone suppression agents, and physical therapy (PT) (TABLE).

Analgesics

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, work by inhibiting cyclooxygenase enzyme, which decreases assembly of peripheral prostaglandins and thromboxane. In a large Cochrane review, NSAIDs were associated with moderate or excellent pain relief for approximately 50% of patients with dysmenorrhea, and they have been shown to reduce menstrual flow due to decreased production of uterine prostaglandins.¹³ There is little evidence for use of NSAIDs in chronic pain conditions.

Acetaminophen’s mechanism of action is unclear, but the drug likely inhibits central prostaglandin synthesis, and it works synergistically with other analgesics.

Opioids act on μ and δ opioid receptors in the central and peripheral nervous systems as well as in the gastrointestinal system. No evidence supports opioid use in CPP or other chronic pain conditions. Long-term opioid use is associated with a multitude of adverse effects, risk for dependence, and the induction of opioid-induced hyperalgesia (in which patients develop greater sensitivity to pain stimuli).

Analgesics, specifically NSAIDs, can be considered for use in patients with dysmenorrhea, cyclic pain exacerbation, or a suspected inflammatory component of pain. Best practices include scheduling NSAID use before the onset of menses and continuing the drugs on a scheduled basis throughout. NSAIDs should be used for a brief period, and regular use on an empty stomach should be avoided.

Hormone suppression

Many types of hormone suppression therapy are available, including combined estrogen-progestin medications, progestin-only medications, and gonadotropin-releasing hormone (GnRH) agonists and antagonists.

Combined estrogen-progestin medications include oral contraceptive pills (OCPs), vaginal rings, and transdermal patches. Combined estrogen-progestin methods cause atrophy of eutopic and ectopic endometrium and suppress GnRH.

Progestin-only methods include oral formulations, the levonorgestrel intrauterine device, intramuscular and subcuticular injections, and subdermal implants. Progestin-only methods lead to atrophy of eutopic and ectopic endometrium.

A GnRH agonist, leuprolide depot works by downregulating luteinizing hormone and follicle stimulating hormone release from the pituitary, causing suppression of ovarian follicular development and ovulation, leading to a hypoestrogenic state.

Combined estrogen-progestin formulations and progestin-only options are often considered first-line therapy for dysmenorrhea and endometriosis.¹³ Continuous administration, with the goal of inducing amenorrhea, is effective in the treatment of dysmenorrhea. Several randomized controlled trials have shown that different types of hormone suppression agents are, essentially, equally effective.^13–15 Treatment recommendations therefore should focus on adverse effects, cost, and patient preference. GnRH agonists and norethindrone are not FDA approved for the treatment of endometriosis.

It may be appropriate to consider use of hormone suppression therapy in patients with menstrual exacerbation of pain symptoms, including those with a history of endometriosis. We generally advise patients that the goal is amenorrhea and that achieving it often involves a process of trying different formulations to find the best fit. Remember that GnRH agonists are dependent on a functional hypothalamic-pituitary-ovarian axis, and they are unlikely to be effective in women with suspected residual endometriosis who have had a bilateral oophorectomy.

Physical therapy

For CPP, PT typically targets musculoskeletal dysfunction in the pelvic floor, abdominal wall, hips, and back. Interventions include muscle control, mobilization, and biofeedback. Pelvic PT has been shown to improve pain and dyspareunia in patients with CPP, coccydynia, and vestibulodynia.^16–18 One large study found a significant, patient-directed decrease in pain medication use after pelvic floor PT.¹⁹ Pelvic PT for patients with interstitial cystitis and pelvic floor tenderness resulted in improved pain and bladder symptoms.²⁰

Pelvic PT can be considered for patients with pain reproducible with palpation of the pelvic floor, abdominal wall, paraspinal-lumbar muscles, or sacroiliac joints. Best practices include referral to a therapist who has specialized training in CPP, including pelvic floor therapy. It is important to clearly list the indication for referral, as many of these therapists also treat stress urinary incontinence. The wrong exercises can result in increased hypercontractility of pelvic floor muscles, which can worsen pelvic pain.

It is also critical to clarify expectations with your patient at the time of PT referral. Specifically, advise patients that when beginning therapy, it is common to experience a temporary increase in discomfort of the pelvic muscles. Inform patients also to expect that their therapist will perform internal manipulation of the pelvic floor muscles through the vagina, as this can be surprising for some patients. Finally, counsel patients that their adherence to daily home exercises improves their chance of a durable, long-term successful response.²¹

CASE 1 Treatment recommendations

For treatment of this patient’s CPP, consider scheduled naproxen therapy during menses, continuous OCPs, and referral for pelvic floor PT.

Read about treating a case of pain, sleep disturbance, and depression.

CASE 2 Patient with long-standing CPP, multiple diagnoses, and sleep problems

A 30-year-old woman (G2P2) reports having had CPP for 17 years. She is amenorrheic with continuous OCP treatment. She had experienced some improvement with pelvic PT. The patient reports that she has daily pain with intermittent pain flares and that she is exhausted and has poor sleep quality, which she attributes to pain. She has been diagnosed with interstitial cystitis, irritable bowel syndrome, and temporomandibular joint disorder. She has a history of depression, which she feels is well controlled with bupropion. Physical examination reveals that the patient has diffuse but mild pain in the pelvic floor and abdominal wall muscles.

What further pain management options can you offer for this patient?

Managing pain, sleep disturbance, and depression

This patient has been living with CPP for many years, and she has sleep difficulties that might be exacerbating pain or result from pain (or both). She is already on continuous OCPs and has had some relief with pelvic PT. Other options that may help with her multiple issues include antidepressants, cyclobenzaprine, and calcium channel blockers.

Antidepressants

Several classes of antidepressants have been used in the treatment of chronic pain conditions, specifically, tricyclic antidepressants (TCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Commonly used TCAs include amitriptyline, nortriptyline, desipramine, and doxepin. Commonly used SNRIs are duloxetine and milnacipran. Both TCAs and SNRIs increase the availability of norepinephrine and serotonin, which are thought to act on the descending pain inhibitory systems to decrease pain sensitivity. Of note, most selective serotonin reuptake inhibitors (SSRIs) at typical doses do not exert a significant enough impact on norepinephrine to be useful for chronic pain.²²

Evidence is limited on the use of antidepressants for treating CPP. Amitriptyline is the most extensively studied antidepressant. Amitriptyline treatment resulted in modest pain improvement in patients with CPP and fibromyalgia.^23,24 Bothersome anticholinergic effects, including fatigue, dry mouth, and constipation, often are reported with TCAs. Adverse effects tend to be less with nortriptyline or desipramine compared with amitriptyline, but possibly at the expense of efficacy.

While SNRIs have not yet been studied in CPP, several investigations have shown that they improve pain and quality of life in fibromyalgia patients.^22,25

Antidepressant therapy may be appropriate for patients with suspected central pain amplification, widespread pain, and sleep disturbances. Best practices include patient education and careful discussion of this option with your patient. We suggest that clinicians explain that antidepressant medications alter the function of neurotransmitters, which modulate pain signals. While neurotransmitters also are involved in mood modulation, this is not the therapeutic goal in this circumstance. In addition, the doses used for the effective treatment of chronic pain are significantly lower than those needed to treat depression effectively.

Patients often need to hear that you believe that their pain is real and is not a manifestation of depression or another mood disorder. If you suspect that the patient also has untreated depression, address this as its own issue and use medications that have greater efficacy for mood symptoms.

Because many antidepressants can cause sedation, they are best taken before bedtime. Also, slow dose titration over several weeks will reduce the chance of bothersome adverse effects. Counsel patients that efficacy is not generally seen until at goal dose for several weeks. Be aware of interactions with other medications that can cause serotonin syndrome.

Cyclobenzaprine

Cyclobenzaprine is a muscle relaxant that also has activity in the central nervous system. The drug’s precise mechanism of action is not known, but it appears to potentiate norepinephrine and bind to serotonin receptors. Thus, it also likely has some TCA-like activity.

Cyclobenzaprine has not been studied in patients with CPP. In fibromyalgia patients, however, it produced significant improvements in pain, sleep, fatigue, and tenderness.^26,27 In our anecdotal experience with CPP patients, cyclobenzaprine has been one of the most impactful therapies. It hits the “chronic pain triad,” meaning that it helps with myofascial pain, neuropathic pain, and sleep disturbances.

Cyclobenzaprine treatment may be considered for patients with myofascial pain, sleep disturbances, and clinical symptoms of central pain amplification. Best practices include starting with low (5 mg) scheduled doses at bedtime and slowly titrating the dose. Drowsiness is a very common side effect, so we try to use that to the patient’s advantage to help with sleep quality.

Notably, sleep disturbances are highly prevalent in patients with chronic pain.²⁸ The relationship appears to be bidirectional, meaning that chronic pain negatively impacts sleep quality, and poor sleep quality causes amplified perception of pain.^28–30 Interventions that improve sleep quality have been associated with improvements in pain, coping, mood, and functional status.³¹ Helping a patient to improve her sleep generally requires a multifaceted approach. It always involves “sleep hygiene” or a behavioral component, and pharmacologic assistance may be considered when improved sleep hygiene does not provide adequately improved sleep quality.

Calcium channel blockers

Gabapentin and pregabalin are calcium channel blockers that inhibit the reuptake of glutamate, norepinephrine, and substance P, which helps to decrease pain sensitivity. They also act as membrane stabilizers, reducing hyperexcitability of peripheral and central nerves. Studies have shown that in patients with CPP, gabapentin resulted in improved pain and mood symptoms with few adverse effects.^23,32 Patients with fibromyalgia had improvements in pain, sleep, quality of life, fatigue, and anxiety with both gabapentin and pregabalin.³³

It is appropriate to consider use of gabapentin or pregabalin in patients with central pain amplification and sleep disturbances. Best practices include starting with a low dose at bedtime. Traditionally, gabapentin is given in 3 equal doses throughout the day. In our experience, patients report less daytime drowsiness and better sleep quality if two-thirds of the daily dose is given at night, with the remaining daily dose broken up into 2 smaller daytime doses. Slow titration over several weeks will reduce risk of bothersome adverse effects. Patients should be counseled that efficacy is not generally seen until treatment is at goal dose for several weeks.

CASE 2 Treatment recommendations

For this patient with daily pelvic pain, multiple diagnoses that have a pain component, and poor sleep quality, consider a treatment plan that includes scheduled cyclobenzaprine, improved sleep hygiene, and, if needed, gabapentin.

Read about treating a case of focal pain.

CASE 3 Cesarean delivery, hysterectomy, and continued pelvic pain

A 38-year-old woman (G2P2) has had CPP for the past 10 years. She developed persistent left lower-quadrant pain after cesarean delivery of her son. She had a hysterectomy 2 years ago for CPP, after which her pain worsened. She describes daily pain with intermittent flares. On examination, the patient has focal left lower-quadrant pain lateral to the left apex of her Pfannenstiel incision.

What treatment approach would be appropriate for this patient?

Focal pain requires a precisely targeted treatment

This patient with focal left lower-quadrant pain is a candidate for anesthetic trigger point injections in the affected area near her Pfannenstiel incision.

Anesthetic injections

Consider the presence of trigger points and peripheral neuropathy in patients with focal abdominal wall pain. Trigger points are focal, palpable nodules within muscles. They are markedly painful to palpation and are associated with referred pain, motor dysfunction, and occasionally autonomic symptoms. They frequently are seen in abdominal wall or pelvic floor muscles in patients with CPP and are caused by abnormal neuromuscular depolarization.

The ilioinguinal, iliohypogastric, and genitofemoral nerves are in close proximity to Pfannenstiel and laparoscopic port site incisions. These nerves may be injured directly during surgery, but they also may be compressed by postoperative scarring.

Anesthetics, such as lidocaine and bupivacaine, which act as sodium channel blockers, can be injected into this area, and improvement often substantially outlasts the anesthetic’s duration of action. While these drugs’ mechanism of action is not clear, theories include altered function of sodium channels on sensory nerves with repeated anesthetic exposure, dry needling that occurs during injection, hydrodissection of tight connective tissue bands surrounding neuromuscular bundles, or depletion of substance P and neuropeptides as a result of injection.^34,35

In several studies, patients with CPP reported decreased pain with lidocaine injections in pelvic floor or abdominal wall trigger points.^36–38 Patients with fibromyalgia reported improvement in pain and a decreased need for NSAIDs with bupivacaine trigger point injections.³⁹ While abdominal wall nerve blocks have not been extensively studied in patients with chronic neuropathic pain following gynecologic surgery, they have been shown to substantially improve chronic neuropathic pain following inguinal hernia repair.⁴⁰

Anesthetic injections appropriately may be considered in patients with focal pain in a muscle or in the distribution of abdominal wall nerves, palpation of which reproduces pain symptoms. Patients with diffuse pain are less likely to benefit from anesthetic injections. Best practices include careful examination with attention to areas of prior abdominal incisions.

Our practice is to inject each affected area with a mix of 9 mL of 1% lidocaine and 1 mL of sodium bicarbonate. If a patient reports at least 24 hours of improvement, we repeat the injection in 2 to 4 weeks. The goal is for the patient to experience a progressively longer duration of benefit with subsequent injections. We perform repeat injections shortly after pain begins to recur at that site. The patient should eventually graduate from receiving regular injections and may return for a remedial injection if pain recurs.

CASE 3 Treatment recommendations

For this patient with persistent focal left-lower quadrant pain and a defined trigger point near her Pfannenstiel incision, consider anesthetic injection in the left lower quadrant.

Work toward realistic symptom improvement

Remember that living with chronic pain is exhausting, and empathy with a patient-centered approach is the most important ingredient for patient improvement and satisfaction. Discuss realistic expectations with patients. Remind them that there is no magic bullet for the complex problem of CPP, and that chronic conditions generally do not improve overnight. Focus on improving the patient’s function and quality of life, and applaud symptom improvement rather than focusing on complete pain resolution.

As these visits often require a good deal of patient education, budget more appointment time if feasible. We find that scheduling frequent return visits (approximately every 3 to 4 months) allows timely treatment follow-up so that changes may be made if needed. If you have maximized your available treatment options, referring the patient to a specialist with additional training in CPP is a sensible next step.

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.