OBG Management

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

NEW CERVICAL DILATOR

Hologic, Inc. announces the launch of the Definity Cervical Dilator, allowing tenaculum-free access to the uterine cavity, which lessens patient discomfort and reduces the risk of perforation during dilation, says Hologic. The dilator uses SureAccess—an expandable balloon technology designed to eliminate multiple passes and ensure safety during insertion, even for patients with complex or challenging cervical anatomy. Definity Cervical Dilator is not intended for use during induction of labor; some examples for its use include treatment of cervical stenosis, intrauterine device placement and removal, uterine tissue removal, diagnostic hysteroscopy, and operative hysteroscopy. Use of the system is contraindicated in patients with active genital tract infection, pelvic structure abnormality preventing device passage, or invasive cervical cancer. The Definity Cervical Dilator is now available across the United States in 5 mm, 7 mm, and 9 mm sizes.

FOR MORE INFORMATION, VISIT: https://www.hologic.com/

LIGHT DEVICE FOR HAIR REJUVENATION

Pattern hair loss (androgenetic alopecia) affects about 80 million men and women in the United States. In women, the hair loss typically occurs as thinning or widening of the midline. Revian, Inc. is focused on improving overall scalp health by stimulating the body’s natural processes for hair and skin rejuvenation with light therapy. REVIAN RED, a dual-wavelength LED hair growth cap, has successfully demonstrated the ability to stop hair loss and subsequently grow new hair, says Revian. In a recent clinical trial, women who were at least 80% compliant with wearing REVIAN RED (versus a placebo cap with no light therapy) for 10 minutes per day had a mean improvement of 26.3 hairs/cm². Scalp irritations were assessed during the trial, with patient-reported itching and burning/stinging treated with at-home therapies.

The REVIAN RED wireless cap system is controlled by a mobile app and is US Food and Drug Administration (FDA) cleared as a hair loss treatment for men and women. The mechanism of action for improved scalp symptoms, says Revian, is the patented dual-wavelength light, which releases nitric oxide and is proposed to be anti-inflammatory.

The REVIAN RED system is indicated to treat androgenetic alopecia and to promote hair growth in men with Norwood-Hamilton classifications of IIa–V patterns of hair loss and to treat androgenetic alopecia and promote hair growth in women with Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I–IV.

FOR MORE INFORMATION, VISIT: https://www.revian.com/

SUI TREATMENT

ELITONE from Elidah is the first transcutaneous pelvic floor muscle stimulation treatment for stress urinary incontinence (SUI). It is FDA cleared and works to train women to perform Kegel techniques by naturally contracting the correct pelvic floor muscles and surrounding tissues. The device is placed where a pad would go, according to Elidah, with conductive gel areas within the device delivering electrical muscle stimulation. Twenty-minute treatments 4 to 5 times per week are recommended, with improved SUI symptoms, depending on severity, for many women in 6 weeks. Three-quarters of women had significant reduction in daily leaks after 6 weeks of self-administered treatment with ELITONE, reports the manufacturer.

Elidah says that ELITONE is ideal for women with mild to moderate SUI symptoms who would benefit from pelvic floor muscle training, including those who are resistant to intravaginal treatments, need postpartum care, or have limited access to physical therapy. The device is contraindicated in women who have an implanted cardiac device, cancer, epilepsy, or recent pelvic floor surgery.

FOR OTHER CONTRAINDICATIONS AND MORE INFORMATION, VISIT: https:/elitone.com/

NEW CERVICAL DILATOR

Hologic, Inc. announces the launch of the Definity Cervical Dilator, allowing tenaculum-free access to the uterine cavity, which lessens patient discomfort and reduces the risk of perforation during dilation, says Hologic. The dilator uses SureAccess—an expandable balloon technology designed to eliminate multiple passes and ensure safety during insertion, even for patients with complex or challenging cervical anatomy. Definity Cervical Dilator is not intended for use during induction of labor; some examples for its use include treatment of cervical stenosis, intrauterine device placement and removal, uterine tissue removal, diagnostic hysteroscopy, and operative hysteroscopy. Use of the system is contraindicated in patients with active genital tract infection, pelvic structure abnormality preventing device passage, or invasive cervical cancer. The Definity Cervical Dilator is now available across the United States in 5 mm, 7 mm, and 9 mm sizes.

FOR MORE INFORMATION, VISIT: https://www.hologic.com/

LIGHT DEVICE FOR HAIR REJUVENATION

Pattern hair loss (androgenetic alopecia) affects about 80 million men and women in the United States. In women, the hair loss typically occurs as thinning or widening of the midline. Revian, Inc. is focused on improving overall scalp health by stimulating the body’s natural processes for hair and skin rejuvenation with light therapy. REVIAN RED, a dual-wavelength LED hair growth cap, has successfully demonstrated the ability to stop hair loss and subsequently grow new hair, says Revian. In a recent clinical trial, women who were at least 80% compliant with wearing REVIAN RED (versus a placebo cap with no light therapy) for 10 minutes per day had a mean improvement of 26.3 hairs/cm². Scalp irritations were assessed during the trial, with patient-reported itching and burning/stinging treated with at-home therapies.

The REVIAN RED wireless cap system is controlled by a mobile app and is US Food and Drug Administration (FDA) cleared as a hair loss treatment for men and women. The mechanism of action for improved scalp symptoms, says Revian, is the patented dual-wavelength light, which releases nitric oxide and is proposed to be anti-inflammatory.

The REVIAN RED system is indicated to treat androgenetic alopecia and to promote hair growth in men with Norwood-Hamilton classifications of IIa–V patterns of hair loss and to treat androgenetic alopecia and promote hair growth in women with Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I–IV.

FOR MORE INFORMATION, VISIT: https://www.revian.com/

SUI TREATMENT

ELITONE from Elidah is the first transcutaneous pelvic floor muscle stimulation treatment for stress urinary incontinence (SUI). It is FDA cleared and works to train women to perform Kegel techniques by naturally contracting the correct pelvic floor muscles and surrounding tissues. The device is placed where a pad would go, according to Elidah, with conductive gel areas within the device delivering electrical muscle stimulation. Twenty-minute treatments 4 to 5 times per week are recommended, with improved SUI symptoms, depending on severity, for many women in 6 weeks. Three-quarters of women had significant reduction in daily leaks after 6 weeks of self-administered treatment with ELITONE, reports the manufacturer.

Elidah says that ELITONE is ideal for women with mild to moderate SUI symptoms who would benefit from pelvic floor muscle training, including those who are resistant to intravaginal treatments, need postpartum care, or have limited access to physical therapy. The device is contraindicated in women who have an implanted cardiac device, cancer, epilepsy, or recent pelvic floor surgery.

FOR OTHER CONTRAINDICATIONS AND MORE INFORMATION, VISIT: https:/elitone.com/

NEW CERVICAL DILATOR

Hologic, Inc. announces the launch of the Definity Cervical Dilator, allowing tenaculum-free access to the uterine cavity, which lessens patient discomfort and reduces the risk of perforation during dilation, says Hologic. The dilator uses SureAccess—an expandable balloon technology designed to eliminate multiple passes and ensure safety during insertion, even for patients with complex or challenging cervical anatomy. Definity Cervical Dilator is not intended for use during induction of labor; some examples for its use include treatment of cervical stenosis, intrauterine device placement and removal, uterine tissue removal, diagnostic hysteroscopy, and operative hysteroscopy. Use of the system is contraindicated in patients with active genital tract infection, pelvic structure abnormality preventing device passage, or invasive cervical cancer. The Definity Cervical Dilator is now available across the United States in 5 mm, 7 mm, and 9 mm sizes.

FOR MORE INFORMATION, VISIT: https://www.hologic.com/

LIGHT DEVICE FOR HAIR REJUVENATION

Pattern hair loss (androgenetic alopecia) affects about 80 million men and women in the United States. In women, the hair loss typically occurs as thinning or widening of the midline. Revian, Inc. is focused on improving overall scalp health by stimulating the body’s natural processes for hair and skin rejuvenation with light therapy. REVIAN RED, a dual-wavelength LED hair growth cap, has successfully demonstrated the ability to stop hair loss and subsequently grow new hair, says Revian. In a recent clinical trial, women who were at least 80% compliant with wearing REVIAN RED (versus a placebo cap with no light therapy) for 10 minutes per day had a mean improvement of 26.3 hairs/cm². Scalp irritations were assessed during the trial, with patient-reported itching and burning/stinging treated with at-home therapies.

The REVIAN RED wireless cap system is controlled by a mobile app and is US Food and Drug Administration (FDA) cleared as a hair loss treatment for men and women. The mechanism of action for improved scalp symptoms, says Revian, is the patented dual-wavelength light, which releases nitric oxide and is proposed to be anti-inflammatory.

The REVIAN RED system is indicated to treat androgenetic alopecia and to promote hair growth in men with Norwood-Hamilton classifications of IIa–V patterns of hair loss and to treat androgenetic alopecia and promote hair growth in women with Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I–IV.

FOR MORE INFORMATION, VISIT: https://www.revian.com/

SUI TREATMENT

ELITONE from Elidah is the first transcutaneous pelvic floor muscle stimulation treatment for stress urinary incontinence (SUI). It is FDA cleared and works to train women to perform Kegel techniques by naturally contracting the correct pelvic floor muscles and surrounding tissues. The device is placed where a pad would go, according to Elidah, with conductive gel areas within the device delivering electrical muscle stimulation. Twenty-minute treatments 4 to 5 times per week are recommended, with improved SUI symptoms, depending on severity, for many women in 6 weeks. Three-quarters of women had significant reduction in daily leaks after 6 weeks of self-administered treatment with ELITONE, reports the manufacturer.

Elidah says that ELITONE is ideal for women with mild to moderate SUI symptoms who would benefit from pelvic floor muscle training, including those who are resistant to intravaginal treatments, need postpartum care, or have limited access to physical therapy. The device is contraindicated in women who have an implanted cardiac device, cancer, epilepsy, or recent pelvic floor surgery.

FOR OTHER CONTRAINDICATIONS AND MORE INFORMATION, VISIT: https:/elitone.com/

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●