Gynecology

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Infection with high-risk human papillomavirus (hrHPV) is an essential step in the development of cervical cancer and its precursors, as well as in several other cancers, including oropharyngeal, vulvar, vaginal, anal, and penile cancers. At least 13 HPV strains, known collectively as hrHPV, have been associated with cervical cancer, in addition to more than 150 low-risk HPV types that have not been associated with cancer (for example, HPV 6 and 11).¹ Up to 80% of women (and most men, although men are not tested routinely) will become infected with at least one of the high-risk HPV types throughout their lives, although in most cases these infections will be transient and have no clinical impact for the patient. Patients who test positive consecutively over time for hrHPV, and especially those who test positive for one of the most virulent HPV types (HPV 16 or 18), have a higher risk of developing cervical cancer or precancer. In addition, many patients who acquire HPV at a young age may “clear” the infection, which usually means that the virus becomes inactive; however, often, for unknown reasons, the virus can be reactivated in some women later in life.

This knowledge of the natural history of HPV has led to improved approaches to cervical cancer prevention, which relies on a combined strategy that includes vaccinating as many children and young adults as possible against hrHPV, screening and triaging approaches that use HPV-based tests, and applying risk-based evaluation for abnormal screening results. New guidelines and information address the best approaches to each of these aspects of cervical cancer prevention, which we review here.

HPV vaccination: Recommendations and effect on cervical cancer rates

Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68:698-702.

Lei J, Ploner A, Elfstrom KM, et al. HPV vaccination and the risk of invasive cervical cancer. N Engl J Med. 2020;383;1340-1348.

Vaccination at ages 27 to 45, although approved by the US Food and Drug Administration, is recommended only in a shared decision-making capacity by ACIP and the American College of Obstetricians and Gynecologists (ACOG) due to the vaccine’s minimal effect on cancer prevention in this age group. The ACIP and ACOG do not recommend catch-up vaccination for adults aged 27 to 45 years, but they recognize that some who are not adequately vaccinated might be at risk for new HPV infection and thus may benefit from vaccination.⁴

In contrast, the American Cancer Society (ACS) does not endorse the 2019 ACIP recommendation for shared clinical decision making in 27- to 45-year-olds because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on selecting individuals who might benefit.⁵

Decline in HPV infections

A study in the United States between 2003 and 2014 showed a 71% decline in vaccine-type HPV infections among girls and women aged 14 to 19 in the post–vaccine available era as compared with the prevaccine era, and a lesser but still reasonable decline among women in the 20- to 24-year-old age group.⁶ Overall, vaccine-type HPV infections decreased 89% for vaccinated girls and 34% for unvaccinated girls, demonstrating some herd immunity.⁶ Ideally, the vaccine is given before the onset of skin-to-skin genital sexual activity. Many studies have found the vaccine to be safe and that immunogenicity is maintained for at least 9 years.^7-11

Decrease in invasive cervical cancer

Recently, Lei and colleagues published a study in the New England Journal of Medicine that reviewed outcomes for more than 1.6 million girls and women vaccinated against HPV in Sweden between 2006 and 2017.¹² Among girls who were vaccinated at younger than 17 years of age, there were only 2 cases of cancer, in contrast to 17 cases among those vaccinated at age 17 to 30 and 538 cases among those not vaccinated.

This is the first study to show definitively the preventive effect of HPV vaccination on the development of invasive cancer and the tremendous advantage of vaccinating at a young age. Nonetheless, the advantage conferred by catch-up vaccination (that is, vaccinating those at ages 17–30) also was significant.

Continue to: Updated guidance on cervical cancer screening for average-risk women...

Updated guidance on cervical cancer screening for average-risk women

US Preventive Services Task Force; Curry SJ, Frist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.

Fontham ET, Wolf AM, Church TR, et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin. 2020;70:321-346.

As more is understood about the natural history of HPV and its role in the development of cervical cancer and its precursors, refinements and updates have been made to our approaches for screening people at risk. There is much evidence and experience available on recommending Pap testing and HPV cotesting (testing for HPV along with cytology even if the cytology result is normal) among women aged 30 to 65 years, as that has been an option since the 2012 guidelines were published.¹⁵

We know also that HPV testing is more sensitive for detecting cervical intraepithelial neoplasia grade 3 (CIN 3) or greater at 5 years and that a negative HPV test is more reassuring than a negative Pap test.¹⁶

Primary HPV tests

HPV tests can be used in conjunction with cytology (that is, cotesting) or as a primary screening that if positive, can reflex either to cytology or to testing for the most oncogenic subtypes. Currently, only 2 FDA-approved primary screening tests are available, the cobas 4800 HPV test system (Roche Diagnostics) and the BD Onclarity HPV assay (Becton, Dickinson and Company).¹⁷ Most laboratories in the United States do not yet have the technology for primary testing, and so instead they offer one of the remaining tests (Hybrid Capture 2 [Qiagen] and Cervista and Aptima [Hologic]), which do not necessarily have the same positive and negative predictive value as the tests specifically approved for primary testing. Thus, many clinicians and patients do not yet have access to primary HPV testing.

In addition, due to slow uptake of the HPV vaccine in many parts of the United States,¹³ there is concern that adding HPV testing in nonvaccinated women under age 30 would result in a surge of unnecessary colposcopy procedures for women with transient infections. Thus, several large expert organizations differ in opinion regarding screening among certain populations and by which test.

Screening guidance from national organizations

The US Preventive Services Task Force (USPSTF) and the American Cancer Society (ACS) differ in their recommendations for screening women in their 20s for cervical cancer.^18,19 The USPSTF guidelines, which were published first, focus not only on the best test but also on what is feasible and likely to benefit public health, given our current testing capacity and vaccine coverage. The USPSTF recommends starting screening at age 21 with cytology and, if all results are normal, continuing every 3 years until age 30, at which point they recommend cytology every 3 years or cotesting every 5 years or primary HPV testing alone every 5 years (if all results are normal in each case).

In contrast, the ACS published "aspirational” guidelines, with the best evidence-based recommendations, but they acknowledge that due to availability of different testing options, some patients still need to be screened with existing modalities. The ACS recommends the onset of screening at age 25 with either primary HPV testing every 5 years (preferred) or cotesting every 5 years or cytology every 3 years.

Both the USPSTF and ACS guidelines state that if using cytology alone, the screening frequency should be every 3 years, and if using an HPV-based test, the screening interval (if all results are normal) can be extended to every 5 years.

Continue to: New ASCCP management guidelines focus on individualized risk assessment...

New ASCCP management guidelines focus on individualized risk assessment

Perkins RB, Guido RS, Castle PE, et al; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis. 2020;24:102-131.

The ASCCP risk-based management guidelines introduce a paradigm shift from managing a specific cervical cancer screening result to using a clinical action threshold based on risk estimates that use both current and past test results to determine frequency and urgency of testing, management, and surveillance (FIGURE).²⁰ The individualized risk estimate helps to target prevention for those at highest risk while minimizing overtesting and overtreatment.

Estimating risk and determining management

The new risk-based management consensus guidelines use risk and clinical action thresholds to determine the appropriate management course for cervical screening abnormalities.²⁰ New data indicate that a patient’s risk of developing cervical precancer or cancer can be estimated using current screening results and previous screening test and biopsy results, while considering personal factors such as age and immunosuppression.²⁰ For each combination of current test results and screening history (including unknown history), the immediate and 5-year risk of CIN 3+ is estimated.

With respect to risk, the following concepts underlie the changes from the 2012 guidelines:

• Negative HPV tests reduce risk.
• Colposcopy performed for low-grade abnormalities, which confirms the absence of CIN 2+, reduces risk.
• A history of HPV-positive results increases risk.
• Prior treatment for CIN 2 or CIN 3 increases risk, and women with this history need to be followed closely for at least 25 years, regardless of age.

Once an individual’s risk is estimated, it is compared with 1 of the 6 proposed “clinical action thresholds”: treatment, optional treatment or colposcopy/biopsy, colposcopy/ biopsy, 1-year surveillance, 3-year surveillance, or 5-year return to regular screening (<0.15% 5-year CIN 3+ risk).

Key takeaways

Increasing knowledge of the natural history of HPV has led to improved approaches to prevention, including the nonvalent HPV vaccine, which protects against 7 high-risk and 2 low-risk HPV types; specific screening guidelines that take into consideration age, immune status, and prior abnormality; and risk-based management guidelines that use both current and prior results as well as age to recommend the best approach for managing an abnormal result and providing surveillance after an abnormal result. ●

Infection with high-risk human papillomavirus (hrHPV) is an essential step in the development of cervical cancer and its precursors, as well as in several other cancers, including oropharyngeal, vulvar, vaginal, anal, and penile cancers. At least 13 HPV strains, known collectively as hrHPV, have been associated with cervical cancer, in addition to more than 150 low-risk HPV types that have not been associated with cancer (for example, HPV 6 and 11).¹ Up to 80% of women (and most men, although men are not tested routinely) will become infected with at least one of the high-risk HPV types throughout their lives, although in most cases these infections will be transient and have no clinical impact for the patient. Patients who test positive consecutively over time for hrHPV, and especially those who test positive for one of the most virulent HPV types (HPV 16 or 18), have a higher risk of developing cervical cancer or precancer. In addition, many patients who acquire HPV at a young age may “clear” the infection, which usually means that the virus becomes inactive; however, often, for unknown reasons, the virus can be reactivated in some women later in life.

This knowledge of the natural history of HPV has led to improved approaches to cervical cancer prevention, which relies on a combined strategy that includes vaccinating as many children and young adults as possible against hrHPV, screening and triaging approaches that use HPV-based tests, and applying risk-based evaluation for abnormal screening results. New guidelines and information address the best approaches to each of these aspects of cervical cancer prevention, which we review here.

HPV vaccination: Recommendations and effect on cervical cancer rates

Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68:698-702.

Lei J, Ploner A, Elfstrom KM, et al. HPV vaccination and the risk of invasive cervical cancer. N Engl J Med. 2020;383;1340-1348.

Vaccination at ages 27 to 45, although approved by the US Food and Drug Administration, is recommended only in a shared decision-making capacity by ACIP and the American College of Obstetricians and Gynecologists (ACOG) due to the vaccine’s minimal effect on cancer prevention in this age group. The ACIP and ACOG do not recommend catch-up vaccination for adults aged 27 to 45 years, but they recognize that some who are not adequately vaccinated might be at risk for new HPV infection and thus may benefit from vaccination.⁴

In contrast, the American Cancer Society (ACS) does not endorse the 2019 ACIP recommendation for shared clinical decision making in 27- to 45-year-olds because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on selecting individuals who might benefit.⁵

Decline in HPV infections

A study in the United States between 2003 and 2014 showed a 71% decline in vaccine-type HPV infections among girls and women aged 14 to 19 in the post–vaccine available era as compared with the prevaccine era, and a lesser but still reasonable decline among women in the 20- to 24-year-old age group.⁶ Overall, vaccine-type HPV infections decreased 89% for vaccinated girls and 34% for unvaccinated girls, demonstrating some herd immunity.⁶ Ideally, the vaccine is given before the onset of skin-to-skin genital sexual activity. Many studies have found the vaccine to be safe and that immunogenicity is maintained for at least 9 years.^7-11

Decrease in invasive cervical cancer

Recently, Lei and colleagues published a study in the New England Journal of Medicine that reviewed outcomes for more than 1.6 million girls and women vaccinated against HPV in Sweden between 2006 and 2017.¹² Among girls who were vaccinated at younger than 17 years of age, there were only 2 cases of cancer, in contrast to 17 cases among those vaccinated at age 17 to 30 and 538 cases among those not vaccinated.

This is the first study to show definitively the preventive effect of HPV vaccination on the development of invasive cancer and the tremendous advantage of vaccinating at a young age. Nonetheless, the advantage conferred by catch-up vaccination (that is, vaccinating those at ages 17–30) also was significant.

Continue to: Updated guidance on cervical cancer screening for average-risk women...

Updated guidance on cervical cancer screening for average-risk women

US Preventive Services Task Force; Curry SJ, Frist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.

Fontham ET, Wolf AM, Church TR, et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin. 2020;70:321-346.

As more is understood about the natural history of HPV and its role in the development of cervical cancer and its precursors, refinements and updates have been made to our approaches for screening people at risk. There is much evidence and experience available on recommending Pap testing and HPV cotesting (testing for HPV along with cytology even if the cytology result is normal) among women aged 30 to 65 years, as that has been an option since the 2012 guidelines were published.¹⁵

We know also that HPV testing is more sensitive for detecting cervical intraepithelial neoplasia grade 3 (CIN 3) or greater at 5 years and that a negative HPV test is more reassuring than a negative Pap test.¹⁶

Primary HPV tests

HPV tests can be used in conjunction with cytology (that is, cotesting) or as a primary screening that if positive, can reflex either to cytology or to testing for the most oncogenic subtypes. Currently, only 2 FDA-approved primary screening tests are available, the cobas 4800 HPV test system (Roche Diagnostics) and the BD Onclarity HPV assay (Becton, Dickinson and Company).¹⁷ Most laboratories in the United States do not yet have the technology for primary testing, and so instead they offer one of the remaining tests (Hybrid Capture 2 [Qiagen] and Cervista and Aptima [Hologic]), which do not necessarily have the same positive and negative predictive value as the tests specifically approved for primary testing. Thus, many clinicians and patients do not yet have access to primary HPV testing.

In addition, due to slow uptake of the HPV vaccine in many parts of the United States,¹³ there is concern that adding HPV testing in nonvaccinated women under age 30 would result in a surge of unnecessary colposcopy procedures for women with transient infections. Thus, several large expert organizations differ in opinion regarding screening among certain populations and by which test.

Screening guidance from national organizations

The US Preventive Services Task Force (USPSTF) and the American Cancer Society (ACS) differ in their recommendations for screening women in their 20s for cervical cancer.^18,19 The USPSTF guidelines, which were published first, focus not only on the best test but also on what is feasible and likely to benefit public health, given our current testing capacity and vaccine coverage. The USPSTF recommends starting screening at age 21 with cytology and, if all results are normal, continuing every 3 years until age 30, at which point they recommend cytology every 3 years or cotesting every 5 years or primary HPV testing alone every 5 years (if all results are normal in each case).

In contrast, the ACS published "aspirational” guidelines, with the best evidence-based recommendations, but they acknowledge that due to availability of different testing options, some patients still need to be screened with existing modalities. The ACS recommends the onset of screening at age 25 with either primary HPV testing every 5 years (preferred) or cotesting every 5 years or cytology every 3 years.

Both the USPSTF and ACS guidelines state that if using cytology alone, the screening frequency should be every 3 years, and if using an HPV-based test, the screening interval (if all results are normal) can be extended to every 5 years.

Continue to: New ASCCP management guidelines focus on individualized risk assessment...

New ASCCP management guidelines focus on individualized risk assessment

Perkins RB, Guido RS, Castle PE, et al; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis. 2020;24:102-131.

The ASCCP risk-based management guidelines introduce a paradigm shift from managing a specific cervical cancer screening result to using a clinical action threshold based on risk estimates that use both current and past test results to determine frequency and urgency of testing, management, and surveillance (FIGURE).²⁰ The individualized risk estimate helps to target prevention for those at highest risk while minimizing overtesting and overtreatment.

Estimating risk and determining management

The new risk-based management consensus guidelines use risk and clinical action thresholds to determine the appropriate management course for cervical screening abnormalities.²⁰ New data indicate that a patient’s risk of developing cervical precancer or cancer can be estimated using current screening results and previous screening test and biopsy results, while considering personal factors such as age and immunosuppression.²⁰ For each combination of current test results and screening history (including unknown history), the immediate and 5-year risk of CIN 3+ is estimated.

With respect to risk, the following concepts underlie the changes from the 2012 guidelines:

• Negative HPV tests reduce risk.
• Colposcopy performed for low-grade abnormalities, which confirms the absence of CIN 2+, reduces risk.
• A history of HPV-positive results increases risk.
• Prior treatment for CIN 2 or CIN 3 increases risk, and women with this history need to be followed closely for at least 25 years, regardless of age.

Once an individual’s risk is estimated, it is compared with 1 of the 6 proposed “clinical action thresholds”: treatment, optional treatment or colposcopy/biopsy, colposcopy/ biopsy, 1-year surveillance, 3-year surveillance, or 5-year return to regular screening (<0.15% 5-year CIN 3+ risk).

Key takeaways

Increasing knowledge of the natural history of HPV has led to improved approaches to prevention, including the nonvalent HPV vaccine, which protects against 7 high-risk and 2 low-risk HPV types; specific screening guidelines that take into consideration age, immune status, and prior abnormality; and risk-based management guidelines that use both current and prior results as well as age to recommend the best approach for managing an abnormal result and providing surveillance after an abnormal result. ●

Infection with high-risk human papillomavirus (hrHPV) is an essential step in the development of cervical cancer and its precursors, as well as in several other cancers, including oropharyngeal, vulvar, vaginal, anal, and penile cancers. At least 13 HPV strains, known collectively as hrHPV, have been associated with cervical cancer, in addition to more than 150 low-risk HPV types that have not been associated with cancer (for example, HPV 6 and 11).¹ Up to 80% of women (and most men, although men are not tested routinely) will become infected with at least one of the high-risk HPV types throughout their lives, although in most cases these infections will be transient and have no clinical impact for the patient. Patients who test positive consecutively over time for hrHPV, and especially those who test positive for one of the most virulent HPV types (HPV 16 or 18), have a higher risk of developing cervical cancer or precancer. In addition, many patients who acquire HPV at a young age may “clear” the infection, which usually means that the virus becomes inactive; however, often, for unknown reasons, the virus can be reactivated in some women later in life.

This knowledge of the natural history of HPV has led to improved approaches to cervical cancer prevention, which relies on a combined strategy that includes vaccinating as many children and young adults as possible against hrHPV, screening and triaging approaches that use HPV-based tests, and applying risk-based evaluation for abnormal screening results. New guidelines and information address the best approaches to each of these aspects of cervical cancer prevention, which we review here.

HPV vaccination: Recommendations and effect on cervical cancer rates

Meites E, Szilagyi PG, Chesson HW, et al. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68:698-702.

Lei J, Ploner A, Elfstrom KM, et al. HPV vaccination and the risk of invasive cervical cancer. N Engl J Med. 2020;383;1340-1348.

Vaccination at ages 27 to 45, although approved by the US Food and Drug Administration, is recommended only in a shared decision-making capacity by ACIP and the American College of Obstetricians and Gynecologists (ACOG) due to the vaccine’s minimal effect on cancer prevention in this age group. The ACIP and ACOG do not recommend catch-up vaccination for adults aged 27 to 45 years, but they recognize that some who are not adequately vaccinated might be at risk for new HPV infection and thus may benefit from vaccination.⁴

In contrast, the American Cancer Society (ACS) does not endorse the 2019 ACIP recommendation for shared clinical decision making in 27- to 45-year-olds because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on selecting individuals who might benefit.⁵

Decline in HPV infections

A study in the United States between 2003 and 2014 showed a 71% decline in vaccine-type HPV infections among girls and women aged 14 to 19 in the post–vaccine available era as compared with the prevaccine era, and a lesser but still reasonable decline among women in the 20- to 24-year-old age group.⁶ Overall, vaccine-type HPV infections decreased 89% for vaccinated girls and 34% for unvaccinated girls, demonstrating some herd immunity.⁶ Ideally, the vaccine is given before the onset of skin-to-skin genital sexual activity. Many studies have found the vaccine to be safe and that immunogenicity is maintained for at least 9 years.^7-11

Decrease in invasive cervical cancer

Recently, Lei and colleagues published a study in the New England Journal of Medicine that reviewed outcomes for more than 1.6 million girls and women vaccinated against HPV in Sweden between 2006 and 2017.¹² Among girls who were vaccinated at younger than 17 years of age, there were only 2 cases of cancer, in contrast to 17 cases among those vaccinated at age 17 to 30 and 538 cases among those not vaccinated.

This is the first study to show definitively the preventive effect of HPV vaccination on the development of invasive cancer and the tremendous advantage of vaccinating at a young age. Nonetheless, the advantage conferred by catch-up vaccination (that is, vaccinating those at ages 17–30) also was significant.

Continue to: Updated guidance on cervical cancer screening for average-risk women...

Updated guidance on cervical cancer screening for average-risk women

US Preventive Services Task Force; Curry SJ, Frist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.

Fontham ET, Wolf AM, Church TR, et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin. 2020;70:321-346.

As more is understood about the natural history of HPV and its role in the development of cervical cancer and its precursors, refinements and updates have been made to our approaches for screening people at risk. There is much evidence and experience available on recommending Pap testing and HPV cotesting (testing for HPV along with cytology even if the cytology result is normal) among women aged 30 to 65 years, as that has been an option since the 2012 guidelines were published.¹⁵

We know also that HPV testing is more sensitive for detecting cervical intraepithelial neoplasia grade 3 (CIN 3) or greater at 5 years and that a negative HPV test is more reassuring than a negative Pap test.¹⁶

Primary HPV tests

HPV tests can be used in conjunction with cytology (that is, cotesting) or as a primary screening that if positive, can reflex either to cytology or to testing for the most oncogenic subtypes. Currently, only 2 FDA-approved primary screening tests are available, the cobas 4800 HPV test system (Roche Diagnostics) and the BD Onclarity HPV assay (Becton, Dickinson and Company).¹⁷ Most laboratories in the United States do not yet have the technology for primary testing, and so instead they offer one of the remaining tests (Hybrid Capture 2 [Qiagen] and Cervista and Aptima [Hologic]), which do not necessarily have the same positive and negative predictive value as the tests specifically approved for primary testing. Thus, many clinicians and patients do not yet have access to primary HPV testing.

In addition, due to slow uptake of the HPV vaccine in many parts of the United States,¹³ there is concern that adding HPV testing in nonvaccinated women under age 30 would result in a surge of unnecessary colposcopy procedures for women with transient infections. Thus, several large expert organizations differ in opinion regarding screening among certain populations and by which test.

Screening guidance from national organizations

The US Preventive Services Task Force (USPSTF) and the American Cancer Society (ACS) differ in their recommendations for screening women in their 20s for cervical cancer.^18,19 The USPSTF guidelines, which were published first, focus not only on the best test but also on what is feasible and likely to benefit public health, given our current testing capacity and vaccine coverage. The USPSTF recommends starting screening at age 21 with cytology and, if all results are normal, continuing every 3 years until age 30, at which point they recommend cytology every 3 years or cotesting every 5 years or primary HPV testing alone every 5 years (if all results are normal in each case).

In contrast, the ACS published "aspirational” guidelines, with the best evidence-based recommendations, but they acknowledge that due to availability of different testing options, some patients still need to be screened with existing modalities. The ACS recommends the onset of screening at age 25 with either primary HPV testing every 5 years (preferred) or cotesting every 5 years or cytology every 3 years.

Both the USPSTF and ACS guidelines state that if using cytology alone, the screening frequency should be every 3 years, and if using an HPV-based test, the screening interval (if all results are normal) can be extended to every 5 years.

Continue to: New ASCCP management guidelines focus on individualized risk assessment...

New ASCCP management guidelines focus on individualized risk assessment

Perkins RB, Guido RS, Castle PE, et al; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis. 2020;24:102-131.

The ASCCP risk-based management guidelines introduce a paradigm shift from managing a specific cervical cancer screening result to using a clinical action threshold based on risk estimates that use both current and past test results to determine frequency and urgency of testing, management, and surveillance (FIGURE).²⁰ The individualized risk estimate helps to target prevention for those at highest risk while minimizing overtesting and overtreatment.

Estimating risk and determining management

The new risk-based management consensus guidelines use risk and clinical action thresholds to determine the appropriate management course for cervical screening abnormalities.²⁰ New data indicate that a patient’s risk of developing cervical precancer or cancer can be estimated using current screening results and previous screening test and biopsy results, while considering personal factors such as age and immunosuppression.²⁰ For each combination of current test results and screening history (including unknown history), the immediate and 5-year risk of CIN 3+ is estimated.

With respect to risk, the following concepts underlie the changes from the 2012 guidelines:

• Negative HPV tests reduce risk.
• Colposcopy performed for low-grade abnormalities, which confirms the absence of CIN 2+, reduces risk.
• A history of HPV-positive results increases risk.
• Prior treatment for CIN 2 or CIN 3 increases risk, and women with this history need to be followed closely for at least 25 years, regardless of age.

Once an individual’s risk is estimated, it is compared with 1 of the 6 proposed “clinical action thresholds”: treatment, optional treatment or colposcopy/biopsy, colposcopy/ biopsy, 1-year surveillance, 3-year surveillance, or 5-year return to regular screening (<0.15% 5-year CIN 3+ risk).

Key takeaways

Increasing knowledge of the natural history of HPV has led to improved approaches to prevention, including the nonvalent HPV vaccine, which protects against 7 high-risk and 2 low-risk HPV types; specific screening guidelines that take into consideration age, immune status, and prior abnormality; and risk-based management guidelines that use both current and prior results as well as age to recommend the best approach for managing an abnormal result and providing surveillance after an abnormal result. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

FDA guidance for power morcellation

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

For more information, visit: https://medical.olympusamerica.com/

FDA guidance for power morcellation

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

For more information, visit: https://medical.olympusamerica.com/

FDA guidance for power morcellation

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

For more information, visit: https://medical.olympusamerica.com/

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Primary care providers can confidently pick any of three cervical cancer screening strategies recommended by the American Cancer Society and the United States Preventive Services Task Force, experts said.

Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.

“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.

To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.

First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.

“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”

Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.

In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.

“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.

Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
 

Primary HPV vs. cytology testing

Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.

Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.

Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.

“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
 

Self-swabbing could improve screening in certain groups

To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.

Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.

“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”

Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.

“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”

Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.

“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”

Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.

Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.

“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”

“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.

Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.

Pregnancy increases the risk for first-time symptomatic kidney stone formation which peaks close to the time of delivery but can persist even a year later, a population-based, case-controlled study suggests.

“We suspected the risk of a kidney stone event would be high during pregnancy, but we were surprised that the risk remained high for up to a year after delivery,” senior author Andrew Rule, MD, a nephrologist at Mayo Clinic, Rochester, Minn, said in a statement from his institution.

“[So] while most kidney stones that form during pregnancy are detected early by painful passage, some may remain stable in the kidney undetected for a longer period before dislodging and [again] resulting in a painful passage,” he added.

The study was published online April 15, 2021, in the American Journal of Kidney Diseases by Charat Thongprayoon, MD, also of the Mayo Clinic, and colleagues.

“The results of this study indicate that prenatal counseling regarding kidney stones may be warranted, especially for women with other risk factors for kidney stones, such as obesity,” he noted.
 

First-time stone formers

The observational study included 945 first-time symptomatic kidney stone formers aged between 15 and 45 years who were compared with 1,890 age-matched female controls from the Rochester Epidemiology Project. The latter is a medical record linkage system for almost all medical care administered in Olmsted County in Minnesota.

Compared with nonpregnant women, the odds of a symptomatic kidney stone forming in a pregnant woman was similar in the first trimester (odds ratio, 0.92; P = .8), began to increase during the second trimester (OR, 2.00; P = .007), further increased during the third trimester (OR, 2.69; P = .001), and peaked at 0-3 months after delivery (OR, 3.53; P < .001). The risk returned to baseline by 1 year after delivery.

These associations persisted after adjustment for age and race or for diabetes, hypertension, and obesity. These results did not significantly differ by age, race, time period, or number of prior pregnancies.

The risk of a pregnant woman developing a symptomatic kidney stone was higher in women with obesity, compared with those of normal weight (P = .01).

And compared with women who had not been pregnant before, one prior pregnancy also increased the risk of having a symptomatic kidney stone by approximately 30% (OR, 1.29; P = .03), although two or more prior pregnancies did not significantly increase symptomatic kidney stone risk.

Thus, “it can be inferred that the odds of a symptomatic kidney stone peak around the time of delivery,” the authors emphasized. “The odds of a first-time symptomatic kidney stone then decreased over time and were fully attenuated and no longer statistically significant by 12 months after delivery.”

Dr. Thongprayoon said there are several physiologic reasons why pregnancy might contribute to kidney stone formation.

During pregnancy, ureteral compression and ureteral relaxation caused by elevated progesterone levels can cause urinary stasis.

Furthermore, increased urinary calcium excretion and elevated urine pH during pregnancy can promote calcium phosphate stone formation. It is noteworthy that almost all pregnant, first-time stone formers had calcium phosphate stones.

“During pregnancy, a kidney stone may contribute to serious complications,” Dr. Thongprayoon explained.

General dietary recommendations for preventing kidney stones include drinking abundant fluids and consuming a low-salt diet.

The study was supported by the Mayo Clinic O’Brien Urology Research Center and a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnancy increases the risk for first-time symptomatic kidney stone formation which peaks close to the time of delivery but can persist even a year later, a population-based, case-controlled study suggests.

“We suspected the risk of a kidney stone event would be high during pregnancy, but we were surprised that the risk remained high for up to a year after delivery,” senior author Andrew Rule, MD, a nephrologist at Mayo Clinic, Rochester, Minn, said in a statement from his institution.

“[So] while most kidney stones that form during pregnancy are detected early by painful passage, some may remain stable in the kidney undetected for a longer period before dislodging and [again] resulting in a painful passage,” he added.

The study was published online April 15, 2021, in the American Journal of Kidney Diseases by Charat Thongprayoon, MD, also of the Mayo Clinic, and colleagues.

“The results of this study indicate that prenatal counseling regarding kidney stones may be warranted, especially for women with other risk factors for kidney stones, such as obesity,” he noted.
 

First-time stone formers

The observational study included 945 first-time symptomatic kidney stone formers aged between 15 and 45 years who were compared with 1,890 age-matched female controls from the Rochester Epidemiology Project. The latter is a medical record linkage system for almost all medical care administered in Olmsted County in Minnesota.

Compared with nonpregnant women, the odds of a symptomatic kidney stone forming in a pregnant woman was similar in the first trimester (odds ratio, 0.92; P = .8), began to increase during the second trimester (OR, 2.00; P = .007), further increased during the third trimester (OR, 2.69; P = .001), and peaked at 0-3 months after delivery (OR, 3.53; P < .001). The risk returned to baseline by 1 year after delivery.

These associations persisted after adjustment for age and race or for diabetes, hypertension, and obesity. These results did not significantly differ by age, race, time period, or number of prior pregnancies.

The risk of a pregnant woman developing a symptomatic kidney stone was higher in women with obesity, compared with those of normal weight (P = .01).

And compared with women who had not been pregnant before, one prior pregnancy also increased the risk of having a symptomatic kidney stone by approximately 30% (OR, 1.29; P = .03), although two or more prior pregnancies did not significantly increase symptomatic kidney stone risk.

Thus, “it can be inferred that the odds of a symptomatic kidney stone peak around the time of delivery,” the authors emphasized. “The odds of a first-time symptomatic kidney stone then decreased over time and were fully attenuated and no longer statistically significant by 12 months after delivery.”

Dr. Thongprayoon said there are several physiologic reasons why pregnancy might contribute to kidney stone formation.

During pregnancy, ureteral compression and ureteral relaxation caused by elevated progesterone levels can cause urinary stasis.

Furthermore, increased urinary calcium excretion and elevated urine pH during pregnancy can promote calcium phosphate stone formation. It is noteworthy that almost all pregnant, first-time stone formers had calcium phosphate stones.

“During pregnancy, a kidney stone may contribute to serious complications,” Dr. Thongprayoon explained.

General dietary recommendations for preventing kidney stones include drinking abundant fluids and consuming a low-salt diet.

The study was supported by the Mayo Clinic O’Brien Urology Research Center and a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnancy increases the risk for first-time symptomatic kidney stone formation which peaks close to the time of delivery but can persist even a year later, a population-based, case-controlled study suggests.

“We suspected the risk of a kidney stone event would be high during pregnancy, but we were surprised that the risk remained high for up to a year after delivery,” senior author Andrew Rule, MD, a nephrologist at Mayo Clinic, Rochester, Minn, said in a statement from his institution.

“[So] while most kidney stones that form during pregnancy are detected early by painful passage, some may remain stable in the kidney undetected for a longer period before dislodging and [again] resulting in a painful passage,” he added.

The study was published online April 15, 2021, in the American Journal of Kidney Diseases by Charat Thongprayoon, MD, also of the Mayo Clinic, and colleagues.

“The results of this study indicate that prenatal counseling regarding kidney stones may be warranted, especially for women with other risk factors for kidney stones, such as obesity,” he noted.
 

First-time stone formers

The observational study included 945 first-time symptomatic kidney stone formers aged between 15 and 45 years who were compared with 1,890 age-matched female controls from the Rochester Epidemiology Project. The latter is a medical record linkage system for almost all medical care administered in Olmsted County in Minnesota.

Compared with nonpregnant women, the odds of a symptomatic kidney stone forming in a pregnant woman was similar in the first trimester (odds ratio, 0.92; P = .8), began to increase during the second trimester (OR, 2.00; P = .007), further increased during the third trimester (OR, 2.69; P = .001), and peaked at 0-3 months after delivery (OR, 3.53; P < .001). The risk returned to baseline by 1 year after delivery.

These associations persisted after adjustment for age and race or for diabetes, hypertension, and obesity. These results did not significantly differ by age, race, time period, or number of prior pregnancies.

The risk of a pregnant woman developing a symptomatic kidney stone was higher in women with obesity, compared with those of normal weight (P = .01).

And compared with women who had not been pregnant before, one prior pregnancy also increased the risk of having a symptomatic kidney stone by approximately 30% (OR, 1.29; P = .03), although two or more prior pregnancies did not significantly increase symptomatic kidney stone risk.

Thus, “it can be inferred that the odds of a symptomatic kidney stone peak around the time of delivery,” the authors emphasized. “The odds of a first-time symptomatic kidney stone then decreased over time and were fully attenuated and no longer statistically significant by 12 months after delivery.”

Dr. Thongprayoon said there are several physiologic reasons why pregnancy might contribute to kidney stone formation.

During pregnancy, ureteral compression and ureteral relaxation caused by elevated progesterone levels can cause urinary stasis.

Furthermore, increased urinary calcium excretion and elevated urine pH during pregnancy can promote calcium phosphate stone formation. It is noteworthy that almost all pregnant, first-time stone formers had calcium phosphate stones.

“During pregnancy, a kidney stone may contribute to serious complications,” Dr. Thongprayoon explained.

General dietary recommendations for preventing kidney stones include drinking abundant fluids and consuming a low-salt diet.

The study was supported by the Mayo Clinic O’Brien Urology Research Center and a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”¹ It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.¹ Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.²

Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.^3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,⁵ and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.⁶ It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.

FGC: Through the lens of inequity

Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.

Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.

Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.⁷ Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.⁸ These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.

Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.⁹

Continue to: Classifying FGC types...

Classifying FGC types

The WHO has classified FGC into 4 different types¹:

• type 1, partial or total removal of the clitoris or prepuce
• type 2, partial or total removal of part of the clitoris and labia minora
• type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
• type 4, all other procedures to the female genitalia for nonmedical reasons.

Long-term complications

Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).

The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.¹⁰ One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.¹¹

Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.¹² Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.¹³ Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.¹³

Clinical management recommendations

It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.

Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.¹⁴ Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.

Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.¹² Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.

Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.¹² In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.

The defibulation procedure

Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.¹⁵ Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.¹⁶

Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.¹² The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.¹⁶

The ethical conundrum of reinfibulation

Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.¹⁷

Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.^18,19

The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.²⁰

Conclusion

It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.

Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”¹ It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.¹ Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.²

Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.^3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,⁵ and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.⁶ It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.

FGC: Through the lens of inequity

Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.

Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.

Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.⁷ Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.⁸ These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.

Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.⁹

Continue to: Classifying FGC types...

Classifying FGC types

The WHO has classified FGC into 4 different types¹:

• type 1, partial or total removal of the clitoris or prepuce
• type 2, partial or total removal of part of the clitoris and labia minora
• type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
• type 4, all other procedures to the female genitalia for nonmedical reasons.

Long-term complications

Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).

The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.¹⁰ One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.¹¹

Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.¹² Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.¹³ Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.¹³

Clinical management recommendations

It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.

Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.¹⁴ Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.

Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.¹² Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.

Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.¹² In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.

The defibulation procedure

Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.¹⁵ Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.¹⁶

Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.¹² The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.¹⁶

The ethical conundrum of reinfibulation

Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.¹⁷

Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.^18,19

The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.²⁰

Conclusion

It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.

Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”¹ It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.¹ Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.²

Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.^3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,⁵ and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.⁶ It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.

FGC: Through the lens of inequity

Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.

Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.

Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.⁷ Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.⁸ These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.

Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.⁹

Continue to: Classifying FGC types...

Classifying FGC types

The WHO has classified FGC into 4 different types¹:

• type 1, partial or total removal of the clitoris or prepuce
• type 2, partial or total removal of part of the clitoris and labia minora
• type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
• type 4, all other procedures to the female genitalia for nonmedical reasons.

Long-term complications

Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).

The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.¹⁰ One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.¹¹

Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.¹² Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.¹³ Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.¹³

Clinical management recommendations

It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.

Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.¹⁴ Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.

Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.¹² Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.

Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.¹² In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.

The defibulation procedure

Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.¹⁵ Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.¹⁶

Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.¹² The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.¹⁶

The ethical conundrum of reinfibulation

Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.¹⁷

Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.^18,19

The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.²⁰

Conclusion

It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.

In his editorial, "9vHPV vaccine: Prevention of oropharyngeal cancer" (November 2020), Editor in Chief Robert L. Barbieri, MD, asked, "As a gynecologist, should you receive the 9vHPV vaccine?" He noted that the American Society for Colposcopy and Cervical Pathology (ASCCP) now recommends that clinicians "who are routinely exposed to HPVs consider 9vHPV vaccination" and cited a study that found that 19% of 700 gynecologists who performed LEEP procedures without a surgical mask had HPV DNA present in the nose (which was no longer detectable at 24 months). OBG MANAGEMENT followed up with a poll for readers to ask, "will you get the [9vHPV] vaccine?" based on the new ASCCP recommendations.

In his editorial, "9vHPV vaccine: Prevention of oropharyngeal cancer" (November 2020), Editor in Chief Robert L. Barbieri, MD, asked, "As a gynecologist, should you receive the 9vHPV vaccine?" He noted that the American Society for Colposcopy and Cervical Pathology (ASCCP) now recommends that clinicians "who are routinely exposed to HPVs consider 9vHPV vaccination" and cited a study that found that 19% of 700 gynecologists who performed LEEP procedures without a surgical mask had HPV DNA present in the nose (which was no longer detectable at 24 months). OBG MANAGEMENT followed up with a poll for readers to ask, "will you get the [9vHPV] vaccine?" based on the new ASCCP recommendations.

In his editorial, "9vHPV vaccine: Prevention of oropharyngeal cancer" (November 2020), Editor in Chief Robert L. Barbieri, MD, asked, "As a gynecologist, should you receive the 9vHPV vaccine?" He noted that the American Society for Colposcopy and Cervical Pathology (ASCCP) now recommends that clinicians "who are routinely exposed to HPVs consider 9vHPV vaccination" and cited a study that found that 19% of 700 gynecologists who performed LEEP procedures without a surgical mask had HPV DNA present in the nose (which was no longer detectable at 24 months). OBG MANAGEMENT followed up with a poll for readers to ask, "will you get the [9vHPV] vaccine?" based on the new ASCCP recommendations.

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

A version of this article first appeared on Medscape.com.

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

A version of this article first appeared on Medscape.com.

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]