In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

AGA has released a new Clinical Practice Update providing best practice advice for clinicians screening and diagnosing pancreatic cancer in high-risk individuals. Screening to detect pancreas cancers and their precursor lesions in high-risk patients can improve survival if it facilitates surgical resection for early-stage disease.

In the AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review, published in Gastroenterology’s July issue, the authors provide 13 best practice advice statements to address key issues in clinical management of these patients.

For more information, visit www.gastro.org/PancreasCPU.

[email protected]

AGA has released a new Clinical Practice Update providing best practice advice for clinicians screening and diagnosing pancreatic cancer in high-risk individuals. Screening to detect pancreas cancers and their precursor lesions in high-risk patients can improve survival if it facilitates surgical resection for early-stage disease.

In the AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review, published in Gastroenterology’s July issue, the authors provide 13 best practice advice statements to address key issues in clinical management of these patients.

For more information, visit www.gastro.org/PancreasCPU.

[email protected]

AGA has released a new Clinical Practice Update providing best practice advice for clinicians screening and diagnosing pancreatic cancer in high-risk individuals. Screening to detect pancreas cancers and their precursor lesions in high-risk patients can improve survival if it facilitates surgical resection for early-stage disease.

In the AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review, published in Gastroenterology’s July issue, the authors provide 13 best practice advice statements to address key issues in clinical management of these patients.

For more information, visit www.gastro.org/PancreasCPU.

[email protected]

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

Women rheumatologists have made inroads in closing the gender gap as their numbers have risen in the profession, but disparities remain. They’re less likely to hold a higher-level professorship position, feature as a senior author on a paper, or receive a federal grant. Two recent studies underscore progress for and barriers to career advancement.

One cross-sectional analysis of practicing U.S. rheumatologists found that fewer women are professors compared with men (12.6% vs. 36.8%) or associate professors (17.5% vs. 28%). A larger proportion of women serve as assistant professors (55.5% vs. 31.5%). From a leadership perspective, women are making progress. Their odds are similar to men as far as holding a fellowship or division director position in a rheumatology division.

For this study, published in Arthritis & Rheumatology on Aug. 16, April Jorge, MD, and her colleagues at Massachusetts General Hospital and Harvard Medical School, both in Boston, identified 6,125 rheumatologists from a database of all licensed physicians and used multivariate logistic regression to assess gender differences in academic advancement. They arrived at their results after accounting for variables such as age, research and academic appointments, publications, achievements, and years since residency graduation.

Women rheumatologists are younger, completing their residency more recently than their male colleagues. Their numbers in academic rheumatology have gradually increased over the last few decades, recently outpacing men. In 2015, the American College of Rheumatology reported that women made up 41% of the workforce and 66% of rheumatology fellows. Dr. Jorge and associates stressed the importance of fostering women in leadership positions and ensuring gender equity in academic career advancement.

Women also had fewer publications and grants from the National Institutes of Health. Several factors could account for this, such as time spent in the workforce or on parental leave, work-life balance, and mentorship. “However, gender differences in academic promotion remained after adjusting for each of these typical promotion criteria, indicating that other unidentified factors also contribute to the gap in promotion for women academic rheumatologists,” the investigators noted.

The authors weren’t able to assess how parental leave and work effort affected results or why pay differences existed between men and women. They also weren’t able to determine how many physicians left academic practice. “If greater numbers of women than men left the academic rheumatology workforce – for one of many reasons, including that they were not promoted – our findings could underestimate sex differences in academic rank,” they acknowledged.

Lower authorship rate examined

Fewer women in full or associate professor positions might explain why female authorship on research papers is underrepresented, according to another study published Aug. 18 in Arthritis & Rheumatology. Ekta Bagga and colleagues at the University of Auckland (New Zealand) examined 7,651 original research articles from high-impact rheumatology and general medical journals published during 2015-2019 and reported that women were much less likely to achieve first or senior author positions in reports of randomized, controlled trials. This was especially true for studies initiated and funded by industry, compared with other research designs.

More gender parity existed for first authorship than senior authorship – women first authors and senior authors appeared in 51.5% and 35.3% of the papers, respectively. For all geographical regions, the proportion of women senior authors fell below 40%. Representation was especially low in regions other than Europe and North America. These observations likely reflect gender disparities in the medical workforce, Nicola Dalbeth, MD, the study’s senior author, said in an interview.

“We know that, although women make up almost half the rheumatology workforce in many countries around the world, we are less likely to be in positions of senior academic leadership,” added Dr. Dalbeth, a rheumatologist and professor at the University of Auckland’s Bone and Joint Research Group. Institutions and industry should take steps to ensure that women rheumatologists get equal representation, particularly in clinical trial development, she added.

The study had its limitations, one of which was that the researchers didn’t analyze individual author names. This means that one person may have authored multiple articles. “Given the relatively low number of women in academic rheumatology leadership positions, our method of analysis may have overrepresented the number of women authors of rheumatology publications, particularly in senior positions,” stated Dr. Dalbeth and colleagues.
 

Implicit bias in academia

The articles by Jorge et al. and Bagga et al. suggest that implicit bias is as prevalent in medicine as it is in general society, Jason Kolfenbach, MD, said in an interview. Dr. Kolfenbach is an associate professor of medicine and rheumatology and director of the rheumatology fellowship program at University of Colorado at Denver, Aurora.

“The study by Jorge et al. is eye opening because it demonstrates that academic promotion is lower among women even after adjustment for some of these measures of academic productivity,” Dr. Kolfenbach said. It’s likely that bias plays some role “since there is a human element behind promotions committees, as well as committees selecting faculty for the creation of guidelines and speaker panels at national conferences.”

The study by Bagga et al. “matches my personal perception of industry-sponsored studies and pharmaceutical-sponsored speakers bureaus, namely that they are overrepresented by male faculty,” Dr. Kolfenbach continued.

Prior to COVID-19, the department of medicine at the University of Colorado had begun participating in a formal program called the Bias Reduction in Internal Medicine Initiative, a National Institutes of Health–sponsored study. “I’m hopeful programs such as this can lead to a more equitable situation than described by the findings in these two studies,” he added.
 

Article type, country of origin play a role

Other research corroborates the findings in these two papers. Giovanni Adami, MD, and coauthors examined 366 rheumatology guidelines and recommendations and determined that only 32% featured a female first author. However, authorship did increase for women over time, achieving parity in 2017.

There are several points to consider when exploring gender disparity, Dr. Adami said in an interview. “Original articles, industry-sponsored articles, and recommendation articles explore different disparities,” he offered. Recommendations and industry-sponsored articles are usually authored by international experts such as division directors or full professors. Original articles, in comparison, aren’t as affected by the “opinion leader” effect, he added.

Country of origin is also a crucial aspect, Dr. Adami said. In his own search of guidelines and articles published by Japanese or Chinese researchers, he noticed that males made up the vast majority of authors. “The cultural aspects of the country where research develops is a vital thing to consider when analyzing gender disparity.”

Dr. Adami’s homeland of Italy is a case in point: most of the division chiefs and professors are male. “Here in Italy, there’s a common belief that a woman cannot pursue an academic career or aim for a leadership position,” he noted.

Italy’s public university system has seen some improvements in gender parity, he continued. “For example, in 2009 there were 61,000 new medical students in Italy, and the majority [57%] were female. Nonetheless, we still have more male professors of medicine and more male PhD candidates.”
 

Gender gap narrows for conference speakers

In another study, rheumatologists Jean Liew, MD, of the University of Washington, Seattle, and Kanika Monga, MD, of the University of Texas Health Science Center at Houston, found notable gender gaps in speakers at ACR conferences. Women represented under 50% of speakers at these meetings over a 2-year period. “Although the gender gap at recent ACR meetings was narrower as compared with other conferences, we must remain cognizant of its presence and continue to work towards equal representation,” the authors wrote in a correspondence letter in Annals of the Rheumatic Diseases.

Dr. Monga said she was excited to see so many studies on the topic of gender disparities in rheumatology. The Jorge et al. and Bagga et al. papers “delve deeper into quantifying the gender gap in rheumatology. These studies allow us to better identify where the discrepancies may be,” she said in an interview.

“I found it very interesting that women were less likely to be promoted in academic rank but as likely as men to hold leadership positions,” Dr. Monga said. She agreed with the authors that criteria for academic promotion should be reassessed to ensure that it values the diversity of scholarly work that rheumatologists pursue.

Men may still outnumber women speakers at ACR meetings, but the Liew and Monga study did report a 4.2% increase in female speaker representation from 2017 to 2018. “We were happy to note that that continued to be the case at The American College of Rheumatology’s Annual Meeting in 2019. I hope that this reflects a positive change in our specialty,” she said.

Dr. Dalbeth’s study received support from a University of Auckland Summer Studentship Award. She has received consulting fees, speaker fees, or grants from AstraZeneca, Horizon, Amgen, Janssen, and other companies outside of the submitted work. The other authors declared no competing interests.

Dr. Jorge receives funds from the Rheumatology Research Foundation. The senior author on her study receives funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Women rheumatologists have made inroads in closing the gender gap as their numbers have risen in the profession, but disparities remain. They’re less likely to hold a higher-level professorship position, feature as a senior author on a paper, or receive a federal grant. Two recent studies underscore progress for and barriers to career advancement.

One cross-sectional analysis of practicing U.S. rheumatologists found that fewer women are professors compared with men (12.6% vs. 36.8%) or associate professors (17.5% vs. 28%). A larger proportion of women serve as assistant professors (55.5% vs. 31.5%). From a leadership perspective, women are making progress. Their odds are similar to men as far as holding a fellowship or division director position in a rheumatology division.

For this study, published in Arthritis & Rheumatology on Aug. 16, April Jorge, MD, and her colleagues at Massachusetts General Hospital and Harvard Medical School, both in Boston, identified 6,125 rheumatologists from a database of all licensed physicians and used multivariate logistic regression to assess gender differences in academic advancement. They arrived at their results after accounting for variables such as age, research and academic appointments, publications, achievements, and years since residency graduation.

Women rheumatologists are younger, completing their residency more recently than their male colleagues. Their numbers in academic rheumatology have gradually increased over the last few decades, recently outpacing men. In 2015, the American College of Rheumatology reported that women made up 41% of the workforce and 66% of rheumatology fellows. Dr. Jorge and associates stressed the importance of fostering women in leadership positions and ensuring gender equity in academic career advancement.

Women also had fewer publications and grants from the National Institutes of Health. Several factors could account for this, such as time spent in the workforce or on parental leave, work-life balance, and mentorship. “However, gender differences in academic promotion remained after adjusting for each of these typical promotion criteria, indicating that other unidentified factors also contribute to the gap in promotion for women academic rheumatologists,” the investigators noted.

The authors weren’t able to assess how parental leave and work effort affected results or why pay differences existed between men and women. They also weren’t able to determine how many physicians left academic practice. “If greater numbers of women than men left the academic rheumatology workforce – for one of many reasons, including that they were not promoted – our findings could underestimate sex differences in academic rank,” they acknowledged.

Lower authorship rate examined

Fewer women in full or associate professor positions might explain why female authorship on research papers is underrepresented, according to another study published Aug. 18 in Arthritis & Rheumatology. Ekta Bagga and colleagues at the University of Auckland (New Zealand) examined 7,651 original research articles from high-impact rheumatology and general medical journals published during 2015-2019 and reported that women were much less likely to achieve first or senior author positions in reports of randomized, controlled trials. This was especially true for studies initiated and funded by industry, compared with other research designs.

More gender parity existed for first authorship than senior authorship – women first authors and senior authors appeared in 51.5% and 35.3% of the papers, respectively. For all geographical regions, the proportion of women senior authors fell below 40%. Representation was especially low in regions other than Europe and North America. These observations likely reflect gender disparities in the medical workforce, Nicola Dalbeth, MD, the study’s senior author, said in an interview.

“We know that, although women make up almost half the rheumatology workforce in many countries around the world, we are less likely to be in positions of senior academic leadership,” added Dr. Dalbeth, a rheumatologist and professor at the University of Auckland’s Bone and Joint Research Group. Institutions and industry should take steps to ensure that women rheumatologists get equal representation, particularly in clinical trial development, she added.

The study had its limitations, one of which was that the researchers didn’t analyze individual author names. This means that one person may have authored multiple articles. “Given the relatively low number of women in academic rheumatology leadership positions, our method of analysis may have overrepresented the number of women authors of rheumatology publications, particularly in senior positions,” stated Dr. Dalbeth and colleagues.
 

Implicit bias in academia

The articles by Jorge et al. and Bagga et al. suggest that implicit bias is as prevalent in medicine as it is in general society, Jason Kolfenbach, MD, said in an interview. Dr. Kolfenbach is an associate professor of medicine and rheumatology and director of the rheumatology fellowship program at University of Colorado at Denver, Aurora.

“The study by Jorge et al. is eye opening because it demonstrates that academic promotion is lower among women even after adjustment for some of these measures of academic productivity,” Dr. Kolfenbach said. It’s likely that bias plays some role “since there is a human element behind promotions committees, as well as committees selecting faculty for the creation of guidelines and speaker panels at national conferences.”

The study by Bagga et al. “matches my personal perception of industry-sponsored studies and pharmaceutical-sponsored speakers bureaus, namely that they are overrepresented by male faculty,” Dr. Kolfenbach continued.

Prior to COVID-19, the department of medicine at the University of Colorado had begun participating in a formal program called the Bias Reduction in Internal Medicine Initiative, a National Institutes of Health–sponsored study. “I’m hopeful programs such as this can lead to a more equitable situation than described by the findings in these two studies,” he added.
 

Article type, country of origin play a role

Other research corroborates the findings in these two papers. Giovanni Adami, MD, and coauthors examined 366 rheumatology guidelines and recommendations and determined that only 32% featured a female first author. However, authorship did increase for women over time, achieving parity in 2017.

There are several points to consider when exploring gender disparity, Dr. Adami said in an interview. “Original articles, industry-sponsored articles, and recommendation articles explore different disparities,” he offered. Recommendations and industry-sponsored articles are usually authored by international experts such as division directors or full professors. Original articles, in comparison, aren’t as affected by the “opinion leader” effect, he added.

Country of origin is also a crucial aspect, Dr. Adami said. In his own search of guidelines and articles published by Japanese or Chinese researchers, he noticed that males made up the vast majority of authors. “The cultural aspects of the country where research develops is a vital thing to consider when analyzing gender disparity.”

Dr. Adami’s homeland of Italy is a case in point: most of the division chiefs and professors are male. “Here in Italy, there’s a common belief that a woman cannot pursue an academic career or aim for a leadership position,” he noted.

Italy’s public university system has seen some improvements in gender parity, he continued. “For example, in 2009 there were 61,000 new medical students in Italy, and the majority [57%] were female. Nonetheless, we still have more male professors of medicine and more male PhD candidates.”
 

Gender gap narrows for conference speakers

In another study, rheumatologists Jean Liew, MD, of the University of Washington, Seattle, and Kanika Monga, MD, of the University of Texas Health Science Center at Houston, found notable gender gaps in speakers at ACR conferences. Women represented under 50% of speakers at these meetings over a 2-year period. “Although the gender gap at recent ACR meetings was narrower as compared with other conferences, we must remain cognizant of its presence and continue to work towards equal representation,” the authors wrote in a correspondence letter in Annals of the Rheumatic Diseases.

Dr. Monga said she was excited to see so many studies on the topic of gender disparities in rheumatology. The Jorge et al. and Bagga et al. papers “delve deeper into quantifying the gender gap in rheumatology. These studies allow us to better identify where the discrepancies may be,” she said in an interview.

“I found it very interesting that women were less likely to be promoted in academic rank but as likely as men to hold leadership positions,” Dr. Monga said. She agreed with the authors that criteria for academic promotion should be reassessed to ensure that it values the diversity of scholarly work that rheumatologists pursue.

Men may still outnumber women speakers at ACR meetings, but the Liew and Monga study did report a 4.2% increase in female speaker representation from 2017 to 2018. “We were happy to note that that continued to be the case at The American College of Rheumatology’s Annual Meeting in 2019. I hope that this reflects a positive change in our specialty,” she said.

Dr. Dalbeth’s study received support from a University of Auckland Summer Studentship Award. She has received consulting fees, speaker fees, or grants from AstraZeneca, Horizon, Amgen, Janssen, and other companies outside of the submitted work. The other authors declared no competing interests.

Dr. Jorge receives funds from the Rheumatology Research Foundation. The senior author on her study receives funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Women rheumatologists have made inroads in closing the gender gap as their numbers have risen in the profession, but disparities remain. They’re less likely to hold a higher-level professorship position, feature as a senior author on a paper, or receive a federal grant. Two recent studies underscore progress for and barriers to career advancement.

One cross-sectional analysis of practicing U.S. rheumatologists found that fewer women are professors compared with men (12.6% vs. 36.8%) or associate professors (17.5% vs. 28%). A larger proportion of women serve as assistant professors (55.5% vs. 31.5%). From a leadership perspective, women are making progress. Their odds are similar to men as far as holding a fellowship or division director position in a rheumatology division.

For this study, published in Arthritis & Rheumatology on Aug. 16, April Jorge, MD, and her colleagues at Massachusetts General Hospital and Harvard Medical School, both in Boston, identified 6,125 rheumatologists from a database of all licensed physicians and used multivariate logistic regression to assess gender differences in academic advancement. They arrived at their results after accounting for variables such as age, research and academic appointments, publications, achievements, and years since residency graduation.

Women rheumatologists are younger, completing their residency more recently than their male colleagues. Their numbers in academic rheumatology have gradually increased over the last few decades, recently outpacing men. In 2015, the American College of Rheumatology reported that women made up 41% of the workforce and 66% of rheumatology fellows. Dr. Jorge and associates stressed the importance of fostering women in leadership positions and ensuring gender equity in academic career advancement.

Women also had fewer publications and grants from the National Institutes of Health. Several factors could account for this, such as time spent in the workforce or on parental leave, work-life balance, and mentorship. “However, gender differences in academic promotion remained after adjusting for each of these typical promotion criteria, indicating that other unidentified factors also contribute to the gap in promotion for women academic rheumatologists,” the investigators noted.

The authors weren’t able to assess how parental leave and work effort affected results or why pay differences existed between men and women. They also weren’t able to determine how many physicians left academic practice. “If greater numbers of women than men left the academic rheumatology workforce – for one of many reasons, including that they were not promoted – our findings could underestimate sex differences in academic rank,” they acknowledged.

Lower authorship rate examined

Fewer women in full or associate professor positions might explain why female authorship on research papers is underrepresented, according to another study published Aug. 18 in Arthritis & Rheumatology. Ekta Bagga and colleagues at the University of Auckland (New Zealand) examined 7,651 original research articles from high-impact rheumatology and general medical journals published during 2015-2019 and reported that women were much less likely to achieve first or senior author positions in reports of randomized, controlled trials. This was especially true for studies initiated and funded by industry, compared with other research designs.

More gender parity existed for first authorship than senior authorship – women first authors and senior authors appeared in 51.5% and 35.3% of the papers, respectively. For all geographical regions, the proportion of women senior authors fell below 40%. Representation was especially low in regions other than Europe and North America. These observations likely reflect gender disparities in the medical workforce, Nicola Dalbeth, MD, the study’s senior author, said in an interview.

“We know that, although women make up almost half the rheumatology workforce in many countries around the world, we are less likely to be in positions of senior academic leadership,” added Dr. Dalbeth, a rheumatologist and professor at the University of Auckland’s Bone and Joint Research Group. Institutions and industry should take steps to ensure that women rheumatologists get equal representation, particularly in clinical trial development, she added.

The study had its limitations, one of which was that the researchers didn’t analyze individual author names. This means that one person may have authored multiple articles. “Given the relatively low number of women in academic rheumatology leadership positions, our method of analysis may have overrepresented the number of women authors of rheumatology publications, particularly in senior positions,” stated Dr. Dalbeth and colleagues.
 

Implicit bias in academia

The articles by Jorge et al. and Bagga et al. suggest that implicit bias is as prevalent in medicine as it is in general society, Jason Kolfenbach, MD, said in an interview. Dr. Kolfenbach is an associate professor of medicine and rheumatology and director of the rheumatology fellowship program at University of Colorado at Denver, Aurora.

“The study by Jorge et al. is eye opening because it demonstrates that academic promotion is lower among women even after adjustment for some of these measures of academic productivity,” Dr. Kolfenbach said. It’s likely that bias plays some role “since there is a human element behind promotions committees, as well as committees selecting faculty for the creation of guidelines and speaker panels at national conferences.”

The study by Bagga et al. “matches my personal perception of industry-sponsored studies and pharmaceutical-sponsored speakers bureaus, namely that they are overrepresented by male faculty,” Dr. Kolfenbach continued.

Prior to COVID-19, the department of medicine at the University of Colorado had begun participating in a formal program called the Bias Reduction in Internal Medicine Initiative, a National Institutes of Health–sponsored study. “I’m hopeful programs such as this can lead to a more equitable situation than described by the findings in these two studies,” he added.
 

Article type, country of origin play a role

Other research corroborates the findings in these two papers. Giovanni Adami, MD, and coauthors examined 366 rheumatology guidelines and recommendations and determined that only 32% featured a female first author. However, authorship did increase for women over time, achieving parity in 2017.

There are several points to consider when exploring gender disparity, Dr. Adami said in an interview. “Original articles, industry-sponsored articles, and recommendation articles explore different disparities,” he offered. Recommendations and industry-sponsored articles are usually authored by international experts such as division directors or full professors. Original articles, in comparison, aren’t as affected by the “opinion leader” effect, he added.

Country of origin is also a crucial aspect, Dr. Adami said. In his own search of guidelines and articles published by Japanese or Chinese researchers, he noticed that males made up the vast majority of authors. “The cultural aspects of the country where research develops is a vital thing to consider when analyzing gender disparity.”

Dr. Adami’s homeland of Italy is a case in point: most of the division chiefs and professors are male. “Here in Italy, there’s a common belief that a woman cannot pursue an academic career or aim for a leadership position,” he noted.

Italy’s public university system has seen some improvements in gender parity, he continued. “For example, in 2009 there were 61,000 new medical students in Italy, and the majority [57%] were female. Nonetheless, we still have more male professors of medicine and more male PhD candidates.”
 

Gender gap narrows for conference speakers

In another study, rheumatologists Jean Liew, MD, of the University of Washington, Seattle, and Kanika Monga, MD, of the University of Texas Health Science Center at Houston, found notable gender gaps in speakers at ACR conferences. Women represented under 50% of speakers at these meetings over a 2-year period. “Although the gender gap at recent ACR meetings was narrower as compared with other conferences, we must remain cognizant of its presence and continue to work towards equal representation,” the authors wrote in a correspondence letter in Annals of the Rheumatic Diseases.

Dr. Monga said she was excited to see so many studies on the topic of gender disparities in rheumatology. The Jorge et al. and Bagga et al. papers “delve deeper into quantifying the gender gap in rheumatology. These studies allow us to better identify where the discrepancies may be,” she said in an interview.

“I found it very interesting that women were less likely to be promoted in academic rank but as likely as men to hold leadership positions,” Dr. Monga said. She agreed with the authors that criteria for academic promotion should be reassessed to ensure that it values the diversity of scholarly work that rheumatologists pursue.

Men may still outnumber women speakers at ACR meetings, but the Liew and Monga study did report a 4.2% increase in female speaker representation from 2017 to 2018. “We were happy to note that that continued to be the case at The American College of Rheumatology’s Annual Meeting in 2019. I hope that this reflects a positive change in our specialty,” she said.

Dr. Dalbeth’s study received support from a University of Auckland Summer Studentship Award. She has received consulting fees, speaker fees, or grants from AstraZeneca, Horizon, Amgen, Janssen, and other companies outside of the submitted work. The other authors declared no competing interests.

Dr. Jorge receives funds from the Rheumatology Research Foundation. The senior author on her study receives funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

A new evidence-based review published in Gastroenterology helps you answer the question: Should my endoscopy center test asymptomatic patients for SARS-CoV-2 prior to endoscopy?

Key guidance for GIs

1. Endoscopy centers in areas with an intermediate prevalence of SARS-CoV-2 infection should consider testing patients for the virus before endoscopy. Several important factors contribute to this decision including testing feasibility, personal protective equipment (PPE) availability, and risk aversion threshold of endoscopists and staff.

2. Endoscopy centers in both low- and high-prevalence areas may not benefit from a pre-testing strategy.

• Rationale for low-prevalence areas: Diagnostic tests have a high proportion of false positives with significant downstream consequences, such as patient burden (quarantining and out of work for 14 days), unnecessarily delayed cases, and over-utilization of testing which may already be limited in availability. Therefore, PPE availability may drive decision-making for case triage instead. If PPE is not limited, then the majority of endoscopists and staff may reasonably select to use N95/N99 respirators or PAPRs.
• Rationale for high-prevalence areas: Highest available PPE (such as N95/N99 respirators or PAPRs) would be used universally, as available. Additionally, testing is often limited because of a high demand for a potential surge of cases.

AGA created an online tool to help endoscopy centers make decisions about their pre-endoscopy testing strategy. This tool combines local prevalence with diagnostic test performance data to calculate the proportion of true versus false positives and negatives to help endoscopy centers understand the downstream consequences of implementing a pre-procedure testing strategy.

To access the Rapid Review and online tool, visit www.gastro.org/COVID.

[email protected]

A new evidence-based review published in Gastroenterology helps you answer the question: Should my endoscopy center test asymptomatic patients for SARS-CoV-2 prior to endoscopy?

Key guidance for GIs

1. Endoscopy centers in areas with an intermediate prevalence of SARS-CoV-2 infection should consider testing patients for the virus before endoscopy. Several important factors contribute to this decision including testing feasibility, personal protective equipment (PPE) availability, and risk aversion threshold of endoscopists and staff.

2. Endoscopy centers in both low- and high-prevalence areas may not benefit from a pre-testing strategy.

• Rationale for low-prevalence areas: Diagnostic tests have a high proportion of false positives with significant downstream consequences, such as patient burden (quarantining and out of work for 14 days), unnecessarily delayed cases, and over-utilization of testing which may already be limited in availability. Therefore, PPE availability may drive decision-making for case triage instead. If PPE is not limited, then the majority of endoscopists and staff may reasonably select to use N95/N99 respirators or PAPRs.
• Rationale for high-prevalence areas: Highest available PPE (such as N95/N99 respirators or PAPRs) would be used universally, as available. Additionally, testing is often limited because of a high demand for a potential surge of cases.

AGA created an online tool to help endoscopy centers make decisions about their pre-endoscopy testing strategy. This tool combines local prevalence with diagnostic test performance data to calculate the proportion of true versus false positives and negatives to help endoscopy centers understand the downstream consequences of implementing a pre-procedure testing strategy.

To access the Rapid Review and online tool, visit www.gastro.org/COVID.

[email protected]

A new evidence-based review published in Gastroenterology helps you answer the question: Should my endoscopy center test asymptomatic patients for SARS-CoV-2 prior to endoscopy?

Key guidance for GIs

1. Endoscopy centers in areas with an intermediate prevalence of SARS-CoV-2 infection should consider testing patients for the virus before endoscopy. Several important factors contribute to this decision including testing feasibility, personal protective equipment (PPE) availability, and risk aversion threshold of endoscopists and staff.

2. Endoscopy centers in both low- and high-prevalence areas may not benefit from a pre-testing strategy.

• Rationale for low-prevalence areas: Diagnostic tests have a high proportion of false positives with significant downstream consequences, such as patient burden (quarantining and out of work for 14 days), unnecessarily delayed cases, and over-utilization of testing which may already be limited in availability. Therefore, PPE availability may drive decision-making for case triage instead. If PPE is not limited, then the majority of endoscopists and staff may reasonably select to use N95/N99 respirators or PAPRs.
• Rationale for high-prevalence areas: Highest available PPE (such as N95/N99 respirators or PAPRs) would be used universally, as available. Additionally, testing is often limited because of a high demand for a potential surge of cases.

AGA created an online tool to help endoscopy centers make decisions about their pre-endoscopy testing strategy. This tool combines local prevalence with diagnostic test performance data to calculate the proportion of true versus false positives and negatives to help endoscopy centers understand the downstream consequences of implementing a pre-procedure testing strategy.

To access the Rapid Review and online tool, visit www.gastro.org/COVID.

[email protected]

The AGA Equity Project advisory board has released a new commentary in Gastroenterology: “From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology.”

The commentary provides a transparent self-examination of AGA’s recent racial and ethnic demographic data of its members, volunteer leaders, and staff compared with U.S. population data. It also assesses AGA’s previous initiatives focused on diversity, equity, and inclusion. It then looks ahead by detailing AGA’s plans to further operationalize the goals enumerated in the AGA Diversity Policy.

For more information, read the full commentary at www.gastro.org/diversitycommentary.

[email protected]

The AGA Equity Project advisory board has released a new commentary in Gastroenterology: “From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology.”

The commentary provides a transparent self-examination of AGA’s recent racial and ethnic demographic data of its members, volunteer leaders, and staff compared with U.S. population data. It also assesses AGA’s previous initiatives focused on diversity, equity, and inclusion. It then looks ahead by detailing AGA’s plans to further operationalize the goals enumerated in the AGA Diversity Policy.

For more information, read the full commentary at www.gastro.org/diversitycommentary.

[email protected]

The AGA Equity Project advisory board has released a new commentary in Gastroenterology: “From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology.”

The commentary provides a transparent self-examination of AGA’s recent racial and ethnic demographic data of its members, volunteer leaders, and staff compared with U.S. population data. It also assesses AGA’s previous initiatives focused on diversity, equity, and inclusion. It then looks ahead by detailing AGA’s plans to further operationalize the goals enumerated in the AGA Diversity Policy.

For more information, read the full commentary at www.gastro.org/diversitycommentary.

[email protected]

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff, and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

Demystifying publishing in AGA journals: Perspectives from our authors and editors: Sept. 3, 2020, 5:30 p.m. EDT

Flexing your communications skills during a time of crisis: Sept. 17, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff, and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

Demystifying publishing in AGA journals: Perspectives from our authors and editors: Sept. 3, 2020, 5:30 p.m. EDT

Flexing your communications skills during a time of crisis: Sept. 17, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff, and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

Demystifying publishing in AGA journals: Perspectives from our authors and editors: Sept. 3, 2020, 5:30 p.m. EDT

Flexing your communications skills during a time of crisis: Sept. 17, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]

To the Editor:

The concept of field cancerization has been well described since its initial proposal by Slaughter et al¹ in 1953. It describes a field of genetically altered cells where multiple clonally related neoplasms can develop.^2,3 Treatment of patients with multiple neoplasms within an area of field cancerization can be especially challenging. We report a patient with field cancerization who had multiple squamous cell carcinomas (SCCs) and keratoacanthomas (KAs) that arose within the field.

A 78-year-old man initially presented with a papule on the right forearm of 3 months’ duration. He had a medical history of cutaneous SCC, myocardial infarction, type 2 diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hypercholesterolemia, gout, and diverticulosis. He was not taking any chronic immunosuppressants that may have predisposed him to the development of nonmelanoma skin cancer. The papule was biopsied and diagnosed as a well-differentiated invasive SCC. A month later it was excised with clear margins.

Approximately 5 weeks after the excision, he returned with an enlarging lesion on the right forearm just medial to the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. Two months later the lesion was excised with clear margins. Four weeks later he returned with a new lesion adjacent to the medial aspect of the prior excision. The lesion was biopsied and diagnosed as a well-differentiated SCC. Four weeks later the lesion was excised with clear margins.

Another 4 weeks later the patient returned with a new lesion on the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. The lesion was treated with radiotherapy, with a 5800-cGy course completed 2 months later. The next month, 2 papules just adjacent to the radiotherapy treatment field were biopsied and diagnosed as well-differentiated SCC, KA type. One week later, 2 additional new papules adjacent to the radiotherapy treatment field were biopsied and diagnosed as moderately differentiated SCC, KA type. At this time, the patient had 4 biopsy-proven KAs on the right forearm in the area of prior radiation (Figure, A). The radiation oncologist felt that further radiation was no longer indicated. A consultation was sought with surgical oncology, and wide excision of the field with sentinel lymph node biopsy and skin grafting was recommended. Computed tomography with contrast of the chest and right arm ordered by surgical oncology did not reveal metastatic disease.

After discussion of the risks, alternatives, and benefits of surgery, the patient elected to try nonsurgical treatment. He was treated with 5-fluorouracil (5-FU) cream 5% twice daily for 4 weeks. It was applied to the right arm from the elbow to the wrist and occluded under an elastic bandage. The patient stated that the biopsy sites became sore and inflamed during the treatment. After 4 weeks of treatment, all 4 KAs had healed without clinical evidence of tumor. During this time, however, the previously treated 2 sites had developed adjacent firm pink papules (Figure, B); these 2 lesions were then treated with intralesional 5-FU 50 mg/mL once weekly to resolution at 4 and 5 weeks, respectively. The proximal lesion was treated with 7.5 mg on week 1 and 5 mg on weeks 2, 3, and 4. The larger distal lesion was treated with 12.5 mg on week 1 and 5 mg on weeks 2, 3, 4, and 5. The volume injected was determined by ability to blanch and indurate the lesion and was decreased due to the shrinking size of the tumor. After 3 injections, both tumors had substantially decreased in size (Figure, C). The patient noted pain during injection but found the procedure tolerable and preferable to surgery. There were no other adverse events. At the end of treatment, both tumors had clinically resolved. No recurrence or development of new tumors was reported over 3 years of follow-up after the last injection.

The development of an expanding neoplastic field appears to play an important role in cutaneous carcinogenesis. It is necessary to consider the cutaneous field cancerization as a highly photodamaged area that contains clinical and subclinical lesions.^2-4 The treatment of cutaneous neoplasms, SCC in particular, should focus not only on the tumor itself but also on the surrounding tissue. Adjunctive field-directed therapies should be considered after treatment of the primary tumor.⁴

Our patient continued to develop SCCs on the right forearm after multiple excisions with clear margins and subsequently was treated with radiation therapy. He then developed 4 KAs after radiation therapy to the right forearm. Topical 5-FU is a well-described treatment of field cancerization.² In our patient, 5-FU cream 5% applied twice daily from the wrist to the elbow under occlusion for 4 weeks led to the involution of all 4 KAs. During this time, our patient developed 2 additional firm pink papules near the previously treated sites, which resolved with intralesional 5-FU weekly for 4 and 5 weeks, respectively.

Intralesional 5-FU has been described for the treatment of multiple and difficult-to-treat KAs. It is an antimetabolite and structural analog of uracil that disrupts DNA and RNA synthesis. It is contraindicated in liver disease, pregnancy or breastfeeding, and allergy to the medication.⁶ Intralesional 5-FU dosing recommendations for KAs include use of a 50-mg/mL solution and injecting 0.1 to 1 mL until the lesion blanches in color, which may be repeated every 1 to 4 weeks.^7,8 The maximum recommended daily dose is 800 mg.⁶ Pretreatment with intralesional 1% lidocaine has been recommended by some authors due to pain with injection.⁸ Recommendations for laboratory monitoring include a complete blood cell count with differential at baseline and weekly. Side effects include local pain, erythema, crusting, ulceration, and necrosis. Systemic side effects include cytopenia and gastrointestinal tract upset.⁶ Intralesional 5-FU has been used successfully in a single dose of 10 mg per lesion in combination with systemic acitretin for the treatment of multiple KAs induced by vemurafenib.⁹ It also has been effective in the treatment of multiple recurrent reactive KAs developing in surgical margins.⁷ A review article reported that the use of intralesional 5-FU produced a 98% cure rate in 56 treated KAs.⁶ Alternative intralesional agents that may be considered for KAs include methotrexate, bleomycin, and interferon alfa-2b.^6,7

Field cancerization may cause the development of multiple clonally related neoplasms within a field of genetically altered cells that may continue to develop after excision with clear margins or radiation therapy. Given the success of treatment in our patient, we recommend consideration for topical and intralesional 5-FU in patients who develop SCCs and KAs within an area of field cancerization.

To the Editor:

The concept of field cancerization has been well described since its initial proposal by Slaughter et al¹ in 1953. It describes a field of genetically altered cells where multiple clonally related neoplasms can develop.^2,3 Treatment of patients with multiple neoplasms within an area of field cancerization can be especially challenging. We report a patient with field cancerization who had multiple squamous cell carcinomas (SCCs) and keratoacanthomas (KAs) that arose within the field.

A 78-year-old man initially presented with a papule on the right forearm of 3 months’ duration. He had a medical history of cutaneous SCC, myocardial infarction, type 2 diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hypercholesterolemia, gout, and diverticulosis. He was not taking any chronic immunosuppressants that may have predisposed him to the development of nonmelanoma skin cancer. The papule was biopsied and diagnosed as a well-differentiated invasive SCC. A month later it was excised with clear margins.

Approximately 5 weeks after the excision, he returned with an enlarging lesion on the right forearm just medial to the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. Two months later the lesion was excised with clear margins. Four weeks later he returned with a new lesion adjacent to the medial aspect of the prior excision. The lesion was biopsied and diagnosed as a well-differentiated SCC. Four weeks later the lesion was excised with clear margins.

Another 4 weeks later the patient returned with a new lesion on the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. The lesion was treated with radiotherapy, with a 5800-cGy course completed 2 months later. The next month, 2 papules just adjacent to the radiotherapy treatment field were biopsied and diagnosed as well-differentiated SCC, KA type. One week later, 2 additional new papules adjacent to the radiotherapy treatment field were biopsied and diagnosed as moderately differentiated SCC, KA type. At this time, the patient had 4 biopsy-proven KAs on the right forearm in the area of prior radiation (Figure, A). The radiation oncologist felt that further radiation was no longer indicated. A consultation was sought with surgical oncology, and wide excision of the field with sentinel lymph node biopsy and skin grafting was recommended. Computed tomography with contrast of the chest and right arm ordered by surgical oncology did not reveal metastatic disease.

After discussion of the risks, alternatives, and benefits of surgery, the patient elected to try nonsurgical treatment. He was treated with 5-fluorouracil (5-FU) cream 5% twice daily for 4 weeks. It was applied to the right arm from the elbow to the wrist and occluded under an elastic bandage. The patient stated that the biopsy sites became sore and inflamed during the treatment. After 4 weeks of treatment, all 4 KAs had healed without clinical evidence of tumor. During this time, however, the previously treated 2 sites had developed adjacent firm pink papules (Figure, B); these 2 lesions were then treated with intralesional 5-FU 50 mg/mL once weekly to resolution at 4 and 5 weeks, respectively. The proximal lesion was treated with 7.5 mg on week 1 and 5 mg on weeks 2, 3, and 4. The larger distal lesion was treated with 12.5 mg on week 1 and 5 mg on weeks 2, 3, 4, and 5. The volume injected was determined by ability to blanch and indurate the lesion and was decreased due to the shrinking size of the tumor. After 3 injections, both tumors had substantially decreased in size (Figure, C). The patient noted pain during injection but found the procedure tolerable and preferable to surgery. There were no other adverse events. At the end of treatment, both tumors had clinically resolved. No recurrence or development of new tumors was reported over 3 years of follow-up after the last injection.

The development of an expanding neoplastic field appears to play an important role in cutaneous carcinogenesis. It is necessary to consider the cutaneous field cancerization as a highly photodamaged area that contains clinical and subclinical lesions.^2-4 The treatment of cutaneous neoplasms, SCC in particular, should focus not only on the tumor itself but also on the surrounding tissue. Adjunctive field-directed therapies should be considered after treatment of the primary tumor.⁴

Our patient continued to develop SCCs on the right forearm after multiple excisions with clear margins and subsequently was treated with radiation therapy. He then developed 4 KAs after radiation therapy to the right forearm. Topical 5-FU is a well-described treatment of field cancerization.² In our patient, 5-FU cream 5% applied twice daily from the wrist to the elbow under occlusion for 4 weeks led to the involution of all 4 KAs. During this time, our patient developed 2 additional firm pink papules near the previously treated sites, which resolved with intralesional 5-FU weekly for 4 and 5 weeks, respectively.

Intralesional 5-FU has been described for the treatment of multiple and difficult-to-treat KAs. It is an antimetabolite and structural analog of uracil that disrupts DNA and RNA synthesis. It is contraindicated in liver disease, pregnancy or breastfeeding, and allergy to the medication.⁶ Intralesional 5-FU dosing recommendations for KAs include use of a 50-mg/mL solution and injecting 0.1 to 1 mL until the lesion blanches in color, which may be repeated every 1 to 4 weeks.^7,8 The maximum recommended daily dose is 800 mg.⁶ Pretreatment with intralesional 1% lidocaine has been recommended by some authors due to pain with injection.⁸ Recommendations for laboratory monitoring include a complete blood cell count with differential at baseline and weekly. Side effects include local pain, erythema, crusting, ulceration, and necrosis. Systemic side effects include cytopenia and gastrointestinal tract upset.⁶ Intralesional 5-FU has been used successfully in a single dose of 10 mg per lesion in combination with systemic acitretin for the treatment of multiple KAs induced by vemurafenib.⁹ It also has been effective in the treatment of multiple recurrent reactive KAs developing in surgical margins.⁷ A review article reported that the use of intralesional 5-FU produced a 98% cure rate in 56 treated KAs.⁶ Alternative intralesional agents that may be considered for KAs include methotrexate, bleomycin, and interferon alfa-2b.^6,7

Field cancerization may cause the development of multiple clonally related neoplasms within a field of genetically altered cells that may continue to develop after excision with clear margins or radiation therapy. Given the success of treatment in our patient, we recommend consideration for topical and intralesional 5-FU in patients who develop SCCs and KAs within an area of field cancerization.

To the Editor:

The concept of field cancerization has been well described since its initial proposal by Slaughter et al¹ in 1953. It describes a field of genetically altered cells where multiple clonally related neoplasms can develop.^2,3 Treatment of patients with multiple neoplasms within an area of field cancerization can be especially challenging. We report a patient with field cancerization who had multiple squamous cell carcinomas (SCCs) and keratoacanthomas (KAs) that arose within the field.

A 78-year-old man initially presented with a papule on the right forearm of 3 months’ duration. He had a medical history of cutaneous SCC, myocardial infarction, type 2 diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hypercholesterolemia, gout, and diverticulosis. He was not taking any chronic immunosuppressants that may have predisposed him to the development of nonmelanoma skin cancer. The papule was biopsied and diagnosed as a well-differentiated invasive SCC. A month later it was excised with clear margins.

Approximately 5 weeks after the excision, he returned with an enlarging lesion on the right forearm just medial to the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. Two months later the lesion was excised with clear margins. Four weeks later he returned with a new lesion adjacent to the medial aspect of the prior excision. The lesion was biopsied and diagnosed as a well-differentiated SCC. Four weeks later the lesion was excised with clear margins.

Another 4 weeks later the patient returned with a new lesion on the excision site. The lesion was biopsied and diagnosed as a well-differentiated SCC. The lesion was treated with radiotherapy, with a 5800-cGy course completed 2 months later. The next month, 2 papules just adjacent to the radiotherapy treatment field were biopsied and diagnosed as well-differentiated SCC, KA type. One week later, 2 additional new papules adjacent to the radiotherapy treatment field were biopsied and diagnosed as moderately differentiated SCC, KA type. At this time, the patient had 4 biopsy-proven KAs on the right forearm in the area of prior radiation (Figure, A). The radiation oncologist felt that further radiation was no longer indicated. A consultation was sought with surgical oncology, and wide excision of the field with sentinel lymph node biopsy and skin grafting was recommended. Computed tomography with contrast of the chest and right arm ordered by surgical oncology did not reveal metastatic disease.

After discussion of the risks, alternatives, and benefits of surgery, the patient elected to try nonsurgical treatment. He was treated with 5-fluorouracil (5-FU) cream 5% twice daily for 4 weeks. It was applied to the right arm from the elbow to the wrist and occluded under an elastic bandage. The patient stated that the biopsy sites became sore and inflamed during the treatment. After 4 weeks of treatment, all 4 KAs had healed without clinical evidence of tumor. During this time, however, the previously treated 2 sites had developed adjacent firm pink papules (Figure, B); these 2 lesions were then treated with intralesional 5-FU 50 mg/mL once weekly to resolution at 4 and 5 weeks, respectively. The proximal lesion was treated with 7.5 mg on week 1 and 5 mg on weeks 2, 3, and 4. The larger distal lesion was treated with 12.5 mg on week 1 and 5 mg on weeks 2, 3, 4, and 5. The volume injected was determined by ability to blanch and indurate the lesion and was decreased due to the shrinking size of the tumor. After 3 injections, both tumors had substantially decreased in size (Figure, C). The patient noted pain during injection but found the procedure tolerable and preferable to surgery. There were no other adverse events. At the end of treatment, both tumors had clinically resolved. No recurrence or development of new tumors was reported over 3 years of follow-up after the last injection.

The development of an expanding neoplastic field appears to play an important role in cutaneous carcinogenesis. It is necessary to consider the cutaneous field cancerization as a highly photodamaged area that contains clinical and subclinical lesions.^2-4 The treatment of cutaneous neoplasms, SCC in particular, should focus not only on the tumor itself but also on the surrounding tissue. Adjunctive field-directed therapies should be considered after treatment of the primary tumor.⁴

Our patient continued to develop SCCs on the right forearm after multiple excisions with clear margins and subsequently was treated with radiation therapy. He then developed 4 KAs after radiation therapy to the right forearm. Topical 5-FU is a well-described treatment of field cancerization.² In our patient, 5-FU cream 5% applied twice daily from the wrist to the elbow under occlusion for 4 weeks led to the involution of all 4 KAs. During this time, our patient developed 2 additional firm pink papules near the previously treated sites, which resolved with intralesional 5-FU weekly for 4 and 5 weeks, respectively.

Intralesional 5-FU has been described for the treatment of multiple and difficult-to-treat KAs. It is an antimetabolite and structural analog of uracil that disrupts DNA and RNA synthesis. It is contraindicated in liver disease, pregnancy or breastfeeding, and allergy to the medication.⁶ Intralesional 5-FU dosing recommendations for KAs include use of a 50-mg/mL solution and injecting 0.1 to 1 mL until the lesion blanches in color, which may be repeated every 1 to 4 weeks.^7,8 The maximum recommended daily dose is 800 mg.⁶ Pretreatment with intralesional 1% lidocaine has been recommended by some authors due to pain with injection.⁸ Recommendations for laboratory monitoring include a complete blood cell count with differential at baseline and weekly. Side effects include local pain, erythema, crusting, ulceration, and necrosis. Systemic side effects include cytopenia and gastrointestinal tract upset.⁶ Intralesional 5-FU has been used successfully in a single dose of 10 mg per lesion in combination with systemic acitretin for the treatment of multiple KAs induced by vemurafenib.⁹ It also has been effective in the treatment of multiple recurrent reactive KAs developing in surgical margins.⁷ A review article reported that the use of intralesional 5-FU produced a 98% cure rate in 56 treated KAs.⁶ Alternative intralesional agents that may be considered for KAs include methotrexate, bleomycin, and interferon alfa-2b.^6,7

Field cancerization may cause the development of multiple clonally related neoplasms within a field of genetically altered cells that may continue to develop after excision with clear margins or radiation therapy. Given the success of treatment in our patient, we recommend consideration for topical and intralesional 5-FU in patients who develop SCCs and KAs within an area of field cancerization.

NEW CERVICAL DILATOR

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

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

LIGHT DEVICE FOR HAIR REJUVENATION

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

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

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

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

SUI TREATMENT

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

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

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

NEW CERVICAL DILATOR

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

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

LIGHT DEVICE FOR HAIR REJUVENATION

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

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

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

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

SUI TREATMENT

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

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

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

NEW CERVICAL DILATOR

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

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

LIGHT DEVICE FOR HAIR REJUVENATION

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

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

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

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

SUI TREATMENT

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

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

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

Two COVID-19 vaccines are entering phase 3 clinical trials, according to data presented at a virtual meeting of vaccine and infectious disease experts.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) yesterday held its third meeting this summer to discuss the vaccines and plan how initial vaccines will be allocated, inasmuch as supplies will likely be limited at first. Vaccines are expected to be more available as production ramps up and as more than one vaccine become available, but vaccine allocation initially will need to take place in phases.

Considerations include first getting the vaccine to individuals who need it the most, such as healthcare personnel and essential workers, as well as those at higher risk for severe illness or death, including the elderly, those with underlying conditions, and certain racial and ethnic minorities. Other factors include storage requirements that might be difficult to meet in certain settings and the fact that both vaccines must be given in two doses.

Vaccine allocation models

The group presented two possible models for allocating initial vaccine supplies.

The first population model considers risk status within each age group on the basis of underlying health conditions and occupational group, with priority given to healthcare personnel (paid or unpaid) and essential workers. The model considers partial reopening and social distancing, expected vaccine efficacy, prevaccination immunity, mortality, and the direct and indirect benefits of vaccination.

In this model, COVID-19 infections and deaths were reduced when healthcare personnel, essential workers, or adults with underlying conditions were vaccinated. There were smaller differences between the groups with respect to the impact of vaccination. Declines in infections were “more modest” and declines in deaths were greater when adults aged 65 years and older were vaccinated in comparison with other age groups.

The second model focused on vaccination of nursing home healthcare personnel and residents. Vaccinating nursing home healthcare personnel reduced infections and deaths more than vaccinating nursing home residents.

In settings such as long-term care facilities and correction facilities, where people gather in groups, cases increase first among staff. The vaccine working group suggests that vaccinating staff may also benefit individuals living in those facilities.

The working group expects that from 15 to 45 million doses of vaccine will be available by the end of December, depending on which vaccine is approved by then or whether both are approved.

Supplies won’t be nearly enough to vaccinate everyone: There are approximately 17 to 20 million healthcare workers in the United States and 60 to 80 million essential workers who do not work in healthcare. More than 100 million adults have underlying medical conditions that put them at higher risk for hospitalization and death, such as obesity, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease. And approximately 53 million adults are aged 65 years or older.

The group reviewed promising early data for two vaccines under development.

The mRNA-1273 vaccine, made by Moderna with support from two federal agencies, is moving into phase 3 clinical trials – enrollment into the COVID-19 Efficacy and Safety (COVE) study is ongoing, according to Jacqueline M. Miller, MD, senior vice president and therapeutic area head of infectious diseases. The study’s primary objective will be to determine whether two doses can prevent symptomatic COVID-19, according to an NIH news release.

A second mRNA vaccine, BNT 162b2, made by Pfizer and BioNTech, is entering phase 2/3 trials. Nearly 20% of people enrolled are Black or Hispanic persons, and 4% are Asian persons. The team is also trying to recruit Native American participants, Nicholas Kitchin, MD, senior director in Pfizer’s vaccine clinical research and development group, said in a presentation to the advisory committee.

‘Ultra-cold’ temperatures required for storage

Both vaccines require storage at lower temperatures than is usually needed for vaccines. One vaccine must be distributed and stored at -20° C, and the other must be stored, distributed, and handled at -70° C.

This issue stands out most to ACIP Chair Jose Romero, MD. He says the “ultra-cold” temperatures required for storage and transportation of the vaccines will be a “significant problem” for those in rural areas.

High-risk populations such as meat processors and agricultural workers “may have to wait until we have a more stable vaccine that can be transported and delivered more or less at room temperature,” Romero explained. He is the chief medical officer at the Arkansas Department of Health and is a professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences, both in Little Rock.

The advisory committee will meet again on September 22. At that time, they’ll vote on an interim plan for prioritization of the first COVID-19 vaccine.

This article first appeared on Medscape.com.

Two COVID-19 vaccines are entering phase 3 clinical trials, according to data presented at a virtual meeting of vaccine and infectious disease experts.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) yesterday held its third meeting this summer to discuss the vaccines and plan how initial vaccines will be allocated, inasmuch as supplies will likely be limited at first. Vaccines are expected to be more available as production ramps up and as more than one vaccine become available, but vaccine allocation initially will need to take place in phases.

Considerations include first getting the vaccine to individuals who need it the most, such as healthcare personnel and essential workers, as well as those at higher risk for severe illness or death, including the elderly, those with underlying conditions, and certain racial and ethnic minorities. Other factors include storage requirements that might be difficult to meet in certain settings and the fact that both vaccines must be given in two doses.

Vaccine allocation models

The group presented two possible models for allocating initial vaccine supplies.

The first population model considers risk status within each age group on the basis of underlying health conditions and occupational group, with priority given to healthcare personnel (paid or unpaid) and essential workers. The model considers partial reopening and social distancing, expected vaccine efficacy, prevaccination immunity, mortality, and the direct and indirect benefits of vaccination.

In this model, COVID-19 infections and deaths were reduced when healthcare personnel, essential workers, or adults with underlying conditions were vaccinated. There were smaller differences between the groups with respect to the impact of vaccination. Declines in infections were “more modest” and declines in deaths were greater when adults aged 65 years and older were vaccinated in comparison with other age groups.

The second model focused on vaccination of nursing home healthcare personnel and residents. Vaccinating nursing home healthcare personnel reduced infections and deaths more than vaccinating nursing home residents.

In settings such as long-term care facilities and correction facilities, where people gather in groups, cases increase first among staff. The vaccine working group suggests that vaccinating staff may also benefit individuals living in those facilities.

The working group expects that from 15 to 45 million doses of vaccine will be available by the end of December, depending on which vaccine is approved by then or whether both are approved.

Supplies won’t be nearly enough to vaccinate everyone: There are approximately 17 to 20 million healthcare workers in the United States and 60 to 80 million essential workers who do not work in healthcare. More than 100 million adults have underlying medical conditions that put them at higher risk for hospitalization and death, such as obesity, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease. And approximately 53 million adults are aged 65 years or older.

The group reviewed promising early data for two vaccines under development.

The mRNA-1273 vaccine, made by Moderna with support from two federal agencies, is moving into phase 3 clinical trials – enrollment into the COVID-19 Efficacy and Safety (COVE) study is ongoing, according to Jacqueline M. Miller, MD, senior vice president and therapeutic area head of infectious diseases. The study’s primary objective will be to determine whether two doses can prevent symptomatic COVID-19, according to an NIH news release.

A second mRNA vaccine, BNT 162b2, made by Pfizer and BioNTech, is entering phase 2/3 trials. Nearly 20% of people enrolled are Black or Hispanic persons, and 4% are Asian persons. The team is also trying to recruit Native American participants, Nicholas Kitchin, MD, senior director in Pfizer’s vaccine clinical research and development group, said in a presentation to the advisory committee.

‘Ultra-cold’ temperatures required for storage

Both vaccines require storage at lower temperatures than is usually needed for vaccines. One vaccine must be distributed and stored at -20° C, and the other must be stored, distributed, and handled at -70° C.

This issue stands out most to ACIP Chair Jose Romero, MD. He says the “ultra-cold” temperatures required for storage and transportation of the vaccines will be a “significant problem” for those in rural areas.

High-risk populations such as meat processors and agricultural workers “may have to wait until we have a more stable vaccine that can be transported and delivered more or less at room temperature,” Romero explained. He is the chief medical officer at the Arkansas Department of Health and is a professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences, both in Little Rock.

The advisory committee will meet again on September 22. At that time, they’ll vote on an interim plan for prioritization of the first COVID-19 vaccine.

This article first appeared on Medscape.com.

Two COVID-19 vaccines are entering phase 3 clinical trials, according to data presented at a virtual meeting of vaccine and infectious disease experts.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) yesterday held its third meeting this summer to discuss the vaccines and plan how initial vaccines will be allocated, inasmuch as supplies will likely be limited at first. Vaccines are expected to be more available as production ramps up and as more than one vaccine become available, but vaccine allocation initially will need to take place in phases.

Considerations include first getting the vaccine to individuals who need it the most, such as healthcare personnel and essential workers, as well as those at higher risk for severe illness or death, including the elderly, those with underlying conditions, and certain racial and ethnic minorities. Other factors include storage requirements that might be difficult to meet in certain settings and the fact that both vaccines must be given in two doses.

Vaccine allocation models

The group presented two possible models for allocating initial vaccine supplies.

The first population model considers risk status within each age group on the basis of underlying health conditions and occupational group, with priority given to healthcare personnel (paid or unpaid) and essential workers. The model considers partial reopening and social distancing, expected vaccine efficacy, prevaccination immunity, mortality, and the direct and indirect benefits of vaccination.

In this model, COVID-19 infections and deaths were reduced when healthcare personnel, essential workers, or adults with underlying conditions were vaccinated. There were smaller differences between the groups with respect to the impact of vaccination. Declines in infections were “more modest” and declines in deaths were greater when adults aged 65 years and older were vaccinated in comparison with other age groups.

The second model focused on vaccination of nursing home healthcare personnel and residents. Vaccinating nursing home healthcare personnel reduced infections and deaths more than vaccinating nursing home residents.

In settings such as long-term care facilities and correction facilities, where people gather in groups, cases increase first among staff. The vaccine working group suggests that vaccinating staff may also benefit individuals living in those facilities.

The working group expects that from 15 to 45 million doses of vaccine will be available by the end of December, depending on which vaccine is approved by then or whether both are approved.

Supplies won’t be nearly enough to vaccinate everyone: There are approximately 17 to 20 million healthcare workers in the United States and 60 to 80 million essential workers who do not work in healthcare. More than 100 million adults have underlying medical conditions that put them at higher risk for hospitalization and death, such as obesity, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease. And approximately 53 million adults are aged 65 years or older.

The group reviewed promising early data for two vaccines under development.

The mRNA-1273 vaccine, made by Moderna with support from two federal agencies, is moving into phase 3 clinical trials – enrollment into the COVID-19 Efficacy and Safety (COVE) study is ongoing, according to Jacqueline M. Miller, MD, senior vice president and therapeutic area head of infectious diseases. The study’s primary objective will be to determine whether two doses can prevent symptomatic COVID-19, according to an NIH news release.

A second mRNA vaccine, BNT 162b2, made by Pfizer and BioNTech, is entering phase 2/3 trials. Nearly 20% of people enrolled are Black or Hispanic persons, and 4% are Asian persons. The team is also trying to recruit Native American participants, Nicholas Kitchin, MD, senior director in Pfizer’s vaccine clinical research and development group, said in a presentation to the advisory committee.

‘Ultra-cold’ temperatures required for storage

Both vaccines require storage at lower temperatures than is usually needed for vaccines. One vaccine must be distributed and stored at -20° C, and the other must be stored, distributed, and handled at -70° C.

This issue stands out most to ACIP Chair Jose Romero, MD. He says the “ultra-cold” temperatures required for storage and transportation of the vaccines will be a “significant problem” for those in rural areas.

High-risk populations such as meat processors and agricultural workers “may have to wait until we have a more stable vaccine that can be transported and delivered more or less at room temperature,” Romero explained. He is the chief medical officer at the Arkansas Department of Health and is a professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences, both in Little Rock.

The advisory committee will meet again on September 22. At that time, they’ll vote on an interim plan for prioritization of the first COVID-19 vaccine.

This article first appeared on Medscape.com.