Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials. 

Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease. 

Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy. 

Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials. 

-- 

Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,  

New York, New York 

Benjamin Cooper, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca. 

Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials. 

Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease. 

Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy. 

Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials. 

-- 

Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,  

New York, New York 

Benjamin Cooper, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca. 

Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials. 

Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease. 

Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy. 

Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials. 

-- 

Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,  

New York, New York 

Benjamin Cooper, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca. 

Dr. Ponni V. Perumalswami is an Associate Professor of Internal Medicine in the Division of Gastroenterology and Hepatology at the University of Michigan; Ann Arbor VA Healthcare System. Dr. Perumalswami's areas of clinical interest include cirrhosis, acute/chronic liver diseases and liver transplantation. Her research program focuses on community outreach for hepatitis B and C screening and linking patients to care. 

Q: For patients with liver disease who live in underserved and vulnerable communities, what barriers to that care are more prominent or at the primary systemic-level?

Dr. Perumalswami: I think a major barrier has been our approach to thinking about these barriers, so I'm glad you are asking this question in terms of what the systemic-level barriers are rather than, for example, patient-level barriers. I'll use viral hepatitis as an example in terms of liver-disease care. I think for a very long time we've placed an unfair, onus on patients, leaving them to find their own care and to navigate existing system-level barriers such as language proficiency, health literacy, lack of insurance, and long distances to access specialists by themselves. This “do-it-yourself” approach has created a systemic-level barrier to finding specialists, and it remains a major problem. We would do a better job of improving access to care by re-thinking all barriers to care as system-and provider-level barriers rather than patient-level barriers because it is often the case that solutions that address systems barriers can address these issues.

Many specialists, like myself, are often geographically clustered at tertiary care and urban academic centers but the reality is that patients who are at risk for living with liver disease live all over, including rural areas, where fewer specialists practice. But advancements in treatments of certain liver diseases, such as hepatitis C virus (HCV), have made it possible for frontline community providers to treat patients. Expanding these patients' treatment options, in large part, is dependent on payer policy changes to allow treatment by non-specialists, reducing the cost of treatment and giving frontline workers the support they need so that they are more confident to offer treatment while differentiating the occasional patient who may need referral to a specialist.

Cost is also a systemic-level barrier for our underserved patients with liver disease and comes in many forms. Barriers related to cost include lack or type of insurance, traveling distances which also entails a cost for time (i.e. loss of wages, caregiver support), and cost of treatments. There are certain restrictions on HCV treatments that designate who can administer them and at what point in disease progression the therapy be introduced. These restrictions have been arbitrarily set by payers for treatments like direct-acting antivirals (DAA) and unfortunately dictate "when they can be obtained" and "who can prescribe them." Instead, we should spend time and effort to determine how we can have more providers practicing in different spaces, who might be equipped and motivated to provide treatment, and do it safely and easily.

Another barrier I will mention is the lack of integrated care for patients with certain liver diseases within healthcare systems. Notable examples include integrated care for those with alcohol-associated liver disease and viral hepatitis, who often have co-occurring mental health issues and substance use, addiction, or opioid use disorders. We need to think through how we can get integrated treatment and care to these patients, instead of making them come to us as individual specialists. By integrating medical care into behavioral health practices or other treatment settings, and perhaps by considering nontraditional treatment modalities, we can overcome barriers to care that are all too often siloed.

The last thing that I will mention with regards to patient-level barriers is that liver diseases and their care by providers has been very stigmatized, particularly for patients with underlying mental health and/or addiction disorders. These patients do not always feel comfortable coming to see clinicians in their practices so we must recognize that our offices may be stigmatized places for some patients with liver disease. Because of this, it is vital to think about how we can integrate care into trusted spaces for patient populations who might be at risk or are living with liver disease.

Q: What aspects of these barriers have you focused on to improve screening and links to care in communities at risk?

Dr. Perumalswami: A lot of my work is focused on patients in populations who are at risk for viral hepatitis and on screening them, educating them, and linking them to care in their communities. The challenge in successfully treating patients with a liver disease is that most liver diseases remain silent until they've progressed to a very advanced stage. Certain populations are at a higher risk for contracting these diseases compared to others. For example, with hepatitis B virus, we know that foreign-born populations have a higher infection rate, and how and when they seek care might be very different in terms of being symptom-driven versus preventive care as a result of cultural factors around health seeking behaviors. Our team has attempted to take a more proactive approach; first, to understand who might be at risk, and second, to try to bring screening to trusted places where patients can easily access care. We have found this proactive approach to be very successful in terms of identifying people who are not yet diagnosed with liver disease and then linking them into care.

The first step is knowing which populations you want to target with respect to individual types of liver disease, then working with community partners to bring screening out into the community. Obviously, the challenging part is getting people linked into care. As stated previously, many liver diseases in their earlier stages stay silent and manifest without symptoms, thus why it is vital to offer at-risk patients testing or screening. 

The next step is to raise patient awareness and provide education as to why it is important to seek care; to get a thorough evaluation in terms of the extent of the liver disease and how to best manage and treat it, long term. For example, we have found that care coordination works very well with patients living with HCV. For patients with hepatitis B, we have found that culturally informed patient navigation services are very helpful, so we work with peers in the community who speak the same language and who come from the same communities as the patients identified as at-risk. This combined strategy of testing and then linking to care has been very successful.

I will say an important part of the care-coordination piece is addressing the competing priorities that patients have in their lives. For example, if they need housing, we refer them to housing services; if they have food insecurities, we try to address the need. Once you address their basic determinants of health, you have established a basis for trust while helping patients contend with important competing priorities. This way, your team has enabled potential patients to prioritize and engage in health care.

Q: How have you integrated HCV treatment into harm reduction and opioid use disorder settings?

Dr. Perumalswami: I am fortunate to be involved with a program here in Michigan whose goal is to increase HCV treatment through an open access, HCV consultation program through the Michigan Opioid Collaborative. The premise is to find motivated, interested providers who want to learn how to offer HCV treatment to patients in their communities; the majority of these providers are in rural parts of Michigan. In this setting, we are working with frontline medical personnel in the community, many of whom are either addiction providers or are offering opioid use disorder treatment, and who are also seeing HCV patients. We have set up an open-case consulting program where providers can submit cases for review with guidance from hepatologists. Attendance is optional and we meet for an hour, every other week and we talk through cases in more detail as a group. The result is that the providers have reported that they feel less isolated doing this as a team, having a place to discuss cases and work through practical challenges that can arise with this patient base. While HCV treatment advances have made great strides, many providers want reassurance or guidance in terms how to implement these programs so as a group, we walk through a few cases, demonstrate how to check for drug-drug interactions and how to perform fibrosis assessments. After these providers go through this training, they become more comfortable giving treatment on their own.

The second project, which I have also been fortunate to be involved in, is led by my colleague Dr. Jeffrey Weiss at Mount Sinai Hospital and is located at a syringe exchange program in a Brooklyn, New York. Here, patients attend receive in-person and/or telemedicine-based HCV treatment, which is a new model of care for us. While it has produced a different set of challenges in terms of engaging and bringing treatment to patients in a new space, it has been a great way to meet our objectives of helping patients to be treated where they are comfortable accessing care and services.

Q: Has the pandemic created any new challenges in treating at risk or special populations?

Dr. Perumalswami: The pandemic presented many new challenges. The primary impact that COVID-19 has had on our patients has been with the disruption in care; particularly for those patients who already found it challenging to seek and receive care. For patients who benefitted from following a routine, other pandemic-related challenges were the restrictions placed on our practices, and the reduced hours patients had to contend with access services and treatments at places such as syringe exchange programs or methadone programs.

Many of our patients have expressed feeling isolated as they are not able to get the same type of support that they were previously receiving. The decreases in viral hepatitis outreach, in screening in the community, and in practices resulted in a decrease in diagnosis and treatment.

We have also heard numerous discussions with regards to better reimbursements for phone call and telehealth sessions, but we must recognize that those things are not accessible to all patients. Many of our most vulnerable populations, do not have working phones, stable housing, or smart devices to access telehealth, so while there have been technological advances that can provide access to care and better reimbursement procedures, there are still many limitations that our patients are facing.

(AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project).

Dr. Ponni V. Perumalswami is an Associate Professor of Internal Medicine in the Division of Gastroenterology and Hepatology at the University of Michigan; Ann Arbor VA Healthcare System. Dr. Perumalswami's areas of clinical interest include cirrhosis, acute/chronic liver diseases and liver transplantation. Her research program focuses on community outreach for hepatitis B and C screening and linking patients to care. 

Q: For patients with liver disease who live in underserved and vulnerable communities, what barriers to that care are more prominent or at the primary systemic-level?

Dr. Perumalswami: I think a major barrier has been our approach to thinking about these barriers, so I'm glad you are asking this question in terms of what the systemic-level barriers are rather than, for example, patient-level barriers. I'll use viral hepatitis as an example in terms of liver-disease care. I think for a very long time we've placed an unfair, onus on patients, leaving them to find their own care and to navigate existing system-level barriers such as language proficiency, health literacy, lack of insurance, and long distances to access specialists by themselves. This “do-it-yourself” approach has created a systemic-level barrier to finding specialists, and it remains a major problem. We would do a better job of improving access to care by re-thinking all barriers to care as system-and provider-level barriers rather than patient-level barriers because it is often the case that solutions that address systems barriers can address these issues.

Many specialists, like myself, are often geographically clustered at tertiary care and urban academic centers but the reality is that patients who are at risk for living with liver disease live all over, including rural areas, where fewer specialists practice. But advancements in treatments of certain liver diseases, such as hepatitis C virus (HCV), have made it possible for frontline community providers to treat patients. Expanding these patients' treatment options, in large part, is dependent on payer policy changes to allow treatment by non-specialists, reducing the cost of treatment and giving frontline workers the support they need so that they are more confident to offer treatment while differentiating the occasional patient who may need referral to a specialist.

Cost is also a systemic-level barrier for our underserved patients with liver disease and comes in many forms. Barriers related to cost include lack or type of insurance, traveling distances which also entails a cost for time (i.e. loss of wages, caregiver support), and cost of treatments. There are certain restrictions on HCV treatments that designate who can administer them and at what point in disease progression the therapy be introduced. These restrictions have been arbitrarily set by payers for treatments like direct-acting antivirals (DAA) and unfortunately dictate "when they can be obtained" and "who can prescribe them." Instead, we should spend time and effort to determine how we can have more providers practicing in different spaces, who might be equipped and motivated to provide treatment, and do it safely and easily.

Another barrier I will mention is the lack of integrated care for patients with certain liver diseases within healthcare systems. Notable examples include integrated care for those with alcohol-associated liver disease and viral hepatitis, who often have co-occurring mental health issues and substance use, addiction, or opioid use disorders. We need to think through how we can get integrated treatment and care to these patients, instead of making them come to us as individual specialists. By integrating medical care into behavioral health practices or other treatment settings, and perhaps by considering nontraditional treatment modalities, we can overcome barriers to care that are all too often siloed.

The last thing that I will mention with regards to patient-level barriers is that liver diseases and their care by providers has been very stigmatized, particularly for patients with underlying mental health and/or addiction disorders. These patients do not always feel comfortable coming to see clinicians in their practices so we must recognize that our offices may be stigmatized places for some patients with liver disease. Because of this, it is vital to think about how we can integrate care into trusted spaces for patient populations who might be at risk or are living with liver disease.

Q: What aspects of these barriers have you focused on to improve screening and links to care in communities at risk?

Dr. Perumalswami: A lot of my work is focused on patients in populations who are at risk for viral hepatitis and on screening them, educating them, and linking them to care in their communities. The challenge in successfully treating patients with a liver disease is that most liver diseases remain silent until they've progressed to a very advanced stage. Certain populations are at a higher risk for contracting these diseases compared to others. For example, with hepatitis B virus, we know that foreign-born populations have a higher infection rate, and how and when they seek care might be very different in terms of being symptom-driven versus preventive care as a result of cultural factors around health seeking behaviors. Our team has attempted to take a more proactive approach; first, to understand who might be at risk, and second, to try to bring screening to trusted places where patients can easily access care. We have found this proactive approach to be very successful in terms of identifying people who are not yet diagnosed with liver disease and then linking them into care.

The first step is knowing which populations you want to target with respect to individual types of liver disease, then working with community partners to bring screening out into the community. Obviously, the challenging part is getting people linked into care. As stated previously, many liver diseases in their earlier stages stay silent and manifest without symptoms, thus why it is vital to offer at-risk patients testing or screening. 

The next step is to raise patient awareness and provide education as to why it is important to seek care; to get a thorough evaluation in terms of the extent of the liver disease and how to best manage and treat it, long term. For example, we have found that care coordination works very well with patients living with HCV. For patients with hepatitis B, we have found that culturally informed patient navigation services are very helpful, so we work with peers in the community who speak the same language and who come from the same communities as the patients identified as at-risk. This combined strategy of testing and then linking to care has been very successful.

I will say an important part of the care-coordination piece is addressing the competing priorities that patients have in their lives. For example, if they need housing, we refer them to housing services; if they have food insecurities, we try to address the need. Once you address their basic determinants of health, you have established a basis for trust while helping patients contend with important competing priorities. This way, your team has enabled potential patients to prioritize and engage in health care.

Q: How have you integrated HCV treatment into harm reduction and opioid use disorder settings?

Dr. Perumalswami: I am fortunate to be involved with a program here in Michigan whose goal is to increase HCV treatment through an open access, HCV consultation program through the Michigan Opioid Collaborative. The premise is to find motivated, interested providers who want to learn how to offer HCV treatment to patients in their communities; the majority of these providers are in rural parts of Michigan. In this setting, we are working with frontline medical personnel in the community, many of whom are either addiction providers or are offering opioid use disorder treatment, and who are also seeing HCV patients. We have set up an open-case consulting program where providers can submit cases for review with guidance from hepatologists. Attendance is optional and we meet for an hour, every other week and we talk through cases in more detail as a group. The result is that the providers have reported that they feel less isolated doing this as a team, having a place to discuss cases and work through practical challenges that can arise with this patient base. While HCV treatment advances have made great strides, many providers want reassurance or guidance in terms how to implement these programs so as a group, we walk through a few cases, demonstrate how to check for drug-drug interactions and how to perform fibrosis assessments. After these providers go through this training, they become more comfortable giving treatment on their own.

The second project, which I have also been fortunate to be involved in, is led by my colleague Dr. Jeffrey Weiss at Mount Sinai Hospital and is located at a syringe exchange program in a Brooklyn, New York. Here, patients attend receive in-person and/or telemedicine-based HCV treatment, which is a new model of care for us. While it has produced a different set of challenges in terms of engaging and bringing treatment to patients in a new space, it has been a great way to meet our objectives of helping patients to be treated where they are comfortable accessing care and services.

Q: Has the pandemic created any new challenges in treating at risk or special populations?

Dr. Perumalswami: The pandemic presented many new challenges. The primary impact that COVID-19 has had on our patients has been with the disruption in care; particularly for those patients who already found it challenging to seek and receive care. For patients who benefitted from following a routine, other pandemic-related challenges were the restrictions placed on our practices, and the reduced hours patients had to contend with access services and treatments at places such as syringe exchange programs or methadone programs.

Many of our patients have expressed feeling isolated as they are not able to get the same type of support that they were previously receiving. The decreases in viral hepatitis outreach, in screening in the community, and in practices resulted in a decrease in diagnosis and treatment.

We have also heard numerous discussions with regards to better reimbursements for phone call and telehealth sessions, but we must recognize that those things are not accessible to all patients. Many of our most vulnerable populations, do not have working phones, stable housing, or smart devices to access telehealth, so while there have been technological advances that can provide access to care and better reimbursement procedures, there are still many limitations that our patients are facing.

(AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project).

Dr. Ponni V. Perumalswami is an Associate Professor of Internal Medicine in the Division of Gastroenterology and Hepatology at the University of Michigan; Ann Arbor VA Healthcare System. Dr. Perumalswami's areas of clinical interest include cirrhosis, acute/chronic liver diseases and liver transplantation. Her research program focuses on community outreach for hepatitis B and C screening and linking patients to care. 

Q: For patients with liver disease who live in underserved and vulnerable communities, what barriers to that care are more prominent or at the primary systemic-level?

Dr. Perumalswami: I think a major barrier has been our approach to thinking about these barriers, so I'm glad you are asking this question in terms of what the systemic-level barriers are rather than, for example, patient-level barriers. I'll use viral hepatitis as an example in terms of liver-disease care. I think for a very long time we've placed an unfair, onus on patients, leaving them to find their own care and to navigate existing system-level barriers such as language proficiency, health literacy, lack of insurance, and long distances to access specialists by themselves. This “do-it-yourself” approach has created a systemic-level barrier to finding specialists, and it remains a major problem. We would do a better job of improving access to care by re-thinking all barriers to care as system-and provider-level barriers rather than patient-level barriers because it is often the case that solutions that address systems barriers can address these issues.

Many specialists, like myself, are often geographically clustered at tertiary care and urban academic centers but the reality is that patients who are at risk for living with liver disease live all over, including rural areas, where fewer specialists practice. But advancements in treatments of certain liver diseases, such as hepatitis C virus (HCV), have made it possible for frontline community providers to treat patients. Expanding these patients' treatment options, in large part, is dependent on payer policy changes to allow treatment by non-specialists, reducing the cost of treatment and giving frontline workers the support they need so that they are more confident to offer treatment while differentiating the occasional patient who may need referral to a specialist.

Cost is also a systemic-level barrier for our underserved patients with liver disease and comes in many forms. Barriers related to cost include lack or type of insurance, traveling distances which also entails a cost for time (i.e. loss of wages, caregiver support), and cost of treatments. There are certain restrictions on HCV treatments that designate who can administer them and at what point in disease progression the therapy be introduced. These restrictions have been arbitrarily set by payers for treatments like direct-acting antivirals (DAA) and unfortunately dictate "when they can be obtained" and "who can prescribe them." Instead, we should spend time and effort to determine how we can have more providers practicing in different spaces, who might be equipped and motivated to provide treatment, and do it safely and easily.

Another barrier I will mention is the lack of integrated care for patients with certain liver diseases within healthcare systems. Notable examples include integrated care for those with alcohol-associated liver disease and viral hepatitis, who often have co-occurring mental health issues and substance use, addiction, or opioid use disorders. We need to think through how we can get integrated treatment and care to these patients, instead of making them come to us as individual specialists. By integrating medical care into behavioral health practices or other treatment settings, and perhaps by considering nontraditional treatment modalities, we can overcome barriers to care that are all too often siloed.

The last thing that I will mention with regards to patient-level barriers is that liver diseases and their care by providers has been very stigmatized, particularly for patients with underlying mental health and/or addiction disorders. These patients do not always feel comfortable coming to see clinicians in their practices so we must recognize that our offices may be stigmatized places for some patients with liver disease. Because of this, it is vital to think about how we can integrate care into trusted spaces for patient populations who might be at risk or are living with liver disease.

Q: What aspects of these barriers have you focused on to improve screening and links to care in communities at risk?

Dr. Perumalswami: A lot of my work is focused on patients in populations who are at risk for viral hepatitis and on screening them, educating them, and linking them to care in their communities. The challenge in successfully treating patients with a liver disease is that most liver diseases remain silent until they've progressed to a very advanced stage. Certain populations are at a higher risk for contracting these diseases compared to others. For example, with hepatitis B virus, we know that foreign-born populations have a higher infection rate, and how and when they seek care might be very different in terms of being symptom-driven versus preventive care as a result of cultural factors around health seeking behaviors. Our team has attempted to take a more proactive approach; first, to understand who might be at risk, and second, to try to bring screening to trusted places where patients can easily access care. We have found this proactive approach to be very successful in terms of identifying people who are not yet diagnosed with liver disease and then linking them into care.

The first step is knowing which populations you want to target with respect to individual types of liver disease, then working with community partners to bring screening out into the community. Obviously, the challenging part is getting people linked into care. As stated previously, many liver diseases in their earlier stages stay silent and manifest without symptoms, thus why it is vital to offer at-risk patients testing or screening. 

The next step is to raise patient awareness and provide education as to why it is important to seek care; to get a thorough evaluation in terms of the extent of the liver disease and how to best manage and treat it, long term. For example, we have found that care coordination works very well with patients living with HCV. For patients with hepatitis B, we have found that culturally informed patient navigation services are very helpful, so we work with peers in the community who speak the same language and who come from the same communities as the patients identified as at-risk. This combined strategy of testing and then linking to care has been very successful.

I will say an important part of the care-coordination piece is addressing the competing priorities that patients have in their lives. For example, if they need housing, we refer them to housing services; if they have food insecurities, we try to address the need. Once you address their basic determinants of health, you have established a basis for trust while helping patients contend with important competing priorities. This way, your team has enabled potential patients to prioritize and engage in health care.

Q: How have you integrated HCV treatment into harm reduction and opioid use disorder settings?

Dr. Perumalswami: I am fortunate to be involved with a program here in Michigan whose goal is to increase HCV treatment through an open access, HCV consultation program through the Michigan Opioid Collaborative. The premise is to find motivated, interested providers who want to learn how to offer HCV treatment to patients in their communities; the majority of these providers are in rural parts of Michigan. In this setting, we are working with frontline medical personnel in the community, many of whom are either addiction providers or are offering opioid use disorder treatment, and who are also seeing HCV patients. We have set up an open-case consulting program where providers can submit cases for review with guidance from hepatologists. Attendance is optional and we meet for an hour, every other week and we talk through cases in more detail as a group. The result is that the providers have reported that they feel less isolated doing this as a team, having a place to discuss cases and work through practical challenges that can arise with this patient base. While HCV treatment advances have made great strides, many providers want reassurance or guidance in terms how to implement these programs so as a group, we walk through a few cases, demonstrate how to check for drug-drug interactions and how to perform fibrosis assessments. After these providers go through this training, they become more comfortable giving treatment on their own.

The second project, which I have also been fortunate to be involved in, is led by my colleague Dr. Jeffrey Weiss at Mount Sinai Hospital and is located at a syringe exchange program in a Brooklyn, New York. Here, patients attend receive in-person and/or telemedicine-based HCV treatment, which is a new model of care for us. While it has produced a different set of challenges in terms of engaging and bringing treatment to patients in a new space, it has been a great way to meet our objectives of helping patients to be treated where they are comfortable accessing care and services.

Q: Has the pandemic created any new challenges in treating at risk or special populations?

Dr. Perumalswami: The pandemic presented many new challenges. The primary impact that COVID-19 has had on our patients has been with the disruption in care; particularly for those patients who already found it challenging to seek and receive care. For patients who benefitted from following a routine, other pandemic-related challenges were the restrictions placed on our practices, and the reduced hours patients had to contend with access services and treatments at places such as syringe exchange programs or methadone programs.

Many of our patients have expressed feeling isolated as they are not able to get the same type of support that they were previously receiving. The decreases in viral hepatitis outreach, in screening in the community, and in practices resulted in a decrease in diagnosis and treatment.

We have also heard numerous discussions with regards to better reimbursements for phone call and telehealth sessions, but we must recognize that those things are not accessible to all patients. Many of our most vulnerable populations, do not have working phones, stable housing, or smart devices to access telehealth, so while there have been technological advances that can provide access to care and better reimbursement procedures, there are still many limitations that our patients are facing.

(AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project).

Q1: How do/can fibroids influence fertility?

When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.

It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.

We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has.  But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids  are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.

There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.

Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?

One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of  high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.

It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.

What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.

Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.

Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?

I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is  to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.

We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.

The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.

For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.

I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.

There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.

Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?

The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.

For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.

Q1: How do/can fibroids influence fertility?

When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.

It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.

We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has.  But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids  are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.

There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.

Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?

One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of  high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.

It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.

What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.

Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.

Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?

I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is  to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.

We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.

The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.

For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.

I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.

There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.

Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?

The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.

For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.

Q1: How do/can fibroids influence fertility?

When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.

It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.

We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has.  But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids  are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.

There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.

Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?

One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of  high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.

It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.

What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.

Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.

Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?

I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is  to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.

We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.

The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.

For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.

I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.

There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.

Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?

The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.

For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.

Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.

Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).

Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).

Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.

Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.

Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.

Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).

Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).

Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.

Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.

Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.

Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).

Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).

Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.

Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.

Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.

Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.

Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).

Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.

Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.

Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.

Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.

Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).

Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.

Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.

Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.

Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.

Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).

Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.

Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.

Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.

Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).

Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).

Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.

Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.

Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.

Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).

Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).

Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.

Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.

Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.

Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).

Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).

Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.

Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.

Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.

Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.

Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).

Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.

Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.

Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.

Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.

Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).

Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.

Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.

Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.

Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.

Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).

Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.

Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.

Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.

Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).

Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.

Disclosures: No funding information was available. The authors declared no conflict of interests.

Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.

Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.

Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).

Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.

Disclosures: No funding information was available. The authors declared no conflict of interests.

Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.

Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.

Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).

Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.

Disclosures: No funding information was available. The authors declared no conflict of interests.

Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.