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Improving ILD diagnosis in primary care settings

Article Type
Changed
Thu, 08/01/2024 - 16:13

Interstitial lung diseases (ILDs), with their many ubiquitous symptoms, are often hard to diagnose in patients. That’s why Amirahwaty Abdullah, MBBS, and Kavitha Selvan, MD, see value in educating clinicians on how to identify and diagnose ILD.

CHEST
Dr. Amirahwaty Abdullah

Both Dr. Abdullah and Dr. Selvan received quality improvement grants from CHEST in October 2023 to do just that. Their projects put the ILD Clinician Toolkit into practice, created as a part of CHEST’s Bridging Specialties™: Timely Diagnosis for ILD initiative aimed at shortening the time to diagnosis.

CHEST
Dr. Kavitha Selvan


Recently, CHEST caught up with the two grant recipients to see how their projects were progressing.

Combating the prevalence of ILDs in West Virginia

Dr. Abdullah and Co-Principal Investigator, Haroon Ahmed, MD, are two of the staff members supporting West Virginia University ILD Clinic, where the ILD Clinician Toolkit is being utilized.

CHEST
Dr. Haroon Ahmed

“ILD is so prevalent here, so we thought it would be an excellent opportunity to do the quality improvement project here because we really do need the resources to improve the care of our [patients with ILD],” Dr. Abdullah said. “For the entire state of West Virginia, we’re the only ILD center.”

In West Virginia, many factors are at play making ILD prevalent, with a recent study showing that the state has the second highest rate of interstitial pulmonary fibrosis, Dr. Abdullah said. This is all due to the economy of the state, the rurality of the population, and the occupational hazards with common jobs like coal mining and farming.

“This topic about bridging the gap and early diagnosis really resonated with us because we see all these patients who end up seeing us after they’ve been on oxygen for years, when they can’t do anything else,” Dr. Ahmed said. “There was a big gap here, and we saw that every day in our clinical practice.”

Since implementing the ILD Clinician Toolkit into their program, the two have started providing these resources to primary care physicians in an effort to help expedite their workups when they see patients with common ILD symptoms. This was done through grand rounds and educational conferences for those practicing in family medicine, internal medicine, and pediatric medicine. And more education is planned for the future.

They have also created working relationships with these departments and have encouraged them to send patients to the ILD Clinic, so patients don’t have to be referred to multiple different physicians.

The next step for the project is to implement telemedicine capabilities, which will allow the team to roll out the patient questionnaire from the toolkit. The questionnaire helps physicians gather a detailed history about their patients, including their past and current medications, surgeries, occupational and environmental exposures, and known comorbidities.

“We definitely want to reach out via telemedicine to patients because, at this point in time, some of our patients travel 3, 4 hours one way just to come see us. So, if we can make it more accessible, we will,” Dr. Abdullah said.

Their plan is to provide iPads that are equipped with the questionnaire and other toolkit resources to the providers. Through this method, the team will be able to see how often the questionnaire is used.

“We are very thankful for this grant because I do think we are saving lives,” Dr. Abdullah said. “Any little thing that we can do to improve the outcomes of these patients who have a rare but difficult-to-treat disease—it’s crucial. This gives us the ability to reach out and help patients who are out of our physical bounds.”
 

 

 

Diagnosing ILD among underrepresented minority populations in Chicago

Dr. Kavitha Selvan is conducting her quality improvement research project at the University of Chicago, alongside her team.

“The community we serve in South Chicago houses a significant number of underrepresented [minority populations],” she said.

“We know that Black patients with ILD experience higher rates of hospitalization, compared with White patients,” she said. “And they are hospitalized, require lung transplants, and die at a younger age too.”

In clinical practice, Dr. Selvan has noticed a trend of patients being referred for evaluation of possible ILD later and later. In some cases, several years go by before the appropriate work for ILD is initiated, and that valuable time lost leads to irreversible loss of lung function.

Dr. Selvan’s plan is to partner with primary care providers who are seeing these patients first in order to expedite the work-up and referral of ILD when appropriate and, ultimately, reduce the amount of time that passes between symptom onset and definitive diagnosis.

“To me, this grant and the resources it provided represented an important opportunity to improve outcomes in the high-risk patients we care for through early disease recognition and treatment,” she said.

Dr. Selvan’s project began with educating members of the Primary Care Group at UChicago on risk factors and exam findings that may suggest ILD in patients coming to clinic with nonspecific respiratory complaints. Then they had to equip providers with the ILD Clinician Toolkit and reach patients by handing out the patient questionnaire in primary care clinic.

The next step for this project is going to be dissecting the answers to a postintervention survey that was sent out to understand the practices and comfort of primary care providers in evaluating suspected ILD and the utility of the additional resources created by Dr. Selvan’s team.

“My hope is that we can utilize this partnership with the Primary Care Group to provide the education that’s needed both on the patient side and the provider side, like knowing not to ignore respiratory symptoms, knowing which patients warrant ILD-specific testing, and knowing what the appropriate tests are. In doing so, we can get patients into ILD clinic earlier, confirm their diagnosis, and get them initiated on the appropriate therapies sooner,” she said.

Dr. Selvan credits the quality improvement grant as being fundamental in her success as a fellow and early faculty at UChicago Medicine and believes that this project has created a culture of awareness that wouldn’t have been possible without funding.

“I truly believe that early detection and risk factor modification is the most critical aspect of interstitial lung disease care, and the mechanism for how we’re going to actually improve patient outcomes in our community,” Dr. Selvan said. “Building the infrastructure to accomplish that requires time, resources, and support from institutions and philanthropic foundations that believe in that mission too."

Opportunities like this are made possible by generous contributions from our donors. Make a gift to CHEST and select “Clinical Research” to help aid future research into interstitial lung disease and much more.

Publications
Topics
Sections

Interstitial lung diseases (ILDs), with their many ubiquitous symptoms, are often hard to diagnose in patients. That’s why Amirahwaty Abdullah, MBBS, and Kavitha Selvan, MD, see value in educating clinicians on how to identify and diagnose ILD.

CHEST
Dr. Amirahwaty Abdullah

Both Dr. Abdullah and Dr. Selvan received quality improvement grants from CHEST in October 2023 to do just that. Their projects put the ILD Clinician Toolkit into practice, created as a part of CHEST’s Bridging Specialties™: Timely Diagnosis for ILD initiative aimed at shortening the time to diagnosis.

CHEST
Dr. Kavitha Selvan


Recently, CHEST caught up with the two grant recipients to see how their projects were progressing.

Combating the prevalence of ILDs in West Virginia

Dr. Abdullah and Co-Principal Investigator, Haroon Ahmed, MD, are two of the staff members supporting West Virginia University ILD Clinic, where the ILD Clinician Toolkit is being utilized.

CHEST
Dr. Haroon Ahmed

“ILD is so prevalent here, so we thought it would be an excellent opportunity to do the quality improvement project here because we really do need the resources to improve the care of our [patients with ILD],” Dr. Abdullah said. “For the entire state of West Virginia, we’re the only ILD center.”

In West Virginia, many factors are at play making ILD prevalent, with a recent study showing that the state has the second highest rate of interstitial pulmonary fibrosis, Dr. Abdullah said. This is all due to the economy of the state, the rurality of the population, and the occupational hazards with common jobs like coal mining and farming.

“This topic about bridging the gap and early diagnosis really resonated with us because we see all these patients who end up seeing us after they’ve been on oxygen for years, when they can’t do anything else,” Dr. Ahmed said. “There was a big gap here, and we saw that every day in our clinical practice.”

Since implementing the ILD Clinician Toolkit into their program, the two have started providing these resources to primary care physicians in an effort to help expedite their workups when they see patients with common ILD symptoms. This was done through grand rounds and educational conferences for those practicing in family medicine, internal medicine, and pediatric medicine. And more education is planned for the future.

They have also created working relationships with these departments and have encouraged them to send patients to the ILD Clinic, so patients don’t have to be referred to multiple different physicians.

The next step for the project is to implement telemedicine capabilities, which will allow the team to roll out the patient questionnaire from the toolkit. The questionnaire helps physicians gather a detailed history about their patients, including their past and current medications, surgeries, occupational and environmental exposures, and known comorbidities.

“We definitely want to reach out via telemedicine to patients because, at this point in time, some of our patients travel 3, 4 hours one way just to come see us. So, if we can make it more accessible, we will,” Dr. Abdullah said.

Their plan is to provide iPads that are equipped with the questionnaire and other toolkit resources to the providers. Through this method, the team will be able to see how often the questionnaire is used.

“We are very thankful for this grant because I do think we are saving lives,” Dr. Abdullah said. “Any little thing that we can do to improve the outcomes of these patients who have a rare but difficult-to-treat disease—it’s crucial. This gives us the ability to reach out and help patients who are out of our physical bounds.”
 

 

 

Diagnosing ILD among underrepresented minority populations in Chicago

Dr. Kavitha Selvan is conducting her quality improvement research project at the University of Chicago, alongside her team.

“The community we serve in South Chicago houses a significant number of underrepresented [minority populations],” she said.

“We know that Black patients with ILD experience higher rates of hospitalization, compared with White patients,” she said. “And they are hospitalized, require lung transplants, and die at a younger age too.”

In clinical practice, Dr. Selvan has noticed a trend of patients being referred for evaluation of possible ILD later and later. In some cases, several years go by before the appropriate work for ILD is initiated, and that valuable time lost leads to irreversible loss of lung function.

Dr. Selvan’s plan is to partner with primary care providers who are seeing these patients first in order to expedite the work-up and referral of ILD when appropriate and, ultimately, reduce the amount of time that passes between symptom onset and definitive diagnosis.

“To me, this grant and the resources it provided represented an important opportunity to improve outcomes in the high-risk patients we care for through early disease recognition and treatment,” she said.

Dr. Selvan’s project began with educating members of the Primary Care Group at UChicago on risk factors and exam findings that may suggest ILD in patients coming to clinic with nonspecific respiratory complaints. Then they had to equip providers with the ILD Clinician Toolkit and reach patients by handing out the patient questionnaire in primary care clinic.

The next step for this project is going to be dissecting the answers to a postintervention survey that was sent out to understand the practices and comfort of primary care providers in evaluating suspected ILD and the utility of the additional resources created by Dr. Selvan’s team.

“My hope is that we can utilize this partnership with the Primary Care Group to provide the education that’s needed both on the patient side and the provider side, like knowing not to ignore respiratory symptoms, knowing which patients warrant ILD-specific testing, and knowing what the appropriate tests are. In doing so, we can get patients into ILD clinic earlier, confirm their diagnosis, and get them initiated on the appropriate therapies sooner,” she said.

Dr. Selvan credits the quality improvement grant as being fundamental in her success as a fellow and early faculty at UChicago Medicine and believes that this project has created a culture of awareness that wouldn’t have been possible without funding.

“I truly believe that early detection and risk factor modification is the most critical aspect of interstitial lung disease care, and the mechanism for how we’re going to actually improve patient outcomes in our community,” Dr. Selvan said. “Building the infrastructure to accomplish that requires time, resources, and support from institutions and philanthropic foundations that believe in that mission too."

Opportunities like this are made possible by generous contributions from our donors. Make a gift to CHEST and select “Clinical Research” to help aid future research into interstitial lung disease and much more.

Interstitial lung diseases (ILDs), with their many ubiquitous symptoms, are often hard to diagnose in patients. That’s why Amirahwaty Abdullah, MBBS, and Kavitha Selvan, MD, see value in educating clinicians on how to identify and diagnose ILD.

CHEST
Dr. Amirahwaty Abdullah

Both Dr. Abdullah and Dr. Selvan received quality improvement grants from CHEST in October 2023 to do just that. Their projects put the ILD Clinician Toolkit into practice, created as a part of CHEST’s Bridging Specialties™: Timely Diagnosis for ILD initiative aimed at shortening the time to diagnosis.

CHEST
Dr. Kavitha Selvan


Recently, CHEST caught up with the two grant recipients to see how their projects were progressing.

Combating the prevalence of ILDs in West Virginia

Dr. Abdullah and Co-Principal Investigator, Haroon Ahmed, MD, are two of the staff members supporting West Virginia University ILD Clinic, where the ILD Clinician Toolkit is being utilized.

CHEST
Dr. Haroon Ahmed

“ILD is so prevalent here, so we thought it would be an excellent opportunity to do the quality improvement project here because we really do need the resources to improve the care of our [patients with ILD],” Dr. Abdullah said. “For the entire state of West Virginia, we’re the only ILD center.”

In West Virginia, many factors are at play making ILD prevalent, with a recent study showing that the state has the second highest rate of interstitial pulmonary fibrosis, Dr. Abdullah said. This is all due to the economy of the state, the rurality of the population, and the occupational hazards with common jobs like coal mining and farming.

“This topic about bridging the gap and early diagnosis really resonated with us because we see all these patients who end up seeing us after they’ve been on oxygen for years, when they can’t do anything else,” Dr. Ahmed said. “There was a big gap here, and we saw that every day in our clinical practice.”

Since implementing the ILD Clinician Toolkit into their program, the two have started providing these resources to primary care physicians in an effort to help expedite their workups when they see patients with common ILD symptoms. This was done through grand rounds and educational conferences for those practicing in family medicine, internal medicine, and pediatric medicine. And more education is planned for the future.

They have also created working relationships with these departments and have encouraged them to send patients to the ILD Clinic, so patients don’t have to be referred to multiple different physicians.

The next step for the project is to implement telemedicine capabilities, which will allow the team to roll out the patient questionnaire from the toolkit. The questionnaire helps physicians gather a detailed history about their patients, including their past and current medications, surgeries, occupational and environmental exposures, and known comorbidities.

“We definitely want to reach out via telemedicine to patients because, at this point in time, some of our patients travel 3, 4 hours one way just to come see us. So, if we can make it more accessible, we will,” Dr. Abdullah said.

Their plan is to provide iPads that are equipped with the questionnaire and other toolkit resources to the providers. Through this method, the team will be able to see how often the questionnaire is used.

“We are very thankful for this grant because I do think we are saving lives,” Dr. Abdullah said. “Any little thing that we can do to improve the outcomes of these patients who have a rare but difficult-to-treat disease—it’s crucial. This gives us the ability to reach out and help patients who are out of our physical bounds.”
 

 

 

Diagnosing ILD among underrepresented minority populations in Chicago

Dr. Kavitha Selvan is conducting her quality improvement research project at the University of Chicago, alongside her team.

“The community we serve in South Chicago houses a significant number of underrepresented [minority populations],” she said.

“We know that Black patients with ILD experience higher rates of hospitalization, compared with White patients,” she said. “And they are hospitalized, require lung transplants, and die at a younger age too.”

In clinical practice, Dr. Selvan has noticed a trend of patients being referred for evaluation of possible ILD later and later. In some cases, several years go by before the appropriate work for ILD is initiated, and that valuable time lost leads to irreversible loss of lung function.

Dr. Selvan’s plan is to partner with primary care providers who are seeing these patients first in order to expedite the work-up and referral of ILD when appropriate and, ultimately, reduce the amount of time that passes between symptom onset and definitive diagnosis.

“To me, this grant and the resources it provided represented an important opportunity to improve outcomes in the high-risk patients we care for through early disease recognition and treatment,” she said.

Dr. Selvan’s project began with educating members of the Primary Care Group at UChicago on risk factors and exam findings that may suggest ILD in patients coming to clinic with nonspecific respiratory complaints. Then they had to equip providers with the ILD Clinician Toolkit and reach patients by handing out the patient questionnaire in primary care clinic.

The next step for this project is going to be dissecting the answers to a postintervention survey that was sent out to understand the practices and comfort of primary care providers in evaluating suspected ILD and the utility of the additional resources created by Dr. Selvan’s team.

“My hope is that we can utilize this partnership with the Primary Care Group to provide the education that’s needed both on the patient side and the provider side, like knowing not to ignore respiratory symptoms, knowing which patients warrant ILD-specific testing, and knowing what the appropriate tests are. In doing so, we can get patients into ILD clinic earlier, confirm their diagnosis, and get them initiated on the appropriate therapies sooner,” she said.

Dr. Selvan credits the quality improvement grant as being fundamental in her success as a fellow and early faculty at UChicago Medicine and believes that this project has created a culture of awareness that wouldn’t have been possible without funding.

“I truly believe that early detection and risk factor modification is the most critical aspect of interstitial lung disease care, and the mechanism for how we’re going to actually improve patient outcomes in our community,” Dr. Selvan said. “Building the infrastructure to accomplish that requires time, resources, and support from institutions and philanthropic foundations that believe in that mission too."

Opportunities like this are made possible by generous contributions from our donors. Make a gift to CHEST and select “Clinical Research” to help aid future research into interstitial lung disease and much more.

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Top reads from the CHEST journal portfolio

Article Type
Changed
Thu, 08/01/2024 - 12:03
Display Headline
Top reads from the CHEST journal portfolio

Studying endotypes in sleep apnea, diagnostic testing in ILD, and inhaled corticosteroid use in children

 

Journal CHEST®

Differences in Physiologic Endotypes Between Nonpositional and Positional OSA: Results From the Shanghai Sleep Health Study Cohort

By Xiaoting Wang, MM, and colleagues

This study from the Shanghai Sleep Health Study cohort enhances our understanding of physiologic endotypes in sleep apnea—nonpositional OSA (NPOSA) and positional OSA (POSA). The study found that nonanatomic traits play a more significant role in POSA severity. Patients with POSA exhibited lower arousal thresholds and greater ventilatory compensation, while anatomical abnormalities were more prominent in NPOSA. This research underscores the need for personalized treatment strategies based on specific endotypes, especially with the increasing emergence of alternatives to CPAP therapy, such as mandibular advancement therapy and hypoglossal nerve stimulation. Patients with obesity with NPOSA were found to have elevated loop gain, which is known to be impacted by weight loss. This is particularly relevant in light of recent studies showing that new GLP-1 agonists can dramatically reduce sleep apnea severity. Future research should focus on refining these personalized approaches and integrating alternative treatments to provide a more individualized approach to managing sleep apnea.

CHEST
Dr. Shyam Subramanian

– Commentary by Shyam Subramanian, MD, FCCP, Member of the CHEST Physician Editorial Board
 

CHEST® Pulmonary

Employment of the Envisia Genomic Classifier in Conjunction With Cryobiopsy in Patients With Undiagnosed Interstitial Lung Disease

By Fayez Kheir, MD, and colleagues

The novel mRNA genomic array, Envisia Genomic Classifier (EGC), used in this study has been shown to be highly specific for a histopathologic diagnosis of usual interstitial pneumonia (UIP). A diagnosis of UIP carries significant prognostic import as patients exhibit a higher risk for progressive fibrosis and death compared with other interstitial lung diseases (ILDs). In this retrospective study, the combination of bronchoscopic lung cryobiopsy and EGC testing was associated with a significant change in clinical management of those living with an indeterminate ILD. Participants were more likely to be started on antifibrotic therapy following this intervention. This study emphasizes the need for prospective trials on the diagnostic yield of molecular phenotyping with bronchoscopic lung biopsy compared with the traditional surgical approach for the undifferentiated ILD.

CHEST
Dr. Michael Marll

– Commentary by Michael Marll, MD, Member of the CHEST Physician Editorial Board


CHEST® Critical Care

Inhaled Corticosteroids Use Before Hospitalization May Be Protective in Children With Direct Lung Injury

By Elizabeth Landzberg, MD, and colleagues

Respiratory illness is the most common reason for both hospitalization and ICU admission in children. Studies suggest inhaled corticosteroids (ICSs) may protect adults with direct lung injury (DLI) from developing respiratory failure. However, there is a paucity of literature on this therapeutic intervention within the pediatric population. This retrospective, large, single-center study identified children seeking treatment at the emergency department (ED) with DLI before hospitalization. ICS use before hospitalization was associated with one-half the odds of escalation to intubation and noninvasive respiratory support (NRS) in pediatric patients seeking treatment in the ED with DLI. The protective effect was greatest in patients with a history of asthma. According to the authors, this is the first study to assess ICS exposure before hospitalization and progression to respiratory failure in all-cause pediatric DLI. It highlights the need for future studies to evaluate whether a role exists for early prophylactic ICS use in pediatric DLI without status asthmaticus, stratified by history of asthma.

CHEST
Dr. Anne C. Coates

– Commentary by Anne C. Coates, MD, FCCP, Member of the CHEST Physician Editorial Board

Publications
Topics
Sections

Studying endotypes in sleep apnea, diagnostic testing in ILD, and inhaled corticosteroid use in children

Studying endotypes in sleep apnea, diagnostic testing in ILD, and inhaled corticosteroid use in children

 

Journal CHEST®

Differences in Physiologic Endotypes Between Nonpositional and Positional OSA: Results From the Shanghai Sleep Health Study Cohort

By Xiaoting Wang, MM, and colleagues

This study from the Shanghai Sleep Health Study cohort enhances our understanding of physiologic endotypes in sleep apnea—nonpositional OSA (NPOSA) and positional OSA (POSA). The study found that nonanatomic traits play a more significant role in POSA severity. Patients with POSA exhibited lower arousal thresholds and greater ventilatory compensation, while anatomical abnormalities were more prominent in NPOSA. This research underscores the need for personalized treatment strategies based on specific endotypes, especially with the increasing emergence of alternatives to CPAP therapy, such as mandibular advancement therapy and hypoglossal nerve stimulation. Patients with obesity with NPOSA were found to have elevated loop gain, which is known to be impacted by weight loss. This is particularly relevant in light of recent studies showing that new GLP-1 agonists can dramatically reduce sleep apnea severity. Future research should focus on refining these personalized approaches and integrating alternative treatments to provide a more individualized approach to managing sleep apnea.

CHEST
Dr. Shyam Subramanian

– Commentary by Shyam Subramanian, MD, FCCP, Member of the CHEST Physician Editorial Board
 

CHEST® Pulmonary

Employment of the Envisia Genomic Classifier in Conjunction With Cryobiopsy in Patients With Undiagnosed Interstitial Lung Disease

By Fayez Kheir, MD, and colleagues

The novel mRNA genomic array, Envisia Genomic Classifier (EGC), used in this study has been shown to be highly specific for a histopathologic diagnosis of usual interstitial pneumonia (UIP). A diagnosis of UIP carries significant prognostic import as patients exhibit a higher risk for progressive fibrosis and death compared with other interstitial lung diseases (ILDs). In this retrospective study, the combination of bronchoscopic lung cryobiopsy and EGC testing was associated with a significant change in clinical management of those living with an indeterminate ILD. Participants were more likely to be started on antifibrotic therapy following this intervention. This study emphasizes the need for prospective trials on the diagnostic yield of molecular phenotyping with bronchoscopic lung biopsy compared with the traditional surgical approach for the undifferentiated ILD.

CHEST
Dr. Michael Marll

– Commentary by Michael Marll, MD, Member of the CHEST Physician Editorial Board


CHEST® Critical Care

Inhaled Corticosteroids Use Before Hospitalization May Be Protective in Children With Direct Lung Injury

By Elizabeth Landzberg, MD, and colleagues

Respiratory illness is the most common reason for both hospitalization and ICU admission in children. Studies suggest inhaled corticosteroids (ICSs) may protect adults with direct lung injury (DLI) from developing respiratory failure. However, there is a paucity of literature on this therapeutic intervention within the pediatric population. This retrospective, large, single-center study identified children seeking treatment at the emergency department (ED) with DLI before hospitalization. ICS use before hospitalization was associated with one-half the odds of escalation to intubation and noninvasive respiratory support (NRS) in pediatric patients seeking treatment in the ED with DLI. The protective effect was greatest in patients with a history of asthma. According to the authors, this is the first study to assess ICS exposure before hospitalization and progression to respiratory failure in all-cause pediatric DLI. It highlights the need for future studies to evaluate whether a role exists for early prophylactic ICS use in pediatric DLI without status asthmaticus, stratified by history of asthma.

CHEST
Dr. Anne C. Coates

– Commentary by Anne C. Coates, MD, FCCP, Member of the CHEST Physician Editorial Board

 

Journal CHEST®

Differences in Physiologic Endotypes Between Nonpositional and Positional OSA: Results From the Shanghai Sleep Health Study Cohort

By Xiaoting Wang, MM, and colleagues

This study from the Shanghai Sleep Health Study cohort enhances our understanding of physiologic endotypes in sleep apnea—nonpositional OSA (NPOSA) and positional OSA (POSA). The study found that nonanatomic traits play a more significant role in POSA severity. Patients with POSA exhibited lower arousal thresholds and greater ventilatory compensation, while anatomical abnormalities were more prominent in NPOSA. This research underscores the need for personalized treatment strategies based on specific endotypes, especially with the increasing emergence of alternatives to CPAP therapy, such as mandibular advancement therapy and hypoglossal nerve stimulation. Patients with obesity with NPOSA were found to have elevated loop gain, which is known to be impacted by weight loss. This is particularly relevant in light of recent studies showing that new GLP-1 agonists can dramatically reduce sleep apnea severity. Future research should focus on refining these personalized approaches and integrating alternative treatments to provide a more individualized approach to managing sleep apnea.

CHEST
Dr. Shyam Subramanian

– Commentary by Shyam Subramanian, MD, FCCP, Member of the CHEST Physician Editorial Board
 

CHEST® Pulmonary

Employment of the Envisia Genomic Classifier in Conjunction With Cryobiopsy in Patients With Undiagnosed Interstitial Lung Disease

By Fayez Kheir, MD, and colleagues

The novel mRNA genomic array, Envisia Genomic Classifier (EGC), used in this study has been shown to be highly specific for a histopathologic diagnosis of usual interstitial pneumonia (UIP). A diagnosis of UIP carries significant prognostic import as patients exhibit a higher risk for progressive fibrosis and death compared with other interstitial lung diseases (ILDs). In this retrospective study, the combination of bronchoscopic lung cryobiopsy and EGC testing was associated with a significant change in clinical management of those living with an indeterminate ILD. Participants were more likely to be started on antifibrotic therapy following this intervention. This study emphasizes the need for prospective trials on the diagnostic yield of molecular phenotyping with bronchoscopic lung biopsy compared with the traditional surgical approach for the undifferentiated ILD.

CHEST
Dr. Michael Marll

– Commentary by Michael Marll, MD, Member of the CHEST Physician Editorial Board


CHEST® Critical Care

Inhaled Corticosteroids Use Before Hospitalization May Be Protective in Children With Direct Lung Injury

By Elizabeth Landzberg, MD, and colleagues

Respiratory illness is the most common reason for both hospitalization and ICU admission in children. Studies suggest inhaled corticosteroids (ICSs) may protect adults with direct lung injury (DLI) from developing respiratory failure. However, there is a paucity of literature on this therapeutic intervention within the pediatric population. This retrospective, large, single-center study identified children seeking treatment at the emergency department (ED) with DLI before hospitalization. ICS use before hospitalization was associated with one-half the odds of escalation to intubation and noninvasive respiratory support (NRS) in pediatric patients seeking treatment in the ED with DLI. The protective effect was greatest in patients with a history of asthma. According to the authors, this is the first study to assess ICS exposure before hospitalization and progression to respiratory failure in all-cause pediatric DLI. It highlights the need for future studies to evaluate whether a role exists for early prophylactic ICS use in pediatric DLI without status asthmaticus, stratified by history of asthma.

CHEST
Dr. Anne C. Coates

– Commentary by Anne C. Coates, MD, FCCP, Member of the CHEST Physician Editorial Board

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Article Type
Display Headline
Top reads from the CHEST journal portfolio
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APPs and POCUS: Overcoming credentialing challenges

Article Type
Changed
Thu, 08/01/2024 - 13:37

CHEST
Rhea Votipka

APP INTERSECTION

Advanced practice providers (APPs) play an integral role in the care and management of patients both in the ICU and across the spectrum of health care. Due to reduced residency hours and the coming physician shortage, APPs are playing, and will continue to play, a greater role in the care and management of critically ill patients.

Point of care ultrasound (POCUS) is a key diagnostic modality that promotes rapid diagnosis, shortens time to key interventions, and allows for interval reassessment. However, the benefit relies heavily on operator skill to obtain good quality images, interpret this within the context of the patient, and know what interventions, if any, to make. It is imperative that APPs, given their role within critical care, become not only familiar with POCUS but demonstrate proficiency in practice.

Before this can become standard, there are a number of challenges to overcome. Educational institutions are behind on integrating POCUS into the APP curriculum.1 Additionally, APPs have few opportunities to develop these skills as residencies and fellowships are not required prior to entering the workforce. Instead, for a majority of APPs, POCUS training relies on nonstandardized on-the-job training or an (typically expensive) off-site training, for which they may not receive reimbursement. Other barriers include cultural practices that limit POCUS use by APPs; inability to upload and document images obtained; lack of willing, skilled mentors with time to provide feedback and assess for clinical competence; and even accessibility of ultrasound machines.2

Despite these challenges, the clinical benefits of utilizing ultrasound in practice necessitates overcoming these barriers. Institutionally, when APPs perform POCUS, it can lead to more rapid diagnosis and triage of patients, provide billing opportunities, and may reduce overall costs of care. From an APP perspective, having formalized training and credentialing can lead to more consistent POCUS assessment between providers, comprehensive patient care, security in one’s skills and knowledge base, and a tangible way of communicating one’s credibility between institutions.

While some institutions have overcome these barriers and APPs are trained and credentialed in POCUS, this is not always the norm. For this to come to fruition, we need educators to incorporate this into curriculum, colleagues who are willing to mentor learners, cultural changes to allow APPs to develop and utilize necessary skills for practice, clear structure for obtaining and maintaining competency, physicians to champion these efforts, and institutions to credential skilled APPs. Until then, it is important that we as APPs seek to facilitate these institutional changes and continue to set and maintain high quality standards for ourselves.


CHEST 2024 is for APPs too

With more than 300 educational sessions on the CHEST 2024 program, it can be overwhelming to figure out which ones you should put on your schedule. That’s why CHEST asked Danielle McCamey, DNP, CRNP, ACNP-BC, FCCP, and LaDonna Brown, DNP, CRNA, of DNPs of Color (DOC), as well as Corinne Young, MSN, FNP-C, FCCP, of the Association of Pulmonary Advanced Practice Providers (APAPP), for their recommendations on sessions that advanced practice providers shouldn’t miss. Visit chestnet.org/annual-meeting-apps for all of their recommendations.


References

1. Rudy S, Widmar B, Wilbeck J. Ultrasound education for nurse practitioner students: strategies for curricular integration. J Nurse Pract. 2024;20(6):104986.

2. Resnyk J, Weichold A. Barriers to learning and performing point-of-care ultrasound (POCUS): An integrative review. J Prof Nursing. 2024;54:54-62.




 

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Rhea Votipka

APP INTERSECTION

Advanced practice providers (APPs) play an integral role in the care and management of patients both in the ICU and across the spectrum of health care. Due to reduced residency hours and the coming physician shortage, APPs are playing, and will continue to play, a greater role in the care and management of critically ill patients.

Point of care ultrasound (POCUS) is a key diagnostic modality that promotes rapid diagnosis, shortens time to key interventions, and allows for interval reassessment. However, the benefit relies heavily on operator skill to obtain good quality images, interpret this within the context of the patient, and know what interventions, if any, to make. It is imperative that APPs, given their role within critical care, become not only familiar with POCUS but demonstrate proficiency in practice.

Before this can become standard, there are a number of challenges to overcome. Educational institutions are behind on integrating POCUS into the APP curriculum.1 Additionally, APPs have few opportunities to develop these skills as residencies and fellowships are not required prior to entering the workforce. Instead, for a majority of APPs, POCUS training relies on nonstandardized on-the-job training or an (typically expensive) off-site training, for which they may not receive reimbursement. Other barriers include cultural practices that limit POCUS use by APPs; inability to upload and document images obtained; lack of willing, skilled mentors with time to provide feedback and assess for clinical competence; and even accessibility of ultrasound machines.2

Despite these challenges, the clinical benefits of utilizing ultrasound in practice necessitates overcoming these barriers. Institutionally, when APPs perform POCUS, it can lead to more rapid diagnosis and triage of patients, provide billing opportunities, and may reduce overall costs of care. From an APP perspective, having formalized training and credentialing can lead to more consistent POCUS assessment between providers, comprehensive patient care, security in one’s skills and knowledge base, and a tangible way of communicating one’s credibility between institutions.

While some institutions have overcome these barriers and APPs are trained and credentialed in POCUS, this is not always the norm. For this to come to fruition, we need educators to incorporate this into curriculum, colleagues who are willing to mentor learners, cultural changes to allow APPs to develop and utilize necessary skills for practice, clear structure for obtaining and maintaining competency, physicians to champion these efforts, and institutions to credential skilled APPs. Until then, it is important that we as APPs seek to facilitate these institutional changes and continue to set and maintain high quality standards for ourselves.


CHEST 2024 is for APPs too

With more than 300 educational sessions on the CHEST 2024 program, it can be overwhelming to figure out which ones you should put on your schedule. That’s why CHEST asked Danielle McCamey, DNP, CRNP, ACNP-BC, FCCP, and LaDonna Brown, DNP, CRNA, of DNPs of Color (DOC), as well as Corinne Young, MSN, FNP-C, FCCP, of the Association of Pulmonary Advanced Practice Providers (APAPP), for their recommendations on sessions that advanced practice providers shouldn’t miss. Visit chestnet.org/annual-meeting-apps for all of their recommendations.


References

1. Rudy S, Widmar B, Wilbeck J. Ultrasound education for nurse practitioner students: strategies for curricular integration. J Nurse Pract. 2024;20(6):104986.

2. Resnyk J, Weichold A. Barriers to learning and performing point-of-care ultrasound (POCUS): An integrative review. J Prof Nursing. 2024;54:54-62.




 

CHEST
Rhea Votipka

APP INTERSECTION

Advanced practice providers (APPs) play an integral role in the care and management of patients both in the ICU and across the spectrum of health care. Due to reduced residency hours and the coming physician shortage, APPs are playing, and will continue to play, a greater role in the care and management of critically ill patients.

Point of care ultrasound (POCUS) is a key diagnostic modality that promotes rapid diagnosis, shortens time to key interventions, and allows for interval reassessment. However, the benefit relies heavily on operator skill to obtain good quality images, interpret this within the context of the patient, and know what interventions, if any, to make. It is imperative that APPs, given their role within critical care, become not only familiar with POCUS but demonstrate proficiency in practice.

Before this can become standard, there are a number of challenges to overcome. Educational institutions are behind on integrating POCUS into the APP curriculum.1 Additionally, APPs have few opportunities to develop these skills as residencies and fellowships are not required prior to entering the workforce. Instead, for a majority of APPs, POCUS training relies on nonstandardized on-the-job training or an (typically expensive) off-site training, for which they may not receive reimbursement. Other barriers include cultural practices that limit POCUS use by APPs; inability to upload and document images obtained; lack of willing, skilled mentors with time to provide feedback and assess for clinical competence; and even accessibility of ultrasound machines.2

Despite these challenges, the clinical benefits of utilizing ultrasound in practice necessitates overcoming these barriers. Institutionally, when APPs perform POCUS, it can lead to more rapid diagnosis and triage of patients, provide billing opportunities, and may reduce overall costs of care. From an APP perspective, having formalized training and credentialing can lead to more consistent POCUS assessment between providers, comprehensive patient care, security in one’s skills and knowledge base, and a tangible way of communicating one’s credibility between institutions.

While some institutions have overcome these barriers and APPs are trained and credentialed in POCUS, this is not always the norm. For this to come to fruition, we need educators to incorporate this into curriculum, colleagues who are willing to mentor learners, cultural changes to allow APPs to develop and utilize necessary skills for practice, clear structure for obtaining and maintaining competency, physicians to champion these efforts, and institutions to credential skilled APPs. Until then, it is important that we as APPs seek to facilitate these institutional changes and continue to set and maintain high quality standards for ourselves.


CHEST 2024 is for APPs too

With more than 300 educational sessions on the CHEST 2024 program, it can be overwhelming to figure out which ones you should put on your schedule. That’s why CHEST asked Danielle McCamey, DNP, CRNP, ACNP-BC, FCCP, and LaDonna Brown, DNP, CRNA, of DNPs of Color (DOC), as well as Corinne Young, MSN, FNP-C, FCCP, of the Association of Pulmonary Advanced Practice Providers (APAPP), for their recommendations on sessions that advanced practice providers shouldn’t miss. Visit chestnet.org/annual-meeting-apps for all of their recommendations.


References

1. Rudy S, Widmar B, Wilbeck J. Ultrasound education for nurse practitioner students: strategies for curricular integration. J Nurse Pract. 2024;20(6):104986.

2. Resnyk J, Weichold A. Barriers to learning and performing point-of-care ultrasound (POCUS): An integrative review. J Prof Nursing. 2024;54:54-62.




 

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In memoriam: Dr. James E. Dalen

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Thu, 08/01/2024 - 10:09

CHEST
Dr. James E. Dalen

CHEST was recently informed of the death of former CHEST President, James E. Dalen, MD, MPH, Master FCCP. He served as CHEST President from 1985 to 1986.

Dr. Dalen was a graduate of Washington State University. (His undergraduate education was temporarily interrupted when he served as a Corpsman in the Navy and Marines.) He held a master’s degree from the University of Michigan, an MD from the University of Washington, an MPH from Harvard University, and an honorary Doctor of Science degree from the University of Massachusetts. He was internationally recognized as a medical visionary and esteemed cardiologist.

Dr. Dalen’s academic career spanned 3 medical schools. During the time he spent at each, he achieved great things and nurtured great ideas that helped transform medicine. From 1967 to 1975, he was on the faculty of Harvard Medical School (and the Peter Bent Brigham Hospital). From 1975 to 1988, he was a faculty member at the University of Massachusetts Medical School where he served as Chairman of Cardiovascular Medicine from 1975 to 1977 and as Chairman of Medicine from 1977 to 1988. From 1986 to 1987, he served as Interim Chancellor of the University of Massachusetts at the Worcester Campus. Dr. Dalen left Massachusetts in 1988 to become the Dean of the University of Arizona College of Medicine.

During his tenure as Dean and Vice-President at the University of Arizona, Dr. Dalen oversaw the establishment of the Zuckerman College of Public Health, the Arizona Center for Integrative Medicine, and the Arizona Telemedicine Program. Successful fundraising under his leadership led to the establishment of new research facilities, including the Children’s Research Center, the Sarver Heart Center, the Arizona Arthritis Center, and a major expansion of the Arizona Cancer Center. While at the University of Arizona College of Medicine, Dr. Dalen recognized the importance of integrative medicine and the need to promote integrative medicine in the academic environment. With the active participation of Dr. Andrew Weil, this led to the creation of the Academic Consortium for Integrative Medicine and Health and the Arizona Center for Integrative Medicine.

Dr. Dalen received many teaching awards. In 1987, he received the Distinguished Public Service Award from the University of Massachusetts. In 1988, he was named the University of Washington Distinguished Medical Alumnus of the Year and received the Alumni Achievement Award from Washington State University. In 2000, he received the College Medal from CHEST and was named a Master Fellow. In 2010, he was awarded the Harvard School of Public Health’s highest honor for its alumni: the 2010 Alumni Award of Merit. In 2012, he was named a Master Fellow of the American College of Physicians and was awarded an honorary Doctor of Science degree by the University of Massachusetts in 2013. In 2015, he received the Bravewell Distinguished Service Award from the Academic Consortium for Integrative Medicine and Health for his role as one of the founders of the consortium and as one of the founders of the Arizona Center for Integrative Medicine at the University of Arizona.

In his spare time, he enjoyed reading, gardening, sailing, art, and music and was a lifelong student with a passion for the pursuit of knowledge. Dr. Dalen enjoyed watching basketball, particularly the Arizona Wildcats. His favorite place to spend time was by the ocean in Coronado, California. Dr. Dalen was an advocate for public health, social justice, and health care reform throughout his life and career. He mentored thousands of medical students and championed access to health care for populations who were underserved. He touched many lives as a leading physician and caring friend.

Dr. Dalen is survived by his devoted wife, Priscilla M. Dalen (Dunton); loving children, James E. Dalen, Jr, and Angela M. Snodgrass (Dalen); daughter-in-law, Suzan M. Dalen; son-in-law, Daniel N. Snodgrass; and many step-grandchildren. We remember our colleague and extend our sincere condolences.

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Dr. James E. Dalen

CHEST was recently informed of the death of former CHEST President, James E. Dalen, MD, MPH, Master FCCP. He served as CHEST President from 1985 to 1986.

Dr. Dalen was a graduate of Washington State University. (His undergraduate education was temporarily interrupted when he served as a Corpsman in the Navy and Marines.) He held a master’s degree from the University of Michigan, an MD from the University of Washington, an MPH from Harvard University, and an honorary Doctor of Science degree from the University of Massachusetts. He was internationally recognized as a medical visionary and esteemed cardiologist.

Dr. Dalen’s academic career spanned 3 medical schools. During the time he spent at each, he achieved great things and nurtured great ideas that helped transform medicine. From 1967 to 1975, he was on the faculty of Harvard Medical School (and the Peter Bent Brigham Hospital). From 1975 to 1988, he was a faculty member at the University of Massachusetts Medical School where he served as Chairman of Cardiovascular Medicine from 1975 to 1977 and as Chairman of Medicine from 1977 to 1988. From 1986 to 1987, he served as Interim Chancellor of the University of Massachusetts at the Worcester Campus. Dr. Dalen left Massachusetts in 1988 to become the Dean of the University of Arizona College of Medicine.

During his tenure as Dean and Vice-President at the University of Arizona, Dr. Dalen oversaw the establishment of the Zuckerman College of Public Health, the Arizona Center for Integrative Medicine, and the Arizona Telemedicine Program. Successful fundraising under his leadership led to the establishment of new research facilities, including the Children’s Research Center, the Sarver Heart Center, the Arizona Arthritis Center, and a major expansion of the Arizona Cancer Center. While at the University of Arizona College of Medicine, Dr. Dalen recognized the importance of integrative medicine and the need to promote integrative medicine in the academic environment. With the active participation of Dr. Andrew Weil, this led to the creation of the Academic Consortium for Integrative Medicine and Health and the Arizona Center for Integrative Medicine.

Dr. Dalen received many teaching awards. In 1987, he received the Distinguished Public Service Award from the University of Massachusetts. In 1988, he was named the University of Washington Distinguished Medical Alumnus of the Year and received the Alumni Achievement Award from Washington State University. In 2000, he received the College Medal from CHEST and was named a Master Fellow. In 2010, he was awarded the Harvard School of Public Health’s highest honor for its alumni: the 2010 Alumni Award of Merit. In 2012, he was named a Master Fellow of the American College of Physicians and was awarded an honorary Doctor of Science degree by the University of Massachusetts in 2013. In 2015, he received the Bravewell Distinguished Service Award from the Academic Consortium for Integrative Medicine and Health for his role as one of the founders of the consortium and as one of the founders of the Arizona Center for Integrative Medicine at the University of Arizona.

In his spare time, he enjoyed reading, gardening, sailing, art, and music and was a lifelong student with a passion for the pursuit of knowledge. Dr. Dalen enjoyed watching basketball, particularly the Arizona Wildcats. His favorite place to spend time was by the ocean in Coronado, California. Dr. Dalen was an advocate for public health, social justice, and health care reform throughout his life and career. He mentored thousands of medical students and championed access to health care for populations who were underserved. He touched many lives as a leading physician and caring friend.

Dr. Dalen is survived by his devoted wife, Priscilla M. Dalen (Dunton); loving children, James E. Dalen, Jr, and Angela M. Snodgrass (Dalen); daughter-in-law, Suzan M. Dalen; son-in-law, Daniel N. Snodgrass; and many step-grandchildren. We remember our colleague and extend our sincere condolences.

CHEST
Dr. James E. Dalen

CHEST was recently informed of the death of former CHEST President, James E. Dalen, MD, MPH, Master FCCP. He served as CHEST President from 1985 to 1986.

Dr. Dalen was a graduate of Washington State University. (His undergraduate education was temporarily interrupted when he served as a Corpsman in the Navy and Marines.) He held a master’s degree from the University of Michigan, an MD from the University of Washington, an MPH from Harvard University, and an honorary Doctor of Science degree from the University of Massachusetts. He was internationally recognized as a medical visionary and esteemed cardiologist.

Dr. Dalen’s academic career spanned 3 medical schools. During the time he spent at each, he achieved great things and nurtured great ideas that helped transform medicine. From 1967 to 1975, he was on the faculty of Harvard Medical School (and the Peter Bent Brigham Hospital). From 1975 to 1988, he was a faculty member at the University of Massachusetts Medical School where he served as Chairman of Cardiovascular Medicine from 1975 to 1977 and as Chairman of Medicine from 1977 to 1988. From 1986 to 1987, he served as Interim Chancellor of the University of Massachusetts at the Worcester Campus. Dr. Dalen left Massachusetts in 1988 to become the Dean of the University of Arizona College of Medicine.

During his tenure as Dean and Vice-President at the University of Arizona, Dr. Dalen oversaw the establishment of the Zuckerman College of Public Health, the Arizona Center for Integrative Medicine, and the Arizona Telemedicine Program. Successful fundraising under his leadership led to the establishment of new research facilities, including the Children’s Research Center, the Sarver Heart Center, the Arizona Arthritis Center, and a major expansion of the Arizona Cancer Center. While at the University of Arizona College of Medicine, Dr. Dalen recognized the importance of integrative medicine and the need to promote integrative medicine in the academic environment. With the active participation of Dr. Andrew Weil, this led to the creation of the Academic Consortium for Integrative Medicine and Health and the Arizona Center for Integrative Medicine.

Dr. Dalen received many teaching awards. In 1987, he received the Distinguished Public Service Award from the University of Massachusetts. In 1988, he was named the University of Washington Distinguished Medical Alumnus of the Year and received the Alumni Achievement Award from Washington State University. In 2000, he received the College Medal from CHEST and was named a Master Fellow. In 2010, he was awarded the Harvard School of Public Health’s highest honor for its alumni: the 2010 Alumni Award of Merit. In 2012, he was named a Master Fellow of the American College of Physicians and was awarded an honorary Doctor of Science degree by the University of Massachusetts in 2013. In 2015, he received the Bravewell Distinguished Service Award from the Academic Consortium for Integrative Medicine and Health for his role as one of the founders of the consortium and as one of the founders of the Arizona Center for Integrative Medicine at the University of Arizona.

In his spare time, he enjoyed reading, gardening, sailing, art, and music and was a lifelong student with a passion for the pursuit of knowledge. Dr. Dalen enjoyed watching basketball, particularly the Arizona Wildcats. His favorite place to spend time was by the ocean in Coronado, California. Dr. Dalen was an advocate for public health, social justice, and health care reform throughout his life and career. He mentored thousands of medical students and championed access to health care for populations who were underserved. He touched many lives as a leading physician and caring friend.

Dr. Dalen is survived by his devoted wife, Priscilla M. Dalen (Dunton); loving children, James E. Dalen, Jr, and Angela M. Snodgrass (Dalen); daughter-in-law, Suzan M. Dalen; son-in-law, Daniel N. Snodgrass; and many step-grandchildren. We remember our colleague and extend our sincere condolences.

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Will Hospital-at-Home Go Mainstream?

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Jordan Stohler, a 42-year-old nurse in Knoxville, Tennessee, was readmitted to Fort Sanders Medical Center in June 2023 with sepsis after a double mastectomy. 

She spent 5 days in the hospital after surgery to clear up the infection. Then she was offered a choice: She could either stay in the hospital while she received IV antibiotics, or she could go home and have the antibiotics given to her there under the Advanced Care at Home program of Covenant Health, the nine-hospital system to which Fort Sanders belongs.

She opted to go home, where she knew she’d be more comfortable and would be close to her beloved dog. In the end, she was very glad she did. 

“I received great care in the hospital, but to be allowed to be in the comfort of your own home, to be around my dog, who I think is therapeutic, to be able to cook my own meals, and to have the same one-on-one nursing care that I would have gotten in the hospital was great,” Ms. Stohler said. “

Being cared for at home helped her heal, she said. “I probably would have gotten a little stir crazy if I’d stayed in the hospital any longer. I received excellent care at home.”

Covenant’s Advanced Care at Home program is an example of the hospital-at-home trend that has been growing rapidly since Medicare began reimbursing hospitals for this approach during the COVID pandemic. Currently, 322 hospitals in 37 states have Medicare waivers for these kinds of programs, although not all of them are currently functioning.

A recent survey published in JAMA found that nearly half of consumers would accept hospital-at-home, and more than a third were neutral on it. Only 17% said they’d rather be cared for in a brick-and-mortar hospital. 

The findings of the JAMA survey confirm those of earlier studies, said Bruce Leff, MD, a professor at Johns Hopkins Medical School in Baltimore, who has researched hospital-at-home since the 1990s. Like the new study, those trials found that the results had no relationship to individual traits, such as socioeconomic status, medical conditions, age, gender, or race. 

Whether a person felt comfortable with the idea of hospital-at-home boiled down “to a preference for receiving care at home or in the hospital,” he said. Some people distrust hospitals, and others feel insecure about receiving care at home, even if it is provided by qualified health care professionals.
 

How Patients Are Selected 

While the details of hospital-at-home vary from program to program, the basic scenario is that patients who need certain kinds of acute care can be sent home from hospitals, emergency departments, or clinics to receive that care at home. Among the kinds of conditions that make stable patients eligible are heart failure, COPD, pneumonia, cellulitis, and COVID-19, said John Busigin, MD, a hospitalist and medical director of Covenant Advanced Care at Home. 

When a patient is admitted to hospital-at-home, the hospital will send along whatever equipment and medications that person needs. In some cases, this may include a hospital bed, although Ms. Stohler used her own. An IV line was put into her arm, and the IV stand was placed next to the bed. 

Ms. Stohler received a computer tablet that she used to communicate with doctors and nurses in Covenant’s “command center” in Knoxville. She also wore a watch with a button she could push in case of an emergency. And she had a telephone line that went directly to her medical team, in case she had an issue and the tablet didn’t work.

Twice a day, or as needed, specially trained paramedics came to Ms. Stohler’s home. They checked on the IV line, changed the IV bag, performed tests, and uploaded vital signs from monitoring equipment to Ms. Stohler’s tablet so it could be transmitted to the command center. A physician assistant came in on the second and fourth days of her weeklong stay in the program, and she saw a hospitalist remotely every day.

While some hospital-at-home programs have registered nurses visit patients at home, RNs are in short supply. To fill this gap, Covenant’s program uses community paramedics who have been in the field for at least 5 years, doing everything from intubating patients and placing them on ventilators to providing advanced cardiac life support, Dr. Busigin said. To get certified as community paramedics, they go through a 3-month training program.

Shortly after Ms. Stohler went into hospital-at-home, she had another crisis. Excess fluid had built up in her body because of all the IV fluids she’d received in the hospital while fighting the sepsis. As a result, she became short of breath. If she had been discharged to home rather than hospital-at-home, she said, she would have had to go to the emergency room. Instead, she sent out a distress call. One of the paramedics rushed to her house and gave her an IV diuretic medication, which helped her urinate to get rid of the excess fluid.

A small number of the estimated 300 people who have gone through the program had to be admitted to the hospital, Dr. Busigin said. Nationally, he said, about 5%-10% are admitted. But readmissions among the patients in the Covenant program have been 25% lower than for patients who received conventional hospital care and had the same conditions as those in hospital-at-home.

Studies have shown that these programs not only reduce readmissions, but also cost less, on average, and create a better patient experience than traditional hospital care does. And, according to the JAMA survey, most consumers like the idea. Fifty-six percent of people who took the survey agreed with the statement that people recover faster at home than in the hospital. Fifty-nine percent agreed they’d feel safe being treated at home, and 49% said they’d be more comfortable if treated at home. 

The 1134 people who took the survey were also asked about their comfort level with providing various kinds of care to their loved ones during a hospital-at-home episode. The results varied with the type of task: For example, 82% of the respondents agreed or strongly agreed they could manage a patient’s medications, while just 41% said they’d be willing to change a feeding tube. Smaller percentages were willing to change an IV bag or a catheter or do wound care.

However, hospital-at-home programs don’t allow caregivers to take part in clinical care, which is prohibited by Medicare waivers and state licensing regulations. None of the 22 health systems that use the hospital-at-home services of Medically Home, including Covenant, ask caregivers to do anything along this line, said Pippa Shulman, DO, medical director of the company, which provides equipment, technology, and protocols for hospital programs

The only exception at Covenant, Dr. Busigin said, is that the hospital may train family members to do wound care when a patient is discharged from the hospital to Advanced Care at Home. They may also prepare meals for their loved ones, although the program provides balanced meals to patients if they want them. Ms. Stohler had some of these meals, which just had to be heated up, for the first few days of hospital-at-home, and later her relatives brought meals to her house.
 

 

 

Challenges for the Future

The number of Medicare hospital-at-home waivers has nearly doubled since 2021. A year earlier, when Medicare began reimbursing hospitals for acute care at home to help them cope with the overflow of COVID patients, there were only about 15-20 programs in the United States, said Dr. Leff of Johns Hopkins.

A big reason for the lack of use before the pandemic, Dr. Leff said, is that there was no payment system for hospitals that offered hospital-at-home. Now, they can get paid by Medicare and 10 state Medicaid programs, and a number of private payers are also coming on board. Ms. Stohler’s private insurer covered her hospital-at-home stay, and Dr. Busigin said several plans that contract with Covenant will pay for it.

Dr. Leff said he’s cautiously optimistic Congress will extend the Medicare waiver program, which is scheduled to end in December, for another 5 years. A couple of key House committees have signed off on a bill to do that, he said, and a Congressional Budget Office report found that the program did not cost Medicare more money. 

But even if the waiver is renewed, some health systems may find it tough to deliver the service. The current version of this model depends a lot on technology, because telemedicine is used and reliable communication is needed for patients in hospital-at-home. That’s why many of the hospitals hire outside vendors like Medically Home to provide the infrastructure they need.

Medically Home manages the tablets given to patients and all connection and networking services, including internet and cellphone connections. It also provides technical services in the command centers that hospitals set up for the doctors and nurses who provide care remotely. 

And the firm figures out how to deliver the standard care for each condition in each hospital-at-home. “We need to make sure that the patient is going to get what they need in the time frame it needs to be delivered in, and that it’s safe and effective for the patient,” Dr. Shulman said. “So we’ve developed logistical protocols for a multitude of disease states that allow us to provide high-acuity care in the home to a variety of complex patients.”

The health care workers use the hospital electronic health record for hospital-at-home patients, and vital signs uploaded from patient tablets flow directly into the electronic health record, she said.
 

Rural Areas Need Help

The use of hospital-at-home in rural areas holds a lot of promise, Dr. Leff said. 

“A lot of rural hospitals have been closing, and hospital-at-home could be a mechanism to create hospital-level care where facilities have closed down. It’s easier to do this in urban areas, but it can be done in rural environments as well.”

Rami Karjian, CEO of Medically Home, agreed. The firm services hospital-at-home programs in rural areas of Oklahoma and California, using cellphones and paramedics in areas that lack broadband connections and nurses, he pointed out. 

“Hospital-at-home can’t just be available to people who live in big cities,” he said. “The access problems in health care are pervasive, and this is part of how we solve access problems in rural areas.”
 

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

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Jordan Stohler, a 42-year-old nurse in Knoxville, Tennessee, was readmitted to Fort Sanders Medical Center in June 2023 with sepsis after a double mastectomy. 

She spent 5 days in the hospital after surgery to clear up the infection. Then she was offered a choice: She could either stay in the hospital while she received IV antibiotics, or she could go home and have the antibiotics given to her there under the Advanced Care at Home program of Covenant Health, the nine-hospital system to which Fort Sanders belongs.

She opted to go home, where she knew she’d be more comfortable and would be close to her beloved dog. In the end, she was very glad she did. 

“I received great care in the hospital, but to be allowed to be in the comfort of your own home, to be around my dog, who I think is therapeutic, to be able to cook my own meals, and to have the same one-on-one nursing care that I would have gotten in the hospital was great,” Ms. Stohler said. “

Being cared for at home helped her heal, she said. “I probably would have gotten a little stir crazy if I’d stayed in the hospital any longer. I received excellent care at home.”

Covenant’s Advanced Care at Home program is an example of the hospital-at-home trend that has been growing rapidly since Medicare began reimbursing hospitals for this approach during the COVID pandemic. Currently, 322 hospitals in 37 states have Medicare waivers for these kinds of programs, although not all of them are currently functioning.

A recent survey published in JAMA found that nearly half of consumers would accept hospital-at-home, and more than a third were neutral on it. Only 17% said they’d rather be cared for in a brick-and-mortar hospital. 

The findings of the JAMA survey confirm those of earlier studies, said Bruce Leff, MD, a professor at Johns Hopkins Medical School in Baltimore, who has researched hospital-at-home since the 1990s. Like the new study, those trials found that the results had no relationship to individual traits, such as socioeconomic status, medical conditions, age, gender, or race. 

Whether a person felt comfortable with the idea of hospital-at-home boiled down “to a preference for receiving care at home or in the hospital,” he said. Some people distrust hospitals, and others feel insecure about receiving care at home, even if it is provided by qualified health care professionals.
 

How Patients Are Selected 

While the details of hospital-at-home vary from program to program, the basic scenario is that patients who need certain kinds of acute care can be sent home from hospitals, emergency departments, or clinics to receive that care at home. Among the kinds of conditions that make stable patients eligible are heart failure, COPD, pneumonia, cellulitis, and COVID-19, said John Busigin, MD, a hospitalist and medical director of Covenant Advanced Care at Home. 

When a patient is admitted to hospital-at-home, the hospital will send along whatever equipment and medications that person needs. In some cases, this may include a hospital bed, although Ms. Stohler used her own. An IV line was put into her arm, and the IV stand was placed next to the bed. 

Ms. Stohler received a computer tablet that she used to communicate with doctors and nurses in Covenant’s “command center” in Knoxville. She also wore a watch with a button she could push in case of an emergency. And she had a telephone line that went directly to her medical team, in case she had an issue and the tablet didn’t work.

Twice a day, or as needed, specially trained paramedics came to Ms. Stohler’s home. They checked on the IV line, changed the IV bag, performed tests, and uploaded vital signs from monitoring equipment to Ms. Stohler’s tablet so it could be transmitted to the command center. A physician assistant came in on the second and fourth days of her weeklong stay in the program, and she saw a hospitalist remotely every day.

While some hospital-at-home programs have registered nurses visit patients at home, RNs are in short supply. To fill this gap, Covenant’s program uses community paramedics who have been in the field for at least 5 years, doing everything from intubating patients and placing them on ventilators to providing advanced cardiac life support, Dr. Busigin said. To get certified as community paramedics, they go through a 3-month training program.

Shortly after Ms. Stohler went into hospital-at-home, she had another crisis. Excess fluid had built up in her body because of all the IV fluids she’d received in the hospital while fighting the sepsis. As a result, she became short of breath. If she had been discharged to home rather than hospital-at-home, she said, she would have had to go to the emergency room. Instead, she sent out a distress call. One of the paramedics rushed to her house and gave her an IV diuretic medication, which helped her urinate to get rid of the excess fluid.

A small number of the estimated 300 people who have gone through the program had to be admitted to the hospital, Dr. Busigin said. Nationally, he said, about 5%-10% are admitted. But readmissions among the patients in the Covenant program have been 25% lower than for patients who received conventional hospital care and had the same conditions as those in hospital-at-home.

Studies have shown that these programs not only reduce readmissions, but also cost less, on average, and create a better patient experience than traditional hospital care does. And, according to the JAMA survey, most consumers like the idea. Fifty-six percent of people who took the survey agreed with the statement that people recover faster at home than in the hospital. Fifty-nine percent agreed they’d feel safe being treated at home, and 49% said they’d be more comfortable if treated at home. 

The 1134 people who took the survey were also asked about their comfort level with providing various kinds of care to their loved ones during a hospital-at-home episode. The results varied with the type of task: For example, 82% of the respondents agreed or strongly agreed they could manage a patient’s medications, while just 41% said they’d be willing to change a feeding tube. Smaller percentages were willing to change an IV bag or a catheter or do wound care.

However, hospital-at-home programs don’t allow caregivers to take part in clinical care, which is prohibited by Medicare waivers and state licensing regulations. None of the 22 health systems that use the hospital-at-home services of Medically Home, including Covenant, ask caregivers to do anything along this line, said Pippa Shulman, DO, medical director of the company, which provides equipment, technology, and protocols for hospital programs

The only exception at Covenant, Dr. Busigin said, is that the hospital may train family members to do wound care when a patient is discharged from the hospital to Advanced Care at Home. They may also prepare meals for their loved ones, although the program provides balanced meals to patients if they want them. Ms. Stohler had some of these meals, which just had to be heated up, for the first few days of hospital-at-home, and later her relatives brought meals to her house.
 

 

 

Challenges for the Future

The number of Medicare hospital-at-home waivers has nearly doubled since 2021. A year earlier, when Medicare began reimbursing hospitals for acute care at home to help them cope with the overflow of COVID patients, there were only about 15-20 programs in the United States, said Dr. Leff of Johns Hopkins.

A big reason for the lack of use before the pandemic, Dr. Leff said, is that there was no payment system for hospitals that offered hospital-at-home. Now, they can get paid by Medicare and 10 state Medicaid programs, and a number of private payers are also coming on board. Ms. Stohler’s private insurer covered her hospital-at-home stay, and Dr. Busigin said several plans that contract with Covenant will pay for it.

Dr. Leff said he’s cautiously optimistic Congress will extend the Medicare waiver program, which is scheduled to end in December, for another 5 years. A couple of key House committees have signed off on a bill to do that, he said, and a Congressional Budget Office report found that the program did not cost Medicare more money. 

But even if the waiver is renewed, some health systems may find it tough to deliver the service. The current version of this model depends a lot on technology, because telemedicine is used and reliable communication is needed for patients in hospital-at-home. That’s why many of the hospitals hire outside vendors like Medically Home to provide the infrastructure they need.

Medically Home manages the tablets given to patients and all connection and networking services, including internet and cellphone connections. It also provides technical services in the command centers that hospitals set up for the doctors and nurses who provide care remotely. 

And the firm figures out how to deliver the standard care for each condition in each hospital-at-home. “We need to make sure that the patient is going to get what they need in the time frame it needs to be delivered in, and that it’s safe and effective for the patient,” Dr. Shulman said. “So we’ve developed logistical protocols for a multitude of disease states that allow us to provide high-acuity care in the home to a variety of complex patients.”

The health care workers use the hospital electronic health record for hospital-at-home patients, and vital signs uploaded from patient tablets flow directly into the electronic health record, she said.
 

Rural Areas Need Help

The use of hospital-at-home in rural areas holds a lot of promise, Dr. Leff said. 

“A lot of rural hospitals have been closing, and hospital-at-home could be a mechanism to create hospital-level care where facilities have closed down. It’s easier to do this in urban areas, but it can be done in rural environments as well.”

Rami Karjian, CEO of Medically Home, agreed. The firm services hospital-at-home programs in rural areas of Oklahoma and California, using cellphones and paramedics in areas that lack broadband connections and nurses, he pointed out. 

“Hospital-at-home can’t just be available to people who live in big cities,” he said. “The access problems in health care are pervasive, and this is part of how we solve access problems in rural areas.”
 

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

Jordan Stohler, a 42-year-old nurse in Knoxville, Tennessee, was readmitted to Fort Sanders Medical Center in June 2023 with sepsis after a double mastectomy. 

She spent 5 days in the hospital after surgery to clear up the infection. Then she was offered a choice: She could either stay in the hospital while she received IV antibiotics, or she could go home and have the antibiotics given to her there under the Advanced Care at Home program of Covenant Health, the nine-hospital system to which Fort Sanders belongs.

She opted to go home, where she knew she’d be more comfortable and would be close to her beloved dog. In the end, she was very glad she did. 

“I received great care in the hospital, but to be allowed to be in the comfort of your own home, to be around my dog, who I think is therapeutic, to be able to cook my own meals, and to have the same one-on-one nursing care that I would have gotten in the hospital was great,” Ms. Stohler said. “

Being cared for at home helped her heal, she said. “I probably would have gotten a little stir crazy if I’d stayed in the hospital any longer. I received excellent care at home.”

Covenant’s Advanced Care at Home program is an example of the hospital-at-home trend that has been growing rapidly since Medicare began reimbursing hospitals for this approach during the COVID pandemic. Currently, 322 hospitals in 37 states have Medicare waivers for these kinds of programs, although not all of them are currently functioning.

A recent survey published in JAMA found that nearly half of consumers would accept hospital-at-home, and more than a third were neutral on it. Only 17% said they’d rather be cared for in a brick-and-mortar hospital. 

The findings of the JAMA survey confirm those of earlier studies, said Bruce Leff, MD, a professor at Johns Hopkins Medical School in Baltimore, who has researched hospital-at-home since the 1990s. Like the new study, those trials found that the results had no relationship to individual traits, such as socioeconomic status, medical conditions, age, gender, or race. 

Whether a person felt comfortable with the idea of hospital-at-home boiled down “to a preference for receiving care at home or in the hospital,” he said. Some people distrust hospitals, and others feel insecure about receiving care at home, even if it is provided by qualified health care professionals.
 

How Patients Are Selected 

While the details of hospital-at-home vary from program to program, the basic scenario is that patients who need certain kinds of acute care can be sent home from hospitals, emergency departments, or clinics to receive that care at home. Among the kinds of conditions that make stable patients eligible are heart failure, COPD, pneumonia, cellulitis, and COVID-19, said John Busigin, MD, a hospitalist and medical director of Covenant Advanced Care at Home. 

When a patient is admitted to hospital-at-home, the hospital will send along whatever equipment and medications that person needs. In some cases, this may include a hospital bed, although Ms. Stohler used her own. An IV line was put into her arm, and the IV stand was placed next to the bed. 

Ms. Stohler received a computer tablet that she used to communicate with doctors and nurses in Covenant’s “command center” in Knoxville. She also wore a watch with a button she could push in case of an emergency. And she had a telephone line that went directly to her medical team, in case she had an issue and the tablet didn’t work.

Twice a day, or as needed, specially trained paramedics came to Ms. Stohler’s home. They checked on the IV line, changed the IV bag, performed tests, and uploaded vital signs from monitoring equipment to Ms. Stohler’s tablet so it could be transmitted to the command center. A physician assistant came in on the second and fourth days of her weeklong stay in the program, and she saw a hospitalist remotely every day.

While some hospital-at-home programs have registered nurses visit patients at home, RNs are in short supply. To fill this gap, Covenant’s program uses community paramedics who have been in the field for at least 5 years, doing everything from intubating patients and placing them on ventilators to providing advanced cardiac life support, Dr. Busigin said. To get certified as community paramedics, they go through a 3-month training program.

Shortly after Ms. Stohler went into hospital-at-home, she had another crisis. Excess fluid had built up in her body because of all the IV fluids she’d received in the hospital while fighting the sepsis. As a result, she became short of breath. If she had been discharged to home rather than hospital-at-home, she said, she would have had to go to the emergency room. Instead, she sent out a distress call. One of the paramedics rushed to her house and gave her an IV diuretic medication, which helped her urinate to get rid of the excess fluid.

A small number of the estimated 300 people who have gone through the program had to be admitted to the hospital, Dr. Busigin said. Nationally, he said, about 5%-10% are admitted. But readmissions among the patients in the Covenant program have been 25% lower than for patients who received conventional hospital care and had the same conditions as those in hospital-at-home.

Studies have shown that these programs not only reduce readmissions, but also cost less, on average, and create a better patient experience than traditional hospital care does. And, according to the JAMA survey, most consumers like the idea. Fifty-six percent of people who took the survey agreed with the statement that people recover faster at home than in the hospital. Fifty-nine percent agreed they’d feel safe being treated at home, and 49% said they’d be more comfortable if treated at home. 

The 1134 people who took the survey were also asked about their comfort level with providing various kinds of care to their loved ones during a hospital-at-home episode. The results varied with the type of task: For example, 82% of the respondents agreed or strongly agreed they could manage a patient’s medications, while just 41% said they’d be willing to change a feeding tube. Smaller percentages were willing to change an IV bag or a catheter or do wound care.

However, hospital-at-home programs don’t allow caregivers to take part in clinical care, which is prohibited by Medicare waivers and state licensing regulations. None of the 22 health systems that use the hospital-at-home services of Medically Home, including Covenant, ask caregivers to do anything along this line, said Pippa Shulman, DO, medical director of the company, which provides equipment, technology, and protocols for hospital programs

The only exception at Covenant, Dr. Busigin said, is that the hospital may train family members to do wound care when a patient is discharged from the hospital to Advanced Care at Home. They may also prepare meals for their loved ones, although the program provides balanced meals to patients if they want them. Ms. Stohler had some of these meals, which just had to be heated up, for the first few days of hospital-at-home, and later her relatives brought meals to her house.
 

 

 

Challenges for the Future

The number of Medicare hospital-at-home waivers has nearly doubled since 2021. A year earlier, when Medicare began reimbursing hospitals for acute care at home to help them cope with the overflow of COVID patients, there were only about 15-20 programs in the United States, said Dr. Leff of Johns Hopkins.

A big reason for the lack of use before the pandemic, Dr. Leff said, is that there was no payment system for hospitals that offered hospital-at-home. Now, they can get paid by Medicare and 10 state Medicaid programs, and a number of private payers are also coming on board. Ms. Stohler’s private insurer covered her hospital-at-home stay, and Dr. Busigin said several plans that contract with Covenant will pay for it.

Dr. Leff said he’s cautiously optimistic Congress will extend the Medicare waiver program, which is scheduled to end in December, for another 5 years. A couple of key House committees have signed off on a bill to do that, he said, and a Congressional Budget Office report found that the program did not cost Medicare more money. 

But even if the waiver is renewed, some health systems may find it tough to deliver the service. The current version of this model depends a lot on technology, because telemedicine is used and reliable communication is needed for patients in hospital-at-home. That’s why many of the hospitals hire outside vendors like Medically Home to provide the infrastructure they need.

Medically Home manages the tablets given to patients and all connection and networking services, including internet and cellphone connections. It also provides technical services in the command centers that hospitals set up for the doctors and nurses who provide care remotely. 

And the firm figures out how to deliver the standard care for each condition in each hospital-at-home. “We need to make sure that the patient is going to get what they need in the time frame it needs to be delivered in, and that it’s safe and effective for the patient,” Dr. Shulman said. “So we’ve developed logistical protocols for a multitude of disease states that allow us to provide high-acuity care in the home to a variety of complex patients.”

The health care workers use the hospital electronic health record for hospital-at-home patients, and vital signs uploaded from patient tablets flow directly into the electronic health record, she said.
 

Rural Areas Need Help

The use of hospital-at-home in rural areas holds a lot of promise, Dr. Leff said. 

“A lot of rural hospitals have been closing, and hospital-at-home could be a mechanism to create hospital-level care where facilities have closed down. It’s easier to do this in urban areas, but it can be done in rural environments as well.”

Rami Karjian, CEO of Medically Home, agreed. The firm services hospital-at-home programs in rural areas of Oklahoma and California, using cellphones and paramedics in areas that lack broadband connections and nurses, he pointed out. 

“Hospital-at-home can’t just be available to people who live in big cities,” he said. “The access problems in health care are pervasive, and this is part of how we solve access problems in rural areas.”
 

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

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Shortage of Blood Bottles Could Disrupt Care

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Tue, 07/30/2024 - 16:10

Hospitals and laboratories across the United States are grappling with a shortage of Becton Dickinson BACTEC blood culture bottles that threatens to extend at least until September.

In a health advisory, the Centers for Disease Control and Prevention (CDC) warned that the critical shortage could lead to “delays in diagnosis, misdiagnosis, or other challenges” in the management of patients with infectious diseases.

Most blood cultures in the United States are performed using continuous-monitoring blood culture systems; the Becton Dickinson system is used in about half of all US laboratories and is only compatible with the brand’s BACTEC blood culture media bottles.

Healthcare providers, laboratories, healthcare facility administrators, and state, tribal, local, and territorial health departments affected by the shortage “should immediately begin to assess their situations and develop plans and options to mitigate the potential impact,” according to the health advisory.
 

What to Do

To reduce the impact of the shortage, facilities are urged to:

  • Determine the type of blood culture bottles they have
  • Optimize the use of blood cultures at their facility
  • Take steps to prevent blood culture contamination
  • Ensure that the appropriate volume of blood is collected for culture
  • Assess alternate options for blood cultures
  • Work with a nearby facility or send samples to another laboratory

Health departments are advised to contact hospitals and laboratories in their jurisdictions to determine whether the shortage will affect them. Health departments are also encouraged to educate others on the supply shortage, optimal use of blood cultures, and mechanisms for reporting supply chain shortages or interruptions to the Food and Drug Administration (FDA), as well as to help with communication between laboratories and facilities willing to assist others in need.

To further assist affected providers, the CDC, in collaboration with the Infectious Diseases Society of America, hosted a webinar with speakers from Johns Hopkins University, Massachusetts General Hospital, and Vanderbilt University, who shared what their institutions are doing to cope with the shortage and protect patients.
 

Why It Happened

In June, Becton Dickinson warned its customers that they may experience “intermittent delays” in the supply of some BACTEC blood culture media over the coming months because of reduced availability of plastic bottles from its supplier.

In a July 22 update, the company said the supplier issues were “more complex” than originally communicated and it is taking steps to “resolve this challenge as quickly as possible.”

In July, the FDA published a letter to healthcare providers acknowledging the supply disruptions and recommended strategies to preserve the supply for patients at highest risk.

Becton Dickinson has promised an update by September to this “dynamic and evolving situation.”

A version of this article appeared on Medscape.com.

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Hospitals and laboratories across the United States are grappling with a shortage of Becton Dickinson BACTEC blood culture bottles that threatens to extend at least until September.

In a health advisory, the Centers for Disease Control and Prevention (CDC) warned that the critical shortage could lead to “delays in diagnosis, misdiagnosis, or other challenges” in the management of patients with infectious diseases.

Most blood cultures in the United States are performed using continuous-monitoring blood culture systems; the Becton Dickinson system is used in about half of all US laboratories and is only compatible with the brand’s BACTEC blood culture media bottles.

Healthcare providers, laboratories, healthcare facility administrators, and state, tribal, local, and territorial health departments affected by the shortage “should immediately begin to assess their situations and develop plans and options to mitigate the potential impact,” according to the health advisory.
 

What to Do

To reduce the impact of the shortage, facilities are urged to:

  • Determine the type of blood culture bottles they have
  • Optimize the use of blood cultures at their facility
  • Take steps to prevent blood culture contamination
  • Ensure that the appropriate volume of blood is collected for culture
  • Assess alternate options for blood cultures
  • Work with a nearby facility or send samples to another laboratory

Health departments are advised to contact hospitals and laboratories in their jurisdictions to determine whether the shortage will affect them. Health departments are also encouraged to educate others on the supply shortage, optimal use of blood cultures, and mechanisms for reporting supply chain shortages or interruptions to the Food and Drug Administration (FDA), as well as to help with communication between laboratories and facilities willing to assist others in need.

To further assist affected providers, the CDC, in collaboration with the Infectious Diseases Society of America, hosted a webinar with speakers from Johns Hopkins University, Massachusetts General Hospital, and Vanderbilt University, who shared what their institutions are doing to cope with the shortage and protect patients.
 

Why It Happened

In June, Becton Dickinson warned its customers that they may experience “intermittent delays” in the supply of some BACTEC blood culture media over the coming months because of reduced availability of plastic bottles from its supplier.

In a July 22 update, the company said the supplier issues were “more complex” than originally communicated and it is taking steps to “resolve this challenge as quickly as possible.”

In July, the FDA published a letter to healthcare providers acknowledging the supply disruptions and recommended strategies to preserve the supply for patients at highest risk.

Becton Dickinson has promised an update by September to this “dynamic and evolving situation.”

A version of this article appeared on Medscape.com.

Hospitals and laboratories across the United States are grappling with a shortage of Becton Dickinson BACTEC blood culture bottles that threatens to extend at least until September.

In a health advisory, the Centers for Disease Control and Prevention (CDC) warned that the critical shortage could lead to “delays in diagnosis, misdiagnosis, or other challenges” in the management of patients with infectious diseases.

Most blood cultures in the United States are performed using continuous-monitoring blood culture systems; the Becton Dickinson system is used in about half of all US laboratories and is only compatible with the brand’s BACTEC blood culture media bottles.

Healthcare providers, laboratories, healthcare facility administrators, and state, tribal, local, and territorial health departments affected by the shortage “should immediately begin to assess their situations and develop plans and options to mitigate the potential impact,” according to the health advisory.
 

What to Do

To reduce the impact of the shortage, facilities are urged to:

  • Determine the type of blood culture bottles they have
  • Optimize the use of blood cultures at their facility
  • Take steps to prevent blood culture contamination
  • Ensure that the appropriate volume of blood is collected for culture
  • Assess alternate options for blood cultures
  • Work with a nearby facility or send samples to another laboratory

Health departments are advised to contact hospitals and laboratories in their jurisdictions to determine whether the shortage will affect them. Health departments are also encouraged to educate others on the supply shortage, optimal use of blood cultures, and mechanisms for reporting supply chain shortages or interruptions to the Food and Drug Administration (FDA), as well as to help with communication between laboratories and facilities willing to assist others in need.

To further assist affected providers, the CDC, in collaboration with the Infectious Diseases Society of America, hosted a webinar with speakers from Johns Hopkins University, Massachusetts General Hospital, and Vanderbilt University, who shared what their institutions are doing to cope with the shortage and protect patients.
 

Why It Happened

In June, Becton Dickinson warned its customers that they may experience “intermittent delays” in the supply of some BACTEC blood culture media over the coming months because of reduced availability of plastic bottles from its supplier.

In a July 22 update, the company said the supplier issues were “more complex” than originally communicated and it is taking steps to “resolve this challenge as quickly as possible.”

In July, the FDA published a letter to healthcare providers acknowledging the supply disruptions and recommended strategies to preserve the supply for patients at highest risk.

Becton Dickinson has promised an update by September to this “dynamic and evolving situation.”

A version of this article appeared on Medscape.com.

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FDA Calls AstraZeneca’s NSCLC Trial Design Into Question

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Changed
Wed, 07/31/2024 - 06:54

AstraZeneca was taken to task July 25 by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency request about the design of a durvalumab (Imfinzi) trial for non–small cell lung cancer (NSCLC).

The trial in questionAEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone. 

Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has

However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points. 

Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned. 

When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery. 

The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio. 

AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.

One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment. 

Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said. 

To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.

The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.

However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so. 

The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies. 

FDA usually follows the advice of its advisory panels.
 

A version of this article appeared on Medscape.com.

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AstraZeneca was taken to task July 25 by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency request about the design of a durvalumab (Imfinzi) trial for non–small cell lung cancer (NSCLC).

The trial in questionAEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone. 

Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has

However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points. 

Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned. 

When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery. 

The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio. 

AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.

One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment. 

Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said. 

To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.

The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.

However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so. 

The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies. 

FDA usually follows the advice of its advisory panels.
 

A version of this article appeared on Medscape.com.

AstraZeneca was taken to task July 25 by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency request about the design of a durvalumab (Imfinzi) trial for non–small cell lung cancer (NSCLC).

The trial in questionAEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone. 

Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has

However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points. 

Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned. 

When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery. 

The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio. 

AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.

One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment. 

Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said. 

To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.

The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.

However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so. 

The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies. 

FDA usually follows the advice of its advisory panels.
 

A version of this article appeared on Medscape.com.

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A Guide to Eating Healthy While Working in Healthcare

Article Type
Changed
Mon, 07/29/2024 - 13:04

Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.
 

 

 

Torpedo Temptation

From free treats in the break room to always-present pizza for residents, high-fat, high-sugar, low-nutrient fare is a constant temptation. “I worked with a physician who would bring a balanced lunch to work every day, then find whatever sweet was around for his afternoon treat,” recalled Ms. Margulies.“The cookies, cakes, and donuts were starting to add up — and stopping at one wasn’t working for him.”

What did work was Ms. Margulies’ suggestion to bring a single serving of dark chocolate and fruit to savor during a longer break. “Bringing your favorite treats in appropriate portions can help you stick with your plan throughout the day,” she explained, and you’ll have an easier time resisting what’s in the break room. “When you desire a treat, tell yourself you have what you need and don’t need to indulge in the ‘free food’ just because it’s there. You have power over your choices.”

How about tricking yourself into perceiving cherry tomatoes as treats? That might be unusual, but one of Dr. La Puma’s physician patients did just that, displaying the produce in a candy dish on his office counter. Not only did this strategy help remind him to snack healthfully, it also prompted his patients to ask about eating better, he said.
 

Preparation Is Still Underrated

Many people find meal prepping intimidating. But it doesn’t need to be complicated. For instance, try purchasing precut veggies, cooked chicken breasts, or other healthy convenience options. You can then combine them in packable containers to prep a few meals at a time. For less busy weeks, consider cooking the protein yourself and whipping up basic sauces (like pesto and vinaigrette) to jazz up your meals.

“I worked with a resident who was gaining weight each month,” recalled Ms. Margulies. “She would skip lunch, grab a random snack, then wait until she got home to eat anything she could find.”

Encouraged by Ms. Margulies, she prepared and portioned one or two balanced dinners each week, which she’d later reheat. She also bought fresh and dried fruit and high-protein snacks, keeping single servings in her car to eat on the way home.

Similarly, Jess DeGore, RD, LDN, CDCES, CHWC, a diabetes educator and owner of Dietitian Jess Nutrition, recalled an ob.gyn. client who constantly skipped meals and relied on vending machine snacks. To combat her resulting energy crashes, she followed Ms. DeGore’s advice to prep workday lunches (like quinoa salads) over the weekend and bring fruit and nut snacks to work.
 

Automate as Much as You Can

If healthy is already on hand, you’ll eat healthy, said Ms. Andrews. Build up a snack stash focusing on fiber and protein. Tote a lunch bag with a cooler pack if needed. Some suggestions:

  • Oatmeal packets
  • Individual Greek yogurt cups or drinkable yogurts
  • Protein bars
  • Protein shakes
  • Fresh fruit
  • Fresh veggie sticks
  • Nuts, dried chickpeas, or edamame
  • Trail mix
  • Single servings of hummus, nut butter, or guacamole
  • Dried seaweed snacks
  • Whole grain crackers
  • Hard-boiled eggs
  • String cheese
  • Peanut butter sandwich
  • 95% cacao chocolate bar
 

 

Try a Meal Delivery Service

Meal delivery services can be pricey, but potentially worth the expense. By bringing meals or having them sent to your office, you won’t have to find time to go to the cafeteria and stand in line, noted Janese S. Laster, MD, an internal medicine, gastroenterology, obesity medicine, and nutrition physician and founder of Gut Theory Total Digestive Care. Instead, “you’ll have something to warm up and eat while writing notes or in between patients,” she said. Plus, “you won’t have an excuse to skip meals.”

Hydration Yes, Junk Drinks No

The following can be filed in the Doctors-Know-It-But-Don’t-Always-Do-It section: “Hunger can be mistaken for thirst,” said Ms. Margulies. “Staying hydrated will help you better assess whether you’re hungry or thirsty.” Choose water over soda or energy drinks, she added, to hydrate your body without unnecessary extra sugars, sugar substitutes, calories, caffeine, or sodium — all of which can affect how you feel.

Advocate for Your Health

Convincing your institution to make changes might be difficult or even impossible, but consider asking your workplace to implement initiatives like these to boost provider nutrition, suggested Jabe Brown, BHSc (Nat), founder of Melbourne Functional Medicine:

  • Establish protected break times when doctors can step away from their duties to eat
  • Add more nutritious cafeteria options, like salads, whole grains, and lean proteins
  • Overhaul vending machine offerings
  • Offer educational workshops on nutrition

Be Tenacious About Good Eating

For Dr. Toomer, that meant taking several years off from work to improve her health. After losing more than 100 pounds, she founded TOTAL Weight Care Institute to help other healthcare professionals follow in her footsteps.

For you, the path toward a healthier diet might be gradual — grabbing a more nutritious snack, spending an extra hour per week on food shopping or prep, remembering a water bottle. Whatever it looks like, make realistic lifestyle tweaks that work for you.

Maybe even try that apple-a-day thing.
 

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

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Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.
 

 

 

Torpedo Temptation

From free treats in the break room to always-present pizza for residents, high-fat, high-sugar, low-nutrient fare is a constant temptation. “I worked with a physician who would bring a balanced lunch to work every day, then find whatever sweet was around for his afternoon treat,” recalled Ms. Margulies.“The cookies, cakes, and donuts were starting to add up — and stopping at one wasn’t working for him.”

What did work was Ms. Margulies’ suggestion to bring a single serving of dark chocolate and fruit to savor during a longer break. “Bringing your favorite treats in appropriate portions can help you stick with your plan throughout the day,” she explained, and you’ll have an easier time resisting what’s in the break room. “When you desire a treat, tell yourself you have what you need and don’t need to indulge in the ‘free food’ just because it’s there. You have power over your choices.”

How about tricking yourself into perceiving cherry tomatoes as treats? That might be unusual, but one of Dr. La Puma’s physician patients did just that, displaying the produce in a candy dish on his office counter. Not only did this strategy help remind him to snack healthfully, it also prompted his patients to ask about eating better, he said.
 

Preparation Is Still Underrated

Many people find meal prepping intimidating. But it doesn’t need to be complicated. For instance, try purchasing precut veggies, cooked chicken breasts, or other healthy convenience options. You can then combine them in packable containers to prep a few meals at a time. For less busy weeks, consider cooking the protein yourself and whipping up basic sauces (like pesto and vinaigrette) to jazz up your meals.

“I worked with a resident who was gaining weight each month,” recalled Ms. Margulies. “She would skip lunch, grab a random snack, then wait until she got home to eat anything she could find.”

Encouraged by Ms. Margulies, she prepared and portioned one or two balanced dinners each week, which she’d later reheat. She also bought fresh and dried fruit and high-protein snacks, keeping single servings in her car to eat on the way home.

Similarly, Jess DeGore, RD, LDN, CDCES, CHWC, a diabetes educator and owner of Dietitian Jess Nutrition, recalled an ob.gyn. client who constantly skipped meals and relied on vending machine snacks. To combat her resulting energy crashes, she followed Ms. DeGore’s advice to prep workday lunches (like quinoa salads) over the weekend and bring fruit and nut snacks to work.
 

Automate as Much as You Can

If healthy is already on hand, you’ll eat healthy, said Ms. Andrews. Build up a snack stash focusing on fiber and protein. Tote a lunch bag with a cooler pack if needed. Some suggestions:

  • Oatmeal packets
  • Individual Greek yogurt cups or drinkable yogurts
  • Protein bars
  • Protein shakes
  • Fresh fruit
  • Fresh veggie sticks
  • Nuts, dried chickpeas, or edamame
  • Trail mix
  • Single servings of hummus, nut butter, or guacamole
  • Dried seaweed snacks
  • Whole grain crackers
  • Hard-boiled eggs
  • String cheese
  • Peanut butter sandwich
  • 95% cacao chocolate bar
 

 

Try a Meal Delivery Service

Meal delivery services can be pricey, but potentially worth the expense. By bringing meals or having them sent to your office, you won’t have to find time to go to the cafeteria and stand in line, noted Janese S. Laster, MD, an internal medicine, gastroenterology, obesity medicine, and nutrition physician and founder of Gut Theory Total Digestive Care. Instead, “you’ll have something to warm up and eat while writing notes or in between patients,” she said. Plus, “you won’t have an excuse to skip meals.”

Hydration Yes, Junk Drinks No

The following can be filed in the Doctors-Know-It-But-Don’t-Always-Do-It section: “Hunger can be mistaken for thirst,” said Ms. Margulies. “Staying hydrated will help you better assess whether you’re hungry or thirsty.” Choose water over soda or energy drinks, she added, to hydrate your body without unnecessary extra sugars, sugar substitutes, calories, caffeine, or sodium — all of which can affect how you feel.

Advocate for Your Health

Convincing your institution to make changes might be difficult or even impossible, but consider asking your workplace to implement initiatives like these to boost provider nutrition, suggested Jabe Brown, BHSc (Nat), founder of Melbourne Functional Medicine:

  • Establish protected break times when doctors can step away from their duties to eat
  • Add more nutritious cafeteria options, like salads, whole grains, and lean proteins
  • Overhaul vending machine offerings
  • Offer educational workshops on nutrition

Be Tenacious About Good Eating

For Dr. Toomer, that meant taking several years off from work to improve her health. After losing more than 100 pounds, she founded TOTAL Weight Care Institute to help other healthcare professionals follow in her footsteps.

For you, the path toward a healthier diet might be gradual — grabbing a more nutritious snack, spending an extra hour per week on food shopping or prep, remembering a water bottle. Whatever it looks like, make realistic lifestyle tweaks that work for you.

Maybe even try that apple-a-day thing.
 

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

Eat as fast as you can whenever you can.

That was the med student mindset around food, as Catherine Harmon Toomer, MD, discovered during her school years. “Without a good system in place to counter that,” she explains, “unhealthy eating can get out of control, and that’s what happened to me.”

After med school, things got worse for Dr. Toomer. By her second year in practice as a family medicine physician, she’d gained a lot of weight and had been diagnosed with type 2 diabetes and cardiomyopathy. At 36, she went into congestive heart failure and was told she likely had 5 years to live.

A moment she described as “a huge wake-up call.”

Dr. Toomer is far from alone in her struggles to balance working in medicine and eating healthfully.

“Physicians face unique stresses because of the ubiquity of junk food in the clinical setting, easy use of food as a reward and stress reliever, and lack of time to create better wellness habits while counseling patients to do exactly that,” said John La Puma, MD, FACP, internist and cofounder of ChefMD and founder of Chef Clinic.

There is also the culture of medicine, which Dr. Toomer said looks down on self-care. “Even with break times, patient needs come before our own.” So, you sit down to eat, and there’s an emergency. Your clinic closes for lunch, but the phones still ring, and patients continue to email questions. Charting is also so time-consuming that “everything else gets put on the back burner.”

Sticking to a nutritious diet in this context can feel hopeless. But it isn’t. Really. Here are some doctor-tested, real-life ways you can nourish yourself while getting it all done.
 

Something Is Always Better Than Nothing

Sure, you might not be able to eat a balanced lunch or dinner while at work, conceded Amy Margulies, RD, LDN, owner of The Rebellious RD. But try to focus on the bigger picture and take small steps.

First, make sure you eat something, Ms. Margulies advised. “Skipping meals can lead to overeating later and negatively impact energy levels and concentration.”

Lisa Andrews, MEd, RD, LD, owner of Sound Bites Nutrition, recalled one of her patients, a gastrointestinal surgeon with reactive hypoglycemia and fatigue. “She was experiencing energy crashes mid-afternoon,” she said. It was only after starting to eat every 4-5 hours that her patient felt better.

Of course, this is easier said than done. “When you are running from one patient to the other and trying to keep on time with your schedule, there is very little time for eating and no time at all for cooking or even heating up food,” recalled Hélène Bertrand, MD, author of Low Back Pain: 3 Steps to Relief in 2 Minutes.

But during her 55 years as a family medicine physician, Dr. Bertrand found ways to improve (if not perfect) the situation. She lunched on nuts or seeds during the day or grabbed a 95% cacao chocolate bar — higher in antioxidants and lower in sugar than a candy bar.

If you don’t have time for breakfast, try drinking a complete protein shake while driving to work, Dr. Toomer recommended. “It’s not ideal, but it’s better than nothing.” Similarly, if the only way you’ll eat a high-protein, lower-carb snack like hummus is with potato chips, go for it, she said.

Basically, don’t be type A striving for perfection. Take good enough when you can and balance the rest when you have time.
 

 

 

Torpedo Temptation

From free treats in the break room to always-present pizza for residents, high-fat, high-sugar, low-nutrient fare is a constant temptation. “I worked with a physician who would bring a balanced lunch to work every day, then find whatever sweet was around for his afternoon treat,” recalled Ms. Margulies.“The cookies, cakes, and donuts were starting to add up — and stopping at one wasn’t working for him.”

What did work was Ms. Margulies’ suggestion to bring a single serving of dark chocolate and fruit to savor during a longer break. “Bringing your favorite treats in appropriate portions can help you stick with your plan throughout the day,” she explained, and you’ll have an easier time resisting what’s in the break room. “When you desire a treat, tell yourself you have what you need and don’t need to indulge in the ‘free food’ just because it’s there. You have power over your choices.”

How about tricking yourself into perceiving cherry tomatoes as treats? That might be unusual, but one of Dr. La Puma’s physician patients did just that, displaying the produce in a candy dish on his office counter. Not only did this strategy help remind him to snack healthfully, it also prompted his patients to ask about eating better, he said.
 

Preparation Is Still Underrated

Many people find meal prepping intimidating. But it doesn’t need to be complicated. For instance, try purchasing precut veggies, cooked chicken breasts, or other healthy convenience options. You can then combine them in packable containers to prep a few meals at a time. For less busy weeks, consider cooking the protein yourself and whipping up basic sauces (like pesto and vinaigrette) to jazz up your meals.

“I worked with a resident who was gaining weight each month,” recalled Ms. Margulies. “She would skip lunch, grab a random snack, then wait until she got home to eat anything she could find.”

Encouraged by Ms. Margulies, she prepared and portioned one or two balanced dinners each week, which she’d later reheat. She also bought fresh and dried fruit and high-protein snacks, keeping single servings in her car to eat on the way home.

Similarly, Jess DeGore, RD, LDN, CDCES, CHWC, a diabetes educator and owner of Dietitian Jess Nutrition, recalled an ob.gyn. client who constantly skipped meals and relied on vending machine snacks. To combat her resulting energy crashes, she followed Ms. DeGore’s advice to prep workday lunches (like quinoa salads) over the weekend and bring fruit and nut snacks to work.
 

Automate as Much as You Can

If healthy is already on hand, you’ll eat healthy, said Ms. Andrews. Build up a snack stash focusing on fiber and protein. Tote a lunch bag with a cooler pack if needed. Some suggestions:

  • Oatmeal packets
  • Individual Greek yogurt cups or drinkable yogurts
  • Protein bars
  • Protein shakes
  • Fresh fruit
  • Fresh veggie sticks
  • Nuts, dried chickpeas, or edamame
  • Trail mix
  • Single servings of hummus, nut butter, or guacamole
  • Dried seaweed snacks
  • Whole grain crackers
  • Hard-boiled eggs
  • String cheese
  • Peanut butter sandwich
  • 95% cacao chocolate bar
 

 

Try a Meal Delivery Service

Meal delivery services can be pricey, but potentially worth the expense. By bringing meals or having them sent to your office, you won’t have to find time to go to the cafeteria and stand in line, noted Janese S. Laster, MD, an internal medicine, gastroenterology, obesity medicine, and nutrition physician and founder of Gut Theory Total Digestive Care. Instead, “you’ll have something to warm up and eat while writing notes or in between patients,” she said. Plus, “you won’t have an excuse to skip meals.”

Hydration Yes, Junk Drinks No

The following can be filed in the Doctors-Know-It-But-Don’t-Always-Do-It section: “Hunger can be mistaken for thirst,” said Ms. Margulies. “Staying hydrated will help you better assess whether you’re hungry or thirsty.” Choose water over soda or energy drinks, she added, to hydrate your body without unnecessary extra sugars, sugar substitutes, calories, caffeine, or sodium — all of which can affect how you feel.

Advocate for Your Health

Convincing your institution to make changes might be difficult or even impossible, but consider asking your workplace to implement initiatives like these to boost provider nutrition, suggested Jabe Brown, BHSc (Nat), founder of Melbourne Functional Medicine:

  • Establish protected break times when doctors can step away from their duties to eat
  • Add more nutritious cafeteria options, like salads, whole grains, and lean proteins
  • Overhaul vending machine offerings
  • Offer educational workshops on nutrition

Be Tenacious About Good Eating

For Dr. Toomer, that meant taking several years off from work to improve her health. After losing more than 100 pounds, she founded TOTAL Weight Care Institute to help other healthcare professionals follow in her footsteps.

For you, the path toward a healthier diet might be gradual — grabbing a more nutritious snack, spending an extra hour per week on food shopping or prep, remembering a water bottle. Whatever it looks like, make realistic lifestyle tweaks that work for you.

Maybe even try that apple-a-day thing.
 

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

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Paxlovid, Supplements May Improve Long COVID Symptoms

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Mon, 07/29/2024 - 12:15

Paxlovid, an antiviral approved in 2023 to treat acute infections of COVID-19, is showing great potential as a new treatment for long COVID and may be the most promising experimental therapy now being studied for treating the condition.

New research offers strong evidence that Paxlovid provides significant benefits for COVID-19 patients who are at high risk for severe or prolonged disease, particularly older adults and those who are immunocompromised, said Lisa Sanders, MD, medical director of Yale’s Long COVID Multidisciplinary Care Center, New Haven, Connecticut. 

“We all know that long COVID is a disease smorgasbord of illnesses that have been somehow triggered by COVID. So, the question is, are there some types of these disorders that can respond to Paxlovid?” Dr. Sanders said. 

Some patients have also benefited from supplements such as N-acetyl cysteine (NAC), as well as vitamins B, C, D and alpha lipoic acid, in which the risks are low and there are potential benefits, Dr. Sanders said.

As researchers continue to study new treatments for long COVID, for which there are no standard approved therapies, Dr. Sanders suggested doctors might turn to Paxlovid and other promising therapeutics that have shown benefits in preliminary study findings.

A study published in 2023 by JAMA Internal Medicine reviewed the charts of nearly 300,000 veterans with severe acute COVID infections. The study found that Paxlovid treatment reduced the likelihood of developing long COVID. But a more recent study at Stanford University, Palo Alto, California — the STOP-PASC trial— did not find Paxlovid improved symptoms when given to 155 patients who had already recovered from acute infection. Participants with long COVID symptoms — and who had on average recovered from acute infection around 16 months earlier — were given a 15-day course of Paxlovid. Common symptoms like fog, fatigue, and cardiovascular or gastrointestinal symptoms did not improve.

However, long COVID likely has multiple drivers. Viral persistence may still be at play for a subset of patients. This means that, despite the fact that patients recover from acute infection, hidden reservoirs of SARS-CoV-2 are still present in the body, possibly bringing on long COVID symptoms. Which means Paxlovid may help some long COVID patients but not others, Dr. Sanders explained. That’s why research needs to continue to identify the best cases for Paxlovid’s use and to identify other treatments for those who do not benefit from Paxlovid.

The PAX LC trial at Yale suggests there may not be a one-size-fits-all treatment for the condition, but a range of factors that may determine the best therapy for individual patients. Led by Yale School of Medicine’s Harlan Krumholz, MD, and Akiko Iwasaki, PhD, the study tested the effects of Paxlovid overall and was designed to determine who is most likely to benefit from antiviral treatment and gain further understanding of the immune response in long COVID. Results should be reported soon. 

“This acknowledges one line of thinking that long COVID is caused by viral persistence,” Dr. Sanders said. “Do these people have hidden reservoirs of the virus? The question is, are there people who seem to respond [to Paxlovid]? And if so, what characterizes these people?”
 

 

 

Low-Risk, High-Reward Supplements

Some of Dr. Sanders’ colleagues at Yale are focusing on long COVID’s neurological symptoms and neuropathogenesis. There’s evidence showing these symptoms — notably brain fog — can be treated with supplements. 

In 2022, a Yale study by Arman Fesharaki-Zadeh, MD, PhD, found promise in treating brain fog through a combination supplement of NAC and guanfacine — the latter developed by Yale neuroscientist, Amy Arnsten, PhD. 

The two published their study in Neuroimmunology Reports in November 2023. NAC is available over the counter and patients can get a prescription for guanfacine off label from their physician. Guanfacine is approved to treat high blood pressure by decreasing heart rate and relaxing blood vessels. But it’s also been shown to treat attention-deficit/hyperactivity disorder (ADHD) and other cognitive issues. 

Though NAC can treat respiratory problems, it’s also commonly used to treat postconcussion symptoms. Dr. Fesharaki-Zadeh found that it helps treat brain fog, increases energy, and improves memory. When paired with guanfacine, substantial benefits were reported, such as better multitasking abilities and markedly improved organizational skills. 

Dr. Sanders is now using NAC and guanfacine for patients in her clinic. 
 

‘Mitochondrial Enhancement’ Through Vitamins

Dr. Sanders has also used a combination of alpha lipoic acid and vitamin C, and a combo of B vitamins that make up what’s called a “mitochondrial enhancement regimen.”

To treat a very common symptom like fatigue, Dr. Sanders prefers supplement combinations over other drugs like Modafinil or Adderall. 

Modafinil is a central nervous system stimulant used to reduce extreme sleepiness caused by narcolepsy or other sleep disorders. Adderall is an amphetamine also used to treat narcolepsy as well as ADHD. Both work on your sleep and alertness, but long COVID affects the whole body, causing a physical fatigue similar to postexertional malaise (PEM) that isn’t remedied by those kinds of drugs, as studies suggest what’s involved in PEM is mitochondria, Dr. Sanders said. 

PEM is a worsening of symptoms that occurs after minimal physical or mental exertion. These are activities that should be well tolerated, but PEM causes extreme fatigue and flu-like symptoms. It’s become a hallmark symptom of long COVID after having already been a key diagnostic factor in myalgic encephalomyelitis/chronic fatigue syndrome.

As Dr. Sanders noted in her long COVID blog, which tracks the latest research and treatment options for doctors who treat long COVID patients, previous studies have shown low vitamin D levels may not only increase the risk for severe COVID-19 but delay recovery from long COVID. Those without long COVID had higher levels of vitamin D, compared with long COVID patients. Vitamin D is known to boost the immune system.

Dr. Sanders found that those with vitamin D deficiencies are most likely to benefit from this approach. For people who don’t have sufficient sun exposure, which prompts the production of vitamin D, she says supplementation with 1000 IUs of vitamin D3 daily is enough for most adults.

Research is also currently being underway on the use of the diabetes drug metformin in people with acute COVID infections to determine if it may reduce the likelihood of developing long COVID. In a recent long COVID clinical trial, early outpatient COVID-19 treatment with metformin decreased the subsequent risk for long COVID by 41.3% during 10-month follow-up. 
 

 

 

Other New Treatments Under Study

Dr. Sanders believes the foundation for many of long COVID’s symptoms could be neurological. 

“I think that long COVID is probably a neurologic disorder,” Dr. Sanders said. 

Lindsey McAlpine, MD, director of the Yale Medicine NeuroCovid Clinic, is focusing on neuropsychiatric long COVID and the causes of neurologic post-acute sequelae of SARS-CoV-2 infection (neuro-PASC). Symptoms of neuro-PASC include cognitive impairment, headaches, and dizziness.

“Lindsey is trying to see which parts of the brain are involved and see if there are phenotypes of brain abnormalities that match up with clinical abnormalities,” Dr. Sanders said.

The National Institute of Neurological Disorders and Stroke recently awarded her a 5-year K23 grant to support her ongoing study, “Magnetic Resonance Imaging Biomarkers of Post-COVID-19 Cerebral Microvascular Dysfunction.”

Utilizing advanced MRI techniques to identify microvascular dysfunction biomarkers in the brain, Dr. McAlpine hopes to unearth and better understand the pathophysiology behind neurological issues post COVID.

Many of Dr. McAlpine’s patients with cognitive symptoms have responded well to NAC and guanfacine. 

Still, the hope is that her brain-imaging studies will bear fruit that leads to a better understanding of long COVID and new treatment methods.

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

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Paxlovid, an antiviral approved in 2023 to treat acute infections of COVID-19, is showing great potential as a new treatment for long COVID and may be the most promising experimental therapy now being studied for treating the condition.

New research offers strong evidence that Paxlovid provides significant benefits for COVID-19 patients who are at high risk for severe or prolonged disease, particularly older adults and those who are immunocompromised, said Lisa Sanders, MD, medical director of Yale’s Long COVID Multidisciplinary Care Center, New Haven, Connecticut. 

“We all know that long COVID is a disease smorgasbord of illnesses that have been somehow triggered by COVID. So, the question is, are there some types of these disorders that can respond to Paxlovid?” Dr. Sanders said. 

Some patients have also benefited from supplements such as N-acetyl cysteine (NAC), as well as vitamins B, C, D and alpha lipoic acid, in which the risks are low and there are potential benefits, Dr. Sanders said.

As researchers continue to study new treatments for long COVID, for which there are no standard approved therapies, Dr. Sanders suggested doctors might turn to Paxlovid and other promising therapeutics that have shown benefits in preliminary study findings.

A study published in 2023 by JAMA Internal Medicine reviewed the charts of nearly 300,000 veterans with severe acute COVID infections. The study found that Paxlovid treatment reduced the likelihood of developing long COVID. But a more recent study at Stanford University, Palo Alto, California — the STOP-PASC trial— did not find Paxlovid improved symptoms when given to 155 patients who had already recovered from acute infection. Participants with long COVID symptoms — and who had on average recovered from acute infection around 16 months earlier — were given a 15-day course of Paxlovid. Common symptoms like fog, fatigue, and cardiovascular or gastrointestinal symptoms did not improve.

However, long COVID likely has multiple drivers. Viral persistence may still be at play for a subset of patients. This means that, despite the fact that patients recover from acute infection, hidden reservoirs of SARS-CoV-2 are still present in the body, possibly bringing on long COVID symptoms. Which means Paxlovid may help some long COVID patients but not others, Dr. Sanders explained. That’s why research needs to continue to identify the best cases for Paxlovid’s use and to identify other treatments for those who do not benefit from Paxlovid.

The PAX LC trial at Yale suggests there may not be a one-size-fits-all treatment for the condition, but a range of factors that may determine the best therapy for individual patients. Led by Yale School of Medicine’s Harlan Krumholz, MD, and Akiko Iwasaki, PhD, the study tested the effects of Paxlovid overall and was designed to determine who is most likely to benefit from antiviral treatment and gain further understanding of the immune response in long COVID. Results should be reported soon. 

“This acknowledges one line of thinking that long COVID is caused by viral persistence,” Dr. Sanders said. “Do these people have hidden reservoirs of the virus? The question is, are there people who seem to respond [to Paxlovid]? And if so, what characterizes these people?”
 

 

 

Low-Risk, High-Reward Supplements

Some of Dr. Sanders’ colleagues at Yale are focusing on long COVID’s neurological symptoms and neuropathogenesis. There’s evidence showing these symptoms — notably brain fog — can be treated with supplements. 

In 2022, a Yale study by Arman Fesharaki-Zadeh, MD, PhD, found promise in treating brain fog through a combination supplement of NAC and guanfacine — the latter developed by Yale neuroscientist, Amy Arnsten, PhD. 

The two published their study in Neuroimmunology Reports in November 2023. NAC is available over the counter and patients can get a prescription for guanfacine off label from their physician. Guanfacine is approved to treat high blood pressure by decreasing heart rate and relaxing blood vessels. But it’s also been shown to treat attention-deficit/hyperactivity disorder (ADHD) and other cognitive issues. 

Though NAC can treat respiratory problems, it’s also commonly used to treat postconcussion symptoms. Dr. Fesharaki-Zadeh found that it helps treat brain fog, increases energy, and improves memory. When paired with guanfacine, substantial benefits were reported, such as better multitasking abilities and markedly improved organizational skills. 

Dr. Sanders is now using NAC and guanfacine for patients in her clinic. 
 

‘Mitochondrial Enhancement’ Through Vitamins

Dr. Sanders has also used a combination of alpha lipoic acid and vitamin C, and a combo of B vitamins that make up what’s called a “mitochondrial enhancement regimen.”

To treat a very common symptom like fatigue, Dr. Sanders prefers supplement combinations over other drugs like Modafinil or Adderall. 

Modafinil is a central nervous system stimulant used to reduce extreme sleepiness caused by narcolepsy or other sleep disorders. Adderall is an amphetamine also used to treat narcolepsy as well as ADHD. Both work on your sleep and alertness, but long COVID affects the whole body, causing a physical fatigue similar to postexertional malaise (PEM) that isn’t remedied by those kinds of drugs, as studies suggest what’s involved in PEM is mitochondria, Dr. Sanders said. 

PEM is a worsening of symptoms that occurs after minimal physical or mental exertion. These are activities that should be well tolerated, but PEM causes extreme fatigue and flu-like symptoms. It’s become a hallmark symptom of long COVID after having already been a key diagnostic factor in myalgic encephalomyelitis/chronic fatigue syndrome.

As Dr. Sanders noted in her long COVID blog, which tracks the latest research and treatment options for doctors who treat long COVID patients, previous studies have shown low vitamin D levels may not only increase the risk for severe COVID-19 but delay recovery from long COVID. Those without long COVID had higher levels of vitamin D, compared with long COVID patients. Vitamin D is known to boost the immune system.

Dr. Sanders found that those with vitamin D deficiencies are most likely to benefit from this approach. For people who don’t have sufficient sun exposure, which prompts the production of vitamin D, she says supplementation with 1000 IUs of vitamin D3 daily is enough for most adults.

Research is also currently being underway on the use of the diabetes drug metformin in people with acute COVID infections to determine if it may reduce the likelihood of developing long COVID. In a recent long COVID clinical trial, early outpatient COVID-19 treatment with metformin decreased the subsequent risk for long COVID by 41.3% during 10-month follow-up. 
 

 

 

Other New Treatments Under Study

Dr. Sanders believes the foundation for many of long COVID’s symptoms could be neurological. 

“I think that long COVID is probably a neurologic disorder,” Dr. Sanders said. 

Lindsey McAlpine, MD, director of the Yale Medicine NeuroCovid Clinic, is focusing on neuropsychiatric long COVID and the causes of neurologic post-acute sequelae of SARS-CoV-2 infection (neuro-PASC). Symptoms of neuro-PASC include cognitive impairment, headaches, and dizziness.

“Lindsey is trying to see which parts of the brain are involved and see if there are phenotypes of brain abnormalities that match up with clinical abnormalities,” Dr. Sanders said.

The National Institute of Neurological Disorders and Stroke recently awarded her a 5-year K23 grant to support her ongoing study, “Magnetic Resonance Imaging Biomarkers of Post-COVID-19 Cerebral Microvascular Dysfunction.”

Utilizing advanced MRI techniques to identify microvascular dysfunction biomarkers in the brain, Dr. McAlpine hopes to unearth and better understand the pathophysiology behind neurological issues post COVID.

Many of Dr. McAlpine’s patients with cognitive symptoms have responded well to NAC and guanfacine. 

Still, the hope is that her brain-imaging studies will bear fruit that leads to a better understanding of long COVID and new treatment methods.

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

Paxlovid, an antiviral approved in 2023 to treat acute infections of COVID-19, is showing great potential as a new treatment for long COVID and may be the most promising experimental therapy now being studied for treating the condition.

New research offers strong evidence that Paxlovid provides significant benefits for COVID-19 patients who are at high risk for severe or prolonged disease, particularly older adults and those who are immunocompromised, said Lisa Sanders, MD, medical director of Yale’s Long COVID Multidisciplinary Care Center, New Haven, Connecticut. 

“We all know that long COVID is a disease smorgasbord of illnesses that have been somehow triggered by COVID. So, the question is, are there some types of these disorders that can respond to Paxlovid?” Dr. Sanders said. 

Some patients have also benefited from supplements such as N-acetyl cysteine (NAC), as well as vitamins B, C, D and alpha lipoic acid, in which the risks are low and there are potential benefits, Dr. Sanders said.

As researchers continue to study new treatments for long COVID, for which there are no standard approved therapies, Dr. Sanders suggested doctors might turn to Paxlovid and other promising therapeutics that have shown benefits in preliminary study findings.

A study published in 2023 by JAMA Internal Medicine reviewed the charts of nearly 300,000 veterans with severe acute COVID infections. The study found that Paxlovid treatment reduced the likelihood of developing long COVID. But a more recent study at Stanford University, Palo Alto, California — the STOP-PASC trial— did not find Paxlovid improved symptoms when given to 155 patients who had already recovered from acute infection. Participants with long COVID symptoms — and who had on average recovered from acute infection around 16 months earlier — were given a 15-day course of Paxlovid. Common symptoms like fog, fatigue, and cardiovascular or gastrointestinal symptoms did not improve.

However, long COVID likely has multiple drivers. Viral persistence may still be at play for a subset of patients. This means that, despite the fact that patients recover from acute infection, hidden reservoirs of SARS-CoV-2 are still present in the body, possibly bringing on long COVID symptoms. Which means Paxlovid may help some long COVID patients but not others, Dr. Sanders explained. That’s why research needs to continue to identify the best cases for Paxlovid’s use and to identify other treatments for those who do not benefit from Paxlovid.

The PAX LC trial at Yale suggests there may not be a one-size-fits-all treatment for the condition, but a range of factors that may determine the best therapy for individual patients. Led by Yale School of Medicine’s Harlan Krumholz, MD, and Akiko Iwasaki, PhD, the study tested the effects of Paxlovid overall and was designed to determine who is most likely to benefit from antiviral treatment and gain further understanding of the immune response in long COVID. Results should be reported soon. 

“This acknowledges one line of thinking that long COVID is caused by viral persistence,” Dr. Sanders said. “Do these people have hidden reservoirs of the virus? The question is, are there people who seem to respond [to Paxlovid]? And if so, what characterizes these people?”
 

 

 

Low-Risk, High-Reward Supplements

Some of Dr. Sanders’ colleagues at Yale are focusing on long COVID’s neurological symptoms and neuropathogenesis. There’s evidence showing these symptoms — notably brain fog — can be treated with supplements. 

In 2022, a Yale study by Arman Fesharaki-Zadeh, MD, PhD, found promise in treating brain fog through a combination supplement of NAC and guanfacine — the latter developed by Yale neuroscientist, Amy Arnsten, PhD. 

The two published their study in Neuroimmunology Reports in November 2023. NAC is available over the counter and patients can get a prescription for guanfacine off label from their physician. Guanfacine is approved to treat high blood pressure by decreasing heart rate and relaxing blood vessels. But it’s also been shown to treat attention-deficit/hyperactivity disorder (ADHD) and other cognitive issues. 

Though NAC can treat respiratory problems, it’s also commonly used to treat postconcussion symptoms. Dr. Fesharaki-Zadeh found that it helps treat brain fog, increases energy, and improves memory. When paired with guanfacine, substantial benefits were reported, such as better multitasking abilities and markedly improved organizational skills. 

Dr. Sanders is now using NAC and guanfacine for patients in her clinic. 
 

‘Mitochondrial Enhancement’ Through Vitamins

Dr. Sanders has also used a combination of alpha lipoic acid and vitamin C, and a combo of B vitamins that make up what’s called a “mitochondrial enhancement regimen.”

To treat a very common symptom like fatigue, Dr. Sanders prefers supplement combinations over other drugs like Modafinil or Adderall. 

Modafinil is a central nervous system stimulant used to reduce extreme sleepiness caused by narcolepsy or other sleep disorders. Adderall is an amphetamine also used to treat narcolepsy as well as ADHD. Both work on your sleep and alertness, but long COVID affects the whole body, causing a physical fatigue similar to postexertional malaise (PEM) that isn’t remedied by those kinds of drugs, as studies suggest what’s involved in PEM is mitochondria, Dr. Sanders said. 

PEM is a worsening of symptoms that occurs after minimal physical or mental exertion. These are activities that should be well tolerated, but PEM causes extreme fatigue and flu-like symptoms. It’s become a hallmark symptom of long COVID after having already been a key diagnostic factor in myalgic encephalomyelitis/chronic fatigue syndrome.

As Dr. Sanders noted in her long COVID blog, which tracks the latest research and treatment options for doctors who treat long COVID patients, previous studies have shown low vitamin D levels may not only increase the risk for severe COVID-19 but delay recovery from long COVID. Those without long COVID had higher levels of vitamin D, compared with long COVID patients. Vitamin D is known to boost the immune system.

Dr. Sanders found that those with vitamin D deficiencies are most likely to benefit from this approach. For people who don’t have sufficient sun exposure, which prompts the production of vitamin D, she says supplementation with 1000 IUs of vitamin D3 daily is enough for most adults.

Research is also currently being underway on the use of the diabetes drug metformin in people with acute COVID infections to determine if it may reduce the likelihood of developing long COVID. In a recent long COVID clinical trial, early outpatient COVID-19 treatment with metformin decreased the subsequent risk for long COVID by 41.3% during 10-month follow-up. 
 

 

 

Other New Treatments Under Study

Dr. Sanders believes the foundation for many of long COVID’s symptoms could be neurological. 

“I think that long COVID is probably a neurologic disorder,” Dr. Sanders said. 

Lindsey McAlpine, MD, director of the Yale Medicine NeuroCovid Clinic, is focusing on neuropsychiatric long COVID and the causes of neurologic post-acute sequelae of SARS-CoV-2 infection (neuro-PASC). Symptoms of neuro-PASC include cognitive impairment, headaches, and dizziness.

“Lindsey is trying to see which parts of the brain are involved and see if there are phenotypes of brain abnormalities that match up with clinical abnormalities,” Dr. Sanders said.

The National Institute of Neurological Disorders and Stroke recently awarded her a 5-year K23 grant to support her ongoing study, “Magnetic Resonance Imaging Biomarkers of Post-COVID-19 Cerebral Microvascular Dysfunction.”

Utilizing advanced MRI techniques to identify microvascular dysfunction biomarkers in the brain, Dr. McAlpine hopes to unearth and better understand the pathophysiology behind neurological issues post COVID.

Many of Dr. McAlpine’s patients with cognitive symptoms have responded well to NAC and guanfacine. 

Still, the hope is that her brain-imaging studies will bear fruit that leads to a better understanding of long COVID and new treatment methods.

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

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New, Near-to-Market PCSK9s Could Help Patients Meet Cholesterol Targets

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Thu, 07/25/2024 - 12:54

The market for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to lower cholesterol is taking off with several new drugs being introduced or nearing the market, which will increase competition and enable more patients to reach low-density lipoprotein (LDL) goals, experts said.

One new anti-PCSK9 agent — lerodalcibep from LIB Therapeutics — is a small protein molecule, which is expected to reach the market by early 2026. It is being positioned as a step forward from the two monoclonal antibody products already available — evolocumab (Repatha; Amgen) and alirocumab (Praluent; Sanofi/Regeneron).

The new option can be given less frequently than the antibodies with a once-a-month injection instead of every 2 weeks. It also does not need to be kept refrigerated like the antibodies, Evan Stein, MD, chief scientific and operating officer of LIB Therapeutics, said in an interview.

Two phase 3 trials have recently been reported, showing impressive reductions in LDL in patients already taking statins.
 

The LIBerate Trials

The LIBerate-HR trial, published in JAMA Cardiology, involved 922 patients who still had LDL above target despite taking maximally tolerated statin therapy plus other lipid-lowering agents in some cases.

The trial found a time-averaged mean reduction in LDL cholesterol of 62%.

“This large reduction resulted in more than 90% of patients reaching the new lower LDL targets set in recent guidelines of less than 55 mg/dL for patients with cardiovascular disease or at very high risk, and less than 70 mg/dL in patients at risk,” said Stein.

Another phase 3 trial, LIBerate-CVD, has also shown reductions in LDL cholesterol levels of more than 60% in patients at high risk for cardiovascular disease on maximally tolerated statins.

LIB Therapeutics plans to file approval applications for lerodalcibep in the United States and Europe later this year.
 

A Crowded Field

Dr. Stein said PCSK9 inhibitors have been underused so far, but this is starting to change.

“The monoclonal antibodies were way overpriced costing around $14,000 per year when they were first introduced, which resulted in huge pushback from insurance companies,” Dr. Stein said, which made the drugs difficult to prescribe. “Then a few years ago, the price dropped a bit, and now they’re probably running at about $4000 per year, which made them more accessible.”

He said the market is now rapidly taking off. Lerodalcibep will compete in the anti-PCSK9 market with not only the two monoclonal antibodies but also with the new short-interfering RNA agent, inclisiran (Leqvio; Novartis) , a novel injectable agent that is given just twice a year but has to be administered at a medical facility.

Despite the crowded field, there appears to be plenty of room in the market. “Last year, growth was just under 40%. The first quarter of this year, it has increased by 44%. While the introduction of inclisiran has added to this growth, it hasn’t dented the sales of the existing monoclonal antibodies,” said Dr. Stein.

He estimates that the anti-PCSK9 market will reach $3 billion globally this year, and by the time lerodalcibep is launched, it could be worth $5 billion.

As well as inclisiran and lerodalcibep, there are other innovations in the anti-PCSK9 field in development, with oral drugs now also in the pipeline. The first one of these, in development by Merck, is in early phase 3 trials, and AstraZeneca has an oral agent in earlier development.
 

 

 

Enthusiastic Response

Other experts in the lipid field are also enthusiastic about new developments in the PCSK9s.

Jorge Plutzky, MD, director of preventive cardiology at Brigham and Women’s Hospital in Boston, said he welcomes the prospect of new approaches to PCSK9 inhibition.

“The increase in the number of safe, effective tools for LDL lowering, whether through PCSK9 or other targets, is inevitably beneficial for patients and the field,” he said during an interview.

Dr. Plutzky pointed out that although the current agents are effective, cost and coverage remain issues despite some recent progress in these areas, and new agents will increase competition and should hopefully drive prices down. Having a variety of dosing methods and frequencies provides more options for patients to find the one that works best for them.

Lerodalcibep’s once-monthly dosing schedule and the lack of need for refrigeration may be appreciated by some patients, he said, particularly those who need to travel for long periods.

Connie Newman, MD, adjunct professor of medicine at NYU School of Medicine, New York City, said there is plenty of room in the market to accommodate patient’s needs and preferences.

“Despite the US FDA approval of three medications that target PCSK9, there is a need for more anti-PCSK9 agents that reduce LDL and cardiovascular events,” she said. “In the US alone, 25% of adults have LDL levels of 130 mg/dL and above. Of all the non-statin therapies, medications targeting PCSK9 produce the greatest reduction in LDL. However, some patients may not tolerate one or more of the medications available or may prefer a monthly injection of lower volume.”

Dr. Newman said she believes there will still be a market for injectable formulations of PCSK9 inhibitors in the future, even if oral formulations are approved.

“Oral formulations usually require more frequent administration. Some people prefer longer-acting medications that can be taken less often. This might lead to better adherence,” she said.

Dr. Stein said he agrees there will always be room for different options. “And you only have to look at what is happening with the weight loss drugs to see that there is a market for injectables.” The ability to get patients to the new, more aggressive LDL goals is what is important, he added. “These drugs do that, and offering patients a choice of agents and delivery mechanisms is helpful.”

A version of this article appeared on Medscape.com.

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The market for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to lower cholesterol is taking off with several new drugs being introduced or nearing the market, which will increase competition and enable more patients to reach low-density lipoprotein (LDL) goals, experts said.

One new anti-PCSK9 agent — lerodalcibep from LIB Therapeutics — is a small protein molecule, which is expected to reach the market by early 2026. It is being positioned as a step forward from the two monoclonal antibody products already available — evolocumab (Repatha; Amgen) and alirocumab (Praluent; Sanofi/Regeneron).

The new option can be given less frequently than the antibodies with a once-a-month injection instead of every 2 weeks. It also does not need to be kept refrigerated like the antibodies, Evan Stein, MD, chief scientific and operating officer of LIB Therapeutics, said in an interview.

Two phase 3 trials have recently been reported, showing impressive reductions in LDL in patients already taking statins.
 

The LIBerate Trials

The LIBerate-HR trial, published in JAMA Cardiology, involved 922 patients who still had LDL above target despite taking maximally tolerated statin therapy plus other lipid-lowering agents in some cases.

The trial found a time-averaged mean reduction in LDL cholesterol of 62%.

“This large reduction resulted in more than 90% of patients reaching the new lower LDL targets set in recent guidelines of less than 55 mg/dL for patients with cardiovascular disease or at very high risk, and less than 70 mg/dL in patients at risk,” said Stein.

Another phase 3 trial, LIBerate-CVD, has also shown reductions in LDL cholesterol levels of more than 60% in patients at high risk for cardiovascular disease on maximally tolerated statins.

LIB Therapeutics plans to file approval applications for lerodalcibep in the United States and Europe later this year.
 

A Crowded Field

Dr. Stein said PCSK9 inhibitors have been underused so far, but this is starting to change.

“The monoclonal antibodies were way overpriced costing around $14,000 per year when they were first introduced, which resulted in huge pushback from insurance companies,” Dr. Stein said, which made the drugs difficult to prescribe. “Then a few years ago, the price dropped a bit, and now they’re probably running at about $4000 per year, which made them more accessible.”

He said the market is now rapidly taking off. Lerodalcibep will compete in the anti-PCSK9 market with not only the two monoclonal antibodies but also with the new short-interfering RNA agent, inclisiran (Leqvio; Novartis) , a novel injectable agent that is given just twice a year but has to be administered at a medical facility.

Despite the crowded field, there appears to be plenty of room in the market. “Last year, growth was just under 40%. The first quarter of this year, it has increased by 44%. While the introduction of inclisiran has added to this growth, it hasn’t dented the sales of the existing monoclonal antibodies,” said Dr. Stein.

He estimates that the anti-PCSK9 market will reach $3 billion globally this year, and by the time lerodalcibep is launched, it could be worth $5 billion.

As well as inclisiran and lerodalcibep, there are other innovations in the anti-PCSK9 field in development, with oral drugs now also in the pipeline. The first one of these, in development by Merck, is in early phase 3 trials, and AstraZeneca has an oral agent in earlier development.
 

 

 

Enthusiastic Response

Other experts in the lipid field are also enthusiastic about new developments in the PCSK9s.

Jorge Plutzky, MD, director of preventive cardiology at Brigham and Women’s Hospital in Boston, said he welcomes the prospect of new approaches to PCSK9 inhibition.

“The increase in the number of safe, effective tools for LDL lowering, whether through PCSK9 or other targets, is inevitably beneficial for patients and the field,” he said during an interview.

Dr. Plutzky pointed out that although the current agents are effective, cost and coverage remain issues despite some recent progress in these areas, and new agents will increase competition and should hopefully drive prices down. Having a variety of dosing methods and frequencies provides more options for patients to find the one that works best for them.

Lerodalcibep’s once-monthly dosing schedule and the lack of need for refrigeration may be appreciated by some patients, he said, particularly those who need to travel for long periods.

Connie Newman, MD, adjunct professor of medicine at NYU School of Medicine, New York City, said there is plenty of room in the market to accommodate patient’s needs and preferences.

“Despite the US FDA approval of three medications that target PCSK9, there is a need for more anti-PCSK9 agents that reduce LDL and cardiovascular events,” she said. “In the US alone, 25% of adults have LDL levels of 130 mg/dL and above. Of all the non-statin therapies, medications targeting PCSK9 produce the greatest reduction in LDL. However, some patients may not tolerate one or more of the medications available or may prefer a monthly injection of lower volume.”

Dr. Newman said she believes there will still be a market for injectable formulations of PCSK9 inhibitors in the future, even if oral formulations are approved.

“Oral formulations usually require more frequent administration. Some people prefer longer-acting medications that can be taken less often. This might lead to better adherence,” she said.

Dr. Stein said he agrees there will always be room for different options. “And you only have to look at what is happening with the weight loss drugs to see that there is a market for injectables.” The ability to get patients to the new, more aggressive LDL goals is what is important, he added. “These drugs do that, and offering patients a choice of agents and delivery mechanisms is helpful.”

A version of this article appeared on Medscape.com.

The market for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to lower cholesterol is taking off with several new drugs being introduced or nearing the market, which will increase competition and enable more patients to reach low-density lipoprotein (LDL) goals, experts said.

One new anti-PCSK9 agent — lerodalcibep from LIB Therapeutics — is a small protein molecule, which is expected to reach the market by early 2026. It is being positioned as a step forward from the two monoclonal antibody products already available — evolocumab (Repatha; Amgen) and alirocumab (Praluent; Sanofi/Regeneron).

The new option can be given less frequently than the antibodies with a once-a-month injection instead of every 2 weeks. It also does not need to be kept refrigerated like the antibodies, Evan Stein, MD, chief scientific and operating officer of LIB Therapeutics, said in an interview.

Two phase 3 trials have recently been reported, showing impressive reductions in LDL in patients already taking statins.
 

The LIBerate Trials

The LIBerate-HR trial, published in JAMA Cardiology, involved 922 patients who still had LDL above target despite taking maximally tolerated statin therapy plus other lipid-lowering agents in some cases.

The trial found a time-averaged mean reduction in LDL cholesterol of 62%.

“This large reduction resulted in more than 90% of patients reaching the new lower LDL targets set in recent guidelines of less than 55 mg/dL for patients with cardiovascular disease or at very high risk, and less than 70 mg/dL in patients at risk,” said Stein.

Another phase 3 trial, LIBerate-CVD, has also shown reductions in LDL cholesterol levels of more than 60% in patients at high risk for cardiovascular disease on maximally tolerated statins.

LIB Therapeutics plans to file approval applications for lerodalcibep in the United States and Europe later this year.
 

A Crowded Field

Dr. Stein said PCSK9 inhibitors have been underused so far, but this is starting to change.

“The monoclonal antibodies were way overpriced costing around $14,000 per year when they were first introduced, which resulted in huge pushback from insurance companies,” Dr. Stein said, which made the drugs difficult to prescribe. “Then a few years ago, the price dropped a bit, and now they’re probably running at about $4000 per year, which made them more accessible.”

He said the market is now rapidly taking off. Lerodalcibep will compete in the anti-PCSK9 market with not only the two monoclonal antibodies but also with the new short-interfering RNA agent, inclisiran (Leqvio; Novartis) , a novel injectable agent that is given just twice a year but has to be administered at a medical facility.

Despite the crowded field, there appears to be plenty of room in the market. “Last year, growth was just under 40%. The first quarter of this year, it has increased by 44%. While the introduction of inclisiran has added to this growth, it hasn’t dented the sales of the existing monoclonal antibodies,” said Dr. Stein.

He estimates that the anti-PCSK9 market will reach $3 billion globally this year, and by the time lerodalcibep is launched, it could be worth $5 billion.

As well as inclisiran and lerodalcibep, there are other innovations in the anti-PCSK9 field in development, with oral drugs now also in the pipeline. The first one of these, in development by Merck, is in early phase 3 trials, and AstraZeneca has an oral agent in earlier development.
 

 

 

Enthusiastic Response

Other experts in the lipid field are also enthusiastic about new developments in the PCSK9s.

Jorge Plutzky, MD, director of preventive cardiology at Brigham and Women’s Hospital in Boston, said he welcomes the prospect of new approaches to PCSK9 inhibition.

“The increase in the number of safe, effective tools for LDL lowering, whether through PCSK9 or other targets, is inevitably beneficial for patients and the field,” he said during an interview.

Dr. Plutzky pointed out that although the current agents are effective, cost and coverage remain issues despite some recent progress in these areas, and new agents will increase competition and should hopefully drive prices down. Having a variety of dosing methods and frequencies provides more options for patients to find the one that works best for them.

Lerodalcibep’s once-monthly dosing schedule and the lack of need for refrigeration may be appreciated by some patients, he said, particularly those who need to travel for long periods.

Connie Newman, MD, adjunct professor of medicine at NYU School of Medicine, New York City, said there is plenty of room in the market to accommodate patient’s needs and preferences.

“Despite the US FDA approval of three medications that target PCSK9, there is a need for more anti-PCSK9 agents that reduce LDL and cardiovascular events,” she said. “In the US alone, 25% of adults have LDL levels of 130 mg/dL and above. Of all the non-statin therapies, medications targeting PCSK9 produce the greatest reduction in LDL. However, some patients may not tolerate one or more of the medications available or may prefer a monthly injection of lower volume.”

Dr. Newman said she believes there will still be a market for injectable formulations of PCSK9 inhibitors in the future, even if oral formulations are approved.

“Oral formulations usually require more frequent administration. Some people prefer longer-acting medications that can be taken less often. This might lead to better adherence,” she said.

Dr. Stein said he agrees there will always be room for different options. “And you only have to look at what is happening with the weight loss drugs to see that there is a market for injectables.” The ability to get patients to the new, more aggressive LDL goals is what is important, he added. “These drugs do that, and offering patients a choice of agents and delivery mechanisms is helpful.”

A version of this article appeared on Medscape.com.

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