One of the most significant shifts in hospital practice over recent decades has been the widespread adoption of electronic medical records as a replacement for conventional paper records.

While EMRs show a lot of promise – having the potential to centralize and simplify clinician notes, make information more accessible and reduce paper waste – there is strong evidence that they are not working as well as they could.

Some research suggests that these systems may decrease the working efficiency of clinicians. Now, major health care institutions are looking to understand why these systems are not working — as well as how they may be improved.

A recent white paper from the Society of Hospital Medicine’s Healthcare Information Technology Special Interest Group – titled “More Caring, Less Clicking” – reviews the current shortcomings of EMRs from a hospitalist perspective and provides recommendations for how these systems can be made more workable and efficient.

The current state of EMRs

“Numerous previous papers – including SHM’s 2017 white paper ‘Hospitalist Perspectives on Electronic Medical Records’ – have linked EMRs to decreased provider satisfaction and increased burnout related to multiple issues, including an increase in ‘screen time’ as opposed to patient ‘face-to-face’ time, and limitations in usability and interoperability,” said Rupesh Prasad, MD, SFHM, medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. “Studies have shown that most of a provider’s time spent is in areas like clinical documentation, entry of orders, and accessing patient information.”

The 2017 SHM white paper referenced by Dr. Prasad reported that 74% of hospitalists surveyed were dissatisfied with their EMR. A full one-quarter of surveyed physicians went so far as saying they would prefer switching to paper record keeping.

Other research has also found a possible link between EMRs and physician burnout and dissatisfaction. It is also not uncommon for hospitalists to spend up to 25% of their time at work using their EMR – time that should, ideally, be spent with patients.

The 2017 paper also showed that clinician notes in the United States are four times longer, on average, than notes in other countries. There are a few reasons for this – including technology design and billing requirements encouraging longer notes. Whatever the cause, however, longer notes linked to physician burnout may be partially responsible for the large amounts of time physicians spend looking at EMRs.

While EMRs may hold significant potential for hospitalists, as they are designed currently, they are simply not delivering the value many expected. The new white paper from the Healthcare Information Technology Special Interest Group outlines practical changes that could be made to EMRs to improve their use in hospitals.

The paper breaks down current issues with EMRs into five broad categories – documentation, clinical decision support, order entry, communication, and data review – to discuss how EMRs are currently failing in these areas as well as how they might be improved.

Improving EMR documentation

One of the most significant hurdles clinicians currently face lies in how EMRs currently store and display documentation. Combined with physician note-taking habits, this makes these systems much less usable than they could be. Longer notes, when displayed in current EMR UIs, mostly lead to clutter, making them harder to navigate and difficult to scan quickly for important information.

The authors identify a few different ways that future EMRs may be able to help with this problem.

EMR documentation tools will likely need to be redesigned to optimize documentation entry, standardize note formatting, and improve readability. Many electronic notes contain vestigial formatting and data left over from the design of paper notes. As a result, many of these electronic notes include information that is stored elsewhere and does not need to be explicitly included in every note. Cutting down on repetitive information storage will make important information more visible and help make patient notes easier to scan.

The paper also recommends a few other features that would make documentation more readable – like allowing clinicians to write documentation in SOAP format (subjective, objective, assessment, and plan), to facilitate critical thinking during the note-taking process, and having the EMR display that documentation in APSO format (assessment, plan, subjective, objective).

Doctors have long called for APSO or another note-taking format to replace SOAP in EMRs. Designing EMRs to rearrange SOAP notes to APSO could be a compromise that improves note readability while not requiring that clinicians learn new note-taking strategies.

The paper’s authors also recommended more extensive clinician training on writing notes. While clinicians are often taught how to write certain notes – like progress notes, histories, and physical and discharge summaries – more specific guidance is not always provided. Better training provided by institutions could help improve the quality and readability of clinician notes.

These changes, however, may not be as beneficial as possible without better institutional support for clinicians. Implementing some of the biggest changes recommended by the SHM will require some level of standardization across platforms and institution commitment to training clinicians on best use practices for EMRs. Improved responsiveness to clinician needs will require a coordinated effort with backing from both administrative and governance groups.

Expanding EMR usability

“Our white paper presents evidence-based recommendations that can be implemented at the ground level in collaboration with other stakeholders, including IT, informatics, and administration, to help improve on the current state,” Dr. Prasad said.

“We believe that hospitalists as key stakeholders in health care, have both the responsibility and are uniquely positioned to directly impact EMR functionality,” he noted. “For example, hospitalists can participate in designing appropriate, actionable alerts that would help with patient safety while also improving provider efficiency. Simple steps like limiting hard stops in order entry to would help speed up the process, and free up time for direct patient care. Availability of tools like secure text messaging would help with effective patient care team communication to improve safety and care delivery.”

EMRs often lack features like voice control and speech-to-text transcription, along with other basic accessibility features like compatibility with screen readers. Implementing these features could improve the efficiency of clinicians’ note-taking while also providing wider software usability.

EMRs are not typically designed to work with mobile devices, meaning clinicians cannot enter notes or order medications until they’ve returned to their desk or workstation.

This lack of functionality creates issues in several ways. When clinicians are unable to enter notes on the move, they will need to either keep mental notes or quickly jot down paper notes. This can effectively double the amount of note-taking that clinicians must do or introduce greater room for error. In cases where progress notes are taken throughout the day, this also means the EMR’s documentation timeline may not be accurate or usable.

Requiring clinicians to return to workstations before entering order information can also increase the risk of medication errors, which remains high despite hopes that EMRs could reduce error rates.

Adding support for cross-device and mobile EMR use could help improve the efficiency of note-taking and help cut down on error. Implementing mobile access could have a few different benefits for clinicians – like improving note-taking efficiency in hospitals, where doctors often see patients far away from their workstations.

EMRs also often lack support for certain hardware, like mobile stations and widescreen monitors, which can improve a clinician’s ability to document in real-time and are a better fit in certain work flows.

The SHM paper also recommends a few other tweaks to usability – like reducing the amount of password entry and reentry – that could make these systems easier to use and more efficient.

New features – like the use of natural language processing technology to analyze and organize information contained in clinicians’ notes – could provide further benefits and take full advantage of the advanced technologies that EMRs can integrate.

Dr. Prasad noted, however, that some of these upgrades – especially EMR compatibility with mobile devices – will require some institutional support. Bring-your-own-device policies or system-provided mobile devices will be necessary if institutions want their clinicians to be able to take advantage of mobile EMR access.

These policies will also likely require some kind of mobile device management solution to manage the security of sensitive patient data as it is accessed from personal devices. This may increase the level of necessary institutional buy-in for this support to work.

Designing EMRs with clinician needs in mind

Dr. Prasad said he and his coauthors recommend that EMR developers base more of their design on the needs of clinicians.

Currently, EMR interfaces can make important data unavailable, depending on what a clinician is trying to do. As a result, clinicians often need to rely on mental recall of important information as they navigate EMR systems.

These interfaces also typically do not support any level of user customization or process-specific interfaces, meaning every clinician is working with the same interface regardless of the tasks they need to perform or the information they need access to. Allowing for customization or implementing new process- or disease-specific interfaces could help avoid some of the problems caused by one-size-fits-all interfaces, which are not necessarily compatible with every clinician work flow.

EMR interfaces should also be designed, wherever possible, with familiar or standardized formats and the use of color coding and other techniques that can make interfaces easier to navigate quickly. Right now, many EMR systems utilize inconsistent layout design that can be cluttered with irrelevant information, slowing down interface navigation and sometimes requiring backtracking from clinicians.

Ideally, this will improve the speed of information gathering and data review, reducing the amount of time clinicians need to spend working with their EMR.

The white paper also recommends that EMR designers improve alert systems so that they are more actionable and interrupt clinicians less often – and that, when they do, they ensure that clinicians can respond to them. Designers should also reduce hard-stops or in-line alerts that halt clinicians’ work flows and require immediate responses where possible.

Increased EMR support for clinical decision support systems is one of the biggest health care trends expected to be seen throughout this decade. However, many clinicians are disappointed with the lack of flexibility and optimization of the current alerts that CDS provides. Updating and improving these knowledge-based systems will likely become essential for delivering better alerts and improving decision-making and efficiency.

Overall, EMR design should be informed by the needs of the people these products are designed to support, Dr. Prasad said. The people that work with EMRs – especially frontline staff like providers, nurses, and pharmacists that regularly interact with EMRs to provide care – should be involved early on in the EMR design process. Right now, their needs are not reflected in current EMR design. EMR companies, by working with these hospital staff members, could help improve ease of use and, ideally, prevent some of the errors associated with the current implementation of these systems.

“System designers should be able to avoid some of the most common problems of EMRs – and predict potential problems – by consistently soliciting and integrating clinician feedback during the design process and over the lifespan of a product,” Dr. Prasad said.

How EMRs can be improved

Over the past few years, EMRs have become quickly adopted by health care professionals and institutions. However, despite hopes that EMRs could significantly improve record keeping and note-taking, these systems continue to pose serious challenges for the clinicians who use them. Evidence from recent research suggests that these systems are inefficient and may contribute to physician burnout.

As a result, organizations like SHM are looking for ways that these systems can be improved.

“The growth of health IT has led to availability of large amounts of data and opportunities for applications in [artificial intelligence and machine learning,” Dr. Prasad noted. “While this has opened many avenues to help positively impact patient care and outcomes, it also poses multiple challenges like validation, customization, and governance. Hospitalists can partner with other health professions and IT leaders to work toward the common goal of improving the health of the population while also providing a positive experience to the end user.”

Another problem with current EMRs is their lack of flexibility. These systems are often not compatible with mobile devices and certain types of hardware and may be difficult or impossible to customize. They also frequently require unnecessary information during the note-taking process that results in cluttered and difficult-to-scan documentation. Improving EMR flexibility – and inviting clinicians to consult during the design process – could solve many of these problems.

New technological developments may also soon help developers improve their EMRs. In the future, as technology like natural language processing becomes more advanced and more commonly used, they may be able to make EMRs even more efficient and user friendly.

One of the most significant shifts in hospital practice over recent decades has been the widespread adoption of electronic medical records as a replacement for conventional paper records.

While EMRs show a lot of promise – having the potential to centralize and simplify clinician notes, make information more accessible and reduce paper waste – there is strong evidence that they are not working as well as they could.

Some research suggests that these systems may decrease the working efficiency of clinicians. Now, major health care institutions are looking to understand why these systems are not working — as well as how they may be improved.

A recent white paper from the Society of Hospital Medicine’s Healthcare Information Technology Special Interest Group – titled “More Caring, Less Clicking” – reviews the current shortcomings of EMRs from a hospitalist perspective and provides recommendations for how these systems can be made more workable and efficient.

The current state of EMRs

“Numerous previous papers – including SHM’s 2017 white paper ‘Hospitalist Perspectives on Electronic Medical Records’ – have linked EMRs to decreased provider satisfaction and increased burnout related to multiple issues, including an increase in ‘screen time’ as opposed to patient ‘face-to-face’ time, and limitations in usability and interoperability,” said Rupesh Prasad, MD, SFHM, medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. “Studies have shown that most of a provider’s time spent is in areas like clinical documentation, entry of orders, and accessing patient information.”

The 2017 SHM white paper referenced by Dr. Prasad reported that 74% of hospitalists surveyed were dissatisfied with their EMR. A full one-quarter of surveyed physicians went so far as saying they would prefer switching to paper record keeping.

Other research has also found a possible link between EMRs and physician burnout and dissatisfaction. It is also not uncommon for hospitalists to spend up to 25% of their time at work using their EMR – time that should, ideally, be spent with patients.

The 2017 paper also showed that clinician notes in the United States are four times longer, on average, than notes in other countries. There are a few reasons for this – including technology design and billing requirements encouraging longer notes. Whatever the cause, however, longer notes linked to physician burnout may be partially responsible for the large amounts of time physicians spend looking at EMRs.

While EMRs may hold significant potential for hospitalists, as they are designed currently, they are simply not delivering the value many expected. The new white paper from the Healthcare Information Technology Special Interest Group outlines practical changes that could be made to EMRs to improve their use in hospitals.

The paper breaks down current issues with EMRs into five broad categories – documentation, clinical decision support, order entry, communication, and data review – to discuss how EMRs are currently failing in these areas as well as how they might be improved.

Improving EMR documentation

One of the most significant hurdles clinicians currently face lies in how EMRs currently store and display documentation. Combined with physician note-taking habits, this makes these systems much less usable than they could be. Longer notes, when displayed in current EMR UIs, mostly lead to clutter, making them harder to navigate and difficult to scan quickly for important information.

The authors identify a few different ways that future EMRs may be able to help with this problem.

EMR documentation tools will likely need to be redesigned to optimize documentation entry, standardize note formatting, and improve readability. Many electronic notes contain vestigial formatting and data left over from the design of paper notes. As a result, many of these electronic notes include information that is stored elsewhere and does not need to be explicitly included in every note. Cutting down on repetitive information storage will make important information more visible and help make patient notes easier to scan.

The paper also recommends a few other features that would make documentation more readable – like allowing clinicians to write documentation in SOAP format (subjective, objective, assessment, and plan), to facilitate critical thinking during the note-taking process, and having the EMR display that documentation in APSO format (assessment, plan, subjective, objective).

Doctors have long called for APSO or another note-taking format to replace SOAP in EMRs. Designing EMRs to rearrange SOAP notes to APSO could be a compromise that improves note readability while not requiring that clinicians learn new note-taking strategies.

The paper’s authors also recommended more extensive clinician training on writing notes. While clinicians are often taught how to write certain notes – like progress notes, histories, and physical and discharge summaries – more specific guidance is not always provided. Better training provided by institutions could help improve the quality and readability of clinician notes.

These changes, however, may not be as beneficial as possible without better institutional support for clinicians. Implementing some of the biggest changes recommended by the SHM will require some level of standardization across platforms and institution commitment to training clinicians on best use practices for EMRs. Improved responsiveness to clinician needs will require a coordinated effort with backing from both administrative and governance groups.

Expanding EMR usability

“Our white paper presents evidence-based recommendations that can be implemented at the ground level in collaboration with other stakeholders, including IT, informatics, and administration, to help improve on the current state,” Dr. Prasad said.

“We believe that hospitalists as key stakeholders in health care, have both the responsibility and are uniquely positioned to directly impact EMR functionality,” he noted. “For example, hospitalists can participate in designing appropriate, actionable alerts that would help with patient safety while also improving provider efficiency. Simple steps like limiting hard stops in order entry to would help speed up the process, and free up time for direct patient care. Availability of tools like secure text messaging would help with effective patient care team communication to improve safety and care delivery.”

EMRs often lack features like voice control and speech-to-text transcription, along with other basic accessibility features like compatibility with screen readers. Implementing these features could improve the efficiency of clinicians’ note-taking while also providing wider software usability.

EMRs are not typically designed to work with mobile devices, meaning clinicians cannot enter notes or order medications until they’ve returned to their desk or workstation.

This lack of functionality creates issues in several ways. When clinicians are unable to enter notes on the move, they will need to either keep mental notes or quickly jot down paper notes. This can effectively double the amount of note-taking that clinicians must do or introduce greater room for error. In cases where progress notes are taken throughout the day, this also means the EMR’s documentation timeline may not be accurate or usable.

Requiring clinicians to return to workstations before entering order information can also increase the risk of medication errors, which remains high despite hopes that EMRs could reduce error rates.

Adding support for cross-device and mobile EMR use could help improve the efficiency of note-taking and help cut down on error. Implementing mobile access could have a few different benefits for clinicians – like improving note-taking efficiency in hospitals, where doctors often see patients far away from their workstations.

EMRs also often lack support for certain hardware, like mobile stations and widescreen monitors, which can improve a clinician’s ability to document in real-time and are a better fit in certain work flows.

The SHM paper also recommends a few other tweaks to usability – like reducing the amount of password entry and reentry – that could make these systems easier to use and more efficient.

New features – like the use of natural language processing technology to analyze and organize information contained in clinicians’ notes – could provide further benefits and take full advantage of the advanced technologies that EMRs can integrate.

Dr. Prasad noted, however, that some of these upgrades – especially EMR compatibility with mobile devices – will require some institutional support. Bring-your-own-device policies or system-provided mobile devices will be necessary if institutions want their clinicians to be able to take advantage of mobile EMR access.

These policies will also likely require some kind of mobile device management solution to manage the security of sensitive patient data as it is accessed from personal devices. This may increase the level of necessary institutional buy-in for this support to work.

Designing EMRs with clinician needs in mind

Dr. Prasad said he and his coauthors recommend that EMR developers base more of their design on the needs of clinicians.

Currently, EMR interfaces can make important data unavailable, depending on what a clinician is trying to do. As a result, clinicians often need to rely on mental recall of important information as they navigate EMR systems.

These interfaces also typically do not support any level of user customization or process-specific interfaces, meaning every clinician is working with the same interface regardless of the tasks they need to perform or the information they need access to. Allowing for customization or implementing new process- or disease-specific interfaces could help avoid some of the problems caused by one-size-fits-all interfaces, which are not necessarily compatible with every clinician work flow.

EMR interfaces should also be designed, wherever possible, with familiar or standardized formats and the use of color coding and other techniques that can make interfaces easier to navigate quickly. Right now, many EMR systems utilize inconsistent layout design that can be cluttered with irrelevant information, slowing down interface navigation and sometimes requiring backtracking from clinicians.

Ideally, this will improve the speed of information gathering and data review, reducing the amount of time clinicians need to spend working with their EMR.

The white paper also recommends that EMR designers improve alert systems so that they are more actionable and interrupt clinicians less often – and that, when they do, they ensure that clinicians can respond to them. Designers should also reduce hard-stops or in-line alerts that halt clinicians’ work flows and require immediate responses where possible.

Increased EMR support for clinical decision support systems is one of the biggest health care trends expected to be seen throughout this decade. However, many clinicians are disappointed with the lack of flexibility and optimization of the current alerts that CDS provides. Updating and improving these knowledge-based systems will likely become essential for delivering better alerts and improving decision-making and efficiency.

Overall, EMR design should be informed by the needs of the people these products are designed to support, Dr. Prasad said. The people that work with EMRs – especially frontline staff like providers, nurses, and pharmacists that regularly interact with EMRs to provide care – should be involved early on in the EMR design process. Right now, their needs are not reflected in current EMR design. EMR companies, by working with these hospital staff members, could help improve ease of use and, ideally, prevent some of the errors associated with the current implementation of these systems.

“System designers should be able to avoid some of the most common problems of EMRs – and predict potential problems – by consistently soliciting and integrating clinician feedback during the design process and over the lifespan of a product,” Dr. Prasad said.

How EMRs can be improved

Over the past few years, EMRs have become quickly adopted by health care professionals and institutions. However, despite hopes that EMRs could significantly improve record keeping and note-taking, these systems continue to pose serious challenges for the clinicians who use them. Evidence from recent research suggests that these systems are inefficient and may contribute to physician burnout.

As a result, organizations like SHM are looking for ways that these systems can be improved.

“The growth of health IT has led to availability of large amounts of data and opportunities for applications in [artificial intelligence and machine learning,” Dr. Prasad noted. “While this has opened many avenues to help positively impact patient care and outcomes, it also poses multiple challenges like validation, customization, and governance. Hospitalists can partner with other health professions and IT leaders to work toward the common goal of improving the health of the population while also providing a positive experience to the end user.”

Another problem with current EMRs is their lack of flexibility. These systems are often not compatible with mobile devices and certain types of hardware and may be difficult or impossible to customize. They also frequently require unnecessary information during the note-taking process that results in cluttered and difficult-to-scan documentation. Improving EMR flexibility – and inviting clinicians to consult during the design process – could solve many of these problems.

New technological developments may also soon help developers improve their EMRs. In the future, as technology like natural language processing becomes more advanced and more commonly used, they may be able to make EMRs even more efficient and user friendly.

One of the most significant shifts in hospital practice over recent decades has been the widespread adoption of electronic medical records as a replacement for conventional paper records.

While EMRs show a lot of promise – having the potential to centralize and simplify clinician notes, make information more accessible and reduce paper waste – there is strong evidence that they are not working as well as they could.

Some research suggests that these systems may decrease the working efficiency of clinicians. Now, major health care institutions are looking to understand why these systems are not working — as well as how they may be improved.

A recent white paper from the Society of Hospital Medicine’s Healthcare Information Technology Special Interest Group – titled “More Caring, Less Clicking” – reviews the current shortcomings of EMRs from a hospitalist perspective and provides recommendations for how these systems can be made more workable and efficient.

The current state of EMRs

“Numerous previous papers – including SHM’s 2017 white paper ‘Hospitalist Perspectives on Electronic Medical Records’ – have linked EMRs to decreased provider satisfaction and increased burnout related to multiple issues, including an increase in ‘screen time’ as opposed to patient ‘face-to-face’ time, and limitations in usability and interoperability,” said Rupesh Prasad, MD, SFHM, medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. “Studies have shown that most of a provider’s time spent is in areas like clinical documentation, entry of orders, and accessing patient information.”

The 2017 SHM white paper referenced by Dr. Prasad reported that 74% of hospitalists surveyed were dissatisfied with their EMR. A full one-quarter of surveyed physicians went so far as saying they would prefer switching to paper record keeping.

Other research has also found a possible link between EMRs and physician burnout and dissatisfaction. It is also not uncommon for hospitalists to spend up to 25% of their time at work using their EMR – time that should, ideally, be spent with patients.

The 2017 paper also showed that clinician notes in the United States are four times longer, on average, than notes in other countries. There are a few reasons for this – including technology design and billing requirements encouraging longer notes. Whatever the cause, however, longer notes linked to physician burnout may be partially responsible for the large amounts of time physicians spend looking at EMRs.

While EMRs may hold significant potential for hospitalists, as they are designed currently, they are simply not delivering the value many expected. The new white paper from the Healthcare Information Technology Special Interest Group outlines practical changes that could be made to EMRs to improve their use in hospitals.

The paper breaks down current issues with EMRs into five broad categories – documentation, clinical decision support, order entry, communication, and data review – to discuss how EMRs are currently failing in these areas as well as how they might be improved.

Improving EMR documentation

One of the most significant hurdles clinicians currently face lies in how EMRs currently store and display documentation. Combined with physician note-taking habits, this makes these systems much less usable than they could be. Longer notes, when displayed in current EMR UIs, mostly lead to clutter, making them harder to navigate and difficult to scan quickly for important information.

The authors identify a few different ways that future EMRs may be able to help with this problem.

EMR documentation tools will likely need to be redesigned to optimize documentation entry, standardize note formatting, and improve readability. Many electronic notes contain vestigial formatting and data left over from the design of paper notes. As a result, many of these electronic notes include information that is stored elsewhere and does not need to be explicitly included in every note. Cutting down on repetitive information storage will make important information more visible and help make patient notes easier to scan.

The paper also recommends a few other features that would make documentation more readable – like allowing clinicians to write documentation in SOAP format (subjective, objective, assessment, and plan), to facilitate critical thinking during the note-taking process, and having the EMR display that documentation in APSO format (assessment, plan, subjective, objective).

Doctors have long called for APSO or another note-taking format to replace SOAP in EMRs. Designing EMRs to rearrange SOAP notes to APSO could be a compromise that improves note readability while not requiring that clinicians learn new note-taking strategies.

The paper’s authors also recommended more extensive clinician training on writing notes. While clinicians are often taught how to write certain notes – like progress notes, histories, and physical and discharge summaries – more specific guidance is not always provided. Better training provided by institutions could help improve the quality and readability of clinician notes.

These changes, however, may not be as beneficial as possible without better institutional support for clinicians. Implementing some of the biggest changes recommended by the SHM will require some level of standardization across platforms and institution commitment to training clinicians on best use practices for EMRs. Improved responsiveness to clinician needs will require a coordinated effort with backing from both administrative and governance groups.

Expanding EMR usability

“Our white paper presents evidence-based recommendations that can be implemented at the ground level in collaboration with other stakeholders, including IT, informatics, and administration, to help improve on the current state,” Dr. Prasad said.

“We believe that hospitalists as key stakeholders in health care, have both the responsibility and are uniquely positioned to directly impact EMR functionality,” he noted. “For example, hospitalists can participate in designing appropriate, actionable alerts that would help with patient safety while also improving provider efficiency. Simple steps like limiting hard stops in order entry to would help speed up the process, and free up time for direct patient care. Availability of tools like secure text messaging would help with effective patient care team communication to improve safety and care delivery.”

EMRs often lack features like voice control and speech-to-text transcription, along with other basic accessibility features like compatibility with screen readers. Implementing these features could improve the efficiency of clinicians’ note-taking while also providing wider software usability.

EMRs are not typically designed to work with mobile devices, meaning clinicians cannot enter notes or order medications until they’ve returned to their desk or workstation.

This lack of functionality creates issues in several ways. When clinicians are unable to enter notes on the move, they will need to either keep mental notes or quickly jot down paper notes. This can effectively double the amount of note-taking that clinicians must do or introduce greater room for error. In cases where progress notes are taken throughout the day, this also means the EMR’s documentation timeline may not be accurate or usable.

Requiring clinicians to return to workstations before entering order information can also increase the risk of medication errors, which remains high despite hopes that EMRs could reduce error rates.

Adding support for cross-device and mobile EMR use could help improve the efficiency of note-taking and help cut down on error. Implementing mobile access could have a few different benefits for clinicians – like improving note-taking efficiency in hospitals, where doctors often see patients far away from their workstations.

EMRs also often lack support for certain hardware, like mobile stations and widescreen monitors, which can improve a clinician’s ability to document in real-time and are a better fit in certain work flows.

The SHM paper also recommends a few other tweaks to usability – like reducing the amount of password entry and reentry – that could make these systems easier to use and more efficient.

New features – like the use of natural language processing technology to analyze and organize information contained in clinicians’ notes – could provide further benefits and take full advantage of the advanced technologies that EMRs can integrate.

Dr. Prasad noted, however, that some of these upgrades – especially EMR compatibility with mobile devices – will require some institutional support. Bring-your-own-device policies or system-provided mobile devices will be necessary if institutions want their clinicians to be able to take advantage of mobile EMR access.

These policies will also likely require some kind of mobile device management solution to manage the security of sensitive patient data as it is accessed from personal devices. This may increase the level of necessary institutional buy-in for this support to work.

Designing EMRs with clinician needs in mind

Dr. Prasad said he and his coauthors recommend that EMR developers base more of their design on the needs of clinicians.

Currently, EMR interfaces can make important data unavailable, depending on what a clinician is trying to do. As a result, clinicians often need to rely on mental recall of important information as they navigate EMR systems.

These interfaces also typically do not support any level of user customization or process-specific interfaces, meaning every clinician is working with the same interface regardless of the tasks they need to perform or the information they need access to. Allowing for customization or implementing new process- or disease-specific interfaces could help avoid some of the problems caused by one-size-fits-all interfaces, which are not necessarily compatible with every clinician work flow.

EMR interfaces should also be designed, wherever possible, with familiar or standardized formats and the use of color coding and other techniques that can make interfaces easier to navigate quickly. Right now, many EMR systems utilize inconsistent layout design that can be cluttered with irrelevant information, slowing down interface navigation and sometimes requiring backtracking from clinicians.

Ideally, this will improve the speed of information gathering and data review, reducing the amount of time clinicians need to spend working with their EMR.

The white paper also recommends that EMR designers improve alert systems so that they are more actionable and interrupt clinicians less often – and that, when they do, they ensure that clinicians can respond to them. Designers should also reduce hard-stops or in-line alerts that halt clinicians’ work flows and require immediate responses where possible.

Increased EMR support for clinical decision support systems is one of the biggest health care trends expected to be seen throughout this decade. However, many clinicians are disappointed with the lack of flexibility and optimization of the current alerts that CDS provides. Updating and improving these knowledge-based systems will likely become essential for delivering better alerts and improving decision-making and efficiency.

Overall, EMR design should be informed by the needs of the people these products are designed to support, Dr. Prasad said. The people that work with EMRs – especially frontline staff like providers, nurses, and pharmacists that regularly interact with EMRs to provide care – should be involved early on in the EMR design process. Right now, their needs are not reflected in current EMR design. EMR companies, by working with these hospital staff members, could help improve ease of use and, ideally, prevent some of the errors associated with the current implementation of these systems.

“System designers should be able to avoid some of the most common problems of EMRs – and predict potential problems – by consistently soliciting and integrating clinician feedback during the design process and over the lifespan of a product,” Dr. Prasad said.

How EMRs can be improved

Over the past few years, EMRs have become quickly adopted by health care professionals and institutions. However, despite hopes that EMRs could significantly improve record keeping and note-taking, these systems continue to pose serious challenges for the clinicians who use them. Evidence from recent research suggests that these systems are inefficient and may contribute to physician burnout.

As a result, organizations like SHM are looking for ways that these systems can be improved.

“The growth of health IT has led to availability of large amounts of data and opportunities for applications in [artificial intelligence and machine learning,” Dr. Prasad noted. “While this has opened many avenues to help positively impact patient care and outcomes, it also poses multiple challenges like validation, customization, and governance. Hospitalists can partner with other health professions and IT leaders to work toward the common goal of improving the health of the population while also providing a positive experience to the end user.”

Another problem with current EMRs is their lack of flexibility. These systems are often not compatible with mobile devices and certain types of hardware and may be difficult or impossible to customize. They also frequently require unnecessary information during the note-taking process that results in cluttered and difficult-to-scan documentation. Improving EMR flexibility – and inviting clinicians to consult during the design process – could solve many of these problems.

New technological developments may also soon help developers improve their EMRs. In the future, as technology like natural language processing becomes more advanced and more commonly used, they may be able to make EMRs even more efficient and user friendly.

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

A group of experts representing various international professional societies has drafted a consensus statement on the determination of brain death or death by neurologic criteria (BD/DNC). The document, a result of the World Brain Death Project, surveys the clinical aspects of this determination, such as clinical testing, apnea testing, and the number of examinations required, as well as its social and legal aspects, including documentation, qualifications for making the determination, and religious attitudes toward BD/DNC.

The recommendations are the minimum criteria for BD/DNC, and countries and professional societies may choose to adopt stricter criteria, the authors noted. Seventeen supplements to the consensus statement contain detailed reports on topics the statement examines, including focuses on both adults and children.

“Perhaps the most important points of this project are, first, to show the worldwide acceptance of the concept of BD/DNC and what the minimum requirements are for BD/DNC,” said corresponding author Gene Sung, MD, MPH, director of the neurocritical care and stroke division at the University of Southern California, Los Angeles. Second, “this standard is centered around a clinical determination without the need for other testing.”

The consensus document and supplements were published online Aug. 3 in JAMA.

Comprehensive review

A lack of rigor has led to many differences in the determination of BD/DNC, said Dr. Sung. “Some of the variance that is common are the numbers of exams and examiners that are required and whether ancillary tests are required for determination of BD/DNC. In addition, a lot of guidelines and protocols that are in use are not thorough in detailing how to do the examinations and what to do in different circumstances.”

Professional societies such as the World Federation of Intensive and Critical Care recruited experts in BD/DNC to develop recommendations, which were based on relevant articles that they identified during a literature search. “We wanted to develop a fairly comprehensive document that, along with the 17 supplements, builds a foundation to show how to determine BD/DNC – what the minimum clinical criteria needed are and what to do in special circumstances,” Dr. Sung said.

Major sections of the statement include recommendations for the minimum clinical standards for the determination of BD/DNC in adults and children.

Determination must begin by establishing that the patient has sustained an irreversible brain injury that resulted in the loss of all brain function, according to the authors. Confounders such as pharmacologic paralysis and the effect of CNS depressant medications should be ruled out.

In addition, clinical evaluation must include an assessment for coma and an evaluation for brain stem areflexia. Among other criteria, the pupils should be fixed and nonresponsive to light, the face should not move in response to noxious cranial stimulation, and the gag and cough reflexes should be absent. Apnea testing is recommended to evaluate the responsiveness of respiratory centers in the medulla.

Although the definition of BD/DNC is the same in children as in adults, less evidence is available for the determination of BD/DNC in the very young. The authors thus advised a cautious approach to the evaluation of infants and younger children.

Recommendations vary by age and often require serial examinations, including apnea testing, they noted.

Ancillary testing

The consensus statement also reviews ancillary testing, which the authors recommend be required when the minimum clinical examination, including the apnea test, cannot be completed and when it is in the presence of confounding conditions that cannot be resolved.

The authors recommended digital subtraction angiography, radionuclide studies, and transcranial Doppler ultrasonography as ancillary tests based on blood flow in the brain. However, CT angiography and magnetic resonance angiography not be used.

A lack of guidance makes performing an apnea test in patients receiving extracorporeal membrane oxygenation (ECMO) challenging, according to the authors. Nevertheless, they recommended that the same principles of BD/DNC be applied to adults and children receiving ECMO.

They further recommended a period of preoxygenation before the apnea test, and the document describes in detail the method for administering this test to people receiving ECMO.

Another potentially challenging situation pointed out in the consensus document is the determination of BD/DNC in patients who have been treated with targeted temperature management. Therapeutic hypothermia, particularly if it is preceded or accompanied by sedation, can temporarily impair brain stem reflexes, thus mimicking BD/DNC.

The new document includes a flowchart and step-by-step recommendations as well as suggestions for determining BD/DNC under these circumstances.

Among document limitations acknowledged by the authors is the lack of high-quality data from randomized, controlled trials on which to base their recommendations.

In addition, economic, technological, or personnel limitations may reduce the available options for ancillary testing, they added. Also, the recommendations do not incorporate contributions from patients or social or religious groups, although the authors were mindful of their concerns.

To promote the national and international harmonization of BD/DNC criteria, “medical societies and countries can evaluate their own policies in relation to this document and fix any deficiencies,” Dr. Sung said.

“Many countries do not have any BD/DNC policies and can use the documents from this project to create their own. There may need to be discussions with legal, governmental, religious, and societal leaders to help understand and accept BD/DNC and to help enact policies in different communities,” he added.

Divergent definitions

The determination of death is not simply a scientific question, but also a philosophical, religious, and cultural question, wrote Robert D. Truog, MD, director of the Harvard Center for Bioethics, Boston, and colleagues in an accompanying editorial. Future research should consider cultural differences over these questions.

“Most important is that there be a clear and logical consistency between the definition of death and the tests that are used to diagnose it,” Dr. Truog said.

The concept of whole brain death was advanced as an equivalent to biological death, “such that, when the brain dies, the body literally disintegrates, just as it does after cardiac arrest,” but evidence indicates that this claim is untrue, Dr. Truog said. Current tests also do not diagnose the death of the whole brain.

Another hypothesis is that brain stem death represents the irreversible loss of consciousness and the capacity for spontaneous respiration.

“Instead of focusing on biology, [this definition] focuses on values and is based on the claim that when a person is in a state of irreversible apneic unconsciousness, we may consider them to be dead,” said Dr. Truog. He and his coeditorialists argued that the concept of whole brain death should be replaced with that of brain stem death.

“This report should be a call for our profession, as well as for federal and state lawmakers, to reform our laws so that they are consistent with our diagnostic criteria,” Dr. Truog said.

“The most straightforward way of doing this would be to change U.S. law and adopt the British standard of brain stem death, and then refine our testing to make the diagnosis of irreversible apneic unconsciousness as reliable and safe as possible,” he concluded.

The drafting of the consensus statement was not supported by outside funding. Dr. Sung reported no relevant financial relationships. Dr. Truog reported receiving compensation from Sanofi and Covance for participating in data and safety monitoring boards unrelated to the consensus document.

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

A group of experts representing various international professional societies has drafted a consensus statement on the determination of brain death or death by neurologic criteria (BD/DNC). The document, a result of the World Brain Death Project, surveys the clinical aspects of this determination, such as clinical testing, apnea testing, and the number of examinations required, as well as its social and legal aspects, including documentation, qualifications for making the determination, and religious attitudes toward BD/DNC.

The recommendations are the minimum criteria for BD/DNC, and countries and professional societies may choose to adopt stricter criteria, the authors noted. Seventeen supplements to the consensus statement contain detailed reports on topics the statement examines, including focuses on both adults and children.

“Perhaps the most important points of this project are, first, to show the worldwide acceptance of the concept of BD/DNC and what the minimum requirements are for BD/DNC,” said corresponding author Gene Sung, MD, MPH, director of the neurocritical care and stroke division at the University of Southern California, Los Angeles. Second, “this standard is centered around a clinical determination without the need for other testing.”

The consensus document and supplements were published online Aug. 3 in JAMA.

Comprehensive review

A lack of rigor has led to many differences in the determination of BD/DNC, said Dr. Sung. “Some of the variance that is common are the numbers of exams and examiners that are required and whether ancillary tests are required for determination of BD/DNC. In addition, a lot of guidelines and protocols that are in use are not thorough in detailing how to do the examinations and what to do in different circumstances.”

Professional societies such as the World Federation of Intensive and Critical Care recruited experts in BD/DNC to develop recommendations, which were based on relevant articles that they identified during a literature search. “We wanted to develop a fairly comprehensive document that, along with the 17 supplements, builds a foundation to show how to determine BD/DNC – what the minimum clinical criteria needed are and what to do in special circumstances,” Dr. Sung said.

Major sections of the statement include recommendations for the minimum clinical standards for the determination of BD/DNC in adults and children.

Determination must begin by establishing that the patient has sustained an irreversible brain injury that resulted in the loss of all brain function, according to the authors. Confounders such as pharmacologic paralysis and the effect of CNS depressant medications should be ruled out.

In addition, clinical evaluation must include an assessment for coma and an evaluation for brain stem areflexia. Among other criteria, the pupils should be fixed and nonresponsive to light, the face should not move in response to noxious cranial stimulation, and the gag and cough reflexes should be absent. Apnea testing is recommended to evaluate the responsiveness of respiratory centers in the medulla.

Although the definition of BD/DNC is the same in children as in adults, less evidence is available for the determination of BD/DNC in the very young. The authors thus advised a cautious approach to the evaluation of infants and younger children.

Recommendations vary by age and often require serial examinations, including apnea testing, they noted.

Ancillary testing

The consensus statement also reviews ancillary testing, which the authors recommend be required when the minimum clinical examination, including the apnea test, cannot be completed and when it is in the presence of confounding conditions that cannot be resolved.

The authors recommended digital subtraction angiography, radionuclide studies, and transcranial Doppler ultrasonography as ancillary tests based on blood flow in the brain. However, CT angiography and magnetic resonance angiography not be used.

A lack of guidance makes performing an apnea test in patients receiving extracorporeal membrane oxygenation (ECMO) challenging, according to the authors. Nevertheless, they recommended that the same principles of BD/DNC be applied to adults and children receiving ECMO.

They further recommended a period of preoxygenation before the apnea test, and the document describes in detail the method for administering this test to people receiving ECMO.

Another potentially challenging situation pointed out in the consensus document is the determination of BD/DNC in patients who have been treated with targeted temperature management. Therapeutic hypothermia, particularly if it is preceded or accompanied by sedation, can temporarily impair brain stem reflexes, thus mimicking BD/DNC.

The new document includes a flowchart and step-by-step recommendations as well as suggestions for determining BD/DNC under these circumstances.

Among document limitations acknowledged by the authors is the lack of high-quality data from randomized, controlled trials on which to base their recommendations.

In addition, economic, technological, or personnel limitations may reduce the available options for ancillary testing, they added. Also, the recommendations do not incorporate contributions from patients or social or religious groups, although the authors were mindful of their concerns.

To promote the national and international harmonization of BD/DNC criteria, “medical societies and countries can evaluate their own policies in relation to this document and fix any deficiencies,” Dr. Sung said.

“Many countries do not have any BD/DNC policies and can use the documents from this project to create their own. There may need to be discussions with legal, governmental, religious, and societal leaders to help understand and accept BD/DNC and to help enact policies in different communities,” he added.

Divergent definitions

The determination of death is not simply a scientific question, but also a philosophical, religious, and cultural question, wrote Robert D. Truog, MD, director of the Harvard Center for Bioethics, Boston, and colleagues in an accompanying editorial. Future research should consider cultural differences over these questions.

“Most important is that there be a clear and logical consistency between the definition of death and the tests that are used to diagnose it,” Dr. Truog said.

The concept of whole brain death was advanced as an equivalent to biological death, “such that, when the brain dies, the body literally disintegrates, just as it does after cardiac arrest,” but evidence indicates that this claim is untrue, Dr. Truog said. Current tests also do not diagnose the death of the whole brain.

Another hypothesis is that brain stem death represents the irreversible loss of consciousness and the capacity for spontaneous respiration.

“Instead of focusing on biology, [this definition] focuses on values and is based on the claim that when a person is in a state of irreversible apneic unconsciousness, we may consider them to be dead,” said Dr. Truog. He and his coeditorialists argued that the concept of whole brain death should be replaced with that of brain stem death.

“This report should be a call for our profession, as well as for federal and state lawmakers, to reform our laws so that they are consistent with our diagnostic criteria,” Dr. Truog said.

“The most straightforward way of doing this would be to change U.S. law and adopt the British standard of brain stem death, and then refine our testing to make the diagnosis of irreversible apneic unconsciousness as reliable and safe as possible,” he concluded.

The drafting of the consensus statement was not supported by outside funding. Dr. Sung reported no relevant financial relationships. Dr. Truog reported receiving compensation from Sanofi and Covance for participating in data and safety monitoring boards unrelated to the consensus document.

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

A group of experts representing various international professional societies has drafted a consensus statement on the determination of brain death or death by neurologic criteria (BD/DNC). The document, a result of the World Brain Death Project, surveys the clinical aspects of this determination, such as clinical testing, apnea testing, and the number of examinations required, as well as its social and legal aspects, including documentation, qualifications for making the determination, and religious attitudes toward BD/DNC.

The recommendations are the minimum criteria for BD/DNC, and countries and professional societies may choose to adopt stricter criteria, the authors noted. Seventeen supplements to the consensus statement contain detailed reports on topics the statement examines, including focuses on both adults and children.

“Perhaps the most important points of this project are, first, to show the worldwide acceptance of the concept of BD/DNC and what the minimum requirements are for BD/DNC,” said corresponding author Gene Sung, MD, MPH, director of the neurocritical care and stroke division at the University of Southern California, Los Angeles. Second, “this standard is centered around a clinical determination without the need for other testing.”

The consensus document and supplements were published online Aug. 3 in JAMA.

Comprehensive review

A lack of rigor has led to many differences in the determination of BD/DNC, said Dr. Sung. “Some of the variance that is common are the numbers of exams and examiners that are required and whether ancillary tests are required for determination of BD/DNC. In addition, a lot of guidelines and protocols that are in use are not thorough in detailing how to do the examinations and what to do in different circumstances.”

Professional societies such as the World Federation of Intensive and Critical Care recruited experts in BD/DNC to develop recommendations, which were based on relevant articles that they identified during a literature search. “We wanted to develop a fairly comprehensive document that, along with the 17 supplements, builds a foundation to show how to determine BD/DNC – what the minimum clinical criteria needed are and what to do in special circumstances,” Dr. Sung said.

Major sections of the statement include recommendations for the minimum clinical standards for the determination of BD/DNC in adults and children.

Determination must begin by establishing that the patient has sustained an irreversible brain injury that resulted in the loss of all brain function, according to the authors. Confounders such as pharmacologic paralysis and the effect of CNS depressant medications should be ruled out.

In addition, clinical evaluation must include an assessment for coma and an evaluation for brain stem areflexia. Among other criteria, the pupils should be fixed and nonresponsive to light, the face should not move in response to noxious cranial stimulation, and the gag and cough reflexes should be absent. Apnea testing is recommended to evaluate the responsiveness of respiratory centers in the medulla.

Although the definition of BD/DNC is the same in children as in adults, less evidence is available for the determination of BD/DNC in the very young. The authors thus advised a cautious approach to the evaluation of infants and younger children.

Recommendations vary by age and often require serial examinations, including apnea testing, they noted.

Ancillary testing

The consensus statement also reviews ancillary testing, which the authors recommend be required when the minimum clinical examination, including the apnea test, cannot be completed and when it is in the presence of confounding conditions that cannot be resolved.

The authors recommended digital subtraction angiography, radionuclide studies, and transcranial Doppler ultrasonography as ancillary tests based on blood flow in the brain. However, CT angiography and magnetic resonance angiography not be used.

A lack of guidance makes performing an apnea test in patients receiving extracorporeal membrane oxygenation (ECMO) challenging, according to the authors. Nevertheless, they recommended that the same principles of BD/DNC be applied to adults and children receiving ECMO.

They further recommended a period of preoxygenation before the apnea test, and the document describes in detail the method for administering this test to people receiving ECMO.

Another potentially challenging situation pointed out in the consensus document is the determination of BD/DNC in patients who have been treated with targeted temperature management. Therapeutic hypothermia, particularly if it is preceded or accompanied by sedation, can temporarily impair brain stem reflexes, thus mimicking BD/DNC.

The new document includes a flowchart and step-by-step recommendations as well as suggestions for determining BD/DNC under these circumstances.

Among document limitations acknowledged by the authors is the lack of high-quality data from randomized, controlled trials on which to base their recommendations.

In addition, economic, technological, or personnel limitations may reduce the available options for ancillary testing, they added. Also, the recommendations do not incorporate contributions from patients or social or religious groups, although the authors were mindful of their concerns.

To promote the national and international harmonization of BD/DNC criteria, “medical societies and countries can evaluate their own policies in relation to this document and fix any deficiencies,” Dr. Sung said.

“Many countries do not have any BD/DNC policies and can use the documents from this project to create their own. There may need to be discussions with legal, governmental, religious, and societal leaders to help understand and accept BD/DNC and to help enact policies in different communities,” he added.

Divergent definitions

The determination of death is not simply a scientific question, but also a philosophical, religious, and cultural question, wrote Robert D. Truog, MD, director of the Harvard Center for Bioethics, Boston, and colleagues in an accompanying editorial. Future research should consider cultural differences over these questions.

“Most important is that there be a clear and logical consistency between the definition of death and the tests that are used to diagnose it,” Dr. Truog said.

The concept of whole brain death was advanced as an equivalent to biological death, “such that, when the brain dies, the body literally disintegrates, just as it does after cardiac arrest,” but evidence indicates that this claim is untrue, Dr. Truog said. Current tests also do not diagnose the death of the whole brain.

Another hypothesis is that brain stem death represents the irreversible loss of consciousness and the capacity for spontaneous respiration.

“Instead of focusing on biology, [this definition] focuses on values and is based on the claim that when a person is in a state of irreversible apneic unconsciousness, we may consider them to be dead,” said Dr. Truog. He and his coeditorialists argued that the concept of whole brain death should be replaced with that of brain stem death.

“This report should be a call for our profession, as well as for federal and state lawmakers, to reform our laws so that they are consistent with our diagnostic criteria,” Dr. Truog said.

“The most straightforward way of doing this would be to change U.S. law and adopt the British standard of brain stem death, and then refine our testing to make the diagnosis of irreversible apneic unconsciousness as reliable and safe as possible,” he concluded.

The drafting of the consensus statement was not supported by outside funding. Dr. Sung reported no relevant financial relationships. Dr. Truog reported receiving compensation from Sanofi and Covance for participating in data and safety monitoring boards unrelated to the consensus document.

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

Resident wellness is a topic that has become increasingly important in recent years due to physician burnout. A prior Cutis Resident Corner column discussed the prevalence of physician burnout and how it can affect dermatologists.¹ When discussing resident burnout, dermatology may not be a specialty that immediately comes to mind, considering that dermatology is mostly outpatient based, with few emergencies and critically ill patients. In a JAMA study assessing levels of burnout by specialty, dermatology residents were the lowest at approximately 30%.² However, this still means that 3 out of every 10 dermatology residents feel burnt out.

Burnout in Dermatology

In 2017, results from a survey of 112 dermatology residents in Canada about burnout was published in the British Journal of Dermatology.³ The numbers were staggering; the results showed that more than 50% of dermatology residents experienced high levels of emotional exhaustion and depersonalization, and 40% had low levels of personal accomplishment. Additionally, 52% experienced low or depressed mood, 20% reported feelings of hurting themselves within the last year, and more than 25% had high anxiety levels.³

Dermatology requires a high level of daily studying, which is a major source of stress for many dermatology residents. The survey of dermatology residents in Canada showed that the top stressor for 61% of survey respondents was studying, specifically for the board examination.³ Dermatology is an academically rigorous specialty. We are responsible for recognizing every disease process affecting the skin, including hundreds that are extremely uncommon. We must understand these disease processes at a molecular level from a basic science standpoint and at a microscopic level through our knowledge of dermatopathology. Much of what we see in clinic are bread-and-butter dermatologic conditions that do not necessarily correlate with the rare diseases that we study. This differs from other specialties in which residents learn much of their specialty knowledge through their clinical work.

Current Challenges

We are training in a uniquely challenging time, providing care for our patients amid the coronavirus disease 2019 pandemic. Many of us are dealing with constant levels of stress and worry about the health and safety of ourselves, along with our friends, families, and patients. Some residents have been redeployed to work in unfamiliar roles in the emergency department or hospital wards, while others adjust to new roles in teledermatology. I also cannot talk about resident wellness without recognizing the challenges faced by physicians who are racial and religious minorities. This is especially true for black physicians, as they face unconscious biases and microaggressions daily derived from implicit racism; this leads to discrimination in every area of life and ultimately harms their emotional and psychological well-being.⁴ Additionally, black physicians are underrepresented in dermatology, making up only 4.3% of dermatology residents in the 2013-2014 academic year.^5,6 Underrepresentation can serve as a major stressor for racial and religious minorities and should be considered when addressing resident wellness to ensure their voices are heard and validated.

Focusing on Wellness

What can we do to improve wellness? A viewpoint published in JAMA Surgery in 2015 by Salles et al⁷ from the Stanford University Department of Surgery (Stanford, California) discussed their Balance in Life (BIL) program, which was established after one of their residency graduates tragically died by suicide shortly after graduating from residency. The BIL program addresses 4 different facets of well-being—professional, physical, psychological, and social—and lists the specific actions taken to improve these areas of well-being.⁷

I completed my transitional year residency at St. Vincent Hospital (Indianapolis, Indiana). The program emphasizes the importance of resident wellness. They established a department-sponsored well-being program to improve resident wellness,⁸ with its objectives aligning with the 4 areas of well-being that were outlined in the Stanford viewpoint.⁷ A short Q&A with me was published in the supplemental material as a way of highlighting their residents.⁹ I will outline the 4 areas of well-being, with suggestions based on the Stanford BIL program, the well-being innovation program at St. Vincent, and initiatives at my current dermatology residency program at the University of Wisconsin (UW) in Madison.

The 4 Areas of Well-being

Professional Well-being

Stanford BIL Program
One of the changes implemented was starting a resident mentorship program. Each junior resident selects a senior resident as a mentor with department-sponsored quarterly lunch meetings.⁷ Another initiative is a leadership training program, which includes an outdoor rope course each year focusing on leadership and team building.⁷

UW Dermatology
Monthly meetings are held with our program director and coordinator so that we can address any concerns or issues as they arise and brainstorm solutions together. During the coronavirus disease 2019 pandemic, we had weekly resident town halls with department leadership with transparency about our institution’s current status.

Physical Well-being

Stanford BIL Program
One method of improving physical well-being included stocking healthy snacks for residents and providing incoming residents with a guide of physicians, dentists, and fitness venues to promote regular health care. We have adopted the same at UW with healthy snacks available in our resident workroom.

St. Vincent Internal Medicine Wellness
There are monthly fitness challenges for a variety of physical wellness activities such as sleep, mindfulness minutes, nutrition, and step challenges.⁸

UW Dermatology
In addition to healthy snacks in our workroom, we also have various discounted fitness classes available for employees, along with discounts on gym memberships, kayak rentals, and city bike-share programs.

Psychological Well-Being

Stanford BIL Program
They enlisted a clinical psychologist available for residents to talk to regularly about any issues they face and to help manage stress in their lives.⁷

St. Vincent Internal Medicine Wellness
Faculty and coordinators provide S.A.F.E.—secure, affirming, friendly, and empathetic—zones to provide confidential and judgment-free support for residents.⁸ They also host photography competitions; residents submit photographs of nature, and the winning photographs are printed and displayed throughout the work area.

UW Dermatology
We have made changes to beautify our resident workroom with photograph collages of residents and other assorted décor to make it a more work-friendly space.

Social Well-being

Common themes highlighted by all 3 programs include the importance of socializing outside of the workplace, team-building activities, and resident retreats. Social media accounts on Instagram at St. Vincent (@stvimresidency) and at UW (@uwderm) highlight resident accomplishments and promote interconnectedness when residents are not together in clinics or hospitals.

Final Thoughts

Resident wellness will continue to be an important topic for discussion in the future, especially given the uncertain times right now during our training. Focusing on the 4 areas of well-being can help to prevent burnout and improve resident wellness.

Resident wellness is a topic that has become increasingly important in recent years due to physician burnout. A prior Cutis Resident Corner column discussed the prevalence of physician burnout and how it can affect dermatologists.¹ When discussing resident burnout, dermatology may not be a specialty that immediately comes to mind, considering that dermatology is mostly outpatient based, with few emergencies and critically ill patients. In a JAMA study assessing levels of burnout by specialty, dermatology residents were the lowest at approximately 30%.² However, this still means that 3 out of every 10 dermatology residents feel burnt out.

Burnout in Dermatology

In 2017, results from a survey of 112 dermatology residents in Canada about burnout was published in the British Journal of Dermatology.³ The numbers were staggering; the results showed that more than 50% of dermatology residents experienced high levels of emotional exhaustion and depersonalization, and 40% had low levels of personal accomplishment. Additionally, 52% experienced low or depressed mood, 20% reported feelings of hurting themselves within the last year, and more than 25% had high anxiety levels.³

Dermatology requires a high level of daily studying, which is a major source of stress for many dermatology residents. The survey of dermatology residents in Canada showed that the top stressor for 61% of survey respondents was studying, specifically for the board examination.³ Dermatology is an academically rigorous specialty. We are responsible for recognizing every disease process affecting the skin, including hundreds that are extremely uncommon. We must understand these disease processes at a molecular level from a basic science standpoint and at a microscopic level through our knowledge of dermatopathology. Much of what we see in clinic are bread-and-butter dermatologic conditions that do not necessarily correlate with the rare diseases that we study. This differs from other specialties in which residents learn much of their specialty knowledge through their clinical work.

Current Challenges

We are training in a uniquely challenging time, providing care for our patients amid the coronavirus disease 2019 pandemic. Many of us are dealing with constant levels of stress and worry about the health and safety of ourselves, along with our friends, families, and patients. Some residents have been redeployed to work in unfamiliar roles in the emergency department or hospital wards, while others adjust to new roles in teledermatology. I also cannot talk about resident wellness without recognizing the challenges faced by physicians who are racial and religious minorities. This is especially true for black physicians, as they face unconscious biases and microaggressions daily derived from implicit racism; this leads to discrimination in every area of life and ultimately harms their emotional and psychological well-being.⁴ Additionally, black physicians are underrepresented in dermatology, making up only 4.3% of dermatology residents in the 2013-2014 academic year.^5,6 Underrepresentation can serve as a major stressor for racial and religious minorities and should be considered when addressing resident wellness to ensure their voices are heard and validated.

Focusing on Wellness

What can we do to improve wellness? A viewpoint published in JAMA Surgery in 2015 by Salles et al⁷ from the Stanford University Department of Surgery (Stanford, California) discussed their Balance in Life (BIL) program, which was established after one of their residency graduates tragically died by suicide shortly after graduating from residency. The BIL program addresses 4 different facets of well-being—professional, physical, psychological, and social—and lists the specific actions taken to improve these areas of well-being.⁷

I completed my transitional year residency at St. Vincent Hospital (Indianapolis, Indiana). The program emphasizes the importance of resident wellness. They established a department-sponsored well-being program to improve resident wellness,⁸ with its objectives aligning with the 4 areas of well-being that were outlined in the Stanford viewpoint.⁷ A short Q&A with me was published in the supplemental material as a way of highlighting their residents.⁹ I will outline the 4 areas of well-being, with suggestions based on the Stanford BIL program, the well-being innovation program at St. Vincent, and initiatives at my current dermatology residency program at the University of Wisconsin (UW) in Madison.

The 4 Areas of Well-being

Professional Well-being

Stanford BIL Program
One of the changes implemented was starting a resident mentorship program. Each junior resident selects a senior resident as a mentor with department-sponsored quarterly lunch meetings.⁷ Another initiative is a leadership training program, which includes an outdoor rope course each year focusing on leadership and team building.⁷

UW Dermatology
Monthly meetings are held with our program director and coordinator so that we can address any concerns or issues as they arise and brainstorm solutions together. During the coronavirus disease 2019 pandemic, we had weekly resident town halls with department leadership with transparency about our institution’s current status.

Physical Well-being

Stanford BIL Program
One method of improving physical well-being included stocking healthy snacks for residents and providing incoming residents with a guide of physicians, dentists, and fitness venues to promote regular health care. We have adopted the same at UW with healthy snacks available in our resident workroom.

St. Vincent Internal Medicine Wellness
There are monthly fitness challenges for a variety of physical wellness activities such as sleep, mindfulness minutes, nutrition, and step challenges.⁸

UW Dermatology
In addition to healthy snacks in our workroom, we also have various discounted fitness classes available for employees, along with discounts on gym memberships, kayak rentals, and city bike-share programs.

Psychological Well-Being

Stanford BIL Program
They enlisted a clinical psychologist available for residents to talk to regularly about any issues they face and to help manage stress in their lives.⁷

St. Vincent Internal Medicine Wellness
Faculty and coordinators provide S.A.F.E.—secure, affirming, friendly, and empathetic—zones to provide confidential and judgment-free support for residents.⁸ They also host photography competitions; residents submit photographs of nature, and the winning photographs are printed and displayed throughout the work area.

UW Dermatology
We have made changes to beautify our resident workroom with photograph collages of residents and other assorted décor to make it a more work-friendly space.

Social Well-being

Common themes highlighted by all 3 programs include the importance of socializing outside of the workplace, team-building activities, and resident retreats. Social media accounts on Instagram at St. Vincent (@stvimresidency) and at UW (@uwderm) highlight resident accomplishments and promote interconnectedness when residents are not together in clinics or hospitals.

Final Thoughts

Resident wellness will continue to be an important topic for discussion in the future, especially given the uncertain times right now during our training. Focusing on the 4 areas of well-being can help to prevent burnout and improve resident wellness.

Resident wellness is a topic that has become increasingly important in recent years due to physician burnout. A prior Cutis Resident Corner column discussed the prevalence of physician burnout and how it can affect dermatologists.¹ When discussing resident burnout, dermatology may not be a specialty that immediately comes to mind, considering that dermatology is mostly outpatient based, with few emergencies and critically ill patients. In a JAMA study assessing levels of burnout by specialty, dermatology residents were the lowest at approximately 30%.² However, this still means that 3 out of every 10 dermatology residents feel burnt out.

Burnout in Dermatology

In 2017, results from a survey of 112 dermatology residents in Canada about burnout was published in the British Journal of Dermatology.³ The numbers were staggering; the results showed that more than 50% of dermatology residents experienced high levels of emotional exhaustion and depersonalization, and 40% had low levels of personal accomplishment. Additionally, 52% experienced low or depressed mood, 20% reported feelings of hurting themselves within the last year, and more than 25% had high anxiety levels.³

Dermatology requires a high level of daily studying, which is a major source of stress for many dermatology residents. The survey of dermatology residents in Canada showed that the top stressor for 61% of survey respondents was studying, specifically for the board examination.³ Dermatology is an academically rigorous specialty. We are responsible for recognizing every disease process affecting the skin, including hundreds that are extremely uncommon. We must understand these disease processes at a molecular level from a basic science standpoint and at a microscopic level through our knowledge of dermatopathology. Much of what we see in clinic are bread-and-butter dermatologic conditions that do not necessarily correlate with the rare diseases that we study. This differs from other specialties in which residents learn much of their specialty knowledge through their clinical work.

Current Challenges

We are training in a uniquely challenging time, providing care for our patients amid the coronavirus disease 2019 pandemic. Many of us are dealing with constant levels of stress and worry about the health and safety of ourselves, along with our friends, families, and patients. Some residents have been redeployed to work in unfamiliar roles in the emergency department or hospital wards, while others adjust to new roles in teledermatology. I also cannot talk about resident wellness without recognizing the challenges faced by physicians who are racial and religious minorities. This is especially true for black physicians, as they face unconscious biases and microaggressions daily derived from implicit racism; this leads to discrimination in every area of life and ultimately harms their emotional and psychological well-being.⁴ Additionally, black physicians are underrepresented in dermatology, making up only 4.3% of dermatology residents in the 2013-2014 academic year.^5,6 Underrepresentation can serve as a major stressor for racial and religious minorities and should be considered when addressing resident wellness to ensure their voices are heard and validated.

Focusing on Wellness

What can we do to improve wellness? A viewpoint published in JAMA Surgery in 2015 by Salles et al⁷ from the Stanford University Department of Surgery (Stanford, California) discussed their Balance in Life (BIL) program, which was established after one of their residency graduates tragically died by suicide shortly after graduating from residency. The BIL program addresses 4 different facets of well-being—professional, physical, psychological, and social—and lists the specific actions taken to improve these areas of well-being.⁷

I completed my transitional year residency at St. Vincent Hospital (Indianapolis, Indiana). The program emphasizes the importance of resident wellness. They established a department-sponsored well-being program to improve resident wellness,⁸ with its objectives aligning with the 4 areas of well-being that were outlined in the Stanford viewpoint.⁷ A short Q&A with me was published in the supplemental material as a way of highlighting their residents.⁹ I will outline the 4 areas of well-being, with suggestions based on the Stanford BIL program, the well-being innovation program at St. Vincent, and initiatives at my current dermatology residency program at the University of Wisconsin (UW) in Madison.

The 4 Areas of Well-being

Professional Well-being

Stanford BIL Program
One of the changes implemented was starting a resident mentorship program. Each junior resident selects a senior resident as a mentor with department-sponsored quarterly lunch meetings.⁷ Another initiative is a leadership training program, which includes an outdoor rope course each year focusing on leadership and team building.⁷

UW Dermatology
Monthly meetings are held with our program director and coordinator so that we can address any concerns or issues as they arise and brainstorm solutions together. During the coronavirus disease 2019 pandemic, we had weekly resident town halls with department leadership with transparency about our institution’s current status.

Physical Well-being

Stanford BIL Program
One method of improving physical well-being included stocking healthy snacks for residents and providing incoming residents with a guide of physicians, dentists, and fitness venues to promote regular health care. We have adopted the same at UW with healthy snacks available in our resident workroom.

St. Vincent Internal Medicine Wellness
There are monthly fitness challenges for a variety of physical wellness activities such as sleep, mindfulness minutes, nutrition, and step challenges.⁸

UW Dermatology
In addition to healthy snacks in our workroom, we also have various discounted fitness classes available for employees, along with discounts on gym memberships, kayak rentals, and city bike-share programs.

Psychological Well-Being

Stanford BIL Program
They enlisted a clinical psychologist available for residents to talk to regularly about any issues they face and to help manage stress in their lives.⁷

St. Vincent Internal Medicine Wellness
Faculty and coordinators provide S.A.F.E.—secure, affirming, friendly, and empathetic—zones to provide confidential and judgment-free support for residents.⁸ They also host photography competitions; residents submit photographs of nature, and the winning photographs are printed and displayed throughout the work area.

UW Dermatology
We have made changes to beautify our resident workroom with photograph collages of residents and other assorted décor to make it a more work-friendly space.

Social Well-being

Common themes highlighted by all 3 programs include the importance of socializing outside of the workplace, team-building activities, and resident retreats. Social media accounts on Instagram at St. Vincent (@stvimresidency) and at UW (@uwderm) highlight resident accomplishments and promote interconnectedness when residents are not together in clinics or hospitals.

Final Thoughts

Resident wellness will continue to be an important topic for discussion in the future, especially given the uncertain times right now during our training. Focusing on the 4 areas of well-being can help to prevent burnout and improve resident wellness.

Patients with sarcoidosis have an increased risk of heart failure and other adverse outcomes, including all-cause mortality, according to a decade-long nationwide study of Danish patients with the inflammatory disease.

“Although these findings are suggestive of the need for regular monitoring of cardiac manifestations in patients with sarcoidosis, it is important to emphasize that no causal relationships can be established from an observational study. Further studies are therefore needed to confirm our findings,” said first author Adelina Yafasova, MB, of Copenhagen University Hospital in Denmark, in an interview. The study was published in the Journal of the American College of Cardiology.

To determine the long-term risk of cardiac outcomes, and beyond – including incident heart failure; a composite of implantable cardioverter-defibrillator (ICD) implantation, ventricular arrhythmias or cardiac arrest; and all-cause mortality – Dr. Yafasova and her colleagues analyzed data from all Danish residents 18 years or older who were diagnosed with sarcoidosis from 1996 to 2016. Patients with any history of cardiac events were excluded. Of the 12,883 diagnosed patients, 11,834 were matched with subjects from a nationwide background population of more than 47,000 based on age, sex, and comorbidity. The median age of both populations was 42.8 (33.1-55.8) and 54.3% were men.

Median follow-up was 8.2 years for the sarcoidosis population and 8.4 years for the background population. The absolute 10-year risk of heart failure was 3.18% (95% confidence interval, 2.83%-3.57%) for sarcoidosis patients and 1.72% (95% CI, 1.58%-1.86%) for their matched controls. The 10-year risk for the composite of ICD implantation, ventricular arrhythmias and cardiac arrest was 0.96% (95% CI, 0.77%-1.18%) for sarcoidosis patients and 0.45% (95% CI, 0.38%-0.53%) for the background population.

For all-cause mortality, the 10-year risk was 10.88% (95% CI, 10.23%-11.55%) for sarcoidosis patients and 7.43% (95% CI, 7.15%-7.72%) for the background population. In a secondary analysis that compared all-cause mortality between the 364 sarcoidosis patients who developed heart failure and the 1,456 patients with heart failure without a history of sarcoidosis, the sarcoidosis group had a 35% higher rate than the nonsarcoidosis group (adjusted hazard ratio 1.35; 95% CI, 1.10-1.64).

“It’s not necessarily surprising that sarcoidosis patients would have a higher rate of heart failure,” said Melissa A. Lyle, MD, of the Mayo Clinic in Jacksonville, Fla., in an interview. “But the key takeaway is that sarcoidosis was associated with a higher rate of all-cause mortality compared to patients with heart failure and no sarcoidosis. That was more of a surprise.”

“There’s been some discrepancy in previous studies describing the cardiovascular outcomes in sarcoidosis,” Dr. Lyle added, “so I think this study provides excellent information while also highlighting the need for additional large-scale studies. We need to have further data on cardiovascular outcomes, which will allow us to refine the consensus statements and guidelines for management and the diagnosis of cardiac sarcoidosis.”

Dr. Lyle and Leslie T. Cooper Jr., MD, also of the Mayo Clinic, extrapolated on those thoughts in an editorial that accompanied the study. In it, the two authors praised the size and lengthy follow-up of the study, while noting its limitations. Specifically, they stressed that the study’s Danish population “may not be representative of other general populations” because of notable differences in ethnicity, age, and comorbidities.

That said, they reinforced that the study did feature “important takeaways” and that its findings emphasize the “need for monitoring for cardiac manifestations in patients with systemic sarcoidosis.”

In addition to the limitations noted in the editorial, the study’s authors acknowledged that the observational nature limited its “assessment of cause-effect relationships” and that the diagnosis codes for sarcoidosis had not been validated in the Danish National Patient Registry.

The authors of both the study and the editorial reported no conflicts of interest.

SOURCE: Yafasova A et al. J Am Coll Cardiol. 2020 Aug 10. doi: 10.1016/j.jacc.2020.06.038.

Patients with sarcoidosis have an increased risk of heart failure and other adverse outcomes, including all-cause mortality, according to a decade-long nationwide study of Danish patients with the inflammatory disease.

“Although these findings are suggestive of the need for regular monitoring of cardiac manifestations in patients with sarcoidosis, it is important to emphasize that no causal relationships can be established from an observational study. Further studies are therefore needed to confirm our findings,” said first author Adelina Yafasova, MB, of Copenhagen University Hospital in Denmark, in an interview. The study was published in the Journal of the American College of Cardiology.

To determine the long-term risk of cardiac outcomes, and beyond – including incident heart failure; a composite of implantable cardioverter-defibrillator (ICD) implantation, ventricular arrhythmias or cardiac arrest; and all-cause mortality – Dr. Yafasova and her colleagues analyzed data from all Danish residents 18 years or older who were diagnosed with sarcoidosis from 1996 to 2016. Patients with any history of cardiac events were excluded. Of the 12,883 diagnosed patients, 11,834 were matched with subjects from a nationwide background population of more than 47,000 based on age, sex, and comorbidity. The median age of both populations was 42.8 (33.1-55.8) and 54.3% were men.

Median follow-up was 8.2 years for the sarcoidosis population and 8.4 years for the background population. The absolute 10-year risk of heart failure was 3.18% (95% confidence interval, 2.83%-3.57%) for sarcoidosis patients and 1.72% (95% CI, 1.58%-1.86%) for their matched controls. The 10-year risk for the composite of ICD implantation, ventricular arrhythmias and cardiac arrest was 0.96% (95% CI, 0.77%-1.18%) for sarcoidosis patients and 0.45% (95% CI, 0.38%-0.53%) for the background population.

For all-cause mortality, the 10-year risk was 10.88% (95% CI, 10.23%-11.55%) for sarcoidosis patients and 7.43% (95% CI, 7.15%-7.72%) for the background population. In a secondary analysis that compared all-cause mortality between the 364 sarcoidosis patients who developed heart failure and the 1,456 patients with heart failure without a history of sarcoidosis, the sarcoidosis group had a 35% higher rate than the nonsarcoidosis group (adjusted hazard ratio 1.35; 95% CI, 1.10-1.64).

“It’s not necessarily surprising that sarcoidosis patients would have a higher rate of heart failure,” said Melissa A. Lyle, MD, of the Mayo Clinic in Jacksonville, Fla., in an interview. “But the key takeaway is that sarcoidosis was associated with a higher rate of all-cause mortality compared to patients with heart failure and no sarcoidosis. That was more of a surprise.”

“There’s been some discrepancy in previous studies describing the cardiovascular outcomes in sarcoidosis,” Dr. Lyle added, “so I think this study provides excellent information while also highlighting the need for additional large-scale studies. We need to have further data on cardiovascular outcomes, which will allow us to refine the consensus statements and guidelines for management and the diagnosis of cardiac sarcoidosis.”

Dr. Lyle and Leslie T. Cooper Jr., MD, also of the Mayo Clinic, extrapolated on those thoughts in an editorial that accompanied the study. In it, the two authors praised the size and lengthy follow-up of the study, while noting its limitations. Specifically, they stressed that the study’s Danish population “may not be representative of other general populations” because of notable differences in ethnicity, age, and comorbidities.

That said, they reinforced that the study did feature “important takeaways” and that its findings emphasize the “need for monitoring for cardiac manifestations in patients with systemic sarcoidosis.”

In addition to the limitations noted in the editorial, the study’s authors acknowledged that the observational nature limited its “assessment of cause-effect relationships” and that the diagnosis codes for sarcoidosis had not been validated in the Danish National Patient Registry.

The authors of both the study and the editorial reported no conflicts of interest.

SOURCE: Yafasova A et al. J Am Coll Cardiol. 2020 Aug 10. doi: 10.1016/j.jacc.2020.06.038.

Patients with sarcoidosis have an increased risk of heart failure and other adverse outcomes, including all-cause mortality, according to a decade-long nationwide study of Danish patients with the inflammatory disease.

“Although these findings are suggestive of the need for regular monitoring of cardiac manifestations in patients with sarcoidosis, it is important to emphasize that no causal relationships can be established from an observational study. Further studies are therefore needed to confirm our findings,” said first author Adelina Yafasova, MB, of Copenhagen University Hospital in Denmark, in an interview. The study was published in the Journal of the American College of Cardiology.

To determine the long-term risk of cardiac outcomes, and beyond – including incident heart failure; a composite of implantable cardioverter-defibrillator (ICD) implantation, ventricular arrhythmias or cardiac arrest; and all-cause mortality – Dr. Yafasova and her colleagues analyzed data from all Danish residents 18 years or older who were diagnosed with sarcoidosis from 1996 to 2016. Patients with any history of cardiac events were excluded. Of the 12,883 diagnosed patients, 11,834 were matched with subjects from a nationwide background population of more than 47,000 based on age, sex, and comorbidity. The median age of both populations was 42.8 (33.1-55.8) and 54.3% were men.

Median follow-up was 8.2 years for the sarcoidosis population and 8.4 years for the background population. The absolute 10-year risk of heart failure was 3.18% (95% confidence interval, 2.83%-3.57%) for sarcoidosis patients and 1.72% (95% CI, 1.58%-1.86%) for their matched controls. The 10-year risk for the composite of ICD implantation, ventricular arrhythmias and cardiac arrest was 0.96% (95% CI, 0.77%-1.18%) for sarcoidosis patients and 0.45% (95% CI, 0.38%-0.53%) for the background population.

For all-cause mortality, the 10-year risk was 10.88% (95% CI, 10.23%-11.55%) for sarcoidosis patients and 7.43% (95% CI, 7.15%-7.72%) for the background population. In a secondary analysis that compared all-cause mortality between the 364 sarcoidosis patients who developed heart failure and the 1,456 patients with heart failure without a history of sarcoidosis, the sarcoidosis group had a 35% higher rate than the nonsarcoidosis group (adjusted hazard ratio 1.35; 95% CI, 1.10-1.64).

“It’s not necessarily surprising that sarcoidosis patients would have a higher rate of heart failure,” said Melissa A. Lyle, MD, of the Mayo Clinic in Jacksonville, Fla., in an interview. “But the key takeaway is that sarcoidosis was associated with a higher rate of all-cause mortality compared to patients with heart failure and no sarcoidosis. That was more of a surprise.”

“There’s been some discrepancy in previous studies describing the cardiovascular outcomes in sarcoidosis,” Dr. Lyle added, “so I think this study provides excellent information while also highlighting the need for additional large-scale studies. We need to have further data on cardiovascular outcomes, which will allow us to refine the consensus statements and guidelines for management and the diagnosis of cardiac sarcoidosis.”

Dr. Lyle and Leslie T. Cooper Jr., MD, also of the Mayo Clinic, extrapolated on those thoughts in an editorial that accompanied the study. In it, the two authors praised the size and lengthy follow-up of the study, while noting its limitations. Specifically, they stressed that the study’s Danish population “may not be representative of other general populations” because of notable differences in ethnicity, age, and comorbidities.

That said, they reinforced that the study did feature “important takeaways” and that its findings emphasize the “need for monitoring for cardiac manifestations in patients with systemic sarcoidosis.”

In addition to the limitations noted in the editorial, the study’s authors acknowledged that the observational nature limited its “assessment of cause-effect relationships” and that the diagnosis codes for sarcoidosis had not been validated in the Danish National Patient Registry.

The authors of both the study and the editorial reported no conflicts of interest.

SOURCE: Yafasova A et al. J Am Coll Cardiol. 2020 Aug 10. doi: 10.1016/j.jacc.2020.06.038.

The BALL score was able to identify a subset of patients with chronic lymphocytic leukemia (CLL) who particularly benefit from single-agent ibrutinib therapy, according to the results of a study of 111 patients followed from two different institutions.

The BALL model consists of four factors: serum beta₂-microglobulin at 5 mg/dL or greater, hemoglobin < 110 g/L for women or < 120 g/L for men, lactate dehydrogenase [LDH] > upper limit of normal [UNL], and time elapsed from last therapy less than 24 months. Each parameter was alloted 1 point, leading to a stratification of patients into three different prognostic groups: low risk (score 0-1), intermediate risk (2-3), and high risk (score 4), according to a report published online in Leukemia Research.

According to Stefano Molica, MD, of the Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy, and his colleagues, the majority of patients (82%) were clinical Rai stage II-IV. The median patient age was 63 years and nearly 68% were men.

The researchers assessed four models for predicting overall survival. The modified version of CLL-International Prognostic Index (CLL-IPI) failed to provide prognostic information in relapsed/refractory (R/R) CLL (P = .77) as did the Ahn et al. model (P = .95) and a simplified BALL model (P = .09). In contrast, the full BALL score captured two groups of patients with significant differences in survival (hazard ratio, 0.240; 95 % confidence interval, 0.10-0.54; P = .0005); however, because of the low number of patients in the high-risk category, these cases were combined with the intermediate-risk group.

The BALL score identified a subset of patients, accounting for about 50% of the whole population, who particularly benefit from single-agent ibrutinib, according to Dr. Molica and his colleagues. These patients had a survival rate of 85% at 3 years.

“In contrast, the outcome of subjects with intermediate-high risk is disappointing. These patients should be considered for a combination of targeted drugs or cellular-based therapies,” the researchers concluded.

The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Molica S et al. Leuk Res. 2020 Jun 10. https://doi.org/10.1016/j.leukres.2020.

The BALL score was able to identify a subset of patients with chronic lymphocytic leukemia (CLL) who particularly benefit from single-agent ibrutinib therapy, according to the results of a study of 111 patients followed from two different institutions.

The BALL model consists of four factors: serum beta₂-microglobulin at 5 mg/dL or greater, hemoglobin < 110 g/L for women or < 120 g/L for men, lactate dehydrogenase [LDH] > upper limit of normal [UNL], and time elapsed from last therapy less than 24 months. Each parameter was alloted 1 point, leading to a stratification of patients into three different prognostic groups: low risk (score 0-1), intermediate risk (2-3), and high risk (score 4), according to a report published online in Leukemia Research.

According to Stefano Molica, MD, of the Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy, and his colleagues, the majority of patients (82%) were clinical Rai stage II-IV. The median patient age was 63 years and nearly 68% were men.

The researchers assessed four models for predicting overall survival. The modified version of CLL-International Prognostic Index (CLL-IPI) failed to provide prognostic information in relapsed/refractory (R/R) CLL (P = .77) as did the Ahn et al. model (P = .95) and a simplified BALL model (P = .09). In contrast, the full BALL score captured two groups of patients with significant differences in survival (hazard ratio, 0.240; 95 % confidence interval, 0.10-0.54; P = .0005); however, because of the low number of patients in the high-risk category, these cases were combined with the intermediate-risk group.

The BALL score identified a subset of patients, accounting for about 50% of the whole population, who particularly benefit from single-agent ibrutinib, according to Dr. Molica and his colleagues. These patients had a survival rate of 85% at 3 years.

“In contrast, the outcome of subjects with intermediate-high risk is disappointing. These patients should be considered for a combination of targeted drugs or cellular-based therapies,” the researchers concluded.

The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Molica S et al. Leuk Res. 2020 Jun 10. https://doi.org/10.1016/j.leukres.2020.

The BALL score was able to identify a subset of patients with chronic lymphocytic leukemia (CLL) who particularly benefit from single-agent ibrutinib therapy, according to the results of a study of 111 patients followed from two different institutions.

The BALL model consists of four factors: serum beta₂-microglobulin at 5 mg/dL or greater, hemoglobin < 110 g/L for women or < 120 g/L for men, lactate dehydrogenase [LDH] > upper limit of normal [UNL], and time elapsed from last therapy less than 24 months. Each parameter was alloted 1 point, leading to a stratification of patients into three different prognostic groups: low risk (score 0-1), intermediate risk (2-3), and high risk (score 4), according to a report published online in Leukemia Research.

According to Stefano Molica, MD, of the Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy, and his colleagues, the majority of patients (82%) were clinical Rai stage II-IV. The median patient age was 63 years and nearly 68% were men.

The researchers assessed four models for predicting overall survival. The modified version of CLL-International Prognostic Index (CLL-IPI) failed to provide prognostic information in relapsed/refractory (R/R) CLL (P = .77) as did the Ahn et al. model (P = .95) and a simplified BALL model (P = .09). In contrast, the full BALL score captured two groups of patients with significant differences in survival (hazard ratio, 0.240; 95 % confidence interval, 0.10-0.54; P = .0005); however, because of the low number of patients in the high-risk category, these cases were combined with the intermediate-risk group.

The BALL score identified a subset of patients, accounting for about 50% of the whole population, who particularly benefit from single-agent ibrutinib, according to Dr. Molica and his colleagues. These patients had a survival rate of 85% at 3 years.

“In contrast, the outcome of subjects with intermediate-high risk is disappointing. These patients should be considered for a combination of targeted drugs or cellular-based therapies,” the researchers concluded.

The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Molica S et al. Leuk Res. 2020 Jun 10. https://doi.org/10.1016/j.leukres.2020.

September every year means one thing to students across the country: Summer break is over, and it is time to go back to school. For LGBTQ youth, this can be both a blessing and a curse. Schools can be a refuge from being stuck at home with unsupportive family, but it also can mean returning to hallways full of harassment from other students and/or staff. Groups such as a gender-sexuality alliance (GSA) or a chapter of the Gay, Lesbian, and Straight Education Network (GLSEN) can provide a safe space for these students at school. Pediatricians can play an important role in ensuring that their patients know about access to these resources.

SolStock/E+

Gender-sexuality alliances, or gay-straight alliances as they have been more commonly known, have been around since the late 1980s. The first one was founded at Concord Academy in Massachusetts in 1988 by a straight student who was upset at how her gay classmates were being treated. Today’s GSAs continue this mission to create a welcoming environment for students of all gender identities and sexual orientations to gather, increase awareness on their campus of LGBTQ issues, and make the school environment safer for all students. According to the GSA network, there are over 4,000 active GSAs today in the United States located in 40 states.¹

GLSEN was founded in 1990 initially as a network of gay and lesbian educators who wanted to create safer spaces in schools for LGBTQ students. Over the last 30 years, GLSEN continues to support this mission but has expanded into research and advocacy as well. There are currently 43 chapters of GLSEN in 30 states.² GLSEN sponsors a number of national events throughout the year to raise awareness of LGBTQ issues in schools, including No Name Calling Week and the Day of Silence. Many chapters provide mentoring to local GSAs and volunteering as a mentor can be a great way for pediatricians to become involved in their local schools.

You may be asking yourself, why are GSAs important? According to GLSEN’s 2017 National School Climate Survey, nearly 35% of LGBTQ students missed at least 1 day of school in the previous month because of feeling unsafe, and nearly 57% of students reported hearing homophobic remarks from teachers and staff at their school.³ Around 10% of LGBTQ students reported being physically assaulted based on their sexual orientation and/or gender identity. Those LGBTQ students who experienced discrimination based on their sexual orientation and/or gender identity were more likely to have lower grade point averages and were more likely to be disciplined than those students who had not experienced discrimination.³ The cumulative effect of these negative experiences at school lead a sizable portion of affected students to drop out of school and possibly not pursue postsecondary education. This then leads to decreased job opportunities or career advancement, which could then lead to unemployment or low-wage jobs. Creating safe spaces for education to take place can have a lasting effect on the lives of LGBTQ students.

The 53% of students who reported having a GSA at their school in the National School Climate survey were less likely to report hearing negative comments about LGBTQ students, were less likely to miss school, experienced lower levels of victimization, and reported higher levels of supportive teachers and staff. All of these factors taken together ensure that LGBTQ students are more likely to complete their high school education. Russell B. Toomey, PhD, and colleagues were able to show that LGBTQ students with a perceived effective GSA were two times more likely than those without an effective GSA to attain a college education.⁴ Research also has shown that the presence of a GSA can have a beneficial impact on reducing bullying in general for all students, whether they identify as LGBTQ or not.⁵

What active steps can a pediatrician take to support their LGBTQ students? First, encourage your patients and families to talk to their schools about starting a GSA at their campus. If the families run into trouble from the school, have your social workers help them connect with legal resources, as many court cases have established precedent that public schools cannot have a blanket ban on GSAs solely because they focus on LGBTQ issues. Second, if your patient has a GSA at their school and seems to be struggling with his/her sexual orientation and/or gender identity, encourage that student to consider attending their GSA so that they are able to spend time with other students like themselves. Third, as many schools will be starting virtually this year, you can provide your LGBTQ patients with a list of local online groups that students can participate in virtually if their school’s GSA is not meeting (see my LGBTQ Youth Consult column entitled, “Resources for LGBTQ youth during challenging times” at mdedge.com/pediatrics for a few ideas).* Lastly, be an active advocate in your own local school district for the inclusion of comprehensive nondiscrimination policies and the presence of GSAs for students. These small steps can go a long way to helping your LGBTQ patients thrive and succeed in school.

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Dr. Cooper has no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. gsanetwork.org/mission-vision-history/.

2. www.glsen.org/find_chapter?field_chapter_state_target_id=All.

3. live-glsen-website.pantheonsite.io/sites/default/files/2019-10/GLSEN-2017-National-School-Climate-Survey-NSCS-Full-Report.pdf.

4. Appl Dev Sci. 2011 Nov 7;15(4):175-85.

5.www.usnews.com/news/articles/2016-08-04/gay-straight-alliances-in-schools-pay-off-for-all-students-study-finds.

*This article was updated 8/17/2020.

September every year means one thing to students across the country: Summer break is over, and it is time to go back to school. For LGBTQ youth, this can be both a blessing and a curse. Schools can be a refuge from being stuck at home with unsupportive family, but it also can mean returning to hallways full of harassment from other students and/or staff. Groups such as a gender-sexuality alliance (GSA) or a chapter of the Gay, Lesbian, and Straight Education Network (GLSEN) can provide a safe space for these students at school. Pediatricians can play an important role in ensuring that their patients know about access to these resources.

SolStock/E+

Gender-sexuality alliances, or gay-straight alliances as they have been more commonly known, have been around since the late 1980s. The first one was founded at Concord Academy in Massachusetts in 1988 by a straight student who was upset at how her gay classmates were being treated. Today’s GSAs continue this mission to create a welcoming environment for students of all gender identities and sexual orientations to gather, increase awareness on their campus of LGBTQ issues, and make the school environment safer for all students. According to the GSA network, there are over 4,000 active GSAs today in the United States located in 40 states.¹

GLSEN was founded in 1990 initially as a network of gay and lesbian educators who wanted to create safer spaces in schools for LGBTQ students. Over the last 30 years, GLSEN continues to support this mission but has expanded into research and advocacy as well. There are currently 43 chapters of GLSEN in 30 states.² GLSEN sponsors a number of national events throughout the year to raise awareness of LGBTQ issues in schools, including No Name Calling Week and the Day of Silence. Many chapters provide mentoring to local GSAs and volunteering as a mentor can be a great way for pediatricians to become involved in their local schools.

You may be asking yourself, why are GSAs important? According to GLSEN’s 2017 National School Climate Survey, nearly 35% of LGBTQ students missed at least 1 day of school in the previous month because of feeling unsafe, and nearly 57% of students reported hearing homophobic remarks from teachers and staff at their school.³ Around 10% of LGBTQ students reported being physically assaulted based on their sexual orientation and/or gender identity. Those LGBTQ students who experienced discrimination based on their sexual orientation and/or gender identity were more likely to have lower grade point averages and were more likely to be disciplined than those students who had not experienced discrimination.³ The cumulative effect of these negative experiences at school lead a sizable portion of affected students to drop out of school and possibly not pursue postsecondary education. This then leads to decreased job opportunities or career advancement, which could then lead to unemployment or low-wage jobs. Creating safe spaces for education to take place can have a lasting effect on the lives of LGBTQ students.

The 53% of students who reported having a GSA at their school in the National School Climate survey were less likely to report hearing negative comments about LGBTQ students, were less likely to miss school, experienced lower levels of victimization, and reported higher levels of supportive teachers and staff. All of these factors taken together ensure that LGBTQ students are more likely to complete their high school education. Russell B. Toomey, PhD, and colleagues were able to show that LGBTQ students with a perceived effective GSA were two times more likely than those without an effective GSA to attain a college education.⁴ Research also has shown that the presence of a GSA can have a beneficial impact on reducing bullying in general for all students, whether they identify as LGBTQ or not.⁵

What active steps can a pediatrician take to support their LGBTQ students? First, encourage your patients and families to talk to their schools about starting a GSA at their campus. If the families run into trouble from the school, have your social workers help them connect with legal resources, as many court cases have established precedent that public schools cannot have a blanket ban on GSAs solely because they focus on LGBTQ issues. Second, if your patient has a GSA at their school and seems to be struggling with his/her sexual orientation and/or gender identity, encourage that student to consider attending their GSA so that they are able to spend time with other students like themselves. Third, as many schools will be starting virtually this year, you can provide your LGBTQ patients with a list of local online groups that students can participate in virtually if their school’s GSA is not meeting (see my LGBTQ Youth Consult column entitled, “Resources for LGBTQ youth during challenging times” at mdedge.com/pediatrics for a few ideas).* Lastly, be an active advocate in your own local school district for the inclusion of comprehensive nondiscrimination policies and the presence of GSAs for students. These small steps can go a long way to helping your LGBTQ patients thrive and succeed in school.

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Dr. Cooper has no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. gsanetwork.org/mission-vision-history/.

2. www.glsen.org/find_chapter?field_chapter_state_target_id=All.

3. live-glsen-website.pantheonsite.io/sites/default/files/2019-10/GLSEN-2017-National-School-Climate-Survey-NSCS-Full-Report.pdf.

4. Appl Dev Sci. 2011 Nov 7;15(4):175-85.

5.www.usnews.com/news/articles/2016-08-04/gay-straight-alliances-in-schools-pay-off-for-all-students-study-finds.

*This article was updated 8/17/2020.

September every year means one thing to students across the country: Summer break is over, and it is time to go back to school. For LGBTQ youth, this can be both a blessing and a curse. Schools can be a refuge from being stuck at home with unsupportive family, but it also can mean returning to hallways full of harassment from other students and/or staff. Groups such as a gender-sexuality alliance (GSA) or a chapter of the Gay, Lesbian, and Straight Education Network (GLSEN) can provide a safe space for these students at school. Pediatricians can play an important role in ensuring that their patients know about access to these resources.

SolStock/E+

Gender-sexuality alliances, or gay-straight alliances as they have been more commonly known, have been around since the late 1980s. The first one was founded at Concord Academy in Massachusetts in 1988 by a straight student who was upset at how her gay classmates were being treated. Today’s GSAs continue this mission to create a welcoming environment for students of all gender identities and sexual orientations to gather, increase awareness on their campus of LGBTQ issues, and make the school environment safer for all students. According to the GSA network, there are over 4,000 active GSAs today in the United States located in 40 states.¹

GLSEN was founded in 1990 initially as a network of gay and lesbian educators who wanted to create safer spaces in schools for LGBTQ students. Over the last 30 years, GLSEN continues to support this mission but has expanded into research and advocacy as well. There are currently 43 chapters of GLSEN in 30 states.² GLSEN sponsors a number of national events throughout the year to raise awareness of LGBTQ issues in schools, including No Name Calling Week and the Day of Silence. Many chapters provide mentoring to local GSAs and volunteering as a mentor can be a great way for pediatricians to become involved in their local schools.

You may be asking yourself, why are GSAs important? According to GLSEN’s 2017 National School Climate Survey, nearly 35% of LGBTQ students missed at least 1 day of school in the previous month because of feeling unsafe, and nearly 57% of students reported hearing homophobic remarks from teachers and staff at their school.³ Around 10% of LGBTQ students reported being physically assaulted based on their sexual orientation and/or gender identity. Those LGBTQ students who experienced discrimination based on their sexual orientation and/or gender identity were more likely to have lower grade point averages and were more likely to be disciplined than those students who had not experienced discrimination.³ The cumulative effect of these negative experiences at school lead a sizable portion of affected students to drop out of school and possibly not pursue postsecondary education. This then leads to decreased job opportunities or career advancement, which could then lead to unemployment or low-wage jobs. Creating safe spaces for education to take place can have a lasting effect on the lives of LGBTQ students.

The 53% of students who reported having a GSA at their school in the National School Climate survey were less likely to report hearing negative comments about LGBTQ students, were less likely to miss school, experienced lower levels of victimization, and reported higher levels of supportive teachers and staff. All of these factors taken together ensure that LGBTQ students are more likely to complete their high school education. Russell B. Toomey, PhD, and colleagues were able to show that LGBTQ students with a perceived effective GSA were two times more likely than those without an effective GSA to attain a college education.⁴ Research also has shown that the presence of a GSA can have a beneficial impact on reducing bullying in general for all students, whether they identify as LGBTQ or not.⁵

What active steps can a pediatrician take to support their LGBTQ students? First, encourage your patients and families to talk to their schools about starting a GSA at their campus. If the families run into trouble from the school, have your social workers help them connect with legal resources, as many court cases have established precedent that public schools cannot have a blanket ban on GSAs solely because they focus on LGBTQ issues. Second, if your patient has a GSA at their school and seems to be struggling with his/her sexual orientation and/or gender identity, encourage that student to consider attending their GSA so that they are able to spend time with other students like themselves. Third, as many schools will be starting virtually this year, you can provide your LGBTQ patients with a list of local online groups that students can participate in virtually if their school’s GSA is not meeting (see my LGBTQ Youth Consult column entitled, “Resources for LGBTQ youth during challenging times” at mdedge.com/pediatrics for a few ideas).* Lastly, be an active advocate in your own local school district for the inclusion of comprehensive nondiscrimination policies and the presence of GSAs for students. These small steps can go a long way to helping your LGBTQ patients thrive and succeed in school.

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Dr. Cooper has no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. gsanetwork.org/mission-vision-history/.

2. www.glsen.org/find_chapter?field_chapter_state_target_id=All.

3. live-glsen-website.pantheonsite.io/sites/default/files/2019-10/GLSEN-2017-National-School-Climate-Survey-NSCS-Full-Report.pdf.

4. Appl Dev Sci. 2011 Nov 7;15(4):175-85.

5.www.usnews.com/news/articles/2016-08-04/gay-straight-alliances-in-schools-pay-off-for-all-students-study-finds.

*This article was updated 8/17/2020.

For some patients, a bout of COVID-19 may not be over after hospital discharge, acute symptoms subside, or a couple of tests for SARS-CoV-2 come back negative. Those who have reached these milestones of conquering the disease may find that their recovery journey has only begun. Debilitating symptoms such as fatigue, headache, and dyspnea may linger for weeks or longer. Patients with persistent symptoms, often referred to as “long haulers” in reference to the duration of their recovery, are looking for answers about their condition and when their COVID-19 illness will finally resolve.

Long-haul patients organize

What started as an accumulation of anecdotal evidence in social media, blogs, and the mainstream press about slow recovery and long-lasting symptoms of COVID-19 is now the focus of clinical trials in the population of recovering patients. Projects such as the COVID Symptom Study, initiated by the Massachusetts General Hospital, Boston; the Harvard School of Public Health, Boston; King’s College London; and Stanford (Calif.) University, are collecting data on symptoms from millions of patients and will eventually contribute to a better understanding of prolonged recovery.

Patients looking for answers have created groups on social media such as Facebook to exchange information about their experiences (e.g., Survivor Corps, COVID-19 Support Group, COVID-19 Recovered Survivors). Recovering patients have created patient-led research organizations (Body Politic COVID-19 Support Group) to explore persistent symptoms and begin to create data for research.
 

Some data on lingering symptoms

A small study of 143 previously hospitalized, recovering patients in Italy found that 87.4% of the cohort had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge. In this sample, only 5% had been intubated. (JAMA 2020 Jul 9. doi: 10.1001/jama.2020.12603).

One study found that even patients who have had relatively mild symptoms and were not hospitalized can have persistent symptoms. The Centers for Disease Control and Prevention conducted a survey of adults who tested positive for the positive reverse transcription–polymerase chain reaction test for SARS-CoV-2 and found that, among the 292 respondents, 35% were still feeling the impact of the disease 2-3 weeks after testing. Fatigue (71%), cough (61%), and headache (61%) were the most commonly reported symptoms. The survey found that delayed recovery was evident in nearly a quarter of 18- to 34-year-olds and in a third of 35- to 49-year-olds who were not sick enough to require hospitalization (MMWR. 2020 Jul 24. doi: 10.15585/mmwr.mm6930e1).

Sachin Gupta, MD, FCCP, ATSF, a pulmonologist and member of the CHEST Physician editorial advisory board, has treated patients with COVID-19 and shared some of his thoughts on the problem of prolonged symptoms of COVID-19.
 

Q: Should clinicians expect to see COVID-19 patients who have symptoms persisting weeks after they are diagnosed?

Dr. Gupta: I think clinicians, especially in primary care, are already seeing many patients with lingering symptoms, both respiratory and nonrespiratory related, and debility. A few patients here in the San Francisco Bay Area that I have spoken with 4-6 weeks out from their acute illness have complained of persisting, though improving, fatigue and cough. Early studies are confirming this as a topical issue. There may be other long-lasting sequelae of COVID-19 beyond the common mild lingering symptoms. It will also be important to consider (and get more data on) to what degree asymptomatic patients develop some degree of mild inflammatory and subsequent fibrotic changes in organs like the lungs and heart

Q: How does the recovery phase of COVID-19 compare with recovery from severe influenza or ARDS?

Dr. Gupta: Most prior influenza and acute respiratory distress syndrome (ARDS) studies have provided initial follow-up at 3 months and beyond, so technically speaking, it is a little difficult to compare the symptomatology patterns in the JAMA study of 2 months on follow-up. Nevertheless, the key takeaway is that, even though few patients in the study had ARDS requiring intubation (severe disease), many patients with milder disease had significant lingering symptoms (55% with three or more symptoms) at 2 months.

This fits logically with the premise, which we have some limited data on with ARDS (N Engl J Med. 2003;348:683-93. doi: 10.1056/NEJMoa022450) and severe influenza infection survivors (Nature Sci Rep. 2017;7:17275. doi: 10.1038/s41598-017-17497-6) that varying degrees of the inflammation cascade triggered by certain viruses can lead to changes in important patient-reported outcomes, and objective measures such as pulmonary function over the long term.

Q: What can you do for patients with lingering symptoms of COVID-19 or what can you tell them about their symptoms?

Dr. Gupta: For many patients, there is fear, given the novel nature of the virus/pandemic, that their symptoms may persist long term. Acknowledgment of their symptoms is validating and important for us to recognize as we learn more about the virus. As we are finding, many patients are going online to find answers, after sometimes feeling rushed or dismissed initially in the clinical setting.

In my experience, the bar is fairly high for most patients to reach out to their physicians with complaints of lingering symptoms after acute infection. For the ones who do reach out, they tend to have either a greater constellation of symptoms or higher severity of one or two key symptoms. After assessing and, when appropriate, ruling out secondary infections or newly developed conditions, I shift toward symptom management. I encourage such patients to build up slowly. I suggest they work first on their activities of daily living (bathing, grooming), then their instrumental activities of daily living (cooking, cleaning, checking the mail), and then to engage, based on their tolerance of symptoms, to light purposeful exercise. There are many online resources for at-home exercise activities that I recommend to patients who are more debilitated; some larger centers are beginning to offer some forms of telepulmonary rehab.

Based on what we know about other causes of viral pneumonitis and ARDS, I ask such symptomatic patients to expect a slow, gradual, and in most cases a complete recovery, and depending on the individual case, I recommend pulmonary function tests and imaging that may be helpful to track that progress.

I remind myself, and patients, that our understanding may change as we learn more over time. Checking in at set intervals, even if not in person but through a phone call, can go a long way in a setting where we do not have a specific therapy, other than gradual exercise training, to help these patients recover faster. Reassurance and encouragement are vital for patients who are struggling with the lingering burden of disease and who may find it difficult to return to work or function as usual at home. The final point is to be mindful of our patient’s mental health and, where our reassurance is not enough, to consider appropriate mental health referrals.

Q: Can you handle this kind of problem with telemedicine or which patients with lingering symptoms need to come into the office – or failing that, the ED?

Dr. Gupta: Telemedicine in the outpatient setting provides a helpful tool to assess and manage patients, in my experience, with limited and straightforward complaints. Its scope is limited diagnostically (assessing symptoms and signs) as is its reach (ability to connect with elderly, disabled, or patients without/limited telemedicine access). In many instances, telemedicine limits our ability to connect with patients emotionally and build trust. Many patients who have gone through the acute illness that we see in pulmonary clinic on follow-up are older in age, and for many, video visits are not a practical solution. Telemedicine visits can sometimes present challenges for me as well in terms of thoroughly conveying lifestyle and symptom management strategies. Health literacy is typically easier to gauge and address in person.

For patients with any degree of enduring dyspnea, more so in the acute phase, I recommend home pulse oximetry for monitoring their oxygen saturation if it is financially and technically feasible for them to obtain one. Sending a patient to the ED is an option of last resort, but one that is necessary in some cases. I expect patients with lingering symptoms to tell me that symptoms may be persisting, hopefully gradually improving, and not getting worse. If post–COVID-19 symptoms such as fever, dyspnea, fatigue, or lightheadedness are new or worsening, particularly rapidly, the safest and best option I advise patients is to go to the ED for further assessment and testing. Postviral bacterial pneumonia is something we should consider, and there is some potential for aspergillosis as well.

Q: Do you have any concerns about patients with asthma, chronic obstructive pulmonary disease, or other pulmonary issues having lingering symptoms that may mask exacerbations or may cause exacerbation of their disease?

Dr. Gupta: So far, patients with chronic lung conditions do not appear to have not been disproportionately affected by the pandemic in terms of absolute numbers or percentage wise compared to the general public. I think that sheltering in place has been readily followed by many of these patients, and in addition, I assume better adherence to their maintenance therapies has likely helped. The very few cases of patients with underlying chronic obstructive pulmonary disease and interstitial lung disease that I have seen have fared very poorly when they were diagnosed with COVID-19 in the hospital. There are emerging data about short-term outcomes from severe COVID-19 infection in patients with interstitial lung disease in Europe (medRxiv. 2020 Jul 17. doi: 10.1101/2020.07.15.20152967), and from physicians treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (Ann Am Thorac Soc. 2020 Jul 29. doi: 10.1513/AnnalsATS.202005-521OC). But so far, little has been published on the outcomes of mild disease in these patients with chronic lung disease.

Q: It’s still early days to know the significance of lingering symptoms. But at what point do you begin to consider the possibility of some kind of relapse? And what is your next move if the symptoms get worse?

Dr. Gupta: COVID-19 recurrence, whether because of reinfection or relapse, is a potential concern but not one that is very commonly seen so far in my purview. Generally, symptoms of post–COVID-19 infection that are lingering trend toward getting better, even if slowly. If post–COVID-19 infection symptoms are progressing (particularly if rapidly), that would be a strong indication to evaluate that patient in the ED (less likely in clinic), reswab them for SARS-CoV-2, and obtain further testing such as blood work and imaging. A significant challenge from a research perspective will be determining if coinfection with another virus is playing a role as we move closer to the fall season.

tborden@mdedge.com

For some patients, a bout of COVID-19 may not be over after hospital discharge, acute symptoms subside, or a couple of tests for SARS-CoV-2 come back negative. Those who have reached these milestones of conquering the disease may find that their recovery journey has only begun. Debilitating symptoms such as fatigue, headache, and dyspnea may linger for weeks or longer. Patients with persistent symptoms, often referred to as “long haulers” in reference to the duration of their recovery, are looking for answers about their condition and when their COVID-19 illness will finally resolve.

Long-haul patients organize

What started as an accumulation of anecdotal evidence in social media, blogs, and the mainstream press about slow recovery and long-lasting symptoms of COVID-19 is now the focus of clinical trials in the population of recovering patients. Projects such as the COVID Symptom Study, initiated by the Massachusetts General Hospital, Boston; the Harvard School of Public Health, Boston; King’s College London; and Stanford (Calif.) University, are collecting data on symptoms from millions of patients and will eventually contribute to a better understanding of prolonged recovery.

Patients looking for answers have created groups on social media such as Facebook to exchange information about their experiences (e.g., Survivor Corps, COVID-19 Support Group, COVID-19 Recovered Survivors). Recovering patients have created patient-led research organizations (Body Politic COVID-19 Support Group) to explore persistent symptoms and begin to create data for research.
 

Some data on lingering symptoms

A small study of 143 previously hospitalized, recovering patients in Italy found that 87.4% of the cohort had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge. In this sample, only 5% had been intubated. (JAMA 2020 Jul 9. doi: 10.1001/jama.2020.12603).

One study found that even patients who have had relatively mild symptoms and were not hospitalized can have persistent symptoms. The Centers for Disease Control and Prevention conducted a survey of adults who tested positive for the positive reverse transcription–polymerase chain reaction test for SARS-CoV-2 and found that, among the 292 respondents, 35% were still feeling the impact of the disease 2-3 weeks after testing. Fatigue (71%), cough (61%), and headache (61%) were the most commonly reported symptoms. The survey found that delayed recovery was evident in nearly a quarter of 18- to 34-year-olds and in a third of 35- to 49-year-olds who were not sick enough to require hospitalization (MMWR. 2020 Jul 24. doi: 10.15585/mmwr.mm6930e1).

Sachin Gupta, MD, FCCP, ATSF, a pulmonologist and member of the CHEST Physician editorial advisory board, has treated patients with COVID-19 and shared some of his thoughts on the problem of prolonged symptoms of COVID-19.
 

Q: Should clinicians expect to see COVID-19 patients who have symptoms persisting weeks after they are diagnosed?

Dr. Gupta: I think clinicians, especially in primary care, are already seeing many patients with lingering symptoms, both respiratory and nonrespiratory related, and debility. A few patients here in the San Francisco Bay Area that I have spoken with 4-6 weeks out from their acute illness have complained of persisting, though improving, fatigue and cough. Early studies are confirming this as a topical issue. There may be other long-lasting sequelae of COVID-19 beyond the common mild lingering symptoms. It will also be important to consider (and get more data on) to what degree asymptomatic patients develop some degree of mild inflammatory and subsequent fibrotic changes in organs like the lungs and heart

Q: How does the recovery phase of COVID-19 compare with recovery from severe influenza or ARDS?

Dr. Gupta: Most prior influenza and acute respiratory distress syndrome (ARDS) studies have provided initial follow-up at 3 months and beyond, so technically speaking, it is a little difficult to compare the symptomatology patterns in the JAMA study of 2 months on follow-up. Nevertheless, the key takeaway is that, even though few patients in the study had ARDS requiring intubation (severe disease), many patients with milder disease had significant lingering symptoms (55% with three or more symptoms) at 2 months.

This fits logically with the premise, which we have some limited data on with ARDS (N Engl J Med. 2003;348:683-93. doi: 10.1056/NEJMoa022450) and severe influenza infection survivors (Nature Sci Rep. 2017;7:17275. doi: 10.1038/s41598-017-17497-6) that varying degrees of the inflammation cascade triggered by certain viruses can lead to changes in important patient-reported outcomes, and objective measures such as pulmonary function over the long term.

Q: What can you do for patients with lingering symptoms of COVID-19 or what can you tell them about their symptoms?

Dr. Gupta: For many patients, there is fear, given the novel nature of the virus/pandemic, that their symptoms may persist long term. Acknowledgment of their symptoms is validating and important for us to recognize as we learn more about the virus. As we are finding, many patients are going online to find answers, after sometimes feeling rushed or dismissed initially in the clinical setting.

In my experience, the bar is fairly high for most patients to reach out to their physicians with complaints of lingering symptoms after acute infection. For the ones who do reach out, they tend to have either a greater constellation of symptoms or higher severity of one or two key symptoms. After assessing and, when appropriate, ruling out secondary infections or newly developed conditions, I shift toward symptom management. I encourage such patients to build up slowly. I suggest they work first on their activities of daily living (bathing, grooming), then their instrumental activities of daily living (cooking, cleaning, checking the mail), and then to engage, based on their tolerance of symptoms, to light purposeful exercise. There are many online resources for at-home exercise activities that I recommend to patients who are more debilitated; some larger centers are beginning to offer some forms of telepulmonary rehab.

Based on what we know about other causes of viral pneumonitis and ARDS, I ask such symptomatic patients to expect a slow, gradual, and in most cases a complete recovery, and depending on the individual case, I recommend pulmonary function tests and imaging that may be helpful to track that progress.

I remind myself, and patients, that our understanding may change as we learn more over time. Checking in at set intervals, even if not in person but through a phone call, can go a long way in a setting where we do not have a specific therapy, other than gradual exercise training, to help these patients recover faster. Reassurance and encouragement are vital for patients who are struggling with the lingering burden of disease and who may find it difficult to return to work or function as usual at home. The final point is to be mindful of our patient’s mental health and, where our reassurance is not enough, to consider appropriate mental health referrals.

Q: Can you handle this kind of problem with telemedicine or which patients with lingering symptoms need to come into the office – or failing that, the ED?

Dr. Gupta: Telemedicine in the outpatient setting provides a helpful tool to assess and manage patients, in my experience, with limited and straightforward complaints. Its scope is limited diagnostically (assessing symptoms and signs) as is its reach (ability to connect with elderly, disabled, or patients without/limited telemedicine access). In many instances, telemedicine limits our ability to connect with patients emotionally and build trust. Many patients who have gone through the acute illness that we see in pulmonary clinic on follow-up are older in age, and for many, video visits are not a practical solution. Telemedicine visits can sometimes present challenges for me as well in terms of thoroughly conveying lifestyle and symptom management strategies. Health literacy is typically easier to gauge and address in person.

For patients with any degree of enduring dyspnea, more so in the acute phase, I recommend home pulse oximetry for monitoring their oxygen saturation if it is financially and technically feasible for them to obtain one. Sending a patient to the ED is an option of last resort, but one that is necessary in some cases. I expect patients with lingering symptoms to tell me that symptoms may be persisting, hopefully gradually improving, and not getting worse. If post–COVID-19 symptoms such as fever, dyspnea, fatigue, or lightheadedness are new or worsening, particularly rapidly, the safest and best option I advise patients is to go to the ED for further assessment and testing. Postviral bacterial pneumonia is something we should consider, and there is some potential for aspergillosis as well.

Q: Do you have any concerns about patients with asthma, chronic obstructive pulmonary disease, or other pulmonary issues having lingering symptoms that may mask exacerbations or may cause exacerbation of their disease?

Dr. Gupta: So far, patients with chronic lung conditions do not appear to have not been disproportionately affected by the pandemic in terms of absolute numbers or percentage wise compared to the general public. I think that sheltering in place has been readily followed by many of these patients, and in addition, I assume better adherence to their maintenance therapies has likely helped. The very few cases of patients with underlying chronic obstructive pulmonary disease and interstitial lung disease that I have seen have fared very poorly when they were diagnosed with COVID-19 in the hospital. There are emerging data about short-term outcomes from severe COVID-19 infection in patients with interstitial lung disease in Europe (medRxiv. 2020 Jul 17. doi: 10.1101/2020.07.15.20152967), and from physicians treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (Ann Am Thorac Soc. 2020 Jul 29. doi: 10.1513/AnnalsATS.202005-521OC). But so far, little has been published on the outcomes of mild disease in these patients with chronic lung disease.

Q: It’s still early days to know the significance of lingering symptoms. But at what point do you begin to consider the possibility of some kind of relapse? And what is your next move if the symptoms get worse?

Dr. Gupta: COVID-19 recurrence, whether because of reinfection or relapse, is a potential concern but not one that is very commonly seen so far in my purview. Generally, symptoms of post–COVID-19 infection that are lingering trend toward getting better, even if slowly. If post–COVID-19 infection symptoms are progressing (particularly if rapidly), that would be a strong indication to evaluate that patient in the ED (less likely in clinic), reswab them for SARS-CoV-2, and obtain further testing such as blood work and imaging. A significant challenge from a research perspective will be determining if coinfection with another virus is playing a role as we move closer to the fall season.

tborden@mdedge.com

For some patients, a bout of COVID-19 may not be over after hospital discharge, acute symptoms subside, or a couple of tests for SARS-CoV-2 come back negative. Those who have reached these milestones of conquering the disease may find that their recovery journey has only begun. Debilitating symptoms such as fatigue, headache, and dyspnea may linger for weeks or longer. Patients with persistent symptoms, often referred to as “long haulers” in reference to the duration of their recovery, are looking for answers about their condition and when their COVID-19 illness will finally resolve.

Long-haul patients organize

What started as an accumulation of anecdotal evidence in social media, blogs, and the mainstream press about slow recovery and long-lasting symptoms of COVID-19 is now the focus of clinical trials in the population of recovering patients. Projects such as the COVID Symptom Study, initiated by the Massachusetts General Hospital, Boston; the Harvard School of Public Health, Boston; King’s College London; and Stanford (Calif.) University, are collecting data on symptoms from millions of patients and will eventually contribute to a better understanding of prolonged recovery.

Patients looking for answers have created groups on social media such as Facebook to exchange information about their experiences (e.g., Survivor Corps, COVID-19 Support Group, COVID-19 Recovered Survivors). Recovering patients have created patient-led research organizations (Body Politic COVID-19 Support Group) to explore persistent symptoms and begin to create data for research.
 

Some data on lingering symptoms

A small study of 143 previously hospitalized, recovering patients in Italy found that 87.4% of the cohort had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge. In this sample, only 5% had been intubated. (JAMA 2020 Jul 9. doi: 10.1001/jama.2020.12603).

One study found that even patients who have had relatively mild symptoms and were not hospitalized can have persistent symptoms. The Centers for Disease Control and Prevention conducted a survey of adults who tested positive for the positive reverse transcription–polymerase chain reaction test for SARS-CoV-2 and found that, among the 292 respondents, 35% were still feeling the impact of the disease 2-3 weeks after testing. Fatigue (71%), cough (61%), and headache (61%) were the most commonly reported symptoms. The survey found that delayed recovery was evident in nearly a quarter of 18- to 34-year-olds and in a third of 35- to 49-year-olds who were not sick enough to require hospitalization (MMWR. 2020 Jul 24. doi: 10.15585/mmwr.mm6930e1).

Sachin Gupta, MD, FCCP, ATSF, a pulmonologist and member of the CHEST Physician editorial advisory board, has treated patients with COVID-19 and shared some of his thoughts on the problem of prolonged symptoms of COVID-19.
 

Q: Should clinicians expect to see COVID-19 patients who have symptoms persisting weeks after they are diagnosed?

Dr. Gupta: I think clinicians, especially in primary care, are already seeing many patients with lingering symptoms, both respiratory and nonrespiratory related, and debility. A few patients here in the San Francisco Bay Area that I have spoken with 4-6 weeks out from their acute illness have complained of persisting, though improving, fatigue and cough. Early studies are confirming this as a topical issue. There may be other long-lasting sequelae of COVID-19 beyond the common mild lingering symptoms. It will also be important to consider (and get more data on) to what degree asymptomatic patients develop some degree of mild inflammatory and subsequent fibrotic changes in organs like the lungs and heart

Q: How does the recovery phase of COVID-19 compare with recovery from severe influenza or ARDS?

Dr. Gupta: Most prior influenza and acute respiratory distress syndrome (ARDS) studies have provided initial follow-up at 3 months and beyond, so technically speaking, it is a little difficult to compare the symptomatology patterns in the JAMA study of 2 months on follow-up. Nevertheless, the key takeaway is that, even though few patients in the study had ARDS requiring intubation (severe disease), many patients with milder disease had significant lingering symptoms (55% with three or more symptoms) at 2 months.

This fits logically with the premise, which we have some limited data on with ARDS (N Engl J Med. 2003;348:683-93. doi: 10.1056/NEJMoa022450) and severe influenza infection survivors (Nature Sci Rep. 2017;7:17275. doi: 10.1038/s41598-017-17497-6) that varying degrees of the inflammation cascade triggered by certain viruses can lead to changes in important patient-reported outcomes, and objective measures such as pulmonary function over the long term.

Q: What can you do for patients with lingering symptoms of COVID-19 or what can you tell them about their symptoms?

Dr. Gupta: For many patients, there is fear, given the novel nature of the virus/pandemic, that their symptoms may persist long term. Acknowledgment of their symptoms is validating and important for us to recognize as we learn more about the virus. As we are finding, many patients are going online to find answers, after sometimes feeling rushed or dismissed initially in the clinical setting.

In my experience, the bar is fairly high for most patients to reach out to their physicians with complaints of lingering symptoms after acute infection. For the ones who do reach out, they tend to have either a greater constellation of symptoms or higher severity of one or two key symptoms. After assessing and, when appropriate, ruling out secondary infections or newly developed conditions, I shift toward symptom management. I encourage such patients to build up slowly. I suggest they work first on their activities of daily living (bathing, grooming), then their instrumental activities of daily living (cooking, cleaning, checking the mail), and then to engage, based on their tolerance of symptoms, to light purposeful exercise. There are many online resources for at-home exercise activities that I recommend to patients who are more debilitated; some larger centers are beginning to offer some forms of telepulmonary rehab.

Based on what we know about other causes of viral pneumonitis and ARDS, I ask such symptomatic patients to expect a slow, gradual, and in most cases a complete recovery, and depending on the individual case, I recommend pulmonary function tests and imaging that may be helpful to track that progress.

I remind myself, and patients, that our understanding may change as we learn more over time. Checking in at set intervals, even if not in person but through a phone call, can go a long way in a setting where we do not have a specific therapy, other than gradual exercise training, to help these patients recover faster. Reassurance and encouragement are vital for patients who are struggling with the lingering burden of disease and who may find it difficult to return to work or function as usual at home. The final point is to be mindful of our patient’s mental health and, where our reassurance is not enough, to consider appropriate mental health referrals.

Q: Can you handle this kind of problem with telemedicine or which patients with lingering symptoms need to come into the office – or failing that, the ED?

Dr. Gupta: Telemedicine in the outpatient setting provides a helpful tool to assess and manage patients, in my experience, with limited and straightforward complaints. Its scope is limited diagnostically (assessing symptoms and signs) as is its reach (ability to connect with elderly, disabled, or patients without/limited telemedicine access). In many instances, telemedicine limits our ability to connect with patients emotionally and build trust. Many patients who have gone through the acute illness that we see in pulmonary clinic on follow-up are older in age, and for many, video visits are not a practical solution. Telemedicine visits can sometimes present challenges for me as well in terms of thoroughly conveying lifestyle and symptom management strategies. Health literacy is typically easier to gauge and address in person.

For patients with any degree of enduring dyspnea, more so in the acute phase, I recommend home pulse oximetry for monitoring their oxygen saturation if it is financially and technically feasible for them to obtain one. Sending a patient to the ED is an option of last resort, but one that is necessary in some cases. I expect patients with lingering symptoms to tell me that symptoms may be persisting, hopefully gradually improving, and not getting worse. If post–COVID-19 symptoms such as fever, dyspnea, fatigue, or lightheadedness are new or worsening, particularly rapidly, the safest and best option I advise patients is to go to the ED for further assessment and testing. Postviral bacterial pneumonia is something we should consider, and there is some potential for aspergillosis as well.

Q: Do you have any concerns about patients with asthma, chronic obstructive pulmonary disease, or other pulmonary issues having lingering symptoms that may mask exacerbations or may cause exacerbation of their disease?

Dr. Gupta: So far, patients with chronic lung conditions do not appear to have not been disproportionately affected by the pandemic in terms of absolute numbers or percentage wise compared to the general public. I think that sheltering in place has been readily followed by many of these patients, and in addition, I assume better adherence to their maintenance therapies has likely helped. The very few cases of patients with underlying chronic obstructive pulmonary disease and interstitial lung disease that I have seen have fared very poorly when they were diagnosed with COVID-19 in the hospital. There are emerging data about short-term outcomes from severe COVID-19 infection in patients with interstitial lung disease in Europe (medRxiv. 2020 Jul 17. doi: 10.1101/2020.07.15.20152967), and from physicians treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (Ann Am Thorac Soc. 2020 Jul 29. doi: 10.1513/AnnalsATS.202005-521OC). But so far, little has been published on the outcomes of mild disease in these patients with chronic lung disease.

Q: It’s still early days to know the significance of lingering symptoms. But at what point do you begin to consider the possibility of some kind of relapse? And what is your next move if the symptoms get worse?

Dr. Gupta: COVID-19 recurrence, whether because of reinfection or relapse, is a potential concern but not one that is very commonly seen so far in my purview. Generally, symptoms of post–COVID-19 infection that are lingering trend toward getting better, even if slowly. If post–COVID-19 infection symptoms are progressing (particularly if rapidly), that would be a strong indication to evaluate that patient in the ED (less likely in clinic), reswab them for SARS-CoV-2, and obtain further testing such as blood work and imaging. A significant challenge from a research perspective will be determining if coinfection with another virus is playing a role as we move closer to the fall season.

tborden@mdedge.com

The Food and Drug Administration has approved Evrysdi (risdiplam) for the treatment of adults and children at least 2 months old who have spinal muscular atrophy (SMA). This marks the first approval of an oral therapy for the rare and devastating condition.

Risdiplam, marketed by Roche and PTC Therapeutics, provides “an important treatment option for patients with SMA, following the approval of the first treatment for this devastating disease less than 4 years ago,” Billy Dunn, MD, director of the Office of Neuroscience in the Center for Drug Evaluation and Research at the FDA, said in a release from the agency.

The approval was based on the results from two trials. In the open-label FIREFISH study of infantile-onset SMA, 7 (41%) of the 17 participants (mean baseline age, 6.7 months) were able to sit independently for more than 5 seconds after 12 months of treatment with risdiplam. This was a “meaningful difference from the natural progression of the disease because all untreated infants with infantile-onset SMA cannot sit independently,” the FDA noted. In addition, 81% of the participants were alive after 23 or more months of treatment – and without need of permanent ventilation.

The second study was the randomized controlled trial known as SUNFISH and included 180 patients with SMA between the ages of 2 and 25 years. Those who received the study drug had an average 1.36 increase from baseline on a motor function measure versus a 0.19 decrease in function for those who received placebo.

The FDA noted that the most common treatment-related adverse events (AEs) include fever, diarrhea, rash, ulcers of the mouth, arthralgia, and urinary tract infections. Additional AEs reported in some patients with infantile-onset SMA included upper respiratory tract infection, pneumonia, constipation, and vomiting.

The drug received fast track designation and priority review from the FDA, as well as orphan drug designation.
 

‘Eagerly awaited’

“Today marks an incredibly important moment for the broader SMA patient community that had been in dire need of safe and effective treatment options,” Stuart W. Peltz, PhD, chief executive officer of PTC Therapeutics, said in a company statement.

“Given [that] the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, added in the company’s press release. Genentech is a member of the Roche Group.

The drug is continuing to be studied in more than 450 individuals as part of a “large and robust clinical trial program in SMA,” the company reports. These participants are between the ages of 2 months and 60 years.

“The approval of Evrysdi is an eagerly awaited milestone for our community. We appreciate Genentech’s commitment to … developing a treatment that can be administered at home,” Kenneth Hobby, president of the nonprofit Cure SMA, said in the same release.

In May 2019, the FDA approved the first gene therapy for SMA – the infusion drug onasemnogene abeparvovec-xioi (Zolgensma, AveXis Inc).

Genentech announced that the new oral drug will be available in the United States within 2 weeks “for direct delivery to patients’ homes.”

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

The Food and Drug Administration has approved Evrysdi (risdiplam) for the treatment of adults and children at least 2 months old who have spinal muscular atrophy (SMA). This marks the first approval of an oral therapy for the rare and devastating condition.

Risdiplam, marketed by Roche and PTC Therapeutics, provides “an important treatment option for patients with SMA, following the approval of the first treatment for this devastating disease less than 4 years ago,” Billy Dunn, MD, director of the Office of Neuroscience in the Center for Drug Evaluation and Research at the FDA, said in a release from the agency.

The approval was based on the results from two trials. In the open-label FIREFISH study of infantile-onset SMA, 7 (41%) of the 17 participants (mean baseline age, 6.7 months) were able to sit independently for more than 5 seconds after 12 months of treatment with risdiplam. This was a “meaningful difference from the natural progression of the disease because all untreated infants with infantile-onset SMA cannot sit independently,” the FDA noted. In addition, 81% of the participants were alive after 23 or more months of treatment – and without need of permanent ventilation.

The second study was the randomized controlled trial known as SUNFISH and included 180 patients with SMA between the ages of 2 and 25 years. Those who received the study drug had an average 1.36 increase from baseline on a motor function measure versus a 0.19 decrease in function for those who received placebo.

The FDA noted that the most common treatment-related adverse events (AEs) include fever, diarrhea, rash, ulcers of the mouth, arthralgia, and urinary tract infections. Additional AEs reported in some patients with infantile-onset SMA included upper respiratory tract infection, pneumonia, constipation, and vomiting.

The drug received fast track designation and priority review from the FDA, as well as orphan drug designation.
 

‘Eagerly awaited’

“Today marks an incredibly important moment for the broader SMA patient community that had been in dire need of safe and effective treatment options,” Stuart W. Peltz, PhD, chief executive officer of PTC Therapeutics, said in a company statement.

“Given [that] the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, added in the company’s press release. Genentech is a member of the Roche Group.

The drug is continuing to be studied in more than 450 individuals as part of a “large and robust clinical trial program in SMA,” the company reports. These participants are between the ages of 2 months and 60 years.

“The approval of Evrysdi is an eagerly awaited milestone for our community. We appreciate Genentech’s commitment to … developing a treatment that can be administered at home,” Kenneth Hobby, president of the nonprofit Cure SMA, said in the same release.

In May 2019, the FDA approved the first gene therapy for SMA – the infusion drug onasemnogene abeparvovec-xioi (Zolgensma, AveXis Inc).

Genentech announced that the new oral drug will be available in the United States within 2 weeks “for direct delivery to patients’ homes.”

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

The Food and Drug Administration has approved Evrysdi (risdiplam) for the treatment of adults and children at least 2 months old who have spinal muscular atrophy (SMA). This marks the first approval of an oral therapy for the rare and devastating condition.

Risdiplam, marketed by Roche and PTC Therapeutics, provides “an important treatment option for patients with SMA, following the approval of the first treatment for this devastating disease less than 4 years ago,” Billy Dunn, MD, director of the Office of Neuroscience in the Center for Drug Evaluation and Research at the FDA, said in a release from the agency.

The approval was based on the results from two trials. In the open-label FIREFISH study of infantile-onset SMA, 7 (41%) of the 17 participants (mean baseline age, 6.7 months) were able to sit independently for more than 5 seconds after 12 months of treatment with risdiplam. This was a “meaningful difference from the natural progression of the disease because all untreated infants with infantile-onset SMA cannot sit independently,” the FDA noted. In addition, 81% of the participants were alive after 23 or more months of treatment – and without need of permanent ventilation.

The second study was the randomized controlled trial known as SUNFISH and included 180 patients with SMA between the ages of 2 and 25 years. Those who received the study drug had an average 1.36 increase from baseline on a motor function measure versus a 0.19 decrease in function for those who received placebo.

The FDA noted that the most common treatment-related adverse events (AEs) include fever, diarrhea, rash, ulcers of the mouth, arthralgia, and urinary tract infections. Additional AEs reported in some patients with infantile-onset SMA included upper respiratory tract infection, pneumonia, constipation, and vomiting.

The drug received fast track designation and priority review from the FDA, as well as orphan drug designation.
 

‘Eagerly awaited’

“Today marks an incredibly important moment for the broader SMA patient community that had been in dire need of safe and effective treatment options,” Stuart W. Peltz, PhD, chief executive officer of PTC Therapeutics, said in a company statement.

“Given [that] the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, added in the company’s press release. Genentech is a member of the Roche Group.

The drug is continuing to be studied in more than 450 individuals as part of a “large and robust clinical trial program in SMA,” the company reports. These participants are between the ages of 2 months and 60 years.

“The approval of Evrysdi is an eagerly awaited milestone for our community. We appreciate Genentech’s commitment to … developing a treatment that can be administered at home,” Kenneth Hobby, president of the nonprofit Cure SMA, said in the same release.

In May 2019, the FDA approved the first gene therapy for SMA – the infusion drug onasemnogene abeparvovec-xioi (Zolgensma, AveXis Inc).

Genentech announced that the new oral drug will be available in the United States within 2 weeks “for direct delivery to patients’ homes.”

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