What is the real risk of smart phones in medicine?

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Mon, 08/09/2021 - 14:47

 

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

 

 

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

 

 

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

 

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

 

 

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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The Cures Act: Is the “cure” worse than the disease?

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Thu, 06/17/2021 - 11:03

 

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

smartphone_hand_web.jpg

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

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Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

smartphone_hand_web.jpg

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

 

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

smartphone_hand_web.jpg

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

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Change is hard: Lessons from an EHR conversion

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Thu, 03/25/2021 - 14:49

ecently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

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Dr. Chris Notte and Dr. Neil Skolnik

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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ecently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

ecently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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Home devices screen for atrial fibrillation

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Changed
Wed, 02/24/2021 - 12:47

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.1 In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.2

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.3 Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.4,5
 

What should we do with the results?

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

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If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.1 In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.2

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.3 Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.4,5
 

What should we do with the results?

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.1 In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.2

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.3 Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.4,5
 

What should we do with the results?

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

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Medication adherence challenges and helpers

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Changed
Tue, 05/03/2022 - 15:08

Medication adherence remains a truly challenging issue. For most chronic diseases, up to 20%-30% of the pills that are prescribed are not taken. In the case of inhalers for asthma and COPD, patients miss over half of the prescribed doses.

There are many things that contribute to the problem of poor adherence, but people often just simply forget. Thankfully, there are tools designed to help remind patients of what they need to take and when. A survey of apps developed to help patients remember to take their medicines found more than 700 available in Apple and Android app stores.1 Most apps focus on medication alerts, reminders, and medication logs.2 A recent review showed that apps have some – yet limited – effectiveness in increasing adherence, with patient self-reported improvements of 7%-40%.3

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Another perhaps more promising area of improving adherence involves high-tech advances in the way medications can be taken. Inhalers are a primary target as they are complicated devices. A patient has to breathe in at the correct time after the inhaler is actuated, and the inhaler works optimally only if the rate of inhalation is sufficient to carry the medication into the lungs.

A number of companies have developed attachments for inhalers (and even inhalers themselves) that can record when the medication is taken through a Bluetooth connection to a patient’s smartphone. These can also assess inspiratory flow. Reminders to take the medication are built into the app, and those reminders disappear if the medication is taken. Patients can receive feedback about the quality of their timing and inspiratory rate to maximize medication delivery to the lungs.4

We learned long ago that it is difficult to take medications three to four times a day, so extended-release tablets were developed to reduce the frequency to once or twice a day. A great deal of work is now being done behind the scenes to develop medications that decrease the need for patients to remember to take their medications. The best examples of this are the long-acting reversible contraception (LARC) devices, specifically IUDs and Nexplanon. Compared with traditional oral contraceptives that need to be taken daily, LARCs reduce the rate of pregnancy by five- to tenfold.

We also now have medications for osteoporosis that can be taken monthly, or even annually. When bisphosphonates were first developed for osteoporosis prevention, they needed to be taken daily. Then a weekly bisphosphonate was developed. Now there is a once-monthly oral bisphosphonate, Ibandronate, and even a once yearly IV bisphosphonate.

Exciting developments have also occurred in the management of diabetes. We may be tempted to take for granted how once-daily long-acting insulin, which releases insulin slowly over the course of a day, has revolutionized the diabetic treatment since its Food and Drug Administration approval in 2000. Yet progress did not end there. The first GLP-1 receptor agonist for diabetes was approved in 2005 and was a twice-a-day medicine. Shortly afterward, a daily GLP-1 was approved, and now there are three once-weekly GLP-1 receptor agonists.

Several pharmaceutical manufacturers are now working on a once-weekly insulin,5 as well as an implantable GLP-1 receptor agonist that will need to be replaced every 6-12 months.6 Imagine your patient coming in once a year to replace his or her potent glucose lowering medication – one that offers a low incidence of hypoglycemia, maintains glucose control all year long, and requires no adherence to a complicated medication regimen.

Similar technology is being used to develop a once-yearly anti-HIV prophylactic medication delivery system.7 This could help prevent the spread of HIV in areas of the world where it may be difficult for people to take daily medications.7

The many technological advances we have described may help us reduce our likelihood of missing a dose of a medication. We are hopeful that progress in this area will continue, and that one day medication adherence will require even less effort from patients than it does today.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Tabi K et al. Mobile apps for medication management: Review and analysis. JMIR Mhealth Uhealth. 2019 Sep 7(9):13608.

2. Park JYE et al. Mobile phone apps targeting medication adherence: Quality assessment and content analysis of user reviews. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11919.

3. Pérez-Jover V et al. Mobile apps for increasing treatment adherence: Systematic review. J Med Internet Res. 2019;21(6):e12505. doi: 10.2196/12505.

4. 4 Smart inhalers that could be lifesaving for people living with asthma & COPD. MyTherapy, July 11, 2019.

5. Rosenstock J et al. Once-weekly insulin for type 2 diabetes without previous insulin treatment. N Engl J Med. 2020 Sep 22. doi: 10.1056/NEJMoa2022474.

6. GLP-1 agonists: From 2 daily injections to 1 per week and beyond. DiaTribe, Jan. 10, 2018.

7. Long-acting HIV prevention tools. Hiv.gov, July 20, 2019.

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Medication adherence remains a truly challenging issue. For most chronic diseases, up to 20%-30% of the pills that are prescribed are not taken. In the case of inhalers for asthma and COPD, patients miss over half of the prescribed doses.

There are many things that contribute to the problem of poor adherence, but people often just simply forget. Thankfully, there are tools designed to help remind patients of what they need to take and when. A survey of apps developed to help patients remember to take their medicines found more than 700 available in Apple and Android app stores.1 Most apps focus on medication alerts, reminders, and medication logs.2 A recent review showed that apps have some – yet limited – effectiveness in increasing adherence, with patient self-reported improvements of 7%-40%.3

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Another perhaps more promising area of improving adherence involves high-tech advances in the way medications can be taken. Inhalers are a primary target as they are complicated devices. A patient has to breathe in at the correct time after the inhaler is actuated, and the inhaler works optimally only if the rate of inhalation is sufficient to carry the medication into the lungs.

A number of companies have developed attachments for inhalers (and even inhalers themselves) that can record when the medication is taken through a Bluetooth connection to a patient’s smartphone. These can also assess inspiratory flow. Reminders to take the medication are built into the app, and those reminders disappear if the medication is taken. Patients can receive feedback about the quality of their timing and inspiratory rate to maximize medication delivery to the lungs.4

We learned long ago that it is difficult to take medications three to four times a day, so extended-release tablets were developed to reduce the frequency to once or twice a day. A great deal of work is now being done behind the scenes to develop medications that decrease the need for patients to remember to take their medications. The best examples of this are the long-acting reversible contraception (LARC) devices, specifically IUDs and Nexplanon. Compared with traditional oral contraceptives that need to be taken daily, LARCs reduce the rate of pregnancy by five- to tenfold.

We also now have medications for osteoporosis that can be taken monthly, or even annually. When bisphosphonates were first developed for osteoporosis prevention, they needed to be taken daily. Then a weekly bisphosphonate was developed. Now there is a once-monthly oral bisphosphonate, Ibandronate, and even a once yearly IV bisphosphonate.

Exciting developments have also occurred in the management of diabetes. We may be tempted to take for granted how once-daily long-acting insulin, which releases insulin slowly over the course of a day, has revolutionized the diabetic treatment since its Food and Drug Administration approval in 2000. Yet progress did not end there. The first GLP-1 receptor agonist for diabetes was approved in 2005 and was a twice-a-day medicine. Shortly afterward, a daily GLP-1 was approved, and now there are three once-weekly GLP-1 receptor agonists.

Several pharmaceutical manufacturers are now working on a once-weekly insulin,5 as well as an implantable GLP-1 receptor agonist that will need to be replaced every 6-12 months.6 Imagine your patient coming in once a year to replace his or her potent glucose lowering medication – one that offers a low incidence of hypoglycemia, maintains glucose control all year long, and requires no adherence to a complicated medication regimen.

Similar technology is being used to develop a once-yearly anti-HIV prophylactic medication delivery system.7 This could help prevent the spread of HIV in areas of the world where it may be difficult for people to take daily medications.7

The many technological advances we have described may help us reduce our likelihood of missing a dose of a medication. We are hopeful that progress in this area will continue, and that one day medication adherence will require even less effort from patients than it does today.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Tabi K et al. Mobile apps for medication management: Review and analysis. JMIR Mhealth Uhealth. 2019 Sep 7(9):13608.

2. Park JYE et al. Mobile phone apps targeting medication adherence: Quality assessment and content analysis of user reviews. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11919.

3. Pérez-Jover V et al. Mobile apps for increasing treatment adherence: Systematic review. J Med Internet Res. 2019;21(6):e12505. doi: 10.2196/12505.

4. 4 Smart inhalers that could be lifesaving for people living with asthma & COPD. MyTherapy, July 11, 2019.

5. Rosenstock J et al. Once-weekly insulin for type 2 diabetes without previous insulin treatment. N Engl J Med. 2020 Sep 22. doi: 10.1056/NEJMoa2022474.

6. GLP-1 agonists: From 2 daily injections to 1 per week and beyond. DiaTribe, Jan. 10, 2018.

7. Long-acting HIV prevention tools. Hiv.gov, July 20, 2019.

Medication adherence remains a truly challenging issue. For most chronic diseases, up to 20%-30% of the pills that are prescribed are not taken. In the case of inhalers for asthma and COPD, patients miss over half of the prescribed doses.

There are many things that contribute to the problem of poor adherence, but people often just simply forget. Thankfully, there are tools designed to help remind patients of what they need to take and when. A survey of apps developed to help patients remember to take their medicines found more than 700 available in Apple and Android app stores.1 Most apps focus on medication alerts, reminders, and medication logs.2 A recent review showed that apps have some – yet limited – effectiveness in increasing adherence, with patient self-reported improvements of 7%-40%.3

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

Another perhaps more promising area of improving adherence involves high-tech advances in the way medications can be taken. Inhalers are a primary target as they are complicated devices. A patient has to breathe in at the correct time after the inhaler is actuated, and the inhaler works optimally only if the rate of inhalation is sufficient to carry the medication into the lungs.

A number of companies have developed attachments for inhalers (and even inhalers themselves) that can record when the medication is taken through a Bluetooth connection to a patient’s smartphone. These can also assess inspiratory flow. Reminders to take the medication are built into the app, and those reminders disappear if the medication is taken. Patients can receive feedback about the quality of their timing and inspiratory rate to maximize medication delivery to the lungs.4

We learned long ago that it is difficult to take medications three to four times a day, so extended-release tablets were developed to reduce the frequency to once or twice a day. A great deal of work is now being done behind the scenes to develop medications that decrease the need for patients to remember to take their medications. The best examples of this are the long-acting reversible contraception (LARC) devices, specifically IUDs and Nexplanon. Compared with traditional oral contraceptives that need to be taken daily, LARCs reduce the rate of pregnancy by five- to tenfold.

We also now have medications for osteoporosis that can be taken monthly, or even annually. When bisphosphonates were first developed for osteoporosis prevention, they needed to be taken daily. Then a weekly bisphosphonate was developed. Now there is a once-monthly oral bisphosphonate, Ibandronate, and even a once yearly IV bisphosphonate.

Exciting developments have also occurred in the management of diabetes. We may be tempted to take for granted how once-daily long-acting insulin, which releases insulin slowly over the course of a day, has revolutionized the diabetic treatment since its Food and Drug Administration approval in 2000. Yet progress did not end there. The first GLP-1 receptor agonist for diabetes was approved in 2005 and was a twice-a-day medicine. Shortly afterward, a daily GLP-1 was approved, and now there are three once-weekly GLP-1 receptor agonists.

Several pharmaceutical manufacturers are now working on a once-weekly insulin,5 as well as an implantable GLP-1 receptor agonist that will need to be replaced every 6-12 months.6 Imagine your patient coming in once a year to replace his or her potent glucose lowering medication – one that offers a low incidence of hypoglycemia, maintains glucose control all year long, and requires no adherence to a complicated medication regimen.

Similar technology is being used to develop a once-yearly anti-HIV prophylactic medication delivery system.7 This could help prevent the spread of HIV in areas of the world where it may be difficult for people to take daily medications.7

The many technological advances we have described may help us reduce our likelihood of missing a dose of a medication. We are hopeful that progress in this area will continue, and that one day medication adherence will require even less effort from patients than it does today.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Tabi K et al. Mobile apps for medication management: Review and analysis. JMIR Mhealth Uhealth. 2019 Sep 7(9):13608.

2. Park JYE et al. Mobile phone apps targeting medication adherence: Quality assessment and content analysis of user reviews. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11919.

3. Pérez-Jover V et al. Mobile apps for increasing treatment adherence: Systematic review. J Med Internet Res. 2019;21(6):e12505. doi: 10.2196/12505.

4. 4 Smart inhalers that could be lifesaving for people living with asthma & COPD. MyTherapy, July 11, 2019.

5. Rosenstock J et al. Once-weekly insulin for type 2 diabetes without previous insulin treatment. N Engl J Med. 2020 Sep 22. doi: 10.1056/NEJMoa2022474.

6. GLP-1 agonists: From 2 daily injections to 1 per week and beyond. DiaTribe, Jan. 10, 2018.

7. Long-acting HIV prevention tools. Hiv.gov, July 20, 2019.

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Medscape Article

What to do when a patient is not ready to stop smoking

Article Type
Changed
Thu, 09/24/2020 - 14:10

Recommendations from the American Thoracic Society

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Sprogell_Anne_Skolnik_Neil_web.jpg
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

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Recommendations from the American Thoracic Society

Recommendations from the American Thoracic Society

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Sprogell_Anne_Skolnik_Neil_web.jpg
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Sprogell_Anne_Skolnik_Neil_web.jpg
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

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Smart health devices – promises and pitfalls

Article Type
Changed
Tue, 05/03/2022 - 15:08

What needs to be done before the data deluge hits the office

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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What needs to be done before the data deluge hits the office

What needs to be done before the data deluge hits the office

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

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Pharmacologic Management of COPD

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Fri, 09/18/2020 - 16:04

A Discussion of the new American Thoracic Society Clinical Practice Guideline

Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1The American Thoracic Society released a guideline on the pharmacologic management of COPD after formulating specific questions to be answered using rigorous GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.2

Recommendation 1

Skolnik_Neil_Abington_web.jpg
Dr. Neil Skolnik

Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.

This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.

The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.

The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
 

Recommendation 2

Matthews_Jeffrey_Abington_web.jpg
Dr. Jeffrey Matthews

In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.

In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
 

Recommendation 3

In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.

It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
 

 

 

Recommendation 4

ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.

An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
 

Recommendation 5

In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.

It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
 

The Bottom Line

Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.

Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.

References

1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.

2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.

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A Discussion of the new American Thoracic Society Clinical Practice Guideline

A Discussion of the new American Thoracic Society Clinical Practice Guideline

Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1The American Thoracic Society released a guideline on the pharmacologic management of COPD after formulating specific questions to be answered using rigorous GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.2

Recommendation 1

Skolnik_Neil_Abington_web.jpg
Dr. Neil Skolnik

Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.

This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.

The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.

The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
 

Recommendation 2

Matthews_Jeffrey_Abington_web.jpg
Dr. Jeffrey Matthews

In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.

In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
 

Recommendation 3

In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.

It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
 

 

 

Recommendation 4

ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.

An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
 

Recommendation 5

In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.

It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
 

The Bottom Line

Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.

Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.

References

1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.

2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.

Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1The American Thoracic Society released a guideline on the pharmacologic management of COPD after formulating specific questions to be answered using rigorous GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.2

Recommendation 1

Skolnik_Neil_Abington_web.jpg
Dr. Neil Skolnik

Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.

This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.

The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.

The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
 

Recommendation 2

Matthews_Jeffrey_Abington_web.jpg
Dr. Jeffrey Matthews

In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.

In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
 

Recommendation 3

In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.

It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
 

 

 

Recommendation 4

ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.

An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
 

Recommendation 5

In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.

It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
 

The Bottom Line

Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.

Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.

References

1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.

2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.

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Patient visits post COVID-19

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Thu, 08/26/2021 - 16:01

Has telemedicine found its footing?

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

Telemedicine_dr_patient_web.jpg

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

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Has telemedicine found its footing?

Has telemedicine found its footing?

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

Telemedicine_dr_patient_web.jpg

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

Telemedicine_dr_patient_web.jpg

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Skolnik_and_Notte_web.jpg
Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

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Treatment for a tobacco-dependent adult

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Thu, 08/20/2020 - 15:48

Applying American Thoracic Society’s new clinical practice guideline

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Sprogell_Anne_Skolnik_Neil_web.jpg
%3Cp%3EDr.%20Anne%20Sprogell%20and%20Dr.%20Neil%20Skolnik%3C%2Fp%3E


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

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Applying American Thoracic Society’s new clinical practice guideline

Applying American Thoracic Society’s new clinical practice guideline

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Sprogell_Anne_Skolnik_Neil_web.jpg
%3Cp%3EDr.%20Anne%20Sprogell%20and%20Dr.%20Neil%20Skolnik%3C%2Fp%3E


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Sprogell_Anne_Skolnik_Neil_web.jpg
%3Cp%3EDr.%20Anne%20Sprogell%20and%20Dr.%20Neil%20Skolnik%3C%2Fp%3E


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

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