Federal Practitioner

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

In a joint discussion with European counterparts, the top US regulator for cancer medicines called for the streamlining of processes for testing oncology medicines and for a greater focus on designing research that answers the most important questions raised by physicians and their patients.

Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.

“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.

Dr. Pazdur said informed consent forms can be “mind-boggling” these days.

“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”

Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).

The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?

Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.

“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.

Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.

“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.

She noted that advances in treatment have also let some female patients get pregnant and have children.

“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.

Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.

“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.

 

Seeking clinician feedback

To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.

The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.

“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.

He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.

Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.

The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.

“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.

In a joint discussion with European counterparts, the top US regulator for cancer medicines called for the streamlining of processes for testing oncology medicines and for a greater focus on designing research that answers the most important questions raised by physicians and their patients.

Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.

“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.

Dr. Pazdur said informed consent forms can be “mind-boggling” these days.

“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”

Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).

The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?

Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.

“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.

Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.

“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.

She noted that advances in treatment have also let some female patients get pregnant and have children.

“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.

Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.

“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.

 

Seeking clinician feedback

To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.

The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.

“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.

He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.

Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.

The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.

“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.

In a joint discussion with European counterparts, the top US regulator for cancer medicines called for the streamlining of processes for testing oncology medicines and for a greater focus on designing research that answers the most important questions raised by physicians and their patients.

Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.

“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.

Dr. Pazdur said informed consent forms can be “mind-boggling” these days.

“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”

Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).

The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?

Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.

“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.

Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.

“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.

She noted that advances in treatment have also let some female patients get pregnant and have children.

“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.

Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.

“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.

 

Seeking clinician feedback

To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.

The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.

“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.

He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.

Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.

The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.

“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.

An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.

He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.

What medication adjustments would you recommend?

A. Begin insulin glargine at bedtime

B. Begin mealtime insulin aspart

C. Begin semaglutide

D. Begin metformin

E. No changes

I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.¹

In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.

I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.

I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.^2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.

The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.⁴ Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.


Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.

2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.

3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.

4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.

An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.

He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.

What medication adjustments would you recommend?

A. Begin insulin glargine at bedtime

B. Begin mealtime insulin aspart

C. Begin semaglutide

D. Begin metformin

E. No changes

I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.¹

In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.

I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.

I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.^2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.

The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.⁴ Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.


Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.

2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.

3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.

4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.

An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.

He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.

What medication adjustments would you recommend?

A. Begin insulin glargine at bedtime

B. Begin mealtime insulin aspart

C. Begin semaglutide

D. Begin metformin

E. No changes

I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.¹

In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.

I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.

I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.^2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.

The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.⁴ Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.


Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.

2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.

3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.

4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.

Telemedicine visits skyrocketed during the pandemic, but a new lawsuit alleges that the return to pre-COVID licensing mandates unnecessarily restricts interstate medical practice and reduces patients’ ability to get care from specialists.

In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.

While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.

Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.

“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.

She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.

The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.

The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.

After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.

Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.

Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.

New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
 

Telehealth in a Post-COVID World

“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”

Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.

“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.

The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.

“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”

Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.

In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.

Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
 

A version of this article appeared on Medscape.com.

Telemedicine visits skyrocketed during the pandemic, but a new lawsuit alleges that the return to pre-COVID licensing mandates unnecessarily restricts interstate medical practice and reduces patients’ ability to get care from specialists.

In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.

While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.

Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.

“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.

She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.

The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.

The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.

After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.

Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.

Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.

New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
 

Telehealth in a Post-COVID World

“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”

Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.

“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.

The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.

“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”

Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.

In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.

Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
 

A version of this article appeared on Medscape.com.

Telemedicine visits skyrocketed during the pandemic, but a new lawsuit alleges that the return to pre-COVID licensing mandates unnecessarily restricts interstate medical practice and reduces patients’ ability to get care from specialists.

In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.

While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.

Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.

“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.

She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.

The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.

The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.

After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.

Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.

Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.

New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
 

Telehealth in a Post-COVID World

“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”

Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.

“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.

The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.

“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”

Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.

In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.

Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
 

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.

Why Are Juries Awarding Higher Verdicts?

There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.

One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.

Another theory is that people emerged from the pandemic angrier.

“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”

“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.

Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.

“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.

Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.

Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.

“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.

Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.

“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”

Do High Awards Actually Stick?

Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?

Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.

In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.

A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.

After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.

Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.

“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”

The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.

Higher medical malpractice premiums are another consequence of massive awards.

Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.

Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.

From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.

“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”

However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.

In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.

“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
 

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.

Why Are Juries Awarding Higher Verdicts?

There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.

One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.

Another theory is that people emerged from the pandemic angrier.

“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”

“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.

Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.

“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.

Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.

Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.

“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.

Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.

“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”

Do High Awards Actually Stick?

Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?

Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.

In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.

A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.

After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.

Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.

“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”

The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.

Higher medical malpractice premiums are another consequence of massive awards.

Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.

Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.

From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.

“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”

However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.

In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.

“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
 

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.