Cardiology News

Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.

RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote. 

In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019. 

The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively). 

The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death. 

Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA. 

The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.

Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).

After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.

The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote. 

Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.

The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status. 

Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded. 

The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.

A version of this article appeared on Medscape.com.

Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.

RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote. 

In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019. 

The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively). 

The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death. 

Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA. 

The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.

Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).

After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.

The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote. 

Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.

The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status. 

Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded. 

The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.

A version of this article appeared on Medscape.com.

Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.

RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote. 

In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019. 

The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively). 

The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death. 

Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA. 

The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.

Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).

After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.

The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote. 

Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.

The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status. 

Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded. 

The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.

A version of this article appeared on Medscape.com.

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

This transcript has been edited for clarity.

Here are 10 ways to improve health communication with patients. These tips will place patients at ease, increase their adherence to recommendations, and make the doctor’s visit a lot more enjoyable for them.
 

No. 1: Be an active listener

The first tip is to be an active listener and help guide the history-taking process by asking for clarification when needed.

Quickly figure out the patient’s chief complaint. Which symptom is the most severe?

Ask them for symptom-modifying factors, such as onset, duration, frequency, and a pain description. Is the abdominal pain sharp or crampy, dull and achy, or pressure-like? What makes the symptoms better or worse?

As many of us were taught in medical school, 80% of the diagnosis is in a patient’s history and description.
 

No. 2: Ask questions that resonate with patients

What can we do to help elicit an accurate history from the patient when they’re not providing the needed information or being helpful enough?

The easiest way is to ask your patient in a completely different way but one that resonates with them. For instance, ask how the abdominal pain is affecting their quality of life. That will help focus the history taking and encourage the patient to share details.

Does the pain keep them awake at night? Are they able to eat a normal-sized meal? Or are they forced to eat tiny snacks? Is the pain interfering with work or school?

By providing a framework, the patient will be more passionate about sharing the details of their history.
 

No. 3: Help patients organize their story

Sometimes, patients provide details in a nonchronological order, jumping all over the place.

A super helpful technique is to explain to the patient that you have a story to write for your computer note, and for them to think back to when they first started noticing their abdominal pain or rectal bleeding symptoms. When were the most-severe episodes? How frequent are the episodes? What’s the volume of their rectal bleeding?

If the patient realizes that you’re trying to write a story synopsis, they will provide information in a much more organized way.
 

No. 4: Determine patient’s language preference

Quickly determine the patient’s language preference. We want patients to feel extremely comfortable.

Whenever possible, use a certified interpreter. Language phone lines, in-person interpreters, and video conferencing are widely available today. It’s worth investing in this technology so that we can provide the best possible care to immigrants and refugees.

Conversely, avoid using family members as interpreters because they may not be adequately trained in medical vocabulary.
 

No. 5: Use simple language

When providing explanations, use simple language that your patient can understand and identify with.

For example, use analogies like “the heart is a pump” or the diverticula are thin areas of the colon that can bleed if the blood vessel is too close to the surface.
 

No. 6: Determine level of medical literacy

Determine your patient’s level of medical literacy. Some of our patients did not graduate from high school. Some patients can’t read very well. Therefore, your discharge instructions and handouts should sometimes be written on a third-grade level.

If patients can’t read, write medication instructions with symbols. Draw a sun for medications that are supposed to be taken in the morning and draw a moon if a medication is supposed to be taken at night.

Always very carefully review the instructions with the patient.
 

No. 7: Check in with the patient

During the visit, frequently check in with the patient to make sure that they understand what you’re asking or what you’re trying to explain to them.

No. 8: Include family member as patient advocate

If the patient is accompanied by a family member, help them serve in the important role as a patient advocate.

If the family member wants to take notes, encourage them because that provides an awesome value.

Sometimes patients can forget clinic and hospital medical conversations, and that family member might be the key to improving your patient’s health.
 

No. 9: Follow-up with the patient

If your clinic has the capability, follow up with a patient the next day to make sure that they understood everything.

Check to make sure the patient was able to pick up all of the medications that you prescribed.

Check that laboratory tests are arranged or completed.

Check that important procedures, such as esophagogastroduodenoscopy and colonoscopy, and imaging, such as ultrasounds and CTs, are scheduled.
 

No. 10: Identify barriers to care

Have fun talking with a patient. Find out what they do for a living. Build a rapport. Listen to their stressors in life.

Try to identify any barriers to care or external stressors, like taking care of a sick parent, which might interfere with their scheduling an important diagnostic colonoscopy for rectal bleeding.

Good luck incorporating these communication strategies into your clinic and hospital work. Together, we can help improve the delivery of health care.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Dr. Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Dr. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

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

This transcript has been edited for clarity.

Here are 10 ways to improve health communication with patients. These tips will place patients at ease, increase their adherence to recommendations, and make the doctor’s visit a lot more enjoyable for them.
 

No. 1: Be an active listener

The first tip is to be an active listener and help guide the history-taking process by asking for clarification when needed.

Quickly figure out the patient’s chief complaint. Which symptom is the most severe?

Ask them for symptom-modifying factors, such as onset, duration, frequency, and a pain description. Is the abdominal pain sharp or crampy, dull and achy, or pressure-like? What makes the symptoms better or worse?

As many of us were taught in medical school, 80% of the diagnosis is in a patient’s history and description.
 

No. 2: Ask questions that resonate with patients

What can we do to help elicit an accurate history from the patient when they’re not providing the needed information or being helpful enough?

The easiest way is to ask your patient in a completely different way but one that resonates with them. For instance, ask how the abdominal pain is affecting their quality of life. That will help focus the history taking and encourage the patient to share details.

Does the pain keep them awake at night? Are they able to eat a normal-sized meal? Or are they forced to eat tiny snacks? Is the pain interfering with work or school?

By providing a framework, the patient will be more passionate about sharing the details of their history.
 

No. 3: Help patients organize their story

Sometimes, patients provide details in a nonchronological order, jumping all over the place.

A super helpful technique is to explain to the patient that you have a story to write for your computer note, and for them to think back to when they first started noticing their abdominal pain or rectal bleeding symptoms. When were the most-severe episodes? How frequent are the episodes? What’s the volume of their rectal bleeding?

If the patient realizes that you’re trying to write a story synopsis, they will provide information in a much more organized way.
 

No. 4: Determine patient’s language preference

Quickly determine the patient’s language preference. We want patients to feel extremely comfortable.

Whenever possible, use a certified interpreter. Language phone lines, in-person interpreters, and video conferencing are widely available today. It’s worth investing in this technology so that we can provide the best possible care to immigrants and refugees.

Conversely, avoid using family members as interpreters because they may not be adequately trained in medical vocabulary.
 

No. 5: Use simple language

When providing explanations, use simple language that your patient can understand and identify with.

For example, use analogies like “the heart is a pump” or the diverticula are thin areas of the colon that can bleed if the blood vessel is too close to the surface.
 

No. 6: Determine level of medical literacy

Determine your patient’s level of medical literacy. Some of our patients did not graduate from high school. Some patients can’t read very well. Therefore, your discharge instructions and handouts should sometimes be written on a third-grade level.

If patients can’t read, write medication instructions with symbols. Draw a sun for medications that are supposed to be taken in the morning and draw a moon if a medication is supposed to be taken at night.

Always very carefully review the instructions with the patient.
 

No. 7: Check in with the patient

During the visit, frequently check in with the patient to make sure that they understand what you’re asking or what you’re trying to explain to them.

No. 8: Include family member as patient advocate

If the patient is accompanied by a family member, help them serve in the important role as a patient advocate.

If the family member wants to take notes, encourage them because that provides an awesome value.

Sometimes patients can forget clinic and hospital medical conversations, and that family member might be the key to improving your patient’s health.
 

No. 9: Follow-up with the patient

If your clinic has the capability, follow up with a patient the next day to make sure that they understood everything.

Check to make sure the patient was able to pick up all of the medications that you prescribed.

Check that laboratory tests are arranged or completed.

Check that important procedures, such as esophagogastroduodenoscopy and colonoscopy, and imaging, such as ultrasounds and CTs, are scheduled.
 

No. 10: Identify barriers to care

Have fun talking with a patient. Find out what they do for a living. Build a rapport. Listen to their stressors in life.

Try to identify any barriers to care or external stressors, like taking care of a sick parent, which might interfere with their scheduling an important diagnostic colonoscopy for rectal bleeding.

Good luck incorporating these communication strategies into your clinic and hospital work. Together, we can help improve the delivery of health care.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Dr. Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Dr. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

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

This transcript has been edited for clarity.

Here are 10 ways to improve health communication with patients. These tips will place patients at ease, increase their adherence to recommendations, and make the doctor’s visit a lot more enjoyable for them.
 

No. 1: Be an active listener

The first tip is to be an active listener and help guide the history-taking process by asking for clarification when needed.

Quickly figure out the patient’s chief complaint. Which symptom is the most severe?

Ask them for symptom-modifying factors, such as onset, duration, frequency, and a pain description. Is the abdominal pain sharp or crampy, dull and achy, or pressure-like? What makes the symptoms better or worse?

As many of us were taught in medical school, 80% of the diagnosis is in a patient’s history and description.
 

No. 2: Ask questions that resonate with patients

What can we do to help elicit an accurate history from the patient when they’re not providing the needed information or being helpful enough?

The easiest way is to ask your patient in a completely different way but one that resonates with them. For instance, ask how the abdominal pain is affecting their quality of life. That will help focus the history taking and encourage the patient to share details.

Does the pain keep them awake at night? Are they able to eat a normal-sized meal? Or are they forced to eat tiny snacks? Is the pain interfering with work or school?

By providing a framework, the patient will be more passionate about sharing the details of their history.
 

No. 3: Help patients organize their story

Sometimes, patients provide details in a nonchronological order, jumping all over the place.

A super helpful technique is to explain to the patient that you have a story to write for your computer note, and for them to think back to when they first started noticing their abdominal pain or rectal bleeding symptoms. When were the most-severe episodes? How frequent are the episodes? What’s the volume of their rectal bleeding?

If the patient realizes that you’re trying to write a story synopsis, they will provide information in a much more organized way.
 

No. 4: Determine patient’s language preference

Quickly determine the patient’s language preference. We want patients to feel extremely comfortable.

Whenever possible, use a certified interpreter. Language phone lines, in-person interpreters, and video conferencing are widely available today. It’s worth investing in this technology so that we can provide the best possible care to immigrants and refugees.

Conversely, avoid using family members as interpreters because they may not be adequately trained in medical vocabulary.
 

No. 5: Use simple language

When providing explanations, use simple language that your patient can understand and identify with.

For example, use analogies like “the heart is a pump” or the diverticula are thin areas of the colon that can bleed if the blood vessel is too close to the surface.
 

No. 6: Determine level of medical literacy

Determine your patient’s level of medical literacy. Some of our patients did not graduate from high school. Some patients can’t read very well. Therefore, your discharge instructions and handouts should sometimes be written on a third-grade level.

If patients can’t read, write medication instructions with symbols. Draw a sun for medications that are supposed to be taken in the morning and draw a moon if a medication is supposed to be taken at night.

Always very carefully review the instructions with the patient.
 

No. 7: Check in with the patient

During the visit, frequently check in with the patient to make sure that they understand what you’re asking or what you’re trying to explain to them.

No. 8: Include family member as patient advocate

If the patient is accompanied by a family member, help them serve in the important role as a patient advocate.

If the family member wants to take notes, encourage them because that provides an awesome value.

Sometimes patients can forget clinic and hospital medical conversations, and that family member might be the key to improving your patient’s health.
 

No. 9: Follow-up with the patient

If your clinic has the capability, follow up with a patient the next day to make sure that they understood everything.

Check to make sure the patient was able to pick up all of the medications that you prescribed.

Check that laboratory tests are arranged or completed.

Check that important procedures, such as esophagogastroduodenoscopy and colonoscopy, and imaging, such as ultrasounds and CTs, are scheduled.
 

No. 10: Identify barriers to care

Have fun talking with a patient. Find out what they do for a living. Build a rapport. Listen to their stressors in life.

Try to identify any barriers to care or external stressors, like taking care of a sick parent, which might interfere with their scheduling an important diagnostic colonoscopy for rectal bleeding.

Good luck incorporating these communication strategies into your clinic and hospital work. Together, we can help improve the delivery of health care.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Dr. Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Dr. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

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

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

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

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

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

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

A new study shows that although postoperative cognitive dysfunction can occur following catheter ablation for atrial fibrillation (AFib), it is transient, and patients recover completely within a year.

Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.

Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.

The study was published online in the July issue of JACC: Clinical Electrophysiology.
 

Important pillar

Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.

Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.

The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.

Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).

Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.

AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.

Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).

Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.

The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
 

More research needed

Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.

At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)

But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).

Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).

When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.

At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).

Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).

As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).

“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.

They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
 

‘Reassuring’ findings

In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.

Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.

Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.

Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”

Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”

The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.

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

A new study shows that although postoperative cognitive dysfunction can occur following catheter ablation for atrial fibrillation (AFib), it is transient, and patients recover completely within a year.

Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.

Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.

The study was published online in the July issue of JACC: Clinical Electrophysiology.
 

Important pillar

Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.

Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.

The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.

Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).

Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.

AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.

Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).

Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.

The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
 

More research needed

Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.

At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)

But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).

Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).

When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.

At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).

Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).

As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).

“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.

They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
 

‘Reassuring’ findings

In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.

Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.

Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.

Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”

Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”

The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.

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

A new study shows that although postoperative cognitive dysfunction can occur following catheter ablation for atrial fibrillation (AFib), it is transient, and patients recover completely within a year.

Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.

Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.

The study was published online in the July issue of JACC: Clinical Electrophysiology.
 

Important pillar

Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.

Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.

The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.

Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).

Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.

AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.

Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).

Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.

The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
 

More research needed

Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.

At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)

But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).

Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).

When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.

At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).

Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).

As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).

“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.

They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
 

‘Reassuring’ findings

In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.

Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.

Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.

Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”

Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”

The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to Recall.39004@ge.com.

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to Recall.39004@ge.com.

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to Recall.39004@ge.com.

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.