Prognoses remain extremely poor after hypomethylating agents (HMAs) fail in patients with higher-risk myelodysplastic syndromes (HR-MDS). But a hematologist-oncologist told colleagues that novel therapies are in the works, and some show promise.

Still, “the clinical development for drugs in this setting has been quite challenging, and we have had a lot of drugs that have died in this space over the years,” cautioned Amer Zeidan, MBBS, MHS, an associate professor at Yale University, New Haven, Conn., in a presentation at the virtual Acute Leukemia Forum of Hemedicus. For now, “the best way to manage HMA failure in MDS patients is by preventing HMA failure.”

Dr. Zeidan highlighted a 2016 study – which he led – that found the median overall survival from diagnosis was just a median of 17.0 months (95% confidence interval, 15.8-18.4) in 632 patients with HR-MDS. Another 2016 study, which he also led, reported median overall survival of 11 months (95% CI, 10-14) and 12 months (95% CI, 11-16; P = .26) for patients aged 66 or older who had HR-MDS and took azacitidine and decitabine, respectively. Median survival is even shorter after HMA failure, he said.

The most important obstacle to effective therapy is “the biologic and molecular heterogeneity of the disease,” he said. “Only a certain number of genes are altered in a significant number of patients. And then you have a very long tail, with so many alterations, but most of them are rare. That makes targeting all patients with the same mechanism quite challenging. Also, we poorly understand how hypomethylating agents work and the mechanism of primary and secondary failure. And many MDS patients are older with multiple conditions, multiple comorbidities. By the time of failure, they are generally beaten up and very difficult to enroll in clinical trials.”

Even so, he said, “the understanding of the molecular pathogenesis of MDS is starting to open the door for new drug development opportunities. What’s been changing over the last 5 years is an increased understanding of targeting some of the alterations that are specific to the patient – individualized targeting or precision medicine.”
 

Novel therapies

Dr. Zeidan said the novel therapies for HR-MDS after HMA failure fall into these categories: molecularly targeted agents, genetically agnostic small-molecule inhibitors, immunotherapies, and chemotherapy/epigenetic agents.

Multiple trials, for example, are examining a chemotherapy treatment CPX-351 (liposomal cytarabine-daunorubicin) in HR-MDS, and a 2018 study showed improvement in median survival in older patients with newly diagnosed secondary acute myeloid leukemia. “However, this remains an investigational treatment,” Dr. Zeidan cautioned.

Venetoclax is also being studied. Animal and cell culture data suggest there may be helpful synergistic activity between venetoclax and azacitidine in both the frontline and relapse settings. Dr. Zeidan highlighted his own 2019 report on a phase 1b study of venetoclax versus venetoclax and azacitidine in the HMA failure/HR-MDS setting. The results are “quite exciting,” he said.

The report noted that, “although the study is still ongoing, the 6-month OS [overall survival] estimate of 57% in monotherapy [patients] compares favorably to historical controls.”

Glasdegib is “another drug of interest,” although it’s mostly been studied in the frontline setting, he said, and “we don’t have much data with this drug in the refractory setting for MDS patients.” APR-246 is also intriguing, he said, but again lacks data in the refractory setting.

Dr. Zeidan noted research into other treatments – rigosertib (recent findings have been disappointing), ivosidenib for IDH1-mutated MDS, AG221-001 and enasidenib (targeting IDH2 mutations), trametinib (targeting RAS pathway mutations), and others. For now, “clinical trial participation should be the best way to manage these patients.”

Dr. Zeidan disclosed multiple disclosures, including relationships with Pfizer, Novartis, Abbvie, Pfizer, Medimmune/AstraZeneca and Boehringer Ingelheim, among others.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

Prognoses remain extremely poor after hypomethylating agents (HMAs) fail in patients with higher-risk myelodysplastic syndromes (HR-MDS). But a hematologist-oncologist told colleagues that novel therapies are in the works, and some show promise.

Still, “the clinical development for drugs in this setting has been quite challenging, and we have had a lot of drugs that have died in this space over the years,” cautioned Amer Zeidan, MBBS, MHS, an associate professor at Yale University, New Haven, Conn., in a presentation at the virtual Acute Leukemia Forum of Hemedicus. For now, “the best way to manage HMA failure in MDS patients is by preventing HMA failure.”

Dr. Zeidan highlighted a 2016 study – which he led – that found the median overall survival from diagnosis was just a median of 17.0 months (95% confidence interval, 15.8-18.4) in 632 patients with HR-MDS. Another 2016 study, which he also led, reported median overall survival of 11 months (95% CI, 10-14) and 12 months (95% CI, 11-16; P = .26) for patients aged 66 or older who had HR-MDS and took azacitidine and decitabine, respectively. Median survival is even shorter after HMA failure, he said.

The most important obstacle to effective therapy is “the biologic and molecular heterogeneity of the disease,” he said. “Only a certain number of genes are altered in a significant number of patients. And then you have a very long tail, with so many alterations, but most of them are rare. That makes targeting all patients with the same mechanism quite challenging. Also, we poorly understand how hypomethylating agents work and the mechanism of primary and secondary failure. And many MDS patients are older with multiple conditions, multiple comorbidities. By the time of failure, they are generally beaten up and very difficult to enroll in clinical trials.”

Even so, he said, “the understanding of the molecular pathogenesis of MDS is starting to open the door for new drug development opportunities. What’s been changing over the last 5 years is an increased understanding of targeting some of the alterations that are specific to the patient – individualized targeting or precision medicine.”
 

Novel therapies

Dr. Zeidan said the novel therapies for HR-MDS after HMA failure fall into these categories: molecularly targeted agents, genetically agnostic small-molecule inhibitors, immunotherapies, and chemotherapy/epigenetic agents.

Multiple trials, for example, are examining a chemotherapy treatment CPX-351 (liposomal cytarabine-daunorubicin) in HR-MDS, and a 2018 study showed improvement in median survival in older patients with newly diagnosed secondary acute myeloid leukemia. “However, this remains an investigational treatment,” Dr. Zeidan cautioned.

Venetoclax is also being studied. Animal and cell culture data suggest there may be helpful synergistic activity between venetoclax and azacitidine in both the frontline and relapse settings. Dr. Zeidan highlighted his own 2019 report on a phase 1b study of venetoclax versus venetoclax and azacitidine in the HMA failure/HR-MDS setting. The results are “quite exciting,” he said.

The report noted that, “although the study is still ongoing, the 6-month OS [overall survival] estimate of 57% in monotherapy [patients] compares favorably to historical controls.”

Glasdegib is “another drug of interest,” although it’s mostly been studied in the frontline setting, he said, and “we don’t have much data with this drug in the refractory setting for MDS patients.” APR-246 is also intriguing, he said, but again lacks data in the refractory setting.

Dr. Zeidan noted research into other treatments – rigosertib (recent findings have been disappointing), ivosidenib for IDH1-mutated MDS, AG221-001 and enasidenib (targeting IDH2 mutations), trametinib (targeting RAS pathway mutations), and others. For now, “clinical trial participation should be the best way to manage these patients.”

Dr. Zeidan disclosed multiple disclosures, including relationships with Pfizer, Novartis, Abbvie, Pfizer, Medimmune/AstraZeneca and Boehringer Ingelheim, among others.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

Prognoses remain extremely poor after hypomethylating agents (HMAs) fail in patients with higher-risk myelodysplastic syndromes (HR-MDS). But a hematologist-oncologist told colleagues that novel therapies are in the works, and some show promise.

Still, “the clinical development for drugs in this setting has been quite challenging, and we have had a lot of drugs that have died in this space over the years,” cautioned Amer Zeidan, MBBS, MHS, an associate professor at Yale University, New Haven, Conn., in a presentation at the virtual Acute Leukemia Forum of Hemedicus. For now, “the best way to manage HMA failure in MDS patients is by preventing HMA failure.”

Dr. Zeidan highlighted a 2016 study – which he led – that found the median overall survival from diagnosis was just a median of 17.0 months (95% confidence interval, 15.8-18.4) in 632 patients with HR-MDS. Another 2016 study, which he also led, reported median overall survival of 11 months (95% CI, 10-14) and 12 months (95% CI, 11-16; P = .26) for patients aged 66 or older who had HR-MDS and took azacitidine and decitabine, respectively. Median survival is even shorter after HMA failure, he said.

The most important obstacle to effective therapy is “the biologic and molecular heterogeneity of the disease,” he said. “Only a certain number of genes are altered in a significant number of patients. And then you have a very long tail, with so many alterations, but most of them are rare. That makes targeting all patients with the same mechanism quite challenging. Also, we poorly understand how hypomethylating agents work and the mechanism of primary and secondary failure. And many MDS patients are older with multiple conditions, multiple comorbidities. By the time of failure, they are generally beaten up and very difficult to enroll in clinical trials.”

Even so, he said, “the understanding of the molecular pathogenesis of MDS is starting to open the door for new drug development opportunities. What’s been changing over the last 5 years is an increased understanding of targeting some of the alterations that are specific to the patient – individualized targeting or precision medicine.”
 

Novel therapies

Dr. Zeidan said the novel therapies for HR-MDS after HMA failure fall into these categories: molecularly targeted agents, genetically agnostic small-molecule inhibitors, immunotherapies, and chemotherapy/epigenetic agents.

Multiple trials, for example, are examining a chemotherapy treatment CPX-351 (liposomal cytarabine-daunorubicin) in HR-MDS, and a 2018 study showed improvement in median survival in older patients with newly diagnosed secondary acute myeloid leukemia. “However, this remains an investigational treatment,” Dr. Zeidan cautioned.

Venetoclax is also being studied. Animal and cell culture data suggest there may be helpful synergistic activity between venetoclax and azacitidine in both the frontline and relapse settings. Dr. Zeidan highlighted his own 2019 report on a phase 1b study of venetoclax versus venetoclax and azacitidine in the HMA failure/HR-MDS setting. The results are “quite exciting,” he said.

The report noted that, “although the study is still ongoing, the 6-month OS [overall survival] estimate of 57% in monotherapy [patients] compares favorably to historical controls.”

Glasdegib is “another drug of interest,” although it’s mostly been studied in the frontline setting, he said, and “we don’t have much data with this drug in the refractory setting for MDS patients.” APR-246 is also intriguing, he said, but again lacks data in the refractory setting.

Dr. Zeidan noted research into other treatments – rigosertib (recent findings have been disappointing), ivosidenib for IDH1-mutated MDS, AG221-001 and enasidenib (targeting IDH2 mutations), trametinib (targeting RAS pathway mutations), and others. For now, “clinical trial participation should be the best way to manage these patients.”

Dr. Zeidan disclosed multiple disclosures, including relationships with Pfizer, Novartis, Abbvie, Pfizer, Medimmune/AstraZeneca and Boehringer Ingelheim, among others.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

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

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

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

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

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

An electronic alert may help doctors identify older adults with hearing loss sooner and increase referrals to an audiologist, according to a study published online Nov. 9 in the Annals of Family Medicine.

“Our findings demonstrate that using an electronic alert to prompt primary care clinicians to ask the single question, ‘Do you have difficulty with your hearing?’ to identify and refer appropriate at-risk patients for hearing testing is feasible and improves outcomes,” wrote Philip Zazove, MD, professor and chair, department of family medicine, University of Michigan Medical School, Ann Arbor, and colleagues.

Although hearing loss is known to be associated with an increased risk for a variety of health conditions, including hypertension, diabetes, dementia, and depression, the U.S. Preventive Services Task Force has concluded that there are insufficient data to evaluate the value of widespread screening.

To address that gap, Dr. Zazove and colleagues designed the Early Auditory Referral–Primary Care study. As part of the study, researchers added a hearing loss alert to the EMR systems of 10 family medicine clinics within two large health care systems, the University of Michigan (UM) and Beaumont Health (BH). Clinicians were educated on how to perform hearing loss screenings and the alerts were triggered to appear when clinicians evaluated patients 55 years or older who were being seen for non–hearing-related issues.

Between July 2016 and February 2019, 14,877 patients were enrolled in the study resulting in 36,701 encounters.

The researchers found that clinicians addressed the alert for 10,567 patients, resulting in an increase in referral rates from 3.2% at baseline to 14.4% in the UM system and from 0.7% to 4.7% in the BH system. For 26.2% of patients, the alert was not addressed at any encounter with the family clinician.

At the time of enrollment, patients were asked to complete a Hearing Handicap Index for the Elderly (HHI) questionnaire that was used to identify patients at risk for hearing loss. These results were blinded to clinicians. From the HHI data, available from 5,893 patients, the researchers found that 25.2% of patients had scores suggestive of hearing loss and that these patients had greater overall referral rates during the study period, compared with patients with lower scores (28% vs. 9.2%, respectively; P < .001).

Addressing hearing loss/communication challenges can improve health care utilization and improve quality of life for older patients, noted coauthor Michael McKee, MD, MPH, in an interview.

“This includes their relationships with significant others, better adherence to treatment plans, and possibly reducing their risk for cognitive decline,” Dr. McKee said.

While acknowledging that this type of alert should be relatively easy to implement in most EMR systems, “the issue of electronic medical record alert fatigue must be considered,” said Angela Shoup, PhD, FAAA, FNAP, president of the American Academy of Audiology and executive director of the University of Texas Callier Center for Communication Disorders in Dallas.

“Health care providers and information technology advisers are increasingly sensitive to the need to carefully curate alerts to ensure providers do not become so inundated that they miss important clinical decision support tools,” Dr. Shoup said in an interview.

“Tailoring the alert to specifically trigger only for the specified population, as noted in this article, is one technique recommended to help reduce EMR alert fatigue,” she noted.

The addition of this prompt for family clinicians “should increase the chances that hearing loss patients, who suffer substantial morbidity when untreated, will get better and earlier hearing healthcare with potentially fewer hospitalizations and improved quality of life,” Dr. Zazove and colleagues conclude.

Funding for this study was provided through a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD). The authors and Dr. Shoup have reported no relevant financial relationships.
 

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

An electronic alert may help doctors identify older adults with hearing loss sooner and increase referrals to an audiologist, according to a study published online Nov. 9 in the Annals of Family Medicine.

“Our findings demonstrate that using an electronic alert to prompt primary care clinicians to ask the single question, ‘Do you have difficulty with your hearing?’ to identify and refer appropriate at-risk patients for hearing testing is feasible and improves outcomes,” wrote Philip Zazove, MD, professor and chair, department of family medicine, University of Michigan Medical School, Ann Arbor, and colleagues.

Although hearing loss is known to be associated with an increased risk for a variety of health conditions, including hypertension, diabetes, dementia, and depression, the U.S. Preventive Services Task Force has concluded that there are insufficient data to evaluate the value of widespread screening.

To address that gap, Dr. Zazove and colleagues designed the Early Auditory Referral–Primary Care study. As part of the study, researchers added a hearing loss alert to the EMR systems of 10 family medicine clinics within two large health care systems, the University of Michigan (UM) and Beaumont Health (BH). Clinicians were educated on how to perform hearing loss screenings and the alerts were triggered to appear when clinicians evaluated patients 55 years or older who were being seen for non–hearing-related issues.

Between July 2016 and February 2019, 14,877 patients were enrolled in the study resulting in 36,701 encounters.

The researchers found that clinicians addressed the alert for 10,567 patients, resulting in an increase in referral rates from 3.2% at baseline to 14.4% in the UM system and from 0.7% to 4.7% in the BH system. For 26.2% of patients, the alert was not addressed at any encounter with the family clinician.

At the time of enrollment, patients were asked to complete a Hearing Handicap Index for the Elderly (HHI) questionnaire that was used to identify patients at risk for hearing loss. These results were blinded to clinicians. From the HHI data, available from 5,893 patients, the researchers found that 25.2% of patients had scores suggestive of hearing loss and that these patients had greater overall referral rates during the study period, compared with patients with lower scores (28% vs. 9.2%, respectively; P < .001).

Addressing hearing loss/communication challenges can improve health care utilization and improve quality of life for older patients, noted coauthor Michael McKee, MD, MPH, in an interview.

“This includes their relationships with significant others, better adherence to treatment plans, and possibly reducing their risk for cognitive decline,” Dr. McKee said.

While acknowledging that this type of alert should be relatively easy to implement in most EMR systems, “the issue of electronic medical record alert fatigue must be considered,” said Angela Shoup, PhD, FAAA, FNAP, president of the American Academy of Audiology and executive director of the University of Texas Callier Center for Communication Disorders in Dallas.

“Health care providers and information technology advisers are increasingly sensitive to the need to carefully curate alerts to ensure providers do not become so inundated that they miss important clinical decision support tools,” Dr. Shoup said in an interview.

“Tailoring the alert to specifically trigger only for the specified population, as noted in this article, is one technique recommended to help reduce EMR alert fatigue,” she noted.

The addition of this prompt for family clinicians “should increase the chances that hearing loss patients, who suffer substantial morbidity when untreated, will get better and earlier hearing healthcare with potentially fewer hospitalizations and improved quality of life,” Dr. Zazove and colleagues conclude.

Funding for this study was provided through a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD). The authors and Dr. Shoup have reported no relevant financial relationships.
 

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

An electronic alert may help doctors identify older adults with hearing loss sooner and increase referrals to an audiologist, according to a study published online Nov. 9 in the Annals of Family Medicine.

“Our findings demonstrate that using an electronic alert to prompt primary care clinicians to ask the single question, ‘Do you have difficulty with your hearing?’ to identify and refer appropriate at-risk patients for hearing testing is feasible and improves outcomes,” wrote Philip Zazove, MD, professor and chair, department of family medicine, University of Michigan Medical School, Ann Arbor, and colleagues.

Although hearing loss is known to be associated with an increased risk for a variety of health conditions, including hypertension, diabetes, dementia, and depression, the U.S. Preventive Services Task Force has concluded that there are insufficient data to evaluate the value of widespread screening.

To address that gap, Dr. Zazove and colleagues designed the Early Auditory Referral–Primary Care study. As part of the study, researchers added a hearing loss alert to the EMR systems of 10 family medicine clinics within two large health care systems, the University of Michigan (UM) and Beaumont Health (BH). Clinicians were educated on how to perform hearing loss screenings and the alerts were triggered to appear when clinicians evaluated patients 55 years or older who were being seen for non–hearing-related issues.

Between July 2016 and February 2019, 14,877 patients were enrolled in the study resulting in 36,701 encounters.

The researchers found that clinicians addressed the alert for 10,567 patients, resulting in an increase in referral rates from 3.2% at baseline to 14.4% in the UM system and from 0.7% to 4.7% in the BH system. For 26.2% of patients, the alert was not addressed at any encounter with the family clinician.

At the time of enrollment, patients were asked to complete a Hearing Handicap Index for the Elderly (HHI) questionnaire that was used to identify patients at risk for hearing loss. These results were blinded to clinicians. From the HHI data, available from 5,893 patients, the researchers found that 25.2% of patients had scores suggestive of hearing loss and that these patients had greater overall referral rates during the study period, compared with patients with lower scores (28% vs. 9.2%, respectively; P < .001).

Addressing hearing loss/communication challenges can improve health care utilization and improve quality of life for older patients, noted coauthor Michael McKee, MD, MPH, in an interview.

“This includes their relationships with significant others, better adherence to treatment plans, and possibly reducing their risk for cognitive decline,” Dr. McKee said.

While acknowledging that this type of alert should be relatively easy to implement in most EMR systems, “the issue of electronic medical record alert fatigue must be considered,” said Angela Shoup, PhD, FAAA, FNAP, president of the American Academy of Audiology and executive director of the University of Texas Callier Center for Communication Disorders in Dallas.

“Health care providers and information technology advisers are increasingly sensitive to the need to carefully curate alerts to ensure providers do not become so inundated that they miss important clinical decision support tools,” Dr. Shoup said in an interview.

“Tailoring the alert to specifically trigger only for the specified population, as noted in this article, is one technique recommended to help reduce EMR alert fatigue,” she noted.

The addition of this prompt for family clinicians “should increase the chances that hearing loss patients, who suffer substantial morbidity when untreated, will get better and earlier hearing healthcare with potentially fewer hospitalizations and improved quality of life,” Dr. Zazove and colleagues conclude.

Funding for this study was provided through a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD). The authors and Dr. Shoup have reported no relevant financial relationships.
 

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

The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020. For the first time, the guidelines are mandated to include dietary recommendations from birth to 24 months and for women who are pregnant or lactating.

Bonnie Becker/MDedge News

An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.

The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.

Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.

While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
 

Promote healthy dietary patterns

The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.

Dr. Meek highlighted some of the advisory committee’s findings and recommendations.

• Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
• Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
• Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
• From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
• The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.

The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
 

Recommendations during pregnancy

Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.

The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.

Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.

The advisory committee recommended universal folic acid supplementation during pregnancy.
 

Addressing a gap

The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.

“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.

Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.

Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.

For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.

Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.

To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”

Dr. Meek and Dr. Dewey had no relevant financial disclosures.

jremaly@mdedge.com

The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020. For the first time, the guidelines are mandated to include dietary recommendations from birth to 24 months and for women who are pregnant or lactating.

Bonnie Becker/MDedge News

An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.

The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.

Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.

While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
 

Promote healthy dietary patterns

The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.

Dr. Meek highlighted some of the advisory committee’s findings and recommendations.

• Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
• Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
• Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
• From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
• The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.

The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
 

Recommendations during pregnancy

Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.

The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.

Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.

The advisory committee recommended universal folic acid supplementation during pregnancy.
 

Addressing a gap

The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.

“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.

Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.

Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.

For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.

Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.

To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”

Dr. Meek and Dr. Dewey had no relevant financial disclosures.

jremaly@mdedge.com

The U.S. Department of Agriculture and the Department of Health & Human Services aim to release new dietary guidelines by the end of 2020. For the first time, the guidelines are mandated to include dietary recommendations from birth to 24 months and for women who are pregnant or lactating.

Bonnie Becker/MDedge News

An advisory committee submitted to the agencies a scientific report that examines relationships between diet and health at various life stages. Four chapters focus on dietary considerations for infants and toddlers, and two chapters focus on diet during pregnancy and lactation.

The report may inform the development of the new guidelines. The advisory committee’s recommendations include introducing infants to foods that are rich in zinc and iron at about age 6 months and having women who are lactating eat sources of omega-3 and omega-6 fatty acids, such as fish, to improve the fatty acid status of infants.

Ahead of the release of the 2020-2025 Dietary Guidelines for Americans, Joan Younger Meek, MD, discussed parts of the scientific report at the annual meeting of the American Academy of Pediatrics, held virtually this year.

While the 2015-2020 guidelines use ChooseMyPlate to help people implement the recommendations, it is not known how the new guidelines will be presented to the public, she said. “Many of you will remember the pyramids earlier and different food groups before that.”
 

Promote healthy dietary patterns

The advisory committee’s report notes that diet in the first years of life contributes to long-term health and shapes taste preferences, said Dr. Meek, professor of clinical sciences at Florida State University, Orlando. Human milk or infant formula are primary sources of nutrition until approximately 6 months, when families may introduce complementary foods and beverages. Between 6 months and 24 months, children transition to the typical family diet.

Dr. Meek highlighted some of the advisory committee’s findings and recommendations.

• Infants who are ever breastfed have a reduced risk of overweight or obesity, type 1 diabetes, and asthma. Likewise, longer duration of breastfeeding is associated with lower risk of type 1 diabetes and asthma, and exclusive breastfeeding is associated with lower risk of type 1 diabetes.
• Complementary foods and beverages should not be introduced before age 4 months. Limited evidence indicates that their introduction before 4 months may be associated with increased odds of overweight or obesity. Introducing complementary foods or beverages at 4 or 5 months, compared with 6 months, is not associated with long-term advantages or disadvantages.
• Introducing peanut and egg after age 4 months may reduce the risk of food allergies.
• From age 12 months to 24 months, children should consume a variety of nutrient-rich protein sources from animals – including meat, poultry, seafood, eggs, and dairy – plus nuts, seeds, fruits, vegetables, and grains.
• The report prioritizes oils over solid fats, and whole grains over refined grains. It also discourages added sugars, particularly from sugar-sweetened beverages. Other sources of added sugars include sweets, baked goods, and sweetened dairy products.

The report acknowledges that dietary guidelines should accommodate cultural preferences and cost considerations.
 

Recommendations during pregnancy

Healthy dietary patterns before or during pregnancy may modestly reduce the odds of gestational diabetes, hypertensive disorders of pregnancy, and preterm birth, according to the report.

The report recommends that during pregnancy women consume 8-12 ounces per week of seafood with high levels of omega-3 fatty acids and low levels of methylmercury, consistent with existing recommendations.

Egg and milk consumption during pregnancy does not influence the risk of food allergy, asthma, or atopic disease in the child, according to the report.

The advisory committee recommended universal folic acid supplementation during pregnancy.
 

Addressing a gap

The Agricultural Act of 2014 required that infants and toddlers and women who are pregnant or lactating be included in the 2020-2025 guidelines. Covering these populations in the scientific report was a substantial undertaking, said Kathryn Dewey, PhD, of the Institute for Global Nutrition at the University of California, Davis. Dr. Dewey chaired the subcommittee on birth to 24 months for the 2020 Dietary Guidelines Advisory Committee.

“Given that this age group had not been covered before, we could not rely on previous dietary guidelines’ reports,” Dr. Dewey said in an interview.

Outlining food patterns for infants and toddlers proved challenging. The committee explored models that considered various scenarios including children who consumed human milk, children who consumed formula, and those with vegetarian diets. Future research should clarify dietary reference intakes for these age groups, Dr. Dewey said.

Dr. Dewey sees the committee’s report on dietary guidance for birth to 24 months as a starting point and not necessarily an exhaustive look at the subject.

For one, the committee focused more on what to feed infants and toddlers rather than on how to feed them. Information about how to feed children is considered more in depth in a 2020 report from the National Academies of Sciences, Engineering, and Medicine. That report summarizes existing guidance from various organizations on feeding infants and children from birth to 24 months. Dr. Dewey chaired the committee that created the National Academies report.

Sharing the new USDA and HHS guidelines after they are released could be the next important step. “The public does not necessarily know about the guidelines or they do not necessarily seek them out unless there is a very well-constructed strategy for dissemination and implementation,” Dr. Dewey said.

To that end, health care providers can play a role, Dr. Meek said. “Be aware of changes in guidance, adopt those new recommendations, and then advocate those with our patients as well as with the public at large.”

Dr. Meek and Dr. Dewey had no relevant financial disclosures.

jremaly@mdedge.com

How do we discuss race and lung health issues that impact our most deserving, underserved communities? Continuously and uncomfortably. As the Executive Director of the CHEST Foundation and as a young Black man, I am hopeful that we, as CHEST, can lead these uncomfortable conversations to better our communities. Our ability to listen and deliver support to our most-deserving communities is critical in how we fulfill our mission. CHEST continues to be a leader in lung health because we choose to give a voice and a platform in support of better lung health – especially to those who are disproportionately affected by lung disease, specifically addressing the quality of care they receive and bringing to light the fact that too often these patients are forgotten by the rest of society.

How do we discuss race and lung health issues that impact our most deserving, underserved communities? Continuously and uncomfortably. As the Executive Director of the CHEST Foundation and as a young Black man, I am hopeful that we, as CHEST, can lead these uncomfortable conversations to better our communities. Our ability to listen and deliver support to our most-deserving communities is critical in how we fulfill our mission. CHEST continues to be a leader in lung health because we choose to give a voice and a platform in support of better lung health – especially to those who are disproportionately affected by lung disease, specifically addressing the quality of care they receive and bringing to light the fact that too often these patients are forgotten by the rest of society.

How do we discuss race and lung health issues that impact our most deserving, underserved communities? Continuously and uncomfortably. As the Executive Director of the CHEST Foundation and as a young Black man, I am hopeful that we, as CHEST, can lead these uncomfortable conversations to better our communities. Our ability to listen and deliver support to our most-deserving communities is critical in how we fulfill our mission. CHEST continues to be a leader in lung health because we choose to give a voice and a platform in support of better lung health – especially to those who are disproportionately affected by lung disease, specifically addressing the quality of care they receive and bringing to light the fact that too often these patients are forgotten by the rest of society.

International perspective on the new 2019 IDSA/ATS CAP guideline: A critical appraisal by a global expert panel. By Dr. Mathias Pletz, et al.



Development of an accurate bedside swallowing evaluation decision tree algorithm for detecting aspiration in acute respiratory failure survivors. By Dr. Marc Moss, et al.



How I Do It: Managing fatigue in patients with interstitial lung disease. By Dr. Marlies Wijsenbeek, et al.



Life-threatening and non-life-threatening complications associated with coughing: A scoping review. By Dr. Richard S. Irwin, MD, Master FCCP, et al.



Obstructive Sleep Apnea in Professional Transport Operations: Safety, Regulatory, and Economic Impact. By Dr. Indira Gurubhagavatula, et al.

International perspective on the new 2019 IDSA/ATS CAP guideline: A critical appraisal by a global expert panel. By Dr. Mathias Pletz, et al.



Development of an accurate bedside swallowing evaluation decision tree algorithm for detecting aspiration in acute respiratory failure survivors. By Dr. Marc Moss, et al.



How I Do It: Managing fatigue in patients with interstitial lung disease. By Dr. Marlies Wijsenbeek, et al.



Life-threatening and non-life-threatening complications associated with coughing: A scoping review. By Dr. Richard S. Irwin, MD, Master FCCP, et al.



Obstructive Sleep Apnea in Professional Transport Operations: Safety, Regulatory, and Economic Impact. By Dr. Indira Gurubhagavatula, et al.

International perspective on the new 2019 IDSA/ATS CAP guideline: A critical appraisal by a global expert panel. By Dr. Mathias Pletz, et al.



Development of an accurate bedside swallowing evaluation decision tree algorithm for detecting aspiration in acute respiratory failure survivors. By Dr. Marc Moss, et al.



How I Do It: Managing fatigue in patients with interstitial lung disease. By Dr. Marlies Wijsenbeek, et al.



Life-threatening and non-life-threatening complications associated with coughing: A scoping review. By Dr. Richard S. Irwin, MD, Master FCCP, et al.



Obstructive Sleep Apnea in Professional Transport Operations: Safety, Regulatory, and Economic Impact. By Dr. Indira Gurubhagavatula, et al.

CHEST and the American Thoracic Society (ATS) submitted joint comments regarding the proposed Medicare Physician Fee Schedule for 2021 to CMS Administrator Seema Verma on topics of direct interest to members. The letter focuses on:

Medicare payment for critical care services: Further to the joint letter from CHEST, ATS, and the Society of Critical Care Medicine to Department of Health and Human Services Secretary Azar (see article in September 2020 Washington Watchline), the concerns related to the proposed 8% reduction in reimbursement for critical care services are explained, particularly relating to the role of critical care providers during the pandemic. They call for waiving budget neutrality or utilizing the public health emergency declaration to ensure appropriate patient care.

E/M payment changes: ATS and CHEST voice support for the proposed changes to evaluation and management (E/M) office visits and the increased reimbursement for the cognitive component of E/M medicine. They urge CMS to use its authority to waive the budget neutrality requirements while implementing the E/M changes.

Adoption of RUC-recommended values for pulmonary services: They urge CMS to finalize values for specific pulmonary services while acknowledging thanks for the adoption of the Relative Value Scale Update Committee (RUC)-recommended physician work values for a range of Current Procedural Terminology codes.

Telehealth services: While commending CMS for actions related to telehealth to provide care during the pandemic, they suggest it is now appropriate to sunset the telehealth listing for critical care services as providers have acquired additional experience in treating COVID-19.

GPC1X descriptors and utilization projections: They urge CMS to clarify the descriptors and seek additional comments on primary and ongoing health-care services.

Watch for reports of ongoing efforts from CHEST as the fee schedule process continues. Details of other activities in support of CHEST members appear in the November issue of Washington Watchline.

Reprinted from the November 2020 issue of Washington Watchline.

CHEST and the American Thoracic Society (ATS) submitted joint comments regarding the proposed Medicare Physician Fee Schedule for 2021 to CMS Administrator Seema Verma on topics of direct interest to members. The letter focuses on:

Medicare payment for critical care services: Further to the joint letter from CHEST, ATS, and the Society of Critical Care Medicine to Department of Health and Human Services Secretary Azar (see article in September 2020 Washington Watchline), the concerns related to the proposed 8% reduction in reimbursement for critical care services are explained, particularly relating to the role of critical care providers during the pandemic. They call for waiving budget neutrality or utilizing the public health emergency declaration to ensure appropriate patient care.

E/M payment changes: ATS and CHEST voice support for the proposed changes to evaluation and management (E/M) office visits and the increased reimbursement for the cognitive component of E/M medicine. They urge CMS to use its authority to waive the budget neutrality requirements while implementing the E/M changes.

Adoption of RUC-recommended values for pulmonary services: They urge CMS to finalize values for specific pulmonary services while acknowledging thanks for the adoption of the Relative Value Scale Update Committee (RUC)-recommended physician work values for a range of Current Procedural Terminology codes.

Telehealth services: While commending CMS for actions related to telehealth to provide care during the pandemic, they suggest it is now appropriate to sunset the telehealth listing for critical care services as providers have acquired additional experience in treating COVID-19.

GPC1X descriptors and utilization projections: They urge CMS to clarify the descriptors and seek additional comments on primary and ongoing health-care services.

Watch for reports of ongoing efforts from CHEST as the fee schedule process continues. Details of other activities in support of CHEST members appear in the November issue of Washington Watchline.

Reprinted from the November 2020 issue of Washington Watchline.

CHEST and the American Thoracic Society (ATS) submitted joint comments regarding the proposed Medicare Physician Fee Schedule for 2021 to CMS Administrator Seema Verma on topics of direct interest to members. The letter focuses on:

Medicare payment for critical care services: Further to the joint letter from CHEST, ATS, and the Society of Critical Care Medicine to Department of Health and Human Services Secretary Azar (see article in September 2020 Washington Watchline), the concerns related to the proposed 8% reduction in reimbursement for critical care services are explained, particularly relating to the role of critical care providers during the pandemic. They call for waiving budget neutrality or utilizing the public health emergency declaration to ensure appropriate patient care.

E/M payment changes: ATS and CHEST voice support for the proposed changes to evaluation and management (E/M) office visits and the increased reimbursement for the cognitive component of E/M medicine. They urge CMS to use its authority to waive the budget neutrality requirements while implementing the E/M changes.

Adoption of RUC-recommended values for pulmonary services: They urge CMS to finalize values for specific pulmonary services while acknowledging thanks for the adoption of the Relative Value Scale Update Committee (RUC)-recommended physician work values for a range of Current Procedural Terminology codes.

Telehealth services: While commending CMS for actions related to telehealth to provide care during the pandemic, they suggest it is now appropriate to sunset the telehealth listing for critical care services as providers have acquired additional experience in treating COVID-19.

GPC1X descriptors and utilization projections: They urge CMS to clarify the descriptors and seek additional comments on primary and ongoing health-care services.

Watch for reports of ongoing efforts from CHEST as the fee schedule process continues. Details of other activities in support of CHEST members appear in the November issue of Washington Watchline.

Reprinted from the November 2020 issue of Washington Watchline.

The rate of injuries with needles and other sharp instruments among hospital staff jumped sharply in July, which suggests the need for safety instruction early in the academic year, researchers say.

Brandy Sites/Thinkstock.com

“The reason this is important is it gives us an idea of when the best time to intervene might be,” said Jonathan Zampella, MD, an assistant professor of dermatology at New York University.

The findings were published online Nov. 4 in a research letter in JAMA Surgery.

Hundreds of thousands of health care workers incur injuries with needles and other sharp instruments every year, which places them at risk for blood-borne infections.

“Especially amongst dermatologists, it’s not a question of if you get stuck, it’s a question of when,” Dr. Zampella said in an interview. “Most have been stuck at some point in their lives.”

Until now, studies of these injuries have mostly depended on surveys, he said. By contrast, for the current study, Dr. Zampella and colleagues used a dataset of injuries reported to NYU Langone Health’s Occupational Health Services.

They identified 5,395 such injuries that occurred between January 2000 and February 2020. The total number was similar among surgical and nonsurgical specialists, but the mean incident rate was 4.7 for every 10 people among the nonsurgical staff versus 9.4 for every 10 people in the surgical staff.

Dr. Zampella and colleagues further found that the highest rate of injury, at 16.0 incidents for every 10 people, occurred among urology house staff, followed by orthopedic surgery staff, with 14.1, and general surgery staff, with 14.0. The lowest staff rates were among psychiatrists (0.3), radiation oncologists (1.1), and neurologists (2.4).

But even some nonsurgical specialties had high rates. For example, the rate was 11.5 for pathology house staff and 11.3 for dermatology house staff.

Dr. Zampella said his first reaction to the data was, “What the heck? What are pathologists doing that they are getting needlestick injuries?

“But it makes sense,” he said. “Sometimes they do biopsies, and they do fine-needle aspirations – these kinds of things that we might not be paying as much attention to as we should.”

The finding suggests that nonsurgical specialists should receive more training in injury prevention, he said.

The training should be in person, and it should not just be for first-year residents. “Everybody needs to have refreshers on preventing needlesticks,” he said. “And we have to make sure everyone in the hospital is playing for the same team. Residents are learning, and if they see poor technique by one of their attendings, that’s something they may imitate.”

The study’s primary conclusion regards the importance of seasonality in needlestick and other injuries from sharp instruments.

Among house staff, 9.4% of the injuries occurred in July. The proportion then gradually rose to 10.5% in October before gradually going back down to a low of 6.2% in June.

The difference from one quarter to the next was statistically significant (P = .02).

July is when internships and residencies start, Dr. Zampella pointed out. Among the nonhouse staff, the rate was consistent throughout the year.

This suggests that the beginning of the academic year for trainees was the key factor driving the uptick in injuries, he said.

He said that residents are receiving instruction in injury prevention, but perhaps not at the right time of year. For example, dermatology residents at NYU are given a lecture in needlestick injury prevention in February.

Dr. Zampella has received personal fees from X4 pharmaceuticals. The other authors disclosed no relevant financial relationships.
 

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

The rate of injuries with needles and other sharp instruments among hospital staff jumped sharply in July, which suggests the need for safety instruction early in the academic year, researchers say.

Brandy Sites/Thinkstock.com

“The reason this is important is it gives us an idea of when the best time to intervene might be,” said Jonathan Zampella, MD, an assistant professor of dermatology at New York University.

The findings were published online Nov. 4 in a research letter in JAMA Surgery.

Hundreds of thousands of health care workers incur injuries with needles and other sharp instruments every year, which places them at risk for blood-borne infections.

“Especially amongst dermatologists, it’s not a question of if you get stuck, it’s a question of when,” Dr. Zampella said in an interview. “Most have been stuck at some point in their lives.”

Until now, studies of these injuries have mostly depended on surveys, he said. By contrast, for the current study, Dr. Zampella and colleagues used a dataset of injuries reported to NYU Langone Health’s Occupational Health Services.

They identified 5,395 such injuries that occurred between January 2000 and February 2020. The total number was similar among surgical and nonsurgical specialists, but the mean incident rate was 4.7 for every 10 people among the nonsurgical staff versus 9.4 for every 10 people in the surgical staff.

Dr. Zampella and colleagues further found that the highest rate of injury, at 16.0 incidents for every 10 people, occurred among urology house staff, followed by orthopedic surgery staff, with 14.1, and general surgery staff, with 14.0. The lowest staff rates were among psychiatrists (0.3), radiation oncologists (1.1), and neurologists (2.4).

But even some nonsurgical specialties had high rates. For example, the rate was 11.5 for pathology house staff and 11.3 for dermatology house staff.

Dr. Zampella said his first reaction to the data was, “What the heck? What are pathologists doing that they are getting needlestick injuries?

“But it makes sense,” he said. “Sometimes they do biopsies, and they do fine-needle aspirations – these kinds of things that we might not be paying as much attention to as we should.”

The finding suggests that nonsurgical specialists should receive more training in injury prevention, he said.

The training should be in person, and it should not just be for first-year residents. “Everybody needs to have refreshers on preventing needlesticks,” he said. “And we have to make sure everyone in the hospital is playing for the same team. Residents are learning, and if they see poor technique by one of their attendings, that’s something they may imitate.”

The study’s primary conclusion regards the importance of seasonality in needlestick and other injuries from sharp instruments.

Among house staff, 9.4% of the injuries occurred in July. The proportion then gradually rose to 10.5% in October before gradually going back down to a low of 6.2% in June.

The difference from one quarter to the next was statistically significant (P = .02).

July is when internships and residencies start, Dr. Zampella pointed out. Among the nonhouse staff, the rate was consistent throughout the year.

This suggests that the beginning of the academic year for trainees was the key factor driving the uptick in injuries, he said.

He said that residents are receiving instruction in injury prevention, but perhaps not at the right time of year. For example, dermatology residents at NYU are given a lecture in needlestick injury prevention in February.

Dr. Zampella has received personal fees from X4 pharmaceuticals. The other authors disclosed no relevant financial relationships.
 

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

The rate of injuries with needles and other sharp instruments among hospital staff jumped sharply in July, which suggests the need for safety instruction early in the academic year, researchers say.

Brandy Sites/Thinkstock.com

“The reason this is important is it gives us an idea of when the best time to intervene might be,” said Jonathan Zampella, MD, an assistant professor of dermatology at New York University.

The findings were published online Nov. 4 in a research letter in JAMA Surgery.

Hundreds of thousands of health care workers incur injuries with needles and other sharp instruments every year, which places them at risk for blood-borne infections.

“Especially amongst dermatologists, it’s not a question of if you get stuck, it’s a question of when,” Dr. Zampella said in an interview. “Most have been stuck at some point in their lives.”

Until now, studies of these injuries have mostly depended on surveys, he said. By contrast, for the current study, Dr. Zampella and colleagues used a dataset of injuries reported to NYU Langone Health’s Occupational Health Services.

They identified 5,395 such injuries that occurred between January 2000 and February 2020. The total number was similar among surgical and nonsurgical specialists, but the mean incident rate was 4.7 for every 10 people among the nonsurgical staff versus 9.4 for every 10 people in the surgical staff.

Dr. Zampella and colleagues further found that the highest rate of injury, at 16.0 incidents for every 10 people, occurred among urology house staff, followed by orthopedic surgery staff, with 14.1, and general surgery staff, with 14.0. The lowest staff rates were among psychiatrists (0.3), radiation oncologists (1.1), and neurologists (2.4).

But even some nonsurgical specialties had high rates. For example, the rate was 11.5 for pathology house staff and 11.3 for dermatology house staff.

Dr. Zampella said his first reaction to the data was, “What the heck? What are pathologists doing that they are getting needlestick injuries?

“But it makes sense,” he said. “Sometimes they do biopsies, and they do fine-needle aspirations – these kinds of things that we might not be paying as much attention to as we should.”

The finding suggests that nonsurgical specialists should receive more training in injury prevention, he said.

The training should be in person, and it should not just be for first-year residents. “Everybody needs to have refreshers on preventing needlesticks,” he said. “And we have to make sure everyone in the hospital is playing for the same team. Residents are learning, and if they see poor technique by one of their attendings, that’s something they may imitate.”

The study’s primary conclusion regards the importance of seasonality in needlestick and other injuries from sharp instruments.

Among house staff, 9.4% of the injuries occurred in July. The proportion then gradually rose to 10.5% in October before gradually going back down to a low of 6.2% in June.

The difference from one quarter to the next was statistically significant (P = .02).

July is when internships and residencies start, Dr. Zampella pointed out. Among the nonhouse staff, the rate was consistent throughout the year.

This suggests that the beginning of the academic year for trainees was the key factor driving the uptick in injuries, he said.

He said that residents are receiving instruction in injury prevention, but perhaps not at the right time of year. For example, dermatology residents at NYU are given a lecture in needlestick injury prevention in February.

Dr. Zampella has received personal fees from X4 pharmaceuticals. The other authors disclosed no relevant financial relationships.
 

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

After a 50-year hiatus, psychedelic drugs are undergoing a research renaissance. Roland R. Griffiths, PhD, professor in the Departments of Psychiatry and Neuroscience and the Oliver Lee McCabe III, Professor in the Neuropsychopharmacology of Consciousness, and director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, Baltimore, discusses the status of these drugs in the United States and their potential to treat psychiatric disorders.

Classic psychedelics are compounds that bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include the naturally occurring compounds psilocybin, N,N-dimethyltryptamine (DMT, a component of ayahuasca) and mescaline (peyote cactus), as well as the synthesized compound lysergic acid diethylamide (LSD).

Other drugs, such as ketamine, are sometimes referred to as “psychedelics” because they can produce subjective experiences that are similar to those of people who receive classic psychedelics. However, unlike classic psychedelics, the effects of ketamine tend to be short lived. Ketamine also has addictive potential and can be lethal in high doses, which is not the case with psilocybin.

Another compound sometimes referred to as a “psychedelic” is 3,4-methylenedioxymethamphetamine (MDMA), also known as “ecstasy.” The Food and Drug Administration granted breakthrough approval for the study of MDMA for posttraumatic stress disorder (PTSD). FDA-approved registration trials are ongoing. MDMA differs from classic psychedelics in risk profile and pharmacology. In particular, MDMA was widely abused as part of the “rave culture,” while classic psychedelic agents do not lend themselves to that type of misuse.
 

What is the current legal status of psychedelic agents in the United States? Can clinicians prescribe them, or are they available only in a research setting?

All classic psychedelics are considered to be “Schedule 1” which means they are illegal to possess and use except for research and only if approved by the FDA and under licensure of the Drug Enforcement Administration (DEA), so they are not available for clinical use.

In anticipation of the possibility that phase 3 research may support the efficacy and safety of psilocybin for one or more medical or mental health disorders, our team has reviewed available evidence regarding its abuse liability and concluded that, if psilocybin were approved as medication, it could possibly be included in the Schedule IV category, with additional FDA-mandated risk management provisions. However, this is not yet the case.
 

Which psychedelic agents are under investigation in the United States, and for which indications?

Psilocybin is under investigation in our center, as well as elsewhere in the United States. We have previously found it to be effective for smoking cessation, and we are conducting another study that is currently recruiting volunteers for this indication. We are also recruiting volunteers for studies on the use of psilocybin for major depression, Alzheimer’s disease, and anorexia nervosa. Further information about our studies can be found on the Web site for our center, the Center for Psychedelic and Consciousness Research.

Two companies – the Usona Institute and COMPASS Pathways – have received FDA Breakthrough Therapy Designation for their programs seeking approval of psilocybin as a treatment major depressive disorder and treatment-resistant depression (TRD), respectively. In addition, an international multicenter study currently underway, which includes US centers in Houston, Baltimore, New York, San Diego, and Atlanta, is investigating psilocybin for TRD.

A number of studies, including one conducted at our center, have investigated psilocybin for depression and anxiety in patients with cancer and found it effective.

Additional research showed that psilocybin alleviated symptoms of cancer-related anxiety and depression, both in the short-term and 5 years later.

LSD has been studied and found promising in the treatment of alcohol use disorder. Additional studies of LSD that are being conducted in Basel Switzerland and at the University of Chicago are examining its impact on mood in healthy volunteers.

Ayahuasca has been studied extensively for depression and anxiety and is also currently under investigation for PTSD. We found that its use in a naturalistic group setting was associated with unintended improvements in depression and anxiety.

Lastly, a lesser-known psychedelic agent is Salvinorin A, which our center has been studying, is the psychoactive constituent of the Salvia divinorum plant. While this is not a “classic” psychedelic compound, it is nevertheless the focus of much scientific interest because its effects are mediated at opioid receptors, rather than 5-HT2A receptors, and may prove to be a novel nonaddictive opioid that may ultimately be a promising treatment for pain and addiction.
 

What is the typical treatment regimen for psychedelic agents?

It is hard to speak of a “treatment regimen” in agents that are not used in clinical practice. Ongoing clinical trials with psilocybin generally involve one or two 6- to 8-hour sessions involving the oral administration of a moderately high dose under psychologically supported conditions.

Based on the current evidence base, which agents show the most promise?

Psilocybin is currently the most promising classic psychedelic undergoing clinical trials.

Do psychedelics have to be administered in a controlled setting in order to be effective?

Although many people have had meaningful experiences whether inside or outside of a controlled setting, there are serious potential risks associated with use of psilocybin and other classic psychedelics. The safety of psilocybin has been established in clinical studies in which participants have been carefully screened physically and psychologically, are psychologically prepared before their first session, and are psychologically supported during and after sessions. In vulnerable individuals, psilocybin has been associated with enduring psychiatric problems and sometimes persisting visual perceptual conditions. When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others – including life-threatening risk. Thus, for safety reasons, the optimal environment for using these agents is in a controlled setting.

Do results differ between patients who have used psychedelic agents previously and those who have not?

We have not found any difference between psychedelic-naive volunteers and those who have used psychedelics in the past.

Do you provide patient education prior to treatment initiation?

All of our study participants are thoroughly screened for medical concerns or mental health history such as psychosis, which would preclude their participation. They are educated about the effects of these agents and what they might expect and typically receive several hours of psychological preparation before the first session. They are also provided with psychological support after sessions. Additionally, we spend time developing trust and rapport prior to the first session.

How durable are the effects of psychedelic treatment?

Studies in patients and healthy participants suggest that the positive effects of psilocybin are long lasting, with most individuals reporting positive changes in moods, attitudes, and behavior that they attribute to psilocybin and which endure months or years after the session. The qualities of the acute session experience can vary widely ranging from experiences of transcendence or psychological insight to experiences of intense anxiety or fear.

An enduring shift in worldview and sense of self, as well as psychological insight, may increase psychological flexibility, thereby allowing individuals to subsequently avoid maladaptive patterns of behavior or thought and to make more healthy choices.

Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experience of their lives.
 

Do participants experience any adverse effects? If so, how are they managed?

Sometimes, despite all the preparation, screening, and support we provide, some participants can have frightening experiences, such as fear and anxiety during the session. When that occurs, it is often shorted lived. The psychological preparation we provide before the session and the psychological support we provide during the session are important for managing such effects.

We provide support and encourage participants to stay with that experience, which may open to experiences of deep meaning or insight. A number of people report that these psychologically challenging states are a valuable part of the overall experience.

We conducted a survey of roughly 2,000 people who took high doses of psilocybin mushrooms and then had a challenging experience. About 10% reported they put themselves or others at risk of physical harm. Of more concern, of those whose experience occurred more than 1 year before, 8% sought treatment for enduring psychological symptoms. These findings underscore potential risks of psilocybin use but do not provide an estimate of the actual incidence of such effects.

Importantly, in our research at Johns Hopkins, we have not observed such effects in over 700 sessions that we have conducted with almost 400 participants, likely because we thoroughly screen and prepare participants and support them after they have completed the study. The potential for serious lasting harm represents a concern and points to the importance of adequate screening and aftercare.
 

What are the implications for future therapeutics?

We are living in exciting times, in terms of psychedelic research. The potential for a single treatment with a classic psychedelic to produce rapid and sustained therapeutic effects, possibly across a range of psychiatric conditions, is unprecedented in psychiatry. The effect appears to be an “inverse PTSD effect.”

In PTSD, a single exposure to a traumatic event can rewire the nervous system to the point that it produces enduring harm and toxicity. In the case of psychedelics, a single exposure appears to have enduring positive effects in worldview, mood, attitude, behavior, and overall life satisfaction. We can look forward to continued growth and expansion of this research including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.
 

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

After a 50-year hiatus, psychedelic drugs are undergoing a research renaissance. Roland R. Griffiths, PhD, professor in the Departments of Psychiatry and Neuroscience and the Oliver Lee McCabe III, Professor in the Neuropsychopharmacology of Consciousness, and director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, Baltimore, discusses the status of these drugs in the United States and their potential to treat psychiatric disorders.

Classic psychedelics are compounds that bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include the naturally occurring compounds psilocybin, N,N-dimethyltryptamine (DMT, a component of ayahuasca) and mescaline (peyote cactus), as well as the synthesized compound lysergic acid diethylamide (LSD).

Other drugs, such as ketamine, are sometimes referred to as “psychedelics” because they can produce subjective experiences that are similar to those of people who receive classic psychedelics. However, unlike classic psychedelics, the effects of ketamine tend to be short lived. Ketamine also has addictive potential and can be lethal in high doses, which is not the case with psilocybin.

Another compound sometimes referred to as a “psychedelic” is 3,4-methylenedioxymethamphetamine (MDMA), also known as “ecstasy.” The Food and Drug Administration granted breakthrough approval for the study of MDMA for posttraumatic stress disorder (PTSD). FDA-approved registration trials are ongoing. MDMA differs from classic psychedelics in risk profile and pharmacology. In particular, MDMA was widely abused as part of the “rave culture,” while classic psychedelic agents do not lend themselves to that type of misuse.
 

What is the current legal status of psychedelic agents in the United States? Can clinicians prescribe them, or are they available only in a research setting?

All classic psychedelics are considered to be “Schedule 1” which means they are illegal to possess and use except for research and only if approved by the FDA and under licensure of the Drug Enforcement Administration (DEA), so they are not available for clinical use.

In anticipation of the possibility that phase 3 research may support the efficacy and safety of psilocybin for one or more medical or mental health disorders, our team has reviewed available evidence regarding its abuse liability and concluded that, if psilocybin were approved as medication, it could possibly be included in the Schedule IV category, with additional FDA-mandated risk management provisions. However, this is not yet the case.
 

Which psychedelic agents are under investigation in the United States, and for which indications?

Psilocybin is under investigation in our center, as well as elsewhere in the United States. We have previously found it to be effective for smoking cessation, and we are conducting another study that is currently recruiting volunteers for this indication. We are also recruiting volunteers for studies on the use of psilocybin for major depression, Alzheimer’s disease, and anorexia nervosa. Further information about our studies can be found on the Web site for our center, the Center for Psychedelic and Consciousness Research.

Two companies – the Usona Institute and COMPASS Pathways – have received FDA Breakthrough Therapy Designation for their programs seeking approval of psilocybin as a treatment major depressive disorder and treatment-resistant depression (TRD), respectively. In addition, an international multicenter study currently underway, which includes US centers in Houston, Baltimore, New York, San Diego, and Atlanta, is investigating psilocybin for TRD.

A number of studies, including one conducted at our center, have investigated psilocybin for depression and anxiety in patients with cancer and found it effective.

Additional research showed that psilocybin alleviated symptoms of cancer-related anxiety and depression, both in the short-term and 5 years later.

LSD has been studied and found promising in the treatment of alcohol use disorder. Additional studies of LSD that are being conducted in Basel Switzerland and at the University of Chicago are examining its impact on mood in healthy volunteers.

Ayahuasca has been studied extensively for depression and anxiety and is also currently under investigation for PTSD. We found that its use in a naturalistic group setting was associated with unintended improvements in depression and anxiety.

Lastly, a lesser-known psychedelic agent is Salvinorin A, which our center has been studying, is the psychoactive constituent of the Salvia divinorum plant. While this is not a “classic” psychedelic compound, it is nevertheless the focus of much scientific interest because its effects are mediated at opioid receptors, rather than 5-HT2A receptors, and may prove to be a novel nonaddictive opioid that may ultimately be a promising treatment for pain and addiction.
 

What is the typical treatment regimen for psychedelic agents?

It is hard to speak of a “treatment regimen” in agents that are not used in clinical practice. Ongoing clinical trials with psilocybin generally involve one or two 6- to 8-hour sessions involving the oral administration of a moderately high dose under psychologically supported conditions.

Based on the current evidence base, which agents show the most promise?

Psilocybin is currently the most promising classic psychedelic undergoing clinical trials.

Do psychedelics have to be administered in a controlled setting in order to be effective?

Although many people have had meaningful experiences whether inside or outside of a controlled setting, there are serious potential risks associated with use of psilocybin and other classic psychedelics. The safety of psilocybin has been established in clinical studies in which participants have been carefully screened physically and psychologically, are psychologically prepared before their first session, and are psychologically supported during and after sessions. In vulnerable individuals, psilocybin has been associated with enduring psychiatric problems and sometimes persisting visual perceptual conditions. When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others – including life-threatening risk. Thus, for safety reasons, the optimal environment for using these agents is in a controlled setting.

Do results differ between patients who have used psychedelic agents previously and those who have not?

We have not found any difference between psychedelic-naive volunteers and those who have used psychedelics in the past.

Do you provide patient education prior to treatment initiation?

All of our study participants are thoroughly screened for medical concerns or mental health history such as psychosis, which would preclude their participation. They are educated about the effects of these agents and what they might expect and typically receive several hours of psychological preparation before the first session. They are also provided with psychological support after sessions. Additionally, we spend time developing trust and rapport prior to the first session.

How durable are the effects of psychedelic treatment?

Studies in patients and healthy participants suggest that the positive effects of psilocybin are long lasting, with most individuals reporting positive changes in moods, attitudes, and behavior that they attribute to psilocybin and which endure months or years after the session. The qualities of the acute session experience can vary widely ranging from experiences of transcendence or psychological insight to experiences of intense anxiety or fear.

An enduring shift in worldview and sense of self, as well as psychological insight, may increase psychological flexibility, thereby allowing individuals to subsequently avoid maladaptive patterns of behavior or thought and to make more healthy choices.

Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experience of their lives.
 

Do participants experience any adverse effects? If so, how are they managed?

Sometimes, despite all the preparation, screening, and support we provide, some participants can have frightening experiences, such as fear and anxiety during the session. When that occurs, it is often shorted lived. The psychological preparation we provide before the session and the psychological support we provide during the session are important for managing such effects.

We provide support and encourage participants to stay with that experience, which may open to experiences of deep meaning or insight. A number of people report that these psychologically challenging states are a valuable part of the overall experience.

We conducted a survey of roughly 2,000 people who took high doses of psilocybin mushrooms and then had a challenging experience. About 10% reported they put themselves or others at risk of physical harm. Of more concern, of those whose experience occurred more than 1 year before, 8% sought treatment for enduring psychological symptoms. These findings underscore potential risks of psilocybin use but do not provide an estimate of the actual incidence of such effects.

Importantly, in our research at Johns Hopkins, we have not observed such effects in over 700 sessions that we have conducted with almost 400 participants, likely because we thoroughly screen and prepare participants and support them after they have completed the study. The potential for serious lasting harm represents a concern and points to the importance of adequate screening and aftercare.
 

What are the implications for future therapeutics?

We are living in exciting times, in terms of psychedelic research. The potential for a single treatment with a classic psychedelic to produce rapid and sustained therapeutic effects, possibly across a range of psychiatric conditions, is unprecedented in psychiatry. The effect appears to be an “inverse PTSD effect.”

In PTSD, a single exposure to a traumatic event can rewire the nervous system to the point that it produces enduring harm and toxicity. In the case of psychedelics, a single exposure appears to have enduring positive effects in worldview, mood, attitude, behavior, and overall life satisfaction. We can look forward to continued growth and expansion of this research including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.
 

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

After a 50-year hiatus, psychedelic drugs are undergoing a research renaissance. Roland R. Griffiths, PhD, professor in the Departments of Psychiatry and Neuroscience and the Oliver Lee McCabe III, Professor in the Neuropsychopharmacology of Consciousness, and director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, Baltimore, discusses the status of these drugs in the United States and their potential to treat psychiatric disorders.

Classic psychedelics are compounds that bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include the naturally occurring compounds psilocybin, N,N-dimethyltryptamine (DMT, a component of ayahuasca) and mescaline (peyote cactus), as well as the synthesized compound lysergic acid diethylamide (LSD).

Other drugs, such as ketamine, are sometimes referred to as “psychedelics” because they can produce subjective experiences that are similar to those of people who receive classic psychedelics. However, unlike classic psychedelics, the effects of ketamine tend to be short lived. Ketamine also has addictive potential and can be lethal in high doses, which is not the case with psilocybin.

Another compound sometimes referred to as a “psychedelic” is 3,4-methylenedioxymethamphetamine (MDMA), also known as “ecstasy.” The Food and Drug Administration granted breakthrough approval for the study of MDMA for posttraumatic stress disorder (PTSD). FDA-approved registration trials are ongoing. MDMA differs from classic psychedelics in risk profile and pharmacology. In particular, MDMA was widely abused as part of the “rave culture,” while classic psychedelic agents do not lend themselves to that type of misuse.
 

What is the current legal status of psychedelic agents in the United States? Can clinicians prescribe them, or are they available only in a research setting?

All classic psychedelics are considered to be “Schedule 1” which means they are illegal to possess and use except for research and only if approved by the FDA and under licensure of the Drug Enforcement Administration (DEA), so they are not available for clinical use.

In anticipation of the possibility that phase 3 research may support the efficacy and safety of psilocybin for one or more medical or mental health disorders, our team has reviewed available evidence regarding its abuse liability and concluded that, if psilocybin were approved as medication, it could possibly be included in the Schedule IV category, with additional FDA-mandated risk management provisions. However, this is not yet the case.
 

Which psychedelic agents are under investigation in the United States, and for which indications?

Psilocybin is under investigation in our center, as well as elsewhere in the United States. We have previously found it to be effective for smoking cessation, and we are conducting another study that is currently recruiting volunteers for this indication. We are also recruiting volunteers for studies on the use of psilocybin for major depression, Alzheimer’s disease, and anorexia nervosa. Further information about our studies can be found on the Web site for our center, the Center for Psychedelic and Consciousness Research.

Two companies – the Usona Institute and COMPASS Pathways – have received FDA Breakthrough Therapy Designation for their programs seeking approval of psilocybin as a treatment major depressive disorder and treatment-resistant depression (TRD), respectively. In addition, an international multicenter study currently underway, which includes US centers in Houston, Baltimore, New York, San Diego, and Atlanta, is investigating psilocybin for TRD.

A number of studies, including one conducted at our center, have investigated psilocybin for depression and anxiety in patients with cancer and found it effective.

Additional research showed that psilocybin alleviated symptoms of cancer-related anxiety and depression, both in the short-term and 5 years later.

LSD has been studied and found promising in the treatment of alcohol use disorder. Additional studies of LSD that are being conducted in Basel Switzerland and at the University of Chicago are examining its impact on mood in healthy volunteers.

Ayahuasca has been studied extensively for depression and anxiety and is also currently under investigation for PTSD. We found that its use in a naturalistic group setting was associated with unintended improvements in depression and anxiety.

Lastly, a lesser-known psychedelic agent is Salvinorin A, which our center has been studying, is the psychoactive constituent of the Salvia divinorum plant. While this is not a “classic” psychedelic compound, it is nevertheless the focus of much scientific interest because its effects are mediated at opioid receptors, rather than 5-HT2A receptors, and may prove to be a novel nonaddictive opioid that may ultimately be a promising treatment for pain and addiction.
 

What is the typical treatment regimen for psychedelic agents?

It is hard to speak of a “treatment regimen” in agents that are not used in clinical practice. Ongoing clinical trials with psilocybin generally involve one or two 6- to 8-hour sessions involving the oral administration of a moderately high dose under psychologically supported conditions.

Based on the current evidence base, which agents show the most promise?

Psilocybin is currently the most promising classic psychedelic undergoing clinical trials.

Do psychedelics have to be administered in a controlled setting in order to be effective?

Although many people have had meaningful experiences whether inside or outside of a controlled setting, there are serious potential risks associated with use of psilocybin and other classic psychedelics. The safety of psilocybin has been established in clinical studies in which participants have been carefully screened physically and psychologically, are psychologically prepared before their first session, and are psychologically supported during and after sessions. In vulnerable individuals, psilocybin has been associated with enduring psychiatric problems and sometimes persisting visual perceptual conditions. When taken in uncontrolled conditions, classic psychedelics can produce confusion and disorientation resulting in behavior dangerous to the participant and others – including life-threatening risk. Thus, for safety reasons, the optimal environment for using these agents is in a controlled setting.

Do results differ between patients who have used psychedelic agents previously and those who have not?

We have not found any difference between psychedelic-naive volunteers and those who have used psychedelics in the past.

Do you provide patient education prior to treatment initiation?

All of our study participants are thoroughly screened for medical concerns or mental health history such as psychosis, which would preclude their participation. They are educated about the effects of these agents and what they might expect and typically receive several hours of psychological preparation before the first session. They are also provided with psychological support after sessions. Additionally, we spend time developing trust and rapport prior to the first session.

How durable are the effects of psychedelic treatment?

Studies in patients and healthy participants suggest that the positive effects of psilocybin are long lasting, with most individuals reporting positive changes in moods, attitudes, and behavior that they attribute to psilocybin and which endure months or years after the session. The qualities of the acute session experience can vary widely ranging from experiences of transcendence or psychological insight to experiences of intense anxiety or fear.

An enduring shift in worldview and sense of self, as well as psychological insight, may increase psychological flexibility, thereby allowing individuals to subsequently avoid maladaptive patterns of behavior or thought and to make more healthy choices.

Our research has shown that the benefits of these experiences can last as long as 14 months, often longer, and that many participants characterize their psilocybin experience as among the most profound and personally meaningful experience of their lives.
 

Do participants experience any adverse effects? If so, how are they managed?

Sometimes, despite all the preparation, screening, and support we provide, some participants can have frightening experiences, such as fear and anxiety during the session. When that occurs, it is often shorted lived. The psychological preparation we provide before the session and the psychological support we provide during the session are important for managing such effects.

We provide support and encourage participants to stay with that experience, which may open to experiences of deep meaning or insight. A number of people report that these psychologically challenging states are a valuable part of the overall experience.

We conducted a survey of roughly 2,000 people who took high doses of psilocybin mushrooms and then had a challenging experience. About 10% reported they put themselves or others at risk of physical harm. Of more concern, of those whose experience occurred more than 1 year before, 8% sought treatment for enduring psychological symptoms. These findings underscore potential risks of psilocybin use but do not provide an estimate of the actual incidence of such effects.

Importantly, in our research at Johns Hopkins, we have not observed such effects in over 700 sessions that we have conducted with almost 400 participants, likely because we thoroughly screen and prepare participants and support them after they have completed the study. The potential for serious lasting harm represents a concern and points to the importance of adequate screening and aftercare.
 

What are the implications for future therapeutics?

We are living in exciting times, in terms of psychedelic research. The potential for a single treatment with a classic psychedelic to produce rapid and sustained therapeutic effects, possibly across a range of psychiatric conditions, is unprecedented in psychiatry. The effect appears to be an “inverse PTSD effect.”

In PTSD, a single exposure to a traumatic event can rewire the nervous system to the point that it produces enduring harm and toxicity. In the case of psychedelics, a single exposure appears to have enduring positive effects in worldview, mood, attitude, behavior, and overall life satisfaction. We can look forward to continued growth and expansion of this research including the refinement of protocols for a variety of therapeutic indications and to the development of a variety of new classic psychedelic compounds.
 

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

Late-onset epilepsy is linked to a substantial increased risk of subsequent dementia. Results of a retrospective analysis show that patients who develop epilepsy at age 67 or older have a threefold increased risk of subsequent dementia versus their counterparts without epilepsy.

“This is an exciting area, as we are finding that just as the risk of seizures is increased in neurodegenerative diseases, the risk of dementia is increased after late-onset epilepsy and seizures,” study investigator Emily L. Johnson, MD, assistant professor of neurology at Johns Hopkins University, Baltimore, said in an interview. “Several other cohort studies are finding similar results, including the Veterans’ Health Study and the Framingham Study,” she added.

The study was published online Oct. 23 in Neurology
 

Bidirectional relationship?

Previous research has established that dementia is a risk factor for epilepsy, but recent studies also suggest an increased risk of incident dementia among patients with adult-onset epilepsy. Several risk factors for late-onset epilepsy, including diabetes and hypertension, also are risk factors for dementia. However, the effect of late-onset epilepsy on dementia risk in patients with these comorbidities has not been clarified.

To investigate, the researchers examined data from the Atherosclerosis Risk in Communities (ARIC) study. Participants include Black and White men and women from four U.S. communities. Baseline visits in this longitudinal cohort study began between 1987 and 1989, and follow-up included seven additional visits and regular phone calls.

The investigators identified participants with late-onset epilepsy by searching for Medicare claims related to seizures or epilepsy filed between 1991 and 2015. Those with two or more such claims and age of onset of 67 years or greater were considered to have late-onset epilepsy. Participants with preexisting conditions such as brain tumors or multiple sclerosis were excluded.

ARIC participants who presented in person for visits 2, 4, 5, and 6 underwent cognitive testing with the Delayed Word Recall Test, the Digit Symbol Substitution Test, and the Word Fluency Test.

Testing at visits 5 and 6 also included other tests, such as the Mini-Mental State Examination, the Boston Naming test, and the Wechsler Memory Scale-III. Dr. Johnson and colleagues excluded data for visit 7 from the analysis because dementia adjudication was not yet complete.

The researchers identified participants with dementia using data from visits 5 and 6 and ascertained time of dementia onset through participant and informant interviews, phone calls, and hospital discharge data. Participants also were screened for mild cognitive impairment (MCI) at visits 5 and 6.

Data were analyzed using a Cox proportional hazards model and multinomial logistic regression. In subsequent analyses, researchers adjusted the data for age, sex, race, smoking status, alcohol use, hypertension, diabetes, body mass index (BMI), APOE4 status, and prevalent stroke.

The researchers found that of 9,033 study participants, 671 had late-onset epilepsy. The late-onset epilepsy group was older at baseline (56.5 vs. 55.1 years) and more likely to have hypertension (38.9% vs. 33.3%), diabetes (16.1% vs. 9.6%), and two alleles of APOE4 genotype (3.9% vs. 2.5%), compared with those without the disorder.

In all, 1,687 participants developed dementia during follow-up. The rate of incident dementia was 41.6% in participants with late-onset epilepsy and 16.8% in participants without late-onset epilepsy. The adjusted hazard ratio of subsequent dementia in participants with late-onset epilepsy versus those without the disorder was 3.05 (95% confidence interval, 2.65-3.51).

The median time to dementia ascertainment after late-onset epilepsy was 3.66 years.
 

Counterintuitive finding

The relationship between late-onset epilepsy and subsequent dementia was stronger in patients without stroke. The investigators offered a possible explanation for this counterintuitive finding. “We observed an interaction between [late-onset epilepsy] and stroke, with a lower (but still substantial) association between [late-onset epilepsy] and dementia in those with a history of stroke. This may be due to the known strong association between stroke and dementia, which may wash out the contributions of [late-onset epilepsy] to cognitive impairment,” the researchers wrote.

“There may also be under-capturing of dementia diagnoses among participants with stroke in the ascertainment from [Centers for Medicare & Medicaid Services] codes, as physicians may be reluctant to make a separate code for ‘dementia’ in those with cognitive impairment after stroke,” they added.

When the researchers restricted the analysis only to participants who attended visits 5 and 6 and had late-onset epilepsy ascertainment available, they found that the relative risk ratio for dementia at visit 6 was 2.90 (95% CI, 1.22-6.92; P = .009). The RRR for MCI was 0.97 (95% CI, 0.39-2.38; P = .803). The greater functional impairment in patients with late-onset epilepsy may explain the lack of a relationship between late-onset epilepsy and MCI.

“It will be important for neurologists to be aware of the possibility of cognitive impairment following late-onset epilepsy and to check in with patients and family members to see if there are concerns,” said Dr. Johnson.

“We should also be talking about the importance of lowering other risk factors for dementia by making sure cardiovascular risk factors are controlled and encouraging physical and cognitive activity,” she added.

The results require confirmation in a clinical population, the investigators noted. In addition, future research is necessary to clarify whether seizures directly increase the risk of dementia or whether shared neuropathology between epilepsy and dementia explains the risk.

“In the near future, I plan to enroll participants with late-onset epilepsy in an observational study to better understand factors that may contribute to cognitive change. Collaborations will be key as we seek to further understand what causes these changes and what could be done to prevent them,” Dr. Johnson added.
 

Strengths and weaknesses

In an accompanying editorial, W. Allen Hauser, MD, professor emeritus of neurology and epidemiology at Columbia University in New York, and colleagues noted that the findings support a bidirectional relationship between dementia and epilepsy, adding that accumulation of amyloid beta peptide is a plausible underlying pathophysiology that may explain this relationship.

Future research should clarify the effect of factors such as seizure type, seizure frequency, and age of onset on the risk of dementia among patients with epilepsy, the editorialists wrote. Such investigations could help elucidate the underlying mechanisms of these conditions and help to improve treatment, they added.

Commenting on the findings, Ilo Leppik, MD, professor of neurology and pharmacy at the University of Minnesota in Minneapolis described the research as “a very well-done study by qualified researchers in the field. … For the last century, medicine has unfortunately become compartmentalized by specialty and then subspecialty. The brain and disorders of the brain do not recognize these silos. … It is not a stretch of the known science to begin to understand that epilepsy and dementia have common anatomical and physiological underpinnings.”

The long period of prospectively gathering data and the measurement of cognitive function through various modalities are among the study’s great strengths, said Dr. Leppik. However, the study’s weakness is its reliance on Medicare claims data, which mainly would reflect convulsive seizures.

“What is missing is how many persons had subtle focal-unaware seizures that may not be identified unless a careful history is taken,” said Dr. Leppik. “Thus, this study likely underestimates the frequency of epilepsy.”

Neurologists who evaluate a person with early dementia should be on the lookout for a history of subtle seizures, said Dr. Leppik. Animal studies suggest treatment with levetiracetam or brivaracetam may slow the course of dementia, and a clinical study in participants with early dementia is underway.

“Treatment with an antiseizure drug may prove to be beneficial, especially if evidence for the presence of subtle epilepsy can be found,” Dr. Leppik added.

Greater collaboration between epileptologists and dementia specialists and larger studies of antiseizure drugs are necessary, he noted. “These studies can incorporate sophisticated structural and biochemical [analyses] to better identify the relationships between brain mechanisms that likely underlie both seizures and dementia. The ultimate promise is that early treatment of seizures may alter the course of dementia,” Dr. Leppik said.

The study by Dr. Johnson and colleagues was supported by a contract from the National Institute on Aging; ARIC from the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. The authors and Dr. Leppik have disclosed no relevant financial relationships.

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

Late-onset epilepsy is linked to a substantial increased risk of subsequent dementia. Results of a retrospective analysis show that patients who develop epilepsy at age 67 or older have a threefold increased risk of subsequent dementia versus their counterparts without epilepsy.

“This is an exciting area, as we are finding that just as the risk of seizures is increased in neurodegenerative diseases, the risk of dementia is increased after late-onset epilepsy and seizures,” study investigator Emily L. Johnson, MD, assistant professor of neurology at Johns Hopkins University, Baltimore, said in an interview. “Several other cohort studies are finding similar results, including the Veterans’ Health Study and the Framingham Study,” she added.

The study was published online Oct. 23 in Neurology
 

Bidirectional relationship?

Previous research has established that dementia is a risk factor for epilepsy, but recent studies also suggest an increased risk of incident dementia among patients with adult-onset epilepsy. Several risk factors for late-onset epilepsy, including diabetes and hypertension, also are risk factors for dementia. However, the effect of late-onset epilepsy on dementia risk in patients with these comorbidities has not been clarified.

To investigate, the researchers examined data from the Atherosclerosis Risk in Communities (ARIC) study. Participants include Black and White men and women from four U.S. communities. Baseline visits in this longitudinal cohort study began between 1987 and 1989, and follow-up included seven additional visits and regular phone calls.

The investigators identified participants with late-onset epilepsy by searching for Medicare claims related to seizures or epilepsy filed between 1991 and 2015. Those with two or more such claims and age of onset of 67 years or greater were considered to have late-onset epilepsy. Participants with preexisting conditions such as brain tumors or multiple sclerosis were excluded.

ARIC participants who presented in person for visits 2, 4, 5, and 6 underwent cognitive testing with the Delayed Word Recall Test, the Digit Symbol Substitution Test, and the Word Fluency Test.

Testing at visits 5 and 6 also included other tests, such as the Mini-Mental State Examination, the Boston Naming test, and the Wechsler Memory Scale-III. Dr. Johnson and colleagues excluded data for visit 7 from the analysis because dementia adjudication was not yet complete.

The researchers identified participants with dementia using data from visits 5 and 6 and ascertained time of dementia onset through participant and informant interviews, phone calls, and hospital discharge data. Participants also were screened for mild cognitive impairment (MCI) at visits 5 and 6.

Data were analyzed using a Cox proportional hazards model and multinomial logistic regression. In subsequent analyses, researchers adjusted the data for age, sex, race, smoking status, alcohol use, hypertension, diabetes, body mass index (BMI), APOE4 status, and prevalent stroke.

The researchers found that of 9,033 study participants, 671 had late-onset epilepsy. The late-onset epilepsy group was older at baseline (56.5 vs. 55.1 years) and more likely to have hypertension (38.9% vs. 33.3%), diabetes (16.1% vs. 9.6%), and two alleles of APOE4 genotype (3.9% vs. 2.5%), compared with those without the disorder.

In all, 1,687 participants developed dementia during follow-up. The rate of incident dementia was 41.6% in participants with late-onset epilepsy and 16.8% in participants without late-onset epilepsy. The adjusted hazard ratio of subsequent dementia in participants with late-onset epilepsy versus those without the disorder was 3.05 (95% confidence interval, 2.65-3.51).

The median time to dementia ascertainment after late-onset epilepsy was 3.66 years.
 

Counterintuitive finding

The relationship between late-onset epilepsy and subsequent dementia was stronger in patients without stroke. The investigators offered a possible explanation for this counterintuitive finding. “We observed an interaction between [late-onset epilepsy] and stroke, with a lower (but still substantial) association between [late-onset epilepsy] and dementia in those with a history of stroke. This may be due to the known strong association between stroke and dementia, which may wash out the contributions of [late-onset epilepsy] to cognitive impairment,” the researchers wrote.

“There may also be under-capturing of dementia diagnoses among participants with stroke in the ascertainment from [Centers for Medicare & Medicaid Services] codes, as physicians may be reluctant to make a separate code for ‘dementia’ in those with cognitive impairment after stroke,” they added.

When the researchers restricted the analysis only to participants who attended visits 5 and 6 and had late-onset epilepsy ascertainment available, they found that the relative risk ratio for dementia at visit 6 was 2.90 (95% CI, 1.22-6.92; P = .009). The RRR for MCI was 0.97 (95% CI, 0.39-2.38; P = .803). The greater functional impairment in patients with late-onset epilepsy may explain the lack of a relationship between late-onset epilepsy and MCI.

“It will be important for neurologists to be aware of the possibility of cognitive impairment following late-onset epilepsy and to check in with patients and family members to see if there are concerns,” said Dr. Johnson.

“We should also be talking about the importance of lowering other risk factors for dementia by making sure cardiovascular risk factors are controlled and encouraging physical and cognitive activity,” she added.

The results require confirmation in a clinical population, the investigators noted. In addition, future research is necessary to clarify whether seizures directly increase the risk of dementia or whether shared neuropathology between epilepsy and dementia explains the risk.

“In the near future, I plan to enroll participants with late-onset epilepsy in an observational study to better understand factors that may contribute to cognitive change. Collaborations will be key as we seek to further understand what causes these changes and what could be done to prevent them,” Dr. Johnson added.
 

Strengths and weaknesses

In an accompanying editorial, W. Allen Hauser, MD, professor emeritus of neurology and epidemiology at Columbia University in New York, and colleagues noted that the findings support a bidirectional relationship between dementia and epilepsy, adding that accumulation of amyloid beta peptide is a plausible underlying pathophysiology that may explain this relationship.

Future research should clarify the effect of factors such as seizure type, seizure frequency, and age of onset on the risk of dementia among patients with epilepsy, the editorialists wrote. Such investigations could help elucidate the underlying mechanisms of these conditions and help to improve treatment, they added.

Commenting on the findings, Ilo Leppik, MD, professor of neurology and pharmacy at the University of Minnesota in Minneapolis described the research as “a very well-done study by qualified researchers in the field. … For the last century, medicine has unfortunately become compartmentalized by specialty and then subspecialty. The brain and disorders of the brain do not recognize these silos. … It is not a stretch of the known science to begin to understand that epilepsy and dementia have common anatomical and physiological underpinnings.”

The long period of prospectively gathering data and the measurement of cognitive function through various modalities are among the study’s great strengths, said Dr. Leppik. However, the study’s weakness is its reliance on Medicare claims data, which mainly would reflect convulsive seizures.

“What is missing is how many persons had subtle focal-unaware seizures that may not be identified unless a careful history is taken,” said Dr. Leppik. “Thus, this study likely underestimates the frequency of epilepsy.”

Neurologists who evaluate a person with early dementia should be on the lookout for a history of subtle seizures, said Dr. Leppik. Animal studies suggest treatment with levetiracetam or brivaracetam may slow the course of dementia, and a clinical study in participants with early dementia is underway.

“Treatment with an antiseizure drug may prove to be beneficial, especially if evidence for the presence of subtle epilepsy can be found,” Dr. Leppik added.

Greater collaboration between epileptologists and dementia specialists and larger studies of antiseizure drugs are necessary, he noted. “These studies can incorporate sophisticated structural and biochemical [analyses] to better identify the relationships between brain mechanisms that likely underlie both seizures and dementia. The ultimate promise is that early treatment of seizures may alter the course of dementia,” Dr. Leppik said.

The study by Dr. Johnson and colleagues was supported by a contract from the National Institute on Aging; ARIC from the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. The authors and Dr. Leppik have disclosed no relevant financial relationships.

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

Late-onset epilepsy is linked to a substantial increased risk of subsequent dementia. Results of a retrospective analysis show that patients who develop epilepsy at age 67 or older have a threefold increased risk of subsequent dementia versus their counterparts without epilepsy.

“This is an exciting area, as we are finding that just as the risk of seizures is increased in neurodegenerative diseases, the risk of dementia is increased after late-onset epilepsy and seizures,” study investigator Emily L. Johnson, MD, assistant professor of neurology at Johns Hopkins University, Baltimore, said in an interview. “Several other cohort studies are finding similar results, including the Veterans’ Health Study and the Framingham Study,” she added.

The study was published online Oct. 23 in Neurology
 

Bidirectional relationship?

Previous research has established that dementia is a risk factor for epilepsy, but recent studies also suggest an increased risk of incident dementia among patients with adult-onset epilepsy. Several risk factors for late-onset epilepsy, including diabetes and hypertension, also are risk factors for dementia. However, the effect of late-onset epilepsy on dementia risk in patients with these comorbidities has not been clarified.

To investigate, the researchers examined data from the Atherosclerosis Risk in Communities (ARIC) study. Participants include Black and White men and women from four U.S. communities. Baseline visits in this longitudinal cohort study began between 1987 and 1989, and follow-up included seven additional visits and regular phone calls.

The investigators identified participants with late-onset epilepsy by searching for Medicare claims related to seizures or epilepsy filed between 1991 and 2015. Those with two or more such claims and age of onset of 67 years or greater were considered to have late-onset epilepsy. Participants with preexisting conditions such as brain tumors or multiple sclerosis were excluded.

ARIC participants who presented in person for visits 2, 4, 5, and 6 underwent cognitive testing with the Delayed Word Recall Test, the Digit Symbol Substitution Test, and the Word Fluency Test.

Testing at visits 5 and 6 also included other tests, such as the Mini-Mental State Examination, the Boston Naming test, and the Wechsler Memory Scale-III. Dr. Johnson and colleagues excluded data for visit 7 from the analysis because dementia adjudication was not yet complete.

The researchers identified participants with dementia using data from visits 5 and 6 and ascertained time of dementia onset through participant and informant interviews, phone calls, and hospital discharge data. Participants also were screened for mild cognitive impairment (MCI) at visits 5 and 6.

Data were analyzed using a Cox proportional hazards model and multinomial logistic regression. In subsequent analyses, researchers adjusted the data for age, sex, race, smoking status, alcohol use, hypertension, diabetes, body mass index (BMI), APOE4 status, and prevalent stroke.

The researchers found that of 9,033 study participants, 671 had late-onset epilepsy. The late-onset epilepsy group was older at baseline (56.5 vs. 55.1 years) and more likely to have hypertension (38.9% vs. 33.3%), diabetes (16.1% vs. 9.6%), and two alleles of APOE4 genotype (3.9% vs. 2.5%), compared with those without the disorder.

In all, 1,687 participants developed dementia during follow-up. The rate of incident dementia was 41.6% in participants with late-onset epilepsy and 16.8% in participants without late-onset epilepsy. The adjusted hazard ratio of subsequent dementia in participants with late-onset epilepsy versus those without the disorder was 3.05 (95% confidence interval, 2.65-3.51).

The median time to dementia ascertainment after late-onset epilepsy was 3.66 years.
 

Counterintuitive finding

The relationship between late-onset epilepsy and subsequent dementia was stronger in patients without stroke. The investigators offered a possible explanation for this counterintuitive finding. “We observed an interaction between [late-onset epilepsy] and stroke, with a lower (but still substantial) association between [late-onset epilepsy] and dementia in those with a history of stroke. This may be due to the known strong association between stroke and dementia, which may wash out the contributions of [late-onset epilepsy] to cognitive impairment,” the researchers wrote.

“There may also be under-capturing of dementia diagnoses among participants with stroke in the ascertainment from [Centers for Medicare & Medicaid Services] codes, as physicians may be reluctant to make a separate code for ‘dementia’ in those with cognitive impairment after stroke,” they added.

When the researchers restricted the analysis only to participants who attended visits 5 and 6 and had late-onset epilepsy ascertainment available, they found that the relative risk ratio for dementia at visit 6 was 2.90 (95% CI, 1.22-6.92; P = .009). The RRR for MCI was 0.97 (95% CI, 0.39-2.38; P = .803). The greater functional impairment in patients with late-onset epilepsy may explain the lack of a relationship between late-onset epilepsy and MCI.

“It will be important for neurologists to be aware of the possibility of cognitive impairment following late-onset epilepsy and to check in with patients and family members to see if there are concerns,” said Dr. Johnson.

“We should also be talking about the importance of lowering other risk factors for dementia by making sure cardiovascular risk factors are controlled and encouraging physical and cognitive activity,” she added.

The results require confirmation in a clinical population, the investigators noted. In addition, future research is necessary to clarify whether seizures directly increase the risk of dementia or whether shared neuropathology between epilepsy and dementia explains the risk.

“In the near future, I plan to enroll participants with late-onset epilepsy in an observational study to better understand factors that may contribute to cognitive change. Collaborations will be key as we seek to further understand what causes these changes and what could be done to prevent them,” Dr. Johnson added.
 

Strengths and weaknesses

In an accompanying editorial, W. Allen Hauser, MD, professor emeritus of neurology and epidemiology at Columbia University in New York, and colleagues noted that the findings support a bidirectional relationship between dementia and epilepsy, adding that accumulation of amyloid beta peptide is a plausible underlying pathophysiology that may explain this relationship.

Future research should clarify the effect of factors such as seizure type, seizure frequency, and age of onset on the risk of dementia among patients with epilepsy, the editorialists wrote. Such investigations could help elucidate the underlying mechanisms of these conditions and help to improve treatment, they added.

Commenting on the findings, Ilo Leppik, MD, professor of neurology and pharmacy at the University of Minnesota in Minneapolis described the research as “a very well-done study by qualified researchers in the field. … For the last century, medicine has unfortunately become compartmentalized by specialty and then subspecialty. The brain and disorders of the brain do not recognize these silos. … It is not a stretch of the known science to begin to understand that epilepsy and dementia have common anatomical and physiological underpinnings.”

The long period of prospectively gathering data and the measurement of cognitive function through various modalities are among the study’s great strengths, said Dr. Leppik. However, the study’s weakness is its reliance on Medicare claims data, which mainly would reflect convulsive seizures.

“What is missing is how many persons had subtle focal-unaware seizures that may not be identified unless a careful history is taken,” said Dr. Leppik. “Thus, this study likely underestimates the frequency of epilepsy.”

Neurologists who evaluate a person with early dementia should be on the lookout for a history of subtle seizures, said Dr. Leppik. Animal studies suggest treatment with levetiracetam or brivaracetam may slow the course of dementia, and a clinical study in participants with early dementia is underway.

“Treatment with an antiseizure drug may prove to be beneficial, especially if evidence for the presence of subtle epilepsy can be found,” Dr. Leppik added.

Greater collaboration between epileptologists and dementia specialists and larger studies of antiseizure drugs are necessary, he noted. “These studies can incorporate sophisticated structural and biochemical [analyses] to better identify the relationships between brain mechanisms that likely underlie both seizures and dementia. The ultimate promise is that early treatment of seizures may alter the course of dementia,” Dr. Leppik said.

The study by Dr. Johnson and colleagues was supported by a contract from the National Institute on Aging; ARIC from the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. The authors and Dr. Leppik have disclosed no relevant financial relationships.

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