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New DEA CME mandate affects 2 million prescribers

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Wed, 06/28/2023 - 08:43

 

The Consolidated Appropriations Act of 2023 mandates that all Drug Enforcement Administration–registered physicians and health care providers complete a one-time, 8-hour CME training on managing and treating opioid and other substance abuse disorders. This requirement goes into effect on June 27, 2023. New DEA registrants must also comply. Veterinarians are exempt.

A DEA registration is required to prescribe any controlled substance. The DEA categorizes these as Schedule I-V, with V being the least likely to be abused (Table 1). For example, opioids like fentanyl, oxycodone, and morphine are Schedule II. Medications without abuse potential are not scheduled.

Will 16 million hours of opioid education save lives?

One should not underestimate the sweeping scope of this new federal requirement. DEA registrants include physicians and other health care providers such as nurse practitioners, physician assistants, and dentists. There are nearly 2 million DEA registrants, all of whom must now dedicate 8 hours to complete the DEA-mandated CME. That is 8 hours per provider x 2 million providers: 16 million hours of CME!

Many states already require 1 or more hours of opioid training and pain management as part of their relicensure requirements (Table 2). To avoid redundancy, the DEA-mandated 8-hour training satisfies the various states’ requirements. 

An uncompensated mandate

Physicians are no strangers to lifelong learning and most eagerly pursue educational opportunities. Though some physicians may have CME time and stipends allocated by their employers, many others, such as the approximately 50,000 locum tenens doctors, do not. However, as enthusiastic as these physicians may be about this new CME course, they will likely lose a day of seeing patients (and income) to comply with this new obligation.

Not just pain doctors

The mandate’s broad brush includes many health care providers who hold DEA certificates but do not prescribe opioids. For example, as a general neurologist and epileptologist, I do not treat patients with chronic pain and cannot remember the last time I wrote an opioid prescription. However, I frequently prescribe lacosamide, a Schedule V drug. A surprisingly large number of antiseizure drugs are Schedule III, IV, or V drugs (Table 3).

Real-world abuse?

How often scheduled antiseizure drugs are diverted or abused in an epilepsy population is unknown but appears to be infrequent. For example, perampanel abuse has not been reported despite its classification as a Schedule III drug. Anecdotally, in more than 40 years of clinical practice, I have never known a patient with epilepsy to abuse their antiseizure medications.

Take the course

Many organizations are happy to charge for the new 8-hour course. For example, the Tennessee Medical Association offers the training for $299 online or $400 in person. Materials from Elite Learning satisfy the 8-hour requirement for $80. However, NEJM Knowledge+ provides a complimentary 10-hour DEA-compliant course.

I recently completed the NEJM course. The information was thorough and took the whole 10 hours to finish. As excellent as it was, the content was only tangentially relevant to my clinical practice.
 

Conclusions

To obtain or renew a DEA certificate, neurologists, epilepsy specialists, and many other health care providers must comply with the new 8-hour CME opioid training mandate. Because the course requires 1 day to complete, health care providers would be prudent to obtain their CME well before their DEA certificate expires.

Though efforts to control the morbidity and mortality of the opioid epidemic are laudatory, perhaps the training should be more targeted to physicians who actually prescribe opioids rather than every DEA registrant. In the meantime, whether 16 million CME hours will save lives remains to be seen.

Dr. Wilner is professor of neurology at the University of Tennessee Health Science Center, Memphis. He reported a conflict of interest with Accordant Health Services.



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

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The Consolidated Appropriations Act of 2023 mandates that all Drug Enforcement Administration–registered physicians and health care providers complete a one-time, 8-hour CME training on managing and treating opioid and other substance abuse disorders. This requirement goes into effect on June 27, 2023. New DEA registrants must also comply. Veterinarians are exempt.

A DEA registration is required to prescribe any controlled substance. The DEA categorizes these as Schedule I-V, with V being the least likely to be abused (Table 1). For example, opioids like fentanyl, oxycodone, and morphine are Schedule II. Medications without abuse potential are not scheduled.

Will 16 million hours of opioid education save lives?

One should not underestimate the sweeping scope of this new federal requirement. DEA registrants include physicians and other health care providers such as nurse practitioners, physician assistants, and dentists. There are nearly 2 million DEA registrants, all of whom must now dedicate 8 hours to complete the DEA-mandated CME. That is 8 hours per provider x 2 million providers: 16 million hours of CME!

Many states already require 1 or more hours of opioid training and pain management as part of their relicensure requirements (Table 2). To avoid redundancy, the DEA-mandated 8-hour training satisfies the various states’ requirements. 

An uncompensated mandate

Physicians are no strangers to lifelong learning and most eagerly pursue educational opportunities. Though some physicians may have CME time and stipends allocated by their employers, many others, such as the approximately 50,000 locum tenens doctors, do not. However, as enthusiastic as these physicians may be about this new CME course, they will likely lose a day of seeing patients (and income) to comply with this new obligation.

Not just pain doctors

The mandate’s broad brush includes many health care providers who hold DEA certificates but do not prescribe opioids. For example, as a general neurologist and epileptologist, I do not treat patients with chronic pain and cannot remember the last time I wrote an opioid prescription. However, I frequently prescribe lacosamide, a Schedule V drug. A surprisingly large number of antiseizure drugs are Schedule III, IV, or V drugs (Table 3).

Real-world abuse?

How often scheduled antiseizure drugs are diverted or abused in an epilepsy population is unknown but appears to be infrequent. For example, perampanel abuse has not been reported despite its classification as a Schedule III drug. Anecdotally, in more than 40 years of clinical practice, I have never known a patient with epilepsy to abuse their antiseizure medications.

Take the course

Many organizations are happy to charge for the new 8-hour course. For example, the Tennessee Medical Association offers the training for $299 online or $400 in person. Materials from Elite Learning satisfy the 8-hour requirement for $80. However, NEJM Knowledge+ provides a complimentary 10-hour DEA-compliant course.

I recently completed the NEJM course. The information was thorough and took the whole 10 hours to finish. As excellent as it was, the content was only tangentially relevant to my clinical practice.
 

Conclusions

To obtain or renew a DEA certificate, neurologists, epilepsy specialists, and many other health care providers must comply with the new 8-hour CME opioid training mandate. Because the course requires 1 day to complete, health care providers would be prudent to obtain their CME well before their DEA certificate expires.

Though efforts to control the morbidity and mortality of the opioid epidemic are laudatory, perhaps the training should be more targeted to physicians who actually prescribe opioids rather than every DEA registrant. In the meantime, whether 16 million CME hours will save lives remains to be seen.

Dr. Wilner is professor of neurology at the University of Tennessee Health Science Center, Memphis. He reported a conflict of interest with Accordant Health Services.



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

 

The Consolidated Appropriations Act of 2023 mandates that all Drug Enforcement Administration–registered physicians and health care providers complete a one-time, 8-hour CME training on managing and treating opioid and other substance abuse disorders. This requirement goes into effect on June 27, 2023. New DEA registrants must also comply. Veterinarians are exempt.

A DEA registration is required to prescribe any controlled substance. The DEA categorizes these as Schedule I-V, with V being the least likely to be abused (Table 1). For example, opioids like fentanyl, oxycodone, and morphine are Schedule II. Medications without abuse potential are not scheduled.

Will 16 million hours of opioid education save lives?

One should not underestimate the sweeping scope of this new federal requirement. DEA registrants include physicians and other health care providers such as nurse practitioners, physician assistants, and dentists. There are nearly 2 million DEA registrants, all of whom must now dedicate 8 hours to complete the DEA-mandated CME. That is 8 hours per provider x 2 million providers: 16 million hours of CME!

Many states already require 1 or more hours of opioid training and pain management as part of their relicensure requirements (Table 2). To avoid redundancy, the DEA-mandated 8-hour training satisfies the various states’ requirements. 

An uncompensated mandate

Physicians are no strangers to lifelong learning and most eagerly pursue educational opportunities. Though some physicians may have CME time and stipends allocated by their employers, many others, such as the approximately 50,000 locum tenens doctors, do not. However, as enthusiastic as these physicians may be about this new CME course, they will likely lose a day of seeing patients (and income) to comply with this new obligation.

Not just pain doctors

The mandate’s broad brush includes many health care providers who hold DEA certificates but do not prescribe opioids. For example, as a general neurologist and epileptologist, I do not treat patients with chronic pain and cannot remember the last time I wrote an opioid prescription. However, I frequently prescribe lacosamide, a Schedule V drug. A surprisingly large number of antiseizure drugs are Schedule III, IV, or V drugs (Table 3).

Real-world abuse?

How often scheduled antiseizure drugs are diverted or abused in an epilepsy population is unknown but appears to be infrequent. For example, perampanel abuse has not been reported despite its classification as a Schedule III drug. Anecdotally, in more than 40 years of clinical practice, I have never known a patient with epilepsy to abuse their antiseizure medications.

Take the course

Many organizations are happy to charge for the new 8-hour course. For example, the Tennessee Medical Association offers the training for $299 online or $400 in person. Materials from Elite Learning satisfy the 8-hour requirement for $80. However, NEJM Knowledge+ provides a complimentary 10-hour DEA-compliant course.

I recently completed the NEJM course. The information was thorough and took the whole 10 hours to finish. As excellent as it was, the content was only tangentially relevant to my clinical practice.
 

Conclusions

To obtain or renew a DEA certificate, neurologists, epilepsy specialists, and many other health care providers must comply with the new 8-hour CME opioid training mandate. Because the course requires 1 day to complete, health care providers would be prudent to obtain their CME well before their DEA certificate expires.

Though efforts to control the morbidity and mortality of the opioid epidemic are laudatory, perhaps the training should be more targeted to physicians who actually prescribe opioids rather than every DEA registrant. In the meantime, whether 16 million CME hours will save lives remains to be seen.

Dr. Wilner is professor of neurology at the University of Tennessee Health Science Center, Memphis. He reported a conflict of interest with Accordant Health Services.



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

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Pharmacotherapy underprescribed for alcohol use disorder

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Tue, 06/27/2023 - 09:26

Health care providers are missing opportunities to give medical treatment to high-risk individuals hospitalized for alcohol use disorder (AUD), a national analysis of Medicare beneficiaries reported.

Increasing such patients’ access to psychiatric care and addiction medicine, as well as encouraging medication prescribing by generalists and nonaddiction specialists, are remedial strategies recommended by lead author Eden Y. Bernstein, MD, of the division of general internal medicine at Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Hospitalizations for alcohol use disorder are common,” Dr. Bernstein said in an interview. “Our work shows they represent an underutilized opportunity to engage patients with appropriate treatment, including initiation of medications for alcohol use disorder.”

There is a pressing need for such treatment strategies since 29 million U.S. adults have AUD, and alcohol contributes to more than 140,000 deaths annually, the authors noted.

Rarely initiated either at hospital discharge or during follow-up care, medical therapy for AUD was more likely to be provided to younger patients and those involved with psychiatric care or addiction medicine, Dr. Bernstein’s group reported in Annals of Internal Medicine.Hospital admissions, they argued, give patients more access to clinicians and social workers and the vulnerability experienced during hospitalization may motivate behavioral change.


 

National study

The cohort included 28,601 AUD hospitalizations for 20,401 unique Medicare patients from 2015 to 2017. About 30% of admissions were for women and about 72% for non-Hispanic Blacks. Discharge initiation of medication for AUD was defined as a pharmacy claim for naltrexone, acamprosate, or disulfiram from the day before discharge to 2 days after.

Overall, just 206 patients (0.7%) initiated medication for AUD within 2 days of discharge and 364 (1.3%) started it within 30 days. Among those discharged with a primary diagnosis of AUD, only 70 (2.3%) started medical therapy within 2 days.

The most predictive demographic factor for discharge medication for AUD was younger age: 18-39 years versus 75 years and older (adjusted odds ratio, 3.87; 95% confidence interval, 1.34-11.16).

Initiation of medication for AUD should involve a long-term treatment plan, according to Dr. Bernstein’s group, and if that is not feasible during hospitalization, patients should be referred for outpatient treatment.

An accompanying editorial agrees that the results offer strong evidence of a missed opportunity to address AUD at a potential flexion point. “Hospitalization is a critical touch point for identifying and treating AUD,” wrote Michael F. Mayo-Smith, MD, MPH, of White River Junction (Vt.) VA Medical Center, and Geisel School of Medicine at Dartmouth, Hanover, N.H., and David Lawrence, MD, of the VA Greater Los Angeles Healthcare System and the University of California, Los Angeles.

An intentional discharge protocol can be effective, they noted, as evidenced by a 2014 report in which this approach increased medication-assisted treatment from 0% to 64% in tandem with a decrease in all-cause, 30-day readmission rates.

“There is also growing interest in inpatient addiction consultation services, which have shown [medication] for AUD treatment initiation rates of up to 70% as well as improved engagement in posthospital treatment,” Dr. Mayo-Smith and Dr. Lawrence wrote.

Minority populations need particular attention, they added. “Unfortunately, the availability of evidence-based treatments for AUD does not by itself lead to improved care. We need strategies for widespread adoption so that patients can realize the benefits of these treatments.”

Dr. Bernstein reported funding support from a National Research Service Award and the Massachusetts General Hospital division of general internal medicine; he disclosed fees from Alosa Health. One coauthor was supported by the Agency for Healthcare Research and Quality. Another was supported by the National Institute on Aging and reported relationships with the American College of Cardiology, Boston OIAC Pepper Center, American Heart Association, and US Deprescribing Research Network. Dr. Mayo-Smith disclosed no competing interests. Dr. Lawrence reported fees related to presentations at DDW 2023 and the California Society of Addiction Medicine 2022.

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Health care providers are missing opportunities to give medical treatment to high-risk individuals hospitalized for alcohol use disorder (AUD), a national analysis of Medicare beneficiaries reported.

Increasing such patients’ access to psychiatric care and addiction medicine, as well as encouraging medication prescribing by generalists and nonaddiction specialists, are remedial strategies recommended by lead author Eden Y. Bernstein, MD, of the division of general internal medicine at Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Hospitalizations for alcohol use disorder are common,” Dr. Bernstein said in an interview. “Our work shows they represent an underutilized opportunity to engage patients with appropriate treatment, including initiation of medications for alcohol use disorder.”

There is a pressing need for such treatment strategies since 29 million U.S. adults have AUD, and alcohol contributes to more than 140,000 deaths annually, the authors noted.

Rarely initiated either at hospital discharge or during follow-up care, medical therapy for AUD was more likely to be provided to younger patients and those involved with psychiatric care or addiction medicine, Dr. Bernstein’s group reported in Annals of Internal Medicine.Hospital admissions, they argued, give patients more access to clinicians and social workers and the vulnerability experienced during hospitalization may motivate behavioral change.


 

National study

The cohort included 28,601 AUD hospitalizations for 20,401 unique Medicare patients from 2015 to 2017. About 30% of admissions were for women and about 72% for non-Hispanic Blacks. Discharge initiation of medication for AUD was defined as a pharmacy claim for naltrexone, acamprosate, or disulfiram from the day before discharge to 2 days after.

Overall, just 206 patients (0.7%) initiated medication for AUD within 2 days of discharge and 364 (1.3%) started it within 30 days. Among those discharged with a primary diagnosis of AUD, only 70 (2.3%) started medical therapy within 2 days.

The most predictive demographic factor for discharge medication for AUD was younger age: 18-39 years versus 75 years and older (adjusted odds ratio, 3.87; 95% confidence interval, 1.34-11.16).

Initiation of medication for AUD should involve a long-term treatment plan, according to Dr. Bernstein’s group, and if that is not feasible during hospitalization, patients should be referred for outpatient treatment.

An accompanying editorial agrees that the results offer strong evidence of a missed opportunity to address AUD at a potential flexion point. “Hospitalization is a critical touch point for identifying and treating AUD,” wrote Michael F. Mayo-Smith, MD, MPH, of White River Junction (Vt.) VA Medical Center, and Geisel School of Medicine at Dartmouth, Hanover, N.H., and David Lawrence, MD, of the VA Greater Los Angeles Healthcare System and the University of California, Los Angeles.

An intentional discharge protocol can be effective, they noted, as evidenced by a 2014 report in which this approach increased medication-assisted treatment from 0% to 64% in tandem with a decrease in all-cause, 30-day readmission rates.

“There is also growing interest in inpatient addiction consultation services, which have shown [medication] for AUD treatment initiation rates of up to 70% as well as improved engagement in posthospital treatment,” Dr. Mayo-Smith and Dr. Lawrence wrote.

Minority populations need particular attention, they added. “Unfortunately, the availability of evidence-based treatments for AUD does not by itself lead to improved care. We need strategies for widespread adoption so that patients can realize the benefits of these treatments.”

Dr. Bernstein reported funding support from a National Research Service Award and the Massachusetts General Hospital division of general internal medicine; he disclosed fees from Alosa Health. One coauthor was supported by the Agency for Healthcare Research and Quality. Another was supported by the National Institute on Aging and reported relationships with the American College of Cardiology, Boston OIAC Pepper Center, American Heart Association, and US Deprescribing Research Network. Dr. Mayo-Smith disclosed no competing interests. Dr. Lawrence reported fees related to presentations at DDW 2023 and the California Society of Addiction Medicine 2022.

Health care providers are missing opportunities to give medical treatment to high-risk individuals hospitalized for alcohol use disorder (AUD), a national analysis of Medicare beneficiaries reported.

Increasing such patients’ access to psychiatric care and addiction medicine, as well as encouraging medication prescribing by generalists and nonaddiction specialists, are remedial strategies recommended by lead author Eden Y. Bernstein, MD, of the division of general internal medicine at Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Hospitalizations for alcohol use disorder are common,” Dr. Bernstein said in an interview. “Our work shows they represent an underutilized opportunity to engage patients with appropriate treatment, including initiation of medications for alcohol use disorder.”

There is a pressing need for such treatment strategies since 29 million U.S. adults have AUD, and alcohol contributes to more than 140,000 deaths annually, the authors noted.

Rarely initiated either at hospital discharge or during follow-up care, medical therapy for AUD was more likely to be provided to younger patients and those involved with psychiatric care or addiction medicine, Dr. Bernstein’s group reported in Annals of Internal Medicine.Hospital admissions, they argued, give patients more access to clinicians and social workers and the vulnerability experienced during hospitalization may motivate behavioral change.


 

National study

The cohort included 28,601 AUD hospitalizations for 20,401 unique Medicare patients from 2015 to 2017. About 30% of admissions were for women and about 72% for non-Hispanic Blacks. Discharge initiation of medication for AUD was defined as a pharmacy claim for naltrexone, acamprosate, or disulfiram from the day before discharge to 2 days after.

Overall, just 206 patients (0.7%) initiated medication for AUD within 2 days of discharge and 364 (1.3%) started it within 30 days. Among those discharged with a primary diagnosis of AUD, only 70 (2.3%) started medical therapy within 2 days.

The most predictive demographic factor for discharge medication for AUD was younger age: 18-39 years versus 75 years and older (adjusted odds ratio, 3.87; 95% confidence interval, 1.34-11.16).

Initiation of medication for AUD should involve a long-term treatment plan, according to Dr. Bernstein’s group, and if that is not feasible during hospitalization, patients should be referred for outpatient treatment.

An accompanying editorial agrees that the results offer strong evidence of a missed opportunity to address AUD at a potential flexion point. “Hospitalization is a critical touch point for identifying and treating AUD,” wrote Michael F. Mayo-Smith, MD, MPH, of White River Junction (Vt.) VA Medical Center, and Geisel School of Medicine at Dartmouth, Hanover, N.H., and David Lawrence, MD, of the VA Greater Los Angeles Healthcare System and the University of California, Los Angeles.

An intentional discharge protocol can be effective, they noted, as evidenced by a 2014 report in which this approach increased medication-assisted treatment from 0% to 64% in tandem with a decrease in all-cause, 30-day readmission rates.

“There is also growing interest in inpatient addiction consultation services, which have shown [medication] for AUD treatment initiation rates of up to 70% as well as improved engagement in posthospital treatment,” Dr. Mayo-Smith and Dr. Lawrence wrote.

Minority populations need particular attention, they added. “Unfortunately, the availability of evidence-based treatments for AUD does not by itself lead to improved care. We need strategies for widespread adoption so that patients can realize the benefits of these treatments.”

Dr. Bernstein reported funding support from a National Research Service Award and the Massachusetts General Hospital division of general internal medicine; he disclosed fees from Alosa Health. One coauthor was supported by the Agency for Healthcare Research and Quality. Another was supported by the National Institute on Aging and reported relationships with the American College of Cardiology, Boston OIAC Pepper Center, American Heart Association, and US Deprescribing Research Network. Dr. Mayo-Smith disclosed no competing interests. Dr. Lawrence reported fees related to presentations at DDW 2023 and the California Society of Addiction Medicine 2022.

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New law allows international medical graduates to bypass U.S. residency

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Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

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Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

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CBSM phone app eases anxiety, depression in cancer patients

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Fri, 06/23/2023 - 17:19

– One-third of patients with cancer also experience anxiety or depression, and an estimated 70% of the 18 million patients with cancer and cancer survivors in the US experience emotional symptoms, including fear of recurrence.

Despite many having these symptoms, few patients with cancer have access to psycho-oncologic support.

A digital cognitive-behavioral stress management (CBSM) application may help to ease some of the burden, reported Allison Ramiller, MPH, of Blue Note Therapeutics in San Francisco, which developed the app version of the program.

In the randomized controlled RESTORE study, use of the cell phone–based CBSM app was associated with significantly greater reduction in symptoms of anxiety and depression compared with a digital health education control app.

In addition, patients assigned to the CBSM app were twice as likely as control persons to report that their symptoms were “much” or “very much” improved after using the app for 12 weeks, Ms. Ramiller reported at an oral abstract session at the annual meeting of the American Society of Clinical Oncology (ASCO).

However, the investigators did not report baseline characteristics of patients in each of the study arms, which might have helped to clarify the depth of the effects they saw.

The CBSM program was developed by Michael H. Antoni, PhD, and colleagues in the University of Miami Health System. It is based on cognitive-behavioral therapy but also includes stress management and relaxation techniques to help patients cope with cancer-specific stress.

“”It has been clinically validated and shown to benefit patients with cancer,” Ms. Ramiller said. “However, access is a problem,” she said.

“There aren’t enough qualified, trained providers for the need, and patients with cancer encounter barriers to in-person participation, including things like transportation or financial barriers. So to overcome this, we developed a digitized version of CBSM,” she explained.
 

Impressive and elegant

“Everything about [the study] I thought was very impressive, very elegant, very nicely done,” said invited discussant Raymond U. Osarogiagbon, MBBS, FACP, chief scientist at Baptist Memorial Health Care Corp in Memphis, Tenn.

“They showed efficacy, they showed safety – very nice – user friendliness – very good. Certainly they look like they’re trying to address a highly important, unmet need in a very elegant way. Certainly, they pointed out it needs longer follow-up to see sustainability. We need to see will this work in other settings. Will this be cost-effective? You’ve gotta believe it probably will be,” he said.

CBSM has previously been shown to help patients with cancer reduce stress, improve general and cancer-specific quality of life at various stages of treatment, reduce symptom burden, and improve coping skills, Ms. Ramiller said.

To see whether these benefits could be conveyed digitally rather than in face-to-face encounters, Ms. Ramiller and colleagues worked with Dr. Antoni to develop the CBSM app.

Patients using the app received therapeutic content over 10 sessions with audio, video, and interactive tools that mimicked the sessions they would have received during in-person interventions.

They then compared the app against the control educational app in the randomized, decentralized RESTORE study.
 

High-quality control

Ms. Ramiller said that the control app set “a high bar.”

“The control also offered 10 interactive self-guided sessions. Both treatment apps were professionally designed and visually similar in styling, and they were presented as digital therapeutic-specific for cancer patients. And they were also in a match condition, meaning they received the same attention from study staff and cadence of reminders, but importantly, only the intervention app was based on CBSM,” she explained.

A total of 449 patients with cancers of stage I–III who were undergoing active systemic treatment or were planning to undergo such treatment within 6 months were randomly assigned to the CBSM app or the control app.

The CBSM app was superior to the control app for the primary outcome of anxiety reduction over baseline, as measured at 4, 8 and 12 weeks by the Patient-Reported Outcomes Measurement Information System Anxiety Scale (PROMIS-A) (beta = -.03; P = .019).

CBSM was also significantly better than the control app for the secondary endpoints of reducing symptoms of depression, as measured by the PROMIS-D scale (beta = -.02, P = .042), and also at increasing the percentage of patients who reported improvement in anxiety and depression symptoms on the Patient Global Impression of Change instrument (P < .001)

An extension study of the durability of the effects at 3 and 6 months is underway.

The investigators noted that the incremental cost of management of anxiety or depression is greater than $17,000 per patient per year.

“One of the big promises of a digital therapeutic like this is that it could potentially reduce costs,” Ms. Ramiller told the audience, but she acknowledged, “More work is really needed, however, to directly test the potential savings.”

The RESTORE study is funded by Blue Note Therapeutics. Dr. Osarogiagbon owns stock in Gilead, Lilly, and Pfizer, has received honoraria from Biodesix and Medscape, and has a consulting or advisory role for the American Cancer Society AstraZeneca, Genentech/Roche, LUNGevity, National Cancer Institute, and Triptych Health Partners.
 

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

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– One-third of patients with cancer also experience anxiety or depression, and an estimated 70% of the 18 million patients with cancer and cancer survivors in the US experience emotional symptoms, including fear of recurrence.

Despite many having these symptoms, few patients with cancer have access to psycho-oncologic support.

A digital cognitive-behavioral stress management (CBSM) application may help to ease some of the burden, reported Allison Ramiller, MPH, of Blue Note Therapeutics in San Francisco, which developed the app version of the program.

In the randomized controlled RESTORE study, use of the cell phone–based CBSM app was associated with significantly greater reduction in symptoms of anxiety and depression compared with a digital health education control app.

In addition, patients assigned to the CBSM app were twice as likely as control persons to report that their symptoms were “much” or “very much” improved after using the app for 12 weeks, Ms. Ramiller reported at an oral abstract session at the annual meeting of the American Society of Clinical Oncology (ASCO).

However, the investigators did not report baseline characteristics of patients in each of the study arms, which might have helped to clarify the depth of the effects they saw.

The CBSM program was developed by Michael H. Antoni, PhD, and colleagues in the University of Miami Health System. It is based on cognitive-behavioral therapy but also includes stress management and relaxation techniques to help patients cope with cancer-specific stress.

“”It has been clinically validated and shown to benefit patients with cancer,” Ms. Ramiller said. “However, access is a problem,” she said.

“There aren’t enough qualified, trained providers for the need, and patients with cancer encounter barriers to in-person participation, including things like transportation or financial barriers. So to overcome this, we developed a digitized version of CBSM,” she explained.
 

Impressive and elegant

“Everything about [the study] I thought was very impressive, very elegant, very nicely done,” said invited discussant Raymond U. Osarogiagbon, MBBS, FACP, chief scientist at Baptist Memorial Health Care Corp in Memphis, Tenn.

“They showed efficacy, they showed safety – very nice – user friendliness – very good. Certainly they look like they’re trying to address a highly important, unmet need in a very elegant way. Certainly, they pointed out it needs longer follow-up to see sustainability. We need to see will this work in other settings. Will this be cost-effective? You’ve gotta believe it probably will be,” he said.

CBSM has previously been shown to help patients with cancer reduce stress, improve general and cancer-specific quality of life at various stages of treatment, reduce symptom burden, and improve coping skills, Ms. Ramiller said.

To see whether these benefits could be conveyed digitally rather than in face-to-face encounters, Ms. Ramiller and colleagues worked with Dr. Antoni to develop the CBSM app.

Patients using the app received therapeutic content over 10 sessions with audio, video, and interactive tools that mimicked the sessions they would have received during in-person interventions.

They then compared the app against the control educational app in the randomized, decentralized RESTORE study.
 

High-quality control

Ms. Ramiller said that the control app set “a high bar.”

“The control also offered 10 interactive self-guided sessions. Both treatment apps were professionally designed and visually similar in styling, and they were presented as digital therapeutic-specific for cancer patients. And they were also in a match condition, meaning they received the same attention from study staff and cadence of reminders, but importantly, only the intervention app was based on CBSM,” she explained.

A total of 449 patients with cancers of stage I–III who were undergoing active systemic treatment or were planning to undergo such treatment within 6 months were randomly assigned to the CBSM app or the control app.

The CBSM app was superior to the control app for the primary outcome of anxiety reduction over baseline, as measured at 4, 8 and 12 weeks by the Patient-Reported Outcomes Measurement Information System Anxiety Scale (PROMIS-A) (beta = -.03; P = .019).

CBSM was also significantly better than the control app for the secondary endpoints of reducing symptoms of depression, as measured by the PROMIS-D scale (beta = -.02, P = .042), and also at increasing the percentage of patients who reported improvement in anxiety and depression symptoms on the Patient Global Impression of Change instrument (P < .001)

An extension study of the durability of the effects at 3 and 6 months is underway.

The investigators noted that the incremental cost of management of anxiety or depression is greater than $17,000 per patient per year.

“One of the big promises of a digital therapeutic like this is that it could potentially reduce costs,” Ms. Ramiller told the audience, but she acknowledged, “More work is really needed, however, to directly test the potential savings.”

The RESTORE study is funded by Blue Note Therapeutics. Dr. Osarogiagbon owns stock in Gilead, Lilly, and Pfizer, has received honoraria from Biodesix and Medscape, and has a consulting or advisory role for the American Cancer Society AstraZeneca, Genentech/Roche, LUNGevity, National Cancer Institute, and Triptych Health Partners.
 

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

– One-third of patients with cancer also experience anxiety or depression, and an estimated 70% of the 18 million patients with cancer and cancer survivors in the US experience emotional symptoms, including fear of recurrence.

Despite many having these symptoms, few patients with cancer have access to psycho-oncologic support.

A digital cognitive-behavioral stress management (CBSM) application may help to ease some of the burden, reported Allison Ramiller, MPH, of Blue Note Therapeutics in San Francisco, which developed the app version of the program.

In the randomized controlled RESTORE study, use of the cell phone–based CBSM app was associated with significantly greater reduction in symptoms of anxiety and depression compared with a digital health education control app.

In addition, patients assigned to the CBSM app were twice as likely as control persons to report that their symptoms were “much” or “very much” improved after using the app for 12 weeks, Ms. Ramiller reported at an oral abstract session at the annual meeting of the American Society of Clinical Oncology (ASCO).

However, the investigators did not report baseline characteristics of patients in each of the study arms, which might have helped to clarify the depth of the effects they saw.

The CBSM program was developed by Michael H. Antoni, PhD, and colleagues in the University of Miami Health System. It is based on cognitive-behavioral therapy but also includes stress management and relaxation techniques to help patients cope with cancer-specific stress.

“”It has been clinically validated and shown to benefit patients with cancer,” Ms. Ramiller said. “However, access is a problem,” she said.

“There aren’t enough qualified, trained providers for the need, and patients with cancer encounter barriers to in-person participation, including things like transportation or financial barriers. So to overcome this, we developed a digitized version of CBSM,” she explained.
 

Impressive and elegant

“Everything about [the study] I thought was very impressive, very elegant, very nicely done,” said invited discussant Raymond U. Osarogiagbon, MBBS, FACP, chief scientist at Baptist Memorial Health Care Corp in Memphis, Tenn.

“They showed efficacy, they showed safety – very nice – user friendliness – very good. Certainly they look like they’re trying to address a highly important, unmet need in a very elegant way. Certainly, they pointed out it needs longer follow-up to see sustainability. We need to see will this work in other settings. Will this be cost-effective? You’ve gotta believe it probably will be,” he said.

CBSM has previously been shown to help patients with cancer reduce stress, improve general and cancer-specific quality of life at various stages of treatment, reduce symptom burden, and improve coping skills, Ms. Ramiller said.

To see whether these benefits could be conveyed digitally rather than in face-to-face encounters, Ms. Ramiller and colleagues worked with Dr. Antoni to develop the CBSM app.

Patients using the app received therapeutic content over 10 sessions with audio, video, and interactive tools that mimicked the sessions they would have received during in-person interventions.

They then compared the app against the control educational app in the randomized, decentralized RESTORE study.
 

High-quality control

Ms. Ramiller said that the control app set “a high bar.”

“The control also offered 10 interactive self-guided sessions. Both treatment apps were professionally designed and visually similar in styling, and they were presented as digital therapeutic-specific for cancer patients. And they were also in a match condition, meaning they received the same attention from study staff and cadence of reminders, but importantly, only the intervention app was based on CBSM,” she explained.

A total of 449 patients with cancers of stage I–III who were undergoing active systemic treatment or were planning to undergo such treatment within 6 months were randomly assigned to the CBSM app or the control app.

The CBSM app was superior to the control app for the primary outcome of anxiety reduction over baseline, as measured at 4, 8 and 12 weeks by the Patient-Reported Outcomes Measurement Information System Anxiety Scale (PROMIS-A) (beta = -.03; P = .019).

CBSM was also significantly better than the control app for the secondary endpoints of reducing symptoms of depression, as measured by the PROMIS-D scale (beta = -.02, P = .042), and also at increasing the percentage of patients who reported improvement in anxiety and depression symptoms on the Patient Global Impression of Change instrument (P < .001)

An extension study of the durability of the effects at 3 and 6 months is underway.

The investigators noted that the incremental cost of management of anxiety or depression is greater than $17,000 per patient per year.

“One of the big promises of a digital therapeutic like this is that it could potentially reduce costs,” Ms. Ramiller told the audience, but she acknowledged, “More work is really needed, however, to directly test the potential savings.”

The RESTORE study is funded by Blue Note Therapeutics. Dr. Osarogiagbon owns stock in Gilead, Lilly, and Pfizer, has received honoraria from Biodesix and Medscape, and has a consulting or advisory role for the American Cancer Society AstraZeneca, Genentech/Roche, LUNGevity, National Cancer Institute, and Triptych Health Partners.
 

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

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Regular napping linked to greater brain volume

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Wed, 06/28/2023 - 09:00

Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

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Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

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New cannabis laws, higher binge drinking rates linked

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Thu, 06/22/2023 - 15:21

 

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

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TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

 

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

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SSRI improves cognition, major depression in early dementia

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Thu, 06/22/2023 - 15:18

 

TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

  • The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
  • Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
  • Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

  • There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
  • Improvements in depressive symptoms were irrespective of dementia type.
  • There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
  • Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

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TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

  • The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
  • Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
  • Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

  • There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
  • Improvements in depressive symptoms were irrespective of dementia type.
  • There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
  • Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

 

TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

  • The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
  • Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
  • Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

  • There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
  • Improvements in depressive symptoms were irrespective of dementia type.
  • There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
  • Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

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Should you dismiss a difficult patient?

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Wed, 07/12/2023 - 12:13

Some patients continually cancel their appointments, ignore your medical directions, treat your staff rudely, or send you harassing emails.

Do you have to tolerate their behavior?

No, these are all appropriate reasons to terminate patients, attorneys say. Patients also can be dismissed for misleading doctors about their past medical history, chronic drug-seeking, displaying threatening or seductive behavior toward staff members or physicians, or any criminal behavior in the office, experts say.

But even if a reason seems legitimate, that doesn’t make it legal. Doctors should consider whether the reason is legal, said Chicago-area attorney Ericka Adler, JD, a partner at Roetzel & Andress, who advises doctors about terminating patients.

“Although a physician may think a reason to terminate a patient is legitimate, they should always be mindful of whether there is a legal concern at issue and consult with counsel if they’re unsure,” Ms. Adler said.

Terminating patients for an “illegal” reason such as discrimination based on race or gender or sexual orientation – even if couched as a legitimate patient issue – could open the practice to a lawsuit, Ms. Adler said.

Doctors also want to avoid patient abandonment claims by talking to the patient about problems and documenting them as they arise. If they can’t be resolved, doctors should ensure that there’s continuity of care when patients change physicians, said Ms. Adler.

About 90% of physicians have dismissed at least one patient during their career, according to a study of nearly 800 primary care practices. The most common reasons were legitimate: a patient was “extremely disruptive and/or behaved inappropriately toward clinicians or staff”; a patient had “violated chronic pain and controlled substance policies”; and a patient had “repeatedly missed appointments.” 

Jacqui O’Kane, DO, a family physician at South Georgia Medical Center in rural Nashville, said she has dismissed about 15 of 3,000 patients she has seen in the past 3 years at the clinic. Before she dismisses a patient, she looks at whether there has been a pattern of behavior and tries to talk to them about the problem first to find out if there are other reasons for it.

She also gives patients a warning: If the unacceptable behavior continues, it will lead to their dismissal.
 

When patients cross a line

Dr. O’Kane warned an elderly man who used the N-word with her that she wouldn’t tolerate that language in her office. Then, when he later called her front office employee the N-word, she decided to dismiss him.

“I said, ‘That’s it, you can’t say that to someone in this office. I already told you once, and you did it again. I’m sorry, you have to find another doctor,’ ” said Dr. O’Kane.

Another patient crossed a line when she missed four appointments, refused to come in, and kept sending Dr. O’Kane long messages on MyChart demanding medications and advice. One message was fairly obtrusive: “If you don’t give me something stronger for my nerves TODAY, I am going to LOSE MY MIND!!!” Dr. O’Kane said the patient wrote.

“I then told her that’s not how I run my practice and that she needed to find someone else.”

Another common reason doctors dismiss patients is for nonpayment, says Ms. Adler.

Recently, however, some patients have also begun demanding their money back from doctors for services already received and billed because they were unhappy about something that occurred at the doctor’s office, said Ms. Adler.

“I advise doctors to respond: ‘We disagree that you didn’t get the service, but we will give you your money back, and we’re also terminating you from our practice.’  At that point, the doctor-patient relationship has become impossible,” said Ms. Adler.
 

 

 

How to dismiss difficult patients ethically and legally

According to the AMA’s Council on Ethical and Judicial Affairs, a physician may not discontinue treatment of a patient if further treatment is medically indicated without giving the patient reasonable notice and sufficient opportunity to make alternative arrangements for care.

Terminating a patient abruptly without transferring their care could lead to a claim of patient abandonment and the physician being called before a licensing board for potentially violating the state’s Medical Practice Act, said Ms. Adler.

Doctors can take these six steps to set the stage for dismissal and avoid a claim of patient abandonment.

1. Create written policies. Medical practices can describe the rules and behavior they expect from patients in these policies, which can cover, for example, payment, treating staff with courtesy, and medications. “When the rules are in writing and patients sign off on them, that gives doctors a certain comfort level in being able to refer to them and say that the patient hasn’t been compliant,” said Ms. Adler.

She also recommends that your practice create a policy that doctors should let the patient know about their concerns and meet with them to discuss the problem before receiving a termination letter.

2. Document any consistent problems you’re having with a patient. When you start having problems with a patient, you should document when the problem occurred, how often it occurred, any discussions with the patient about the problem, warnings you gave the patient, and if and when you decided to terminate the patient.

3. Meet with the patient to discuss the problem. “Talking and meeting with a patient also allows the physician to assess whether there’s another issue. For example, is there a mental health concern? Is there a financial reason for nonpayment or no-shows? There are multiple benefits to finding out what the problem is,” said Ms. Adler.

Once you’ve decided to terminate a patient, here’s what you should do:

4. Allow enough time for the patient to find alternative care. Ms. Adler recommends giving patients 30 days’ notice and that physicians offer to provide emergency care during that time. However, if the patient is undergoing treatment or has other challenges, more time may be needed to transfer care.

“It’s important to consider the patient’s context – if the patient is receiving cancer treatment, or is in a late stage of pregnancy, or lives in a rural area where few specialists are available, you may want to treat them longer – at least until they finish their treatment,” said Ms. Adler. Also, states may have their own requirements about minimum notice periods, she said.

5. Provide patients with written notice that you intend to terminate their care. Ms. Adler recommends that each letter be tailored to the patient’s specific circumstances. “You could spell out a patient’s history of noncompliance or nonpayment or inappropriate conduct because it’s been documented and the patient is already aware of it from a previous discussion,” she said.

Ms. Adler also recommends that doctors consult with legal counsel when in doubt or if contacted by the patient’s lawyer. Some lawyers will draft the termination letters, she said.

6. Include the following information in the written letter: The date that they will no longer receive care, how they can obtain copies of their medical records, and how they can find a new physician by providing contact information for a state medical association or similar organization, which often maintains a database of clinicians by specialty and location.

The letter should also state that the doctor will provide emergency care during the 30 days. Ms. Adler also recommends sending the notice by certified mail.

Dr. O’Kane said she may be more likely to give patients a second chance because she practices in a rural underserved area, and she understands that her patients don’t have many other options for health care. She also has developed a reputation for being willing to take on difficult patients that other physicians didn’t want to deal with, she said.

She encourages physicians to talk to patients to find out why, for example, they may not be compliant with medications.

“The patient may say, ‘I had to choose between paying for medications and putting food on the table,’ ” said Dr. O’Kane.

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

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Some patients continually cancel their appointments, ignore your medical directions, treat your staff rudely, or send you harassing emails.

Do you have to tolerate their behavior?

No, these are all appropriate reasons to terminate patients, attorneys say. Patients also can be dismissed for misleading doctors about their past medical history, chronic drug-seeking, displaying threatening or seductive behavior toward staff members or physicians, or any criminal behavior in the office, experts say.

But even if a reason seems legitimate, that doesn’t make it legal. Doctors should consider whether the reason is legal, said Chicago-area attorney Ericka Adler, JD, a partner at Roetzel & Andress, who advises doctors about terminating patients.

“Although a physician may think a reason to terminate a patient is legitimate, they should always be mindful of whether there is a legal concern at issue and consult with counsel if they’re unsure,” Ms. Adler said.

Terminating patients for an “illegal” reason such as discrimination based on race or gender or sexual orientation – even if couched as a legitimate patient issue – could open the practice to a lawsuit, Ms. Adler said.

Doctors also want to avoid patient abandonment claims by talking to the patient about problems and documenting them as they arise. If they can’t be resolved, doctors should ensure that there’s continuity of care when patients change physicians, said Ms. Adler.

About 90% of physicians have dismissed at least one patient during their career, according to a study of nearly 800 primary care practices. The most common reasons were legitimate: a patient was “extremely disruptive and/or behaved inappropriately toward clinicians or staff”; a patient had “violated chronic pain and controlled substance policies”; and a patient had “repeatedly missed appointments.” 

Jacqui O’Kane, DO, a family physician at South Georgia Medical Center in rural Nashville, said she has dismissed about 15 of 3,000 patients she has seen in the past 3 years at the clinic. Before she dismisses a patient, she looks at whether there has been a pattern of behavior and tries to talk to them about the problem first to find out if there are other reasons for it.

She also gives patients a warning: If the unacceptable behavior continues, it will lead to their dismissal.
 

When patients cross a line

Dr. O’Kane warned an elderly man who used the N-word with her that she wouldn’t tolerate that language in her office. Then, when he later called her front office employee the N-word, she decided to dismiss him.

“I said, ‘That’s it, you can’t say that to someone in this office. I already told you once, and you did it again. I’m sorry, you have to find another doctor,’ ” said Dr. O’Kane.

Another patient crossed a line when she missed four appointments, refused to come in, and kept sending Dr. O’Kane long messages on MyChart demanding medications and advice. One message was fairly obtrusive: “If you don’t give me something stronger for my nerves TODAY, I am going to LOSE MY MIND!!!” Dr. O’Kane said the patient wrote.

“I then told her that’s not how I run my practice and that she needed to find someone else.”

Another common reason doctors dismiss patients is for nonpayment, says Ms. Adler.

Recently, however, some patients have also begun demanding their money back from doctors for services already received and billed because they were unhappy about something that occurred at the doctor’s office, said Ms. Adler.

“I advise doctors to respond: ‘We disagree that you didn’t get the service, but we will give you your money back, and we’re also terminating you from our practice.’  At that point, the doctor-patient relationship has become impossible,” said Ms. Adler.
 

 

 

How to dismiss difficult patients ethically and legally

According to the AMA’s Council on Ethical and Judicial Affairs, a physician may not discontinue treatment of a patient if further treatment is medically indicated without giving the patient reasonable notice and sufficient opportunity to make alternative arrangements for care.

Terminating a patient abruptly without transferring their care could lead to a claim of patient abandonment and the physician being called before a licensing board for potentially violating the state’s Medical Practice Act, said Ms. Adler.

Doctors can take these six steps to set the stage for dismissal and avoid a claim of patient abandonment.

1. Create written policies. Medical practices can describe the rules and behavior they expect from patients in these policies, which can cover, for example, payment, treating staff with courtesy, and medications. “When the rules are in writing and patients sign off on them, that gives doctors a certain comfort level in being able to refer to them and say that the patient hasn’t been compliant,” said Ms. Adler.

She also recommends that your practice create a policy that doctors should let the patient know about their concerns and meet with them to discuss the problem before receiving a termination letter.

2. Document any consistent problems you’re having with a patient. When you start having problems with a patient, you should document when the problem occurred, how often it occurred, any discussions with the patient about the problem, warnings you gave the patient, and if and when you decided to terminate the patient.

3. Meet with the patient to discuss the problem. “Talking and meeting with a patient also allows the physician to assess whether there’s another issue. For example, is there a mental health concern? Is there a financial reason for nonpayment or no-shows? There are multiple benefits to finding out what the problem is,” said Ms. Adler.

Once you’ve decided to terminate a patient, here’s what you should do:

4. Allow enough time for the patient to find alternative care. Ms. Adler recommends giving patients 30 days’ notice and that physicians offer to provide emergency care during that time. However, if the patient is undergoing treatment or has other challenges, more time may be needed to transfer care.

“It’s important to consider the patient’s context – if the patient is receiving cancer treatment, or is in a late stage of pregnancy, or lives in a rural area where few specialists are available, you may want to treat them longer – at least until they finish their treatment,” said Ms. Adler. Also, states may have their own requirements about minimum notice periods, she said.

5. Provide patients with written notice that you intend to terminate their care. Ms. Adler recommends that each letter be tailored to the patient’s specific circumstances. “You could spell out a patient’s history of noncompliance or nonpayment or inappropriate conduct because it’s been documented and the patient is already aware of it from a previous discussion,” she said.

Ms. Adler also recommends that doctors consult with legal counsel when in doubt or if contacted by the patient’s lawyer. Some lawyers will draft the termination letters, she said.

6. Include the following information in the written letter: The date that they will no longer receive care, how they can obtain copies of their medical records, and how they can find a new physician by providing contact information for a state medical association or similar organization, which often maintains a database of clinicians by specialty and location.

The letter should also state that the doctor will provide emergency care during the 30 days. Ms. Adler also recommends sending the notice by certified mail.

Dr. O’Kane said she may be more likely to give patients a second chance because she practices in a rural underserved area, and she understands that her patients don’t have many other options for health care. She also has developed a reputation for being willing to take on difficult patients that other physicians didn’t want to deal with, she said.

She encourages physicians to talk to patients to find out why, for example, they may not be compliant with medications.

“The patient may say, ‘I had to choose between paying for medications and putting food on the table,’ ” said Dr. O’Kane.

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

Some patients continually cancel their appointments, ignore your medical directions, treat your staff rudely, or send you harassing emails.

Do you have to tolerate their behavior?

No, these are all appropriate reasons to terminate patients, attorneys say. Patients also can be dismissed for misleading doctors about their past medical history, chronic drug-seeking, displaying threatening or seductive behavior toward staff members or physicians, or any criminal behavior in the office, experts say.

But even if a reason seems legitimate, that doesn’t make it legal. Doctors should consider whether the reason is legal, said Chicago-area attorney Ericka Adler, JD, a partner at Roetzel & Andress, who advises doctors about terminating patients.

“Although a physician may think a reason to terminate a patient is legitimate, they should always be mindful of whether there is a legal concern at issue and consult with counsel if they’re unsure,” Ms. Adler said.

Terminating patients for an “illegal” reason such as discrimination based on race or gender or sexual orientation – even if couched as a legitimate patient issue – could open the practice to a lawsuit, Ms. Adler said.

Doctors also want to avoid patient abandonment claims by talking to the patient about problems and documenting them as they arise. If they can’t be resolved, doctors should ensure that there’s continuity of care when patients change physicians, said Ms. Adler.

About 90% of physicians have dismissed at least one patient during their career, according to a study of nearly 800 primary care practices. The most common reasons were legitimate: a patient was “extremely disruptive and/or behaved inappropriately toward clinicians or staff”; a patient had “violated chronic pain and controlled substance policies”; and a patient had “repeatedly missed appointments.” 

Jacqui O’Kane, DO, a family physician at South Georgia Medical Center in rural Nashville, said she has dismissed about 15 of 3,000 patients she has seen in the past 3 years at the clinic. Before she dismisses a patient, she looks at whether there has been a pattern of behavior and tries to talk to them about the problem first to find out if there are other reasons for it.

She also gives patients a warning: If the unacceptable behavior continues, it will lead to their dismissal.
 

When patients cross a line

Dr. O’Kane warned an elderly man who used the N-word with her that she wouldn’t tolerate that language in her office. Then, when he later called her front office employee the N-word, she decided to dismiss him.

“I said, ‘That’s it, you can’t say that to someone in this office. I already told you once, and you did it again. I’m sorry, you have to find another doctor,’ ” said Dr. O’Kane.

Another patient crossed a line when she missed four appointments, refused to come in, and kept sending Dr. O’Kane long messages on MyChart demanding medications and advice. One message was fairly obtrusive: “If you don’t give me something stronger for my nerves TODAY, I am going to LOSE MY MIND!!!” Dr. O’Kane said the patient wrote.

“I then told her that’s not how I run my practice and that she needed to find someone else.”

Another common reason doctors dismiss patients is for nonpayment, says Ms. Adler.

Recently, however, some patients have also begun demanding their money back from doctors for services already received and billed because they were unhappy about something that occurred at the doctor’s office, said Ms. Adler.

“I advise doctors to respond: ‘We disagree that you didn’t get the service, but we will give you your money back, and we’re also terminating you from our practice.’  At that point, the doctor-patient relationship has become impossible,” said Ms. Adler.
 

 

 

How to dismiss difficult patients ethically and legally

According to the AMA’s Council on Ethical and Judicial Affairs, a physician may not discontinue treatment of a patient if further treatment is medically indicated without giving the patient reasonable notice and sufficient opportunity to make alternative arrangements for care.

Terminating a patient abruptly without transferring their care could lead to a claim of patient abandonment and the physician being called before a licensing board for potentially violating the state’s Medical Practice Act, said Ms. Adler.

Doctors can take these six steps to set the stage for dismissal and avoid a claim of patient abandonment.

1. Create written policies. Medical practices can describe the rules and behavior they expect from patients in these policies, which can cover, for example, payment, treating staff with courtesy, and medications. “When the rules are in writing and patients sign off on them, that gives doctors a certain comfort level in being able to refer to them and say that the patient hasn’t been compliant,” said Ms. Adler.

She also recommends that your practice create a policy that doctors should let the patient know about their concerns and meet with them to discuss the problem before receiving a termination letter.

2. Document any consistent problems you’re having with a patient. When you start having problems with a patient, you should document when the problem occurred, how often it occurred, any discussions with the patient about the problem, warnings you gave the patient, and if and when you decided to terminate the patient.

3. Meet with the patient to discuss the problem. “Talking and meeting with a patient also allows the physician to assess whether there’s another issue. For example, is there a mental health concern? Is there a financial reason for nonpayment or no-shows? There are multiple benefits to finding out what the problem is,” said Ms. Adler.

Once you’ve decided to terminate a patient, here’s what you should do:

4. Allow enough time for the patient to find alternative care. Ms. Adler recommends giving patients 30 days’ notice and that physicians offer to provide emergency care during that time. However, if the patient is undergoing treatment or has other challenges, more time may be needed to transfer care.

“It’s important to consider the patient’s context – if the patient is receiving cancer treatment, or is in a late stage of pregnancy, or lives in a rural area where few specialists are available, you may want to treat them longer – at least until they finish their treatment,” said Ms. Adler. Also, states may have their own requirements about minimum notice periods, she said.

5. Provide patients with written notice that you intend to terminate their care. Ms. Adler recommends that each letter be tailored to the patient’s specific circumstances. “You could spell out a patient’s history of noncompliance or nonpayment or inappropriate conduct because it’s been documented and the patient is already aware of it from a previous discussion,” she said.

Ms. Adler also recommends that doctors consult with legal counsel when in doubt or if contacted by the patient’s lawyer. Some lawyers will draft the termination letters, she said.

6. Include the following information in the written letter: The date that they will no longer receive care, how they can obtain copies of their medical records, and how they can find a new physician by providing contact information for a state medical association or similar organization, which often maintains a database of clinicians by specialty and location.

The letter should also state that the doctor will provide emergency care during the 30 days. Ms. Adler also recommends sending the notice by certified mail.

Dr. O’Kane said she may be more likely to give patients a second chance because she practices in a rural underserved area, and she understands that her patients don’t have many other options for health care. She also has developed a reputation for being willing to take on difficult patients that other physicians didn’t want to deal with, she said.

She encourages physicians to talk to patients to find out why, for example, they may not be compliant with medications.

“The patient may say, ‘I had to choose between paying for medications and putting food on the table,’ ” said Dr. O’Kane.

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

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Therapists’ oxytocin levels tied to patient outcomes

Article Type
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Fri, 06/23/2023 - 09:50

 

TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

  • Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
  • Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
  • They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
  • Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

  • Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
  • Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
  • An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

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TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

  • Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
  • Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
  • They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
  • Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

  • Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
  • Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
  • An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

 

TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

  • Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
  • Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
  • They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
  • Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

  • Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
  • Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
  • An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

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Low-calorie tastes sweeter with a little salt

Article Type
Changed
Fri, 06/23/2023 - 08:02

Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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