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Prospect of Better Hours, Less Burnout Fuels Locum Tenens

Article Type
Changed
Fri, 05/03/2024 - 17:49

 

Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

A woman particpates in a video conference from home
Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

  • Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
  • Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
  • Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
  • The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

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Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

A woman particpates in a video conference from home
Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

  • Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
  • Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
  • Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
  • The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

 

Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

A woman particpates in a video conference from home
Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

  • Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
  • Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
  • Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
  • The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

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This Tech Will Change Your Practice Sooner Than You Think

Article Type
Changed
Fri, 05/03/2024 - 16:51

Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience HealthcareAugmedixNuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

 

 

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

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Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience HealthcareAugmedixNuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

 

 

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience HealthcareAugmedixNuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

 

 

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

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Gene Therapy for Dystrophic EB: Extension Study Results Reported

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In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

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In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

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Positive Phase 2 Results Reported for TYK2 Inhibitor for Patients With Moderate to Severe Psoriasis

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Fri, 05/03/2024 - 14:39

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

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A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

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FDA Requests More Information for RDEB Rx Under Review

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Fri, 05/03/2024 - 13:22

 

The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

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The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

 

The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

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Working Hard or Work Addiction — Have You Crossed the Line?

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Mon, 04/29/2024 - 11:13

When child psychiatrist Javeed Sukhera, MD, PhD, was a few years into his career, he found himself doing it all. “I was in a leadership role academically at the medical school, I had a leadership role at the hospital, and I was seeing as many patients as I could. I could work all day every day.”

“It still wouldn’t have been enough,” he said.

Whenever there was a shift available, Dr. Sukhera would take it. His job was stressful, but as a new physician with a young family, he saw this obsession with work as necessary. “I began to cope with the stress from work by doing extra work and feeling like I needed to be everywhere. It was like I became a hamster on a spinning wheel. I was just running, running, running.”

Things shifted for Dr. Sukhera when he realized that while he was emotionally available for the children who were his patients, at home, his own children weren’t getting the best of him. “There was a specific moment when I thought my son was afraid of me,” he said. “I just stopped and realized that there was something happening that I needed to break. I needed to make a change.”

Dr. Sukhera, now chair of psychiatry at the Institute of Living and chief of the Department of Psychiatry at Hartford Hospital, Hartford, Connecticut, believes what he experienced was a steep fall into work addiction. “Workaholism,” often dismissed as simply working hard, is a nonclinical addiction that could fall under the umbrella of a behavioral addiction, and healthcare professionals may be especially at risk.
 

What Does Work Addiction Look Like for Doctors?

Behavioral addictions are fairly new in the addiction space. When gambling disorder, the first and only behavioral addiction in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, was added in 2013, it was seen as a “breakthrough addiction,” said Mark D. Griffiths, PhD, a leading behavioral addiction researcher and a distinguished professor at Nottingham Trent University.

Because there is not enough evidence yet to classify work addiction as a formal diagnosis, there is no clear consensus on how to define it. To further complicate things, the terms “workaholism” and “work addiction” can be used interchangeably, and some experts say the two are not the same, though they can overlap.

That said, a 2018 review of literature from several countries found that work addiction “fits very well into recently postulated criteria for conceptualization of a behavioral addiction.

“If you accept that gambling can be genuinely addictive, then there’s no reason to think that something like work, exercise, or video game playing couldn’t be an addiction as well,” said Dr. Griffiths.

“The neurobiology of addiction is that we get drawn to something that gives us a dopamine hit,” Dr. Sukhera added. “But to do that all day, every day, has consequences. It drains our emotional reserves, and it can greatly impact our relationships.”

On top of that, work addiction has been linked with poor sleep, poor cardiovascular health, high blood pressure, burnout, the development of autoimmune disorders, and other health issues.

Physicians are particularly susceptible. Doctors, after all, are expected to work long hours and put their patients’ needs first, even at the expense of their own health and well-being.

“Workaholism is not just socially acceptable in medicine,” said Dr. Sukhera. “It’s baked into the system and built into the structures. The healthcare system has largely functioned on the emotional labor of health workers, whose tendency to show up and work harder can, at times, in certain organizations, be exploited.”

Dr. Griffiths agreed that with the limited amount of data available, work addiction does appear to exist at higher rates in medicine than in other fields. As early as the 1970s, medical literature describes work as a “socially acceptable” addiction among doctors. A 2014 study published in Occupational Medicine reported that of 445 physicians who took part in the research, nearly half exhibited some level of work addiction with 13% “highly work addicted.”

Of course, working hard or even meeting unreasonable demands from work is not the same as work addiction, as Dr. Griffiths clarified in a 2023 editorial in BMJ Quality & Safety. The difference, as with other behavioral addictions, is when people obsess about work and use it to cope with stress. It can be easier to stay distracted and busy to gain a sense of control rather than learning to deal with complex emotions.

2021 study that Dr. Sukhera conducted with resident physicians found that working harder was one of the main ways they dealt with stress during the COVID-19 pandemic. “This idea that we deal with the stress of being burnt out by doing more and more of what burns us out is fairly ubiquitous at all stages of medical professionals’ careers,” he said.

Financial incentives also can fuel work addiction, said Dr. Sukhera. In residency, there are some safeguards around overwork and duty hours. When you become an attending, those limits no longer exist. As a young physician, Dr. Sukhera had student debt to pay off and a family to support. When he found opportunities to earn more by working more, his answer was always “yes.”

Pressure to produce medical research also can pose issues. Some physicians can become addicted to publishing studies, fearing that they might lose their professional status or position if they stop. It’s a cycle that can force a doctor to not only work long hours doing their job but also practically take on a second one.
 

 

 

How Physicians Can Recognize Work Addiction in Themselves

Work addiction can look and feel different for every person, said Malissa Clark, PhD, associate professor at the University of Georgia and author of the recent book Never Not Working: Why the Always-On Culture Is Bad for Business—and How to Fix It.

Dr. Clark noted that people who are highly engaged in their work tend to be driven by intrinsic motivation: “You work because you love it.” With work addiction, “you work because you feel like you ought to be working all the time.”

Of course, it’s not always so cut and dried; you can experience both forms of motivation and not necessarily become addicted to work. But if you are solely driven by the feeling that you ought to be working all the time, that can be a red flag.

Dr. Griffiths said that while many people may have problematic work habits or work too much, true work addicts must meet six criteria that apply to all addictions:

1. Salience: Work is the single most important thing in your life, to the point of neglecting everything else. Even if you’re on vacation, your mind might be flooded with work thoughts.

2. Mood modification: You use work to modify your mood, either to get a “high” or to cope with stress.

3. Tolerance: Over time, you’ve gone from working 8 or 10 hours a day to 12 hours a day, to a point where you’re working all the time.

4. Withdrawal: On a physiological level, you will have symptoms such as anxiety, nausea, or headaches when unable to work.

5. Conflict: You feel conflicted with yourself (you know you’re working too much) or with others (partners, friends, and children) about work, but you can’t stop.

6. Relapse: If you manage to cut down your hours but can’t resist overworking 1 day, you wind up right back where you were.
 

When It’s Time to Address Work Addiction

The lack of a formal diagnosis for work addiction makes getting treatment difficult. But there are ways to seek help. Unlike the drug and alcohol literature, abstinence is not the goal. “The therapeutic goal is getting a behavior under control and looking for the triggers of why you’re compulsively working,” said Dr. Griffiths.

Practice self-compassion

Dr. Sukhera eventually realized that his work addiction stemmed from the fear of being somehow excluded or unworthy. He actively corrected much of this through self-compassion and self-kindness, which helped him set boundaries. “Self-compassion is the root of everything,” he said. “Reminding ourselves that we’re doing our best is an important ingredient in breaking the cycle.”

Slowly expose yourself to relaxation

Many workaholics find rest very difficult. “When I conducted interviews with people [who considered themselves workaholics], a very common thing I heard was, ‘I have a very hard time being idle,’ ” said Dr. Clark. If rest feels hard, Dr. Sukhera suggests practicing relaxation for 2 minutes to start. Even small periods of downtime can challenge the belief that you must be constantly productive.

Reframe your to-do list 

For work addicts, to-do lists can seem like they must be finished, which prolongs work hours. Instead, use to-do lists to help prioritize what is urgent, identify what can wait, and delegate out tasks to others, Dr. Clark recommends.

Pick up a mastery experience

Research from professor Sabine Sonnentag, Dr. rer. nat., at the University of Mannheim, Mannheim, Germany, suggests that mastery experiences — leisure activities that require thought and focus like learning a new language or taking a woodworking class — can help you actively disengage from work.

Try cognitive behavioral therapy

Widely used for other forms of addiction, cognitive behavioral therapy centers around recognizing emotions, challenging thought patterns, and changing behaviors. However, Dr. Clark admits the research on its impact on work addiction, in particular, is “pretty nascent.”

Shift your mindset

It seems logical to think that detaching from your feelings will allow you to “do more,” but experts say that idea is both untrue and dangerous. “The safest hospitals are the hospitals where people are attuned to their humanness,” said Dr. Sukhera. “It’s normal to overwork in medicine, and if you’re challenging a norm, you really have to be thoughtful about how you frame that for yourself.”

Most importantly: Seek support

Today, there is increased awareness about work addiction and more resources for physicians who are struggling, including programs such as Workaholics Anonymous or Physicians Anonymous and workplace wellness initiatives. But try not to overwhelm yourself with choosing whom to talk to or what specific resource to utilize, Dr. Sukhera advised. “Just talk to someone about it. You don’t have to carry this on your own.”
 

A version of this article appeared on Medscape.com.

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When child psychiatrist Javeed Sukhera, MD, PhD, was a few years into his career, he found himself doing it all. “I was in a leadership role academically at the medical school, I had a leadership role at the hospital, and I was seeing as many patients as I could. I could work all day every day.”

“It still wouldn’t have been enough,” he said.

Whenever there was a shift available, Dr. Sukhera would take it. His job was stressful, but as a new physician with a young family, he saw this obsession with work as necessary. “I began to cope with the stress from work by doing extra work and feeling like I needed to be everywhere. It was like I became a hamster on a spinning wheel. I was just running, running, running.”

Things shifted for Dr. Sukhera when he realized that while he was emotionally available for the children who were his patients, at home, his own children weren’t getting the best of him. “There was a specific moment when I thought my son was afraid of me,” he said. “I just stopped and realized that there was something happening that I needed to break. I needed to make a change.”

Dr. Sukhera, now chair of psychiatry at the Institute of Living and chief of the Department of Psychiatry at Hartford Hospital, Hartford, Connecticut, believes what he experienced was a steep fall into work addiction. “Workaholism,” often dismissed as simply working hard, is a nonclinical addiction that could fall under the umbrella of a behavioral addiction, and healthcare professionals may be especially at risk.
 

What Does Work Addiction Look Like for Doctors?

Behavioral addictions are fairly new in the addiction space. When gambling disorder, the first and only behavioral addiction in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, was added in 2013, it was seen as a “breakthrough addiction,” said Mark D. Griffiths, PhD, a leading behavioral addiction researcher and a distinguished professor at Nottingham Trent University.

Because there is not enough evidence yet to classify work addiction as a formal diagnosis, there is no clear consensus on how to define it. To further complicate things, the terms “workaholism” and “work addiction” can be used interchangeably, and some experts say the two are not the same, though they can overlap.

That said, a 2018 review of literature from several countries found that work addiction “fits very well into recently postulated criteria for conceptualization of a behavioral addiction.

“If you accept that gambling can be genuinely addictive, then there’s no reason to think that something like work, exercise, or video game playing couldn’t be an addiction as well,” said Dr. Griffiths.

“The neurobiology of addiction is that we get drawn to something that gives us a dopamine hit,” Dr. Sukhera added. “But to do that all day, every day, has consequences. It drains our emotional reserves, and it can greatly impact our relationships.”

On top of that, work addiction has been linked with poor sleep, poor cardiovascular health, high blood pressure, burnout, the development of autoimmune disorders, and other health issues.

Physicians are particularly susceptible. Doctors, after all, are expected to work long hours and put their patients’ needs first, even at the expense of their own health and well-being.

“Workaholism is not just socially acceptable in medicine,” said Dr. Sukhera. “It’s baked into the system and built into the structures. The healthcare system has largely functioned on the emotional labor of health workers, whose tendency to show up and work harder can, at times, in certain organizations, be exploited.”

Dr. Griffiths agreed that with the limited amount of data available, work addiction does appear to exist at higher rates in medicine than in other fields. As early as the 1970s, medical literature describes work as a “socially acceptable” addiction among doctors. A 2014 study published in Occupational Medicine reported that of 445 physicians who took part in the research, nearly half exhibited some level of work addiction with 13% “highly work addicted.”

Of course, working hard or even meeting unreasonable demands from work is not the same as work addiction, as Dr. Griffiths clarified in a 2023 editorial in BMJ Quality & Safety. The difference, as with other behavioral addictions, is when people obsess about work and use it to cope with stress. It can be easier to stay distracted and busy to gain a sense of control rather than learning to deal with complex emotions.

2021 study that Dr. Sukhera conducted with resident physicians found that working harder was one of the main ways they dealt with stress during the COVID-19 pandemic. “This idea that we deal with the stress of being burnt out by doing more and more of what burns us out is fairly ubiquitous at all stages of medical professionals’ careers,” he said.

Financial incentives also can fuel work addiction, said Dr. Sukhera. In residency, there are some safeguards around overwork and duty hours. When you become an attending, those limits no longer exist. As a young physician, Dr. Sukhera had student debt to pay off and a family to support. When he found opportunities to earn more by working more, his answer was always “yes.”

Pressure to produce medical research also can pose issues. Some physicians can become addicted to publishing studies, fearing that they might lose their professional status or position if they stop. It’s a cycle that can force a doctor to not only work long hours doing their job but also practically take on a second one.
 

 

 

How Physicians Can Recognize Work Addiction in Themselves

Work addiction can look and feel different for every person, said Malissa Clark, PhD, associate professor at the University of Georgia and author of the recent book Never Not Working: Why the Always-On Culture Is Bad for Business—and How to Fix It.

Dr. Clark noted that people who are highly engaged in their work tend to be driven by intrinsic motivation: “You work because you love it.” With work addiction, “you work because you feel like you ought to be working all the time.”

Of course, it’s not always so cut and dried; you can experience both forms of motivation and not necessarily become addicted to work. But if you are solely driven by the feeling that you ought to be working all the time, that can be a red flag.

Dr. Griffiths said that while many people may have problematic work habits or work too much, true work addicts must meet six criteria that apply to all addictions:

1. Salience: Work is the single most important thing in your life, to the point of neglecting everything else. Even if you’re on vacation, your mind might be flooded with work thoughts.

2. Mood modification: You use work to modify your mood, either to get a “high” or to cope with stress.

3. Tolerance: Over time, you’ve gone from working 8 or 10 hours a day to 12 hours a day, to a point where you’re working all the time.

4. Withdrawal: On a physiological level, you will have symptoms such as anxiety, nausea, or headaches when unable to work.

5. Conflict: You feel conflicted with yourself (you know you’re working too much) or with others (partners, friends, and children) about work, but you can’t stop.

6. Relapse: If you manage to cut down your hours but can’t resist overworking 1 day, you wind up right back where you were.
 

When It’s Time to Address Work Addiction

The lack of a formal diagnosis for work addiction makes getting treatment difficult. But there are ways to seek help. Unlike the drug and alcohol literature, abstinence is not the goal. “The therapeutic goal is getting a behavior under control and looking for the triggers of why you’re compulsively working,” said Dr. Griffiths.

Practice self-compassion

Dr. Sukhera eventually realized that his work addiction stemmed from the fear of being somehow excluded or unworthy. He actively corrected much of this through self-compassion and self-kindness, which helped him set boundaries. “Self-compassion is the root of everything,” he said. “Reminding ourselves that we’re doing our best is an important ingredient in breaking the cycle.”

Slowly expose yourself to relaxation

Many workaholics find rest very difficult. “When I conducted interviews with people [who considered themselves workaholics], a very common thing I heard was, ‘I have a very hard time being idle,’ ” said Dr. Clark. If rest feels hard, Dr. Sukhera suggests practicing relaxation for 2 minutes to start. Even small periods of downtime can challenge the belief that you must be constantly productive.

Reframe your to-do list 

For work addicts, to-do lists can seem like they must be finished, which prolongs work hours. Instead, use to-do lists to help prioritize what is urgent, identify what can wait, and delegate out tasks to others, Dr. Clark recommends.

Pick up a mastery experience

Research from professor Sabine Sonnentag, Dr. rer. nat., at the University of Mannheim, Mannheim, Germany, suggests that mastery experiences — leisure activities that require thought and focus like learning a new language or taking a woodworking class — can help you actively disengage from work.

Try cognitive behavioral therapy

Widely used for other forms of addiction, cognitive behavioral therapy centers around recognizing emotions, challenging thought patterns, and changing behaviors. However, Dr. Clark admits the research on its impact on work addiction, in particular, is “pretty nascent.”

Shift your mindset

It seems logical to think that detaching from your feelings will allow you to “do more,” but experts say that idea is both untrue and dangerous. “The safest hospitals are the hospitals where people are attuned to their humanness,” said Dr. Sukhera. “It’s normal to overwork in medicine, and if you’re challenging a norm, you really have to be thoughtful about how you frame that for yourself.”

Most importantly: Seek support

Today, there is increased awareness about work addiction and more resources for physicians who are struggling, including programs such as Workaholics Anonymous or Physicians Anonymous and workplace wellness initiatives. But try not to overwhelm yourself with choosing whom to talk to or what specific resource to utilize, Dr. Sukhera advised. “Just talk to someone about it. You don’t have to carry this on your own.”
 

A version of this article appeared on Medscape.com.

When child psychiatrist Javeed Sukhera, MD, PhD, was a few years into his career, he found himself doing it all. “I was in a leadership role academically at the medical school, I had a leadership role at the hospital, and I was seeing as many patients as I could. I could work all day every day.”

“It still wouldn’t have been enough,” he said.

Whenever there was a shift available, Dr. Sukhera would take it. His job was stressful, but as a new physician with a young family, he saw this obsession with work as necessary. “I began to cope with the stress from work by doing extra work and feeling like I needed to be everywhere. It was like I became a hamster on a spinning wheel. I was just running, running, running.”

Things shifted for Dr. Sukhera when he realized that while he was emotionally available for the children who were his patients, at home, his own children weren’t getting the best of him. “There was a specific moment when I thought my son was afraid of me,” he said. “I just stopped and realized that there was something happening that I needed to break. I needed to make a change.”

Dr. Sukhera, now chair of psychiatry at the Institute of Living and chief of the Department of Psychiatry at Hartford Hospital, Hartford, Connecticut, believes what he experienced was a steep fall into work addiction. “Workaholism,” often dismissed as simply working hard, is a nonclinical addiction that could fall under the umbrella of a behavioral addiction, and healthcare professionals may be especially at risk.
 

What Does Work Addiction Look Like for Doctors?

Behavioral addictions are fairly new in the addiction space. When gambling disorder, the first and only behavioral addiction in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, was added in 2013, it was seen as a “breakthrough addiction,” said Mark D. Griffiths, PhD, a leading behavioral addiction researcher and a distinguished professor at Nottingham Trent University.

Because there is not enough evidence yet to classify work addiction as a formal diagnosis, there is no clear consensus on how to define it. To further complicate things, the terms “workaholism” and “work addiction” can be used interchangeably, and some experts say the two are not the same, though they can overlap.

That said, a 2018 review of literature from several countries found that work addiction “fits very well into recently postulated criteria for conceptualization of a behavioral addiction.

“If you accept that gambling can be genuinely addictive, then there’s no reason to think that something like work, exercise, or video game playing couldn’t be an addiction as well,” said Dr. Griffiths.

“The neurobiology of addiction is that we get drawn to something that gives us a dopamine hit,” Dr. Sukhera added. “But to do that all day, every day, has consequences. It drains our emotional reserves, and it can greatly impact our relationships.”

On top of that, work addiction has been linked with poor sleep, poor cardiovascular health, high blood pressure, burnout, the development of autoimmune disorders, and other health issues.

Physicians are particularly susceptible. Doctors, after all, are expected to work long hours and put their patients’ needs first, even at the expense of their own health and well-being.

“Workaholism is not just socially acceptable in medicine,” said Dr. Sukhera. “It’s baked into the system and built into the structures. The healthcare system has largely functioned on the emotional labor of health workers, whose tendency to show up and work harder can, at times, in certain organizations, be exploited.”

Dr. Griffiths agreed that with the limited amount of data available, work addiction does appear to exist at higher rates in medicine than in other fields. As early as the 1970s, medical literature describes work as a “socially acceptable” addiction among doctors. A 2014 study published in Occupational Medicine reported that of 445 physicians who took part in the research, nearly half exhibited some level of work addiction with 13% “highly work addicted.”

Of course, working hard or even meeting unreasonable demands from work is not the same as work addiction, as Dr. Griffiths clarified in a 2023 editorial in BMJ Quality & Safety. The difference, as with other behavioral addictions, is when people obsess about work and use it to cope with stress. It can be easier to stay distracted and busy to gain a sense of control rather than learning to deal with complex emotions.

2021 study that Dr. Sukhera conducted with resident physicians found that working harder was one of the main ways they dealt with stress during the COVID-19 pandemic. “This idea that we deal with the stress of being burnt out by doing more and more of what burns us out is fairly ubiquitous at all stages of medical professionals’ careers,” he said.

Financial incentives also can fuel work addiction, said Dr. Sukhera. In residency, there are some safeguards around overwork and duty hours. When you become an attending, those limits no longer exist. As a young physician, Dr. Sukhera had student debt to pay off and a family to support. When he found opportunities to earn more by working more, his answer was always “yes.”

Pressure to produce medical research also can pose issues. Some physicians can become addicted to publishing studies, fearing that they might lose their professional status or position if they stop. It’s a cycle that can force a doctor to not only work long hours doing their job but also practically take on a second one.
 

 

 

How Physicians Can Recognize Work Addiction in Themselves

Work addiction can look and feel different for every person, said Malissa Clark, PhD, associate professor at the University of Georgia and author of the recent book Never Not Working: Why the Always-On Culture Is Bad for Business—and How to Fix It.

Dr. Clark noted that people who are highly engaged in their work tend to be driven by intrinsic motivation: “You work because you love it.” With work addiction, “you work because you feel like you ought to be working all the time.”

Of course, it’s not always so cut and dried; you can experience both forms of motivation and not necessarily become addicted to work. But if you are solely driven by the feeling that you ought to be working all the time, that can be a red flag.

Dr. Griffiths said that while many people may have problematic work habits or work too much, true work addicts must meet six criteria that apply to all addictions:

1. Salience: Work is the single most important thing in your life, to the point of neglecting everything else. Even if you’re on vacation, your mind might be flooded with work thoughts.

2. Mood modification: You use work to modify your mood, either to get a “high” or to cope with stress.

3. Tolerance: Over time, you’ve gone from working 8 or 10 hours a day to 12 hours a day, to a point where you’re working all the time.

4. Withdrawal: On a physiological level, you will have symptoms such as anxiety, nausea, or headaches when unable to work.

5. Conflict: You feel conflicted with yourself (you know you’re working too much) or with others (partners, friends, and children) about work, but you can’t stop.

6. Relapse: If you manage to cut down your hours but can’t resist overworking 1 day, you wind up right back where you were.
 

When It’s Time to Address Work Addiction

The lack of a formal diagnosis for work addiction makes getting treatment difficult. But there are ways to seek help. Unlike the drug and alcohol literature, abstinence is not the goal. “The therapeutic goal is getting a behavior under control and looking for the triggers of why you’re compulsively working,” said Dr. Griffiths.

Practice self-compassion

Dr. Sukhera eventually realized that his work addiction stemmed from the fear of being somehow excluded or unworthy. He actively corrected much of this through self-compassion and self-kindness, which helped him set boundaries. “Self-compassion is the root of everything,” he said. “Reminding ourselves that we’re doing our best is an important ingredient in breaking the cycle.”

Slowly expose yourself to relaxation

Many workaholics find rest very difficult. “When I conducted interviews with people [who considered themselves workaholics], a very common thing I heard was, ‘I have a very hard time being idle,’ ” said Dr. Clark. If rest feels hard, Dr. Sukhera suggests practicing relaxation for 2 minutes to start. Even small periods of downtime can challenge the belief that you must be constantly productive.

Reframe your to-do list 

For work addicts, to-do lists can seem like they must be finished, which prolongs work hours. Instead, use to-do lists to help prioritize what is urgent, identify what can wait, and delegate out tasks to others, Dr. Clark recommends.

Pick up a mastery experience

Research from professor Sabine Sonnentag, Dr. rer. nat., at the University of Mannheim, Mannheim, Germany, suggests that mastery experiences — leisure activities that require thought and focus like learning a new language or taking a woodworking class — can help you actively disengage from work.

Try cognitive behavioral therapy

Widely used for other forms of addiction, cognitive behavioral therapy centers around recognizing emotions, challenging thought patterns, and changing behaviors. However, Dr. Clark admits the research on its impact on work addiction, in particular, is “pretty nascent.”

Shift your mindset

It seems logical to think that detaching from your feelings will allow you to “do more,” but experts say that idea is both untrue and dangerous. “The safest hospitals are the hospitals where people are attuned to their humanness,” said Dr. Sukhera. “It’s normal to overwork in medicine, and if you’re challenging a norm, you really have to be thoughtful about how you frame that for yourself.”

Most importantly: Seek support

Today, there is increased awareness about work addiction and more resources for physicians who are struggling, including programs such as Workaholics Anonymous or Physicians Anonymous and workplace wellness initiatives. But try not to overwhelm yourself with choosing whom to talk to or what specific resource to utilize, Dr. Sukhera advised. “Just talk to someone about it. You don’t have to carry this on your own.”
 

A version of this article appeared on Medscape.com.

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Few Cancer Survivors Meet ACS Nutrition, Exercise Guidelines

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Changed
Mon, 04/29/2024 - 17:35

 

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

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TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

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New British Behçet’s Disease Guidelines Emphasize Multidisciplinary Management

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Fri, 04/26/2024 - 15:23

 

— The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.

The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.

With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.

Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.

The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.

Dr. Robert Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool (England) University Hospitals NHS Foundation Trust
Sara Freeman/Medscape Medical News
Dr. Robert Moots

 

Importance of Raising Awareness

“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”

Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.

“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.

“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
 

Patient Perspective

Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.

“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”

Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
 

 

 

Multifaceted Means Multidisciplinary Management

Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.

“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.

“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
 

Management of Manifestations

One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.

“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”

The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.

With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexateapremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.

To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
 

Future Work and Revision

“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.

More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.

“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.

“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.

The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
 

A version of this article appeared on Medscape.com.

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— The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.

The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.

With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.

Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.

The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.

Dr. Robert Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool (England) University Hospitals NHS Foundation Trust
Sara Freeman/Medscape Medical News
Dr. Robert Moots

 

Importance of Raising Awareness

“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”

Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.

“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.

“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
 

Patient Perspective

Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.

“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”

Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
 

 

 

Multifaceted Means Multidisciplinary Management

Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.

“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.

“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
 

Management of Manifestations

One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.

“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”

The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.

With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexateapremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.

To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
 

Future Work and Revision

“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.

More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.

“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.

“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.

The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
 

A version of this article appeared on Medscape.com.

 

— The British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD) have joined forces for the first time to develop the first British guidelines for the management of people living with Behçet’s disease.

The guidelines will also be the first “living guidelines” produced by either society, which means they will be regularly revised and updated when new evidence emerges that warrants inclusion.

With more than 90 recommendations being made, the new guidelines promise to be the most comprehensive and most up-to-date yet for what is regarded as a rare disease. Robert Moots, MBBS, PhD, provided a “sneak peek” of the guidelines at the annual meeting of the British Society for Rheumatology.

Dr. Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool University Hospitals NHS Foundation Trust in England, noted that while the European Alliance of Associations for Rheumatology has produced a guideline for Behçet’s disease, this was last updated in 2018 and is not specific for the population for patients that is seen in the United Kingdom.

The British recommendations will cover all possible manifestations of Behçet’s disease and give practical advice on how to manage everything from the most common presentations such as skin lesions, mouth ulcers, and genital ulcers, as well as the potentially more serious eye, neurological, and vascular involvement.

Dr. Robert Moots, professor of rheumatology at the University of Liverpool and a consultant rheumatologist for Liverpool (England) University Hospitals NHS Foundation Trust
Sara Freeman/Medscape Medical News
Dr. Robert Moots

 

Importance of Raising Awareness

“Joint and musculoskeletal problems are actually one of the least complained of symptoms in people with Behçet’s, and they often can’t understand why a rheumatologist is seeing them,” Dr. Moot said. “But of course, people do get joint problems, they can get enthesitis and arthralgia.”

Dr. Moots has been leading one of the three National Health Service (NHS) Centres of Excellence for Behçet’s Syndrome in England for more than a decade and told this news organization that diagnosing patients could be challenging. It can take up to 10 years from the first symptoms appearing to getting a diagnosis, so part of the job of the NHS Centres of Excellence is to raise awareness among both the healthcare profession and the general public.

“It’s a condition that people learn about at medical school. Most doctors will have come across it, but because it was thought to be really rare in the UK, nobody perhaps really expects to see it,” Dr. Moot said.

“But we all have these patients,” he added. “In Liverpool, we’re commissioned to be looking after an anticipated 150 people with Behçet’s — we’ve got 700. With more awareness, there’s more diagnoses being made, and people are being looked after better.”
 

Patient Perspective

Tony Thornburn, OBE, chair of the patient advocacy group Behçet’s UK, agreed in a separate interview that raising awareness of the syndrome was key to improving its management.

“Patients have said that it is a bit like having arthritis, lupus, MS [multiple sclerosis], and Crohn’s [disease] all at once,” Mr. Thorburn said. “So what we need is a guideline to ensure that people know what they’re looking at.”

Mr. Thorburn added, “Guidelines are important for raising awareness but also providing the detailed information that clinicians and GPs [general practitioners] need to have to treat a patient when they come in with this multifaceted condition.”
 

 

 

Multifaceted Means Multidisciplinary Management

Because there can be so many different aspects to managing someone with Behçet’s disease, a multispecialty team that was convened to develop the guidelines agreed that multidisciplinary management should be an overarching theme.

“The guideline development group consisted of all the specialties that you would need for a complex multisystem disease like Behçet’s,” Dr. Moot said. He highlighted that working alongside the consultants in adult and pediatric rheumatology were specialists in dermatology, gastroenterology, neurology, ophthalmology, obstetrics and gynecology, and psychology.

“We’re actually looking at psychological interactions and their impact for the first time,” Dr. Moot said, noting that clinicians needed to “take it seriously, and ask about it.”
 

Management of Manifestations

One of the general principles of the guidelines is to assess the involvement of each organ system and target treatment accordingly.

“One of the problems is that the evidence base to tell us what to do is pretty low,” Dr. Moots acknowledged. There have been few good quality randomized trials, so “treatment tends to be eminence-based rather than evidence-based.”

The recommendation wording bears this in mind, stating whether a treatment should or should not be offered, or just considered if there is no strong evidence to back up its use.

With regard to musculoskeletal manifestations, the recommendations say that colchicine should be offered, perhaps as a first-line option, or an intraarticular steroid injection in the case of monoarthritis. An intramuscular depot steroid may also be appropriate to offer, and there was good evidence to offer azathioprine or, as an alternative in refractory cases, a tumor necrosis factor (TNF) inhibitor. Nonsteroidal anti-inflammatory drugs, methotrexateapremilast, secukinumab, and referral to a physiotherapist could only be considered, however, based on weaker levels of evidence for their use.

To treat mucocutaneous disease, the guidelines advise offering topical steroids in the form of ointment for genital ulcers or mouthwash or ointment for oral ulcers. For skin lesions, it is recommended to offer colchicine, azathioprine, mycophenolate mofetil, or TNF inhibitor and to consider the use of apremilast, secukinumab, or dapsone.
 

Future Work and Revision

“One of the key things we would like to see developing is a national registry,” Dr. Moots said. This would include biobanking samples for future research and possible genomic and phenotyping studies.

More work needs to be done in conducting clinical trials in children and young people with Behçet’s disease, studies to find prognostic factors for neurological disease, and clinical trials of potential new drug approaches such as Janus kinase inhibitors. Importantly, an auditing process needs to be set up to see what effect, if any, the guidelines will actually have onpatient management.

“It’s taken 5 years to today” to develop the guidelines, Dr. Moot said. What form the process of updating them will take still has to be decided, he said in the interview. It is likely that the necessary literature searches will be performed every 6 months or so, but it will be a compromise between the ideal situation and having the staffing time to do it.

“It’s a big ask,” Dr. Moot acknowledged, adding that even if updates were only once a year, it would still be much faster than the 5- or 6-year cycle that it traditionally takes for most guidelines to be updated.

The BSR and BAD’s processes for developing guidelines are accredited by the National Institute for Health and Care Excellence in England. Dr. Moots is the chief investigator for the Secukinumab in Behçet’s trial, which is sponsored by the Liverpool University Hospitals NHS Foundation Trust via grant funding from Novartis.
 

A version of this article appeared on Medscape.com.

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Oregon Physician Assistants Get Name Change

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Mon, 04/29/2024 - 17:36

 

On April 4, Oregon’s Governor Tina Kotek signed a bill into law that officially changed the title of “physician assistants” to “physician associates” in the state. The switch is the first of its kind in the United States and comes on the heels of a decision from 2021 by the American Academy of Physician Associates (AAPA) to change the meaning of “PA” to “physician associate” from “physician assistant.”

In the Medscape Physician Assistant Career Satisfaction Report 2023, a diverse range of opinions on the title switch was reflected. Only 40% of PAs favored the name change at the time, 45% neither opposed nor favored it, and 15% opposed the name change, reflecting the complexity of the issue.

According to the AAPA, the change came about to better reflect the work PAs do in not just “assisting” physicians but in working independently with patients. Some also felt that the word “assistant” implies dependence. However, despite associate’s more accurate reflection of the job, PAs mostly remain split on whether they want the new moniker.

Many say that the name change will be confusing for the public and their patients, while others say that physician assistant was already not well understood, as patients often thought of the profession as a doctor’s helper or an assistant, like a medical assistant.

Yet many long-time PAs say that they prefer the title they’ve always had and that explaining to patients the new associate title will be equally confusing. Some mentioned patients may think they’re a business associate of the physician.

Oregon PAs won’t immediately switch to the new name. The new law takes effect on June 6, 2024. The Oregon Medical Board will establish regulations and guidance before PAs adopt the new name in their practices.

The law only changes the name of PAs in Oregon, not in other states. In fact, prematurely using the title of physician associate could subject a PA to regulatory challenges or disciplinary actions.

A version of this article appeared on Medscape.com.

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On April 4, Oregon’s Governor Tina Kotek signed a bill into law that officially changed the title of “physician assistants” to “physician associates” in the state. The switch is the first of its kind in the United States and comes on the heels of a decision from 2021 by the American Academy of Physician Associates (AAPA) to change the meaning of “PA” to “physician associate” from “physician assistant.”

In the Medscape Physician Assistant Career Satisfaction Report 2023, a diverse range of opinions on the title switch was reflected. Only 40% of PAs favored the name change at the time, 45% neither opposed nor favored it, and 15% opposed the name change, reflecting the complexity of the issue.

According to the AAPA, the change came about to better reflect the work PAs do in not just “assisting” physicians but in working independently with patients. Some also felt that the word “assistant” implies dependence. However, despite associate’s more accurate reflection of the job, PAs mostly remain split on whether they want the new moniker.

Many say that the name change will be confusing for the public and their patients, while others say that physician assistant was already not well understood, as patients often thought of the profession as a doctor’s helper or an assistant, like a medical assistant.

Yet many long-time PAs say that they prefer the title they’ve always had and that explaining to patients the new associate title will be equally confusing. Some mentioned patients may think they’re a business associate of the physician.

Oregon PAs won’t immediately switch to the new name. The new law takes effect on June 6, 2024. The Oregon Medical Board will establish regulations and guidance before PAs adopt the new name in their practices.

The law only changes the name of PAs in Oregon, not in other states. In fact, prematurely using the title of physician associate could subject a PA to regulatory challenges or disciplinary actions.

A version of this article appeared on Medscape.com.

 

On April 4, Oregon’s Governor Tina Kotek signed a bill into law that officially changed the title of “physician assistants” to “physician associates” in the state. The switch is the first of its kind in the United States and comes on the heels of a decision from 2021 by the American Academy of Physician Associates (AAPA) to change the meaning of “PA” to “physician associate” from “physician assistant.”

In the Medscape Physician Assistant Career Satisfaction Report 2023, a diverse range of opinions on the title switch was reflected. Only 40% of PAs favored the name change at the time, 45% neither opposed nor favored it, and 15% opposed the name change, reflecting the complexity of the issue.

According to the AAPA, the change came about to better reflect the work PAs do in not just “assisting” physicians but in working independently with patients. Some also felt that the word “assistant” implies dependence. However, despite associate’s more accurate reflection of the job, PAs mostly remain split on whether they want the new moniker.

Many say that the name change will be confusing for the public and their patients, while others say that physician assistant was already not well understood, as patients often thought of the profession as a doctor’s helper or an assistant, like a medical assistant.

Yet many long-time PAs say that they prefer the title they’ve always had and that explaining to patients the new associate title will be equally confusing. Some mentioned patients may think they’re a business associate of the physician.

Oregon PAs won’t immediately switch to the new name. The new law takes effect on June 6, 2024. The Oregon Medical Board will establish regulations and guidance before PAs adopt the new name in their practices.

The law only changes the name of PAs in Oregon, not in other states. In fact, prematurely using the title of physician associate could subject a PA to regulatory challenges or disciplinary actions.

A version of this article appeared on Medscape.com.

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Automated Risk Assessment Tool Reduces Antibiotic Prescribing Rates

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Fri, 04/26/2024 - 10:03

 



An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

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An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

 



An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

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