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Handheld device highly sensitive in detecting amblyopia; can be used in children as young as 2 years of age
A handheld vision screening device to test for amblyopia and strabismus has been found to have a sensitivity of 100%, a specificity of 85%, and a median acquisition time of 28 seconds, according to a study published in the Journal of American Association for Pediatric Ophthalmology and Strabismus.
The prospective study involved 300 children recruited from two Kaiser Permanente Southern California pediatric clinics. The patients, aged 24-72 months, were first screened by trained research staff for amblyopia and strabismus using the device, called the Pediatric Vision Scanner (PVS). They were subsequently screened by a pediatric ophthalmologist who was masked to the previous screening results and who then performed a comprehensive eye examination.
With the gold-standard ophthalmologist examination, six children (2%) were identified as having amblyopia and/or strabismus. Using the PVS, all six children with amblyopia and/or strabismus were identified, yielding 100% sensitivity. PVS findings were normal for 45 children (15%), yielding a specificity rate of 85%. The positive predictive value was 26.0% (95% confidence interval, 12.4%-32.4%), and the negative predictive value was 100% (95% CI, 97.1%-100%).
The findings suggest that the device could be used to screen for amblyopia, according to Shaival S. Shah, MD, the study’s first author, who is a pediatric ophthalmologist and regional section lead of pediatric ophthalmology, Southern California Permanente Medical Group.
“A strength of this device is that it is user friendly and easy to use and very quick, which is essential when working with young children,” said Dr. Shah in an interview. He noted that the device could be used for children as young as 2 years.
Dr. Shah pointed out that the children were recruited from a pediatrician’s office and reflect more of a “real-world setting” than had they been recruited from a pediatric ophthalmology clinic.
Dr. Shah added that, with a negative predictive value of 100%, the device is highly reliable at informing the clinician that amblyopia is not present. “It did have a positive predictive value of 26%, which needs to be considered when deciding one’s vision screening strategy,” he said.
A limitation of the study is that there was no head-to-head comparison with another screening device, noted Dr. Shah. “While it may have been more useful to include another vision screening device to have a head-to-head comparison, we did not do this to limit complexity and cost.”
Michael J. Wan, MD, FRCSC, pediatric ophthalmologist, Sick Kids Hospital, Toronto, and assistant professor at the University of Toronto, told this news organization that the device has multiple strengths, including quick acquisition time and excellent detection rate of amblyopia and strabismus in children as young as 2 years.
“It is highly reliable at informing the clinician that amblyopia is not present,” said Dr. Wan, who was not involved in the study. “The PVS uses an elegant mechanism to test for amblyopia directly (as opposed to other screening devices, which only detect risk factors). This study demonstrates the impressive diagnostic accuracy of this approach. With a study population of 300 children, the PVS had a sensitivity of 100% and specificity of 85% (over 90% in cooperative children). This means that the PVS would detect essentially all cases of amblyopia and strabismus while minimizing the number of unnecessary referrals and examinations.”
He added that, although the study included children as young as 2 years, only 2.5% of the children were unable to complete the PVS test. “Detecting amblyopia in children at an age when treatment is still effective has been a longstanding goal in pediatric ophthalmology,” said Dr. Wan, who described the technology as user friendly. “Based on this study, the search for an accurate and practical pediatric vision screening device appears to be over.”
Dr. Wan said it would be useful to replicate this study with a different population to confirm the findings.
Dr. Shah and Dr. Wan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A handheld vision screening device to test for amblyopia and strabismus has been found to have a sensitivity of 100%, a specificity of 85%, and a median acquisition time of 28 seconds, according to a study published in the Journal of American Association for Pediatric Ophthalmology and Strabismus.
The prospective study involved 300 children recruited from two Kaiser Permanente Southern California pediatric clinics. The patients, aged 24-72 months, were first screened by trained research staff for amblyopia and strabismus using the device, called the Pediatric Vision Scanner (PVS). They were subsequently screened by a pediatric ophthalmologist who was masked to the previous screening results and who then performed a comprehensive eye examination.
With the gold-standard ophthalmologist examination, six children (2%) were identified as having amblyopia and/or strabismus. Using the PVS, all six children with amblyopia and/or strabismus were identified, yielding 100% sensitivity. PVS findings were normal for 45 children (15%), yielding a specificity rate of 85%. The positive predictive value was 26.0% (95% confidence interval, 12.4%-32.4%), and the negative predictive value was 100% (95% CI, 97.1%-100%).
The findings suggest that the device could be used to screen for amblyopia, according to Shaival S. Shah, MD, the study’s first author, who is a pediatric ophthalmologist and regional section lead of pediatric ophthalmology, Southern California Permanente Medical Group.
“A strength of this device is that it is user friendly and easy to use and very quick, which is essential when working with young children,” said Dr. Shah in an interview. He noted that the device could be used for children as young as 2 years.
Dr. Shah pointed out that the children were recruited from a pediatrician’s office and reflect more of a “real-world setting” than had they been recruited from a pediatric ophthalmology clinic.
Dr. Shah added that, with a negative predictive value of 100%, the device is highly reliable at informing the clinician that amblyopia is not present. “It did have a positive predictive value of 26%, which needs to be considered when deciding one’s vision screening strategy,” he said.
A limitation of the study is that there was no head-to-head comparison with another screening device, noted Dr. Shah. “While it may have been more useful to include another vision screening device to have a head-to-head comparison, we did not do this to limit complexity and cost.”
Michael J. Wan, MD, FRCSC, pediatric ophthalmologist, Sick Kids Hospital, Toronto, and assistant professor at the University of Toronto, told this news organization that the device has multiple strengths, including quick acquisition time and excellent detection rate of amblyopia and strabismus in children as young as 2 years.
“It is highly reliable at informing the clinician that amblyopia is not present,” said Dr. Wan, who was not involved in the study. “The PVS uses an elegant mechanism to test for amblyopia directly (as opposed to other screening devices, which only detect risk factors). This study demonstrates the impressive diagnostic accuracy of this approach. With a study population of 300 children, the PVS had a sensitivity of 100% and specificity of 85% (over 90% in cooperative children). This means that the PVS would detect essentially all cases of amblyopia and strabismus while minimizing the number of unnecessary referrals and examinations.”
He added that, although the study included children as young as 2 years, only 2.5% of the children were unable to complete the PVS test. “Detecting amblyopia in children at an age when treatment is still effective has been a longstanding goal in pediatric ophthalmology,” said Dr. Wan, who described the technology as user friendly. “Based on this study, the search for an accurate and practical pediatric vision screening device appears to be over.”
Dr. Wan said it would be useful to replicate this study with a different population to confirm the findings.
Dr. Shah and Dr. Wan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A handheld vision screening device to test for amblyopia and strabismus has been found to have a sensitivity of 100%, a specificity of 85%, and a median acquisition time of 28 seconds, according to a study published in the Journal of American Association for Pediatric Ophthalmology and Strabismus.
The prospective study involved 300 children recruited from two Kaiser Permanente Southern California pediatric clinics. The patients, aged 24-72 months, were first screened by trained research staff for amblyopia and strabismus using the device, called the Pediatric Vision Scanner (PVS). They were subsequently screened by a pediatric ophthalmologist who was masked to the previous screening results and who then performed a comprehensive eye examination.
With the gold-standard ophthalmologist examination, six children (2%) were identified as having amblyopia and/or strabismus. Using the PVS, all six children with amblyopia and/or strabismus were identified, yielding 100% sensitivity. PVS findings were normal for 45 children (15%), yielding a specificity rate of 85%. The positive predictive value was 26.0% (95% confidence interval, 12.4%-32.4%), and the negative predictive value was 100% (95% CI, 97.1%-100%).
The findings suggest that the device could be used to screen for amblyopia, according to Shaival S. Shah, MD, the study’s first author, who is a pediatric ophthalmologist and regional section lead of pediatric ophthalmology, Southern California Permanente Medical Group.
“A strength of this device is that it is user friendly and easy to use and very quick, which is essential when working with young children,” said Dr. Shah in an interview. He noted that the device could be used for children as young as 2 years.
Dr. Shah pointed out that the children were recruited from a pediatrician’s office and reflect more of a “real-world setting” than had they been recruited from a pediatric ophthalmology clinic.
Dr. Shah added that, with a negative predictive value of 100%, the device is highly reliable at informing the clinician that amblyopia is not present. “It did have a positive predictive value of 26%, which needs to be considered when deciding one’s vision screening strategy,” he said.
A limitation of the study is that there was no head-to-head comparison with another screening device, noted Dr. Shah. “While it may have been more useful to include another vision screening device to have a head-to-head comparison, we did not do this to limit complexity and cost.”
Michael J. Wan, MD, FRCSC, pediatric ophthalmologist, Sick Kids Hospital, Toronto, and assistant professor at the University of Toronto, told this news organization that the device has multiple strengths, including quick acquisition time and excellent detection rate of amblyopia and strabismus in children as young as 2 years.
“It is highly reliable at informing the clinician that amblyopia is not present,” said Dr. Wan, who was not involved in the study. “The PVS uses an elegant mechanism to test for amblyopia directly (as opposed to other screening devices, which only detect risk factors). This study demonstrates the impressive diagnostic accuracy of this approach. With a study population of 300 children, the PVS had a sensitivity of 100% and specificity of 85% (over 90% in cooperative children). This means that the PVS would detect essentially all cases of amblyopia and strabismus while minimizing the number of unnecessary referrals and examinations.”
He added that, although the study included children as young as 2 years, only 2.5% of the children were unable to complete the PVS test. “Detecting amblyopia in children at an age when treatment is still effective has been a longstanding goal in pediatric ophthalmology,” said Dr. Wan, who described the technology as user friendly. “Based on this study, the search for an accurate and practical pediatric vision screening device appears to be over.”
Dr. Wan said it would be useful to replicate this study with a different population to confirm the findings.
Dr. Shah and Dr. Wan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Med student’s skills put to the test saving life of accident victim
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Many patients, doctors unaware of advancements in cancer care
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
U.S. study finds racial, gender differences in surgical treatment of dermatofibrosarcoma protuberans
.
Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.
In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.
Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”
In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.
The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.
“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
.
Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.
In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.
Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”
In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.
The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.
“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
.
Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.
In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.
Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”
In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.
The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.
“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM JAAD
Quick Quiz Question 2
Q2. Correct answer: A.
Rationale
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.
References
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.
Q2. Correct answer: A.
Rationale
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.
References
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.
Q2. Correct answer: A.
Rationale
Tropical sprue occurs in patients from or travelers to endemic areas near the equator, such as Puerto Rico, Haiti, Cuba, Southeast Asia, and India for at least 2 weeks to a month and has a likely infectious etiology, but the exact organism(s) has not been identified. Patients may present with malabsorption, steatorrhea, weight loss, and fatigue. Laboratory testing shows anemia, B12 and folate deficiency, and increased fecal fat. Biopsies of the small bowel during upper endoscopy show villous blunting with negative celiac serologies. Treatment is a 3- to 6-month course of tetracycline 250 mg orally four times daily with folate 5 mg orally daily. The macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels argue against celiac disease, so this patient is unlikely to respond to a gluten-free diet.
References
Ghoshal UC et. al. Curr Gastroenterol Rep. 2014;16(6):391.
Batheja MJ et. al. Case Rep Gastroenterol. 2010 May 19;4(2):168-172.
Jansson-Knodell CL et al. Mayo Clin Proc. 2018 Apr;93(4):509-517.
Q2. A 54-year-old man is seen in the clinic for a recent episode of nausea, vomiting, and abdominal pain. He was vacationing with friends in Hawaii, and 1 hour after eating a local dish consisting of rice, macaroni salad, and raw tuna, he developed a headache associated with facial flushing, upper body rash, palpitations, nausea, vomiting, and abdominal pain. His friends who ate burgers did not experience any symptoms. He felt better the next day. He takes only lisinopril for hypertension and has no known drug allergies. His physical examination is unremarkable. Although he has tolerated fish in the past, he did some research on the internet and wonders if he has a seafood allergy.
Quick Quiz Question 1
Correct answer: A.
Rationale
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.
Reference
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.
Correct answer: A.
Rationale
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.
Reference
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.
Correct answer: A.
Rationale
This patient has scromboid poisoning, which occurs when histidine is converted to histamine by bacterial enzymes in improperly refrigerated fish. Most cases in the United States are reported in Hawaii, Florida, and California and involve consumption of affected tuna, mackerel, mahi-mahi, sardines, herring, and other fish. Onset of symptoms occurs about 1 hour after eating the suspect fish; the patient may experience hot flashes, facial flushing, hives, upper body rash, perioral paresthesias or edema, palpitations, lightheadedness, nausea, vomiting, and abdominal pain. Symptoms typically resolve within 1 day, though some patients may experience a longer course. Supportive care and either oral or intravenous administration of antihistamines may be used to improve symptoms. Evaluation of airway patency is also important. Scromboid poisoning may be prevented by immediate refrigeration of fresh fish to below 40°C.
Although ACE inhibitor induced angioedema may cause facial swelling, the time course of the disease and associated risk factors favor scromboid poisoning. Ingestion of Bacillus cereus or Staphylococcus aureus would not be expected to cause flushing, tachycardia, and upper body rash. Ciguatera poisoning has a less immediate onset of symptoms, is associated with neurologic symptoms, and has a more protracted course. This patient is not likely to have an allergy to seafood.
Reference
Hungerford JM. Toxicon. 2010 Aug 15;56(2):231-43.
Q1. A 36-year-old White woman returned from a 3-month missionary trip to India and subsequently developed diarrhea and a 20-pound weight loss in the recent past. She reports increased abdominal bloating and fatigue but denies any symptoms of gastrointestinal bleeding. Her complete blood count reveals a macrocytic anemia, normal iron studies, and low vitamin B12 and folate levels. Her stool tests are negative for routine bacterial pathogens, giardia, ova, and parasites. Her duodenal biopsies show villous blunting.
Seasons of change
Since its inaugural issue in January 2007, the newspaper has evolved into a trusted source of clinically relevant updates on emerging practice trends and technological advances. I am honored to serve as the fourth editor of GIHN, building on the strong foundation set by former editors Charles J. Lightdale, MD, AGAF; Colin W. Howden, MD, AGAF; and most recently John I. Allen, MD, MBA, AGAF. Each of them has played an instrumental role in the publication’s growth and success over the past 15 years.
GIHN is unique among AGA’s flagship publications in that it is designed to bring together content from a variety of sources, including innovative scientific research from leading academic journals, practice management updates, and information regarding emerging policy initiatives impacting frontline GI practice. It also provides a platform to highlight AGA’s important work on behalf of its members. My goal as EIC is to continue to curate high-yield content that has the potential to directly impact how we manage our patients and practices. Several new initiatives are planned, which I am excited to introduce over the next few months. My door is always open, and I welcome your feedback about how GIHN can best serve the needs of AGA’s diverse membership in both academics and community practice.
Highlights of this month’s issue include updates on a unique multidisciplinary collaboration designed to promote a coordinated response among health care providers in caring for patients with NAFLD/NASH and AGA’s Clinical Practice Update on dysplasia management in patients with IBD. If you haven’t already, please consider nominating yourself or a colleague for an AGA committee appointment – the deadline is Nov. 1, and this is a fantastic way to contribute to the national dialogue on important issues affecting frontline GI practice.
Megan A. Adams, MD, JD, MSc
Since its inaugural issue in January 2007, the newspaper has evolved into a trusted source of clinically relevant updates on emerging practice trends and technological advances. I am honored to serve as the fourth editor of GIHN, building on the strong foundation set by former editors Charles J. Lightdale, MD, AGAF; Colin W. Howden, MD, AGAF; and most recently John I. Allen, MD, MBA, AGAF. Each of them has played an instrumental role in the publication’s growth and success over the past 15 years.
GIHN is unique among AGA’s flagship publications in that it is designed to bring together content from a variety of sources, including innovative scientific research from leading academic journals, practice management updates, and information regarding emerging policy initiatives impacting frontline GI practice. It also provides a platform to highlight AGA’s important work on behalf of its members. My goal as EIC is to continue to curate high-yield content that has the potential to directly impact how we manage our patients and practices. Several new initiatives are planned, which I am excited to introduce over the next few months. My door is always open, and I welcome your feedback about how GIHN can best serve the needs of AGA’s diverse membership in both academics and community practice.
Highlights of this month’s issue include updates on a unique multidisciplinary collaboration designed to promote a coordinated response among health care providers in caring for patients with NAFLD/NASH and AGA’s Clinical Practice Update on dysplasia management in patients with IBD. If you haven’t already, please consider nominating yourself or a colleague for an AGA committee appointment – the deadline is Nov. 1, and this is a fantastic way to contribute to the national dialogue on important issues affecting frontline GI practice.
Megan A. Adams, MD, JD, MSc
Since its inaugural issue in January 2007, the newspaper has evolved into a trusted source of clinically relevant updates on emerging practice trends and technological advances. I am honored to serve as the fourth editor of GIHN, building on the strong foundation set by former editors Charles J. Lightdale, MD, AGAF; Colin W. Howden, MD, AGAF; and most recently John I. Allen, MD, MBA, AGAF. Each of them has played an instrumental role in the publication’s growth and success over the past 15 years.
GIHN is unique among AGA’s flagship publications in that it is designed to bring together content from a variety of sources, including innovative scientific research from leading academic journals, practice management updates, and information regarding emerging policy initiatives impacting frontline GI practice. It also provides a platform to highlight AGA’s important work on behalf of its members. My goal as EIC is to continue to curate high-yield content that has the potential to directly impact how we manage our patients and practices. Several new initiatives are planned, which I am excited to introduce over the next few months. My door is always open, and I welcome your feedback about how GIHN can best serve the needs of AGA’s diverse membership in both academics and community practice.
Highlights of this month’s issue include updates on a unique multidisciplinary collaboration designed to promote a coordinated response among health care providers in caring for patients with NAFLD/NASH and AGA’s Clinical Practice Update on dysplasia management in patients with IBD. If you haven’t already, please consider nominating yourself or a colleague for an AGA committee appointment – the deadline is Nov. 1, and this is a fantastic way to contribute to the national dialogue on important issues affecting frontline GI practice.
Megan A. Adams, MD, JD, MSc
Study finds paying people to participate in clinical trials is not unethical
Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.
Research released this week could change that.
Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.
More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.
But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.
“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.
This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.
The study was published online Sept. 20 in JAMA Internal Medicine.
A good first step?
“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.”
“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.
In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”
The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
Recruitment realities
When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”
“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.
Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.
“These studies end up exposing people to research risks and burdens without a compensating social benefit.”
“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.
Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.
Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
Key findings
A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).
In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.
In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).
The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).
“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
Inducement vs. coercion
The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.
Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey.
Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.
After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
Research implications
A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.
“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”
“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
Responding to criticism
The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”
Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”
There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.
“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.
The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”
“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”
The study was supported by funding from the National Cancer Institute.
A version of this article first appeared on Medscape.com.
Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.
Research released this week could change that.
Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.
More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.
But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.
“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.
This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.
The study was published online Sept. 20 in JAMA Internal Medicine.
A good first step?
“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.”
“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.
In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”
The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
Recruitment realities
When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”
“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.
Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.
“These studies end up exposing people to research risks and burdens without a compensating social benefit.”
“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.
Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.
Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
Key findings
A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).
In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.
In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).
The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).
“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
Inducement vs. coercion
The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.
Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey.
Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.
After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
Research implications
A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.
“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”
“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
Responding to criticism
The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”
Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”
There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.
“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.
The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”
“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”
The study was supported by funding from the National Cancer Institute.
A version of this article first appeared on Medscape.com.
Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.
Research released this week could change that.
Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.
More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.
But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.
“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.
This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.
The study was published online Sept. 20 in JAMA Internal Medicine.
A good first step?
“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.”
“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.
In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”
The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
Recruitment realities
When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”
“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.
Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.
“These studies end up exposing people to research risks and burdens without a compensating social benefit.”
“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.
Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.
Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
Key findings
A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).
In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.
In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).
The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).
“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
Inducement vs. coercion
The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.
Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey.
Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.
After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
Research implications
A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.
“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”
“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
Responding to criticism
The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”
Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”
There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.
“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.
The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”
“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”
The study was supported by funding from the National Cancer Institute.
A version of this article first appeared on Medscape.com.
Military sexual trauma tied to risk for hypertension
a new study suggests.
“Understanding a patient’s trauma history is invaluable for treating the whole person,” Allison E. Gaffey, PhD, Yale University, New Haven, Conn., and the Veterans Affairs Connecticut Healthcare System, told this news organization.
“Assessing men and women’s history of trauma, including sexual trauma, is critical for recognizing nontraditional factors that contribute to their cardiovascular risk and to gain a more comprehensive understanding of their mental and physical health,” Dr. Gaffey added.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
Lasting impact on physical health
Dr. Gaffey and colleagues analyzed data from the VA for roughly 1.2 million veterans (mean age, 30.2 years; 12% female) who were discharged from the military after Sept. 30, 2001, and who received health care services at VA medical centers from 2001 to 2017.
All were screened for sexual harassment and assault, known as military sexual trauma (MST), when they first began receiving VA care.
During 16 years of follow-up, 33,881 veterans screened positive for MST (65% women), and 307,332 developed hypertension (15% women).
Overall, MST was associated with a 30% increase in risk for incident hypertension in unadjusted models (hazard ratio, 1.30; 95% confidence interval, 1.28-1.33; P < .001).
After adjustment for demographic characteristics, lifestyle factors, cardiovascular comorbidities, PTSD, anxiety, and depression, MST remained significantly associated with hypertension (adjusted HR, 1.10; 95% CI, 1.08-1.12; P < .001).
When women and men were examined separately, the link between MST and risk for hypertension remained for both groups, but was slightly stronger among women.
“Sexual trauma has been associated with autonomic dysfunction, inflammation, and dysregulation in the hypothalamic pituitary adrenal axis and renin-angiotensin-aldosterone system, which could lead to elevations in BP over time,” Dr. Gaffey told this news organization.
“These findings show that even many years after being discharged from military service, exposure to military sexual trauma can continue to significantly influence veterans’ physical health,” she added.
Dr. Gaffey said it will be important to determine if early treatment of MST improves hypertension risk, particularly among those showing elevated blood pressure or stage 1 hypertension.
Social determinants of health
Willie Lawrence Jr., MD, head of the AHA National Hypertension Control Initiative oversight committee, said the findings in this study are “in line with what we know about the impact of social determinants of health on high blood pressure.”
“There are studies that suggest that things that we historically don’t look at as risk factors for hypertension – lifelong racism, crime, mental health status – do in fact predict your risk of developing hypertension,” Dr. Lawrence, from Spectrum Health in Benton Harbor, Mich., told this news organization.
“It’s not just your genetics that will determine your health, and there are a lot of things that will affect your blood pressure. Your blood pressure is really just a barometer of everything that’s going on in your life and some of the things that have gone on in your life in the past,” added Dr. Lawrence, who wasn’t involved in the study.
Funding for the study was provided by the Department of Veterans Affairs. Dr. Gaffey and Dr. Lawrence have no relevant disclosures.
A version of this article first appeared on Medscape.com.
a new study suggests.
“Understanding a patient’s trauma history is invaluable for treating the whole person,” Allison E. Gaffey, PhD, Yale University, New Haven, Conn., and the Veterans Affairs Connecticut Healthcare System, told this news organization.
“Assessing men and women’s history of trauma, including sexual trauma, is critical for recognizing nontraditional factors that contribute to their cardiovascular risk and to gain a more comprehensive understanding of their mental and physical health,” Dr. Gaffey added.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
Lasting impact on physical health
Dr. Gaffey and colleagues analyzed data from the VA for roughly 1.2 million veterans (mean age, 30.2 years; 12% female) who were discharged from the military after Sept. 30, 2001, and who received health care services at VA medical centers from 2001 to 2017.
All were screened for sexual harassment and assault, known as military sexual trauma (MST), when they first began receiving VA care.
During 16 years of follow-up, 33,881 veterans screened positive for MST (65% women), and 307,332 developed hypertension (15% women).
Overall, MST was associated with a 30% increase in risk for incident hypertension in unadjusted models (hazard ratio, 1.30; 95% confidence interval, 1.28-1.33; P < .001).
After adjustment for demographic characteristics, lifestyle factors, cardiovascular comorbidities, PTSD, anxiety, and depression, MST remained significantly associated with hypertension (adjusted HR, 1.10; 95% CI, 1.08-1.12; P < .001).
When women and men were examined separately, the link between MST and risk for hypertension remained for both groups, but was slightly stronger among women.
“Sexual trauma has been associated with autonomic dysfunction, inflammation, and dysregulation in the hypothalamic pituitary adrenal axis and renin-angiotensin-aldosterone system, which could lead to elevations in BP over time,” Dr. Gaffey told this news organization.
“These findings show that even many years after being discharged from military service, exposure to military sexual trauma can continue to significantly influence veterans’ physical health,” she added.
Dr. Gaffey said it will be important to determine if early treatment of MST improves hypertension risk, particularly among those showing elevated blood pressure or stage 1 hypertension.
Social determinants of health
Willie Lawrence Jr., MD, head of the AHA National Hypertension Control Initiative oversight committee, said the findings in this study are “in line with what we know about the impact of social determinants of health on high blood pressure.”
“There are studies that suggest that things that we historically don’t look at as risk factors for hypertension – lifelong racism, crime, mental health status – do in fact predict your risk of developing hypertension,” Dr. Lawrence, from Spectrum Health in Benton Harbor, Mich., told this news organization.
“It’s not just your genetics that will determine your health, and there are a lot of things that will affect your blood pressure. Your blood pressure is really just a barometer of everything that’s going on in your life and some of the things that have gone on in your life in the past,” added Dr. Lawrence, who wasn’t involved in the study.
Funding for the study was provided by the Department of Veterans Affairs. Dr. Gaffey and Dr. Lawrence have no relevant disclosures.
A version of this article first appeared on Medscape.com.
a new study suggests.
“Understanding a patient’s trauma history is invaluable for treating the whole person,” Allison E. Gaffey, PhD, Yale University, New Haven, Conn., and the Veterans Affairs Connecticut Healthcare System, told this news organization.
“Assessing men and women’s history of trauma, including sexual trauma, is critical for recognizing nontraditional factors that contribute to their cardiovascular risk and to gain a more comprehensive understanding of their mental and physical health,” Dr. Gaffey added.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
Lasting impact on physical health
Dr. Gaffey and colleagues analyzed data from the VA for roughly 1.2 million veterans (mean age, 30.2 years; 12% female) who were discharged from the military after Sept. 30, 2001, and who received health care services at VA medical centers from 2001 to 2017.
All were screened for sexual harassment and assault, known as military sexual trauma (MST), when they first began receiving VA care.
During 16 years of follow-up, 33,881 veterans screened positive for MST (65% women), and 307,332 developed hypertension (15% women).
Overall, MST was associated with a 30% increase in risk for incident hypertension in unadjusted models (hazard ratio, 1.30; 95% confidence interval, 1.28-1.33; P < .001).
After adjustment for demographic characteristics, lifestyle factors, cardiovascular comorbidities, PTSD, anxiety, and depression, MST remained significantly associated with hypertension (adjusted HR, 1.10; 95% CI, 1.08-1.12; P < .001).
When women and men were examined separately, the link between MST and risk for hypertension remained for both groups, but was slightly stronger among women.
“Sexual trauma has been associated with autonomic dysfunction, inflammation, and dysregulation in the hypothalamic pituitary adrenal axis and renin-angiotensin-aldosterone system, which could lead to elevations in BP over time,” Dr. Gaffey told this news organization.
“These findings show that even many years after being discharged from military service, exposure to military sexual trauma can continue to significantly influence veterans’ physical health,” she added.
Dr. Gaffey said it will be important to determine if early treatment of MST improves hypertension risk, particularly among those showing elevated blood pressure or stage 1 hypertension.
Social determinants of health
Willie Lawrence Jr., MD, head of the AHA National Hypertension Control Initiative oversight committee, said the findings in this study are “in line with what we know about the impact of social determinants of health on high blood pressure.”
“There are studies that suggest that things that we historically don’t look at as risk factors for hypertension – lifelong racism, crime, mental health status – do in fact predict your risk of developing hypertension,” Dr. Lawrence, from Spectrum Health in Benton Harbor, Mich., told this news organization.
“It’s not just your genetics that will determine your health, and there are a lot of things that will affect your blood pressure. Your blood pressure is really just a barometer of everything that’s going on in your life and some of the things that have gone on in your life in the past,” added Dr. Lawrence, who wasn’t involved in the study.
Funding for the study was provided by the Department of Veterans Affairs. Dr. Gaffey and Dr. Lawrence have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Two Colorado nurses admit to stealing drugs from hospital patients
, according to the US Attorney’s Office in Denver.
Alicia Nickel-Tangeman, 44, formerly of Woodland Park, Colo., pled guilty to four counts of obtaining controlled substances using fraud and deception. She gained access to rooms of patients who weren’t assigned to her and diverted drugs from their pain-on-demand devices, according to federal officials.
The defendant told patients she was conducting a study on the pumps that deliver drugs to relieve pain when the patient pushes a button, the officials stated. She would open the machine and would remove a portion of the drug with a syringe. She obtained drugs in this way from three patients on four occasions, a press release stated.
When questioned by law enforcement, Ms. Nickel-Tangeman continued to lie about her conduct and produced a false email address to substantiate her claims, the Department of Justice reported. She is scheduled to be sentenced November 30.
Ms. Nickel-Tangeman’s LinkedIn profile shows that she was a nurse with UCHealth in Colorado for 17 years, ending in May 2019.
Katie Muhs, 34, of Littleton, Colo., was convicted of a felony for using fraud and deception to divert fentanyl for her personal use while serving as an intensive care nurse.
The defendant admitted that between June and September 2019 she stole fentanyl by removing it from the IV bags of patients using a syringe. She also admitted to stealing fentanyl that remained in vials after fentanyl had been administered to patients. She would replace the stolen drug with saline and would “then have a fellow nurse witness her ‘waste,’ or dispose of the saline.”
U.S. District Judge Raymond Moore sentenced Ms. Muhs to 3 months of probation as a result of “the defendant’s confession and her cooperation in disclosing full information on her diversion, which is a matter potentially affecting the public health and the integrity of the health care system. The felony offense is punishable by up to four years of imprisonment and a fine of $250,000, per count.”
In pleading guilty to the single count in the case, Ms. Muhs admitted that on September 8, 2019, “she removed a bag of fentanyl from the automated medication control machine at the hospital under a different nurse’s login credentials. She then removed fentanyl from the IV bag for personal use.”
In April, the Colorado Court of Appeals denied her request for unemployment benefits. Court documents reveal that Ms. Muhs lost her job at St. Anthony Hospital after it was discovered that she stole and self-injected fentanyl while working as a registered nurse there.
The investigations in these cases were conducted by the U.S. Food and Drug Administration, the Office of Criminal Investigations, and the Drug Enforcement Administration (DEA).
“We want it to be known that healthcare professionals who take advantage of patients in need by stealing their medications will be held accountable to the law,” said Deanne Reuter, DEA Denver Field Division special agent in charge.
A version of this article first appeared on Medscape.com.
, according to the US Attorney’s Office in Denver.
Alicia Nickel-Tangeman, 44, formerly of Woodland Park, Colo., pled guilty to four counts of obtaining controlled substances using fraud and deception. She gained access to rooms of patients who weren’t assigned to her and diverted drugs from their pain-on-demand devices, according to federal officials.
The defendant told patients she was conducting a study on the pumps that deliver drugs to relieve pain when the patient pushes a button, the officials stated. She would open the machine and would remove a portion of the drug with a syringe. She obtained drugs in this way from three patients on four occasions, a press release stated.
When questioned by law enforcement, Ms. Nickel-Tangeman continued to lie about her conduct and produced a false email address to substantiate her claims, the Department of Justice reported. She is scheduled to be sentenced November 30.
Ms. Nickel-Tangeman’s LinkedIn profile shows that she was a nurse with UCHealth in Colorado for 17 years, ending in May 2019.
Katie Muhs, 34, of Littleton, Colo., was convicted of a felony for using fraud and deception to divert fentanyl for her personal use while serving as an intensive care nurse.
The defendant admitted that between June and September 2019 she stole fentanyl by removing it from the IV bags of patients using a syringe. She also admitted to stealing fentanyl that remained in vials after fentanyl had been administered to patients. She would replace the stolen drug with saline and would “then have a fellow nurse witness her ‘waste,’ or dispose of the saline.”
U.S. District Judge Raymond Moore sentenced Ms. Muhs to 3 months of probation as a result of “the defendant’s confession and her cooperation in disclosing full information on her diversion, which is a matter potentially affecting the public health and the integrity of the health care system. The felony offense is punishable by up to four years of imprisonment and a fine of $250,000, per count.”
In pleading guilty to the single count in the case, Ms. Muhs admitted that on September 8, 2019, “she removed a bag of fentanyl from the automated medication control machine at the hospital under a different nurse’s login credentials. She then removed fentanyl from the IV bag for personal use.”
In April, the Colorado Court of Appeals denied her request for unemployment benefits. Court documents reveal that Ms. Muhs lost her job at St. Anthony Hospital after it was discovered that she stole and self-injected fentanyl while working as a registered nurse there.
The investigations in these cases were conducted by the U.S. Food and Drug Administration, the Office of Criminal Investigations, and the Drug Enforcement Administration (DEA).
“We want it to be known that healthcare professionals who take advantage of patients in need by stealing their medications will be held accountable to the law,” said Deanne Reuter, DEA Denver Field Division special agent in charge.
A version of this article first appeared on Medscape.com.
, according to the US Attorney’s Office in Denver.
Alicia Nickel-Tangeman, 44, formerly of Woodland Park, Colo., pled guilty to four counts of obtaining controlled substances using fraud and deception. She gained access to rooms of patients who weren’t assigned to her and diverted drugs from their pain-on-demand devices, according to federal officials.
The defendant told patients she was conducting a study on the pumps that deliver drugs to relieve pain when the patient pushes a button, the officials stated. She would open the machine and would remove a portion of the drug with a syringe. She obtained drugs in this way from three patients on four occasions, a press release stated.
When questioned by law enforcement, Ms. Nickel-Tangeman continued to lie about her conduct and produced a false email address to substantiate her claims, the Department of Justice reported. She is scheduled to be sentenced November 30.
Ms. Nickel-Tangeman’s LinkedIn profile shows that she was a nurse with UCHealth in Colorado for 17 years, ending in May 2019.
Katie Muhs, 34, of Littleton, Colo., was convicted of a felony for using fraud and deception to divert fentanyl for her personal use while serving as an intensive care nurse.
The defendant admitted that between June and September 2019 she stole fentanyl by removing it from the IV bags of patients using a syringe. She also admitted to stealing fentanyl that remained in vials after fentanyl had been administered to patients. She would replace the stolen drug with saline and would “then have a fellow nurse witness her ‘waste,’ or dispose of the saline.”
U.S. District Judge Raymond Moore sentenced Ms. Muhs to 3 months of probation as a result of “the defendant’s confession and her cooperation in disclosing full information on her diversion, which is a matter potentially affecting the public health and the integrity of the health care system. The felony offense is punishable by up to four years of imprisonment and a fine of $250,000, per count.”
In pleading guilty to the single count in the case, Ms. Muhs admitted that on September 8, 2019, “she removed a bag of fentanyl from the automated medication control machine at the hospital under a different nurse’s login credentials. She then removed fentanyl from the IV bag for personal use.”
In April, the Colorado Court of Appeals denied her request for unemployment benefits. Court documents reveal that Ms. Muhs lost her job at St. Anthony Hospital after it was discovered that she stole and self-injected fentanyl while working as a registered nurse there.
The investigations in these cases were conducted by the U.S. Food and Drug Administration, the Office of Criminal Investigations, and the Drug Enforcement Administration (DEA).
“We want it to be known that healthcare professionals who take advantage of patients in need by stealing their medications will be held accountable to the law,” said Deanne Reuter, DEA Denver Field Division special agent in charge.
A version of this article first appeared on Medscape.com.