MDedge Pediatrics

Children who have greater acute appendicitis pain may be less likely to improve if they’re treated with antibiotics alone, according to a secondary analysis of a nonrandomized clinical trial.

“While approximately 35% of families chose nonoperative management, a high pain score between 7-10 on a 10-point scale nearly doubled in-hospital treatment failure,” Rebecca M. Rentea, MD, a pediatric surgeon and the director of the Comprehensive Colorectal Center at Children’s Mercy Kansas City, Mo., told this news organization in an email.

“Even if nonoperative management of pediatric appendicitis did not work – resulting in the need to remove the appendix in 34% of cases – families were happy with their decisions 1 year later,” added Dr. Rentea, who coauthored an invited commentary about the study.

Lead study author Peter C. Minneci, MD, MHSc, a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, and colleagues analyzed a subgroup of patients from a larger study in 10 tertiary children’s hospitals in the Midwest Pediatric Surgery Consortium.

As they reported in JAMA Network Open, the larger prospective, nonrandomized clinical trial enrolled 1,068 children between 2015 and 2018. The children ranged in age from 7 to 17 years, and they had imaging-confirmed appendicitis with an appendix diameter of 1.1 cm or less, no abscess, no appendicolith, and no phlegmon. White blood cell count was between 5,000 and 18,000 cells/μL, and abdominal pain began less than 48 hours before they received antibiotic therapy.

Caregivers chose either surgery or nonoperative antibiotic management. Patients who were treated first with antibiotics alone and who did not undergo appendectomy within 1 year were considered to have successfully completed nonoperative treatment.

The secondary analysis included the 370 children enrolled in the nonoperative group. Of these, 229 were boys, and the median age was 12.3 years. In this subgroup, the researchers compared outcomes after nonoperative, antibiotic management vs. surgery.

At 1 year, treatment failure had occurred in 125 patients, with 53 having undergone appendectomy during their first hospitalization, and 72 having experienced delayed treatment failure after being discharged.

• Higher patient-reported pain at presentation was linked to higher risk for in-hospital treatment failure (relative risk, 2.1; 95% confidence interval, 1.0-4.4) but not for delayed treatment failure (RR, 1.3; 95% CI, 0.7-2.3) or overall treatment failure at 1 year (RR, 1.5; 95% CI, 1.0-2.2).
• Pain lasting longer than 24 hours was linked to lower risk for delayed treatment failure (RR, 0.3; 95% CI, 0.1-1.0) but not for in-hospital treatment failure (RR, 1.2; 95% CI, 0.5-2.7) or treatment failure at 1 year (RR, 0.7; 95% CI, 0.4-1.2).
• Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs. 27.0; difference, 1.0; 95% CI, 0.01-2.0) and at 1 year (28.1 vs 27.0; difference, 1.1; 95% CI, 0.2-2.0).

The researchers found no increased risk for treatment failure based on age, sex, race, ethnicity, white blood cell count, primary language, insurance status, transfer status, presentation symptoms, or imaging results.

Antibiotics-only is a safe option for children

“This study suggests that pediatric patients with uncomplicated acute appendicitis should be offered treatment options, including nonoperative management,” the authors write. “Treatment with antibiotics alone is a safe and equitable option for children, with no increased risk of treatment failure based on sociodemographic or objective clinical characteristics at presentation.”

But, the authors advise: “Families need to be made aware that treatment failure is not uncommon, and they should be provided with anticipatory guidance on how to proceed should symptoms recur.”

The investigators acknowledged limitations to the study, including the nonrandomized design that may have introduced bias, the loss to follow-up, and the study population being U.S. Midwest children, who may differ from children elsewhere in the country.

Shawn D. St Peter, MD, a pediatric surgeon, medical chair, and a senior vice president at Children’s Mercy Kansas City told this news organization in an email that having a nonoperative alternative to surgical appendectomy is important.

“Antibiotics are the initial treatment for appendicitis and can be the definitive treatment,” he said.

“Surprisingly, no sociodemographic or clinical characteristics were associated with an increased risk of nonoperative appendicitis treatment failure,” added Dr. St Peter, who coauthored the commentary with Dr. Rentea.

Howard C. Jen, MD, a pediatric surgeon at University of California, Los Angeles, Mattel Children’s Hospital, was not surprised by the findings.

“Nonoperative management for acute noncomplicated appendicitis in children continues to be safe and effective in highly selected patients,” he said in an email. “This alternative to surgery should be offered routinely to patients with early acute appendicitis.” 

Dr. Jen, who was not involved with the current study, noted that it did not address the impact and costs to families of nonoperative management vs. surgery.

“For the most vulnerable children who had difficulties accessing medical care, what is the best treatment option? What factors are important to the families when making this decision?” he asked.

All study and editorial authors report no relevant financial relationships. The study was funded by the Patient-Centered Outcomes Research Institute and the National Center for Advancing Translational Sciences.

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

Children who have greater acute appendicitis pain may be less likely to improve if they’re treated with antibiotics alone, according to a secondary analysis of a nonrandomized clinical trial.

“While approximately 35% of families chose nonoperative management, a high pain score between 7-10 on a 10-point scale nearly doubled in-hospital treatment failure,” Rebecca M. Rentea, MD, a pediatric surgeon and the director of the Comprehensive Colorectal Center at Children’s Mercy Kansas City, Mo., told this news organization in an email.

“Even if nonoperative management of pediatric appendicitis did not work – resulting in the need to remove the appendix in 34% of cases – families were happy with their decisions 1 year later,” added Dr. Rentea, who coauthored an invited commentary about the study.

Lead study author Peter C. Minneci, MD, MHSc, a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, and colleagues analyzed a subgroup of patients from a larger study in 10 tertiary children’s hospitals in the Midwest Pediatric Surgery Consortium.

As they reported in JAMA Network Open, the larger prospective, nonrandomized clinical trial enrolled 1,068 children between 2015 and 2018. The children ranged in age from 7 to 17 years, and they had imaging-confirmed appendicitis with an appendix diameter of 1.1 cm or less, no abscess, no appendicolith, and no phlegmon. White blood cell count was between 5,000 and 18,000 cells/μL, and abdominal pain began less than 48 hours before they received antibiotic therapy.

Caregivers chose either surgery or nonoperative antibiotic management. Patients who were treated first with antibiotics alone and who did not undergo appendectomy within 1 year were considered to have successfully completed nonoperative treatment.

The secondary analysis included the 370 children enrolled in the nonoperative group. Of these, 229 were boys, and the median age was 12.3 years. In this subgroup, the researchers compared outcomes after nonoperative, antibiotic management vs. surgery.

At 1 year, treatment failure had occurred in 125 patients, with 53 having undergone appendectomy during their first hospitalization, and 72 having experienced delayed treatment failure after being discharged.

• Higher patient-reported pain at presentation was linked to higher risk for in-hospital treatment failure (relative risk, 2.1; 95% confidence interval, 1.0-4.4) but not for delayed treatment failure (RR, 1.3; 95% CI, 0.7-2.3) or overall treatment failure at 1 year (RR, 1.5; 95% CI, 1.0-2.2).
• Pain lasting longer than 24 hours was linked to lower risk for delayed treatment failure (RR, 0.3; 95% CI, 0.1-1.0) but not for in-hospital treatment failure (RR, 1.2; 95% CI, 0.5-2.7) or treatment failure at 1 year (RR, 0.7; 95% CI, 0.4-1.2).
• Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs. 27.0; difference, 1.0; 95% CI, 0.01-2.0) and at 1 year (28.1 vs 27.0; difference, 1.1; 95% CI, 0.2-2.0).

The researchers found no increased risk for treatment failure based on age, sex, race, ethnicity, white blood cell count, primary language, insurance status, transfer status, presentation symptoms, or imaging results.

Antibiotics-only is a safe option for children

“This study suggests that pediatric patients with uncomplicated acute appendicitis should be offered treatment options, including nonoperative management,” the authors write. “Treatment with antibiotics alone is a safe and equitable option for children, with no increased risk of treatment failure based on sociodemographic or objective clinical characteristics at presentation.”

But, the authors advise: “Families need to be made aware that treatment failure is not uncommon, and they should be provided with anticipatory guidance on how to proceed should symptoms recur.”

The investigators acknowledged limitations to the study, including the nonrandomized design that may have introduced bias, the loss to follow-up, and the study population being U.S. Midwest children, who may differ from children elsewhere in the country.

Shawn D. St Peter, MD, a pediatric surgeon, medical chair, and a senior vice president at Children’s Mercy Kansas City told this news organization in an email that having a nonoperative alternative to surgical appendectomy is important.

“Antibiotics are the initial treatment for appendicitis and can be the definitive treatment,” he said.

“Surprisingly, no sociodemographic or clinical characteristics were associated with an increased risk of nonoperative appendicitis treatment failure,” added Dr. St Peter, who coauthored the commentary with Dr. Rentea.

Howard C. Jen, MD, a pediatric surgeon at University of California, Los Angeles, Mattel Children’s Hospital, was not surprised by the findings.

“Nonoperative management for acute noncomplicated appendicitis in children continues to be safe and effective in highly selected patients,” he said in an email. “This alternative to surgery should be offered routinely to patients with early acute appendicitis.” 

Dr. Jen, who was not involved with the current study, noted that it did not address the impact and costs to families of nonoperative management vs. surgery.

“For the most vulnerable children who had difficulties accessing medical care, what is the best treatment option? What factors are important to the families when making this decision?” he asked.

All study and editorial authors report no relevant financial relationships. The study was funded by the Patient-Centered Outcomes Research Institute and the National Center for Advancing Translational Sciences.

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

Children who have greater acute appendicitis pain may be less likely to improve if they’re treated with antibiotics alone, according to a secondary analysis of a nonrandomized clinical trial.

“While approximately 35% of families chose nonoperative management, a high pain score between 7-10 on a 10-point scale nearly doubled in-hospital treatment failure,” Rebecca M. Rentea, MD, a pediatric surgeon and the director of the Comprehensive Colorectal Center at Children’s Mercy Kansas City, Mo., told this news organization in an email.

“Even if nonoperative management of pediatric appendicitis did not work – resulting in the need to remove the appendix in 34% of cases – families were happy with their decisions 1 year later,” added Dr. Rentea, who coauthored an invited commentary about the study.

Lead study author Peter C. Minneci, MD, MHSc, a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, and colleagues analyzed a subgroup of patients from a larger study in 10 tertiary children’s hospitals in the Midwest Pediatric Surgery Consortium.

As they reported in JAMA Network Open, the larger prospective, nonrandomized clinical trial enrolled 1,068 children between 2015 and 2018. The children ranged in age from 7 to 17 years, and they had imaging-confirmed appendicitis with an appendix diameter of 1.1 cm or less, no abscess, no appendicolith, and no phlegmon. White blood cell count was between 5,000 and 18,000 cells/μL, and abdominal pain began less than 48 hours before they received antibiotic therapy.

Caregivers chose either surgery or nonoperative antibiotic management. Patients who were treated first with antibiotics alone and who did not undergo appendectomy within 1 year were considered to have successfully completed nonoperative treatment.

The secondary analysis included the 370 children enrolled in the nonoperative group. Of these, 229 were boys, and the median age was 12.3 years. In this subgroup, the researchers compared outcomes after nonoperative, antibiotic management vs. surgery.

At 1 year, treatment failure had occurred in 125 patients, with 53 having undergone appendectomy during their first hospitalization, and 72 having experienced delayed treatment failure after being discharged.

• Higher patient-reported pain at presentation was linked to higher risk for in-hospital treatment failure (relative risk, 2.1; 95% confidence interval, 1.0-4.4) but not for delayed treatment failure (RR, 1.3; 95% CI, 0.7-2.3) or overall treatment failure at 1 year (RR, 1.5; 95% CI, 1.0-2.2).
• Pain lasting longer than 24 hours was linked to lower risk for delayed treatment failure (RR, 0.3; 95% CI, 0.1-1.0) but not for in-hospital treatment failure (RR, 1.2; 95% CI, 0.5-2.7) or treatment failure at 1 year (RR, 0.7; 95% CI, 0.4-1.2).
• Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs. 27.0; difference, 1.0; 95% CI, 0.01-2.0) and at 1 year (28.1 vs 27.0; difference, 1.1; 95% CI, 0.2-2.0).

The researchers found no increased risk for treatment failure based on age, sex, race, ethnicity, white blood cell count, primary language, insurance status, transfer status, presentation symptoms, or imaging results.

Antibiotics-only is a safe option for children

“This study suggests that pediatric patients with uncomplicated acute appendicitis should be offered treatment options, including nonoperative management,” the authors write. “Treatment with antibiotics alone is a safe and equitable option for children, with no increased risk of treatment failure based on sociodemographic or objective clinical characteristics at presentation.”

But, the authors advise: “Families need to be made aware that treatment failure is not uncommon, and they should be provided with anticipatory guidance on how to proceed should symptoms recur.”

The investigators acknowledged limitations to the study, including the nonrandomized design that may have introduced bias, the loss to follow-up, and the study population being U.S. Midwest children, who may differ from children elsewhere in the country.

Shawn D. St Peter, MD, a pediatric surgeon, medical chair, and a senior vice president at Children’s Mercy Kansas City told this news organization in an email that having a nonoperative alternative to surgical appendectomy is important.

“Antibiotics are the initial treatment for appendicitis and can be the definitive treatment,” he said.

“Surprisingly, no sociodemographic or clinical characteristics were associated with an increased risk of nonoperative appendicitis treatment failure,” added Dr. St Peter, who coauthored the commentary with Dr. Rentea.

Howard C. Jen, MD, a pediatric surgeon at University of California, Los Angeles, Mattel Children’s Hospital, was not surprised by the findings.

“Nonoperative management for acute noncomplicated appendicitis in children continues to be safe and effective in highly selected patients,” he said in an email. “This alternative to surgery should be offered routinely to patients with early acute appendicitis.” 

Dr. Jen, who was not involved with the current study, noted that it did not address the impact and costs to families of nonoperative management vs. surgery.

“For the most vulnerable children who had difficulties accessing medical care, what is the best treatment option? What factors are important to the families when making this decision?” he asked.

All study and editorial authors report no relevant financial relationships. The study was funded by the Patient-Centered Outcomes Research Institute and the National Center for Advancing Translational Sciences.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

This is a transcript of a video that first appeared on Medscape.com. It has been edited for clarity.

On April 21, 2022, the Centers for Disease Control and Prevention released a Health Alert Network advisory regarding a cluster of nine cases of acute hepatitis in children in Alabama over a 5-month period from October 2021 to February 2022 – a rate substantially higher than what would be expected, given the relative rarity of hepatitis in children.

Standard workup was negative for the common causative agents – hepatitis A, B, and C – and no toxic exposures were identified. But there was one common thread among all these kids: They all tested positive for adenovirus.

And that is really strange.

There are about 100 circulating adenoviruses in the world that we know of, and around 50 of them infect humans. If you are an adult, it’s a virtual certainty that you have been infected with an adenovirus in the past. Most strains cause symptoms we would describe as the common cold: runny nose, sore throat. Some strains cause conjunctivitis (pink eye). Some cause gastrointestinal illness – the stomach bugs that kids get.

It’s the banality of adenovirus that makes this hepatitis finding so surprising.

The United States is not alone in reporting this new hepatitis syndrome. As of April 21, 169 cases have been reported across the world, including 114 in the United Kingdom.

Of the 169 cases reported worldwide, 74 had evidence of adenovirus infection. On molecular testing, 18 of those were adenovirus 41.

What I wanted to do today was go through the various hypotheses for what could be going on with these hepatitis cases, one by one, and highlight the evidence supporting them. We won’t reach a conclusion, but hopefully by the end, the path forward will be more clear. OK, let’s get started.

Hypothesis 1: Nothing is happening.

It’s worth noting that “clusters” of disease occur all the time, even when no relevant epidemiologic process has occurred. If there is some baseline rate of hepatitis, every once in a while, through bad luck alone, you’d see a group of cases all at once. This is known as the clustering illusion. And I’m quite confident in saying that this is not the case here.

For one, this phenomenon is worldwide, as we know from the World Health Organization report. In fact, the CDC didn’t provide the most detailed data about the nine (now 12) cases in the United States. This study from Scotland is the first to give a detailed accounting of cases, reporting on 13 cases of acute hepatitis of unknown cause in kids at a single hospital from January to April. Typically, the hospital sees fewer than four cases of hepatitis per year. Five of these 13 kids tested positive for adenovirus. So let’s take the clustering illusion off the list.

Hypothesis 2: It’s adenovirus.

The major evidence supporting adenovirus as the causative agent here is that a lot of these kids had adenovirus, and adenovirus 41 – a gut-tropic strain – in particular. This is important, because stool testing might be necessary for diagnosis and lots of kids with this condition didn’t get that. In other words, we have hard evidence of adenovirus infection in about 40% of the cases so far, but the true number might be substantially higher.

That said, adenovirus is seasonal, and we are in adenovirus season. Granted, 40% seems quite a bit higher than the background infection rate, but we have to be careful not to assume that correlation means causation.

The evidence against adenovirus, even adenovirus 41, is that this acute hepatitis syndrome is new, and adenovirus 41 is not. To be fair, we know adenoviruses can cause acute hepatitis, but the vast majority of reports are in immunocompromised individuals – organ transplant recipients and those with HIV. I was able to find just a handful of cases of immunocompetent kids developing hepatitis from adenovirus prior to this current outbreak.

The current outbreak would exceed the published literature by nearly two orders of magnitude. It feels like something else has to be going on.

Hypothesis 3: It’s coronavirus.

SARS-CoV-2 is a strange virus, both in its acute presentation and its long-term outcomes. It was clear early in the pandemic that some children infected by the coronavirus would develop MIS-C – multisystem inflammatory syndrome in children. MIS-C is associated with hepatitis in about 10% of children, according to this New England Journal of Medicine

But the presentation of these kids is quite different from MIS-C; fever is rare, for example. The WHO reports that of the 169 identified cases so far, 20 had active COVID infection. The Scotland cohort suggests that a similar proportion had past COVID infections. In other times, we might consider this a smoking gun, but at this point a history of COVID is not remarkable – after the Omicron wave, it’s about as common to have a history of COVID as it is not to have a history of COVID.

A brief aside here. This is not because of coronavirus vaccination. Of the more than 100 cases reported in the United Kingdom, none of these kids were vaccinated. So let’s put aside the possibility that this is a vaccine effect – there’s no real evidence to support that.

Which brings us to …

Hypothesis 4: It’s coronavirus and adenovirus.

This is sort of intriguing and can work a few different ways, via a direct and indirect path.

In the direct path, we posit that COVID infection does something to kids’ immune systems – something we don’t yet understand that limits their ability to fight off adenovirus. There is some support for this idea. This study in Immunity found that COVID infection can functionally impair dendritic cells and T-cells, including natural killer cells. These cells are important components of our innate antiviral immunity.

There’s an indirect path as well. COVID has led to lockdowns, distancing, masking – stuff that prevents kids from being exposed to germs from other kids. Could a lack of exposure to adenovirus or other viruses because of distancing increase the risk for severe disease when restrictions are lifted? Also possible – the severity of respiratory syncytial virus (RSV) infections this year is substantially higher than what we’ve seen in the past, for example.

And finally, hypothesis 5: This is something new.

We can’t ignore the possibility that this is simply a new disease-causing agent. Toxicology studies so far have been negative, and we wouldn’t expect hepatitis from a chemical toxin to appear in multiple countries around the world; this is almost certainly a biological phenomenon. It is possible that this is a new strain of adenovirus 41, or that adenovirus is a red herring altogether. Remember, we knew about “non-A/non-B viral hepatitis” for more than 2 decades before hepatitis C was discovered.

The pace of science is faster now, fortunately, and information is coming out quickly. As we learn more, we’ll share it with you.

Dr. Wilson, MD, MSCE, is an associate professor of medicine at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com. Dr. Wilson has disclosed no relevant financial relationships.

 

This is a transcript of a video that first appeared on Medscape.com. It has been edited for clarity.

On April 21, 2022, the Centers for Disease Control and Prevention released a Health Alert Network advisory regarding a cluster of nine cases of acute hepatitis in children in Alabama over a 5-month period from October 2021 to February 2022 – a rate substantially higher than what would be expected, given the relative rarity of hepatitis in children.

Standard workup was negative for the common causative agents – hepatitis A, B, and C – and no toxic exposures were identified. But there was one common thread among all these kids: They all tested positive for adenovirus.

And that is really strange.

There are about 100 circulating adenoviruses in the world that we know of, and around 50 of them infect humans. If you are an adult, it’s a virtual certainty that you have been infected with an adenovirus in the past. Most strains cause symptoms we would describe as the common cold: runny nose, sore throat. Some strains cause conjunctivitis (pink eye). Some cause gastrointestinal illness – the stomach bugs that kids get.

It’s the banality of adenovirus that makes this hepatitis finding so surprising.

The United States is not alone in reporting this new hepatitis syndrome. As of April 21, 169 cases have been reported across the world, including 114 in the United Kingdom.

Of the 169 cases reported worldwide, 74 had evidence of adenovirus infection. On molecular testing, 18 of those were adenovirus 41.

What I wanted to do today was go through the various hypotheses for what could be going on with these hepatitis cases, one by one, and highlight the evidence supporting them. We won’t reach a conclusion, but hopefully by the end, the path forward will be more clear. OK, let’s get started.

Hypothesis 1: Nothing is happening.

It’s worth noting that “clusters” of disease occur all the time, even when no relevant epidemiologic process has occurred. If there is some baseline rate of hepatitis, every once in a while, through bad luck alone, you’d see a group of cases all at once. This is known as the clustering illusion. And I’m quite confident in saying that this is not the case here.

For one, this phenomenon is worldwide, as we know from the World Health Organization report. In fact, the CDC didn’t provide the most detailed data about the nine (now 12) cases in the United States. This study from Scotland is the first to give a detailed accounting of cases, reporting on 13 cases of acute hepatitis of unknown cause in kids at a single hospital from January to April. Typically, the hospital sees fewer than four cases of hepatitis per year. Five of these 13 kids tested positive for adenovirus. So let’s take the clustering illusion off the list.

Hypothesis 2: It’s adenovirus.

The major evidence supporting adenovirus as the causative agent here is that a lot of these kids had adenovirus, and adenovirus 41 – a gut-tropic strain – in particular. This is important, because stool testing might be necessary for diagnosis and lots of kids with this condition didn’t get that. In other words, we have hard evidence of adenovirus infection in about 40% of the cases so far, but the true number might be substantially higher.

That said, adenovirus is seasonal, and we are in adenovirus season. Granted, 40% seems quite a bit higher than the background infection rate, but we have to be careful not to assume that correlation means causation.

The evidence against adenovirus, even adenovirus 41, is that this acute hepatitis syndrome is new, and adenovirus 41 is not. To be fair, we know adenoviruses can cause acute hepatitis, but the vast majority of reports are in immunocompromised individuals – organ transplant recipients and those with HIV. I was able to find just a handful of cases of immunocompetent kids developing hepatitis from adenovirus prior to this current outbreak.

The current outbreak would exceed the published literature by nearly two orders of magnitude. It feels like something else has to be going on.

Hypothesis 3: It’s coronavirus.

SARS-CoV-2 is a strange virus, both in its acute presentation and its long-term outcomes. It was clear early in the pandemic that some children infected by the coronavirus would develop MIS-C – multisystem inflammatory syndrome in children. MIS-C is associated with hepatitis in about 10% of children, according to this New England Journal of Medicine

But the presentation of these kids is quite different from MIS-C; fever is rare, for example. The WHO reports that of the 169 identified cases so far, 20 had active COVID infection. The Scotland cohort suggests that a similar proportion had past COVID infections. In other times, we might consider this a smoking gun, but at this point a history of COVID is not remarkable – after the Omicron wave, it’s about as common to have a history of COVID as it is not to have a history of COVID.

A brief aside here. This is not because of coronavirus vaccination. Of the more than 100 cases reported in the United Kingdom, none of these kids were vaccinated. So let’s put aside the possibility that this is a vaccine effect – there’s no real evidence to support that.

Which brings us to …

Hypothesis 4: It’s coronavirus and adenovirus.

This is sort of intriguing and can work a few different ways, via a direct and indirect path.

In the direct path, we posit that COVID infection does something to kids’ immune systems – something we don’t yet understand that limits their ability to fight off adenovirus. There is some support for this idea. This study in Immunity found that COVID infection can functionally impair dendritic cells and T-cells, including natural killer cells. These cells are important components of our innate antiviral immunity.

There’s an indirect path as well. COVID has led to lockdowns, distancing, masking – stuff that prevents kids from being exposed to germs from other kids. Could a lack of exposure to adenovirus or other viruses because of distancing increase the risk for severe disease when restrictions are lifted? Also possible – the severity of respiratory syncytial virus (RSV) infections this year is substantially higher than what we’ve seen in the past, for example.

And finally, hypothesis 5: This is something new.

We can’t ignore the possibility that this is simply a new disease-causing agent. Toxicology studies so far have been negative, and we wouldn’t expect hepatitis from a chemical toxin to appear in multiple countries around the world; this is almost certainly a biological phenomenon. It is possible that this is a new strain of adenovirus 41, or that adenovirus is a red herring altogether. Remember, we knew about “non-A/non-B viral hepatitis” for more than 2 decades before hepatitis C was discovered.

The pace of science is faster now, fortunately, and information is coming out quickly. As we learn more, we’ll share it with you.

Dr. Wilson, MD, MSCE, is an associate professor of medicine at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com. Dr. Wilson has disclosed no relevant financial relationships.

 

This is a transcript of a video that first appeared on Medscape.com. It has been edited for clarity.

On April 21, 2022, the Centers for Disease Control and Prevention released a Health Alert Network advisory regarding a cluster of nine cases of acute hepatitis in children in Alabama over a 5-month period from October 2021 to February 2022 – a rate substantially higher than what would be expected, given the relative rarity of hepatitis in children.

Standard workup was negative for the common causative agents – hepatitis A, B, and C – and no toxic exposures were identified. But there was one common thread among all these kids: They all tested positive for adenovirus.

And that is really strange.

There are about 100 circulating adenoviruses in the world that we know of, and around 50 of them infect humans. If you are an adult, it’s a virtual certainty that you have been infected with an adenovirus in the past. Most strains cause symptoms we would describe as the common cold: runny nose, sore throat. Some strains cause conjunctivitis (pink eye). Some cause gastrointestinal illness – the stomach bugs that kids get.

It’s the banality of adenovirus that makes this hepatitis finding so surprising.

The United States is not alone in reporting this new hepatitis syndrome. As of April 21, 169 cases have been reported across the world, including 114 in the United Kingdom.

Of the 169 cases reported worldwide, 74 had evidence of adenovirus infection. On molecular testing, 18 of those were adenovirus 41.

What I wanted to do today was go through the various hypotheses for what could be going on with these hepatitis cases, one by one, and highlight the evidence supporting them. We won’t reach a conclusion, but hopefully by the end, the path forward will be more clear. OK, let’s get started.

Hypothesis 1: Nothing is happening.

It’s worth noting that “clusters” of disease occur all the time, even when no relevant epidemiologic process has occurred. If there is some baseline rate of hepatitis, every once in a while, through bad luck alone, you’d see a group of cases all at once. This is known as the clustering illusion. And I’m quite confident in saying that this is not the case here.

For one, this phenomenon is worldwide, as we know from the World Health Organization report. In fact, the CDC didn’t provide the most detailed data about the nine (now 12) cases in the United States. This study from Scotland is the first to give a detailed accounting of cases, reporting on 13 cases of acute hepatitis of unknown cause in kids at a single hospital from January to April. Typically, the hospital sees fewer than four cases of hepatitis per year. Five of these 13 kids tested positive for adenovirus. So let’s take the clustering illusion off the list.

Hypothesis 2: It’s adenovirus.

The major evidence supporting adenovirus as the causative agent here is that a lot of these kids had adenovirus, and adenovirus 41 – a gut-tropic strain – in particular. This is important, because stool testing might be necessary for diagnosis and lots of kids with this condition didn’t get that. In other words, we have hard evidence of adenovirus infection in about 40% of the cases so far, but the true number might be substantially higher.

That said, adenovirus is seasonal, and we are in adenovirus season. Granted, 40% seems quite a bit higher than the background infection rate, but we have to be careful not to assume that correlation means causation.

The evidence against adenovirus, even adenovirus 41, is that this acute hepatitis syndrome is new, and adenovirus 41 is not. To be fair, we know adenoviruses can cause acute hepatitis, but the vast majority of reports are in immunocompromised individuals – organ transplant recipients and those with HIV. I was able to find just a handful of cases of immunocompetent kids developing hepatitis from adenovirus prior to this current outbreak.

The current outbreak would exceed the published literature by nearly two orders of magnitude. It feels like something else has to be going on.

Hypothesis 3: It’s coronavirus.

SARS-CoV-2 is a strange virus, both in its acute presentation and its long-term outcomes. It was clear early in the pandemic that some children infected by the coronavirus would develop MIS-C – multisystem inflammatory syndrome in children. MIS-C is associated with hepatitis in about 10% of children, according to this New England Journal of Medicine

But the presentation of these kids is quite different from MIS-C; fever is rare, for example. The WHO reports that of the 169 identified cases so far, 20 had active COVID infection. The Scotland cohort suggests that a similar proportion had past COVID infections. In other times, we might consider this a smoking gun, but at this point a history of COVID is not remarkable – after the Omicron wave, it’s about as common to have a history of COVID as it is not to have a history of COVID.

A brief aside here. This is not because of coronavirus vaccination. Of the more than 100 cases reported in the United Kingdom, none of these kids were vaccinated. So let’s put aside the possibility that this is a vaccine effect – there’s no real evidence to support that.

Which brings us to …

Hypothesis 4: It’s coronavirus and adenovirus.

This is sort of intriguing and can work a few different ways, via a direct and indirect path.

In the direct path, we posit that COVID infection does something to kids’ immune systems – something we don’t yet understand that limits their ability to fight off adenovirus. There is some support for this idea. This study in Immunity found that COVID infection can functionally impair dendritic cells and T-cells, including natural killer cells. These cells are important components of our innate antiviral immunity.

There’s an indirect path as well. COVID has led to lockdowns, distancing, masking – stuff that prevents kids from being exposed to germs from other kids. Could a lack of exposure to adenovirus or other viruses because of distancing increase the risk for severe disease when restrictions are lifted? Also possible – the severity of respiratory syncytial virus (RSV) infections this year is substantially higher than what we’ve seen in the past, for example.

And finally, hypothesis 5: This is something new.

We can’t ignore the possibility that this is simply a new disease-causing agent. Toxicology studies so far have been negative, and we wouldn’t expect hepatitis from a chemical toxin to appear in multiple countries around the world; this is almost certainly a biological phenomenon. It is possible that this is a new strain of adenovirus 41, or that adenovirus is a red herring altogether. Remember, we knew about “non-A/non-B viral hepatitis” for more than 2 decades before hepatitis C was discovered.

The pace of science is faster now, fortunately, and information is coming out quickly. As we learn more, we’ll share it with you.

Dr. Wilson, MD, MSCE, is an associate professor of medicine at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com. Dr. Wilson has disclosed no relevant financial relationships.

 

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

Approximately 7% of youth who chose gender identity social transition in early childhood had retransitioned 5 years later, based on data from 317 individuals.

“Increasing numbers of children are socially transitioning to live in line with their gender identity, rather than the gender assumed by their sex at birth – a process that typically involves changing a child’s pronouns, first name, hairstyle, and clothing,” wrote Kristina R. Olson, PhD, of Princeton (N.J.) University, and colleagues.

The question of whether early childhood social transitions will result in high rates of retransition continues to be a subject for debate, and long-term data on retransition rates and identity outcomes in children who transition are limited, they said.

To examine retransition in early-transitioning children, the researchers identified 317 binary socially transitioned transgender children to participate in a longitudinal study known as the Trans Youth Project (TYP) between July 2013 and December 2017. The study was published in Pediatrics. The mean age at baseline was 8 years. At study entry, participants had to have made a complete binary social transition, including changing their pronouns from those used at birth. During the 5-year follow-up period, children and parents were asked about use of puberty blockers and/or gender-affirming hormones. At study entry, 37 children had begun some type of puberty blockers. A total of 124 children initially socially transitioned before 6 years of age, and 193 initially socially transitioned at 6 years or older.

The study did not evaluate whether the participants met the DSM-5 criteria for gender dysphoria in childhood, the researchers noted. “Based on data collected at their initial visit, we do know that these participants showed signs of gender identification and gender-typed preferences commonly associated with their gender, not their sex assigned at birth,” they wrote.

Participants were classified as binary transgender, nonbinary, or cisgender based on their pronouns at follow-up. Binary transgender pronouns were associated with the other binary assigned sex, nonbinary pronouns were they/them or a mix of they/them and binary pronouns, and cisgender pronouns were those associated with assigned sex.

Overall, 7.3% of the participants had retransitioned at least once by 5 years after their initial binary social transition. The majority (94%) were living as binary transgender youth, including 1.3% who retransitioned to cisgender or nonbinary and then back to binary transgender during the follow-up period. A total of 2.5% were living as cisgender youth and 3.5% were living as nonbinary youth. These rates were similar across the initial population, as well as the 291 participants who continue to be in contact with the researchers, the 200 who had gone at least 5 years since their initial social transition, and the 280 participants who began the study before starting puberty blockers.

The researchers found no differences in retransition rates related to participant sex at birth. Rates of retransition were slightly higher among participants who made their initial social transition before 6 years of age, but these rates were low, the researchers noted.

The study findings were limited by several factors including the use of a volunteer community sample, with the potential for bias that may not generalize to the population at large, the researchers noted. Other limitations included the use of pronouns as the main criteria for retransition, and the classification of a change from binary transgender to nonbinary as a transition, they said. “Many nonbinary people consider themselves to be transgender,” they noted.

“If we had used a stricter criterion of retransition, more similar to the common use of terms like “detransition” or “desistence,” referring only to youth who are living as cisgender, then our retransition rate would have been lower (2.5%),” the researchers explained. Another limitation was the disproportionate number of trans girls, the researchers said. However, because no significant gender effect appeared in terms of retransition rates, “we do not predict any change in pattern of results if we had a different ratio of participants by sex at birth,” they said.

The researchers stated that they intend to follow the cohort through adolescence and into adulthood.

“As more youth are coming out and being supported in their transitions early in development, it is increasingly critical that clinicians understand the experiences of this cohort and not make assumptions about them as a function of older data from youth who lived under different circumstances,” the researchers emphasized. “Though we can never predict the exact gender trajectory of any child, these data suggest that many youth who identify as transgender early, and are supported through a social transition, will continue to identify as transgender 5 years after initial social transition.” They concluded that more research is needed to determine how best to support initial and later gender transitions in youth.
 

Study offers support for family discussions

“This study is important to help provide more data regarding the experiences of gender-diverse youth,” M. Brett Cooper, MD, of UT Southwestern Medical Center, Dallas, said in an interview. “The results of a study like this can be used by clinicians to help provide advice and guidance to parents and families as they support their children through their gender journey,” said Dr. Cooper, who was not involved in the study. The current study “also provides evidence to support that persistent, insistent, and consistent youth have an extremely low rate of retransition to a gender that aligns with their sex assigned at birth. This refutes suggestions by politicians and others that those who seek medical care have a high rate of regret or retransition,” Dr. Cooper emphasized.

“I was not surprised at all by their findings,” said Dr. Cooper. “These are very similar to what I have seen in my own panel of gender-diverse patients and what has been seen in other studies,” he noted.

The take-home message of the current study does not suggest any change in clinical practice, Dr. Cooper said. “Guidance already suggests supporting these youth on their gender journey and that for some youth, this may mean retransitioning to identify with their sex assigned at birth,” he explained.

The study was supported in part by grants to the researchers from the National Institutes of Health, the National Science Foundation, the Arcus Foundation, and the MacArthur Foundation. The researchers had no financial conflicts to disclose.

Approximately 7% of youth who chose gender identity social transition in early childhood had retransitioned 5 years later, based on data from 317 individuals.

“Increasing numbers of children are socially transitioning to live in line with their gender identity, rather than the gender assumed by their sex at birth – a process that typically involves changing a child’s pronouns, first name, hairstyle, and clothing,” wrote Kristina R. Olson, PhD, of Princeton (N.J.) University, and colleagues.

The question of whether early childhood social transitions will result in high rates of retransition continues to be a subject for debate, and long-term data on retransition rates and identity outcomes in children who transition are limited, they said.

To examine retransition in early-transitioning children, the researchers identified 317 binary socially transitioned transgender children to participate in a longitudinal study known as the Trans Youth Project (TYP) between July 2013 and December 2017. The study was published in Pediatrics. The mean age at baseline was 8 years. At study entry, participants had to have made a complete binary social transition, including changing their pronouns from those used at birth. During the 5-year follow-up period, children and parents were asked about use of puberty blockers and/or gender-affirming hormones. At study entry, 37 children had begun some type of puberty blockers. A total of 124 children initially socially transitioned before 6 years of age, and 193 initially socially transitioned at 6 years or older.

The study did not evaluate whether the participants met the DSM-5 criteria for gender dysphoria in childhood, the researchers noted. “Based on data collected at their initial visit, we do know that these participants showed signs of gender identification and gender-typed preferences commonly associated with their gender, not their sex assigned at birth,” they wrote.

Participants were classified as binary transgender, nonbinary, or cisgender based on their pronouns at follow-up. Binary transgender pronouns were associated with the other binary assigned sex, nonbinary pronouns were they/them or a mix of they/them and binary pronouns, and cisgender pronouns were those associated with assigned sex.

Overall, 7.3% of the participants had retransitioned at least once by 5 years after their initial binary social transition. The majority (94%) were living as binary transgender youth, including 1.3% who retransitioned to cisgender or nonbinary and then back to binary transgender during the follow-up period. A total of 2.5% were living as cisgender youth and 3.5% were living as nonbinary youth. These rates were similar across the initial population, as well as the 291 participants who continue to be in contact with the researchers, the 200 who had gone at least 5 years since their initial social transition, and the 280 participants who began the study before starting puberty blockers.

The researchers found no differences in retransition rates related to participant sex at birth. Rates of retransition were slightly higher among participants who made their initial social transition before 6 years of age, but these rates were low, the researchers noted.

The study findings were limited by several factors including the use of a volunteer community sample, with the potential for bias that may not generalize to the population at large, the researchers noted. Other limitations included the use of pronouns as the main criteria for retransition, and the classification of a change from binary transgender to nonbinary as a transition, they said. “Many nonbinary people consider themselves to be transgender,” they noted.

“If we had used a stricter criterion of retransition, more similar to the common use of terms like “detransition” or “desistence,” referring only to youth who are living as cisgender, then our retransition rate would have been lower (2.5%),” the researchers explained. Another limitation was the disproportionate number of trans girls, the researchers said. However, because no significant gender effect appeared in terms of retransition rates, “we do not predict any change in pattern of results if we had a different ratio of participants by sex at birth,” they said.

The researchers stated that they intend to follow the cohort through adolescence and into adulthood.

“As more youth are coming out and being supported in their transitions early in development, it is increasingly critical that clinicians understand the experiences of this cohort and not make assumptions about them as a function of older data from youth who lived under different circumstances,” the researchers emphasized. “Though we can never predict the exact gender trajectory of any child, these data suggest that many youth who identify as transgender early, and are supported through a social transition, will continue to identify as transgender 5 years after initial social transition.” They concluded that more research is needed to determine how best to support initial and later gender transitions in youth.
 

Study offers support for family discussions

“This study is important to help provide more data regarding the experiences of gender-diverse youth,” M. Brett Cooper, MD, of UT Southwestern Medical Center, Dallas, said in an interview. “The results of a study like this can be used by clinicians to help provide advice and guidance to parents and families as they support their children through their gender journey,” said Dr. Cooper, who was not involved in the study. The current study “also provides evidence to support that persistent, insistent, and consistent youth have an extremely low rate of retransition to a gender that aligns with their sex assigned at birth. This refutes suggestions by politicians and others that those who seek medical care have a high rate of regret or retransition,” Dr. Cooper emphasized.

“I was not surprised at all by their findings,” said Dr. Cooper. “These are very similar to what I have seen in my own panel of gender-diverse patients and what has been seen in other studies,” he noted.

The take-home message of the current study does not suggest any change in clinical practice, Dr. Cooper said. “Guidance already suggests supporting these youth on their gender journey and that for some youth, this may mean retransitioning to identify with their sex assigned at birth,” he explained.

The study was supported in part by grants to the researchers from the National Institutes of Health, the National Science Foundation, the Arcus Foundation, and the MacArthur Foundation. The researchers had no financial conflicts to disclose.

Approximately 7% of youth who chose gender identity social transition in early childhood had retransitioned 5 years later, based on data from 317 individuals.

“Increasing numbers of children are socially transitioning to live in line with their gender identity, rather than the gender assumed by their sex at birth – a process that typically involves changing a child’s pronouns, first name, hairstyle, and clothing,” wrote Kristina R. Olson, PhD, of Princeton (N.J.) University, and colleagues.

The question of whether early childhood social transitions will result in high rates of retransition continues to be a subject for debate, and long-term data on retransition rates and identity outcomes in children who transition are limited, they said.

To examine retransition in early-transitioning children, the researchers identified 317 binary socially transitioned transgender children to participate in a longitudinal study known as the Trans Youth Project (TYP) between July 2013 and December 2017. The study was published in Pediatrics. The mean age at baseline was 8 years. At study entry, participants had to have made a complete binary social transition, including changing their pronouns from those used at birth. During the 5-year follow-up period, children and parents were asked about use of puberty blockers and/or gender-affirming hormones. At study entry, 37 children had begun some type of puberty blockers. A total of 124 children initially socially transitioned before 6 years of age, and 193 initially socially transitioned at 6 years or older.

The study did not evaluate whether the participants met the DSM-5 criteria for gender dysphoria in childhood, the researchers noted. “Based on data collected at their initial visit, we do know that these participants showed signs of gender identification and gender-typed preferences commonly associated with their gender, not their sex assigned at birth,” they wrote.

Participants were classified as binary transgender, nonbinary, or cisgender based on their pronouns at follow-up. Binary transgender pronouns were associated with the other binary assigned sex, nonbinary pronouns were they/them or a mix of they/them and binary pronouns, and cisgender pronouns were those associated with assigned sex.

Overall, 7.3% of the participants had retransitioned at least once by 5 years after their initial binary social transition. The majority (94%) were living as binary transgender youth, including 1.3% who retransitioned to cisgender or nonbinary and then back to binary transgender during the follow-up period. A total of 2.5% were living as cisgender youth and 3.5% were living as nonbinary youth. These rates were similar across the initial population, as well as the 291 participants who continue to be in contact with the researchers, the 200 who had gone at least 5 years since their initial social transition, and the 280 participants who began the study before starting puberty blockers.

The researchers found no differences in retransition rates related to participant sex at birth. Rates of retransition were slightly higher among participants who made their initial social transition before 6 years of age, but these rates were low, the researchers noted.

The study findings were limited by several factors including the use of a volunteer community sample, with the potential for bias that may not generalize to the population at large, the researchers noted. Other limitations included the use of pronouns as the main criteria for retransition, and the classification of a change from binary transgender to nonbinary as a transition, they said. “Many nonbinary people consider themselves to be transgender,” they noted.

“If we had used a stricter criterion of retransition, more similar to the common use of terms like “detransition” or “desistence,” referring only to youth who are living as cisgender, then our retransition rate would have been lower (2.5%),” the researchers explained. Another limitation was the disproportionate number of trans girls, the researchers said. However, because no significant gender effect appeared in terms of retransition rates, “we do not predict any change in pattern of results if we had a different ratio of participants by sex at birth,” they said.

The researchers stated that they intend to follow the cohort through adolescence and into adulthood.

“As more youth are coming out and being supported in their transitions early in development, it is increasingly critical that clinicians understand the experiences of this cohort and not make assumptions about them as a function of older data from youth who lived under different circumstances,” the researchers emphasized. “Though we can never predict the exact gender trajectory of any child, these data suggest that many youth who identify as transgender early, and are supported through a social transition, will continue to identify as transgender 5 years after initial social transition.” They concluded that more research is needed to determine how best to support initial and later gender transitions in youth.
 

Study offers support for family discussions

“This study is important to help provide more data regarding the experiences of gender-diverse youth,” M. Brett Cooper, MD, of UT Southwestern Medical Center, Dallas, said in an interview. “The results of a study like this can be used by clinicians to help provide advice and guidance to parents and families as they support their children through their gender journey,” said Dr. Cooper, who was not involved in the study. The current study “also provides evidence to support that persistent, insistent, and consistent youth have an extremely low rate of retransition to a gender that aligns with their sex assigned at birth. This refutes suggestions by politicians and others that those who seek medical care have a high rate of regret or retransition,” Dr. Cooper emphasized.

“I was not surprised at all by their findings,” said Dr. Cooper. “These are very similar to what I have seen in my own panel of gender-diverse patients and what has been seen in other studies,” he noted.

The take-home message of the current study does not suggest any change in clinical practice, Dr. Cooper said. “Guidance already suggests supporting these youth on their gender journey and that for some youth, this may mean retransitioning to identify with their sex assigned at birth,” he explained.

The study was supported in part by grants to the researchers from the National Institutes of Health, the National Science Foundation, the Arcus Foundation, and the MacArthur Foundation. The researchers had no financial conflicts to disclose.

Functional abdominal pain in childhood and adolescence is extremely stressful for patients and a therapeutic challenge for the physicians treating them. A meta-analysis of 33 randomized-controlled studies published in JAMA Pediatrics shows that cognitive-behavioral therapy or hypnotherapy promises the greatest therapy success.

“If children or adolescents complain about chronic abdominal pain and a detailed diagnostic does not reveal any somatic cause, this is referred to as functional abdominal pain,” Burkhard Rodeck, MD, general secretary of the German Society of Pediatrics and Adolescent Medicine in Berlin, told this news organization.
 

Signal perception disorder

It is still not completely clear what causes functional abdominal pain. But it is assumed to be a disruption in the communication between the gastrointestinal tract and the brain. “These patients are experiencing a signal perception disorder: normal body signals, such as a slight stomach rumble, are assigned to the pain category for them much more quickly than for other people,” said Dr. Rodeck. “The meta-analysis provides confirmation of this – functional abdominal pain is actually a biopsychosocial matter.”

In the standard therapy of functional abdominal pain, however, it is also possible to choose a medicinal approach. “Studies show that herbal preparations such as peppermint oil capsules have some efficacy, since they attenuate the strength of the signals being sent from the gastrointestinal tract to the brain, with the result that they are not perceived so quickly as pain. Probiotics can also potentially help,” added Dr. Rodeck.

“If this is unsuccessful, the child must be offered a psychologic/psychotherapeutic measure, usually cognitive-behavioral therapy.”
 

Comparison of psychosocial therapies

The meta-analysis was carried out by a research team at the University of Central Lancashire, Preston, United Kingdom. It included 2,657 children and adolescents between the ages of 7 and 17 years, of which two-thirds were girls.

Various psychosocial therapy approaches for functional abdominal pain, such as cognitive-behavioral therapy, educational assistance, hypnotherapy (directed at the digestive system), guided meditation with relaxation, yoga, or (visceral) osteopathy were investigated and compared in the studies – sometimes against each other and sometimes against no intervention.

Lead author Morris Gordon, MBChB, PhD, professor of evidence synthesis and systematic review at the University of Central Lancashire, and his colleagues reported that cognitive-behavioral therapy was 2.37-times more likely to result in therapy success than no intervention. To treat functional abdominal pain successfully in one child or adolescent, five children needed to be treated with cognitive-behavioral therapy.
 

Rarer, milder pain

The children and adolescents treated with cognitive-behavioral therapy also experienced less frequent and less severe abdominal pain than the children and adolescents who did not receive any intervention. The rate of side effect–related therapy discontinuations did not differ between the groups.

Hypnotherapy could also be associated with an improved outcome, compared with no intervention, added Dr. Gordon and his colleagues. Hypnotherapy was 2.86-times more likely to result in therapy success, and the number needed to treat was five.

The other therapeutic approaches investigated did not perform any better in the studies than no intervention. However, the authors noted that evidence of the effectiveness of cognitive-behavioral therapy and hypnotherapy is moderate or weak, especially owing to the high bias risk.

“The therapy for functional abdominal pain cannot be compared with the therapy for scarlet fever, for example, where penicillin is administered in the knowledge that recovery is guaranteed. There is evidence that cognitive-behavioral therapy and possibly also hypnotherapy may help, but this is not true for every patient,” said Dr. Rodeck.
 

Start with the pediatrician

Dr. Gordon and his co-authors suggested considering cognitive-behavioral therapy and hypnotherapy for the treatment of functional abdominal pain in children and adolescents. But they added that further randomized controlled studies are necessary to improve the quality of evidence and therefore the reliability of these results.

Children and adolescents with functional abdominal pain do not need to be sent directly to the psychologist for treatment, said Dr. Rodeck. The pediatric or adolescent medicine specialist can also administer the initial behavioral therapy measures. “Some patients manage with the behavioral therapy approaches we offer as pediatric and adolescent medicine specialists; others require professional support with psychologic expertise,” said Dr. Rodeck. Should outpatient treatment be unsuccessful, inpatient therapy in special psychosomatic clinics or wards remains an option.
 

Education offers relief

For many patients, being informed about the connections and mechanisms that play a role in functional abdominal pain can offer a lot of relief, said Dr. Rodeck. Offering coping strategies that can be used in the event of acute symptoms is also a part of this education.

“If patients have functional abdominal pain for which no organic cause can be found, this can lead to frustration, sadness, and despair. The problem can become even worse if they feel that they are not being taken seriously by the physician,” said Dr. Rodeck. These negative experiences can further exacerbate the pain perception disorder. The aim of behavioral therapy measures is therefore to interrupt and downregulate this vicious cycle.

“Constant investigations are not always helpful for patients with functional abdominal pain. Time must be taken with these patients to talk and explore the options. They have definite abdominal pain, they are not imagining it. They must be taken seriously,” he emphasized.

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

Functional abdominal pain in childhood and adolescence is extremely stressful for patients and a therapeutic challenge for the physicians treating them. A meta-analysis of 33 randomized-controlled studies published in JAMA Pediatrics shows that cognitive-behavioral therapy or hypnotherapy promises the greatest therapy success.

“If children or adolescents complain about chronic abdominal pain and a detailed diagnostic does not reveal any somatic cause, this is referred to as functional abdominal pain,” Burkhard Rodeck, MD, general secretary of the German Society of Pediatrics and Adolescent Medicine in Berlin, told this news organization.
 

Signal perception disorder

It is still not completely clear what causes functional abdominal pain. But it is assumed to be a disruption in the communication between the gastrointestinal tract and the brain. “These patients are experiencing a signal perception disorder: normal body signals, such as a slight stomach rumble, are assigned to the pain category for them much more quickly than for other people,” said Dr. Rodeck. “The meta-analysis provides confirmation of this – functional abdominal pain is actually a biopsychosocial matter.”

In the standard therapy of functional abdominal pain, however, it is also possible to choose a medicinal approach. “Studies show that herbal preparations such as peppermint oil capsules have some efficacy, since they attenuate the strength of the signals being sent from the gastrointestinal tract to the brain, with the result that they are not perceived so quickly as pain. Probiotics can also potentially help,” added Dr. Rodeck.

“If this is unsuccessful, the child must be offered a psychologic/psychotherapeutic measure, usually cognitive-behavioral therapy.”
 

Comparison of psychosocial therapies

The meta-analysis was carried out by a research team at the University of Central Lancashire, Preston, United Kingdom. It included 2,657 children and adolescents between the ages of 7 and 17 years, of which two-thirds were girls.

Various psychosocial therapy approaches for functional abdominal pain, such as cognitive-behavioral therapy, educational assistance, hypnotherapy (directed at the digestive system), guided meditation with relaxation, yoga, or (visceral) osteopathy were investigated and compared in the studies – sometimes against each other and sometimes against no intervention.

Lead author Morris Gordon, MBChB, PhD, professor of evidence synthesis and systematic review at the University of Central Lancashire, and his colleagues reported that cognitive-behavioral therapy was 2.37-times more likely to result in therapy success than no intervention. To treat functional abdominal pain successfully in one child or adolescent, five children needed to be treated with cognitive-behavioral therapy.
 

Rarer, milder pain

The children and adolescents treated with cognitive-behavioral therapy also experienced less frequent and less severe abdominal pain than the children and adolescents who did not receive any intervention. The rate of side effect–related therapy discontinuations did not differ between the groups.

Hypnotherapy could also be associated with an improved outcome, compared with no intervention, added Dr. Gordon and his colleagues. Hypnotherapy was 2.86-times more likely to result in therapy success, and the number needed to treat was five.

The other therapeutic approaches investigated did not perform any better in the studies than no intervention. However, the authors noted that evidence of the effectiveness of cognitive-behavioral therapy and hypnotherapy is moderate or weak, especially owing to the high bias risk.

“The therapy for functional abdominal pain cannot be compared with the therapy for scarlet fever, for example, where penicillin is administered in the knowledge that recovery is guaranteed. There is evidence that cognitive-behavioral therapy and possibly also hypnotherapy may help, but this is not true for every patient,” said Dr. Rodeck.
 

Start with the pediatrician

Dr. Gordon and his co-authors suggested considering cognitive-behavioral therapy and hypnotherapy for the treatment of functional abdominal pain in children and adolescents. But they added that further randomized controlled studies are necessary to improve the quality of evidence and therefore the reliability of these results.

Children and adolescents with functional abdominal pain do not need to be sent directly to the psychologist for treatment, said Dr. Rodeck. The pediatric or adolescent medicine specialist can also administer the initial behavioral therapy measures. “Some patients manage with the behavioral therapy approaches we offer as pediatric and adolescent medicine specialists; others require professional support with psychologic expertise,” said Dr. Rodeck. Should outpatient treatment be unsuccessful, inpatient therapy in special psychosomatic clinics or wards remains an option.
 

Education offers relief

For many patients, being informed about the connections and mechanisms that play a role in functional abdominal pain can offer a lot of relief, said Dr. Rodeck. Offering coping strategies that can be used in the event of acute symptoms is also a part of this education.

“If patients have functional abdominal pain for which no organic cause can be found, this can lead to frustration, sadness, and despair. The problem can become even worse if they feel that they are not being taken seriously by the physician,” said Dr. Rodeck. These negative experiences can further exacerbate the pain perception disorder. The aim of behavioral therapy measures is therefore to interrupt and downregulate this vicious cycle.

“Constant investigations are not always helpful for patients with functional abdominal pain. Time must be taken with these patients to talk and explore the options. They have definite abdominal pain, they are not imagining it. They must be taken seriously,” he emphasized.

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

Functional abdominal pain in childhood and adolescence is extremely stressful for patients and a therapeutic challenge for the physicians treating them. A meta-analysis of 33 randomized-controlled studies published in JAMA Pediatrics shows that cognitive-behavioral therapy or hypnotherapy promises the greatest therapy success.

“If children or adolescents complain about chronic abdominal pain and a detailed diagnostic does not reveal any somatic cause, this is referred to as functional abdominal pain,” Burkhard Rodeck, MD, general secretary of the German Society of Pediatrics and Adolescent Medicine in Berlin, told this news organization.
 

Signal perception disorder

It is still not completely clear what causes functional abdominal pain. But it is assumed to be a disruption in the communication between the gastrointestinal tract and the brain. “These patients are experiencing a signal perception disorder: normal body signals, such as a slight stomach rumble, are assigned to the pain category for them much more quickly than for other people,” said Dr. Rodeck. “The meta-analysis provides confirmation of this – functional abdominal pain is actually a biopsychosocial matter.”

In the standard therapy of functional abdominal pain, however, it is also possible to choose a medicinal approach. “Studies show that herbal preparations such as peppermint oil capsules have some efficacy, since they attenuate the strength of the signals being sent from the gastrointestinal tract to the brain, with the result that they are not perceived so quickly as pain. Probiotics can also potentially help,” added Dr. Rodeck.

“If this is unsuccessful, the child must be offered a psychologic/psychotherapeutic measure, usually cognitive-behavioral therapy.”
 

Comparison of psychosocial therapies

The meta-analysis was carried out by a research team at the University of Central Lancashire, Preston, United Kingdom. It included 2,657 children and adolescents between the ages of 7 and 17 years, of which two-thirds were girls.

Various psychosocial therapy approaches for functional abdominal pain, such as cognitive-behavioral therapy, educational assistance, hypnotherapy (directed at the digestive system), guided meditation with relaxation, yoga, or (visceral) osteopathy were investigated and compared in the studies – sometimes against each other and sometimes against no intervention.

Lead author Morris Gordon, MBChB, PhD, professor of evidence synthesis and systematic review at the University of Central Lancashire, and his colleagues reported that cognitive-behavioral therapy was 2.37-times more likely to result in therapy success than no intervention. To treat functional abdominal pain successfully in one child or adolescent, five children needed to be treated with cognitive-behavioral therapy.
 

Rarer, milder pain

The children and adolescents treated with cognitive-behavioral therapy also experienced less frequent and less severe abdominal pain than the children and adolescents who did not receive any intervention. The rate of side effect–related therapy discontinuations did not differ between the groups.

Hypnotherapy could also be associated with an improved outcome, compared with no intervention, added Dr. Gordon and his colleagues. Hypnotherapy was 2.86-times more likely to result in therapy success, and the number needed to treat was five.

The other therapeutic approaches investigated did not perform any better in the studies than no intervention. However, the authors noted that evidence of the effectiveness of cognitive-behavioral therapy and hypnotherapy is moderate or weak, especially owing to the high bias risk.

“The therapy for functional abdominal pain cannot be compared with the therapy for scarlet fever, for example, where penicillin is administered in the knowledge that recovery is guaranteed. There is evidence that cognitive-behavioral therapy and possibly also hypnotherapy may help, but this is not true for every patient,” said Dr. Rodeck.
 

Start with the pediatrician

Dr. Gordon and his co-authors suggested considering cognitive-behavioral therapy and hypnotherapy for the treatment of functional abdominal pain in children and adolescents. But they added that further randomized controlled studies are necessary to improve the quality of evidence and therefore the reliability of these results.

Children and adolescents with functional abdominal pain do not need to be sent directly to the psychologist for treatment, said Dr. Rodeck. The pediatric or adolescent medicine specialist can also administer the initial behavioral therapy measures. “Some patients manage with the behavioral therapy approaches we offer as pediatric and adolescent medicine specialists; others require professional support with psychologic expertise,” said Dr. Rodeck. Should outpatient treatment be unsuccessful, inpatient therapy in special psychosomatic clinics or wards remains an option.
 

Education offers relief

For many patients, being informed about the connections and mechanisms that play a role in functional abdominal pain can offer a lot of relief, said Dr. Rodeck. Offering coping strategies that can be used in the event of acute symptoms is also a part of this education.

“If patients have functional abdominal pain for which no organic cause can be found, this can lead to frustration, sadness, and despair. The problem can become even worse if they feel that they are not being taken seriously by the physician,” said Dr. Rodeck. These negative experiences can further exacerbate the pain perception disorder. The aim of behavioral therapy measures is therefore to interrupt and downregulate this vicious cycle.

“Constant investigations are not always helpful for patients with functional abdominal pain. Time must be taken with these patients to talk and explore the options. They have definite abdominal pain, they are not imagining it. They must be taken seriously,” he emphasized.

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