Progressive resistance training (PRT) and neuromuscular exercise (NEMEX) programs result in similar improvements in hip function, pain, and hip-related quality of life (QOL) in people with osteoarthritis (OA), according to the results of a randomized controlled trial.

At the end of the 12-week exercise period, both interventions yielded changes from baseline on the 30-second chair stand test (30s-CST) that were below the threshold for a major clinical effect. 

Mean changes in the Hip Disability and Osteoarthritis Outcome Score (HOOS) pain subscale and HOOS QOL score were also similar among the participants, regardless of which exercise program they had been assigned to.

“The lack of superiority of PRT for increasing muscle strength and power is surprising given the principle of specificity (higher-intensity resistance training yields greater improvements in maximal muscle strength),” according to the Danish researchers who reported the results online today in Annals of Internal Medicine.

“However, the point estimates only showed modest and uncertain superiority of PRT for increasing muscle strength and power and no differences for any functional performance tests or self-reported physical function,” they added.
 

The Power of Exercise

Worldwide, most clinical guidelines recommend exercise as a first-line conservative treatment option in both hip and knee OA. However, there is not much evidence to help guide healthcare practitioners in deciding which type of exercises to use with their patients, Troels Kjeldsen, MSc, the principal investigator for the study, told this news organization.

“Neuromuscular exercise is a very commonly used exercise program in clinical practice, but, to our knowledge, it has never been compared to another type of exercise in hip OA,” observed Mr. Kjeldsen, who is a PhD student in the department of orthopedic surgery at Aarhus University Hospital, Aarhus, Denmark.

“Each year, many thousands of patients are referred to having neuromuscular exercise therapy with a physiotherapist,” Mr. Kjeldsen said. “So, we thought it would be worthwhile to compare it to PRT, another promising exercise type, to see if it really did perform as well as I think most people thought it did,” he added.
 

Comparing the Two Exercise Programs

PRT and NEMEX are two different types of exercise programs. PRT involves using resistance-training machines, and the focus is to maximize the exercise intensity by using as high an exercise load or weight as possible. By contrast, NEMEX consists of exercises that are low to moderate in intensity and emphasizes alignment, control, and stability of the movements.

To compare the two exercise strategies, Mr. Kjeldsen and fellow investigators recruited 160 participants at five hospitals and 10 physiotherapy clinics across three of five healthcare regions in Denmark.

For inclusion in the trial, the participants had to have a clinical diagnosis of hip OA, be older than 45 years, and experience pain during activity in one or both hips that was rated as 3 or higher on a 10-point numerical rating scale. Participants also had to have no or less than 30 minutes of hip joint stiffness in the morning as well as no surgery involving the lower extremities in the previous 6 months. 

Participants were then randomized to undertake the PRT (n = 82) or NEMEX (n = 78) program, delivered as two physiotherapist-led group sessions every week for 12 weeks. Exercise sessions were held at least 72 hours apart and consisted of a 10-minute warm-up on an exercise bike and then 50 minutes of PRT or NEMEX. PRT consisted of five generic resistance-based exercises targeting hip and knee joint muscles and NEMEX consisted of 10 exercises that increased in difficulty by varying the number, direction, speed, and surface of the movements performed.
 

Dead Heat Between PRT and NEMEX

The primary endpoint was the 30s-CST, which counted the number of times participants could stand from a seated position in 30 seconds. Participants in the PRT and NEMEX groups were able to do this maneuver a respective 11.3 and 11.6 times at baseline and 12.8 and 13.1 times after completion of the exercise programs. 

Other functional performance tests included a 40-m fast-paced walk, a nine-step timed stair climb, leg extensor power in the affected and unaffected limb, and a unilateral single repetition leg press. None of these showed a statistically significant benefit of PRT over NEMEX, or vice versa.

HOOS pain scores at baseline and 12 weeks for PRT were a respective 57.5 and 66.1, representing an overall 8.6-point increase, and for NEMEX they were 58.9 and 68.2, giving a 9.3-point increase, meaning there was only a -0.7 mean change when comparing the two groups.

Corresponding baseline and 12-week HOOS QOL scores for PRT were 43.7 and 51.7; for NEMEX, they were 47.1 and 52.8 thus giving 8.0- and 5.7-point increases and a 2.3 difference in change between the groups. Again, this wasn’t quite enough to show a clinically meaningful effect.
 

Future Steps

“The effect of exercise seems to be at its highest at 3-4 months when you implement exercise, so we compared the effects of the exercises at the time when they are probably going to be at their highest,” Mr. Kjeldsen explained. He said the research team also plans to look at what happens after 1 year of follow-up.

“The key take home message is that patients can be encouraged to pick the type of exercise that they find the most enjoyable, or the type that is available to them,” Mr. Kjeldsen suggested. 

Stephanie Chang, MD, MPH, who is the Deputy Editor of Annals of Internal Medicine and practices in Rockville, Maryland, commented on the paper to this news organization. “In this small study, we learned that exercises to strengthen lower extremity muscles did not improve pain or function any more than exercises for core stability and balance,” she said.

Dr. Chang pointed out that there was variance in the levels of activity that people already undertook at baseline: 40% of the PRT group and 41% of the NEMEX group already did 150 minutes or more of moderate intensity physical activity. 

“It’s possible that benefit or differences between interventions would be greater in people with different levels of baseline activity or even in those with different osteoarthritis severity,” she said. 

“In the meantime,” Dr. Chang added, “with the findings from this study, I would feel comfortable advising my patients with hip osteoarthritis to engage in whichever type of exercise they prefer — whether that exercise focuses on core strengthening and balance or on specific lower extremity muscle strengthening.”

The trial was funded by the Independent Research Fund Denmark, the Physiotherapy Practice Foundation, the Health Foundation, Aarhus University, Region Zealand, the Association of Danish Physiotherapists, Andelsfonden, and Hede Nielsens Family Foundation. Mr. Kjeldsen and Dr. Chang report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Progressive resistance training (PRT) and neuromuscular exercise (NEMEX) programs result in similar improvements in hip function, pain, and hip-related quality of life (QOL) in people with osteoarthritis (OA), according to the results of a randomized controlled trial.

At the end of the 12-week exercise period, both interventions yielded changes from baseline on the 30-second chair stand test (30s-CST) that were below the threshold for a major clinical effect. 

Mean changes in the Hip Disability and Osteoarthritis Outcome Score (HOOS) pain subscale and HOOS QOL score were also similar among the participants, regardless of which exercise program they had been assigned to.

“The lack of superiority of PRT for increasing muscle strength and power is surprising given the principle of specificity (higher-intensity resistance training yields greater improvements in maximal muscle strength),” according to the Danish researchers who reported the results online today in Annals of Internal Medicine.

“However, the point estimates only showed modest and uncertain superiority of PRT for increasing muscle strength and power and no differences for any functional performance tests or self-reported physical function,” they added.
 

The Power of Exercise

Worldwide, most clinical guidelines recommend exercise as a first-line conservative treatment option in both hip and knee OA. However, there is not much evidence to help guide healthcare practitioners in deciding which type of exercises to use with their patients, Troels Kjeldsen, MSc, the principal investigator for the study, told this news organization.

“Neuromuscular exercise is a very commonly used exercise program in clinical practice, but, to our knowledge, it has never been compared to another type of exercise in hip OA,” observed Mr. Kjeldsen, who is a PhD student in the department of orthopedic surgery at Aarhus University Hospital, Aarhus, Denmark.

“Each year, many thousands of patients are referred to having neuromuscular exercise therapy with a physiotherapist,” Mr. Kjeldsen said. “So, we thought it would be worthwhile to compare it to PRT, another promising exercise type, to see if it really did perform as well as I think most people thought it did,” he added.
 

Comparing the Two Exercise Programs

PRT and NEMEX are two different types of exercise programs. PRT involves using resistance-training machines, and the focus is to maximize the exercise intensity by using as high an exercise load or weight as possible. By contrast, NEMEX consists of exercises that are low to moderate in intensity and emphasizes alignment, control, and stability of the movements.

To compare the two exercise strategies, Mr. Kjeldsen and fellow investigators recruited 160 participants at five hospitals and 10 physiotherapy clinics across three of five healthcare regions in Denmark.

For inclusion in the trial, the participants had to have a clinical diagnosis of hip OA, be older than 45 years, and experience pain during activity in one or both hips that was rated as 3 or higher on a 10-point numerical rating scale. Participants also had to have no or less than 30 minutes of hip joint stiffness in the morning as well as no surgery involving the lower extremities in the previous 6 months. 

Participants were then randomized to undertake the PRT (n = 82) or NEMEX (n = 78) program, delivered as two physiotherapist-led group sessions every week for 12 weeks. Exercise sessions were held at least 72 hours apart and consisted of a 10-minute warm-up on an exercise bike and then 50 minutes of PRT or NEMEX. PRT consisted of five generic resistance-based exercises targeting hip and knee joint muscles and NEMEX consisted of 10 exercises that increased in difficulty by varying the number, direction, speed, and surface of the movements performed.
 

Dead Heat Between PRT and NEMEX

The primary endpoint was the 30s-CST, which counted the number of times participants could stand from a seated position in 30 seconds. Participants in the PRT and NEMEX groups were able to do this maneuver a respective 11.3 and 11.6 times at baseline and 12.8 and 13.1 times after completion of the exercise programs. 

Other functional performance tests included a 40-m fast-paced walk, a nine-step timed stair climb, leg extensor power in the affected and unaffected limb, and a unilateral single repetition leg press. None of these showed a statistically significant benefit of PRT over NEMEX, or vice versa.

HOOS pain scores at baseline and 12 weeks for PRT were a respective 57.5 and 66.1, representing an overall 8.6-point increase, and for NEMEX they were 58.9 and 68.2, giving a 9.3-point increase, meaning there was only a -0.7 mean change when comparing the two groups.

Corresponding baseline and 12-week HOOS QOL scores for PRT were 43.7 and 51.7; for NEMEX, they were 47.1 and 52.8 thus giving 8.0- and 5.7-point increases and a 2.3 difference in change between the groups. Again, this wasn’t quite enough to show a clinically meaningful effect.
 

Future Steps

“The effect of exercise seems to be at its highest at 3-4 months when you implement exercise, so we compared the effects of the exercises at the time when they are probably going to be at their highest,” Mr. Kjeldsen explained. He said the research team also plans to look at what happens after 1 year of follow-up.

“The key take home message is that patients can be encouraged to pick the type of exercise that they find the most enjoyable, or the type that is available to them,” Mr. Kjeldsen suggested. 

Stephanie Chang, MD, MPH, who is the Deputy Editor of Annals of Internal Medicine and practices in Rockville, Maryland, commented on the paper to this news organization. “In this small study, we learned that exercises to strengthen lower extremity muscles did not improve pain or function any more than exercises for core stability and balance,” she said.

Dr. Chang pointed out that there was variance in the levels of activity that people already undertook at baseline: 40% of the PRT group and 41% of the NEMEX group already did 150 minutes or more of moderate intensity physical activity. 

“It’s possible that benefit or differences between interventions would be greater in people with different levels of baseline activity or even in those with different osteoarthritis severity,” she said. 

“In the meantime,” Dr. Chang added, “with the findings from this study, I would feel comfortable advising my patients with hip osteoarthritis to engage in whichever type of exercise they prefer — whether that exercise focuses on core strengthening and balance or on specific lower extremity muscle strengthening.”

The trial was funded by the Independent Research Fund Denmark, the Physiotherapy Practice Foundation, the Health Foundation, Aarhus University, Region Zealand, the Association of Danish Physiotherapists, Andelsfonden, and Hede Nielsens Family Foundation. Mr. Kjeldsen and Dr. Chang report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Progressive resistance training (PRT) and neuromuscular exercise (NEMEX) programs result in similar improvements in hip function, pain, and hip-related quality of life (QOL) in people with osteoarthritis (OA), according to the results of a randomized controlled trial.

At the end of the 12-week exercise period, both interventions yielded changes from baseline on the 30-second chair stand test (30s-CST) that were below the threshold for a major clinical effect. 

Mean changes in the Hip Disability and Osteoarthritis Outcome Score (HOOS) pain subscale and HOOS QOL score were also similar among the participants, regardless of which exercise program they had been assigned to.

“The lack of superiority of PRT for increasing muscle strength and power is surprising given the principle of specificity (higher-intensity resistance training yields greater improvements in maximal muscle strength),” according to the Danish researchers who reported the results online today in Annals of Internal Medicine.

“However, the point estimates only showed modest and uncertain superiority of PRT for increasing muscle strength and power and no differences for any functional performance tests or self-reported physical function,” they added.
 

The Power of Exercise

Worldwide, most clinical guidelines recommend exercise as a first-line conservative treatment option in both hip and knee OA. However, there is not much evidence to help guide healthcare practitioners in deciding which type of exercises to use with their patients, Troels Kjeldsen, MSc, the principal investigator for the study, told this news organization.

“Neuromuscular exercise is a very commonly used exercise program in clinical practice, but, to our knowledge, it has never been compared to another type of exercise in hip OA,” observed Mr. Kjeldsen, who is a PhD student in the department of orthopedic surgery at Aarhus University Hospital, Aarhus, Denmark.

“Each year, many thousands of patients are referred to having neuromuscular exercise therapy with a physiotherapist,” Mr. Kjeldsen said. “So, we thought it would be worthwhile to compare it to PRT, another promising exercise type, to see if it really did perform as well as I think most people thought it did,” he added.
 

Comparing the Two Exercise Programs

PRT and NEMEX are two different types of exercise programs. PRT involves using resistance-training machines, and the focus is to maximize the exercise intensity by using as high an exercise load or weight as possible. By contrast, NEMEX consists of exercises that are low to moderate in intensity and emphasizes alignment, control, and stability of the movements.

To compare the two exercise strategies, Mr. Kjeldsen and fellow investigators recruited 160 participants at five hospitals and 10 physiotherapy clinics across three of five healthcare regions in Denmark.

For inclusion in the trial, the participants had to have a clinical diagnosis of hip OA, be older than 45 years, and experience pain during activity in one or both hips that was rated as 3 or higher on a 10-point numerical rating scale. Participants also had to have no or less than 30 minutes of hip joint stiffness in the morning as well as no surgery involving the lower extremities in the previous 6 months. 

Participants were then randomized to undertake the PRT (n = 82) or NEMEX (n = 78) program, delivered as two physiotherapist-led group sessions every week for 12 weeks. Exercise sessions were held at least 72 hours apart and consisted of a 10-minute warm-up on an exercise bike and then 50 minutes of PRT or NEMEX. PRT consisted of five generic resistance-based exercises targeting hip and knee joint muscles and NEMEX consisted of 10 exercises that increased in difficulty by varying the number, direction, speed, and surface of the movements performed.
 

Dead Heat Between PRT and NEMEX

The primary endpoint was the 30s-CST, which counted the number of times participants could stand from a seated position in 30 seconds. Participants in the PRT and NEMEX groups were able to do this maneuver a respective 11.3 and 11.6 times at baseline and 12.8 and 13.1 times after completion of the exercise programs. 

Other functional performance tests included a 40-m fast-paced walk, a nine-step timed stair climb, leg extensor power in the affected and unaffected limb, and a unilateral single repetition leg press. None of these showed a statistically significant benefit of PRT over NEMEX, or vice versa.

HOOS pain scores at baseline and 12 weeks for PRT were a respective 57.5 and 66.1, representing an overall 8.6-point increase, and for NEMEX they were 58.9 and 68.2, giving a 9.3-point increase, meaning there was only a -0.7 mean change when comparing the two groups.

Corresponding baseline and 12-week HOOS QOL scores for PRT were 43.7 and 51.7; for NEMEX, they were 47.1 and 52.8 thus giving 8.0- and 5.7-point increases and a 2.3 difference in change between the groups. Again, this wasn’t quite enough to show a clinically meaningful effect.
 

Future Steps

“The effect of exercise seems to be at its highest at 3-4 months when you implement exercise, so we compared the effects of the exercises at the time when they are probably going to be at their highest,” Mr. Kjeldsen explained. He said the research team also plans to look at what happens after 1 year of follow-up.

“The key take home message is that patients can be encouraged to pick the type of exercise that they find the most enjoyable, or the type that is available to them,” Mr. Kjeldsen suggested. 

Stephanie Chang, MD, MPH, who is the Deputy Editor of Annals of Internal Medicine and practices in Rockville, Maryland, commented on the paper to this news organization. “In this small study, we learned that exercises to strengthen lower extremity muscles did not improve pain or function any more than exercises for core stability and balance,” she said.

Dr. Chang pointed out that there was variance in the levels of activity that people already undertook at baseline: 40% of the PRT group and 41% of the NEMEX group already did 150 minutes or more of moderate intensity physical activity. 

“It’s possible that benefit or differences between interventions would be greater in people with different levels of baseline activity or even in those with different osteoarthritis severity,” she said. 

“In the meantime,” Dr. Chang added, “with the findings from this study, I would feel comfortable advising my patients with hip osteoarthritis to engage in whichever type of exercise they prefer — whether that exercise focuses on core strengthening and balance or on specific lower extremity muscle strengthening.”

The trial was funded by the Independent Research Fund Denmark, the Physiotherapy Practice Foundation, the Health Foundation, Aarhus University, Region Zealand, the Association of Danish Physiotherapists, Andelsfonden, and Hede Nielsens Family Foundation. Mr. Kjeldsen and Dr. Chang report no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.

METHODOLOGY:

• While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
• In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
• Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
• FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
• On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.

TAKEAWAY:

• The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
• However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
• In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm², and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.

IN PRACTICE:

“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.

SOURCE:

This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).

LIMITATIONS:

This study did not discuss any limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.

A version of this article appeared on Medscape.com.

TOPLINE:

Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.

METHODOLOGY:

• While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
• In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
• Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
• FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
• On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.

TAKEAWAY:

• The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
• However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
• In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm², and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.

IN PRACTICE:

“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.

SOURCE:

This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).

LIMITATIONS:

This study did not discuss any limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.

A version of this article appeared on Medscape.com.

TOPLINE:

Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.

METHODOLOGY:

• While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
• In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
• Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
• FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
• On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.

TAKEAWAY:

• The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
• However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
• In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm², and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.

IN PRACTICE:

“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.

SOURCE:

This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).

LIMITATIONS:

This study did not discuss any limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.

A version of this article appeared on Medscape.com.

You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

A recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

A 2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

A 2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

A study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

A study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

A recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

A 2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

A 2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

A study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

A study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

You are what you eat, as the adage goes. But a growing body of evidence indicates that it’s not just what and how much you eat that influence your health. How fast and when you eat also play a role.

Research now indicates that these two factors may affect the risk for gastrointestinal problems, obesity, and type 2 diabetes (T2D). Because meal timing and speed of consumption are modifiable, they present new opportunities to change patient behavior to help prevent and perhaps address these conditions.

Not So Fast

Most people are well acquainted with the short-term gastrointestinal effects of eating too quickly, which include indigestion, gas, bloating, and nausea. But regularly eating too fast can cause long-term consequences.

Obtaining a sense of fullness is key to staving off overeating and excess caloric intake. However, it takes approximately 20 minutes for the stomach to alert the brain to feelings of fullness. Eat too quickly and the fullness signaling might not set in until you’ve consumed more calories than intended. Research links this habit to excess body weight.

The practice also can lead to gastrointestinal diseases over the long term because overeating causes food to remain in the stomach longer, thus prolonging the time that the gastric mucosa is exposed to gastric acids.

A study of 10,893 adults in Korea reported that those with the fastest eating speed (< 5 min/meal) had a 1.7 times greater likelihood of endoscopic erosive gastritis than those with the slowest times (≥ 15 min/meal). Faster eating also was linked to increased risk for functional dyspepsia in a study involving 89 young-adult female military cadets in Korea with relatively controlled eating patterns.

On the extreme end of the spectrum, researchers who performed an assessment of a competitive speed eater speculated that the observed physiological accommodation required for the role (expanding the stomach to form a large flaccid sac) makes speed eaters vulnerable to morbid obesity, gastroparesis, intractable nausea and vomiting, and the need for gastrectomy.

The risk for metabolic changes and eventual development of T2D also appear to be linked to how quickly food is consumed.

Two clinical studies conducted in Japan — a cohort study of 2050 male factory workers and a nationwide study with 197,825 participants — identified a significant association between faster eating and T2D and insulin resistance. A case-control study involving 234 patients with new onset T2D and 468 controls from Lithuania linked faster eating to a greater than twofold risk for T2D. And a Chinese cross-sectional study of 7972 adults indicated that faster eating significantly increased the risk for metabolic syndrome, elevated blood pressure, and central obesity in adults.

Various hypotheses have been proposed to explain why fast eating may upset metabolic processes, including a delayed sense of fullness contributing to spiking postprandial glucose levels, lack of time for mastication causing higher glucose concentrations, and the triggering of specific cytokines (eg, interleukin-1 beta and interleukin-6) that lead to insulin resistance. It is also possible that the association is the result of people who eat quickly having relatively higher body weights, which translates to a higher risk for T2D.

However, there’s an opportunity in the association of rapid meal consumption with gastrointestinal and metabolic diseases, as people can slow the speed at which they eat so they feel full before they overeat.

A 2019 study in which 21 participants were instructed to eat a 600-kcal meal at a “normal” or “slow” pace (6 minutes or 24 minutes) found that the latter group reported feeling fuller while consuming fewer calories.

This approach may not work for all patients, however. There’s evidence to suggest that tactics to slow down eating may not limit the energy intake of those who are already overweight or obese.

Patients with obesity may physiologically differ in their processing of food, according to Michael Camilleri, MD, consultant in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minnesota.

“We have demonstrated that about 20%-25% of people with obesity actually have rapid gastric emptying,” he told this news organization. “As a result, they don’t feel full after they eat a meal and that might impact the total volume of food that they eat before they really feel full.”

The Ideal Time to Eat

It’s not only the speed at which individuals eat that may influence outcomes but when they take their meals. Research indicates that eating earlier in the day to align meals with the body’s circadian rhythms in metabolism offers health benefits.

“The focus would be to eat a meal that syncs during those daytime hours,” Collin Popp, PhD, MS, RD, a research scientist at the NYU Grossman School of Medicine in New York, told this news organization. “I typically suggest patients have their largest meal in the morning, whether that’s a large or medium-sized breakfast, or a big lunch.”

A recent cross-sectional study of 2050 participants found that having the largest meal at lunch protected against obesity (odds ratio [OR], 0.71), whereas having it at dinner increased the risk for obesity (OR, 1.67) and led to higher body mass index.

Consuming the majority of calories in meals earlier in the day may have metabolic health benefits, as well.

A 2015 randomized controlled trial involving 18 adults with obesity and T2D found that eating a high-energy breakfast and a low-energy dinner leads to reduced hyperglycemia throughout the day compared with eating a low-energy breakfast and a high-energy dinner.

Time-restricted eating (TRE), a form of intermittent fasting, also can improve metabolic health depending on the time of day.

A 2023 meta-analysis found that TRE was more effective at reducing fasting glucose levels in participants who were overweight and obese if done earlier rather than later in the day. Similarly, a 2022 study involving 82 healthy patients without diabetes or obesity found that early TRE was more effective than mid-day TRE at improving insulin sensitivity and that it improved fasting glucose and reduced total body mass and adiposity, while mid-day TRE did not.

A study that analyzed the effects of TRE in eight adult men with overweight and prediabetes found “better insulin resistance when the window of food consumption was earlier in the day,» noted endocrinologist Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Cornell Medicine with a focus on obesity medication.

Patients May Benefit From Behavioral Interventions

Patients potentially negatively affected by eating too quickly or at late hours may benefit from adopting behavioral interventions to address these tendencies. To determine if a patient is a candidate for such interventions, Dr. Popp recommends starting with a simple conversation.

“When I first meet patients, I always ask them to describe to me a typical day for how they eat — when they’re eating, what they’re eating, the food quality, who are they with — to see if there’s social aspects to it. Then try and make the recommendations based on that,” said Dr. Popp, whose work focuses on biobehavioral interventions for the treatment and prevention of obesity, T2D, and other cardiometabolic outcomes.

Dr. Tchang said she encourages her patients to be mindful of hunger and fullness cues.

“Eat if you’re hungry; don’t force yourself to eat if you’re not hungry,” she said. “If you’re not sure whether you’re hungry or not, speak to a doctor because this points to an abnormality in your appetite-regulation system, which can be helped with GLP-1 [glucagon-like peptide 1] receptor agonists.”

Adjusting what patients eat can help them improve their meal timing.

“For example, we know that a high-fiber diet or a diet that has a large amount of fat in it tends to empty from the stomach slower,” Dr. Camilleri said. “That might give a sensation of fullness that lasts longer and that might prevent, for instance, the ingestion of the next meal.”

Those trying to eat more slowly are advised to seek out foods that are hard in texture and minimally processed.

A study involving 50 patients with healthy weights found that hard foods are consumed more slowly than soft foods and that energy intake is lowest with hard, minimally processed foods. Combining hard-textured foods with explicit instructions to reduce eating speed has also been shown to be an effective strategy. For those inclined to seek out technology-based solution, evidence suggests that a self-monitoring wearable device can slow the eating rate.

Although the evidence is mounting that the timing and duration of meals have an impact on certain chronic diseases, clinicians should remember that these two factors are far from the most important contributors, Dr. Popp said.

“We also have to consider total caloric intake, food quality, sleep, alcohol use, smoking, and physical activity,” he said. “Meal timing should be considered as under the umbrella of health that is important for a lot of folks.”

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the launch of the first clinical trial for chimeric antigen receptor (CAR) T-cell therapy in children with systemic lupus erythematosus.

The trial, called Reversing Autoimmunity through Cell Therapy (REACT-01), will take place at Seattle Children’s Hospital in Washington State and is expected to begin this summer.

The CAR-T therapy will target CD19 positive B-cells, an approach that has had promising results in a small number of adult patients. While the FDA has approved a number of clinical trials using CAR-T therapy to treat autoimmune diseases in adults, this is the first authorization for a CAR T-cell therapy trial to treat autoimmune disease in children.

REACT-01 will enroll 12 individuals under 18 years of age, Shaun W. Jackson, MD, PhD, the principal investigator of the trial and attending physician in Pediatric Nephrology and Pediatric Rheumatology at Seattle Children’s Hospital, told this news organization. 

The trial will be initiated in separate phases, using three age cohorts. The first phase will enroll three individuals aged at least 17 years, before moving to the second phase and enrolling three individuals aged 12-17 years. Then, phase 3 will also include children aged 5-12 years.

To be eligible for the trial, participants must have failed at least two standard immunosuppressive therapies as well as have evidence of active lupus disease affecting a major organ system, such as the heart, lungs, and kidneys.

“Seattle Children’s Hospital will be the only site for this study, although patients can travel to Seattle to receive the therapy and then return back to their primary center for ongoing care,” Dr. Jackson said. 

A version of this article appeared on Medscape.com.

Multitarget stool-based tests are showing promise for colorectal cancer (CRC) screening in average-risk individuals and could edge out the current standard fecal immunochemical test (FIT).

These new tests aren’t radical departures from the standard FIT. Like the standard test, the multitarget FIT uses antibodies to test for hemoglobin in stool samples. But these multitarget approaches take the standard FIT a step further by testing for additional DNA, RNA, or protein biomarkers associated with CRC to help improve early detection.

Currently, the US Preventive Services Task Force (USPSTF) recommends two FIT tests — standard FIT and stool FIT-DNA — as well as a third noninvasive CRC screening test, guaiac fecal occult blood test (gFOBT). gFOBT detects heme, a component of hemoglobin, through a chemical reaction.

But both standard FIT and stool FIT-DNA come with caveats. Compared to the standard test, FIT-DNA tends to be better at detecting traces of blood in the stool, and thus can uncover more instances of CRC or other advanced lesions. The flipside is that the DNA test also often leads to more false-positive findings.

In fact, the American College of Physicians does not recommend stool FIT-DNA for screening, citing issues such as cost — more than $600 per test vs about $30 for standard FIT — and the greater likelihood of false-positives compared with both standard FIT and gFOBT.

Given these trade-offs with current noninvasive screening options, developing a FIT option that can improve early detection of CRC and advanced precancerous lesions without increasing false-positives could make a big difference in outcomes. 

Three new noninvasive multitarget tests under investigation — an updated DNA-based test, Cologuard 2.0 (Exact Sciences; Madison, WI); an RNA-based test, ColoSense (Geneoscopy; St Louis, MO); and a protein-based test from CRCbioscreen (Amsterdam, the Netherlands) — may be able to do just that. 
 

Cologuard 2.0: Multitarget Stool DNA-Based Test

An updated version of the stool FIT-DNA is currently under development. Dubbed Next Generation Cologuard, or Cologuard 2.0, this multitarget test detects three novel methylated DNA markers along with fecal hemoglobin.

In a recent trial comparing Cologuard 2.0 vs standard FIT, 20,176 participants aged 40 years or older were screened with Cologuard 2.0 as well as standard FIT before they all also received a colonoscopy. The researchers compared findings with Cologuard 2.0 and standard FIT, which used a positivity cutoff ≥ 20 mcg hemoglobin/g feces. 

The researchers then assessed Cologuard 2.0’s sensitivity (a gauge of how well it detects disease that is truly present) and specificity (a measure of how well a test indicates the absence of disease when no disease is present) compared with standard FIT and the original Cologuard test.

Overall, Cologuard 2.0 demonstrated better sensitivity for CRC than did standard FIT (93.9% vs 67.3%, respectively) and for advanced precancerous lesions (43.4% vs 23.3%). The next-generation test, for instance, identified 92 of 98 participants with colonoscopy-confirmed CRC diagnoses vs 66 cases using standard FIT.

Compared with the original Cologuard, Cologuard 2.0’s sensitivity improved slightly for CRC, from 92% to 93.9%,; for advanced precancerous lesions, from 42% to 43.4%; and for high-grade dysplasia, from 69% to 75%. Specificity also improved with the latest version, from 87% to 90.6%. 

However, Cologuard 2.0’s specificity for advanced neoplasia was worse than that of standard FIT (90.6% vs 94.8%, respectively), which would increase the likelihood of false-positive findings.

Despite its lower specificity compared with standard FIT, Cologuard 2.0 has several advantages. The test can identify more people with CRC and advanced precancerous lesions than the standard test and can lead to fewer false-positives than the original Cologuard test.

Cologuard maker Exact Sciences has submitted trial data to the US Food and Drug Administration (FDA) for approval.
 

Multitarget Stool RNA-Based Test

ColoSense, an RNA-based stool test, looks for eight RNA biomarkers associated with CRC. 

The company says that RNA-based testing has an advantage over DNA biomarker assays, such as the currently marketed Cologuard test, because it isn›t subject to the age-related changes in DNA methylation that can throw off the results from DNA assays. 

Like Cologuard 2.0, Geneoscopy’s Colosense test is under review by the FDA.

The data Geneoscopy submitted to the FDA came from the CRC-PREVENT trial, which included 8920 participants who were screened with both ColoSense and standard FIT before all had a colonoscopy. The participants ranged in age from 45 to 90 years, with 22% between 45 and 50 years old, a population recently added to the USPSTF screening recommendations. 

ColoSense showed higher sensitivity than standard FIT for the presence of CRC (94% vs 78%, respectively) and advanced adenomas (46% vs 29%). In the group aged 45-50 years, the RNA-based test had a sensitivity of 100% for CRC, correctly identifying all five people with colonoscopy-confirmed CRC, and 45% for advanced adenomas.

However, ColoSense was less specific than standard FIT compared with negative colonoscopy findings (88% vs 96%, respectively) and negative findings for advanced lesions or CRC (85.5% vs 94.9%); thus, it was more likely to lead to false-positive results.

Overall, the investigators said ColoSense is comparable to Cologuard — its chief market rival — in terms of sensitivity for CRC and advanced adenomas but has higher sensitivity for colorectal neoplasia in people aged 50 years or younger.
 

Multitarget Protein-Based Test

The multitarget protein-based FIT uses antibodies to test for two additional proteins: calprotectin, an inflammatory marker associated with CRC, and serpin family F member 2, a protease inhibitor thought to be upregulated in colon cancer. 

A 2021 study of 1284 patients found that the sensitivity of the multitarget protein-based test was 42.9% for advanced neoplasias compared with 37.3% with standard FIT. Its specificity was similar to that of standard FIT, at 96.6% for advanced neoplasias. 

In a more recent report published in The Lancet Oncology, the team modeled three scenarios comparing the two FIT tests. These scenarios used different cutoff values for a test to be positive for CRC or an advanced lesion.

Overall, the analysis included stool samples from 13,187 patients aged 55-75 years who were in the Netherlands’ national CRC screening program. Stool samples were evaluated with both the multitarget test and the standard FIT, using a positivity cutoff ≥ 47 mcg hemoglobin/g feces. Colonoscopy data were available for only 1270 participants. 

In scenario 1, the multitarget test had a lower threshold for a positive test and consequently identified more precancerous lesions than the standard FIT (828 vs 354, respectively). The multitarget FIT identified a few more CRC cases: Of 29 colonoscopy-confirmed CRC cases, the multitarget FIT identified 26 vs 23 with standard FIT. 

But the multitarget FIT also had more than double the number of false-positives than the standard FIT (347 vs 161, respectively).

Perhaps the most telling comparison occurred in scenario 2, with both tests set at the same low positivity threshold to minimize false-positives.

As expected, the two tests had similar positivity rates for advanced lesions, with the multitarget test correctly identifying 22 of 29 people with CRC, one fewer than the standard test. The protein-based test identified slightly more people with advanced lesions (156 vs 136 with the standard test), leading to a higher sensitivity for advanced lesions. 

Most notably, the protein-based test resulted in fewer false-positives than did the standard test (295 vs 311, respectively) , resulting in a slightly higher specificity.

In this scenario, “a single screening round might not have the biggest impact on cancer incidence and mortality,” the authors said, but the higher detection rate would still accumulate over 20 years of testing. The authors estimated that, under this scenario, substituting the multitarget FIT for the standard test in the Netherlands’ CRC screening program could reduce CRC incidence by 5% and CRC mortality by 4%.

Gerrit Meijer, MD, PhD, a pathologist at the Netherlands Cancer Institute, and colleagues recently launched a company called CRCbioscreen to commercialize this multitarget FIT for large-scale programs. The company›s priority is to develop and validate a clinical-grade test to sell to federal governments with national screening programs, such as those throughout Europe, Australia, and Asia, Dr. Meijer told this news organization. Dr. Meijer expects this process will take about 4 years.

The test will be developed for the US market, but with no nationwide screening program in the United States, future availability will depend on interest from providers and institutions, noted Dr. Meijer, who is also chief scientific officer at CRCbioscreen.

Overall, these three new multitarget stool-based CRC screening tests could help catch more cancers and advanced precancerous lesions. And, if the tests have a high enough specificity, a negative test result could also allow people to forgo screening colonoscopy. 

Still, people with a positive FIT finding would require follow-up colonoscopy, but about 10% of patients decline colonoscopy following an abnormal FIT, Mark A. Lewis, MD, director of gastrointestinal oncology at Intermountain Health in Murray, Utah, told this news organization last year. That means that even if precancerous lesions and CRC are being caught earlier, treatment can’t be started unless people follow through with colonoscopy.

A version of this article appeared on Medscape.com.

Multitarget stool-based tests are showing promise for colorectal cancer (CRC) screening in average-risk individuals and could edge out the current standard fecal immunochemical test (FIT).

These new tests aren’t radical departures from the standard FIT. Like the standard test, the multitarget FIT uses antibodies to test for hemoglobin in stool samples. But these multitarget approaches take the standard FIT a step further by testing for additional DNA, RNA, or protein biomarkers associated with CRC to help improve early detection.

Currently, the US Preventive Services Task Force (USPSTF) recommends two FIT tests — standard FIT and stool FIT-DNA — as well as a third noninvasive CRC screening test, guaiac fecal occult blood test (gFOBT). gFOBT detects heme, a component of hemoglobin, through a chemical reaction.

But both standard FIT and stool FIT-DNA come with caveats. Compared to the standard test, FIT-DNA tends to be better at detecting traces of blood in the stool, and thus can uncover more instances of CRC or other advanced lesions. The flipside is that the DNA test also often leads to more false-positive findings.

In fact, the American College of Physicians does not recommend stool FIT-DNA for screening, citing issues such as cost — more than $600 per test vs about $30 for standard FIT — and the greater likelihood of false-positives compared with both standard FIT and gFOBT.

Given these trade-offs with current noninvasive screening options, developing a FIT option that can improve early detection of CRC and advanced precancerous lesions without increasing false-positives could make a big difference in outcomes. 

Three new noninvasive multitarget tests under investigation — an updated DNA-based test, Cologuard 2.0 (Exact Sciences; Madison, WI); an RNA-based test, ColoSense (Geneoscopy; St Louis, MO); and a protein-based test from CRCbioscreen (Amsterdam, the Netherlands) — may be able to do just that. 
 

Cologuard 2.0: Multitarget Stool DNA-Based Test

An updated version of the stool FIT-DNA is currently under development. Dubbed Next Generation Cologuard, or Cologuard 2.0, this multitarget test detects three novel methylated DNA markers along with fecal hemoglobin.

In a recent trial comparing Cologuard 2.0 vs standard FIT, 20,176 participants aged 40 years or older were screened with Cologuard 2.0 as well as standard FIT before they all also received a colonoscopy. The researchers compared findings with Cologuard 2.0 and standard FIT, which used a positivity cutoff ≥ 20 mcg hemoglobin/g feces. 

The researchers then assessed Cologuard 2.0’s sensitivity (a gauge of how well it detects disease that is truly present) and specificity (a measure of how well a test indicates the absence of disease when no disease is present) compared with standard FIT and the original Cologuard test.

Overall, Cologuard 2.0 demonstrated better sensitivity for CRC than did standard FIT (93.9% vs 67.3%, respectively) and for advanced precancerous lesions (43.4% vs 23.3%). The next-generation test, for instance, identified 92 of 98 participants with colonoscopy-confirmed CRC diagnoses vs 66 cases using standard FIT.

Compared with the original Cologuard, Cologuard 2.0’s sensitivity improved slightly for CRC, from 92% to 93.9%,; for advanced precancerous lesions, from 42% to 43.4%; and for high-grade dysplasia, from 69% to 75%. Specificity also improved with the latest version, from 87% to 90.6%. 

However, Cologuard 2.0’s specificity for advanced neoplasia was worse than that of standard FIT (90.6% vs 94.8%, respectively), which would increase the likelihood of false-positive findings.

Despite its lower specificity compared with standard FIT, Cologuard 2.0 has several advantages. The test can identify more people with CRC and advanced precancerous lesions than the standard test and can lead to fewer false-positives than the original Cologuard test.

Cologuard maker Exact Sciences has submitted trial data to the US Food and Drug Administration (FDA) for approval.
 

Multitarget Stool RNA-Based Test

ColoSense, an RNA-based stool test, looks for eight RNA biomarkers associated with CRC. 

The company says that RNA-based testing has an advantage over DNA biomarker assays, such as the currently marketed Cologuard test, because it isn›t subject to the age-related changes in DNA methylation that can throw off the results from DNA assays. 

Like Cologuard 2.0, Geneoscopy’s Colosense test is under review by the FDA.

The data Geneoscopy submitted to the FDA came from the CRC-PREVENT trial, which included 8920 participants who were screened with both ColoSense and standard FIT before all had a colonoscopy. The participants ranged in age from 45 to 90 years, with 22% between 45 and 50 years old, a population recently added to the USPSTF screening recommendations. 

ColoSense showed higher sensitivity than standard FIT for the presence of CRC (94% vs 78%, respectively) and advanced adenomas (46% vs 29%). In the group aged 45-50 years, the RNA-based test had a sensitivity of 100% for CRC, correctly identifying all five people with colonoscopy-confirmed CRC, and 45% for advanced adenomas.

However, ColoSense was less specific than standard FIT compared with negative colonoscopy findings (88% vs 96%, respectively) and negative findings for advanced lesions or CRC (85.5% vs 94.9%); thus, it was more likely to lead to false-positive results.

Overall, the investigators said ColoSense is comparable to Cologuard — its chief market rival — in terms of sensitivity for CRC and advanced adenomas but has higher sensitivity for colorectal neoplasia in people aged 50 years or younger.
 

Multitarget Protein-Based Test

The multitarget protein-based FIT uses antibodies to test for two additional proteins: calprotectin, an inflammatory marker associated with CRC, and serpin family F member 2, a protease inhibitor thought to be upregulated in colon cancer. 

A 2021 study of 1284 patients found that the sensitivity of the multitarget protein-based test was 42.9% for advanced neoplasias compared with 37.3% with standard FIT. Its specificity was similar to that of standard FIT, at 96.6% for advanced neoplasias. 

In a more recent report published in The Lancet Oncology, the team modeled three scenarios comparing the two FIT tests. These scenarios used different cutoff values for a test to be positive for CRC or an advanced lesion.

Overall, the analysis included stool samples from 13,187 patients aged 55-75 years who were in the Netherlands’ national CRC screening program. Stool samples were evaluated with both the multitarget test and the standard FIT, using a positivity cutoff ≥ 47 mcg hemoglobin/g feces. Colonoscopy data were available for only 1270 participants. 

In scenario 1, the multitarget test had a lower threshold for a positive test and consequently identified more precancerous lesions than the standard FIT (828 vs 354, respectively). The multitarget FIT identified a few more CRC cases: Of 29 colonoscopy-confirmed CRC cases, the multitarget FIT identified 26 vs 23 with standard FIT. 

But the multitarget FIT also had more than double the number of false-positives than the standard FIT (347 vs 161, respectively).

Perhaps the most telling comparison occurred in scenario 2, with both tests set at the same low positivity threshold to minimize false-positives.

As expected, the two tests had similar positivity rates for advanced lesions, with the multitarget test correctly identifying 22 of 29 people with CRC, one fewer than the standard test. The protein-based test identified slightly more people with advanced lesions (156 vs 136 with the standard test), leading to a higher sensitivity for advanced lesions. 

Most notably, the protein-based test resulted in fewer false-positives than did the standard test (295 vs 311, respectively) , resulting in a slightly higher specificity.

In this scenario, “a single screening round might not have the biggest impact on cancer incidence and mortality,” the authors said, but the higher detection rate would still accumulate over 20 years of testing. The authors estimated that, under this scenario, substituting the multitarget FIT for the standard test in the Netherlands’ CRC screening program could reduce CRC incidence by 5% and CRC mortality by 4%.

Gerrit Meijer, MD, PhD, a pathologist at the Netherlands Cancer Institute, and colleagues recently launched a company called CRCbioscreen to commercialize this multitarget FIT for large-scale programs. The company›s priority is to develop and validate a clinical-grade test to sell to federal governments with national screening programs, such as those throughout Europe, Australia, and Asia, Dr. Meijer told this news organization. Dr. Meijer expects this process will take about 4 years.

The test will be developed for the US market, but with no nationwide screening program in the United States, future availability will depend on interest from providers and institutions, noted Dr. Meijer, who is also chief scientific officer at CRCbioscreen.

Overall, these three new multitarget stool-based CRC screening tests could help catch more cancers and advanced precancerous lesions. And, if the tests have a high enough specificity, a negative test result could also allow people to forgo screening colonoscopy. 

Still, people with a positive FIT finding would require follow-up colonoscopy, but about 10% of patients decline colonoscopy following an abnormal FIT, Mark A. Lewis, MD, director of gastrointestinal oncology at Intermountain Health in Murray, Utah, told this news organization last year. That means that even if precancerous lesions and CRC are being caught earlier, treatment can’t be started unless people follow through with colonoscopy.

A version of this article appeared on Medscape.com.

Multitarget stool-based tests are showing promise for colorectal cancer (CRC) screening in average-risk individuals and could edge out the current standard fecal immunochemical test (FIT).

These new tests aren’t radical departures from the standard FIT. Like the standard test, the multitarget FIT uses antibodies to test for hemoglobin in stool samples. But these multitarget approaches take the standard FIT a step further by testing for additional DNA, RNA, or protein biomarkers associated with CRC to help improve early detection.

Currently, the US Preventive Services Task Force (USPSTF) recommends two FIT tests — standard FIT and stool FIT-DNA — as well as a third noninvasive CRC screening test, guaiac fecal occult blood test (gFOBT). gFOBT detects heme, a component of hemoglobin, through a chemical reaction.

But both standard FIT and stool FIT-DNA come with caveats. Compared to the standard test, FIT-DNA tends to be better at detecting traces of blood in the stool, and thus can uncover more instances of CRC or other advanced lesions. The flipside is that the DNA test also often leads to more false-positive findings.

In fact, the American College of Physicians does not recommend stool FIT-DNA for screening, citing issues such as cost — more than $600 per test vs about $30 for standard FIT — and the greater likelihood of false-positives compared with both standard FIT and gFOBT.

Given these trade-offs with current noninvasive screening options, developing a FIT option that can improve early detection of CRC and advanced precancerous lesions without increasing false-positives could make a big difference in outcomes. 

Three new noninvasive multitarget tests under investigation — an updated DNA-based test, Cologuard 2.0 (Exact Sciences; Madison, WI); an RNA-based test, ColoSense (Geneoscopy; St Louis, MO); and a protein-based test from CRCbioscreen (Amsterdam, the Netherlands) — may be able to do just that. 
 

Cologuard 2.0: Multitarget Stool DNA-Based Test

An updated version of the stool FIT-DNA is currently under development. Dubbed Next Generation Cologuard, or Cologuard 2.0, this multitarget test detects three novel methylated DNA markers along with fecal hemoglobin.

In a recent trial comparing Cologuard 2.0 vs standard FIT, 20,176 participants aged 40 years or older were screened with Cologuard 2.0 as well as standard FIT before they all also received a colonoscopy. The researchers compared findings with Cologuard 2.0 and standard FIT, which used a positivity cutoff ≥ 20 mcg hemoglobin/g feces. 

The researchers then assessed Cologuard 2.0’s sensitivity (a gauge of how well it detects disease that is truly present) and specificity (a measure of how well a test indicates the absence of disease when no disease is present) compared with standard FIT and the original Cologuard test.

Overall, Cologuard 2.0 demonstrated better sensitivity for CRC than did standard FIT (93.9% vs 67.3%, respectively) and for advanced precancerous lesions (43.4% vs 23.3%). The next-generation test, for instance, identified 92 of 98 participants with colonoscopy-confirmed CRC diagnoses vs 66 cases using standard FIT.

Compared with the original Cologuard, Cologuard 2.0’s sensitivity improved slightly for CRC, from 92% to 93.9%,; for advanced precancerous lesions, from 42% to 43.4%; and for high-grade dysplasia, from 69% to 75%. Specificity also improved with the latest version, from 87% to 90.6%. 

However, Cologuard 2.0’s specificity for advanced neoplasia was worse than that of standard FIT (90.6% vs 94.8%, respectively), which would increase the likelihood of false-positive findings.

Despite its lower specificity compared with standard FIT, Cologuard 2.0 has several advantages. The test can identify more people with CRC and advanced precancerous lesions than the standard test and can lead to fewer false-positives than the original Cologuard test.

Cologuard maker Exact Sciences has submitted trial data to the US Food and Drug Administration (FDA) for approval.
 

Multitarget Stool RNA-Based Test

ColoSense, an RNA-based stool test, looks for eight RNA biomarkers associated with CRC. 

The company says that RNA-based testing has an advantage over DNA biomarker assays, such as the currently marketed Cologuard test, because it isn›t subject to the age-related changes in DNA methylation that can throw off the results from DNA assays. 

Like Cologuard 2.0, Geneoscopy’s Colosense test is under review by the FDA.

The data Geneoscopy submitted to the FDA came from the CRC-PREVENT trial, which included 8920 participants who were screened with both ColoSense and standard FIT before all had a colonoscopy. The participants ranged in age from 45 to 90 years, with 22% between 45 and 50 years old, a population recently added to the USPSTF screening recommendations. 

ColoSense showed higher sensitivity than standard FIT for the presence of CRC (94% vs 78%, respectively) and advanced adenomas (46% vs 29%). In the group aged 45-50 years, the RNA-based test had a sensitivity of 100% for CRC, correctly identifying all five people with colonoscopy-confirmed CRC, and 45% for advanced adenomas.

However, ColoSense was less specific than standard FIT compared with negative colonoscopy findings (88% vs 96%, respectively) and negative findings for advanced lesions or CRC (85.5% vs 94.9%); thus, it was more likely to lead to false-positive results.

Overall, the investigators said ColoSense is comparable to Cologuard — its chief market rival — in terms of sensitivity for CRC and advanced adenomas but has higher sensitivity for colorectal neoplasia in people aged 50 years or younger.
 

Multitarget Protein-Based Test

The multitarget protein-based FIT uses antibodies to test for two additional proteins: calprotectin, an inflammatory marker associated with CRC, and serpin family F member 2, a protease inhibitor thought to be upregulated in colon cancer. 

A 2021 study of 1284 patients found that the sensitivity of the multitarget protein-based test was 42.9% for advanced neoplasias compared with 37.3% with standard FIT. Its specificity was similar to that of standard FIT, at 96.6% for advanced neoplasias. 

In a more recent report published in The Lancet Oncology, the team modeled three scenarios comparing the two FIT tests. These scenarios used different cutoff values for a test to be positive for CRC or an advanced lesion.

Overall, the analysis included stool samples from 13,187 patients aged 55-75 years who were in the Netherlands’ national CRC screening program. Stool samples were evaluated with both the multitarget test and the standard FIT, using a positivity cutoff ≥ 47 mcg hemoglobin/g feces. Colonoscopy data were available for only 1270 participants. 

In scenario 1, the multitarget test had a lower threshold for a positive test and consequently identified more precancerous lesions than the standard FIT (828 vs 354, respectively). The multitarget FIT identified a few more CRC cases: Of 29 colonoscopy-confirmed CRC cases, the multitarget FIT identified 26 vs 23 with standard FIT. 

But the multitarget FIT also had more than double the number of false-positives than the standard FIT (347 vs 161, respectively).

Perhaps the most telling comparison occurred in scenario 2, with both tests set at the same low positivity threshold to minimize false-positives.

As expected, the two tests had similar positivity rates for advanced lesions, with the multitarget test correctly identifying 22 of 29 people with CRC, one fewer than the standard test. The protein-based test identified slightly more people with advanced lesions (156 vs 136 with the standard test), leading to a higher sensitivity for advanced lesions. 

Most notably, the protein-based test resulted in fewer false-positives than did the standard test (295 vs 311, respectively) , resulting in a slightly higher specificity.

In this scenario, “a single screening round might not have the biggest impact on cancer incidence and mortality,” the authors said, but the higher detection rate would still accumulate over 20 years of testing. The authors estimated that, under this scenario, substituting the multitarget FIT for the standard test in the Netherlands’ CRC screening program could reduce CRC incidence by 5% and CRC mortality by 4%.

Gerrit Meijer, MD, PhD, a pathologist at the Netherlands Cancer Institute, and colleagues recently launched a company called CRCbioscreen to commercialize this multitarget FIT for large-scale programs. The company›s priority is to develop and validate a clinical-grade test to sell to federal governments with national screening programs, such as those throughout Europe, Australia, and Asia, Dr. Meijer told this news organization. Dr. Meijer expects this process will take about 4 years.

The test will be developed for the US market, but with no nationwide screening program in the United States, future availability will depend on interest from providers and institutions, noted Dr. Meijer, who is also chief scientific officer at CRCbioscreen.

Overall, these three new multitarget stool-based CRC screening tests could help catch more cancers and advanced precancerous lesions. And, if the tests have a high enough specificity, a negative test result could also allow people to forgo screening colonoscopy. 

Still, people with a positive FIT finding would require follow-up colonoscopy, but about 10% of patients decline colonoscopy following an abnormal FIT, Mark A. Lewis, MD, director of gastrointestinal oncology at Intermountain Health in Murray, Utah, told this news organization last year. That means that even if precancerous lesions and CRC are being caught earlier, treatment can’t be started unless people follow through with colonoscopy.

A version of this article appeared on Medscape.com.

In recent years, innovative use of bispecific antibodies and CAR T-cell therapy has ushered in an era when many patients with relapsed/refractory acute lymphoblastic leukemia (ALL) — who once had prognoses of 6 months or less — now survive for multiple years with the malignancy, and some are cured.

The comparative benefits and limitations of these two treatments for r/r ALL were a topic for discussion at the Great Debates & Updates Hematological Malignancies conference, held April 5-6 in New York City.

“Every single patient with ALL should benefit from bispecific antibodies before getting CAR-T cells, and I want to make the case that everybody should get CAR T as well. But they should get blinatumomab before they get CAR T,” said Elias Jabbour, MD, of the MD Anderson Cancer Center at The University of Texas in Houston, whose presentation focused on the merits of bispecific antibodies.

MD Anderson Cancer Center

His argument was based on data indicating that patients have better chances of long-term remission with the use of bispecific antibodies when they are administered in an earlier round of salvage treatment — and the fact that patients who are not cured with these drugs can still achieve a lower disease burden and perform better on CAR T-cell therapy than those who don’t receive the drugs.

“When blinatumomab is used as a consolidation during the first salvage treatment and spaces out transplantation, 3-year overall survival increases in the relapse setting, deepening responses and reducing the rate of VOD (veno-occlusive disease). The safety and efficacy of CAR T depends on a disease burden. If you have a minimal residual disease (MRD), you have a safer outcome and a better outcome in the long run,” Dr. Jabbour explained.

This point of view is supported by data from the treatment of patients r/r ALL with low intensity chemotherapy + inotuzumab ozogamicin (Besponsa; Pfizer) +/- blinatumomab (Blincyto; Amgen), knows as Mini-HCVD + Ino +/-Blina. Trial members achieved a median overall survival (OS) rate of 17 months, a 3-year survival rate of 42%, and an overall MRD negativity rate of 85%.

Dr. Jabbour noted that blinatumomab has its limitations. Generally, this treatment is administered intravenously every few weeks and can be cumbersome for patients who must travel to an infusion center. However, data from a phase 1b trial of single agent subcutaneous blinatumomab for advanced ALL has demonstrated that this formulation can be effective and can lead to MRD negativity, possibly paving the way for easier administration of the drug.

Aditi Shastri, MD, a leukemia specialist at New York’s Montefiore Medical Center who attended the debate, agreed that the data presented did support Dr. Jabbour’s contention that subcutaneous blinatumomab could make treatment available to even more people with r/r ALL. “It’s easier to administer than the blina pump and could act as a bridge to curative therapies like AlloHSCT,” she said.

Jae Park, MD, a leukemia and cellular therapy specialist at Memorial Sloan Kettering Cancer Center in New York City, argued that CAR T is the most potent therapy for r/r ALL. Dr. Park agreed that inotuzumab and blinatumomab have yielded tremendous progress in the treatment of patients with r/r ALL, but he noted that bispecific antibodies lack some of the advantages of CAR T.

Memorial Sloan Kettering Cancer Center

In recent years, innovative use of bispecific antibodies and CAR T-cell therapy has ushered in an era when many patients with relapsed/refractory acute lymphoblastic leukemia (ALL) — who once had prognoses of 6 months or less — now survive for multiple years with the malignancy, and some are cured.

The comparative benefits and limitations of these two treatments for r/r ALL were a topic for discussion at the Great Debates & Updates Hematological Malignancies conference, held April 5-6 in New York City.

“Every single patient with ALL should benefit from bispecific antibodies before getting CAR-T cells, and I want to make the case that everybody should get CAR T as well. But they should get blinatumomab before they get CAR T,” said Elias Jabbour, MD, of the MD Anderson Cancer Center at The University of Texas in Houston, whose presentation focused on the merits of bispecific antibodies.

MD Anderson Cancer Center

His argument was based on data indicating that patients have better chances of long-term remission with the use of bispecific antibodies when they are administered in an earlier round of salvage treatment — and the fact that patients who are not cured with these drugs can still achieve a lower disease burden and perform better on CAR T-cell therapy than those who don’t receive the drugs.

“When blinatumomab is used as a consolidation during the first salvage treatment and spaces out transplantation, 3-year overall survival increases in the relapse setting, deepening responses and reducing the rate of VOD (veno-occlusive disease). The safety and efficacy of CAR T depends on a disease burden. If you have a minimal residual disease (MRD), you have a safer outcome and a better outcome in the long run,” Dr. Jabbour explained.

This point of view is supported by data from the treatment of patients r/r ALL with low intensity chemotherapy + inotuzumab ozogamicin (Besponsa; Pfizer) +/- blinatumomab (Blincyto; Amgen), knows as Mini-HCVD + Ino +/-Blina. Trial members achieved a median overall survival (OS) rate of 17 months, a 3-year survival rate of 42%, and an overall MRD negativity rate of 85%.

Dr. Jabbour noted that blinatumomab has its limitations. Generally, this treatment is administered intravenously every few weeks and can be cumbersome for patients who must travel to an infusion center. However, data from a phase 1b trial of single agent subcutaneous blinatumomab for advanced ALL has demonstrated that this formulation can be effective and can lead to MRD negativity, possibly paving the way for easier administration of the drug.

Aditi Shastri, MD, a leukemia specialist at New York’s Montefiore Medical Center who attended the debate, agreed that the data presented did support Dr. Jabbour’s contention that subcutaneous blinatumomab could make treatment available to even more people with r/r ALL. “It’s easier to administer than the blina pump and could act as a bridge to curative therapies like AlloHSCT,” she said.

Jae Park, MD, a leukemia and cellular therapy specialist at Memorial Sloan Kettering Cancer Center in New York City, argued that CAR T is the most potent therapy for r/r ALL. Dr. Park agreed that inotuzumab and blinatumomab have yielded tremendous progress in the treatment of patients with r/r ALL, but he noted that bispecific antibodies lack some of the advantages of CAR T.

Memorial Sloan Kettering Cancer Center

In recent years, innovative use of bispecific antibodies and CAR T-cell therapy has ushered in an era when many patients with relapsed/refractory acute lymphoblastic leukemia (ALL) — who once had prognoses of 6 months or less — now survive for multiple years with the malignancy, and some are cured.

The comparative benefits and limitations of these two treatments for r/r ALL were a topic for discussion at the Great Debates & Updates Hematological Malignancies conference, held April 5-6 in New York City.

“Every single patient with ALL should benefit from bispecific antibodies before getting CAR-T cells, and I want to make the case that everybody should get CAR T as well. But they should get blinatumomab before they get CAR T,” said Elias Jabbour, MD, of the MD Anderson Cancer Center at The University of Texas in Houston, whose presentation focused on the merits of bispecific antibodies.

MD Anderson Cancer Center

His argument was based on data indicating that patients have better chances of long-term remission with the use of bispecific antibodies when they are administered in an earlier round of salvage treatment — and the fact that patients who are not cured with these drugs can still achieve a lower disease burden and perform better on CAR T-cell therapy than those who don’t receive the drugs.

“When blinatumomab is used as a consolidation during the first salvage treatment and spaces out transplantation, 3-year overall survival increases in the relapse setting, deepening responses and reducing the rate of VOD (veno-occlusive disease). The safety and efficacy of CAR T depends on a disease burden. If you have a minimal residual disease (MRD), you have a safer outcome and a better outcome in the long run,” Dr. Jabbour explained.

This point of view is supported by data from the treatment of patients r/r ALL with low intensity chemotherapy + inotuzumab ozogamicin (Besponsa; Pfizer) +/- blinatumomab (Blincyto; Amgen), knows as Mini-HCVD + Ino +/-Blina. Trial members achieved a median overall survival (OS) rate of 17 months, a 3-year survival rate of 42%, and an overall MRD negativity rate of 85%.

Dr. Jabbour noted that blinatumomab has its limitations. Generally, this treatment is administered intravenously every few weeks and can be cumbersome for patients who must travel to an infusion center. However, data from a phase 1b trial of single agent subcutaneous blinatumomab for advanced ALL has demonstrated that this formulation can be effective and can lead to MRD negativity, possibly paving the way for easier administration of the drug.

Aditi Shastri, MD, a leukemia specialist at New York’s Montefiore Medical Center who attended the debate, agreed that the data presented did support Dr. Jabbour’s contention that subcutaneous blinatumomab could make treatment available to even more people with r/r ALL. “It’s easier to administer than the blina pump and could act as a bridge to curative therapies like AlloHSCT,” she said.

Jae Park, MD, a leukemia and cellular therapy specialist at Memorial Sloan Kettering Cancer Center in New York City, argued that CAR T is the most potent therapy for r/r ALL. Dr. Park agreed that inotuzumab and blinatumomab have yielded tremendous progress in the treatment of patients with r/r ALL, but he noted that bispecific antibodies lack some of the advantages of CAR T.

Memorial Sloan Kettering Cancer Center

The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.

The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.

Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”

The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.

Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.

Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.

Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.

“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
 

Filling the Leadership Gap

Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”

Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.

In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”

Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.

Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.

APSARD felt it was time to act, said Dr. Goodman.

“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
 

Ensuring Psychiatrist Buy-In

Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.

Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.

To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.

Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.

The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.

The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
 

Critical Educational Tool

“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.

Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.

Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.

The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.

“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.

Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.

With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.

Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.

Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
 

Offering Standards, Dispelling Myths

Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.

Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.

Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.

Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.

If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.

“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”

While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.

Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.

And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.

Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.

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

The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.

The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.

Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”

The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.

Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.

Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.

Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.

“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
 

Filling the Leadership Gap

Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”

Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.

In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”

Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.

Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.

APSARD felt it was time to act, said Dr. Goodman.

“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
 

Ensuring Psychiatrist Buy-In

Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.

Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.

To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.

Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.

The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.

The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
 

Critical Educational Tool

“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.

Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.

Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.

The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.

“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.

Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.

With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.

Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.

Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
 

Offering Standards, Dispelling Myths

Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.

Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.

Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.

Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.

If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.

“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”

While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.

Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.

And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.

Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.

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

The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.

The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.

Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”

The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.

Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.

Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.

Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.

“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
 

Filling the Leadership Gap

Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”

Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.

In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”

Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.

Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.

APSARD felt it was time to act, said Dr. Goodman.

“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
 

Ensuring Psychiatrist Buy-In

Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.

Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.

To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.

Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.

The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.

The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
 

Critical Educational Tool

“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.

Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.

Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.

The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.

“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.

Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.

With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.

Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.

Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
 

Offering Standards, Dispelling Myths

Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.

Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.

Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.

Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.

If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.

“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”

While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.

Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.

And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.

Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.

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

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

• Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
• This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
• Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
• Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

• During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
• Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
• Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
• Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

• Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
• This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
• Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
• Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

• During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
• Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
• Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
• Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with rheumatoid arthritis–associated interstitial lung disease (RA-ILD) have a high risk for serious and fatal infections, with age, inflammation, and corticosteroid therapy further increasing this risk.

METHODOLOGY:

• Patients with RA who have extra-articular manifestations such as ILD are highly susceptible to infections, but information on the types of infections, risk factors, and associations of infections with hospitalization and mortality is limited.
• This prospective multicenter cohort study evaluated infections in a cohort of 148 patients with RA-ILD (average age, 70 years; 57% women) recruited from 11 university hospitals in Spain between March 2015 and March 2023.
• Joint, lung, and any infection-related variables were evaluated using clinical and laboratory evaluations at baseline and selected time points till the end of the follow-up period (mean, 56.7 months).
• Researchers also investigated the common infectious sites, the etiology of the infection, vaccination status, variables associated with lung function, and clinical-therapeutic variables associated with RA.

TAKEAWAY:

• During the follow-up period, almost all (96%) patients had at least one infection, with the median time to first infection being 21.2 months and 65% of the deaths being directly related to infections.
• Respiratory infections were the most common first infections (74%) and led to death in 80% of the patients. Urinary tract (9.9%) and skin and soft tissue (9.1%) infections were the second and third most common first infections, respectively.
• Most infections were caused by SARS-CoV-2 (33.5%), Streptococcus pneumoniae (11.9%), Escherichia coli (11.9%), and Pseudomonas aeruginosa (11.1%), with mortality at 25.8% for SARS-CoV-2, 12.9% for P aeruginosa (12.9%), and 9.6% for pneumococci (9.6%).
• Increased age, disease activity, and the use of corticosteroids were associated with an elevated risk for infection and mortality in patients with RA-ILD.

IN PRACTICE:

“Our results demonstrate a high occurrence of serious infections among these patients, occurring early, recurring frequently, and proving fatal in 65% of cases,” the authors wrote.

SOURCE:

This study was led by Natalia Mena-Vázquez, MD, PhD, from Instituto de Investigación Biomédica de Málaga-Plataforma Bionand, Málaga, Spain, and published online March 27 in Frontiers in Immunology.

LIMITATIONS:

The findings of this study have been affected by the COVID-19 pandemic. The lack of a control group also limited the ability of this study to establish any causal relationships between ILD and the clinical outcomes analyzed.

DISCLOSURE:

This study was supported by Redes de Investigación Cooperativa Orientadas a Resultados en Salud and Fundación Andaluza de Reumatología. The authors declared having no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series by this news organization that tells these stories.

It was my first night off after 12 days. It was a Friday night, and I went to a bar in Naples to get a beer with some friends. As it turned out, it wasn’t a night off after all.

As soon as we got inside, we heard over the speaker that they needed medical personnel and to please go to the left side of the bar. I thought it would be syncope or something like that.

I went over there and saw a woman holding up a man. He was basically leaning all over her. The light was low, and the music was pounding. I started to assess him and tried to get him to answer me. No response. I checked for pulses — nothing.

Now, I’m in a bar, right? It’s a cardiac arrest. The first thing you think is overdose or alcohol. I asked the woman if the man was doing any drugs. She said she didn’t know. Turns out they were both employees. He was a bouncer and a DJ.

The woman helped me lower him to the floor. I checked again for a pulse. Still nothing. I said, “Call 911,” and started compressions.

The difficult part was the place was completely dark. I knew where his body was on the floor. I could see his chest. But I couldn’t see his face at all.

It was also extremely loud with the music thumping. After a while, they finally shut it off.

Pretty soon, the security personnel from the bar brought me an automated external defibrillator, and it showed the man was having V-fib arrest. I shocked him. Still no pulse. I continued with cardiopulmonary resuscitation (CPR).

I hadn’t noticed, but lots of people were crowding around us. Somebody came up and said, “He’s my friend. He has a 9-year-old daughter. He can’t die. Let me help with the compressions.” I was like, “Go for it.”

The guy started kind of pushing on the man’s abdomen. He had no idea how to do compressions. I said, “Okay, let me take over again.”

Out of the crowd, nobody else volunteered to help. No one asked me, “Hey, what can I do?” Meanwhile, I found out later that someone was filming the whole thing on their phone.

But what the guy said about the man’s young daughter stayed in my brain. I thought, we need to keep going.

I did more compressions and shocked him again. Still no pulse. At that point, the police and emergency medical services showed up. They checked, nothing had changed, so they got him into the ambulance.

I asked one of the paramedics, “Where are you taking him? I can call ahead.”

But he said, “That’s HIPAA. We can’t tell you.” They also wouldn’t let me go with him in the ambulance.

“I have an active Florida license, and I work in the ICU [intensive care unit],” I said.

“No, we need to follow our protocol,” he replied.

I understood that, but I just wanted to help.

It was around 10:30 PM by then, and I was drenched in sweat. I had to go home. The first thing I did after taking a shower was open the computer and check my system. I needed to find out what happened to the guy.

I was looking for admissions, and I didn’t see him. I called the main hospital downtown and the one in North Naples. I couldn’t find him anywhere. I stayed up until almost 1:00 AM checking for his name. At that point I thought, okay, maybe he died.

The next night, Saturday, I was home and got a call from one of my colleagues. “Hey, were you in a bar yesterday? Did you do CPR on somebody?”

“How did you know?” I said.

He said the paramedics had described me — “a tall doctor with glasses who was a nice guy.” It was funny that he knew that was me.

He told me, “The guy’s alive. He’s sick and needs to be put on dialysis, but he’s alive.”

Apparently, the guy had gone to the emergency department at North Naples, and the doctors in the emergency room (ER) worked on him for over an hour. They did continuous CPR and shocked him for close to 40 minutes. They finally got his pulse back, and after that, he was transferred to the main hospital ICU. They didn’t admit him at the ER, which was why I couldn’t find his name.

On Sunday, I was checking my patients’ charts for the ICU that coming week. And there he was. I saw his name and the documentation by the ED that CPR was provided by a critical care doctor in the field. He was still alive. That gave me so much joy.

So, the man I had helped became my patient. When I saw him on Monday, he was intubated and needed dialysis. I finally saw his face and thought, Oh, so that’s what you look like. I hadn’t realized he was only 39 years old.

When he was awake, I explained to him I was the doctor that provided CPR at the bar. He was very grateful, but of course, he didn’t remember anything.

Eventually, I met his daughter, and she just said, “Thank you for allowing me to have my dad.”

The funny part is that he broke his leg. Well, that’s not funny, but no one had any idea how it happened. That was his only complaint. He was asking me, “Doctor, how did you break my leg?”

“Hey, I have no idea how you broke your leg,” I replied. “I was trying to save your life.”

He was in the hospital for almost a month but made a full recovery. The amazing part: After all the evaluations, he has no neurological deficits. He’s back to a normal life now.

They never found a cause for the cardiac arrest. I mean, he had an ejection fraction of 10%. All my money was on something drug related, but that wasn’t the case. They’d done a cardiac cut, and there was no obstruction. They couldn’t find a reason.

We’ve become friends. He still works as a DJ at the bar. He changed his name to “DJ the Survivor” or something like that.

Sometimes, he’ll text me: “Doctor, what are you doing? You want to come down to the bar?”

I’m like, “No. I don’t.”

It’s been more than a year, but I remember every detail. When you go into medicine, you dream that one day you’ll be able to say, “I saved somebody.”

He texted me a year later and told me he’s celebrating two birthdays now. He said, “I’m turning 1 year old today!”

I think about the value of life. How we can take it for granted. We think, I’m young, nothing is going to happen to me. But this guy was 39. He went to work and died that night.

I was able to help bring him back. That makes me thankful for every day.

Jose Valle Giler, MD, is a pulmonary, critical care, and sleep medicine physician at NCH Healthcare System in Naples, Florida.

A version of this article appeared on Medscape.com .

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series by this news organization that tells these stories.

It was my first night off after 12 days. It was a Friday night, and I went to a bar in Naples to get a beer with some friends. As it turned out, it wasn’t a night off after all.

As soon as we got inside, we heard over the speaker that they needed medical personnel and to please go to the left side of the bar. I thought it would be syncope or something like that.

I went over there and saw a woman holding up a man. He was basically leaning all over her. The light was low, and the music was pounding. I started to assess him and tried to get him to answer me. No response. I checked for pulses — nothing.

Now, I’m in a bar, right? It’s a cardiac arrest. The first thing you think is overdose or alcohol. I asked the woman if the man was doing any drugs. She said she didn’t know. Turns out they were both employees. He was a bouncer and a DJ.

The woman helped me lower him to the floor. I checked again for a pulse. Still nothing. I said, “Call 911,” and started compressions.

The difficult part was the place was completely dark. I knew where his body was on the floor. I could see his chest. But I couldn’t see his face at all.

It was also extremely loud with the music thumping. After a while, they finally shut it off.

Pretty soon, the security personnel from the bar brought me an automated external defibrillator, and it showed the man was having V-fib arrest. I shocked him. Still no pulse. I continued with cardiopulmonary resuscitation (CPR).

I hadn’t noticed, but lots of people were crowding around us. Somebody came up and said, “He’s my friend. He has a 9-year-old daughter. He can’t die. Let me help with the compressions.” I was like, “Go for it.”

The guy started kind of pushing on the man’s abdomen. He had no idea how to do compressions. I said, “Okay, let me take over again.”

Out of the crowd, nobody else volunteered to help. No one asked me, “Hey, what can I do?” Meanwhile, I found out later that someone was filming the whole thing on their phone.

But what the guy said about the man’s young daughter stayed in my brain. I thought, we need to keep going.

I did more compressions and shocked him again. Still no pulse. At that point, the police and emergency medical services showed up. They checked, nothing had changed, so they got him into the ambulance.

I asked one of the paramedics, “Where are you taking him? I can call ahead.”

But he said, “That’s HIPAA. We can’t tell you.” They also wouldn’t let me go with him in the ambulance.

“I have an active Florida license, and I work in the ICU [intensive care unit],” I said.

“No, we need to follow our protocol,” he replied.

I understood that, but I just wanted to help.

It was around 10:30 PM by then, and I was drenched in sweat. I had to go home. The first thing I did after taking a shower was open the computer and check my system. I needed to find out what happened to the guy.

I was looking for admissions, and I didn’t see him. I called the main hospital downtown and the one in North Naples. I couldn’t find him anywhere. I stayed up until almost 1:00 AM checking for his name. At that point I thought, okay, maybe he died.

The next night, Saturday, I was home and got a call from one of my colleagues. “Hey, were you in a bar yesterday? Did you do CPR on somebody?”

“How did you know?” I said.

He said the paramedics had described me — “a tall doctor with glasses who was a nice guy.” It was funny that he knew that was me.

He told me, “The guy’s alive. He’s sick and needs to be put on dialysis, but he’s alive.”

Apparently, the guy had gone to the emergency department at North Naples, and the doctors in the emergency room (ER) worked on him for over an hour. They did continuous CPR and shocked him for close to 40 minutes. They finally got his pulse back, and after that, he was transferred to the main hospital ICU. They didn’t admit him at the ER, which was why I couldn’t find his name.

On Sunday, I was checking my patients’ charts for the ICU that coming week. And there he was. I saw his name and the documentation by the ED that CPR was provided by a critical care doctor in the field. He was still alive. That gave me so much joy.

So, the man I had helped became my patient. When I saw him on Monday, he was intubated and needed dialysis. I finally saw his face and thought, Oh, so that’s what you look like. I hadn’t realized he was only 39 years old.

When he was awake, I explained to him I was the doctor that provided CPR at the bar. He was very grateful, but of course, he didn’t remember anything.

Eventually, I met his daughter, and she just said, “Thank you for allowing me to have my dad.”

The funny part is that he broke his leg. Well, that’s not funny, but no one had any idea how it happened. That was his only complaint. He was asking me, “Doctor, how did you break my leg?”

“Hey, I have no idea how you broke your leg,” I replied. “I was trying to save your life.”

He was in the hospital for almost a month but made a full recovery. The amazing part: After all the evaluations, he has no neurological deficits. He’s back to a normal life now.

They never found a cause for the cardiac arrest. I mean, he had an ejection fraction of 10%. All my money was on something drug related, but that wasn’t the case. They’d done a cardiac cut, and there was no obstruction. They couldn’t find a reason.

We’ve become friends. He still works as a DJ at the bar. He changed his name to “DJ the Survivor” or something like that.

Sometimes, he’ll text me: “Doctor, what are you doing? You want to come down to the bar?”

I’m like, “No. I don’t.”

It’s been more than a year, but I remember every detail. When you go into medicine, you dream that one day you’ll be able to say, “I saved somebody.”

He texted me a year later and told me he’s celebrating two birthdays now. He said, “I’m turning 1 year old today!”

I think about the value of life. How we can take it for granted. We think, I’m young, nothing is going to happen to me. But this guy was 39. He went to work and died that night.

I was able to help bring him back. That makes me thankful for every day.

Jose Valle Giler, MD, is a pulmonary, critical care, and sleep medicine physician at NCH Healthcare System in Naples, Florida.

A version of this article appeared on Medscape.com .

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series by this news organization that tells these stories.

It was my first night off after 12 days. It was a Friday night, and I went to a bar in Naples to get a beer with some friends. As it turned out, it wasn’t a night off after all.

As soon as we got inside, we heard over the speaker that they needed medical personnel and to please go to the left side of the bar. I thought it would be syncope or something like that.

I went over there and saw a woman holding up a man. He was basically leaning all over her. The light was low, and the music was pounding. I started to assess him and tried to get him to answer me. No response. I checked for pulses — nothing.

Now, I’m in a bar, right? It’s a cardiac arrest. The first thing you think is overdose or alcohol. I asked the woman if the man was doing any drugs. She said she didn’t know. Turns out they were both employees. He was a bouncer and a DJ.

The woman helped me lower him to the floor. I checked again for a pulse. Still nothing. I said, “Call 911,” and started compressions.

The difficult part was the place was completely dark. I knew where his body was on the floor. I could see his chest. But I couldn’t see his face at all.

It was also extremely loud with the music thumping. After a while, they finally shut it off.

Pretty soon, the security personnel from the bar brought me an automated external defibrillator, and it showed the man was having V-fib arrest. I shocked him. Still no pulse. I continued with cardiopulmonary resuscitation (CPR).

I hadn’t noticed, but lots of people were crowding around us. Somebody came up and said, “He’s my friend. He has a 9-year-old daughter. He can’t die. Let me help with the compressions.” I was like, “Go for it.”

The guy started kind of pushing on the man’s abdomen. He had no idea how to do compressions. I said, “Okay, let me take over again.”

Out of the crowd, nobody else volunteered to help. No one asked me, “Hey, what can I do?” Meanwhile, I found out later that someone was filming the whole thing on their phone.

But what the guy said about the man’s young daughter stayed in my brain. I thought, we need to keep going.

I did more compressions and shocked him again. Still no pulse. At that point, the police and emergency medical services showed up. They checked, nothing had changed, so they got him into the ambulance.

I asked one of the paramedics, “Where are you taking him? I can call ahead.”

But he said, “That’s HIPAA. We can’t tell you.” They also wouldn’t let me go with him in the ambulance.

“I have an active Florida license, and I work in the ICU [intensive care unit],” I said.

“No, we need to follow our protocol,” he replied.

I understood that, but I just wanted to help.

It was around 10:30 PM by then, and I was drenched in sweat. I had to go home. The first thing I did after taking a shower was open the computer and check my system. I needed to find out what happened to the guy.

I was looking for admissions, and I didn’t see him. I called the main hospital downtown and the one in North Naples. I couldn’t find him anywhere. I stayed up until almost 1:00 AM checking for his name. At that point I thought, okay, maybe he died.

The next night, Saturday, I was home and got a call from one of my colleagues. “Hey, were you in a bar yesterday? Did you do CPR on somebody?”

“How did you know?” I said.

He said the paramedics had described me — “a tall doctor with glasses who was a nice guy.” It was funny that he knew that was me.

He told me, “The guy’s alive. He’s sick and needs to be put on dialysis, but he’s alive.”

Apparently, the guy had gone to the emergency department at North Naples, and the doctors in the emergency room (ER) worked on him for over an hour. They did continuous CPR and shocked him for close to 40 minutes. They finally got his pulse back, and after that, he was transferred to the main hospital ICU. They didn’t admit him at the ER, which was why I couldn’t find his name.

On Sunday, I was checking my patients’ charts for the ICU that coming week. And there he was. I saw his name and the documentation by the ED that CPR was provided by a critical care doctor in the field. He was still alive. That gave me so much joy.

So, the man I had helped became my patient. When I saw him on Monday, he was intubated and needed dialysis. I finally saw his face and thought, Oh, so that’s what you look like. I hadn’t realized he was only 39 years old.

When he was awake, I explained to him I was the doctor that provided CPR at the bar. He was very grateful, but of course, he didn’t remember anything.

Eventually, I met his daughter, and she just said, “Thank you for allowing me to have my dad.”

The funny part is that he broke his leg. Well, that’s not funny, but no one had any idea how it happened. That was his only complaint. He was asking me, “Doctor, how did you break my leg?”

“Hey, I have no idea how you broke your leg,” I replied. “I was trying to save your life.”

He was in the hospital for almost a month but made a full recovery. The amazing part: After all the evaluations, he has no neurological deficits. He’s back to a normal life now.

They never found a cause for the cardiac arrest. I mean, he had an ejection fraction of 10%. All my money was on something drug related, but that wasn’t the case. They’d done a cardiac cut, and there was no obstruction. They couldn’t find a reason.

We’ve become friends. He still works as a DJ at the bar. He changed his name to “DJ the Survivor” or something like that.

Sometimes, he’ll text me: “Doctor, what are you doing? You want to come down to the bar?”

I’m like, “No. I don’t.”

It’s been more than a year, but I remember every detail. When you go into medicine, you dream that one day you’ll be able to say, “I saved somebody.”

He texted me a year later and told me he’s celebrating two birthdays now. He said, “I’m turning 1 year old today!”

I think about the value of life. How we can take it for granted. We think, I’m young, nothing is going to happen to me. But this guy was 39. He went to work and died that night.

I was able to help bring him back. That makes me thankful for every day.

Jose Valle Giler, MD, is a pulmonary, critical care, and sleep medicine physician at NCH Healthcare System in Naples, Florida.

A version of this article appeared on Medscape.com .

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.