TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

People infected multiple times with COVID-19 are more likely to develop long COVID, and most never fully recover from the condition. Those are two of the most striking findings of a comprehensive new research study of 138,000 veterans.

Lead researcher Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, spoke with this news organization about his team’s findings, what we know – and don’t – about long COVID, and what it means for physicians treating patients with the condition.

Excerpts of the interview follow.

Your research concluded that for those infected early in the pandemic, some long COVID symptoms declined over 2 years, but some did not. You have also concluded that long COVID is a chronic disease. Why?

We’ve been in this journey a little bit more than three and a half years. Some patients do experience some recovery. But that’s not the norm. Most people do not really fully recover. The health trajectory for people with long COVID is really very heterogeneous. There is no one-size-fits-all. There’s really no one line that I could give you that could cover all your patients. But it is very, very, very clear that a bunch of them experienced long COVID for sure; that’s really happening.

It happened in the pre-Delta era and in the Delta era, and with Omicron subvariants, even now. There are people who think, “This is a nothing-burger anymore,” or “It’s not an issue anymore.” It’s still happening with the current variants. Vaccines do reduce risk for long COVID, but do not completely eliminate the risk for long COVID.

You work with patients with long COVID in the clinic and also analyze data from thousands more. If long COVID does not go away, what should doctors look for in everyday practice that will help them recognize and help patients with long COVID?

Long COVID is not uncommon. We see it in the clinic in large numbers. Whatever clinic you’re running – if you’re running a cardiology clinic, or a nephrology clinic, or diabetes, or primary care – probably some of your people have it. You may not know about it. They may not tell you about it. You may not recognize it.

Not all long COVID is the same, and that’s really what makes it complex and makes it really hard to deal with in the clinic. But that’s the reality that we’re all dealing with. And it’s multisystemic; it’s not like it affects the heart only, the brain only, or the autonomic nervous system only. It does not behave in the same way in different individuals – they may have different manifestations, various health trajectories, and different outcomes. It’s important for doctors to get up to speed on long COVID as a multisystem illness.

Management at this point is really managing the symptoms. We don’t have a treatment for it; we don’t have a cure for it.

Some patients experience what you’ve described as partial recovery. What does that look like?

Some individuals do experience some recovery over time, but for most individuals, the recovery is long and arduous. Long COVID can last with them for many years. Some people may come back to the clinic and say, “I’m doing better,” but if you really flesh it out and dig deeper, they didn’t do better; they adjusted to a new baseline. They used to walk the dog three to four blocks, and now they walk the dog only half a block. They used to do an activity with their partner every Saturday or Sunday, and now they do half of that.

If you’re a physician, a primary care provider, or any other provider who is dealing with a patient with long COVID, know that this is really happening. It can happen even in vaccinated individuals. The presentation is heterogeneous. Some people may present to you with and say. “Well, before I had COVID I was mentally sharp and now having I’m having difficulty with memory, etc.” It can sometimes present as fatigue or postexertional malaise.

In some instances, it can present as sleep problems. It can present as what we call postural orthostatic tachycardia syndrome (POTS). Those people get a significant increase in heart rate with postural changes.

What the most important thing we can we learn from the emergence of long COVID?

This whole thing taught us that infections can cause chronic disease. That’s really the No. 1 lesson that I take from this pandemic – that infections can cause chronic disease.

Looking at only acute illness from COVID is really only looking at the tip of the iceberg. Beneath that tip of the iceberg lies this hidden toll of disease that we don’t really talk about that much.

This pandemic shone a very, very good light on the idea that there is really an intimate connection between infections and chronic disease. It was really hardwired into our medical training as doctors that most infections, when people get over the hump of the acute phase of the disease, it’s all behind them. I think long COVID has humbled us in many, many ways, but chief among those is the realization – the stark realization – that infections can cause chronic disease.

That’s really going back to your [first] question: What does it mean that some people are not recovering? They actually have chronic illness. I’m hoping that we will find a treatment, that we’ll start finding things that would help them get back to baseline. But at this point in time, what we’re dealing with is people with chronic illness or chronic disease that may continue to affect them for many years to come in the absence of a treatment or a cure.

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

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.