Treatment with sacubitril/valsartan, a pillar of therapy for patients with chronic heart failure with below-normal ejection fraction, came suggestively close to showing efficacy for preventing cardiovascular death or heart failure events in patients who have just had an MI but have no history of heart failure in a controlled trial with more than 5,600 patients.

Although sacubitril/valsartan (Entresto) fell short of producing a significant benefit, it did show good safety that was similar to the study’s comparator treatment, ramipril, an agent from the angiotensin-converting enzyme inhibitor class that is a mainstay of treatment in these patients.

“To say that, with no run-in, sacubitril/valsartan is as well tolerated and as safe as one of the best-studied ACE inhibitors – ramipril – in acutely ill MI patients, is a big statement,” said Marc A. Pfeffer, MD, at the annual scientific sessions of the American College of Cardiology. This high level of safety without gradual uptitration of sacubitril/valsartan (Entresto) “should lower barriers” to broader use of the dual-drug formulation for its approved indication in patients with chronic heart failure, especially patients with a left ventricular ejection fraction that is below normal. In addition, results from the PARADISE-MI trial suggested that “patients seemed to benefit before they develop heart failure. We couldn’t prove that, but we should build on this, and make it easier for patients to use this treatment,” Dr. Pfeffer said during a press briefing following his talk at the sessions.

Preventing heart failures to come

Treatment with sacubitril/valsartan in acute MI patients within a few days of their event “is perhaps addressing prevention of the heart failure that’s to come,” commented Lynne W. Stevenson, MD, designated discussant for the report and professor of medicine at Vanderbilt University Medical Center in Nashville. “Patients who are destined to develop heart failure are beginning their treatment early. The subgroup analyses suggest that it’s the sicker patients who benefited the most,” she said.

But Dr. Pfeffer stressed that “I don’t think this is a subgroup discussion. I would like to pursue this, but that’s up to the sponsor,” Novartis, the company that markets sacubitril/valsartan.

‘Exceedingly reassuring’ safety

The safety data that Dr. Pfeffer reported “are exceedingly reassuring. We didn’t see a signal of harm, and in some of the exploratory endpoints there was some evidence of benefit, so we need to encourage you to continue,” commented Mary N. Walsh, MD, medical director of the heart failure and cardiac transplantation program at Ascension St. Vincent Heart Center of Indiana in Indianapolis.

The PARADISE-MI (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) trial enrolled 5,669 patients with no history of heart failure within an average of 4 days following an acute MI at 495 sites in 41 countries during 2016-2020, with 8% of enrolled patients from the United States. Patients averaged 64 years of age, about three-quarters were men, about 43% had a history of diabetes, and only 1% were Black; Dr. Pfeffer noted that this is because most patients came from countries with low Black populations. The enrollment criteria required a left ventricular ejection fraction no greater than 40%, and among the enrolled patients this averaged about 37%.

A 10% nonsignificant relative risk reduction for the primary endpoint

The study’s primary endpoint was the combined first-event rate of cardiovascular death, hospitalization for heart failure, or an outpatient visit for heart failure. During a median follow-up of 23 months, this occurred at a rate of 7.4/100 patient years in the ramipril arm and 6.7/100 patient years in the sacubitril/valsartan arm, a 10% relative risk reduction with sacubitril/valsartan that was not significant, which meant all other efficacy analyses were exploratory, Dr. Pfeffer stressed.

Several secondary efficacy analyses showed significant benefits from sacubitril/valsartan, compared with ramipril, including the total number of events that comprised the primary endpoint, with a 21% relative risk reduction associated with sacubitril/valsartan, as well as investigator-reported events. The primary-endpoint benefit from sacubitril/valsartan was also significant in two subgroup analyses: patients aged 65 years or older (roughly half the study cohort), who had a 24% relative risk reduction on sacubitril/valsartan, compared with ramipril, and the 88% of patients who received treatment with percutaneous coronary intervention for their acute MI, who had a 19% relative risk reduction on sacubitril/valsartan, compared with patients who received ramipril.

The study’s safety data showed nearly identical rates in the two treatment arms for total adverse events, serious adverse events, adverse events that led to stopping the study drug, as well as in laboratory measures. The biggest between-treatment differences were a modest excess of hypotension on sacubitril valsartan, 28%, compared with 22% on ramipril, and a modest excess rate of cough on ramipril, 13%, compared with 9% on sacubitril/valsartan.

The added insight the results provide about sacubitril/valsartan comes at a time when U.S. patients continue to struggle to get health insurance coverage for an agent that has been approved for U.S. use in treating heart failure since 2015.

“Our patients do not have access to this important treatment,” declared Dr. Walsh during the press briefing. “The prior authorization process is unbelievable, and some patients have no access unless they pay the full cost on their own. This is an important, real-world problem that we face with this drug.”

PARADISE-MI was sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Pfeffer has received research funding from and is a consultant to Novartis. He is also a consultant to AstraZeneca, Boehringer Ingelheim, Corvidia, DalCor, Eli Lilly, GlaxoSmithKline, Novo Nordisk, Peerbridge, and Sanofi, and he holds equity in DalCor and Peerbridge. Dr. Stevenson has received honoraria from LivaNova and has received research support from Abbott. Dr. Walsh had no disclosures.

[email protected]

Treatment with sacubitril/valsartan, a pillar of therapy for patients with chronic heart failure with below-normal ejection fraction, came suggestively close to showing efficacy for preventing cardiovascular death or heart failure events in patients who have just had an MI but have no history of heart failure in a controlled trial with more than 5,600 patients.

Although sacubitril/valsartan (Entresto) fell short of producing a significant benefit, it did show good safety that was similar to the study’s comparator treatment, ramipril, an agent from the angiotensin-converting enzyme inhibitor class that is a mainstay of treatment in these patients.

“To say that, with no run-in, sacubitril/valsartan is as well tolerated and as safe as one of the best-studied ACE inhibitors – ramipril – in acutely ill MI patients, is a big statement,” said Marc A. Pfeffer, MD, at the annual scientific sessions of the American College of Cardiology. This high level of safety without gradual uptitration of sacubitril/valsartan (Entresto) “should lower barriers” to broader use of the dual-drug formulation for its approved indication in patients with chronic heart failure, especially patients with a left ventricular ejection fraction that is below normal. In addition, results from the PARADISE-MI trial suggested that “patients seemed to benefit before they develop heart failure. We couldn’t prove that, but we should build on this, and make it easier for patients to use this treatment,” Dr. Pfeffer said during a press briefing following his talk at the sessions.

Preventing heart failures to come

Treatment with sacubitril/valsartan in acute MI patients within a few days of their event “is perhaps addressing prevention of the heart failure that’s to come,” commented Lynne W. Stevenson, MD, designated discussant for the report and professor of medicine at Vanderbilt University Medical Center in Nashville. “Patients who are destined to develop heart failure are beginning their treatment early. The subgroup analyses suggest that it’s the sicker patients who benefited the most,” she said.

But Dr. Pfeffer stressed that “I don’t think this is a subgroup discussion. I would like to pursue this, but that’s up to the sponsor,” Novartis, the company that markets sacubitril/valsartan.

‘Exceedingly reassuring’ safety

The safety data that Dr. Pfeffer reported “are exceedingly reassuring. We didn’t see a signal of harm, and in some of the exploratory endpoints there was some evidence of benefit, so we need to encourage you to continue,” commented Mary N. Walsh, MD, medical director of the heart failure and cardiac transplantation program at Ascension St. Vincent Heart Center of Indiana in Indianapolis.

The PARADISE-MI (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) trial enrolled 5,669 patients with no history of heart failure within an average of 4 days following an acute MI at 495 sites in 41 countries during 2016-2020, with 8% of enrolled patients from the United States. Patients averaged 64 years of age, about three-quarters were men, about 43% had a history of diabetes, and only 1% were Black; Dr. Pfeffer noted that this is because most patients came from countries with low Black populations. The enrollment criteria required a left ventricular ejection fraction no greater than 40%, and among the enrolled patients this averaged about 37%.

A 10% nonsignificant relative risk reduction for the primary endpoint

The study’s primary endpoint was the combined first-event rate of cardiovascular death, hospitalization for heart failure, or an outpatient visit for heart failure. During a median follow-up of 23 months, this occurred at a rate of 7.4/100 patient years in the ramipril arm and 6.7/100 patient years in the sacubitril/valsartan arm, a 10% relative risk reduction with sacubitril/valsartan that was not significant, which meant all other efficacy analyses were exploratory, Dr. Pfeffer stressed.

Several secondary efficacy analyses showed significant benefits from sacubitril/valsartan, compared with ramipril, including the total number of events that comprised the primary endpoint, with a 21% relative risk reduction associated with sacubitril/valsartan, as well as investigator-reported events. The primary-endpoint benefit from sacubitril/valsartan was also significant in two subgroup analyses: patients aged 65 years or older (roughly half the study cohort), who had a 24% relative risk reduction on sacubitril/valsartan, compared with ramipril, and the 88% of patients who received treatment with percutaneous coronary intervention for their acute MI, who had a 19% relative risk reduction on sacubitril/valsartan, compared with patients who received ramipril.

The study’s safety data showed nearly identical rates in the two treatment arms for total adverse events, serious adverse events, adverse events that led to stopping the study drug, as well as in laboratory measures. The biggest between-treatment differences were a modest excess of hypotension on sacubitril valsartan, 28%, compared with 22% on ramipril, and a modest excess rate of cough on ramipril, 13%, compared with 9% on sacubitril/valsartan.

The added insight the results provide about sacubitril/valsartan comes at a time when U.S. patients continue to struggle to get health insurance coverage for an agent that has been approved for U.S. use in treating heart failure since 2015.

“Our patients do not have access to this important treatment,” declared Dr. Walsh during the press briefing. “The prior authorization process is unbelievable, and some patients have no access unless they pay the full cost on their own. This is an important, real-world problem that we face with this drug.”

PARADISE-MI was sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Pfeffer has received research funding from and is a consultant to Novartis. He is also a consultant to AstraZeneca, Boehringer Ingelheim, Corvidia, DalCor, Eli Lilly, GlaxoSmithKline, Novo Nordisk, Peerbridge, and Sanofi, and he holds equity in DalCor and Peerbridge. Dr. Stevenson has received honoraria from LivaNova and has received research support from Abbott. Dr. Walsh had no disclosures.

[email protected]

Treatment with sacubitril/valsartan, a pillar of therapy for patients with chronic heart failure with below-normal ejection fraction, came suggestively close to showing efficacy for preventing cardiovascular death or heart failure events in patients who have just had an MI but have no history of heart failure in a controlled trial with more than 5,600 patients.

Although sacubitril/valsartan (Entresto) fell short of producing a significant benefit, it did show good safety that was similar to the study’s comparator treatment, ramipril, an agent from the angiotensin-converting enzyme inhibitor class that is a mainstay of treatment in these patients.

“To say that, with no run-in, sacubitril/valsartan is as well tolerated and as safe as one of the best-studied ACE inhibitors – ramipril – in acutely ill MI patients, is a big statement,” said Marc A. Pfeffer, MD, at the annual scientific sessions of the American College of Cardiology. This high level of safety without gradual uptitration of sacubitril/valsartan (Entresto) “should lower barriers” to broader use of the dual-drug formulation for its approved indication in patients with chronic heart failure, especially patients with a left ventricular ejection fraction that is below normal. In addition, results from the PARADISE-MI trial suggested that “patients seemed to benefit before they develop heart failure. We couldn’t prove that, but we should build on this, and make it easier for patients to use this treatment,” Dr. Pfeffer said during a press briefing following his talk at the sessions.

Preventing heart failures to come

Treatment with sacubitril/valsartan in acute MI patients within a few days of their event “is perhaps addressing prevention of the heart failure that’s to come,” commented Lynne W. Stevenson, MD, designated discussant for the report and professor of medicine at Vanderbilt University Medical Center in Nashville. “Patients who are destined to develop heart failure are beginning their treatment early. The subgroup analyses suggest that it’s the sicker patients who benefited the most,” she said.

But Dr. Pfeffer stressed that “I don’t think this is a subgroup discussion. I would like to pursue this, but that’s up to the sponsor,” Novartis, the company that markets sacubitril/valsartan.

‘Exceedingly reassuring’ safety

The safety data that Dr. Pfeffer reported “are exceedingly reassuring. We didn’t see a signal of harm, and in some of the exploratory endpoints there was some evidence of benefit, so we need to encourage you to continue,” commented Mary N. Walsh, MD, medical director of the heart failure and cardiac transplantation program at Ascension St. Vincent Heart Center of Indiana in Indianapolis.

The PARADISE-MI (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) trial enrolled 5,669 patients with no history of heart failure within an average of 4 days following an acute MI at 495 sites in 41 countries during 2016-2020, with 8% of enrolled patients from the United States. Patients averaged 64 years of age, about three-quarters were men, about 43% had a history of diabetes, and only 1% were Black; Dr. Pfeffer noted that this is because most patients came from countries with low Black populations. The enrollment criteria required a left ventricular ejection fraction no greater than 40%, and among the enrolled patients this averaged about 37%.

A 10% nonsignificant relative risk reduction for the primary endpoint

The study’s primary endpoint was the combined first-event rate of cardiovascular death, hospitalization for heart failure, or an outpatient visit for heart failure. During a median follow-up of 23 months, this occurred at a rate of 7.4/100 patient years in the ramipril arm and 6.7/100 patient years in the sacubitril/valsartan arm, a 10% relative risk reduction with sacubitril/valsartan that was not significant, which meant all other efficacy analyses were exploratory, Dr. Pfeffer stressed.

Several secondary efficacy analyses showed significant benefits from sacubitril/valsartan, compared with ramipril, including the total number of events that comprised the primary endpoint, with a 21% relative risk reduction associated with sacubitril/valsartan, as well as investigator-reported events. The primary-endpoint benefit from sacubitril/valsartan was also significant in two subgroup analyses: patients aged 65 years or older (roughly half the study cohort), who had a 24% relative risk reduction on sacubitril/valsartan, compared with ramipril, and the 88% of patients who received treatment with percutaneous coronary intervention for their acute MI, who had a 19% relative risk reduction on sacubitril/valsartan, compared with patients who received ramipril.

The study’s safety data showed nearly identical rates in the two treatment arms for total adverse events, serious adverse events, adverse events that led to stopping the study drug, as well as in laboratory measures. The biggest between-treatment differences were a modest excess of hypotension on sacubitril valsartan, 28%, compared with 22% on ramipril, and a modest excess rate of cough on ramipril, 13%, compared with 9% on sacubitril/valsartan.

The added insight the results provide about sacubitril/valsartan comes at a time when U.S. patients continue to struggle to get health insurance coverage for an agent that has been approved for U.S. use in treating heart failure since 2015.

“Our patients do not have access to this important treatment,” declared Dr. Walsh during the press briefing. “The prior authorization process is unbelievable, and some patients have no access unless they pay the full cost on their own. This is an important, real-world problem that we face with this drug.”

PARADISE-MI was sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Pfeffer has received research funding from and is a consultant to Novartis. He is also a consultant to AstraZeneca, Boehringer Ingelheim, Corvidia, DalCor, Eli Lilly, GlaxoSmithKline, Novo Nordisk, Peerbridge, and Sanofi, and he holds equity in DalCor and Peerbridge. Dr. Stevenson has received honoraria from LivaNova and has received research support from Abbott. Dr. Walsh had no disclosures.

[email protected]

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

Fifty-five chemicals never before reported in humans were found in pregnant women, according to a study from the University of California, San Francisco. The chemicals likely come from consumer products or industrial sources, researchers say.

Findings were published online in Environmental Science and Technology.

Co-first authors Aolin Wang, PhD, and Dimitri Panagopoulos Abrahamsson, PhD, postdoctoral fellows in UCSF’s obstetrics and gynecology department, and colleagues found 109 chemicals in the blood of pregnant women, including 42 “mystery chemicals” whose sources and uses are not known.

The chemicals were also found in their newborns, tests from umbilical cord blood show, suggesting the chemicals cross through the placenta.

Among the chemicals, 40 are used as plasticizers, 28 are used in cosmetics, another 25 are used in consumer products, 29 as pharmaceuticals, 23 as pesticides, three as flame retardants, and seven are PFAS [per- and polyfluoroalkyl substances] compounds used in multiple applications including carpeting and upholstery, the authors report.

Senior author Tracey Woodruff, PhD, MPH, characterized their discoveries as “disturbing.”

She told this news organization that it’s not only frustrating to know the chemicals are present but to know so little about them.

“We know it’s a chemical registered to be manufactured, and it’s used in commerce, but we don’t know where,” she explained. “That’s very disturbing, that we can’t trace them, and that shows a failure in public policy and government.”

“Exposures are occurring without our consent,” said Ms. Woodruff, a former U.S. Environmental Protection Agency scientist, who directs the Program on Reproductive Health and the Environment (PRHE) and the Environmental Research and Translation for Health (EaRTH) Center, both at UCSF.  

She said researchers know from previous studies that when the U.S. government acts to remove harmful chemicals from the marketplace, the levels of those chemicals measured in people drop.

“Examples include lead, certain PFAS, flame retardant chemicals, and certain phthalates,” she said. “So public policies can be effective in preventing exposures that can be harmful.”
 

Technological advances led to the discoveries

The team used high-resolution mass spectrometry (HRMS) to identify human-made chemicals in people.  

Dr. Abrahamsson said in an interview that the technology is relatively new in research and had not previously been used to scan for chemicals in pregnant women and their infants.

Because scientists often study what other scientists have studied, he said, the same chemicals tend to get attention. The wider scope made possible by the new technology helps illumine where to focus future research, he said.

A benefit of the technology is that now researchers don’t have to know which chemicals they are looking for when they scan blood samples, but they can observe whatever appears, he said.

Ms. Woodruff said, “We hope this is further data and evidence that support government policies that require industries to tell us where they are using their chemicals and how we might be exposed to them.”

She said this research will also help identify which chemicals to prioritize for monitoring in the environment.

Average age of the women in the study was 32 years. Nearly half were Hispanic; 37% were non-Hispanic Whites; and 17% were non-Hispanic Asians, Pacific Islanders, and African Americans. Half of the participants were born outside the United States and had lived in the U.S. for an average 22 years.

Sean Palfrey, MD, a professor of clinical pediatrics and public health at Boston University, said more chemical discoveries like these will come as technology continues to evolve.

Dr. Palfrey, who was not involved in the study, agrees with the authors that there is a lack of oversight as to what substances are used in products.

“Our industrial regulations are very poor and therefore our industries get away with using new and untested substances in their products,” he told this news organization.

“This lack of regulation is really important when it results in us not recognizing that known and serious toxins are being put into foods or other products, or when a new class of toxin has been invented which is a serious poison. Most of the toxins, though, are discovered in products in very low levels,” he said.

Dr. Palfrey said, however, that focus should stay on the known and serious toxins that seep into the environment from common products.

“It has taken us decades to ban certain flame retardants from home products,” he said. “TOSCA [the Toxic Substances Control Act passed by Congress in 1976] was too limited when it was passed decades ago and is now fearfully out of date. Unless we discover a COVID among the toxins discovered in studies like this, we should focus on the big stuff.”

The authors and Dr. Palfrey have disclosed no relevant financial relationships.

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

Fifty-five chemicals never before reported in humans were found in pregnant women, according to a study from the University of California, San Francisco. The chemicals likely come from consumer products or industrial sources, researchers say.

Findings were published online in Environmental Science and Technology.

Co-first authors Aolin Wang, PhD, and Dimitri Panagopoulos Abrahamsson, PhD, postdoctoral fellows in UCSF’s obstetrics and gynecology department, and colleagues found 109 chemicals in the blood of pregnant women, including 42 “mystery chemicals” whose sources and uses are not known.

The chemicals were also found in their newborns, tests from umbilical cord blood show, suggesting the chemicals cross through the placenta.

Among the chemicals, 40 are used as plasticizers, 28 are used in cosmetics, another 25 are used in consumer products, 29 as pharmaceuticals, 23 as pesticides, three as flame retardants, and seven are PFAS [per- and polyfluoroalkyl substances] compounds used in multiple applications including carpeting and upholstery, the authors report.

Senior author Tracey Woodruff, PhD, MPH, characterized their discoveries as “disturbing.”

She told this news organization that it’s not only frustrating to know the chemicals are present but to know so little about them.

“We know it’s a chemical registered to be manufactured, and it’s used in commerce, but we don’t know where,” she explained. “That’s very disturbing, that we can’t trace them, and that shows a failure in public policy and government.”

“Exposures are occurring without our consent,” said Ms. Woodruff, a former U.S. Environmental Protection Agency scientist, who directs the Program on Reproductive Health and the Environment (PRHE) and the Environmental Research and Translation for Health (EaRTH) Center, both at UCSF.  

She said researchers know from previous studies that when the U.S. government acts to remove harmful chemicals from the marketplace, the levels of those chemicals measured in people drop.

“Examples include lead, certain PFAS, flame retardant chemicals, and certain phthalates,” she said. “So public policies can be effective in preventing exposures that can be harmful.”
 

Technological advances led to the discoveries

The team used high-resolution mass spectrometry (HRMS) to identify human-made chemicals in people.  

Dr. Abrahamsson said in an interview that the technology is relatively new in research and had not previously been used to scan for chemicals in pregnant women and their infants.

Because scientists often study what other scientists have studied, he said, the same chemicals tend to get attention. The wider scope made possible by the new technology helps illumine where to focus future research, he said.

A benefit of the technology is that now researchers don’t have to know which chemicals they are looking for when they scan blood samples, but they can observe whatever appears, he said.

Ms. Woodruff said, “We hope this is further data and evidence that support government policies that require industries to tell us where they are using their chemicals and how we might be exposed to them.”

She said this research will also help identify which chemicals to prioritize for monitoring in the environment.

Average age of the women in the study was 32 years. Nearly half were Hispanic; 37% were non-Hispanic Whites; and 17% were non-Hispanic Asians, Pacific Islanders, and African Americans. Half of the participants were born outside the United States and had lived in the U.S. for an average 22 years.

Sean Palfrey, MD, a professor of clinical pediatrics and public health at Boston University, said more chemical discoveries like these will come as technology continues to evolve.

Dr. Palfrey, who was not involved in the study, agrees with the authors that there is a lack of oversight as to what substances are used in products.

“Our industrial regulations are very poor and therefore our industries get away with using new and untested substances in their products,” he told this news organization.

“This lack of regulation is really important when it results in us not recognizing that known and serious toxins are being put into foods or other products, or when a new class of toxin has been invented which is a serious poison. Most of the toxins, though, are discovered in products in very low levels,” he said.

Dr. Palfrey said, however, that focus should stay on the known and serious toxins that seep into the environment from common products.

“It has taken us decades to ban certain flame retardants from home products,” he said. “TOSCA [the Toxic Substances Control Act passed by Congress in 1976] was too limited when it was passed decades ago and is now fearfully out of date. Unless we discover a COVID among the toxins discovered in studies like this, we should focus on the big stuff.”

The authors and Dr. Palfrey have disclosed no relevant financial relationships.

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

Fifty-five chemicals never before reported in humans were found in pregnant women, according to a study from the University of California, San Francisco. The chemicals likely come from consumer products or industrial sources, researchers say.

Findings were published online in Environmental Science and Technology.

Co-first authors Aolin Wang, PhD, and Dimitri Panagopoulos Abrahamsson, PhD, postdoctoral fellows in UCSF’s obstetrics and gynecology department, and colleagues found 109 chemicals in the blood of pregnant women, including 42 “mystery chemicals” whose sources and uses are not known.

The chemicals were also found in their newborns, tests from umbilical cord blood show, suggesting the chemicals cross through the placenta.

Among the chemicals, 40 are used as plasticizers, 28 are used in cosmetics, another 25 are used in consumer products, 29 as pharmaceuticals, 23 as pesticides, three as flame retardants, and seven are PFAS [per- and polyfluoroalkyl substances] compounds used in multiple applications including carpeting and upholstery, the authors report.

Senior author Tracey Woodruff, PhD, MPH, characterized their discoveries as “disturbing.”

She told this news organization that it’s not only frustrating to know the chemicals are present but to know so little about them.

“We know it’s a chemical registered to be manufactured, and it’s used in commerce, but we don’t know where,” she explained. “That’s very disturbing, that we can’t trace them, and that shows a failure in public policy and government.”

“Exposures are occurring without our consent,” said Ms. Woodruff, a former U.S. Environmental Protection Agency scientist, who directs the Program on Reproductive Health and the Environment (PRHE) and the Environmental Research and Translation for Health (EaRTH) Center, both at UCSF.  

She said researchers know from previous studies that when the U.S. government acts to remove harmful chemicals from the marketplace, the levels of those chemicals measured in people drop.

“Examples include lead, certain PFAS, flame retardant chemicals, and certain phthalates,” she said. “So public policies can be effective in preventing exposures that can be harmful.”
 

Technological advances led to the discoveries

The team used high-resolution mass spectrometry (HRMS) to identify human-made chemicals in people.  

Dr. Abrahamsson said in an interview that the technology is relatively new in research and had not previously been used to scan for chemicals in pregnant women and their infants.

Because scientists often study what other scientists have studied, he said, the same chemicals tend to get attention. The wider scope made possible by the new technology helps illumine where to focus future research, he said.

A benefit of the technology is that now researchers don’t have to know which chemicals they are looking for when they scan blood samples, but they can observe whatever appears, he said.

Ms. Woodruff said, “We hope this is further data and evidence that support government policies that require industries to tell us where they are using their chemicals and how we might be exposed to them.”

She said this research will also help identify which chemicals to prioritize for monitoring in the environment.

Average age of the women in the study was 32 years. Nearly half were Hispanic; 37% were non-Hispanic Whites; and 17% were non-Hispanic Asians, Pacific Islanders, and African Americans. Half of the participants were born outside the United States and had lived in the U.S. for an average 22 years.

Sean Palfrey, MD, a professor of clinical pediatrics and public health at Boston University, said more chemical discoveries like these will come as technology continues to evolve.

Dr. Palfrey, who was not involved in the study, agrees with the authors that there is a lack of oversight as to what substances are used in products.

“Our industrial regulations are very poor and therefore our industries get away with using new and untested substances in their products,” he told this news organization.

“This lack of regulation is really important when it results in us not recognizing that known and serious toxins are being put into foods or other products, or when a new class of toxin has been invented which is a serious poison. Most of the toxins, though, are discovered in products in very low levels,” he said.

Dr. Palfrey said, however, that focus should stay on the known and serious toxins that seep into the environment from common products.

“It has taken us decades to ban certain flame retardants from home products,” he said. “TOSCA [the Toxic Substances Control Act passed by Congress in 1976] was too limited when it was passed decades ago and is now fearfully out of date. Unless we discover a COVID among the toxins discovered in studies like this, we should focus on the big stuff.”

The authors and Dr. Palfrey have disclosed no relevant financial relationships.

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

The Diagnosis: Trichodysplasia Spinulosa 

Trichodysplasia spinulosa has been described in case reports over the last several decades, with its causative virus trichodysplasia spinulosa-associated polyomavirus (TSPyV) identified in 2010 by van der Meijden et al.¹ Trichodysplasia spinulosa-associated polyomavirus is a small, nonenveloped, double-stranded DNA virus in the Polyomaviridae family, among several other known cutaneous polyomaviruses including Merkel cell polyomavirus, human polyomavirus (HPyV) 6, HPyV7, HPyV10, and possibly HPyV13.² The primary target of TSPyV is follicular keratinocytes, and it is believed to cause trichodysplasia spinulosa by primary infection rather than by reactivation. Trichodysplasia spinulosa presents in immunosuppressed patients as a folliculocentric eruption of papules with keratinous spines on the face, often with concurrent alopecia, eventually spreading to the trunk and extremities.³ The diagnosis often is clinical, but a biopsy may be performed for histopathologic confirmation. Alternatively, lesional spicules can be painlessly collected manually and submitted for viral polymerase chain reaction (PCR).⁴ The diagnosis of trichodysplasia spinulosa can be difficult due to similarities with other more common conditions such as keratosis pilaris, milia, filiform warts, or lichen spinulosus.  

Similar to trichodysplasia spinulosa, keratosis pilaris also presents with folliculocentric and often erythematous papules.⁵ Keratosis pilaris most frequently affects the posterior upper arms and thighs but also may affect the cheeks, as seen in trichodysplasia spinulosa. Differentiation between the 2 diagnoses can be made on a clinical basis, as keratosis pilaris lacks the characteristic keratinous spines and often spares the central face and nose, locations that commonly are affected in trichodysplasia spinulosa.³ 

Milia typically appear as white to yellow papules, often on the cheeks, eyelids, nose, and chin.⁶ Given their predilection for the face, milia can appear similarly to trichodysplasia spinulosa. Differentiation can be made clinically, as milia typically are not as numerous as the spiculed papules seen in trichodysplasia spinulosa. Morphologically, milia will present as smooth, dome-shaped papules as opposed to the keratinous spicules seen in trichodysplasia spinulosa. The diagnosis of milia can be confirmed by incision and removal of the white chalky keratin core, a feature absent in trichodysplasia spinulosa.  

Filiform warts are benign epidermal proliferations caused by human papillomavirus infection that manifest as flesh-colored, verrucous, hyperkeratotic papules.⁷ They can appear on virtually any skin surface, including the face, and thus may be mistaken for trichodysplasia spinulosa. Close inspection usually will reveal tiny black dots that represent thrombosed capillaries, a feature lacking in trichodysplasia spinulosa. In long-standing lesions or immunocompromised patients, confluent verrucous plaques may develop.⁸ Diagnosis of filiform warts can be confirmed with biopsy, which will demonstrate a compact stratum corneum, coarse hypergranulosis, and papillomatosis curving inward, while biopsy of a trichodysplasia spinulosa lesion would show polyomavirus infection of the hair follicle and characteristic eosinophilic inclusion bodies.⁹ 

Lichen spinulosus may appear as multiple folliculocentric scaly papules with hairlike horny spines.¹⁰ Lichen spinulosus differs from trichodysplasia spinulosa in that it commonly appears on the neck, abdomen, trochanteric region, arms, elbows, or knees. Lichen spinulosus also classically appears as a concrete cluster of papules, often localized to a certain region, in contrast to trichodysplasia spinulosa, which will be widespread, often spreading over time. Finally, clinical history may help differentiate the 2 entities. Lichen spinulosus most often appears in children and adolescents and often has an indolent course, typically resolving during puberty, while trichodysplasia spinulosa is seen in immunocompromised patients. 

In our patient, the dermatology team made a diagnosis of trichodysplasia spinulosa based on the characteristic clinical presentation, which was confirmed after approximately 10 lesional spicules were removed by tissue forceps and submitted for PCR analysis showing TSPyV (Figure). Two other cases utilized spicule PCR analysis for confirmation of TSPyV.^11,12 This technique may represent a viable option for diagnostic confirmation in pediatric cases. 

Although some articles have examined the molecular and biologic features of trichodysplasia spinulosa, literature on clinical presentation and management is limited to isolated case reports with no comprehensive studies to establish a standardized treatment. Of these reports, oral valganciclovir 900 mg daily, topical retinoids, cidofovir cream 1% to 3%, and decreasing or altering the immunosuppressive regimen all have been noted to provide clinical improvement.^13,14 Other therapies including leflunomide and routine manual extraction of spicules also have shown effectiveness in the treatment of trichodysplasia spinulosa.¹⁵  

In our patient, treatment included decreasing immunosuppression, as she was getting recurrent sinus and upper respiratory infections. Mycophenolate mofetil was discontinued, and the patient was continued solely on tacrolimus therapy. She demonstrated notable improvement after 3 months, with approximately 50% clearance of the eruption. A mutual decision was made at that visit to initiate therapy with compounded cidofovir cream 1% daily to the lesions until the next follow-up visit. Unfortunately, the patient did not return for her scheduled dermatology visits and was lost to long-term follow-up. 

Acknowledgment
We thank Richard C. Wang, MD, PhD (Dallas, Texas), for his dermatologic expertise and assistance in analysis of lesional samples for TSPyV. 

The Diagnosis: Trichodysplasia Spinulosa 

Trichodysplasia spinulosa has been described in case reports over the last several decades, with its causative virus trichodysplasia spinulosa-associated polyomavirus (TSPyV) identified in 2010 by van der Meijden et al.¹ Trichodysplasia spinulosa-associated polyomavirus is a small, nonenveloped, double-stranded DNA virus in the Polyomaviridae family, among several other known cutaneous polyomaviruses including Merkel cell polyomavirus, human polyomavirus (HPyV) 6, HPyV7, HPyV10, and possibly HPyV13.² The primary target of TSPyV is follicular keratinocytes, and it is believed to cause trichodysplasia spinulosa by primary infection rather than by reactivation. Trichodysplasia spinulosa presents in immunosuppressed patients as a folliculocentric eruption of papules with keratinous spines on the face, often with concurrent alopecia, eventually spreading to the trunk and extremities.³ The diagnosis often is clinical, but a biopsy may be performed for histopathologic confirmation. Alternatively, lesional spicules can be painlessly collected manually and submitted for viral polymerase chain reaction (PCR).⁴ The diagnosis of trichodysplasia spinulosa can be difficult due to similarities with other more common conditions such as keratosis pilaris, milia, filiform warts, or lichen spinulosus.  

Similar to trichodysplasia spinulosa, keratosis pilaris also presents with folliculocentric and often erythematous papules.⁵ Keratosis pilaris most frequently affects the posterior upper arms and thighs but also may affect the cheeks, as seen in trichodysplasia spinulosa. Differentiation between the 2 diagnoses can be made on a clinical basis, as keratosis pilaris lacks the characteristic keratinous spines and often spares the central face and nose, locations that commonly are affected in trichodysplasia spinulosa.³ 

Milia typically appear as white to yellow papules, often on the cheeks, eyelids, nose, and chin.⁶ Given their predilection for the face, milia can appear similarly to trichodysplasia spinulosa. Differentiation can be made clinically, as milia typically are not as numerous as the spiculed papules seen in trichodysplasia spinulosa. Morphologically, milia will present as smooth, dome-shaped papules as opposed to the keratinous spicules seen in trichodysplasia spinulosa. The diagnosis of milia can be confirmed by incision and removal of the white chalky keratin core, a feature absent in trichodysplasia spinulosa.  

Filiform warts are benign epidermal proliferations caused by human papillomavirus infection that manifest as flesh-colored, verrucous, hyperkeratotic papules.⁷ They can appear on virtually any skin surface, including the face, and thus may be mistaken for trichodysplasia spinulosa. Close inspection usually will reveal tiny black dots that represent thrombosed capillaries, a feature lacking in trichodysplasia spinulosa. In long-standing lesions or immunocompromised patients, confluent verrucous plaques may develop.⁸ Diagnosis of filiform warts can be confirmed with biopsy, which will demonstrate a compact stratum corneum, coarse hypergranulosis, and papillomatosis curving inward, while biopsy of a trichodysplasia spinulosa lesion would show polyomavirus infection of the hair follicle and characteristic eosinophilic inclusion bodies.⁹ 

Lichen spinulosus may appear as multiple folliculocentric scaly papules with hairlike horny spines.¹⁰ Lichen spinulosus differs from trichodysplasia spinulosa in that it commonly appears on the neck, abdomen, trochanteric region, arms, elbows, or knees. Lichen spinulosus also classically appears as a concrete cluster of papules, often localized to a certain region, in contrast to trichodysplasia spinulosa, which will be widespread, often spreading over time. Finally, clinical history may help differentiate the 2 entities. Lichen spinulosus most often appears in children and adolescents and often has an indolent course, typically resolving during puberty, while trichodysplasia spinulosa is seen in immunocompromised patients. 

In our patient, the dermatology team made a diagnosis of trichodysplasia spinulosa based on the characteristic clinical presentation, which was confirmed after approximately 10 lesional spicules were removed by tissue forceps and submitted for PCR analysis showing TSPyV (Figure). Two other cases utilized spicule PCR analysis for confirmation of TSPyV.^11,12 This technique may represent a viable option for diagnostic confirmation in pediatric cases. 

Although some articles have examined the molecular and biologic features of trichodysplasia spinulosa, literature on clinical presentation and management is limited to isolated case reports with no comprehensive studies to establish a standardized treatment. Of these reports, oral valganciclovir 900 mg daily, topical retinoids, cidofovir cream 1% to 3%, and decreasing or altering the immunosuppressive regimen all have been noted to provide clinical improvement.^13,14 Other therapies including leflunomide and routine manual extraction of spicules also have shown effectiveness in the treatment of trichodysplasia spinulosa.¹⁵  

In our patient, treatment included decreasing immunosuppression, as she was getting recurrent sinus and upper respiratory infections. Mycophenolate mofetil was discontinued, and the patient was continued solely on tacrolimus therapy. She demonstrated notable improvement after 3 months, with approximately 50% clearance of the eruption. A mutual decision was made at that visit to initiate therapy with compounded cidofovir cream 1% daily to the lesions until the next follow-up visit. Unfortunately, the patient did not return for her scheduled dermatology visits and was lost to long-term follow-up. 

Acknowledgment
We thank Richard C. Wang, MD, PhD (Dallas, Texas), for his dermatologic expertise and assistance in analysis of lesional samples for TSPyV. 

The Diagnosis: Trichodysplasia Spinulosa 

Trichodysplasia spinulosa has been described in case reports over the last several decades, with its causative virus trichodysplasia spinulosa-associated polyomavirus (TSPyV) identified in 2010 by van der Meijden et al.¹ Trichodysplasia spinulosa-associated polyomavirus is a small, nonenveloped, double-stranded DNA virus in the Polyomaviridae family, among several other known cutaneous polyomaviruses including Merkel cell polyomavirus, human polyomavirus (HPyV) 6, HPyV7, HPyV10, and possibly HPyV13.² The primary target of TSPyV is follicular keratinocytes, and it is believed to cause trichodysplasia spinulosa by primary infection rather than by reactivation. Trichodysplasia spinulosa presents in immunosuppressed patients as a folliculocentric eruption of papules with keratinous spines on the face, often with concurrent alopecia, eventually spreading to the trunk and extremities.³ The diagnosis often is clinical, but a biopsy may be performed for histopathologic confirmation. Alternatively, lesional spicules can be painlessly collected manually and submitted for viral polymerase chain reaction (PCR).⁴ The diagnosis of trichodysplasia spinulosa can be difficult due to similarities with other more common conditions such as keratosis pilaris, milia, filiform warts, or lichen spinulosus.  

Similar to trichodysplasia spinulosa, keratosis pilaris also presents with folliculocentric and often erythematous papules.⁵ Keratosis pilaris most frequently affects the posterior upper arms and thighs but also may affect the cheeks, as seen in trichodysplasia spinulosa. Differentiation between the 2 diagnoses can be made on a clinical basis, as keratosis pilaris lacks the characteristic keratinous spines and often spares the central face and nose, locations that commonly are affected in trichodysplasia spinulosa.³ 

Milia typically appear as white to yellow papules, often on the cheeks, eyelids, nose, and chin.⁶ Given their predilection for the face, milia can appear similarly to trichodysplasia spinulosa. Differentiation can be made clinically, as milia typically are not as numerous as the spiculed papules seen in trichodysplasia spinulosa. Morphologically, milia will present as smooth, dome-shaped papules as opposed to the keratinous spicules seen in trichodysplasia spinulosa. The diagnosis of milia can be confirmed by incision and removal of the white chalky keratin core, a feature absent in trichodysplasia spinulosa.  

Filiform warts are benign epidermal proliferations caused by human papillomavirus infection that manifest as flesh-colored, verrucous, hyperkeratotic papules.⁷ They can appear on virtually any skin surface, including the face, and thus may be mistaken for trichodysplasia spinulosa. Close inspection usually will reveal tiny black dots that represent thrombosed capillaries, a feature lacking in trichodysplasia spinulosa. In long-standing lesions or immunocompromised patients, confluent verrucous plaques may develop.⁸ Diagnosis of filiform warts can be confirmed with biopsy, which will demonstrate a compact stratum corneum, coarse hypergranulosis, and papillomatosis curving inward, while biopsy of a trichodysplasia spinulosa lesion would show polyomavirus infection of the hair follicle and characteristic eosinophilic inclusion bodies.⁹ 

Lichen spinulosus may appear as multiple folliculocentric scaly papules with hairlike horny spines.¹⁰ Lichen spinulosus differs from trichodysplasia spinulosa in that it commonly appears on the neck, abdomen, trochanteric region, arms, elbows, or knees. Lichen spinulosus also classically appears as a concrete cluster of papules, often localized to a certain region, in contrast to trichodysplasia spinulosa, which will be widespread, often spreading over time. Finally, clinical history may help differentiate the 2 entities. Lichen spinulosus most often appears in children and adolescents and often has an indolent course, typically resolving during puberty, while trichodysplasia spinulosa is seen in immunocompromised patients. 

In our patient, the dermatology team made a diagnosis of trichodysplasia spinulosa based on the characteristic clinical presentation, which was confirmed after approximately 10 lesional spicules were removed by tissue forceps and submitted for PCR analysis showing TSPyV (Figure). Two other cases utilized spicule PCR analysis for confirmation of TSPyV.^11,12 This technique may represent a viable option for diagnostic confirmation in pediatric cases. 

Although some articles have examined the molecular and biologic features of trichodysplasia spinulosa, literature on clinical presentation and management is limited to isolated case reports with no comprehensive studies to establish a standardized treatment. Of these reports, oral valganciclovir 900 mg daily, topical retinoids, cidofovir cream 1% to 3%, and decreasing or altering the immunosuppressive regimen all have been noted to provide clinical improvement.^13,14 Other therapies including leflunomide and routine manual extraction of spicules also have shown effectiveness in the treatment of trichodysplasia spinulosa.¹⁵  

In our patient, treatment included decreasing immunosuppression, as she was getting recurrent sinus and upper respiratory infections. Mycophenolate mofetil was discontinued, and the patient was continued solely on tacrolimus therapy. She demonstrated notable improvement after 3 months, with approximately 50% clearance of the eruption. A mutual decision was made at that visit to initiate therapy with compounded cidofovir cream 1% daily to the lesions until the next follow-up visit. Unfortunately, the patient did not return for her scheduled dermatology visits and was lost to long-term follow-up. 

Acknowledgment
We thank Richard C. Wang, MD, PhD (Dallas, Texas), for his dermatologic expertise and assistance in analysis of lesional samples for TSPyV. 

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.
 

Vital lessons from the past

In a previous column, I described my role as New York City’s mental health commissioner after 9/11 and the many lessons we learned during that multiyear process. Our work served as a template for other disasters to follow, such as Hurricane Sandy. Its value to COVID-19 is equally apparent.

We learned that those most at risk of developing symptomatic, functionally impairing mental illness had prior traumatic experiences (for example, from childhood abuse or neglect, violence, war, and forced displacement from their native land) and/or a preexisting mental or substance use disorder.

Once these individuals and communities were identified, we could prioritize their treatment and care. Doing so required mobilizing both inner and external (social) resources, which can be used before disaster strikes or in its wake.

For individuals, adaptive resources include developing any of a number of mind-body activities (for example, meditation, mindfulness, slow breathing, and yoga); sufficient but not necessarily excessive levels of exercise (as has been said, if exercise were a pill, it would be the most potent of medicines); nourishing diets; sleep, nature’s restorative state; and perhaps most important, attachment and human connection to people who care about you and whom you care about and trust.

One unexpected, yet now consistent, predictor of resilience in the wake of disaster is faith. This does not necessarily mean holding or following an institutional religion or belonging to house of worship (though, of course, that melds and augments faith with community). For a great many, myself included, there is spirituality, the belief in a greater power, which need not be a God yet instills a sense of the vastness, universality, and continuity of life.

For communities, adaptive resources include safe homes and neighborhoods; diminishing housing and food insecurity; education, including pre-K; employment, with a livable wage; ridding human interactions of the endless, so-called microaggressions (which are not micro at all, because they accrue) of race, ethnic, class, and age discrimination and injustice; and ready access to quality and affordable health care, now more than ever for the rising tide of mental and substance use disorders that COVID-19 has unleashed.

Every gain we make to ablate racism, social injustice, discrimination, and widely and deeply spread resource and opportunity inequities means more cohesion among the members of our collective tribe. Greater cohesion, a love for thy neighbor, and equity (in action, not polemics) will fuel the resilience we will need to withstand more of COVID-19’s ongoing trauma; that of other, inescapable disasters and losses; and the wear and tear of everyday life. The rewards of equity are priceless and include the dignity that derives from fairness and justice – given and received.
 

An unprecedented disaster requires a bold response

My, what a list. But to me, the encompassing nature of what’s needed means that we can make differences anywhere, everywhere, and in countless and continuous ways.

The measure of any society is in how it cares for those who are foreclosed, through no fault of their own, from what we all want: a life safe from violence, secure in housing and food, with loving relationships and the pride that comes of making contributions, each in our own, wonderfully unique way.

Where will we all be in a year, 2, or 3 from now? Prepared, or not? Emotionally inoculated, or not? Better equipped, or not? As divided, or more cohesive?

Well, I imagine that depends on each and every one of us.

Lloyd I. Sederer, MD, is a psychiatrist, public health doctor, and writer. He is an adjunct professor at the Columbia University School of Public Health, director of Columbia Psychiatry Media, chief medical officer of Bongo Media, and chair of the advisory board of Get Help. He has been chief medical officer of McLean Hospital, a Harvard teaching hospital; mental health commissioner of New York City (in the Bloomberg administration); and chief medical officer of the New York State Office of Mental Health, the nation’s largest state mental health agency.

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

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.
 

Vital lessons from the past

In a previous column, I described my role as New York City’s mental health commissioner after 9/11 and the many lessons we learned during that multiyear process. Our work served as a template for other disasters to follow, such as Hurricane Sandy. Its value to COVID-19 is equally apparent.

We learned that those most at risk of developing symptomatic, functionally impairing mental illness had prior traumatic experiences (for example, from childhood abuse or neglect, violence, war, and forced displacement from their native land) and/or a preexisting mental or substance use disorder.

Once these individuals and communities were identified, we could prioritize their treatment and care. Doing so required mobilizing both inner and external (social) resources, which can be used before disaster strikes or in its wake.

For individuals, adaptive resources include developing any of a number of mind-body activities (for example, meditation, mindfulness, slow breathing, and yoga); sufficient but not necessarily excessive levels of exercise (as has been said, if exercise were a pill, it would be the most potent of medicines); nourishing diets; sleep, nature’s restorative state; and perhaps most important, attachment and human connection to people who care about you and whom you care about and trust.

One unexpected, yet now consistent, predictor of resilience in the wake of disaster is faith. This does not necessarily mean holding or following an institutional religion or belonging to house of worship (though, of course, that melds and augments faith with community). For a great many, myself included, there is spirituality, the belief in a greater power, which need not be a God yet instills a sense of the vastness, universality, and continuity of life.

For communities, adaptive resources include safe homes and neighborhoods; diminishing housing and food insecurity; education, including pre-K; employment, with a livable wage; ridding human interactions of the endless, so-called microaggressions (which are not micro at all, because they accrue) of race, ethnic, class, and age discrimination and injustice; and ready access to quality and affordable health care, now more than ever for the rising tide of mental and substance use disorders that COVID-19 has unleashed.

Every gain we make to ablate racism, social injustice, discrimination, and widely and deeply spread resource and opportunity inequities means more cohesion among the members of our collective tribe. Greater cohesion, a love for thy neighbor, and equity (in action, not polemics) will fuel the resilience we will need to withstand more of COVID-19’s ongoing trauma; that of other, inescapable disasters and losses; and the wear and tear of everyday life. The rewards of equity are priceless and include the dignity that derives from fairness and justice – given and received.
 

An unprecedented disaster requires a bold response

My, what a list. But to me, the encompassing nature of what’s needed means that we can make differences anywhere, everywhere, and in countless and continuous ways.

The measure of any society is in how it cares for those who are foreclosed, through no fault of their own, from what we all want: a life safe from violence, secure in housing and food, with loving relationships and the pride that comes of making contributions, each in our own, wonderfully unique way.

Where will we all be in a year, 2, or 3 from now? Prepared, or not? Emotionally inoculated, or not? Better equipped, or not? As divided, or more cohesive?

Well, I imagine that depends on each and every one of us.

Lloyd I. Sederer, MD, is a psychiatrist, public health doctor, and writer. He is an adjunct professor at the Columbia University School of Public Health, director of Columbia Psychiatry Media, chief medical officer of Bongo Media, and chair of the advisory board of Get Help. He has been chief medical officer of McLean Hospital, a Harvard teaching hospital; mental health commissioner of New York City (in the Bloomberg administration); and chief medical officer of the New York State Office of Mental Health, the nation’s largest state mental health agency.

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

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.
 

Vital lessons from the past

In a previous column, I described my role as New York City’s mental health commissioner after 9/11 and the many lessons we learned during that multiyear process. Our work served as a template for other disasters to follow, such as Hurricane Sandy. Its value to COVID-19 is equally apparent.

We learned that those most at risk of developing symptomatic, functionally impairing mental illness had prior traumatic experiences (for example, from childhood abuse or neglect, violence, war, and forced displacement from their native land) and/or a preexisting mental or substance use disorder.

Once these individuals and communities were identified, we could prioritize their treatment and care. Doing so required mobilizing both inner and external (social) resources, which can be used before disaster strikes or in its wake.

For individuals, adaptive resources include developing any of a number of mind-body activities (for example, meditation, mindfulness, slow breathing, and yoga); sufficient but not necessarily excessive levels of exercise (as has been said, if exercise were a pill, it would be the most potent of medicines); nourishing diets; sleep, nature’s restorative state; and perhaps most important, attachment and human connection to people who care about you and whom you care about and trust.

One unexpected, yet now consistent, predictor of resilience in the wake of disaster is faith. This does not necessarily mean holding or following an institutional religion or belonging to house of worship (though, of course, that melds and augments faith with community). For a great many, myself included, there is spirituality, the belief in a greater power, which need not be a God yet instills a sense of the vastness, universality, and continuity of life.

For communities, adaptive resources include safe homes and neighborhoods; diminishing housing and food insecurity; education, including pre-K; employment, with a livable wage; ridding human interactions of the endless, so-called microaggressions (which are not micro at all, because they accrue) of race, ethnic, class, and age discrimination and injustice; and ready access to quality and affordable health care, now more than ever for the rising tide of mental and substance use disorders that COVID-19 has unleashed.

Every gain we make to ablate racism, social injustice, discrimination, and widely and deeply spread resource and opportunity inequities means more cohesion among the members of our collective tribe. Greater cohesion, a love for thy neighbor, and equity (in action, not polemics) will fuel the resilience we will need to withstand more of COVID-19’s ongoing trauma; that of other, inescapable disasters and losses; and the wear and tear of everyday life. The rewards of equity are priceless and include the dignity that derives from fairness and justice – given and received.
 

An unprecedented disaster requires a bold response

My, what a list. But to me, the encompassing nature of what’s needed means that we can make differences anywhere, everywhere, and in countless and continuous ways.

The measure of any society is in how it cares for those who are foreclosed, through no fault of their own, from what we all want: a life safe from violence, secure in housing and food, with loving relationships and the pride that comes of making contributions, each in our own, wonderfully unique way.

Where will we all be in a year, 2, or 3 from now? Prepared, or not? Emotionally inoculated, or not? Better equipped, or not? As divided, or more cohesive?

Well, I imagine that depends on each and every one of us.

Lloyd I. Sederer, MD, is a psychiatrist, public health doctor, and writer. He is an adjunct professor at the Columbia University School of Public Health, director of Columbia Psychiatry Media, chief medical officer of Bongo Media, and chair of the advisory board of Get Help. He has been chief medical officer of McLean Hospital, a Harvard teaching hospital; mental health commissioner of New York City (in the Bloomberg administration); and chief medical officer of the New York State Office of Mental Health, the nation’s largest state mental health agency.

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

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

[email protected]

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

[email protected]

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

[email protected]

Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.

An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.

The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.

The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
 

Relapse prevention important

Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.

In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.

Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.

She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.

However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.

As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.

To measure the utility of copeptin in predicting psychotic relapse, the researchers conducted a prospective, explorative, single-center observational study involving inpatients with an acute psychotic episode diagnosed with schizophrenia spectrum disorder or affective disorder.

Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
 

Predictive factor

Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.

There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.

Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.

“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).

However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).

When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).

“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.

The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.

In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
 

A proxy for ‘something simpler’?

Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.

Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.

However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”

In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.

She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”

“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”

The study authors and Dr. Rubin have disclosed no relevant financial relationships.

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

Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.

An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.

The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.

The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
 

Relapse prevention important

Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.

In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.

Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.

She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.

However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.

As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.

To measure the utility of copeptin in predicting psychotic relapse, the researchers conducted a prospective, explorative, single-center observational study involving inpatients with an acute psychotic episode diagnosed with schizophrenia spectrum disorder or affective disorder.

Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
 

Predictive factor

Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.

There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.

Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.

“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).

However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).

When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).

“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.

The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.

In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
 

A proxy for ‘something simpler’?

Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.

Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.

However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”

In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.

She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”

“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”

The study authors and Dr. Rubin have disclosed no relevant financial relationships.

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

Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.

An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.

The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.

The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
 

Relapse prevention important

Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.

In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.

Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.

She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.

However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.

As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.

To measure the utility of copeptin in predicting psychotic relapse, the researchers conducted a prospective, explorative, single-center observational study involving inpatients with an acute psychotic episode diagnosed with schizophrenia spectrum disorder or affective disorder.

Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
 

Predictive factor

Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.

There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.

Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.

“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).

However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).

When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).

“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.

The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.

In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
 

A proxy for ‘something simpler’?

Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.

Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.

However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”

In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.

She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”

“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”

The study authors and Dr. Rubin have disclosed no relevant financial relationships.

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

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

• Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket over the medical device.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

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

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.