The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A smartphone-based self-management intervention developed for patients with bipolar disorder (BD) can help decrease depressive symptoms and improve quality of life, new research suggests.

In a randomized clinical trial of usual care plus the experimental smartphone-based intervention known as LiveWell vs. usual care alone, participants in the smartphone group who were categorized as low-risk or in asymptomatic recovery at baseline also showed reduced manic symptom severity.

The results suggest that “apps for individuals with bipolar disorder will likely be useful for some people in managing medication use, sleep duration, routine, and monitoring for and managing signs and symptoms” of the disorder, coinvestigator Evan H. Goulding, MD, PhD, assistant professor of psychiatry and behavioral sciences, Northwestern University, Chicago, told this news organization.

Use of the app may also “lead to decreased recurrence of mood episodes, impact overall depressive and manic symptom levels, and improve some aspects of quality of life,” Dr. Goulding added.

The findings were published online in JAMA Psychiatry.
 

Daily check-ins

The researchers randomly assigned 205 patients with BD to receive either usual care (n = 81; 56% women; mean age, 39 years) or usual care plus the smartphone-based self-management intervention LiveWell (n = 124; 65% women; mean age, 43 years) between March 2017 and April 2020. To be included, participants could not be experiencing a current mood episode or suicidal ideation.

The smartphone intervention included a daily check-in to monitor medication adherence, sleep, and wellness levels; coach visits to support adherence to the app; six phone calls over 16 weeks; and support from mental health professionals whenever needed. Participants in this group were asked to engage their mental health providers in the intervention as well.

Each participant in the control group had a visit with a coach who facilitated self-management support.

Investigators assessed all participants every 8 weeks until week 48 to gather information on mood symptoms and severity over the past 2 weeks and on quality of life.

The patients were also stratified into high- and low-risk relapse groups. The low-risk group was in asymptomatic recovery, meaning that they experienced two or fewer moderate symptoms of mania or depression in the previous 8 weeks. In addition, they had no moderate symptoms of mania or depression at study enrollment.

Patients in the high-risk group were recovering from an episode of mania or depression. They also had two or fewer moderate symptoms, but for 8 weeks or less.
 

Low-risk group fares better

Results showed that the smartphone intervention was significantly associated with a reduction in depressive symptoms vs. usual care (P = .02), as well as improvement in one aspect of the World Health Organization Quality of Life Assessment that measures social relationships (P = .02).

When the investigators stratified participants into risk groups, they found that for those in the low-risk group the smartphone-based intervention was associated with lower episode-relapse rates, lower mean percentage time symptomatic, and decreased manic symptom severity.

Mean estimated relapse rates by 48 weeks for the low-risk group were 12% for those in the intervention group and 37.2% for those in the control group. No differences were noted for the high-risk group.

Low-risk patients in the intervention group also had lower mean percentage-time symptomatic (17.9%) than those in the control group (26.1%) (Cohen d = .31).

“Our results are consistent with literature emphasizing the identification and facilitation of management plans for early warning signs of mood episodes and using these plans as an important self-management technique for avoiding relapse,” Dr. Goulding said.

Study limitations included low engagement by mental health professionals and low data generalizability to other populations, as the sample was mostly White (84% of the app group and 81% of the control group).

“There is a fairly large literature on risk factors, longitudinal trajectories, and stages of diseases that suggest we should already be able to predict relapse risk for individuals,” Dr. Goulding said.

“However, moving from overall risk to individual risk is trickier and will require larger datasets with longer follow-up to better understand what types of help should be delivered when and to whom,” he added.
 

‘Requires commitment’

John Torous, MD, director of the division of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, noted that mental health apps such as LiveWell require “time and energy devoted by both the patient and their clinician for maximal efficacy, which requires commitment from and training for both parties as well.

“But with such an investment in people, there is good evidence apps can help people with bipolar disorder even during the more severe periods of the illness,” added Dr. Torous, who was not involved with the research.

The study was funded by the National Institute of Mental Health.

Dr. Goulding reports having received honoraria from Otsuka. Dr. Torous has reported no relevant financial relationships.

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

A smartphone-based self-management intervention developed for patients with bipolar disorder (BD) can help decrease depressive symptoms and improve quality of life, new research suggests.

In a randomized clinical trial of usual care plus the experimental smartphone-based intervention known as LiveWell vs. usual care alone, participants in the smartphone group who were categorized as low-risk or in asymptomatic recovery at baseline also showed reduced manic symptom severity.

The results suggest that “apps for individuals with bipolar disorder will likely be useful for some people in managing medication use, sleep duration, routine, and monitoring for and managing signs and symptoms” of the disorder, coinvestigator Evan H. Goulding, MD, PhD, assistant professor of psychiatry and behavioral sciences, Northwestern University, Chicago, told this news organization.

Use of the app may also “lead to decreased recurrence of mood episodes, impact overall depressive and manic symptom levels, and improve some aspects of quality of life,” Dr. Goulding added.

The findings were published online in JAMA Psychiatry.
 

Daily check-ins

The researchers randomly assigned 205 patients with BD to receive either usual care (n = 81; 56% women; mean age, 39 years) or usual care plus the smartphone-based self-management intervention LiveWell (n = 124; 65% women; mean age, 43 years) between March 2017 and April 2020. To be included, participants could not be experiencing a current mood episode or suicidal ideation.

The smartphone intervention included a daily check-in to monitor medication adherence, sleep, and wellness levels; coach visits to support adherence to the app; six phone calls over 16 weeks; and support from mental health professionals whenever needed. Participants in this group were asked to engage their mental health providers in the intervention as well.

Each participant in the control group had a visit with a coach who facilitated self-management support.

Investigators assessed all participants every 8 weeks until week 48 to gather information on mood symptoms and severity over the past 2 weeks and on quality of life.

The patients were also stratified into high- and low-risk relapse groups. The low-risk group was in asymptomatic recovery, meaning that they experienced two or fewer moderate symptoms of mania or depression in the previous 8 weeks. In addition, they had no moderate symptoms of mania or depression at study enrollment.

Patients in the high-risk group were recovering from an episode of mania or depression. They also had two or fewer moderate symptoms, but for 8 weeks or less.
 

Low-risk group fares better

Results showed that the smartphone intervention was significantly associated with a reduction in depressive symptoms vs. usual care (P = .02), as well as improvement in one aspect of the World Health Organization Quality of Life Assessment that measures social relationships (P = .02).

When the investigators stratified participants into risk groups, they found that for those in the low-risk group the smartphone-based intervention was associated with lower episode-relapse rates, lower mean percentage time symptomatic, and decreased manic symptom severity.

Mean estimated relapse rates by 48 weeks for the low-risk group were 12% for those in the intervention group and 37.2% for those in the control group. No differences were noted for the high-risk group.

Low-risk patients in the intervention group also had lower mean percentage-time symptomatic (17.9%) than those in the control group (26.1%) (Cohen d = .31).

“Our results are consistent with literature emphasizing the identification and facilitation of management plans for early warning signs of mood episodes and using these plans as an important self-management technique for avoiding relapse,” Dr. Goulding said.

Study limitations included low engagement by mental health professionals and low data generalizability to other populations, as the sample was mostly White (84% of the app group and 81% of the control group).

“There is a fairly large literature on risk factors, longitudinal trajectories, and stages of diseases that suggest we should already be able to predict relapse risk for individuals,” Dr. Goulding said.

“However, moving from overall risk to individual risk is trickier and will require larger datasets with longer follow-up to better understand what types of help should be delivered when and to whom,” he added.
 

‘Requires commitment’

John Torous, MD, director of the division of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, noted that mental health apps such as LiveWell require “time and energy devoted by both the patient and their clinician for maximal efficacy, which requires commitment from and training for both parties as well.

“But with such an investment in people, there is good evidence apps can help people with bipolar disorder even during the more severe periods of the illness,” added Dr. Torous, who was not involved with the research.

The study was funded by the National Institute of Mental Health.

Dr. Goulding reports having received honoraria from Otsuka. Dr. Torous has reported no relevant financial relationships.

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

A smartphone-based self-management intervention developed for patients with bipolar disorder (BD) can help decrease depressive symptoms and improve quality of life, new research suggests.

In a randomized clinical trial of usual care plus the experimental smartphone-based intervention known as LiveWell vs. usual care alone, participants in the smartphone group who were categorized as low-risk or in asymptomatic recovery at baseline also showed reduced manic symptom severity.

The results suggest that “apps for individuals with bipolar disorder will likely be useful for some people in managing medication use, sleep duration, routine, and monitoring for and managing signs and symptoms” of the disorder, coinvestigator Evan H. Goulding, MD, PhD, assistant professor of psychiatry and behavioral sciences, Northwestern University, Chicago, told this news organization.

Use of the app may also “lead to decreased recurrence of mood episodes, impact overall depressive and manic symptom levels, and improve some aspects of quality of life,” Dr. Goulding added.

The findings were published online in JAMA Psychiatry.
 

Daily check-ins

The researchers randomly assigned 205 patients with BD to receive either usual care (n = 81; 56% women; mean age, 39 years) or usual care plus the smartphone-based self-management intervention LiveWell (n = 124; 65% women; mean age, 43 years) between March 2017 and April 2020. To be included, participants could not be experiencing a current mood episode or suicidal ideation.

The smartphone intervention included a daily check-in to monitor medication adherence, sleep, and wellness levels; coach visits to support adherence to the app; six phone calls over 16 weeks; and support from mental health professionals whenever needed. Participants in this group were asked to engage their mental health providers in the intervention as well.

Each participant in the control group had a visit with a coach who facilitated self-management support.

Investigators assessed all participants every 8 weeks until week 48 to gather information on mood symptoms and severity over the past 2 weeks and on quality of life.

The patients were also stratified into high- and low-risk relapse groups. The low-risk group was in asymptomatic recovery, meaning that they experienced two or fewer moderate symptoms of mania or depression in the previous 8 weeks. In addition, they had no moderate symptoms of mania or depression at study enrollment.

Patients in the high-risk group were recovering from an episode of mania or depression. They also had two or fewer moderate symptoms, but for 8 weeks or less.
 

Low-risk group fares better

Results showed that the smartphone intervention was significantly associated with a reduction in depressive symptoms vs. usual care (P = .02), as well as improvement in one aspect of the World Health Organization Quality of Life Assessment that measures social relationships (P = .02).

When the investigators stratified participants into risk groups, they found that for those in the low-risk group the smartphone-based intervention was associated with lower episode-relapse rates, lower mean percentage time symptomatic, and decreased manic symptom severity.

Mean estimated relapse rates by 48 weeks for the low-risk group were 12% for those in the intervention group and 37.2% for those in the control group. No differences were noted for the high-risk group.

Low-risk patients in the intervention group also had lower mean percentage-time symptomatic (17.9%) than those in the control group (26.1%) (Cohen d = .31).

“Our results are consistent with literature emphasizing the identification and facilitation of management plans for early warning signs of mood episodes and using these plans as an important self-management technique for avoiding relapse,” Dr. Goulding said.

Study limitations included low engagement by mental health professionals and low data generalizability to other populations, as the sample was mostly White (84% of the app group and 81% of the control group).

“There is a fairly large literature on risk factors, longitudinal trajectories, and stages of diseases that suggest we should already be able to predict relapse risk for individuals,” Dr. Goulding said.

“However, moving from overall risk to individual risk is trickier and will require larger datasets with longer follow-up to better understand what types of help should be delivered when and to whom,” he added.
 

‘Requires commitment’

John Torous, MD, director of the division of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, noted that mental health apps such as LiveWell require “time and energy devoted by both the patient and their clinician for maximal efficacy, which requires commitment from and training for both parties as well.

“But with such an investment in people, there is good evidence apps can help people with bipolar disorder even during the more severe periods of the illness,” added Dr. Torous, who was not involved with the research.

The study was funded by the National Institute of Mental Health.

Dr. Goulding reports having received honoraria from Otsuka. Dr. Torous has reported no relevant financial relationships.

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

Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.^1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.⁴

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.^5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.^9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.^5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.¹¹ Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.^12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.¹⁴ There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.⁹ The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.¹⁵

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.^7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.^1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.⁴

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.^5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.^9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.^5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.¹¹ Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.^12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.¹⁴ There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.⁹ The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.¹⁵

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.^7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.^1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.⁴

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.^5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.^9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.^5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.¹¹ Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.^12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.¹⁴ There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.⁹ The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.¹⁵

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.^7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

Individuals who regularly take vitamin D supplements are significantly less likely to have a history of malignant melanoma or any type of skin cancers than are nonusers, say Finnish investigators. They also found a trend for benefit with occasional use.

The study, published in Melanoma Research, involved almost 500 individuals attending a dermatology clinic who reported on their use of vitamin D supplements.

Zbynek Pospisil/Getty Images

Regular users had a significant 55% reduction in the odds of having a past or present melanoma diagnosis, while occasional use was associated with a nonsignificant 46% reduction. The reduction was similar for all skin cancer types.

However, senior author Ilkka T. Harvima, MD, PhD, department of dermatology, University of Eastern Finland and Kuopio (Finland) University Hospital, warned there are limitations to the study.

Despite adjustment for several possible confounding factors, “it is still possible that some other, yet unidentified or untested, factors can still confound the present result,” he said.

Consequently, “the causal link between vitamin D and melanoma cannot be confirmed by the present results,” Dr. Harvima said in a statement.

Even if the link were to be proven, “the question about the optimal dose of oral vitamin D in order to for it to have beneficial effects remains to be answered,” he said.

“Until we know more, national intake recommendations should be followed.”

The incidence of cutaneous malignant melanoma and other skin cancers has been increasing steadily in Western populations, particularly in immunosuppressed individuals, the authors pointed out, and they attributed the rise to an increased exposure to ultraviolet radiation.

While ultraviolet radiation exposure is a well-known risk factor, “the other side of the coin is that public sun protection campaigns have led to alerts that insufficient sun exposure is a significant public health problem, resulting in insufficient vitamin D status.”

For their study, the team reviewed the records of 498 patients aged 21-79 years at a  dermatology outpatient clinic who were deemed by an experienced dermatologist to be at risk of any type of skin cancer.

Among these patients, 295 individuals had a history of past or present cutaneous malignancy, with 100 diagnosed with melanoma, 213 with basal cell carcinoma, and 41 with squamous cell carcinoma. A further 70 subjects had cancer elsewhere, including breast, prostate, kidney, bladder, intestine, and blood cancers.

A subgroup of 96 patients were immunocompromised and were considered separately.

The 402 remaining patients were categorized, based on their self-reported use of oral vitamin D preparations, as nonusers (n = 99), occasional users (n = 126), and regular users (n = 177).

Regular use of vitamin D was associated with being more educated (P = .032), less frequent outdoor working (P = .003), lower tobacco pack years (P = .001), and more frequent solarium exposure (P = .002).

There was no significant association between vitamin D use and photoaging, actinic keratoses, nevi, basal or squamous cell carcinoma, body mass index, or self-estimated lifetime exposure to sunlight or sunburns.

However, there were significant associations between regular use of vitamin D and a lower incidence of melanoma and other cancer types.

There were significantly fewer individuals in the regular vitamin D use group with a past or present history of melanoma when compared with the nonuse group, at 18.1% vs. 32.3% (P = .021), or any type of skin cancer, at 62.1% vs. 74.7% (P = .027).

Multivariate logistic regression analysis revealed that regular vitamin D use was significantly associated with a reduced melanoma risk, at an odds ratio vs. nonuse of 0.447 (P = .016).

Occasional use was associated with a reduced, albeit nonsignificant, risk, with an odds ratio versus nonuse of 0.540 (P = .08).

For any type of skin cancers, regular vitamin D use was associated with an odds ratio vs. nonuse of 0.478 (P = .032), while that for occasional vitamin D use was 0.543 (P = .061).

“Somewhat similar” results were obtained when the investigators looked at the subgroup of immunocompromised individuals, although they note that “the number of subjects was low.”

The study was supported by the Cancer Center of Eastern Finland of the University of Eastern Finland, the Finnish Cancer Research Foundation, and the VTR-funding of Kuopio University Hospital. The authors report no relevant financial relationships.

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

Individuals who regularly take vitamin D supplements are significantly less likely to have a history of malignant melanoma or any type of skin cancers than are nonusers, say Finnish investigators. They also found a trend for benefit with occasional use.

The study, published in Melanoma Research, involved almost 500 individuals attending a dermatology clinic who reported on their use of vitamin D supplements.

Zbynek Pospisil/Getty Images

Regular users had a significant 55% reduction in the odds of having a past or present melanoma diagnosis, while occasional use was associated with a nonsignificant 46% reduction. The reduction was similar for all skin cancer types.

However, senior author Ilkka T. Harvima, MD, PhD, department of dermatology, University of Eastern Finland and Kuopio (Finland) University Hospital, warned there are limitations to the study.

Despite adjustment for several possible confounding factors, “it is still possible that some other, yet unidentified or untested, factors can still confound the present result,” he said.

Consequently, “the causal link between vitamin D and melanoma cannot be confirmed by the present results,” Dr. Harvima said in a statement.

Even if the link were to be proven, “the question about the optimal dose of oral vitamin D in order to for it to have beneficial effects remains to be answered,” he said.

“Until we know more, national intake recommendations should be followed.”

The incidence of cutaneous malignant melanoma and other skin cancers has been increasing steadily in Western populations, particularly in immunosuppressed individuals, the authors pointed out, and they attributed the rise to an increased exposure to ultraviolet radiation.

While ultraviolet radiation exposure is a well-known risk factor, “the other side of the coin is that public sun protection campaigns have led to alerts that insufficient sun exposure is a significant public health problem, resulting in insufficient vitamin D status.”

For their study, the team reviewed the records of 498 patients aged 21-79 years at a  dermatology outpatient clinic who were deemed by an experienced dermatologist to be at risk of any type of skin cancer.

Among these patients, 295 individuals had a history of past or present cutaneous malignancy, with 100 diagnosed with melanoma, 213 with basal cell carcinoma, and 41 with squamous cell carcinoma. A further 70 subjects had cancer elsewhere, including breast, prostate, kidney, bladder, intestine, and blood cancers.

A subgroup of 96 patients were immunocompromised and were considered separately.

The 402 remaining patients were categorized, based on their self-reported use of oral vitamin D preparations, as nonusers (n = 99), occasional users (n = 126), and regular users (n = 177).

Regular use of vitamin D was associated with being more educated (P = .032), less frequent outdoor working (P = .003), lower tobacco pack years (P = .001), and more frequent solarium exposure (P = .002).

There was no significant association between vitamin D use and photoaging, actinic keratoses, nevi, basal or squamous cell carcinoma, body mass index, or self-estimated lifetime exposure to sunlight or sunburns.

However, there were significant associations between regular use of vitamin D and a lower incidence of melanoma and other cancer types.

There were significantly fewer individuals in the regular vitamin D use group with a past or present history of melanoma when compared with the nonuse group, at 18.1% vs. 32.3% (P = .021), or any type of skin cancer, at 62.1% vs. 74.7% (P = .027).

Multivariate logistic regression analysis revealed that regular vitamin D use was significantly associated with a reduced melanoma risk, at an odds ratio vs. nonuse of 0.447 (P = .016).

Occasional use was associated with a reduced, albeit nonsignificant, risk, with an odds ratio versus nonuse of 0.540 (P = .08).

For any type of skin cancers, regular vitamin D use was associated with an odds ratio vs. nonuse of 0.478 (P = .032), while that for occasional vitamin D use was 0.543 (P = .061).

“Somewhat similar” results were obtained when the investigators looked at the subgroup of immunocompromised individuals, although they note that “the number of subjects was low.”

The study was supported by the Cancer Center of Eastern Finland of the University of Eastern Finland, the Finnish Cancer Research Foundation, and the VTR-funding of Kuopio University Hospital. The authors report no relevant financial relationships.

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

Individuals who regularly take vitamin D supplements are significantly less likely to have a history of malignant melanoma or any type of skin cancers than are nonusers, say Finnish investigators. They also found a trend for benefit with occasional use.

The study, published in Melanoma Research, involved almost 500 individuals attending a dermatology clinic who reported on their use of vitamin D supplements.

Zbynek Pospisil/Getty Images

Regular users had a significant 55% reduction in the odds of having a past or present melanoma diagnosis, while occasional use was associated with a nonsignificant 46% reduction. The reduction was similar for all skin cancer types.

However, senior author Ilkka T. Harvima, MD, PhD, department of dermatology, University of Eastern Finland and Kuopio (Finland) University Hospital, warned there are limitations to the study.

Despite adjustment for several possible confounding factors, “it is still possible that some other, yet unidentified or untested, factors can still confound the present result,” he said.

Consequently, “the causal link between vitamin D and melanoma cannot be confirmed by the present results,” Dr. Harvima said in a statement.

Even if the link were to be proven, “the question about the optimal dose of oral vitamin D in order to for it to have beneficial effects remains to be answered,” he said.

“Until we know more, national intake recommendations should be followed.”

The incidence of cutaneous malignant melanoma and other skin cancers has been increasing steadily in Western populations, particularly in immunosuppressed individuals, the authors pointed out, and they attributed the rise to an increased exposure to ultraviolet radiation.

While ultraviolet radiation exposure is a well-known risk factor, “the other side of the coin is that public sun protection campaigns have led to alerts that insufficient sun exposure is a significant public health problem, resulting in insufficient vitamin D status.”

For their study, the team reviewed the records of 498 patients aged 21-79 years at a  dermatology outpatient clinic who were deemed by an experienced dermatologist to be at risk of any type of skin cancer.

Among these patients, 295 individuals had a history of past or present cutaneous malignancy, with 100 diagnosed with melanoma, 213 with basal cell carcinoma, and 41 with squamous cell carcinoma. A further 70 subjects had cancer elsewhere, including breast, prostate, kidney, bladder, intestine, and blood cancers.

A subgroup of 96 patients were immunocompromised and were considered separately.

The 402 remaining patients were categorized, based on their self-reported use of oral vitamin D preparations, as nonusers (n = 99), occasional users (n = 126), and regular users (n = 177).

Regular use of vitamin D was associated with being more educated (P = .032), less frequent outdoor working (P = .003), lower tobacco pack years (P = .001), and more frequent solarium exposure (P = .002).

There was no significant association between vitamin D use and photoaging, actinic keratoses, nevi, basal or squamous cell carcinoma, body mass index, or self-estimated lifetime exposure to sunlight or sunburns.

However, there were significant associations between regular use of vitamin D and a lower incidence of melanoma and other cancer types.

There were significantly fewer individuals in the regular vitamin D use group with a past or present history of melanoma when compared with the nonuse group, at 18.1% vs. 32.3% (P = .021), or any type of skin cancer, at 62.1% vs. 74.7% (P = .027).

Multivariate logistic regression analysis revealed that regular vitamin D use was significantly associated with a reduced melanoma risk, at an odds ratio vs. nonuse of 0.447 (P = .016).

Occasional use was associated with a reduced, albeit nonsignificant, risk, with an odds ratio versus nonuse of 0.540 (P = .08).

For any type of skin cancers, regular vitamin D use was associated with an odds ratio vs. nonuse of 0.478 (P = .032), while that for occasional vitamin D use was 0.543 (P = .061).

“Somewhat similar” results were obtained when the investigators looked at the subgroup of immunocompromised individuals, although they note that “the number of subjects was low.”

The study was supported by the Cancer Center of Eastern Finland of the University of Eastern Finland, the Finnish Cancer Research Foundation, and the VTR-funding of Kuopio University Hospital. The authors report no relevant financial relationships.

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

Atropine is often considered a first-line intervention for unstable bradycardia. Unfortunately, atropine often fails when the bradycardia is not vagally induced and is not indicated for high-level atrioventricular blocks (for example, Mobitz II and third-degree AV block).

Transvenous pacing is typically the most effective therapy for unstable bradycardia but it is invasive, takes some time to perform, and is a procedure for which many acute care physicians lack comfort and significant experience. Transcutaneous pacing (TCP), on the other hand, is fast, easy to perform, and tends to be well tolerated by most patients when they receive appropriate doses of analgesia.

Unfortunately, TCP often fails to produce electrical or, more importantly, mechanical capture. Oftentimes when capture initially fails, the electrical current is increased in hopes of gaining capture but much to the discomfort of the patient. Increased body mass index can contribute to failure to capture, but what about TCP pad position? Despite recommendations for TCP in the United States and European resuscitation guidelines for many years, until now, no studies have evaluated optimal pad position for TCP. As a result, the default position for most clinicians using TCP has been the anterior-lateral (AL) position on the chest wall.

A study published in October 2022 compared the common AL position (anterior pad placed at the right upper chest and lateral pad placed over the left lower rib cage at the mid-axillary line) with the anterior-posterior (AP) position (anterior pad placed on the left chest over the apex of the heart and the posterior pad on the left mid-back area approximating the level of the mid-portion of the heart). The AP position has become more commonly used in defibrillating arrested hearts because it more accurately sends the current through the left ventricle. The concern with the AL position, especially in patients with large body habitus, is that the vector of the current may partially or entirely miss the left ventricle.

Moayedi and colleagues hypothesized that optimal TCP should employ pad placement that is similar to that used during optimal defibrillation attempts. They conducted a study comparing AL versus AP position during TCP and published their results in two parts, which will be discussed together.

The investigators evaluated 20 patients (6 women, 14 men) who had elective cardioversion of atrial fibrillation in the electrophysiology lab (Resuscitation. 2022 Dec;181:140-6). After successful cardioversion to sinus rhythm, the cardioversion pads were removed, and two new sets of pacer pads were placed on the patients’ chests. Pads were placed in both the AL and the AP positions, as previously described. Starting at a current output of 40 mA, the output was slowly increased on one set of pads until mechanical capture was obtained at the same rate as the pacer setting for at least 10 seconds. Pacing was then discontinued, but then the process was repeated using the second set of pads. The order in which the positions were tested (that is, AL tested first vs. AP tested first) was alternated. If capture was not obtained by 140 mA (the pacer’s maximum output), failure to capture was documented. Both positions were tested in all patients except for three cases where the second position was not tested because of inadequate analgesia.

The investigators found that 8 in 19 (42%) of the AL trials and 14 in 18 (78%) of the AP trials successfully captured. For the 17 participants who completed both trials, both positions captured in 8 in 17 (47%). AP but not AL was captured in 5 in 17 (29%); AL but not AP was captured in 0 cases. Neither position captured in 4 in 17 (24%). Of note, there was no association between successful capture and body mass index, chest circumference, or chest diameter. The AP position was more successful in both women and men, compared with the AL position. The investigators also found that, among the successful trials, the AP position tended to capture at lower currents than the AL position (93 mA vs. 126 mA).
 

In summary

TCP is a potentially lifesaving intervention in the treatment of patients with unstable bradycardia. Many of us who have attempted to perform TCP on unstable patients have frequently been disappointed with the results. In retrospect, however, I can recall that each time I have attempted this procedure, it has been using pads placed in the AL position.

Now for the first time we have data indicating that the standard AL position may be suboptimal, compared with the AP position. The study by Moayedi and colleagues is small, but the results are compelling, and the AP pad placement intuitively makes more sense. By using the AP pad placement, which provides greater likelihood of electrical current passing through the left ventricle, we should expect a greater likelihood of successful capture during attempts at TCP. In addition, we may anticipate lower analgesia needs if the AP position requires less current for success. Kudos to Moayedi and colleagues for performing a novel study of a critical procedure in acute care medicine.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. He had no disclosures. A version of this article first appeared on Medscape.com.

Atropine is often considered a first-line intervention for unstable bradycardia. Unfortunately, atropine often fails when the bradycardia is not vagally induced and is not indicated for high-level atrioventricular blocks (for example, Mobitz II and third-degree AV block).

Transvenous pacing is typically the most effective therapy for unstable bradycardia but it is invasive, takes some time to perform, and is a procedure for which many acute care physicians lack comfort and significant experience. Transcutaneous pacing (TCP), on the other hand, is fast, easy to perform, and tends to be well tolerated by most patients when they receive appropriate doses of analgesia.

Unfortunately, TCP often fails to produce electrical or, more importantly, mechanical capture. Oftentimes when capture initially fails, the electrical current is increased in hopes of gaining capture but much to the discomfort of the patient. Increased body mass index can contribute to failure to capture, but what about TCP pad position? Despite recommendations for TCP in the United States and European resuscitation guidelines for many years, until now, no studies have evaluated optimal pad position for TCP. As a result, the default position for most clinicians using TCP has been the anterior-lateral (AL) position on the chest wall.

A study published in October 2022 compared the common AL position (anterior pad placed at the right upper chest and lateral pad placed over the left lower rib cage at the mid-axillary line) with the anterior-posterior (AP) position (anterior pad placed on the left chest over the apex of the heart and the posterior pad on the left mid-back area approximating the level of the mid-portion of the heart). The AP position has become more commonly used in defibrillating arrested hearts because it more accurately sends the current through the left ventricle. The concern with the AL position, especially in patients with large body habitus, is that the vector of the current may partially or entirely miss the left ventricle.

Moayedi and colleagues hypothesized that optimal TCP should employ pad placement that is similar to that used during optimal defibrillation attempts. They conducted a study comparing AL versus AP position during TCP and published their results in two parts, which will be discussed together.

The investigators evaluated 20 patients (6 women, 14 men) who had elective cardioversion of atrial fibrillation in the electrophysiology lab (Resuscitation. 2022 Dec;181:140-6). After successful cardioversion to sinus rhythm, the cardioversion pads were removed, and two new sets of pacer pads were placed on the patients’ chests. Pads were placed in both the AL and the AP positions, as previously described. Starting at a current output of 40 mA, the output was slowly increased on one set of pads until mechanical capture was obtained at the same rate as the pacer setting for at least 10 seconds. Pacing was then discontinued, but then the process was repeated using the second set of pads. The order in which the positions were tested (that is, AL tested first vs. AP tested first) was alternated. If capture was not obtained by 140 mA (the pacer’s maximum output), failure to capture was documented. Both positions were tested in all patients except for three cases where the second position was not tested because of inadequate analgesia.

The investigators found that 8 in 19 (42%) of the AL trials and 14 in 18 (78%) of the AP trials successfully captured. For the 17 participants who completed both trials, both positions captured in 8 in 17 (47%). AP but not AL was captured in 5 in 17 (29%); AL but not AP was captured in 0 cases. Neither position captured in 4 in 17 (24%). Of note, there was no association between successful capture and body mass index, chest circumference, or chest diameter. The AP position was more successful in both women and men, compared with the AL position. The investigators also found that, among the successful trials, the AP position tended to capture at lower currents than the AL position (93 mA vs. 126 mA).
 

In summary

TCP is a potentially lifesaving intervention in the treatment of patients with unstable bradycardia. Many of us who have attempted to perform TCP on unstable patients have frequently been disappointed with the results. In retrospect, however, I can recall that each time I have attempted this procedure, it has been using pads placed in the AL position.

Now for the first time we have data indicating that the standard AL position may be suboptimal, compared with the AP position. The study by Moayedi and colleagues is small, but the results are compelling, and the AP pad placement intuitively makes more sense. By using the AP pad placement, which provides greater likelihood of electrical current passing through the left ventricle, we should expect a greater likelihood of successful capture during attempts at TCP. In addition, we may anticipate lower analgesia needs if the AP position requires less current for success. Kudos to Moayedi and colleagues for performing a novel study of a critical procedure in acute care medicine.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. He had no disclosures. A version of this article first appeared on Medscape.com.

Atropine is often considered a first-line intervention for unstable bradycardia. Unfortunately, atropine often fails when the bradycardia is not vagally induced and is not indicated for high-level atrioventricular blocks (for example, Mobitz II and third-degree AV block).

Transvenous pacing is typically the most effective therapy for unstable bradycardia but it is invasive, takes some time to perform, and is a procedure for which many acute care physicians lack comfort and significant experience. Transcutaneous pacing (TCP), on the other hand, is fast, easy to perform, and tends to be well tolerated by most patients when they receive appropriate doses of analgesia.

Unfortunately, TCP often fails to produce electrical or, more importantly, mechanical capture. Oftentimes when capture initially fails, the electrical current is increased in hopes of gaining capture but much to the discomfort of the patient. Increased body mass index can contribute to failure to capture, but what about TCP pad position? Despite recommendations for TCP in the United States and European resuscitation guidelines for many years, until now, no studies have evaluated optimal pad position for TCP. As a result, the default position for most clinicians using TCP has been the anterior-lateral (AL) position on the chest wall.

A study published in October 2022 compared the common AL position (anterior pad placed at the right upper chest and lateral pad placed over the left lower rib cage at the mid-axillary line) with the anterior-posterior (AP) position (anterior pad placed on the left chest over the apex of the heart and the posterior pad on the left mid-back area approximating the level of the mid-portion of the heart). The AP position has become more commonly used in defibrillating arrested hearts because it more accurately sends the current through the left ventricle. The concern with the AL position, especially in patients with large body habitus, is that the vector of the current may partially or entirely miss the left ventricle.

Moayedi and colleagues hypothesized that optimal TCP should employ pad placement that is similar to that used during optimal defibrillation attempts. They conducted a study comparing AL versus AP position during TCP and published their results in two parts, which will be discussed together.

The investigators evaluated 20 patients (6 women, 14 men) who had elective cardioversion of atrial fibrillation in the electrophysiology lab (Resuscitation. 2022 Dec;181:140-6). After successful cardioversion to sinus rhythm, the cardioversion pads were removed, and two new sets of pacer pads were placed on the patients’ chests. Pads were placed in both the AL and the AP positions, as previously described. Starting at a current output of 40 mA, the output was slowly increased on one set of pads until mechanical capture was obtained at the same rate as the pacer setting for at least 10 seconds. Pacing was then discontinued, but then the process was repeated using the second set of pads. The order in which the positions were tested (that is, AL tested first vs. AP tested first) was alternated. If capture was not obtained by 140 mA (the pacer’s maximum output), failure to capture was documented. Both positions were tested in all patients except for three cases where the second position was not tested because of inadequate analgesia.

The investigators found that 8 in 19 (42%) of the AL trials and 14 in 18 (78%) of the AP trials successfully captured. For the 17 participants who completed both trials, both positions captured in 8 in 17 (47%). AP but not AL was captured in 5 in 17 (29%); AL but not AP was captured in 0 cases. Neither position captured in 4 in 17 (24%). Of note, there was no association between successful capture and body mass index, chest circumference, or chest diameter. The AP position was more successful in both women and men, compared with the AL position. The investigators also found that, among the successful trials, the AP position tended to capture at lower currents than the AL position (93 mA vs. 126 mA).
 

In summary

TCP is a potentially lifesaving intervention in the treatment of patients with unstable bradycardia. Many of us who have attempted to perform TCP on unstable patients have frequently been disappointed with the results. In retrospect, however, I can recall that each time I have attempted this procedure, it has been using pads placed in the AL position.

Now for the first time we have data indicating that the standard AL position may be suboptimal, compared with the AP position. The study by Moayedi and colleagues is small, but the results are compelling, and the AP pad placement intuitively makes more sense. By using the AP pad placement, which provides greater likelihood of electrical current passing through the left ventricle, we should expect a greater likelihood of successful capture during attempts at TCP. In addition, we may anticipate lower analgesia needs if the AP position requires less current for success. Kudos to Moayedi and colleagues for performing a novel study of a critical procedure in acute care medicine.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. He had no disclosures. A version of this article first appeared on Medscape.com.

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

Sleep complaints by patients with a major depressive episode (MDE) may be a red flag signaling a higher risk for developing other psychiatric disorders, new research suggests.

Investigators studied 3-year incidence rates of psychiatric disorders in almost 3,000 patients experiencing an MDE. Results showed that having a history of difficulty falling asleep, early morning awakening, and hypersomnia increased risk for incident psychiatric disorders.

“The findings of this study suggest the potential value of including insomnia and hypersomnia in clinical assessments of all psychiatric disorders,” write the investigators, led by Bénédicte Barbotin, MD, Département de Psychiatrie et d’Addictologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, France.

“Insomnia and hypersomnia symptoms may be prodromal transdiagnostic biomarkers and easily modifiable therapeutic targets for the prevention of psychiatric disorders,” they add.

The findings were published online recently in the Journal of Clinical Psychiatry.


 

Bidirectional association

The researchers note that sleep disturbance is “one of the most common symptoms” associated with major depressive disorder (MDD) and may be “both a consequence and a cause.”

Moreover, improving sleep disturbances for patients with an MDE “tends to improve depressive symptom and outcomes,” they add.

Although the possibility of a bidirectional association between MDEs and sleep disturbances “offers a new perspective that sleep complaints might be a predictive prodromal symptom,” the association of sleep complaints with the subsequent development of other psychiatric disorders in MDEs “remains poorly documented,” the investigators write.

The observation that sleep complaints are associated with psychiatric complications and adverse outcomes, such as suicidality and substance overdose, suggests that longitudinal studies “may help to better understand these relationships.”

To investigate these issues, the researchers examined three sleep complaints among patients with MDE: trouble falling asleep, early morning awakening, and hypersomnia. They adjusted for an array of variables, including antisocial personality disorders, use of sedatives or tranquilizers, sociodemographic characteristics, MDE severity, poverty, obesity, educational level, and stressful life events.

They also used a “bifactor latent variable approach” to “disentangle” a number of effects, including those shared by all psychiatric disorders; those specific to dimensions of psychopathology, such as internalizing dimension; and those specific to individual psychiatric disorders, such as dysthymia.

“To our knowledge, this is the most extensive prospective assessment [ever conducted] of associations between sleep complaints and incident psychiatric disorders,” the investigators write.

They drew on data from Waves 1 and 2 of the National Epidemiological Survey on Alcohol and Related Conditions, a large nationally representative survey conducted in 2001-2002 (Wave 1) and 2004-2005 (Wave 2) by the National Institute on Alcoholism and Alcohol Abuse.

The analysis included 2,864 participants who experienced MDE in the year prior to Wave 1 and who completed interviews at both waves.

Researchers assessed past-year DSM-IV Axis I disorders and baseline sleep complaints at Wave 1, as well as incident DSM-IV Axis I disorders between the two waves – including substance use, mood, and anxiety disorders.
 

Screening needed?

Results showed a wide range of incidence rates for psychiatric disorders between Wave 1 and Wave 2, ranging from 2.7% for cannabis use to 8.2% for generalized anxiety disorder.

The lifetime prevalence of sleep complaints was higher among participants who developed a psychiatric disorder between the two waves than among those who did not have sleep complaints. The range (from lowest to highest percentage) is shown in the accompanying table.

A higher number of sleep complaints was also associated with higher percentages of psychiatric disorders.

Hypersomnia, in particular, significantly increased the odds of having another psychiatric disorder. For patients with MDD who reported hypersomnia, the mean number of sleep disorders was significantly higher than for patients without hypersomnia (2.08 vs. 1.32; P < .001).

“This explains why hypersomnia appears more strongly associated with the incidence of psychiatric disorders,” the investigators write.

After adjusting for sociodemographic and clinical characteristics and antisocial personality disorder, the effects shared across all sleep complaints were “significantly associated with the incident general psychopathology factor, representing mechanisms that may lead to incidence of all psychiatric disorder in the model,” they add.

The researchers note that insomnia and hypersomnia can impair cognitive function, decision-making, problem-solving, and emotion processing networks, thereby increasing the onset of psychiatric disorders in vulnerable individuals.

Shared biological determinants, such as monoamine neurotransmitters that play a major role in depression, anxiety, substance use disorders, and the regulation of sleep stages, may also underlie both sleep disturbances and psychiatric disorders, they speculate.

“These results suggest the importance of systematically assessing insomnia and hypersomnia when evaluating psychiatric disorders and considering these symptoms as nonspecific prodromal or at-risk symptoms, also shared with suicidal behaviors,” the investigators write.

“In addition, since most individuals who developed a psychiatric disorder had at least one sleep complaint, all psychiatric disorders should be carefully screened among individuals with sleep complaints,” they add.
 

Transdiagnostic phenomenon

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit, noted that the study replicates previous observations that a bidirectional relationship exists between sleep disturbances and mental disorders and that there “seems to be a relationship between sleep disturbance and suicidality that is bidirectional.”

He added that he appreciated the fact that the investigators “took this knowledge one step further; and what they are saying is that within the syndrome of depression, it is the sleep disturbance that is predicting future problems.”

Dr. McIntyre, who is also chairman and executive director of the Brain and Cognitive Discover Foundation in Toronto, was not involved with the study.

The data suggest that, “conceptually, sleep disturbance is a transdiagnostic phenomenon that may also be the nexus when multiple comorbid mental disorders occur,” he said.

“If this is the case, clinically, there is an opportunity here to prevent incident mental disorders in persons with depression and sleep disturbance, prioritizing sleep management in any patient with a mood disorder,” Dr. McIntyre added.

He noted that “the testable hypothesis” is how this is occurring mechanistically.

“I would conjecture that it could be inflammation and/or insulin resistance that is part of sleep disturbance that could predispose and portend other mental illnesses – and likely other medical conditions too, such as obesity and diabetes,” he said.

The study received no specific funding from any funding agency, commercial, or not-for-profit sectors. The investigators’ relevant financial relationships are listed in the original article. Dr. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; has received speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences; and is a CEO of Braxia Scientific Corp.

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

Sleep complaints by patients with a major depressive episode (MDE) may be a red flag signaling a higher risk for developing other psychiatric disorders, new research suggests.

Investigators studied 3-year incidence rates of psychiatric disorders in almost 3,000 patients experiencing an MDE. Results showed that having a history of difficulty falling asleep, early morning awakening, and hypersomnia increased risk for incident psychiatric disorders.

“The findings of this study suggest the potential value of including insomnia and hypersomnia in clinical assessments of all psychiatric disorders,” write the investigators, led by Bénédicte Barbotin, MD, Département de Psychiatrie et d’Addictologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, France.

“Insomnia and hypersomnia symptoms may be prodromal transdiagnostic biomarkers and easily modifiable therapeutic targets for the prevention of psychiatric disorders,” they add.

The findings were published online recently in the Journal of Clinical Psychiatry.


 

Bidirectional association

The researchers note that sleep disturbance is “one of the most common symptoms” associated with major depressive disorder (MDD) and may be “both a consequence and a cause.”

Moreover, improving sleep disturbances for patients with an MDE “tends to improve depressive symptom and outcomes,” they add.

Although the possibility of a bidirectional association between MDEs and sleep disturbances “offers a new perspective that sleep complaints might be a predictive prodromal symptom,” the association of sleep complaints with the subsequent development of other psychiatric disorders in MDEs “remains poorly documented,” the investigators write.

The observation that sleep complaints are associated with psychiatric complications and adverse outcomes, such as suicidality and substance overdose, suggests that longitudinal studies “may help to better understand these relationships.”

To investigate these issues, the researchers examined three sleep complaints among patients with MDE: trouble falling asleep, early morning awakening, and hypersomnia. They adjusted for an array of variables, including antisocial personality disorders, use of sedatives or tranquilizers, sociodemographic characteristics, MDE severity, poverty, obesity, educational level, and stressful life events.

They also used a “bifactor latent variable approach” to “disentangle” a number of effects, including those shared by all psychiatric disorders; those specific to dimensions of psychopathology, such as internalizing dimension; and those specific to individual psychiatric disorders, such as dysthymia.

“To our knowledge, this is the most extensive prospective assessment [ever conducted] of associations between sleep complaints and incident psychiatric disorders,” the investigators write.

They drew on data from Waves 1 and 2 of the National Epidemiological Survey on Alcohol and Related Conditions, a large nationally representative survey conducted in 2001-2002 (Wave 1) and 2004-2005 (Wave 2) by the National Institute on Alcoholism and Alcohol Abuse.

The analysis included 2,864 participants who experienced MDE in the year prior to Wave 1 and who completed interviews at both waves.

Researchers assessed past-year DSM-IV Axis I disorders and baseline sleep complaints at Wave 1, as well as incident DSM-IV Axis I disorders between the two waves – including substance use, mood, and anxiety disorders.
 

Screening needed?

Results showed a wide range of incidence rates for psychiatric disorders between Wave 1 and Wave 2, ranging from 2.7% for cannabis use to 8.2% for generalized anxiety disorder.

The lifetime prevalence of sleep complaints was higher among participants who developed a psychiatric disorder between the two waves than among those who did not have sleep complaints. The range (from lowest to highest percentage) is shown in the accompanying table.

A higher number of sleep complaints was also associated with higher percentages of psychiatric disorders.

Hypersomnia, in particular, significantly increased the odds of having another psychiatric disorder. For patients with MDD who reported hypersomnia, the mean number of sleep disorders was significantly higher than for patients without hypersomnia (2.08 vs. 1.32; P < .001).

“This explains why hypersomnia appears more strongly associated with the incidence of psychiatric disorders,” the investigators write.

After adjusting for sociodemographic and clinical characteristics and antisocial personality disorder, the effects shared across all sleep complaints were “significantly associated with the incident general psychopathology factor, representing mechanisms that may lead to incidence of all psychiatric disorder in the model,” they add.

The researchers note that insomnia and hypersomnia can impair cognitive function, decision-making, problem-solving, and emotion processing networks, thereby increasing the onset of psychiatric disorders in vulnerable individuals.

Shared biological determinants, such as monoamine neurotransmitters that play a major role in depression, anxiety, substance use disorders, and the regulation of sleep stages, may also underlie both sleep disturbances and psychiatric disorders, they speculate.

“These results suggest the importance of systematically assessing insomnia and hypersomnia when evaluating psychiatric disorders and considering these symptoms as nonspecific prodromal or at-risk symptoms, also shared with suicidal behaviors,” the investigators write.

“In addition, since most individuals who developed a psychiatric disorder had at least one sleep complaint, all psychiatric disorders should be carefully screened among individuals with sleep complaints,” they add.
 

Transdiagnostic phenomenon

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit, noted that the study replicates previous observations that a bidirectional relationship exists between sleep disturbances and mental disorders and that there “seems to be a relationship between sleep disturbance and suicidality that is bidirectional.”

He added that he appreciated the fact that the investigators “took this knowledge one step further; and what they are saying is that within the syndrome of depression, it is the sleep disturbance that is predicting future problems.”

Dr. McIntyre, who is also chairman and executive director of the Brain and Cognitive Discover Foundation in Toronto, was not involved with the study.

The data suggest that, “conceptually, sleep disturbance is a transdiagnostic phenomenon that may also be the nexus when multiple comorbid mental disorders occur,” he said.

“If this is the case, clinically, there is an opportunity here to prevent incident mental disorders in persons with depression and sleep disturbance, prioritizing sleep management in any patient with a mood disorder,” Dr. McIntyre added.

He noted that “the testable hypothesis” is how this is occurring mechanistically.

“I would conjecture that it could be inflammation and/or insulin resistance that is part of sleep disturbance that could predispose and portend other mental illnesses – and likely other medical conditions too, such as obesity and diabetes,” he said.

The study received no specific funding from any funding agency, commercial, or not-for-profit sectors. The investigators’ relevant financial relationships are listed in the original article. Dr. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; has received speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences; and is a CEO of Braxia Scientific Corp.

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

Sleep complaints by patients with a major depressive episode (MDE) may be a red flag signaling a higher risk for developing other psychiatric disorders, new research suggests.

Investigators studied 3-year incidence rates of psychiatric disorders in almost 3,000 patients experiencing an MDE. Results showed that having a history of difficulty falling asleep, early morning awakening, and hypersomnia increased risk for incident psychiatric disorders.

“The findings of this study suggest the potential value of including insomnia and hypersomnia in clinical assessments of all psychiatric disorders,” write the investigators, led by Bénédicte Barbotin, MD, Département de Psychiatrie et d’Addictologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, France.

“Insomnia and hypersomnia symptoms may be prodromal transdiagnostic biomarkers and easily modifiable therapeutic targets for the prevention of psychiatric disorders,” they add.

The findings were published online recently in the Journal of Clinical Psychiatry.


 

Bidirectional association

The researchers note that sleep disturbance is “one of the most common symptoms” associated with major depressive disorder (MDD) and may be “both a consequence and a cause.”

Moreover, improving sleep disturbances for patients with an MDE “tends to improve depressive symptom and outcomes,” they add.

Although the possibility of a bidirectional association between MDEs and sleep disturbances “offers a new perspective that sleep complaints might be a predictive prodromal symptom,” the association of sleep complaints with the subsequent development of other psychiatric disorders in MDEs “remains poorly documented,” the investigators write.

The observation that sleep complaints are associated with psychiatric complications and adverse outcomes, such as suicidality and substance overdose, suggests that longitudinal studies “may help to better understand these relationships.”

To investigate these issues, the researchers examined three sleep complaints among patients with MDE: trouble falling asleep, early morning awakening, and hypersomnia. They adjusted for an array of variables, including antisocial personality disorders, use of sedatives or tranquilizers, sociodemographic characteristics, MDE severity, poverty, obesity, educational level, and stressful life events.

They also used a “bifactor latent variable approach” to “disentangle” a number of effects, including those shared by all psychiatric disorders; those specific to dimensions of psychopathology, such as internalizing dimension; and those specific to individual psychiatric disorders, such as dysthymia.

“To our knowledge, this is the most extensive prospective assessment [ever conducted] of associations between sleep complaints and incident psychiatric disorders,” the investigators write.

They drew on data from Waves 1 and 2 of the National Epidemiological Survey on Alcohol and Related Conditions, a large nationally representative survey conducted in 2001-2002 (Wave 1) and 2004-2005 (Wave 2) by the National Institute on Alcoholism and Alcohol Abuse.

The analysis included 2,864 participants who experienced MDE in the year prior to Wave 1 and who completed interviews at both waves.

Researchers assessed past-year DSM-IV Axis I disorders and baseline sleep complaints at Wave 1, as well as incident DSM-IV Axis I disorders between the two waves – including substance use, mood, and anxiety disorders.
 

Screening needed?

Results showed a wide range of incidence rates for psychiatric disorders between Wave 1 and Wave 2, ranging from 2.7% for cannabis use to 8.2% for generalized anxiety disorder.

The lifetime prevalence of sleep complaints was higher among participants who developed a psychiatric disorder between the two waves than among those who did not have sleep complaints. The range (from lowest to highest percentage) is shown in the accompanying table.

A higher number of sleep complaints was also associated with higher percentages of psychiatric disorders.

Hypersomnia, in particular, significantly increased the odds of having another psychiatric disorder. For patients with MDD who reported hypersomnia, the mean number of sleep disorders was significantly higher than for patients without hypersomnia (2.08 vs. 1.32; P < .001).

“This explains why hypersomnia appears more strongly associated with the incidence of psychiatric disorders,” the investigators write.

After adjusting for sociodemographic and clinical characteristics and antisocial personality disorder, the effects shared across all sleep complaints were “significantly associated with the incident general psychopathology factor, representing mechanisms that may lead to incidence of all psychiatric disorder in the model,” they add.

The researchers note that insomnia and hypersomnia can impair cognitive function, decision-making, problem-solving, and emotion processing networks, thereby increasing the onset of psychiatric disorders in vulnerable individuals.

Shared biological determinants, such as monoamine neurotransmitters that play a major role in depression, anxiety, substance use disorders, and the regulation of sleep stages, may also underlie both sleep disturbances and psychiatric disorders, they speculate.

“These results suggest the importance of systematically assessing insomnia and hypersomnia when evaluating psychiatric disorders and considering these symptoms as nonspecific prodromal or at-risk symptoms, also shared with suicidal behaviors,” the investigators write.

“In addition, since most individuals who developed a psychiatric disorder had at least one sleep complaint, all psychiatric disorders should be carefully screened among individuals with sleep complaints,” they add.
 

Transdiagnostic phenomenon

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit, noted that the study replicates previous observations that a bidirectional relationship exists between sleep disturbances and mental disorders and that there “seems to be a relationship between sleep disturbance and suicidality that is bidirectional.”

He added that he appreciated the fact that the investigators “took this knowledge one step further; and what they are saying is that within the syndrome of depression, it is the sleep disturbance that is predicting future problems.”

Dr. McIntyre, who is also chairman and executive director of the Brain and Cognitive Discover Foundation in Toronto, was not involved with the study.

The data suggest that, “conceptually, sleep disturbance is a transdiagnostic phenomenon that may also be the nexus when multiple comorbid mental disorders occur,” he said.

“If this is the case, clinically, there is an opportunity here to prevent incident mental disorders in persons with depression and sleep disturbance, prioritizing sleep management in any patient with a mood disorder,” Dr. McIntyre added.

He noted that “the testable hypothesis” is how this is occurring mechanistically.

“I would conjecture that it could be inflammation and/or insulin resistance that is part of sleep disturbance that could predispose and portend other mental illnesses – and likely other medical conditions too, such as obesity and diabetes,” he said.

The study received no specific funding from any funding agency, commercial, or not-for-profit sectors. The investigators’ relevant financial relationships are listed in the original article. Dr. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; has received speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences; and is a CEO of Braxia Scientific Corp.

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