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Child suicides drive Colorado hospital to declare state of emergency
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.
From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.
“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.
“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.
Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”
Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”
“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
COVID’s impact
Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.
The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.
One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.
Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”
Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.
“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.
Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.
“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.
However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
Chronic underfunding
Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by
However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.
Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.
Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.
“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.
“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.
Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
Screening is essential
Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.
“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.
She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.
“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.
Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.
“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.
Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.
Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Once-weekly oral antipsychotic for schizophrenia on the horizon
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tai chi as good as working out to shrink waistline
Results of a randomized controlled trial published online May 31 in Annals of Internal Medicine show that people who have a tough time with some kinds of aerobic exercise may gain similar benefits from tai chi.
The study is “very impressive,” said Bavani Nadeswaran, MD, of the University of California Irvine’s Susan Samueli Integrative Health Institute, who was not involved in the study.
Many people have arthritis or back pain, “and aerobic exercise can be hard on them,” she said. “The good thing about exercises like tai chi and yoga is that they are low-impact.” That means that people who can’t run or get access to a pool for swimming have a viable alternative.
The study included nearly 550 adults ages 50 and up in Hong Kong who were randomly assigned to engage in tai chi, aerobic exercise with strength training, or no exercise program for 12 weeks. All had waistlines greater than 35.4 inches for men and 31.5 inches for women.
The tai chi program involved three 1-hour weekly sessions of the practice, led by an instructor. Those who took part in the aerobic exercise group engaged three times each week in an exercise program of brisk tai chi and strength training, also led by an instructor.
The researchers measured changes in waistline size, cholesterol levels, and weight for about 9 months. Those who didn’t exercise had little change in their average waistline. Compared to the group that didn’t exercise, the average waistline of people in the two exercise groups declined more: by 0.7 inches more with tai chi, and 0.5 inches more with brisk walking and strength training.
Both exercise groups also had greater drops in body weight and triglyceride (a type of fat found in the blood) levels, and larger increases in high-density lipoprotein cholesterol, the “good” cholesterol, compared to the no-exercise group. All of these improvements lasted about 9 months with tai chi. But improvements in cholesterol levels did not last as long in those in the brisk-walking program.
The researchers also looked at the effects on blood pressure and blood sugar, but they found no differences between the groups.
The findings don’t necessarily mean that people with larger waistlines should dispense with their current exercise programs and turn to tai chi, said study author Parco Siu, PhD, head of the Division of Kinesiology at the University of Hong Kong’s School of Public Health. They show that tai chi is a good option if a person prefers it.
“This is good news for middle-aged and older adults who may be averse to conventional exercise,” he said in an email. But “certainly it is no problem for people to keep regularly participating in conventional exercise.”
Tai chi may also be a good choice for people without larger waistlines because practicing this form of exercise is a way to follow advice from the World Health Organization on physical activity, said Dr. Siu, though the study did not address this question.
Dr. Siu and the other researchers noted several limits to the study, including that all the people who took part were in China, so how the practice would affect people in different regions is not clear. Also, almost a third of those who began the study dropped out before it ended, and they tended to have a higher body weight than those who remained to the end. The authors said this high dropout rate could mean that some people had negative experiences during their exercise programs.
Next steps, said Dr. Siu, include further assessing how tai chi affects things such as blood sugar and blood pressure. Other, early-stage studies also show tai chi having some positive effects on mood and cognition, he said, pointing to a need for more research.
UC Irvine’s Dr. Nadeswaran agreed. The work opens the door, she said, to taking a long-term look at how practicing tai chi might affect a person’s risk of dying from heart disease or another cause. Her team’s work involves evaluating tai chi’s effects on several conditions, including metabolic syndrome and even the aftermath of COVID-19.
While researchers pursue these questions, tai chi is accessible in many ways. Dr. Siu noted the availability of classes in this “meditation in motion” practice at community centers and fitness clubs. For people who can’t yet rejoin activities in the real world, Dr. Nadeswaran said virtual tai chi classes also are available.
A version of this article first appeared on WebMD.com.
Results of a randomized controlled trial published online May 31 in Annals of Internal Medicine show that people who have a tough time with some kinds of aerobic exercise may gain similar benefits from tai chi.
The study is “very impressive,” said Bavani Nadeswaran, MD, of the University of California Irvine’s Susan Samueli Integrative Health Institute, who was not involved in the study.
Many people have arthritis or back pain, “and aerobic exercise can be hard on them,” she said. “The good thing about exercises like tai chi and yoga is that they are low-impact.” That means that people who can’t run or get access to a pool for swimming have a viable alternative.
The study included nearly 550 adults ages 50 and up in Hong Kong who were randomly assigned to engage in tai chi, aerobic exercise with strength training, or no exercise program for 12 weeks. All had waistlines greater than 35.4 inches for men and 31.5 inches for women.
The tai chi program involved three 1-hour weekly sessions of the practice, led by an instructor. Those who took part in the aerobic exercise group engaged three times each week in an exercise program of brisk tai chi and strength training, also led by an instructor.
The researchers measured changes in waistline size, cholesterol levels, and weight for about 9 months. Those who didn’t exercise had little change in their average waistline. Compared to the group that didn’t exercise, the average waistline of people in the two exercise groups declined more: by 0.7 inches more with tai chi, and 0.5 inches more with brisk walking and strength training.
Both exercise groups also had greater drops in body weight and triglyceride (a type of fat found in the blood) levels, and larger increases in high-density lipoprotein cholesterol, the “good” cholesterol, compared to the no-exercise group. All of these improvements lasted about 9 months with tai chi. But improvements in cholesterol levels did not last as long in those in the brisk-walking program.
The researchers also looked at the effects on blood pressure and blood sugar, but they found no differences between the groups.
The findings don’t necessarily mean that people with larger waistlines should dispense with their current exercise programs and turn to tai chi, said study author Parco Siu, PhD, head of the Division of Kinesiology at the University of Hong Kong’s School of Public Health. They show that tai chi is a good option if a person prefers it.
“This is good news for middle-aged and older adults who may be averse to conventional exercise,” he said in an email. But “certainly it is no problem for people to keep regularly participating in conventional exercise.”
Tai chi may also be a good choice for people without larger waistlines because practicing this form of exercise is a way to follow advice from the World Health Organization on physical activity, said Dr. Siu, though the study did not address this question.
Dr. Siu and the other researchers noted several limits to the study, including that all the people who took part were in China, so how the practice would affect people in different regions is not clear. Also, almost a third of those who began the study dropped out before it ended, and they tended to have a higher body weight than those who remained to the end. The authors said this high dropout rate could mean that some people had negative experiences during their exercise programs.
Next steps, said Dr. Siu, include further assessing how tai chi affects things such as blood sugar and blood pressure. Other, early-stage studies also show tai chi having some positive effects on mood and cognition, he said, pointing to a need for more research.
UC Irvine’s Dr. Nadeswaran agreed. The work opens the door, she said, to taking a long-term look at how practicing tai chi might affect a person’s risk of dying from heart disease or another cause. Her team’s work involves evaluating tai chi’s effects on several conditions, including metabolic syndrome and even the aftermath of COVID-19.
While researchers pursue these questions, tai chi is accessible in many ways. Dr. Siu noted the availability of classes in this “meditation in motion” practice at community centers and fitness clubs. For people who can’t yet rejoin activities in the real world, Dr. Nadeswaran said virtual tai chi classes also are available.
A version of this article first appeared on WebMD.com.
Results of a randomized controlled trial published online May 31 in Annals of Internal Medicine show that people who have a tough time with some kinds of aerobic exercise may gain similar benefits from tai chi.
The study is “very impressive,” said Bavani Nadeswaran, MD, of the University of California Irvine’s Susan Samueli Integrative Health Institute, who was not involved in the study.
Many people have arthritis or back pain, “and aerobic exercise can be hard on them,” she said. “The good thing about exercises like tai chi and yoga is that they are low-impact.” That means that people who can’t run or get access to a pool for swimming have a viable alternative.
The study included nearly 550 adults ages 50 and up in Hong Kong who were randomly assigned to engage in tai chi, aerobic exercise with strength training, or no exercise program for 12 weeks. All had waistlines greater than 35.4 inches for men and 31.5 inches for women.
The tai chi program involved three 1-hour weekly sessions of the practice, led by an instructor. Those who took part in the aerobic exercise group engaged three times each week in an exercise program of brisk tai chi and strength training, also led by an instructor.
The researchers measured changes in waistline size, cholesterol levels, and weight for about 9 months. Those who didn’t exercise had little change in their average waistline. Compared to the group that didn’t exercise, the average waistline of people in the two exercise groups declined more: by 0.7 inches more with tai chi, and 0.5 inches more with brisk walking and strength training.
Both exercise groups also had greater drops in body weight and triglyceride (a type of fat found in the blood) levels, and larger increases in high-density lipoprotein cholesterol, the “good” cholesterol, compared to the no-exercise group. All of these improvements lasted about 9 months with tai chi. But improvements in cholesterol levels did not last as long in those in the brisk-walking program.
The researchers also looked at the effects on blood pressure and blood sugar, but they found no differences between the groups.
The findings don’t necessarily mean that people with larger waistlines should dispense with their current exercise programs and turn to tai chi, said study author Parco Siu, PhD, head of the Division of Kinesiology at the University of Hong Kong’s School of Public Health. They show that tai chi is a good option if a person prefers it.
“This is good news for middle-aged and older adults who may be averse to conventional exercise,” he said in an email. But “certainly it is no problem for people to keep regularly participating in conventional exercise.”
Tai chi may also be a good choice for people without larger waistlines because practicing this form of exercise is a way to follow advice from the World Health Organization on physical activity, said Dr. Siu, though the study did not address this question.
Dr. Siu and the other researchers noted several limits to the study, including that all the people who took part were in China, so how the practice would affect people in different regions is not clear. Also, almost a third of those who began the study dropped out before it ended, and they tended to have a higher body weight than those who remained to the end. The authors said this high dropout rate could mean that some people had negative experiences during their exercise programs.
Next steps, said Dr. Siu, include further assessing how tai chi affects things such as blood sugar and blood pressure. Other, early-stage studies also show tai chi having some positive effects on mood and cognition, he said, pointing to a need for more research.
UC Irvine’s Dr. Nadeswaran agreed. The work opens the door, she said, to taking a long-term look at how practicing tai chi might affect a person’s risk of dying from heart disease or another cause. Her team’s work involves evaluating tai chi’s effects on several conditions, including metabolic syndrome and even the aftermath of COVID-19.
While researchers pursue these questions, tai chi is accessible in many ways. Dr. Siu noted the availability of classes in this “meditation in motion” practice at community centers and fitness clubs. For people who can’t yet rejoin activities in the real world, Dr. Nadeswaran said virtual tai chi classes also are available.
A version of this article first appeared on WebMD.com.
Medical licensing questions continue to violate ADA
With the COVID-19 pandemic, already high rates of suicide, depression, and burnout among physicians became even more acute. Yet, 3 years after the Federation of State Medical Boards issued recommendations on what questions about mental health status license applications should – or mostly should not – include, only North Carolina fully complies with all four recommendations, and most states comply with two or fewer, a study of state medical board applications has found (JAMA. 2021 May 18;325[19];2017-8).
Questions about mental health history or “its hypothetical effect on competency,” violate the Americans with Disabilities Act, the study authors stated. In a research letter to JAMA, the authors also reported that five state boards do not comply with any of the FSMB recommendations. Twenty-four states comply with three of the four recommendations.
Overall, the mean consistency score was 2.1, which means state medical licensing applications typically run afoul of the Americans With Disabilities Act when it comes to mental health history of applicants.
“No one should ever wonder, ‘Will I lose my job, or should I get help?’ ” said co–senior author Jessica A. Gold, MD, MS, a psychiatrist at Washington University in St. Louis. “This should absolutely never be a question on someone’s mind. And the fact that it is, in medicine, is a problem that needs to be solved. I hope that people are beginning to see that, and we can make a change to get people the help they need before it is too late.”
High rates of depression, suicide
She noted that before COVID-19, physicians already had higher rates of depression, burnout, and suicide than the general population. “Over COVID-19, it has become clear that the mental health of physicians has become additionally compounded,” Dr. Gold said.
One study found that physicians had a 44% higher rate of suicide (PLoS One. 2019 Dec;14[12]:e0226361), but they’re notoriously reluctant to seek out mental health care. A 2017 study reported that 40% of physicians would be reluctant to seek mental health care because of concerns about their licensure (Mayo Clin Proc. 2017;92[10]:1486-93).
As the pandemic went on, Dr. Gold and her colleagues decided to study whether state boards had improved their compliance with the FSMB recommendations issued in 2018. Those recommendations include these four limitations regarding questions about mental health conditions on license applications:
- Include only when they result in impairment.
- Include only when the mental health conditions are current – that is, when they’ve occurred within the past 2 years.
- Provide safe haven nonreporting – that is, allow physicians to not report previously diagnosed and treated mental health conditions if they’re being monitored and are in good standing with a physician health program.
- Include supportive or nonjudgmental language about seeking mental health care.
The study considered board applications that had questions about mental health status as consistent with the first three recommendations. Seventeen states complied.
Thirty-nine state boards complied with the first recommendation regarding impairment; 41 with the second recommendation about near-term history; 25 with safe-haven nonreporting. Only eight states were consistent with the recommendation on supportive language.
The ADA limits inquiries about an applicant’s impairment to only current conditions. In a 2017 study, only 21 state boards had limited questions to current impairment. “This is a significant improvement, but this still means the rest of the states are violating an actual law,” Dr. Gold said. “Another plus is that 17 states asked no questions at all that could require mental health disclosure. This, too is significant because it highlights change in thinking.”
But still, the fact that five states didn’t comply with any recommendation and only one followed all of them is “utterly unacceptable,” Dr. Gold said. “Instead, we should have universal adoption of FSMB recommendations.”
Time to remove stigma
Michael F. Myers, MD, a clinical psychiatrist at the State University of New York, Brooklyn, said removing the stigma of seeking help for mental health conditions is especially important for physicians. He’s written several books about physician mental health, including his latest, “Becoming a Doctor’s Doctor: A Memoir.”
“I would say at least 15% of the families that I interviewed who lost a physician loved one to suicide have said the doctor was petrified of going for professional help because of fears of what this could do to their medical license,” he said. “It is extremely important that those licensing questions will be either brought up to speed, or – the ones that are clearly violating the ADA – that they be removed.”
Applications for hospital privileges can also run afoul of the same ADA standard, Dr. Myers added. “Physicians have told me that when they go to get medical privileges at a medical center, they get asked all kinds of questions that are outdated, that are intrusive, that violate the ADA,” he said.
Credentialing is another area that Dr. Gold and her colleagues are interested in studying, she said. “Sometimes the licensing applications can be fine, but then the hospital someone is applying to work at can ask the same illegal questions anyway,” she said. “So it doesn’t matter that the state fixed the problem because the hospital asked them anyway. You feel your job is at risk in the same way, so you still don’t get help.”
Dr. Gold and Dr. Myers have no relevant financial relationships to disclose.
With the COVID-19 pandemic, already high rates of suicide, depression, and burnout among physicians became even more acute. Yet, 3 years after the Federation of State Medical Boards issued recommendations on what questions about mental health status license applications should – or mostly should not – include, only North Carolina fully complies with all four recommendations, and most states comply with two or fewer, a study of state medical board applications has found (JAMA. 2021 May 18;325[19];2017-8).
Questions about mental health history or “its hypothetical effect on competency,” violate the Americans with Disabilities Act, the study authors stated. In a research letter to JAMA, the authors also reported that five state boards do not comply with any of the FSMB recommendations. Twenty-four states comply with three of the four recommendations.
Overall, the mean consistency score was 2.1, which means state medical licensing applications typically run afoul of the Americans With Disabilities Act when it comes to mental health history of applicants.
“No one should ever wonder, ‘Will I lose my job, or should I get help?’ ” said co–senior author Jessica A. Gold, MD, MS, a psychiatrist at Washington University in St. Louis. “This should absolutely never be a question on someone’s mind. And the fact that it is, in medicine, is a problem that needs to be solved. I hope that people are beginning to see that, and we can make a change to get people the help they need before it is too late.”
High rates of depression, suicide
She noted that before COVID-19, physicians already had higher rates of depression, burnout, and suicide than the general population. “Over COVID-19, it has become clear that the mental health of physicians has become additionally compounded,” Dr. Gold said.
One study found that physicians had a 44% higher rate of suicide (PLoS One. 2019 Dec;14[12]:e0226361), but they’re notoriously reluctant to seek out mental health care. A 2017 study reported that 40% of physicians would be reluctant to seek mental health care because of concerns about their licensure (Mayo Clin Proc. 2017;92[10]:1486-93).
As the pandemic went on, Dr. Gold and her colleagues decided to study whether state boards had improved their compliance with the FSMB recommendations issued in 2018. Those recommendations include these four limitations regarding questions about mental health conditions on license applications:
- Include only when they result in impairment.
- Include only when the mental health conditions are current – that is, when they’ve occurred within the past 2 years.
- Provide safe haven nonreporting – that is, allow physicians to not report previously diagnosed and treated mental health conditions if they’re being monitored and are in good standing with a physician health program.
- Include supportive or nonjudgmental language about seeking mental health care.
The study considered board applications that had questions about mental health status as consistent with the first three recommendations. Seventeen states complied.
Thirty-nine state boards complied with the first recommendation regarding impairment; 41 with the second recommendation about near-term history; 25 with safe-haven nonreporting. Only eight states were consistent with the recommendation on supportive language.
The ADA limits inquiries about an applicant’s impairment to only current conditions. In a 2017 study, only 21 state boards had limited questions to current impairment. “This is a significant improvement, but this still means the rest of the states are violating an actual law,” Dr. Gold said. “Another plus is that 17 states asked no questions at all that could require mental health disclosure. This, too is significant because it highlights change in thinking.”
But still, the fact that five states didn’t comply with any recommendation and only one followed all of them is “utterly unacceptable,” Dr. Gold said. “Instead, we should have universal adoption of FSMB recommendations.”
Time to remove stigma
Michael F. Myers, MD, a clinical psychiatrist at the State University of New York, Brooklyn, said removing the stigma of seeking help for mental health conditions is especially important for physicians. He’s written several books about physician mental health, including his latest, “Becoming a Doctor’s Doctor: A Memoir.”
“I would say at least 15% of the families that I interviewed who lost a physician loved one to suicide have said the doctor was petrified of going for professional help because of fears of what this could do to their medical license,” he said. “It is extremely important that those licensing questions will be either brought up to speed, or – the ones that are clearly violating the ADA – that they be removed.”
Applications for hospital privileges can also run afoul of the same ADA standard, Dr. Myers added. “Physicians have told me that when they go to get medical privileges at a medical center, they get asked all kinds of questions that are outdated, that are intrusive, that violate the ADA,” he said.
Credentialing is another area that Dr. Gold and her colleagues are interested in studying, she said. “Sometimes the licensing applications can be fine, but then the hospital someone is applying to work at can ask the same illegal questions anyway,” she said. “So it doesn’t matter that the state fixed the problem because the hospital asked them anyway. You feel your job is at risk in the same way, so you still don’t get help.”
Dr. Gold and Dr. Myers have no relevant financial relationships to disclose.
With the COVID-19 pandemic, already high rates of suicide, depression, and burnout among physicians became even more acute. Yet, 3 years after the Federation of State Medical Boards issued recommendations on what questions about mental health status license applications should – or mostly should not – include, only North Carolina fully complies with all four recommendations, and most states comply with two or fewer, a study of state medical board applications has found (JAMA. 2021 May 18;325[19];2017-8).
Questions about mental health history or “its hypothetical effect on competency,” violate the Americans with Disabilities Act, the study authors stated. In a research letter to JAMA, the authors also reported that five state boards do not comply with any of the FSMB recommendations. Twenty-four states comply with three of the four recommendations.
Overall, the mean consistency score was 2.1, which means state medical licensing applications typically run afoul of the Americans With Disabilities Act when it comes to mental health history of applicants.
“No one should ever wonder, ‘Will I lose my job, or should I get help?’ ” said co–senior author Jessica A. Gold, MD, MS, a psychiatrist at Washington University in St. Louis. “This should absolutely never be a question on someone’s mind. And the fact that it is, in medicine, is a problem that needs to be solved. I hope that people are beginning to see that, and we can make a change to get people the help they need before it is too late.”
High rates of depression, suicide
She noted that before COVID-19, physicians already had higher rates of depression, burnout, and suicide than the general population. “Over COVID-19, it has become clear that the mental health of physicians has become additionally compounded,” Dr. Gold said.
One study found that physicians had a 44% higher rate of suicide (PLoS One. 2019 Dec;14[12]:e0226361), but they’re notoriously reluctant to seek out mental health care. A 2017 study reported that 40% of physicians would be reluctant to seek mental health care because of concerns about their licensure (Mayo Clin Proc. 2017;92[10]:1486-93).
As the pandemic went on, Dr. Gold and her colleagues decided to study whether state boards had improved their compliance with the FSMB recommendations issued in 2018. Those recommendations include these four limitations regarding questions about mental health conditions on license applications:
- Include only when they result in impairment.
- Include only when the mental health conditions are current – that is, when they’ve occurred within the past 2 years.
- Provide safe haven nonreporting – that is, allow physicians to not report previously diagnosed and treated mental health conditions if they’re being monitored and are in good standing with a physician health program.
- Include supportive or nonjudgmental language about seeking mental health care.
The study considered board applications that had questions about mental health status as consistent with the first three recommendations. Seventeen states complied.
Thirty-nine state boards complied with the first recommendation regarding impairment; 41 with the second recommendation about near-term history; 25 with safe-haven nonreporting. Only eight states were consistent with the recommendation on supportive language.
The ADA limits inquiries about an applicant’s impairment to only current conditions. In a 2017 study, only 21 state boards had limited questions to current impairment. “This is a significant improvement, but this still means the rest of the states are violating an actual law,” Dr. Gold said. “Another plus is that 17 states asked no questions at all that could require mental health disclosure. This, too is significant because it highlights change in thinking.”
But still, the fact that five states didn’t comply with any recommendation and only one followed all of them is “utterly unacceptable,” Dr. Gold said. “Instead, we should have universal adoption of FSMB recommendations.”
Time to remove stigma
Michael F. Myers, MD, a clinical psychiatrist at the State University of New York, Brooklyn, said removing the stigma of seeking help for mental health conditions is especially important for physicians. He’s written several books about physician mental health, including his latest, “Becoming a Doctor’s Doctor: A Memoir.”
“I would say at least 15% of the families that I interviewed who lost a physician loved one to suicide have said the doctor was petrified of going for professional help because of fears of what this could do to their medical license,” he said. “It is extremely important that those licensing questions will be either brought up to speed, or – the ones that are clearly violating the ADA – that they be removed.”
Applications for hospital privileges can also run afoul of the same ADA standard, Dr. Myers added. “Physicians have told me that when they go to get medical privileges at a medical center, they get asked all kinds of questions that are outdated, that are intrusive, that violate the ADA,” he said.
Credentialing is another area that Dr. Gold and her colleagues are interested in studying, she said. “Sometimes the licensing applications can be fine, but then the hospital someone is applying to work at can ask the same illegal questions anyway,” she said. “So it doesn’t matter that the state fixed the problem because the hospital asked them anyway. You feel your job is at risk in the same way, so you still don’t get help.”
Dr. Gold and Dr. Myers have no relevant financial relationships to disclose.
FROM JAMA
Emotional support animals help lick symptoms of depression, anxiety in serious mental illness
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“ besides traditional forms of treatment, such as medication and therapy. Even a little relief is important, and having an emotional support pet is a good option,” said Dr. Crawford, associate medical director of the National Alliance on Mental Illness. She was not involved with the study.
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“ besides traditional forms of treatment, such as medication and therapy. Even a little relief is important, and having an emotional support pet is a good option,” said Dr. Crawford, associate medical director of the National Alliance on Mental Illness. She was not involved with the study.
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“ besides traditional forms of treatment, such as medication and therapy. Even a little relief is important, and having an emotional support pet is a good option,” said Dr. Crawford, associate medical director of the National Alliance on Mental Illness. She was not involved with the study.
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Novel text-messaging program boosts ADHD treatment adherence
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Naomi Osaka withdraws from the French Open: When athletes struggle
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
FDA okays new drug option for schizophrenia, bipolar I disorder
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
Psychiatric fallout from long-COVID: How to prepare
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.
This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.
This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.
This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
Implementation of a Symptom–Triggered Protocol for Severe Alcohol Withdrawal Treatment in a Medical Step-down Unit
From Stamford Hospital, Stamford, CT.
Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.
Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.
Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).
Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.
Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.
Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).1 Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.2 Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.6
Methods
The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.
Study groups
The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from
In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.
In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.1 Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.
The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.
Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.
Measures and data
The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.
Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.
Analysis
Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ2 analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.
Results
During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.
Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.
Discussion
We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.3 To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.
Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.
As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.1 MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.3-5 In patients of higher acuity, STT has not proven to be superior.
A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.
This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.7 Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.
Conclusion
Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.
Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; phuang@stamhealth.org.
Financial disclosures: None.
1. DeCarolis DD, Rice KL, Ho L, et al. Symptom-driven lorazepam protocol for treatment of severe alcohol withdrawal delirium in the intensive care unit. Pharmacotherapy. 2007;27(4):510-518.
2. DeBellis R, Smith BS, Choi S, Malloy M. Management of delirium tremens. J Intensive Care Med. 2005;20(3):164-173.
3. Saitz R, Mayo-Smith MF, Roberts MS, et al. Individualized treatment for alcohol withdrawal. A randomized double-blind controlled trial. JAMA. 1994;272(7):519-523.
4. Sachdeva A, Chandra M, Deshpande SN. A comparative study of fixed tapering dose regimen versus symptom-triggered regimen of lorazepam for alcohol detoxification. Alcohol Alcohol. 2014;49(3):287-291.
5. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
6. Jaeger TM, Lohr RH, Pankratz VS. Symptom-triggered therapy for alcohol withdrawal syndrome in medical inpatients. Mayo Clin Proc. 2001;76(7):695-701.
7. Littlefield AJ, Heavner MS, Eng CC, et al. Correlation Between mMINDS and CIWA-Ar Scoring Tools in Patients With Alcohol Withdrawal Syndrome. Am J Crit Care. 2018;27(4):280-286.
From Stamford Hospital, Stamford, CT.
Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.
Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.
Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).
Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.
Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.
Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).1 Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.2 Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.6
Methods
The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.
Study groups
The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from
In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.
In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.1 Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.
The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.
Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.
Measures and data
The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.
Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.
Analysis
Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ2 analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.
Results
During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.
Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.
Discussion
We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.3 To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.
Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.
As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.1 MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.3-5 In patients of higher acuity, STT has not proven to be superior.
A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.
This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.7 Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.
Conclusion
Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.
Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; phuang@stamhealth.org.
Financial disclosures: None.
From Stamford Hospital, Stamford, CT.
Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.
Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.
Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).
Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.
Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.
Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).1 Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.2 Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.6
Methods
The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.
Study groups
The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from
In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.
In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.1 Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.
The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.
Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.
Measures and data
The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.
Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.
Analysis
Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ2 analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.
Results
During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.
Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.
Discussion
We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.3 To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.
Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.
As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.1 MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.3-5 In patients of higher acuity, STT has not proven to be superior.
A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.
This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.7 Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.
Conclusion
Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.
Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; phuang@stamhealth.org.
Financial disclosures: None.
1. DeCarolis DD, Rice KL, Ho L, et al. Symptom-driven lorazepam protocol for treatment of severe alcohol withdrawal delirium in the intensive care unit. Pharmacotherapy. 2007;27(4):510-518.
2. DeBellis R, Smith BS, Choi S, Malloy M. Management of delirium tremens. J Intensive Care Med. 2005;20(3):164-173.
3. Saitz R, Mayo-Smith MF, Roberts MS, et al. Individualized treatment for alcohol withdrawal. A randomized double-blind controlled trial. JAMA. 1994;272(7):519-523.
4. Sachdeva A, Chandra M, Deshpande SN. A comparative study of fixed tapering dose regimen versus symptom-triggered regimen of lorazepam for alcohol detoxification. Alcohol Alcohol. 2014;49(3):287-291.
5. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
6. Jaeger TM, Lohr RH, Pankratz VS. Symptom-triggered therapy for alcohol withdrawal syndrome in medical inpatients. Mayo Clin Proc. 2001;76(7):695-701.
7. Littlefield AJ, Heavner MS, Eng CC, et al. Correlation Between mMINDS and CIWA-Ar Scoring Tools in Patients With Alcohol Withdrawal Syndrome. Am J Crit Care. 2018;27(4):280-286.
1. DeCarolis DD, Rice KL, Ho L, et al. Symptom-driven lorazepam protocol for treatment of severe alcohol withdrawal delirium in the intensive care unit. Pharmacotherapy. 2007;27(4):510-518.
2. DeBellis R, Smith BS, Choi S, Malloy M. Management of delirium tremens. J Intensive Care Med. 2005;20(3):164-173.
3. Saitz R, Mayo-Smith MF, Roberts MS, et al. Individualized treatment for alcohol withdrawal. A randomized double-blind controlled trial. JAMA. 1994;272(7):519-523.
4. Sachdeva A, Chandra M, Deshpande SN. A comparative study of fixed tapering dose regimen versus symptom-triggered regimen of lorazepam for alcohol detoxification. Alcohol Alcohol. 2014;49(3):287-291.
5. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
6. Jaeger TM, Lohr RH, Pankratz VS. Symptom-triggered therapy for alcohol withdrawal syndrome in medical inpatients. Mayo Clin Proc. 2001;76(7):695-701.
7. Littlefield AJ, Heavner MS, Eng CC, et al. Correlation Between mMINDS and CIWA-Ar Scoring Tools in Patients With Alcohol Withdrawal Syndrome. Am J Crit Care. 2018;27(4):280-286.