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What’s pushing cannabis use in first-episode psychosis?
The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.
An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.
The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.
as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.
Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.
The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
Answering the skeptics
Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.
However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.
The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.
The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.
Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.
Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).
In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”
After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).
Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.
The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.
Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
Complex association
Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”
She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.
There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.
“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.
Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”
As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.
Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.
Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.
Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.
An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.
The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.
as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.
Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.
The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
Answering the skeptics
Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.
However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.
The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.
The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.
Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.
Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).
In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”
After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).
Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.
The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.
Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
Complex association
Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”
She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.
There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.
“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.
Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”
As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.
Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.
Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.
Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.
An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.
The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.
as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.
Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.
The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
Answering the skeptics
Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.
However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.
The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.
The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.
Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.
Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).
In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”
After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).
Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.
The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.
Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
Complex association
Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”
She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.
There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.
“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.
Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”
As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.
Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.
Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.
Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM SIRS 2020
T2D plus heart failure packs a deadly punch
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
FROM CIRCULATION: CARDIOVASCULAR QUALITY AND OUTCOMES
FDA approves metoclopramide nasal spray for diabetic gastroparesis
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
Cost of preventable adult hospital stays topped $33 billion in 2017
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
U.S. adults reach Healthy People 2020 cholesterol goal
Good news: High cholesterol is down in the United States. More good news: Low HDL cholesterol is down in the United States.
The prevalence of high total cholesterol in adults aged 20 years and older dropped from 18.3% in 1999-2000 to 10.5% in 2017-2018. And starting in 2007-2008, the prevalence of low HDL cholesterol declined from 22.2% to 16.0% in 2017-2018, the National Center for Health Statistics reported.
HDL cholesterol data before 2007 were not presented because of changes in laboratories and methods, but both trends are significant, and the decline in high total cholesterol means that the Healthy People 2020 goal of dropping prevalence to 13.5% has been met, said Margaret D. Carroll, MSPH, and Cheryl D. Fryar, MSPH, of the NCHS.
The demographic details, however, show some disparities hidden by the broader measures. The prevalence of low HDL cholesterol for women in 2015-2018 was 8.5%, but for men it was 26.6%, the NCHS investigators said.
And that Healthy People 2020 goal for total cholesterol? Age makes a difference: 7.5% of adults aged 20-39 years had high total cholesterol in 2015-2018, as did 11.4% of those aged 60 years and older, but those aged 40-59 years had a significantly higher prevalence of 15.7%, they reported.
Race/ethnicity was also a factor. Prevalence of low HDL was similar for white (16.6%) and Asian (15.8%) adults in 2015-2018, but black adults’ low HDL prevalence was significantly lower (11.9%) and Hispanics’ was significantly higher (21.9%), the researchers said.
The analysis was based on data from the National Health and Nutrition Examination Survey. The investigators defined high total cholesterol as a level of 240 mg/dL or more, and low HDL cholesterol as less than 40 mg/dL. LDL cholesterol was not included in the analysis.
Good news: High cholesterol is down in the United States. More good news: Low HDL cholesterol is down in the United States.
The prevalence of high total cholesterol in adults aged 20 years and older dropped from 18.3% in 1999-2000 to 10.5% in 2017-2018. And starting in 2007-2008, the prevalence of low HDL cholesterol declined from 22.2% to 16.0% in 2017-2018, the National Center for Health Statistics reported.
HDL cholesterol data before 2007 were not presented because of changes in laboratories and methods, but both trends are significant, and the decline in high total cholesterol means that the Healthy People 2020 goal of dropping prevalence to 13.5% has been met, said Margaret D. Carroll, MSPH, and Cheryl D. Fryar, MSPH, of the NCHS.
The demographic details, however, show some disparities hidden by the broader measures. The prevalence of low HDL cholesterol for women in 2015-2018 was 8.5%, but for men it was 26.6%, the NCHS investigators said.
And that Healthy People 2020 goal for total cholesterol? Age makes a difference: 7.5% of adults aged 20-39 years had high total cholesterol in 2015-2018, as did 11.4% of those aged 60 years and older, but those aged 40-59 years had a significantly higher prevalence of 15.7%, they reported.
Race/ethnicity was also a factor. Prevalence of low HDL was similar for white (16.6%) and Asian (15.8%) adults in 2015-2018, but black adults’ low HDL prevalence was significantly lower (11.9%) and Hispanics’ was significantly higher (21.9%), the researchers said.
The analysis was based on data from the National Health and Nutrition Examination Survey. The investigators defined high total cholesterol as a level of 240 mg/dL or more, and low HDL cholesterol as less than 40 mg/dL. LDL cholesterol was not included in the analysis.
Good news: High cholesterol is down in the United States. More good news: Low HDL cholesterol is down in the United States.
The prevalence of high total cholesterol in adults aged 20 years and older dropped from 18.3% in 1999-2000 to 10.5% in 2017-2018. And starting in 2007-2008, the prevalence of low HDL cholesterol declined from 22.2% to 16.0% in 2017-2018, the National Center for Health Statistics reported.
HDL cholesterol data before 2007 were not presented because of changes in laboratories and methods, but both trends are significant, and the decline in high total cholesterol means that the Healthy People 2020 goal of dropping prevalence to 13.5% has been met, said Margaret D. Carroll, MSPH, and Cheryl D. Fryar, MSPH, of the NCHS.
The demographic details, however, show some disparities hidden by the broader measures. The prevalence of low HDL cholesterol for women in 2015-2018 was 8.5%, but for men it was 26.6%, the NCHS investigators said.
And that Healthy People 2020 goal for total cholesterol? Age makes a difference: 7.5% of adults aged 20-39 years had high total cholesterol in 2015-2018, as did 11.4% of those aged 60 years and older, but those aged 40-59 years had a significantly higher prevalence of 15.7%, they reported.
Race/ethnicity was also a factor. Prevalence of low HDL was similar for white (16.6%) and Asian (15.8%) adults in 2015-2018, but black adults’ low HDL prevalence was significantly lower (11.9%) and Hispanics’ was significantly higher (21.9%), the researchers said.
The analysis was based on data from the National Health and Nutrition Examination Survey. The investigators defined high total cholesterol as a level of 240 mg/dL or more, and low HDL cholesterol as less than 40 mg/dL. LDL cholesterol was not included in the analysis.
Circadian rhythm changes linked to future Parkinson’s disease risk
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
FROM JAMA NEUROLOGY
Management of race in psychotherapy and supervision
On the Friday evening after the public execution of George Floyd, we were painfully reminded of the urgency to address the inadequate management of race, racism, and anti-blackness in medical education, residency training, and postgraduate continuing medical education.
The reminder did not originate from the rioting that was occurring in some cities, though we could feel the ground shifting beneath our feet as civic protests that began in U.S. cities spread around the globe. Instead, it occurred during a webinar we were hosting for psychiatry residents focused on techniques for eliminating blind spots in the management of race in clinical psychotherapy supervision. (Dr. Jessica Isom chaired the webinar, Dr. Flavia DeSouza and Dr. Myra Mathis comoderated, and Dr. Ebony Dennis and Dr. Constance E. Dunlap served as discussants.)
Our panel had presented an ambitious agenda that included reviewing how the disavowal of bias, race, racism, and anti-blackness contributes to ineffective psychotherapy, undermines the quality of medical care, and perpetuates mental health disparities. We spent some time exploring how unacknowledged and unexamined conscious and unconscious racial stereotypes affect interpersonal relationships, the psychotherapeutic process, and the supervisory experience. Our presentation included a clinical vignette demonstrating how racism, colorism, and anti-blackness have global impact, influencing the self-esteem, identity formation, and identity consolidation of immigrants as they grapple with the unique form of racism that exists in America. Other clinical vignettes demonstrated blind spots that were retroactively identified though omitted in supervisory discussions. We also discussed alternative interventions and interpretations of the material presented.1-5
Because 21st-century trainees are generally psychologically astute and committed to social justice, we did two things. First, before the webinar, we provided them access to a prerecorded explanation of object relations theorist Melanie Klein’s paranoid-schizoid and depressive positions concepts, which were applied to theoretically explain the development of race, specifically the defenses used by early colonists that contributed to the development of “whiteness” and “blackness” as social constructs, and their influence on the development of the U.S. psyche. For example, as early colonists attempted to develop new and improved identities distinct from those they had in their homelands, they used enslaved black people (and other vulnerable groups) to “other.” What we mean here by othering is the process of using an other to project one’s badness into in order to relieve the self of uncomfortable aspects and feelings originating within the self. If this other accepts the projection (which is often the case with vulnerable parties), the self recognizes, that is, identifies (locates) the bad they just projected in the other, who is now experienced as a bad-other. This is projection in action. If the other accepts the projection and behaves accordingly, for example, in a manner that reflects badness, this becomes projective identification. Conversely, if the other does not accept these projections, the self (who projects) is left to cope with aspects of the self s/he might not have the capacity to manage. By capacity, we are speaking of the Bionian idea of the ability to experience an extreme emotion while also being able to think. Without the ego strength to cope with bad aspects of the self, the ego either collapses (and is unable to think) or further projection is attempted.6-8
We have seen this latter dynamic play out repeatedly when police officers fatally shoot black citizens and then claim that they feared for their lives; these same officers have been exonerated by juries by continuing to portray the deceased victims as threatening, dangerous objects not worthy of living. We are also seeing a global movement of black and nonblack people who are in touch with a justified rage that has motivated them to return these projections by collectively protesting, and in some cases, by rioting.
Back to the webinar
In anticipating the residents’ curiosity, impatience, and anger about the lack of progress, the second thing we did was to show a segment from the “Black Psychoanalysts Speak” trailer. In the clip played, senior psychoanalyst Kirkland C. Vaughans, PhD, shares: “The issue of race so prompts excessive anxiety that it blocks off our ability to think.”
We showed this clip to validate the trainees’ frustrations about the difficulty the broader establishment has had with addressing this serious, longstanding public health problem. We wanted these young psychiatrists to know that there are psychoanalysts, psychiatrists, psychologists, and social workers who have been committed to this work, even though the contributions of this diverse group have curiously been omitted from education and training curricula.9
So, what happened? What was the painful reminder? After the formal panel presentations, a black male psychiatry resident recounted his experience in a clinical supervision meeting that had occurred several days after the murder of George Floyd. In short, a patient had shared his reactions to yet another incident of fatal police use of force and paused to ask how the resident physician, Dr. A., was doing. The question was experienced as sincere concern about the psychiatrist’s mental well-being. The resident was not sure how to answer this question since it was a matter of self-disclosure, which was a reasonable and thoughtful consideration for a seasoned clinician and, certainly, for a novice therapist. The supervisor, Dr. B., seemingly eager to move on, to not think about this, responded to the resident by saying: “Now tell me about the patient.” In other words, what had just been shared by the resident – material that featured a patient’s reaction to another killing of a black man by police and the patient’s expressed concern for his black psychiatrist, and this resident physician appropriately seeking space in supervision to process and receive guidance about how to respond – all of this was considered separate (split off from) and extraneous to the patient’s treatment and the resident’s training. This is a problem. And, unfortunately, this problem or some variation of it is not rare.
Why is this still the state of affairs when we have identified racism as a major health concern and our patients and our trainees are asking for help?
Rethinking a metaphor
Despite calls to action over the last 50 years to encourage medicine to effectively address race and racism, deficits remain in didactic education, clinical rotations, and supervisory experiences of trainees learning how to do psychodynamic psychotherapy.8-10 Earlier that evening, we used the metaphor of a vehicular blind spot to capture what we believe occurs insupervision. Like drivers, supervisors generally have the ability to see. However, there are places (times) and positions (stances) that block their vision (awareness). Racism – whether institutionalized, interpersonally mediated, or internalized – also contributes to this blindness.
As is true of drivers managing a blind spot, what is required is for the drivers – the supervisors – to lean forward or reposition themselves so as to avoid collisions, maintain safety, and continue on course. We use this metaphor because it is understood that any clinician providing psychodynamic supervision to psychiatry residents, regardless of professional discipline, has the requisite skills and training.10-13
Until May 25, we thought eliminating blind spots would be effective. But, in the aftermath of the police killing of George Floyd, our eyes have been opened.
Hiding behind the blue wall of silence is an establishment that has looked the other way while black and brown women, men, and children have come to live in fear as a result of the state-sanctioned violence that repeatedly occurs across the nation. Excessive police use of force is a public health issue of crisis magnitude. However, the house of medicine, like many other established structures in society, has colluded with the societal constructs that have supported law enforcement by remaining willfully blind, often neutral, and by refusing to make the necessary adjustments, including connecting the dots between police violence and physical and mental health.
For example, racism has never been listed even in the index of the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders.14 Being the victim of police use of force is not generally regarded as an adverse childhood experience, even though communities that are heavily policed experience harassment by law enforcement on a regular basis. The 12 causes of trauma listed on the website15 of the National Child Traumatic Stress Network – bullying, community violence, complex trauma, disasters, early childhood trauma, intimate partner violence, medical trauma, physical abuse, refugee trauma, sexual abuse, terrorism and violence, and traumatic grief – do not include maltreatment, abuse, or trauma resulting from interactions with members of law enforcement. Much of the adverse childhood experiences literature focuses on white, upper middle class children and on experiences within the home. When community level experiences, such as discrimination based on race or ethnicity, are included, as in the Philadelphia ACES study,16 as many as 40% reported ACE scores of greater than 4 for community level exposures.
As psychiatrists, we recognize the psychic underpinnings and parallels between the psychic projections onto black and brown people and the actual bullets pumped into the bodies of black and brown people; there is a lurid propensity to use these others as repositories. Those who have the privilege of being protected by law enforcement and the ability to avoid being used as containers for the psychic projections and bullets of some police officers also have the privilege of compartmentalizing and looking the other way when excessive acts of force – projections and projectiles – are used on other human beings. This partly explains why the injuries and deaths of black and brown people caused by police officers’ excessive use of force have continued even though these unjustified deaths are widely televised and disseminated via various social media platforms.
Prior to the death of George Floyd on May 25, other than the American Public Health Association, the National Medical Association (NMA) was the only major medical organization to issue a call to consider police use of force as a public health issue. In its July 2016 press release, provided in the aftermath of the death of Freddie Gray while in the custody of Baltimore police officers, the NMA summarized the scope of injuries citizens sustain during “the pre-custody (commission of a crime, during a fight, chase, and apprehension, during a siege or hostage situation, or during restraint or submission), custody (soon after being admitted to jail, during interrogation, during incarceration, or legal execution), and post-custody (revenge by police or rival criminals or after reentry into the community)” periods. It is noteworthy that the scope of these injuries is comparable to those encountered in a combat zone.17,18 According to the NMA:
“Injuries sustained by civilians at the hands of law enforcement include gunshot wounds, skull fractures, cervical spine injuries, facial fractures, broken legs, blunt trauma orbital floor fractures, laryngeal cartilage fractures, shoulder dislocations, cuts and bruises, concussions, hemorrhage, choking (positional or due to upper body holds), abdominal trauma, hemothorax, and pneumothorax. Complications of such injuries include posttraumatic brain swelling, infections following open fractures and lacerations, hydrocephalus due to blood or infection, as well as subdural and epidural hematomas and, in the most severe cases, death.”
In addition, there are multiple emotional and psychiatric sequelae of these injuries for the victims, families, upstanders, bystanders, and those viewing these images via various social media platforms. Increasingly, many are experiencing retraumatization each time a new death is reported. How do we explain that we are turning away from this as physicians and trainers of physicians? Seeing and not seeing – all of the methods used to avert one’s gaze and look the other way (to protect the psyches of nonmarginalized members of society from being disturbed and possibly traumatized) – these key defense mechanisms creep into consulting rooms and become fertile ground for the enactment described above.
Yet, there is reason to believe in change. It’s not simply because we are mental health professionals and that’s what we do. With the posting of position statements issued by major corporations and a growing number of medical organizations, many of us are experiencing a mixture of hope, anger, and sadness. Hope that widespread awareness will continue to tilt the axis of our country in a manner that opens eyes – and hearts – so that real work can be done; and anger and sadness because it has taken 400 years to receive even this level of validation.
In the meantime, we are encouraged by a joint position statement recently issued by the APA and the NMA, the first joint effort by these two medical organizations to partner and advocate for criminal justice reform. We mention this statement because the NMA has been committed to the needs of the black community since its inception in 1895, and the APA has as its mission a commitment to serve “the needs of evolving, diverse, underrepresented, and underserved patient populations” ... and the resources to do so. This is the kind of partnership that could transform words into meaningful action.19,20
Of course, resident psychiatrist Dr. A. had begun supervision with the discussion of his dyadic experience with his patient, which is set in the context of a global coronavirus pandemic that is disproportionately affecting black and brown people. And, while his peers are marching in protest, he and his fellow trainees deserve our support as they deal with their own psychic pain and prepare to steady themselves. For these psychiatrists will be called to provide care to those who will consult them once they begin to grapple with the experiences and, in some cases, traumas that have compelled them to take action and literally risk their safety and lives while protesting.
That evening, the residents were hungry for methods to fill the gaps in their training and supervision. In some cases, we provided scripts to be taken back to supervision. For example, the following is a potential scripted response for the supervisor in the enactment described above:
Resident speaking to supervisor: This is a black patient who, like many others, is affected by the chronic, repeated televised images of black men killed by police. I am also a black man.
I think what I have shared is pertinent to the patient’s care and my experience as a black male psychiatrist who will need to learn how to address this in my patients who are black and for other racialized groups, as well as with whites who might have rarely been cared for by a black man. Can we discuss this?
We also anticipated that some residents would need to exercise their right to request reassignment to another supervisor. And, until we do better at listening, seeing, and deepening our understanding, outside and inside the consulting room and in supervision, more residents might need to steer around those who have the potential to undermine training and adversely affect treatment. But, as a professional medical community in crisis, do we really want to proceed in such an ad hoc fashion?
Dr. Dunlap is a psychiatrist and psychoanalyst, and clinical professor of psychiatry and behavioral sciences at George Washington University. She is interested in the management of “difference” – race, gender, ethnicity, and intersectionality – in dyadic relationships and group dynamics; and the impact of racism on interpersonal relationships in institutional structures. Dr. Dunlap practices in Washington and has no disclosures.
Dr. Dennis is a clinical psychologist and psychoanalyst. Her interests are in gender and ethnic diversity, health equity, and supervision and training. Dr. Dennis practices in Washington and has no disclosures.
Dr. DeSouza is a PGY-4 psychiatry resident and public psychiatry fellow in the department of psychiatry at Yale University, New Haven, Conn. Her professional interests include health services development and delivery in low- and middle-income settings, as well as the intersection of mental health and spirituality. She has no disclosures.
Dr. Isom is a staff psychiatrist at the Codman Square Health Center in Dorchester, Mass., and Boston Medical Center. Her interests include racial mental health equity and population health approaches to community psychiatry. She has no disclosures.
Dr. Mathis is an addictions fellow in the department of psychiatry at Yale University and former programwide chief resident at Yale. Her interests include the intersection of racial justice and mental health, health equity, and spirituality. She has no disclosures.
References
1. Mental Health: Culture, Race, and Ethnicity. A Supplement to Mental Health: A Report of the Surgeon General. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2001.
2. Banaji MR and Greenwald AG. Blindspot: Hidden Biases of Good People. New York: Delacorte Press, 2013.
3. Anekwe ON. Voices in Bioethics. 2014.
4. Soute BJ. The American Psychoanalyst Magazine. 2017 Winter/Spring.
5. Powell DR. J Am Psychoanal Assoc. 2019 Jan 8. doi: 10.1177/000306511881847.
6. Allen TW. The Invention of the White Race. London: Verso, 1994.
7. Klein M. Int J Psychoanal. 1946;27(pt.3-4):99-100.
8. Bion WR. (1962b). Psychoanal Q. 2013 Apr;82(2):301-10.
9. Black Psychoanalysts Speak trailer.
10. Thomas A and Sillen S. Racism and Psychiatry. New York: Brunner/Mazel, 1972.
11. Jones BE et al. Am J Psychiatry. 1970 Dec;127(6):798-803.
12. Sabshin M et al. Am J Psychiatry. 1970 Dec;126(6):787-93.
13. Medlock M et al. Am J Psychiatry. 2017 May 9. doi: 10.1176/appi.ajp-rj.2016.110206.
14. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). Arlington, Va.: American Psychiatric Association, 2013.
15. “What is Child Trauma?” The National Child Traumatic Stress Network.
16. The Philadelphia Project. Philadelphia ACE Survey.
17. “Addressing law enforcement violence as a public health issue.” Washington: American Public Health Association. 2018 Nov 13. Policy# 20811.
18. National Medical Association position statement on police use of force. NMA 2016.
19. “APA and NMA jointly condemn systemic racism in America.” 2020 Jun 16.
20. APA Strategic Plan. 2015 Mar.
On the Friday evening after the public execution of George Floyd, we were painfully reminded of the urgency to address the inadequate management of race, racism, and anti-blackness in medical education, residency training, and postgraduate continuing medical education.
The reminder did not originate from the rioting that was occurring in some cities, though we could feel the ground shifting beneath our feet as civic protests that began in U.S. cities spread around the globe. Instead, it occurred during a webinar we were hosting for psychiatry residents focused on techniques for eliminating blind spots in the management of race in clinical psychotherapy supervision. (Dr. Jessica Isom chaired the webinar, Dr. Flavia DeSouza and Dr. Myra Mathis comoderated, and Dr. Ebony Dennis and Dr. Constance E. Dunlap served as discussants.)
Our panel had presented an ambitious agenda that included reviewing how the disavowal of bias, race, racism, and anti-blackness contributes to ineffective psychotherapy, undermines the quality of medical care, and perpetuates mental health disparities. We spent some time exploring how unacknowledged and unexamined conscious and unconscious racial stereotypes affect interpersonal relationships, the psychotherapeutic process, and the supervisory experience. Our presentation included a clinical vignette demonstrating how racism, colorism, and anti-blackness have global impact, influencing the self-esteem, identity formation, and identity consolidation of immigrants as they grapple with the unique form of racism that exists in America. Other clinical vignettes demonstrated blind spots that were retroactively identified though omitted in supervisory discussions. We also discussed alternative interventions and interpretations of the material presented.1-5
Because 21st-century trainees are generally psychologically astute and committed to social justice, we did two things. First, before the webinar, we provided them access to a prerecorded explanation of object relations theorist Melanie Klein’s paranoid-schizoid and depressive positions concepts, which were applied to theoretically explain the development of race, specifically the defenses used by early colonists that contributed to the development of “whiteness” and “blackness” as social constructs, and their influence on the development of the U.S. psyche. For example, as early colonists attempted to develop new and improved identities distinct from those they had in their homelands, they used enslaved black people (and other vulnerable groups) to “other.” What we mean here by othering is the process of using an other to project one’s badness into in order to relieve the self of uncomfortable aspects and feelings originating within the self. If this other accepts the projection (which is often the case with vulnerable parties), the self recognizes, that is, identifies (locates) the bad they just projected in the other, who is now experienced as a bad-other. This is projection in action. If the other accepts the projection and behaves accordingly, for example, in a manner that reflects badness, this becomes projective identification. Conversely, if the other does not accept these projections, the self (who projects) is left to cope with aspects of the self s/he might not have the capacity to manage. By capacity, we are speaking of the Bionian idea of the ability to experience an extreme emotion while also being able to think. Without the ego strength to cope with bad aspects of the self, the ego either collapses (and is unable to think) or further projection is attempted.6-8
We have seen this latter dynamic play out repeatedly when police officers fatally shoot black citizens and then claim that they feared for their lives; these same officers have been exonerated by juries by continuing to portray the deceased victims as threatening, dangerous objects not worthy of living. We are also seeing a global movement of black and nonblack people who are in touch with a justified rage that has motivated them to return these projections by collectively protesting, and in some cases, by rioting.
Back to the webinar
In anticipating the residents’ curiosity, impatience, and anger about the lack of progress, the second thing we did was to show a segment from the “Black Psychoanalysts Speak” trailer. In the clip played, senior psychoanalyst Kirkland C. Vaughans, PhD, shares: “The issue of race so prompts excessive anxiety that it blocks off our ability to think.”
We showed this clip to validate the trainees’ frustrations about the difficulty the broader establishment has had with addressing this serious, longstanding public health problem. We wanted these young psychiatrists to know that there are psychoanalysts, psychiatrists, psychologists, and social workers who have been committed to this work, even though the contributions of this diverse group have curiously been omitted from education and training curricula.9
So, what happened? What was the painful reminder? After the formal panel presentations, a black male psychiatry resident recounted his experience in a clinical supervision meeting that had occurred several days after the murder of George Floyd. In short, a patient had shared his reactions to yet another incident of fatal police use of force and paused to ask how the resident physician, Dr. A., was doing. The question was experienced as sincere concern about the psychiatrist’s mental well-being. The resident was not sure how to answer this question since it was a matter of self-disclosure, which was a reasonable and thoughtful consideration for a seasoned clinician and, certainly, for a novice therapist. The supervisor, Dr. B., seemingly eager to move on, to not think about this, responded to the resident by saying: “Now tell me about the patient.” In other words, what had just been shared by the resident – material that featured a patient’s reaction to another killing of a black man by police and the patient’s expressed concern for his black psychiatrist, and this resident physician appropriately seeking space in supervision to process and receive guidance about how to respond – all of this was considered separate (split off from) and extraneous to the patient’s treatment and the resident’s training. This is a problem. And, unfortunately, this problem or some variation of it is not rare.
Why is this still the state of affairs when we have identified racism as a major health concern and our patients and our trainees are asking for help?
Rethinking a metaphor
Despite calls to action over the last 50 years to encourage medicine to effectively address race and racism, deficits remain in didactic education, clinical rotations, and supervisory experiences of trainees learning how to do psychodynamic psychotherapy.8-10 Earlier that evening, we used the metaphor of a vehicular blind spot to capture what we believe occurs insupervision. Like drivers, supervisors generally have the ability to see. However, there are places (times) and positions (stances) that block their vision (awareness). Racism – whether institutionalized, interpersonally mediated, or internalized – also contributes to this blindness.
As is true of drivers managing a blind spot, what is required is for the drivers – the supervisors – to lean forward or reposition themselves so as to avoid collisions, maintain safety, and continue on course. We use this metaphor because it is understood that any clinician providing psychodynamic supervision to psychiatry residents, regardless of professional discipline, has the requisite skills and training.10-13
Until May 25, we thought eliminating blind spots would be effective. But, in the aftermath of the police killing of George Floyd, our eyes have been opened.
Hiding behind the blue wall of silence is an establishment that has looked the other way while black and brown women, men, and children have come to live in fear as a result of the state-sanctioned violence that repeatedly occurs across the nation. Excessive police use of force is a public health issue of crisis magnitude. However, the house of medicine, like many other established structures in society, has colluded with the societal constructs that have supported law enforcement by remaining willfully blind, often neutral, and by refusing to make the necessary adjustments, including connecting the dots between police violence and physical and mental health.
For example, racism has never been listed even in the index of the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders.14 Being the victim of police use of force is not generally regarded as an adverse childhood experience, even though communities that are heavily policed experience harassment by law enforcement on a regular basis. The 12 causes of trauma listed on the website15 of the National Child Traumatic Stress Network – bullying, community violence, complex trauma, disasters, early childhood trauma, intimate partner violence, medical trauma, physical abuse, refugee trauma, sexual abuse, terrorism and violence, and traumatic grief – do not include maltreatment, abuse, or trauma resulting from interactions with members of law enforcement. Much of the adverse childhood experiences literature focuses on white, upper middle class children and on experiences within the home. When community level experiences, such as discrimination based on race or ethnicity, are included, as in the Philadelphia ACES study,16 as many as 40% reported ACE scores of greater than 4 for community level exposures.
As psychiatrists, we recognize the psychic underpinnings and parallels between the psychic projections onto black and brown people and the actual bullets pumped into the bodies of black and brown people; there is a lurid propensity to use these others as repositories. Those who have the privilege of being protected by law enforcement and the ability to avoid being used as containers for the psychic projections and bullets of some police officers also have the privilege of compartmentalizing and looking the other way when excessive acts of force – projections and projectiles – are used on other human beings. This partly explains why the injuries and deaths of black and brown people caused by police officers’ excessive use of force have continued even though these unjustified deaths are widely televised and disseminated via various social media platforms.
Prior to the death of George Floyd on May 25, other than the American Public Health Association, the National Medical Association (NMA) was the only major medical organization to issue a call to consider police use of force as a public health issue. In its July 2016 press release, provided in the aftermath of the death of Freddie Gray while in the custody of Baltimore police officers, the NMA summarized the scope of injuries citizens sustain during “the pre-custody (commission of a crime, during a fight, chase, and apprehension, during a siege or hostage situation, or during restraint or submission), custody (soon after being admitted to jail, during interrogation, during incarceration, or legal execution), and post-custody (revenge by police or rival criminals or after reentry into the community)” periods. It is noteworthy that the scope of these injuries is comparable to those encountered in a combat zone.17,18 According to the NMA:
“Injuries sustained by civilians at the hands of law enforcement include gunshot wounds, skull fractures, cervical spine injuries, facial fractures, broken legs, blunt trauma orbital floor fractures, laryngeal cartilage fractures, shoulder dislocations, cuts and bruises, concussions, hemorrhage, choking (positional or due to upper body holds), abdominal trauma, hemothorax, and pneumothorax. Complications of such injuries include posttraumatic brain swelling, infections following open fractures and lacerations, hydrocephalus due to blood or infection, as well as subdural and epidural hematomas and, in the most severe cases, death.”
In addition, there are multiple emotional and psychiatric sequelae of these injuries for the victims, families, upstanders, bystanders, and those viewing these images via various social media platforms. Increasingly, many are experiencing retraumatization each time a new death is reported. How do we explain that we are turning away from this as physicians and trainers of physicians? Seeing and not seeing – all of the methods used to avert one’s gaze and look the other way (to protect the psyches of nonmarginalized members of society from being disturbed and possibly traumatized) – these key defense mechanisms creep into consulting rooms and become fertile ground for the enactment described above.
Yet, there is reason to believe in change. It’s not simply because we are mental health professionals and that’s what we do. With the posting of position statements issued by major corporations and a growing number of medical organizations, many of us are experiencing a mixture of hope, anger, and sadness. Hope that widespread awareness will continue to tilt the axis of our country in a manner that opens eyes – and hearts – so that real work can be done; and anger and sadness because it has taken 400 years to receive even this level of validation.
In the meantime, we are encouraged by a joint position statement recently issued by the APA and the NMA, the first joint effort by these two medical organizations to partner and advocate for criminal justice reform. We mention this statement because the NMA has been committed to the needs of the black community since its inception in 1895, and the APA has as its mission a commitment to serve “the needs of evolving, diverse, underrepresented, and underserved patient populations” ... and the resources to do so. This is the kind of partnership that could transform words into meaningful action.19,20
Of course, resident psychiatrist Dr. A. had begun supervision with the discussion of his dyadic experience with his patient, which is set in the context of a global coronavirus pandemic that is disproportionately affecting black and brown people. And, while his peers are marching in protest, he and his fellow trainees deserve our support as they deal with their own psychic pain and prepare to steady themselves. For these psychiatrists will be called to provide care to those who will consult them once they begin to grapple with the experiences and, in some cases, traumas that have compelled them to take action and literally risk their safety and lives while protesting.
That evening, the residents were hungry for methods to fill the gaps in their training and supervision. In some cases, we provided scripts to be taken back to supervision. For example, the following is a potential scripted response for the supervisor in the enactment described above:
Resident speaking to supervisor: This is a black patient who, like many others, is affected by the chronic, repeated televised images of black men killed by police. I am also a black man.
I think what I have shared is pertinent to the patient’s care and my experience as a black male psychiatrist who will need to learn how to address this in my patients who are black and for other racialized groups, as well as with whites who might have rarely been cared for by a black man. Can we discuss this?
We also anticipated that some residents would need to exercise their right to request reassignment to another supervisor. And, until we do better at listening, seeing, and deepening our understanding, outside and inside the consulting room and in supervision, more residents might need to steer around those who have the potential to undermine training and adversely affect treatment. But, as a professional medical community in crisis, do we really want to proceed in such an ad hoc fashion?
Dr. Dunlap is a psychiatrist and psychoanalyst, and clinical professor of psychiatry and behavioral sciences at George Washington University. She is interested in the management of “difference” – race, gender, ethnicity, and intersectionality – in dyadic relationships and group dynamics; and the impact of racism on interpersonal relationships in institutional structures. Dr. Dunlap practices in Washington and has no disclosures.
Dr. Dennis is a clinical psychologist and psychoanalyst. Her interests are in gender and ethnic diversity, health equity, and supervision and training. Dr. Dennis practices in Washington and has no disclosures.
Dr. DeSouza is a PGY-4 psychiatry resident and public psychiatry fellow in the department of psychiatry at Yale University, New Haven, Conn. Her professional interests include health services development and delivery in low- and middle-income settings, as well as the intersection of mental health and spirituality. She has no disclosures.
Dr. Isom is a staff psychiatrist at the Codman Square Health Center in Dorchester, Mass., and Boston Medical Center. Her interests include racial mental health equity and population health approaches to community psychiatry. She has no disclosures.
Dr. Mathis is an addictions fellow in the department of psychiatry at Yale University and former programwide chief resident at Yale. Her interests include the intersection of racial justice and mental health, health equity, and spirituality. She has no disclosures.
References
1. Mental Health: Culture, Race, and Ethnicity. A Supplement to Mental Health: A Report of the Surgeon General. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2001.
2. Banaji MR and Greenwald AG. Blindspot: Hidden Biases of Good People. New York: Delacorte Press, 2013.
3. Anekwe ON. Voices in Bioethics. 2014.
4. Soute BJ. The American Psychoanalyst Magazine. 2017 Winter/Spring.
5. Powell DR. J Am Psychoanal Assoc. 2019 Jan 8. doi: 10.1177/000306511881847.
6. Allen TW. The Invention of the White Race. London: Verso, 1994.
7. Klein M. Int J Psychoanal. 1946;27(pt.3-4):99-100.
8. Bion WR. (1962b). Psychoanal Q. 2013 Apr;82(2):301-10.
9. Black Psychoanalysts Speak trailer.
10. Thomas A and Sillen S. Racism and Psychiatry. New York: Brunner/Mazel, 1972.
11. Jones BE et al. Am J Psychiatry. 1970 Dec;127(6):798-803.
12. Sabshin M et al. Am J Psychiatry. 1970 Dec;126(6):787-93.
13. Medlock M et al. Am J Psychiatry. 2017 May 9. doi: 10.1176/appi.ajp-rj.2016.110206.
14. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). Arlington, Va.: American Psychiatric Association, 2013.
15. “What is Child Trauma?” The National Child Traumatic Stress Network.
16. The Philadelphia Project. Philadelphia ACE Survey.
17. “Addressing law enforcement violence as a public health issue.” Washington: American Public Health Association. 2018 Nov 13. Policy# 20811.
18. National Medical Association position statement on police use of force. NMA 2016.
19. “APA and NMA jointly condemn systemic racism in America.” 2020 Jun 16.
20. APA Strategic Plan. 2015 Mar.
On the Friday evening after the public execution of George Floyd, we were painfully reminded of the urgency to address the inadequate management of race, racism, and anti-blackness in medical education, residency training, and postgraduate continuing medical education.
The reminder did not originate from the rioting that was occurring in some cities, though we could feel the ground shifting beneath our feet as civic protests that began in U.S. cities spread around the globe. Instead, it occurred during a webinar we were hosting for psychiatry residents focused on techniques for eliminating blind spots in the management of race in clinical psychotherapy supervision. (Dr. Jessica Isom chaired the webinar, Dr. Flavia DeSouza and Dr. Myra Mathis comoderated, and Dr. Ebony Dennis and Dr. Constance E. Dunlap served as discussants.)
Our panel had presented an ambitious agenda that included reviewing how the disavowal of bias, race, racism, and anti-blackness contributes to ineffective psychotherapy, undermines the quality of medical care, and perpetuates mental health disparities. We spent some time exploring how unacknowledged and unexamined conscious and unconscious racial stereotypes affect interpersonal relationships, the psychotherapeutic process, and the supervisory experience. Our presentation included a clinical vignette demonstrating how racism, colorism, and anti-blackness have global impact, influencing the self-esteem, identity formation, and identity consolidation of immigrants as they grapple with the unique form of racism that exists in America. Other clinical vignettes demonstrated blind spots that were retroactively identified though omitted in supervisory discussions. We also discussed alternative interventions and interpretations of the material presented.1-5
Because 21st-century trainees are generally psychologically astute and committed to social justice, we did two things. First, before the webinar, we provided them access to a prerecorded explanation of object relations theorist Melanie Klein’s paranoid-schizoid and depressive positions concepts, which were applied to theoretically explain the development of race, specifically the defenses used by early colonists that contributed to the development of “whiteness” and “blackness” as social constructs, and their influence on the development of the U.S. psyche. For example, as early colonists attempted to develop new and improved identities distinct from those they had in their homelands, they used enslaved black people (and other vulnerable groups) to “other.” What we mean here by othering is the process of using an other to project one’s badness into in order to relieve the self of uncomfortable aspects and feelings originating within the self. If this other accepts the projection (which is often the case with vulnerable parties), the self recognizes, that is, identifies (locates) the bad they just projected in the other, who is now experienced as a bad-other. This is projection in action. If the other accepts the projection and behaves accordingly, for example, in a manner that reflects badness, this becomes projective identification. Conversely, if the other does not accept these projections, the self (who projects) is left to cope with aspects of the self s/he might not have the capacity to manage. By capacity, we are speaking of the Bionian idea of the ability to experience an extreme emotion while also being able to think. Without the ego strength to cope with bad aspects of the self, the ego either collapses (and is unable to think) or further projection is attempted.6-8
We have seen this latter dynamic play out repeatedly when police officers fatally shoot black citizens and then claim that they feared for their lives; these same officers have been exonerated by juries by continuing to portray the deceased victims as threatening, dangerous objects not worthy of living. We are also seeing a global movement of black and nonblack people who are in touch with a justified rage that has motivated them to return these projections by collectively protesting, and in some cases, by rioting.
Back to the webinar
In anticipating the residents’ curiosity, impatience, and anger about the lack of progress, the second thing we did was to show a segment from the “Black Psychoanalysts Speak” trailer. In the clip played, senior psychoanalyst Kirkland C. Vaughans, PhD, shares: “The issue of race so prompts excessive anxiety that it blocks off our ability to think.”
We showed this clip to validate the trainees’ frustrations about the difficulty the broader establishment has had with addressing this serious, longstanding public health problem. We wanted these young psychiatrists to know that there are psychoanalysts, psychiatrists, psychologists, and social workers who have been committed to this work, even though the contributions of this diverse group have curiously been omitted from education and training curricula.9
So, what happened? What was the painful reminder? After the formal panel presentations, a black male psychiatry resident recounted his experience in a clinical supervision meeting that had occurred several days after the murder of George Floyd. In short, a patient had shared his reactions to yet another incident of fatal police use of force and paused to ask how the resident physician, Dr. A., was doing. The question was experienced as sincere concern about the psychiatrist’s mental well-being. The resident was not sure how to answer this question since it was a matter of self-disclosure, which was a reasonable and thoughtful consideration for a seasoned clinician and, certainly, for a novice therapist. The supervisor, Dr. B., seemingly eager to move on, to not think about this, responded to the resident by saying: “Now tell me about the patient.” In other words, what had just been shared by the resident – material that featured a patient’s reaction to another killing of a black man by police and the patient’s expressed concern for his black psychiatrist, and this resident physician appropriately seeking space in supervision to process and receive guidance about how to respond – all of this was considered separate (split off from) and extraneous to the patient’s treatment and the resident’s training. This is a problem. And, unfortunately, this problem or some variation of it is not rare.
Why is this still the state of affairs when we have identified racism as a major health concern and our patients and our trainees are asking for help?
Rethinking a metaphor
Despite calls to action over the last 50 years to encourage medicine to effectively address race and racism, deficits remain in didactic education, clinical rotations, and supervisory experiences of trainees learning how to do psychodynamic psychotherapy.8-10 Earlier that evening, we used the metaphor of a vehicular blind spot to capture what we believe occurs insupervision. Like drivers, supervisors generally have the ability to see. However, there are places (times) and positions (stances) that block their vision (awareness). Racism – whether institutionalized, interpersonally mediated, or internalized – also contributes to this blindness.
As is true of drivers managing a blind spot, what is required is for the drivers – the supervisors – to lean forward or reposition themselves so as to avoid collisions, maintain safety, and continue on course. We use this metaphor because it is understood that any clinician providing psychodynamic supervision to psychiatry residents, regardless of professional discipline, has the requisite skills and training.10-13
Until May 25, we thought eliminating blind spots would be effective. But, in the aftermath of the police killing of George Floyd, our eyes have been opened.
Hiding behind the blue wall of silence is an establishment that has looked the other way while black and brown women, men, and children have come to live in fear as a result of the state-sanctioned violence that repeatedly occurs across the nation. Excessive police use of force is a public health issue of crisis magnitude. However, the house of medicine, like many other established structures in society, has colluded with the societal constructs that have supported law enforcement by remaining willfully blind, often neutral, and by refusing to make the necessary adjustments, including connecting the dots between police violence and physical and mental health.
For example, racism has never been listed even in the index of the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders.14 Being the victim of police use of force is not generally regarded as an adverse childhood experience, even though communities that are heavily policed experience harassment by law enforcement on a regular basis. The 12 causes of trauma listed on the website15 of the National Child Traumatic Stress Network – bullying, community violence, complex trauma, disasters, early childhood trauma, intimate partner violence, medical trauma, physical abuse, refugee trauma, sexual abuse, terrorism and violence, and traumatic grief – do not include maltreatment, abuse, or trauma resulting from interactions with members of law enforcement. Much of the adverse childhood experiences literature focuses on white, upper middle class children and on experiences within the home. When community level experiences, such as discrimination based on race or ethnicity, are included, as in the Philadelphia ACES study,16 as many as 40% reported ACE scores of greater than 4 for community level exposures.
As psychiatrists, we recognize the psychic underpinnings and parallels between the psychic projections onto black and brown people and the actual bullets pumped into the bodies of black and brown people; there is a lurid propensity to use these others as repositories. Those who have the privilege of being protected by law enforcement and the ability to avoid being used as containers for the psychic projections and bullets of some police officers also have the privilege of compartmentalizing and looking the other way when excessive acts of force – projections and projectiles – are used on other human beings. This partly explains why the injuries and deaths of black and brown people caused by police officers’ excessive use of force have continued even though these unjustified deaths are widely televised and disseminated via various social media platforms.
Prior to the death of George Floyd on May 25, other than the American Public Health Association, the National Medical Association (NMA) was the only major medical organization to issue a call to consider police use of force as a public health issue. In its July 2016 press release, provided in the aftermath of the death of Freddie Gray while in the custody of Baltimore police officers, the NMA summarized the scope of injuries citizens sustain during “the pre-custody (commission of a crime, during a fight, chase, and apprehension, during a siege or hostage situation, or during restraint or submission), custody (soon after being admitted to jail, during interrogation, during incarceration, or legal execution), and post-custody (revenge by police or rival criminals or after reentry into the community)” periods. It is noteworthy that the scope of these injuries is comparable to those encountered in a combat zone.17,18 According to the NMA:
“Injuries sustained by civilians at the hands of law enforcement include gunshot wounds, skull fractures, cervical spine injuries, facial fractures, broken legs, blunt trauma orbital floor fractures, laryngeal cartilage fractures, shoulder dislocations, cuts and bruises, concussions, hemorrhage, choking (positional or due to upper body holds), abdominal trauma, hemothorax, and pneumothorax. Complications of such injuries include posttraumatic brain swelling, infections following open fractures and lacerations, hydrocephalus due to blood or infection, as well as subdural and epidural hematomas and, in the most severe cases, death.”
In addition, there are multiple emotional and psychiatric sequelae of these injuries for the victims, families, upstanders, bystanders, and those viewing these images via various social media platforms. Increasingly, many are experiencing retraumatization each time a new death is reported. How do we explain that we are turning away from this as physicians and trainers of physicians? Seeing and not seeing – all of the methods used to avert one’s gaze and look the other way (to protect the psyches of nonmarginalized members of society from being disturbed and possibly traumatized) – these key defense mechanisms creep into consulting rooms and become fertile ground for the enactment described above.
Yet, there is reason to believe in change. It’s not simply because we are mental health professionals and that’s what we do. With the posting of position statements issued by major corporations and a growing number of medical organizations, many of us are experiencing a mixture of hope, anger, and sadness. Hope that widespread awareness will continue to tilt the axis of our country in a manner that opens eyes – and hearts – so that real work can be done; and anger and sadness because it has taken 400 years to receive even this level of validation.
In the meantime, we are encouraged by a joint position statement recently issued by the APA and the NMA, the first joint effort by these two medical organizations to partner and advocate for criminal justice reform. We mention this statement because the NMA has been committed to the needs of the black community since its inception in 1895, and the APA has as its mission a commitment to serve “the needs of evolving, diverse, underrepresented, and underserved patient populations” ... and the resources to do so. This is the kind of partnership that could transform words into meaningful action.19,20
Of course, resident psychiatrist Dr. A. had begun supervision with the discussion of his dyadic experience with his patient, which is set in the context of a global coronavirus pandemic that is disproportionately affecting black and brown people. And, while his peers are marching in protest, he and his fellow trainees deserve our support as they deal with their own psychic pain and prepare to steady themselves. For these psychiatrists will be called to provide care to those who will consult them once they begin to grapple with the experiences and, in some cases, traumas that have compelled them to take action and literally risk their safety and lives while protesting.
That evening, the residents were hungry for methods to fill the gaps in their training and supervision. In some cases, we provided scripts to be taken back to supervision. For example, the following is a potential scripted response for the supervisor in the enactment described above:
Resident speaking to supervisor: This is a black patient who, like many others, is affected by the chronic, repeated televised images of black men killed by police. I am also a black man.
I think what I have shared is pertinent to the patient’s care and my experience as a black male psychiatrist who will need to learn how to address this in my patients who are black and for other racialized groups, as well as with whites who might have rarely been cared for by a black man. Can we discuss this?
We also anticipated that some residents would need to exercise their right to request reassignment to another supervisor. And, until we do better at listening, seeing, and deepening our understanding, outside and inside the consulting room and in supervision, more residents might need to steer around those who have the potential to undermine training and adversely affect treatment. But, as a professional medical community in crisis, do we really want to proceed in such an ad hoc fashion?
Dr. Dunlap is a psychiatrist and psychoanalyst, and clinical professor of psychiatry and behavioral sciences at George Washington University. She is interested in the management of “difference” – race, gender, ethnicity, and intersectionality – in dyadic relationships and group dynamics; and the impact of racism on interpersonal relationships in institutional structures. Dr. Dunlap practices in Washington and has no disclosures.
Dr. Dennis is a clinical psychologist and psychoanalyst. Her interests are in gender and ethnic diversity, health equity, and supervision and training. Dr. Dennis practices in Washington and has no disclosures.
Dr. DeSouza is a PGY-4 psychiatry resident and public psychiatry fellow in the department of psychiatry at Yale University, New Haven, Conn. Her professional interests include health services development and delivery in low- and middle-income settings, as well as the intersection of mental health and spirituality. She has no disclosures.
Dr. Isom is a staff psychiatrist at the Codman Square Health Center in Dorchester, Mass., and Boston Medical Center. Her interests include racial mental health equity and population health approaches to community psychiatry. She has no disclosures.
Dr. Mathis is an addictions fellow in the department of psychiatry at Yale University and former programwide chief resident at Yale. Her interests include the intersection of racial justice and mental health, health equity, and spirituality. She has no disclosures.
References
1. Mental Health: Culture, Race, and Ethnicity. A Supplement to Mental Health: A Report of the Surgeon General. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2001.
2. Banaji MR and Greenwald AG. Blindspot: Hidden Biases of Good People. New York: Delacorte Press, 2013.
3. Anekwe ON. Voices in Bioethics. 2014.
4. Soute BJ. The American Psychoanalyst Magazine. 2017 Winter/Spring.
5. Powell DR. J Am Psychoanal Assoc. 2019 Jan 8. doi: 10.1177/000306511881847.
6. Allen TW. The Invention of the White Race. London: Verso, 1994.
7. Klein M. Int J Psychoanal. 1946;27(pt.3-4):99-100.
8. Bion WR. (1962b). Psychoanal Q. 2013 Apr;82(2):301-10.
9. Black Psychoanalysts Speak trailer.
10. Thomas A and Sillen S. Racism and Psychiatry. New York: Brunner/Mazel, 1972.
11. Jones BE et al. Am J Psychiatry. 1970 Dec;127(6):798-803.
12. Sabshin M et al. Am J Psychiatry. 1970 Dec;126(6):787-93.
13. Medlock M et al. Am J Psychiatry. 2017 May 9. doi: 10.1176/appi.ajp-rj.2016.110206.
14. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). Arlington, Va.: American Psychiatric Association, 2013.
15. “What is Child Trauma?” The National Child Traumatic Stress Network.
16. The Philadelphia Project. Philadelphia ACE Survey.
17. “Addressing law enforcement violence as a public health issue.” Washington: American Public Health Association. 2018 Nov 13. Policy# 20811.
18. National Medical Association position statement on police use of force. NMA 2016.
19. “APA and NMA jointly condemn systemic racism in America.” 2020 Jun 16.
20. APA Strategic Plan. 2015 Mar.
Study evaluates number of needed to refer, biopsy for diagnosing a melanoma
At the same time, the number needed to refer to diagnose non-melanoma skin cancer was 4 and the number needed to biopsy was 1.5.
The findings come from a retrospective review of 707 patients referred to a tertiary medical center dermatology practice for suspicious lesions, presented in a poster session at the virtual annual meeting of the American Academy of Dermatology
“Multiple studies in the dermatology literature have looked at the number needed to treat (NNT) as a quality metric for dermatology clinics, where a lower number is ‘better,’” the study’s first author, Nikolai Klebanov, MD, said in an interview following the virtual meeting. “Our particular study is unique in that we estimated both the number needed to refer and number needed to biopsy to closely examine the process of referrals for suspicious lesions from primary care settings to specialists. We also looked closely at the underlying patient-centered characteristics, which could be used by all clinicians to streamline the referral process by reducing the volume of low-risk referrals.”
Dr. Klebanov, of the department of dermatology at Massachusetts General Hospital, Boston, and his associates reviewed 707 unique patient visits to the department during July 2015–February 2016. They calculated the number needed to refer and biopsy for melanoma as the ratio of biopsy-proven melanoma diagnoses among benign and dysplastic nevi and seborrheic keratoses. For nonmelanoma skin cancer, they used the ratio of basal and squamous cell carcinoma among actinic keratoses and seborrheic keratoses.
Of the 707 patients, 54% were female, and males were slightly older than females (a mean of 58 vs. 54 years, respectively). The researchers found that lesions were more commonly benign among all age groups, while the frequency of premalignant and malignant lesions such as actinic keratoses, nonmelanoma skin cancer, and melanoma was highest for males and increased with age. Nevi were the most common benign diagnosis among patients 39 years of age and younger, while seborrheic keratoses were more common among patients aged 40 years and older.
The researchers found that the number needed to treat for melanoma was 31.5 and the number needed to biopsy was 7.5, which represents a 4.2-fold difference. Meanwhile, the number needed to refer for nonmelanoma skin cancer was 4, and the number needed to biopsy was 1.5, which represents a 2.7-fold difference. Despite variable rates of skin cancer between demographics, the biopsy rate ranged between 18% and 30%, for a mean of 23.4%.
“We found that most young patients referred for a ‘suspicious lesion’ on clinical prebiopsy assessment by the dermatologist were determined to actually have a benign nevus, and that older patients were most likely to have a seborrheic keratosis as the underlying lesion,” Dr. Klebanov said. “Among the minority of patients in each demographic group who were selected for biopsy, those lesions which were found to be benign were also largely nevi and keratoses. Even by being mindful of just the patient’s age, primary care providers can follow patients clinically with a tailored differential diagnosis in mind before referral, and dermatologists can reduce the number of biopsies they perform on patients who are being referred.”
He added that he and his colleagues were surprised that despite very low rates of skin cancer in young patients, and thus different pretest probabilities of cancer, biopsy rates across demographics were consistently around 20%. “We also found a disproportionate number of female patients younger than age 40 who were referred for suspicious lesions, while in the older age groups, the ratio of males to females was approximately equal.”
Dr. Klebanov acknowledged certain limitations of the study, including its single-center, retrospective design, and that information was not collected on patients’ family history of skin cancer, Fitzpatrick skin type, nor the clinical course of the lesion while it was followed by the primary care office. “The nuanced differences in these factors may certainly play a role in decisions for individual patients,” he said.
The study’s principal investigator was Hensin Tsao MD, PhD, clinical director of the MGH Melanoma & Pigmented Lesion Center The work was supported by the Alpha Omega Alpha Carolyn Kuckein Research Fellowship. The researchers reported having no financial disclosures.
SOURCE: Klebanov N et al. AAD 20. Abstract 15881.
At the same time, the number needed to refer to diagnose non-melanoma skin cancer was 4 and the number needed to biopsy was 1.5.
The findings come from a retrospective review of 707 patients referred to a tertiary medical center dermatology practice for suspicious lesions, presented in a poster session at the virtual annual meeting of the American Academy of Dermatology
“Multiple studies in the dermatology literature have looked at the number needed to treat (NNT) as a quality metric for dermatology clinics, where a lower number is ‘better,’” the study’s first author, Nikolai Klebanov, MD, said in an interview following the virtual meeting. “Our particular study is unique in that we estimated both the number needed to refer and number needed to biopsy to closely examine the process of referrals for suspicious lesions from primary care settings to specialists. We also looked closely at the underlying patient-centered characteristics, which could be used by all clinicians to streamline the referral process by reducing the volume of low-risk referrals.”
Dr. Klebanov, of the department of dermatology at Massachusetts General Hospital, Boston, and his associates reviewed 707 unique patient visits to the department during July 2015–February 2016. They calculated the number needed to refer and biopsy for melanoma as the ratio of biopsy-proven melanoma diagnoses among benign and dysplastic nevi and seborrheic keratoses. For nonmelanoma skin cancer, they used the ratio of basal and squamous cell carcinoma among actinic keratoses and seborrheic keratoses.
Of the 707 patients, 54% were female, and males were slightly older than females (a mean of 58 vs. 54 years, respectively). The researchers found that lesions were more commonly benign among all age groups, while the frequency of premalignant and malignant lesions such as actinic keratoses, nonmelanoma skin cancer, and melanoma was highest for males and increased with age. Nevi were the most common benign diagnosis among patients 39 years of age and younger, while seborrheic keratoses were more common among patients aged 40 years and older.
The researchers found that the number needed to treat for melanoma was 31.5 and the number needed to biopsy was 7.5, which represents a 4.2-fold difference. Meanwhile, the number needed to refer for nonmelanoma skin cancer was 4, and the number needed to biopsy was 1.5, which represents a 2.7-fold difference. Despite variable rates of skin cancer between demographics, the biopsy rate ranged between 18% and 30%, for a mean of 23.4%.
“We found that most young patients referred for a ‘suspicious lesion’ on clinical prebiopsy assessment by the dermatologist were determined to actually have a benign nevus, and that older patients were most likely to have a seborrheic keratosis as the underlying lesion,” Dr. Klebanov said. “Among the minority of patients in each demographic group who were selected for biopsy, those lesions which were found to be benign were also largely nevi and keratoses. Even by being mindful of just the patient’s age, primary care providers can follow patients clinically with a tailored differential diagnosis in mind before referral, and dermatologists can reduce the number of biopsies they perform on patients who are being referred.”
He added that he and his colleagues were surprised that despite very low rates of skin cancer in young patients, and thus different pretest probabilities of cancer, biopsy rates across demographics were consistently around 20%. “We also found a disproportionate number of female patients younger than age 40 who were referred for suspicious lesions, while in the older age groups, the ratio of males to females was approximately equal.”
Dr. Klebanov acknowledged certain limitations of the study, including its single-center, retrospective design, and that information was not collected on patients’ family history of skin cancer, Fitzpatrick skin type, nor the clinical course of the lesion while it was followed by the primary care office. “The nuanced differences in these factors may certainly play a role in decisions for individual patients,” he said.
The study’s principal investigator was Hensin Tsao MD, PhD, clinical director of the MGH Melanoma & Pigmented Lesion Center The work was supported by the Alpha Omega Alpha Carolyn Kuckein Research Fellowship. The researchers reported having no financial disclosures.
SOURCE: Klebanov N et al. AAD 20. Abstract 15881.
At the same time, the number needed to refer to diagnose non-melanoma skin cancer was 4 and the number needed to biopsy was 1.5.
The findings come from a retrospective review of 707 patients referred to a tertiary medical center dermatology practice for suspicious lesions, presented in a poster session at the virtual annual meeting of the American Academy of Dermatology
“Multiple studies in the dermatology literature have looked at the number needed to treat (NNT) as a quality metric for dermatology clinics, where a lower number is ‘better,’” the study’s first author, Nikolai Klebanov, MD, said in an interview following the virtual meeting. “Our particular study is unique in that we estimated both the number needed to refer and number needed to biopsy to closely examine the process of referrals for suspicious lesions from primary care settings to specialists. We also looked closely at the underlying patient-centered characteristics, which could be used by all clinicians to streamline the referral process by reducing the volume of low-risk referrals.”
Dr. Klebanov, of the department of dermatology at Massachusetts General Hospital, Boston, and his associates reviewed 707 unique patient visits to the department during July 2015–February 2016. They calculated the number needed to refer and biopsy for melanoma as the ratio of biopsy-proven melanoma diagnoses among benign and dysplastic nevi and seborrheic keratoses. For nonmelanoma skin cancer, they used the ratio of basal and squamous cell carcinoma among actinic keratoses and seborrheic keratoses.
Of the 707 patients, 54% were female, and males were slightly older than females (a mean of 58 vs. 54 years, respectively). The researchers found that lesions were more commonly benign among all age groups, while the frequency of premalignant and malignant lesions such as actinic keratoses, nonmelanoma skin cancer, and melanoma was highest for males and increased with age. Nevi were the most common benign diagnosis among patients 39 years of age and younger, while seborrheic keratoses were more common among patients aged 40 years and older.
The researchers found that the number needed to treat for melanoma was 31.5 and the number needed to biopsy was 7.5, which represents a 4.2-fold difference. Meanwhile, the number needed to refer for nonmelanoma skin cancer was 4, and the number needed to biopsy was 1.5, which represents a 2.7-fold difference. Despite variable rates of skin cancer between demographics, the biopsy rate ranged between 18% and 30%, for a mean of 23.4%.
“We found that most young patients referred for a ‘suspicious lesion’ on clinical prebiopsy assessment by the dermatologist were determined to actually have a benign nevus, and that older patients were most likely to have a seborrheic keratosis as the underlying lesion,” Dr. Klebanov said. “Among the minority of patients in each demographic group who were selected for biopsy, those lesions which were found to be benign were also largely nevi and keratoses. Even by being mindful of just the patient’s age, primary care providers can follow patients clinically with a tailored differential diagnosis in mind before referral, and dermatologists can reduce the number of biopsies they perform on patients who are being referred.”
He added that he and his colleagues were surprised that despite very low rates of skin cancer in young patients, and thus different pretest probabilities of cancer, biopsy rates across demographics were consistently around 20%. “We also found a disproportionate number of female patients younger than age 40 who were referred for suspicious lesions, while in the older age groups, the ratio of males to females was approximately equal.”
Dr. Klebanov acknowledged certain limitations of the study, including its single-center, retrospective design, and that information was not collected on patients’ family history of skin cancer, Fitzpatrick skin type, nor the clinical course of the lesion while it was followed by the primary care office. “The nuanced differences in these factors may certainly play a role in decisions for individual patients,” he said.
The study’s principal investigator was Hensin Tsao MD, PhD, clinical director of the MGH Melanoma & Pigmented Lesion Center The work was supported by the Alpha Omega Alpha Carolyn Kuckein Research Fellowship. The researchers reported having no financial disclosures.
SOURCE: Klebanov N et al. AAD 20. Abstract 15881.
FROM AAD 20
LAA Closure noninferior to DOACs to prevent AF-related events
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: A composite primary outcome including stroke and death was not significantly different in high-risk patients randomized to left atrial appendage occlusion or direct oral anticoagulants at roughly 20 months’ follow-up (11% vs. 13%, respectively).
Study details: The data come from the PRAGUE-17 study, a randomized trial of 402 adults at increased risk for atrial fibrillation.
Disclosures: The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot.
Sources: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Highlights in Ovarian Cancer From ASCO 2020
The DESKTOP III trial, whose results were eagerly awaited, compared surgery followed by chemotherapy versus chemotherapy only in recurrent platinum-sensitive ovarian cancer. Dr. Maurie Markman, from Cancer Treatment Centers of America in Philadelphia, reports that the DESKTOP results, initially announced in 2017, continue to show an improvement in progression-free survival in favor of surgery plus chemotherapy.
Dr. Markman next comments on the SOLO-2 study assessing maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer and a BRCA mutation, which showed significantly improved overall survival for patients receiving olaparib.
Among other olaparib trials, the phase 3 PAOLA-1 study looked at olaparib plus bevacizumab in platinum-sensitive recurrent ovarian cancer. The study explored the efficacy of this combination in treating tumors with BRCA1/BRCA2 mutations and found that all patients benefited.
Finally, Dr. Markman reports on noteworthy abstracts, including studies examining the adequacy of genetic testing and real-world data in management of patients with ovarian cancer.
Maurie Markman, MD
Maurie Markman, MD, Clinical Professor of Medicine, Drexel University College of Medicine; President, Medicine & Science, Cancer Treatment Centers of America, Philadelphia, Pennsylvania. Maurie Markman, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Merck, Inc. Serve(d) as a speaker or a member of a speakers bureau for: Genentech, Inc; Clovis; Tesaro; AstraZeneca Pharmaceuticals, LP
The DESKTOP III trial, whose results were eagerly awaited, compared surgery followed by chemotherapy versus chemotherapy only in recurrent platinum-sensitive ovarian cancer. Dr. Maurie Markman, from Cancer Treatment Centers of America in Philadelphia, reports that the DESKTOP results, initially announced in 2017, continue to show an improvement in progression-free survival in favor of surgery plus chemotherapy.
Dr. Markman next comments on the SOLO-2 study assessing maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer and a BRCA mutation, which showed significantly improved overall survival for patients receiving olaparib.
Among other olaparib trials, the phase 3 PAOLA-1 study looked at olaparib plus bevacizumab in platinum-sensitive recurrent ovarian cancer. The study explored the efficacy of this combination in treating tumors with BRCA1/BRCA2 mutations and found that all patients benefited.
Finally, Dr. Markman reports on noteworthy abstracts, including studies examining the adequacy of genetic testing and real-world data in management of patients with ovarian cancer.
Maurie Markman, MD
Maurie Markman, MD, Clinical Professor of Medicine, Drexel University College of Medicine; President, Medicine & Science, Cancer Treatment Centers of America, Philadelphia, Pennsylvania. Maurie Markman, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Merck, Inc. Serve(d) as a speaker or a member of a speakers bureau for: Genentech, Inc; Clovis; Tesaro; AstraZeneca Pharmaceuticals, LP
The DESKTOP III trial, whose results were eagerly awaited, compared surgery followed by chemotherapy versus chemotherapy only in recurrent platinum-sensitive ovarian cancer. Dr. Maurie Markman, from Cancer Treatment Centers of America in Philadelphia, reports that the DESKTOP results, initially announced in 2017, continue to show an improvement in progression-free survival in favor of surgery plus chemotherapy.
Dr. Markman next comments on the SOLO-2 study assessing maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer and a BRCA mutation, which showed significantly improved overall survival for patients receiving olaparib.
Among other olaparib trials, the phase 3 PAOLA-1 study looked at olaparib plus bevacizumab in platinum-sensitive recurrent ovarian cancer. The study explored the efficacy of this combination in treating tumors with BRCA1/BRCA2 mutations and found that all patients benefited.
Finally, Dr. Markman reports on noteworthy abstracts, including studies examining the adequacy of genetic testing and real-world data in management of patients with ovarian cancer.
Maurie Markman, MD
Maurie Markman, MD, Clinical Professor of Medicine, Drexel University College of Medicine; President, Medicine & Science, Cancer Treatment Centers of America, Philadelphia, Pennsylvania. Maurie Markman, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Merck, Inc. Serve(d) as a speaker or a member of a speakers bureau for: Genentech, Inc; Clovis; Tesaro; AstraZeneca Pharmaceuticals, LP
