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Ketamine linked to reduced suicidal thoughts, depression, anxiety
, new research suggests.
Results from a retrospective chart review analysis, which included more than 400 participants with TRD, illustrate that ketamine is a safe and rapid treatment in a real-world patient population, lead author Patrick A. Oliver, MD, founder and medical director, MindPeace Clinics, Richmond, Va., told this news organization.
The effect was perhaps most notable for reducing suicidal ideation, he said.
“In 2 weeks, we can take somebody from being suicidal to nonsuicidal. It’s a total game changer,” Dr. Oliver added.
Every year in the United States, about 12 million individuals think about suicide, 3.2 million make a plan to kill themselves, and more than 46,000 succeed, the investigators note.
The findings were published online in the Journal of Clinical Psychiatry.
Molecule mixture
Primarily used as an anesthetic in hospitals, ketamine is also taken illegally as a recreational drug. Users may aim for an intense high or feeling of dissociation, or an out-of-body–type experience.
Ketamine is a mixture of two mirror-image molecules. An intranasal version of one of these molecules (esketamine) is approved by the U.S. Food and Drug Administration for TRD. Both esketamine and ketamine are believed to increase neurotrophic signaling that affects synaptic function.
The study included 424 patients (mean age, 41.7 years) with major depressive disorder or another mood disorder and who received at least one ketamine infusion at a specialty clinic. Most participants had failed prior medication trials.
Patients in the study were typically started on 0.5 mg/kg of ketamine, with the dose titrated to achieve symptoms of partial dissociation. The median dose administered after titration was 0.93 mg/kg over 40 minutes.
The main treatment course of at least six infusions within 21 days was completed by 70% of the patients.
At each clinic visit, all participants completed the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7).
The primary outcome was PHQ-9 total scores, for which researchers looked at seven time periods: 1 week, 2-3 weeks, 4-6 weeks, 7-12 weeks, 13-24 weeks, 25-51 weeks, and 52+ weeks.
‘Blows it out of the water’
Results showed PHQ-9 total scores declined by 50% throughout the course of treatment, with much of the improvement gained within 4-6 weeks. There was a significant difference between week 1 and all later time periods (all P values < .001) and between weeks 2 and 3 and all later periods (all P values < .001).
Other measures included treatment response, defined as at least a 50% improvement on the PHQ-9, and depression remission, defined as a PHQ-9 score of less than 5. After three infusions, 14% of the patients responded and 7% were in remission. After 10 infusions, 72% responded and 38% were in remission.
These results compare favorably to other depression treatments, said Dr. Oliver. “Truthfully, with the exception of ECT [electroconvulsive therapy], this blows it all out of the water,” he added.
Dr. Oliver noted that the success rate for repetitive transcranial magnetic stimulation is 40%-60% depending on the modality; and for selective serotonin reuptake inhibitors, the success rate “is somewhere between the mid-20s and low-30s percent range.”
Another outcome measure was the self-harm/suicidal ideation item of the PHQ-9 questionnaire, which asks about “thoughts that you would be better off dead, or of hurting yourself in some way.” About 22% of the study participants no longer reported suicidal ideation after 3 infusions, 50% by 6 infusions, and 75% by 10 infusions.
By 15 infusions, 85% no longer reported these thoughts. “Nothing else has shown that, ever,” said Dr. Oliver.
Symptoms of generalized anxiety were also substantially improved. There was about a 30% reduction in the GAD-7 score during treatment and, again, most of the response occurred by 4-6 weeks.
Study limitations
Sex, age, and other demographic characteristics did not predict response or remission, but suicide planning trended toward higher response rates (P = .083). This suggests that a more depressed subgroup can achieve greater benefit from the treatment than can less symptomatic patients, the investigators note.
A history of psychosis also trended toward better response to treatment (P = .086) but not remission.
The researchers note that study limitations include that it was retrospective, lacked a control group, and did not require patients to be hospitalized – so the study sample may have been less severely ill than in other studies.
In addition, most patients paid out of pocket for the treatment at $495 per infusion, and they self-reported their symptoms.
As well, the researchers did not assess adverse events, although nurses made follow-up calls to patients. Dr. Oliver noted the most common side effects of ketamine are nausea, vomiting, and anxiety.
Previous research has suggested that ketamine therapy is not linked to long-term side effects, such as sexual dysfunction, weight gain, lethargy, or cognitive issues, said Dr. Oliver.
The investigators point out another study limitation was lack of detailed demographic information, such as race, income, and education, which might affect its generalizability.
Concerns and questions
Pouya Movahed Rad, MD, PhD, senior consultant and researcher in psychiatry, Lund (Sweden) University, noted several concerns, including that the clinics treating the study participants with ketamine profited from it.
He also speculated about who can afford the treatment because only a few patients in the study were reimbursed through insurance.
Dr. Movahed Rad was not involved with the current research but was principal investigator for a recent study that compared intravenous ketamine to ECT.
He questioned whether the patient population in the new study really was “real world.” Well-designed randomized controlled trials have been carried out in a “naturalistic setting, [which] get closer to real-life patients,” he said.
He also noted that the median dose after clinician titration (0.93 mg/kg over 40 minutes) “may be considered very high.”
With regard to doses being titrated to achieve symptoms of partial dissociation, “there is no obvious evidence to my knowledge that patients need to develop dissociative symptoms in order to have antidepressant effect,” said Dr. Movahed Rad.
Finally, he noted that the finding that 28% of the participants were using illegal drugs “is worrying” and wondered what drugs they were taking; he also questioned why 81% of the study population needed to take antidepressants.
The study did not receive outside funding. Dr. Oliver is the founder of MindPeace Clinics, which specialize in ketamine therapeutics. Dr. Movahed Rad has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a retrospective chart review analysis, which included more than 400 participants with TRD, illustrate that ketamine is a safe and rapid treatment in a real-world patient population, lead author Patrick A. Oliver, MD, founder and medical director, MindPeace Clinics, Richmond, Va., told this news organization.
The effect was perhaps most notable for reducing suicidal ideation, he said.
“In 2 weeks, we can take somebody from being suicidal to nonsuicidal. It’s a total game changer,” Dr. Oliver added.
Every year in the United States, about 12 million individuals think about suicide, 3.2 million make a plan to kill themselves, and more than 46,000 succeed, the investigators note.
The findings were published online in the Journal of Clinical Psychiatry.
Molecule mixture
Primarily used as an anesthetic in hospitals, ketamine is also taken illegally as a recreational drug. Users may aim for an intense high or feeling of dissociation, or an out-of-body–type experience.
Ketamine is a mixture of two mirror-image molecules. An intranasal version of one of these molecules (esketamine) is approved by the U.S. Food and Drug Administration for TRD. Both esketamine and ketamine are believed to increase neurotrophic signaling that affects synaptic function.
The study included 424 patients (mean age, 41.7 years) with major depressive disorder or another mood disorder and who received at least one ketamine infusion at a specialty clinic. Most participants had failed prior medication trials.
Patients in the study were typically started on 0.5 mg/kg of ketamine, with the dose titrated to achieve symptoms of partial dissociation. The median dose administered after titration was 0.93 mg/kg over 40 minutes.
The main treatment course of at least six infusions within 21 days was completed by 70% of the patients.
At each clinic visit, all participants completed the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7).
The primary outcome was PHQ-9 total scores, for which researchers looked at seven time periods: 1 week, 2-3 weeks, 4-6 weeks, 7-12 weeks, 13-24 weeks, 25-51 weeks, and 52+ weeks.
‘Blows it out of the water’
Results showed PHQ-9 total scores declined by 50% throughout the course of treatment, with much of the improvement gained within 4-6 weeks. There was a significant difference between week 1 and all later time periods (all P values < .001) and between weeks 2 and 3 and all later periods (all P values < .001).
Other measures included treatment response, defined as at least a 50% improvement on the PHQ-9, and depression remission, defined as a PHQ-9 score of less than 5. After three infusions, 14% of the patients responded and 7% were in remission. After 10 infusions, 72% responded and 38% were in remission.
These results compare favorably to other depression treatments, said Dr. Oliver. “Truthfully, with the exception of ECT [electroconvulsive therapy], this blows it all out of the water,” he added.
Dr. Oliver noted that the success rate for repetitive transcranial magnetic stimulation is 40%-60% depending on the modality; and for selective serotonin reuptake inhibitors, the success rate “is somewhere between the mid-20s and low-30s percent range.”
Another outcome measure was the self-harm/suicidal ideation item of the PHQ-9 questionnaire, which asks about “thoughts that you would be better off dead, or of hurting yourself in some way.” About 22% of the study participants no longer reported suicidal ideation after 3 infusions, 50% by 6 infusions, and 75% by 10 infusions.
By 15 infusions, 85% no longer reported these thoughts. “Nothing else has shown that, ever,” said Dr. Oliver.
Symptoms of generalized anxiety were also substantially improved. There was about a 30% reduction in the GAD-7 score during treatment and, again, most of the response occurred by 4-6 weeks.
Study limitations
Sex, age, and other demographic characteristics did not predict response or remission, but suicide planning trended toward higher response rates (P = .083). This suggests that a more depressed subgroup can achieve greater benefit from the treatment than can less symptomatic patients, the investigators note.
A history of psychosis also trended toward better response to treatment (P = .086) but not remission.
The researchers note that study limitations include that it was retrospective, lacked a control group, and did not require patients to be hospitalized – so the study sample may have been less severely ill than in other studies.
In addition, most patients paid out of pocket for the treatment at $495 per infusion, and they self-reported their symptoms.
As well, the researchers did not assess adverse events, although nurses made follow-up calls to patients. Dr. Oliver noted the most common side effects of ketamine are nausea, vomiting, and anxiety.
Previous research has suggested that ketamine therapy is not linked to long-term side effects, such as sexual dysfunction, weight gain, lethargy, or cognitive issues, said Dr. Oliver.
The investigators point out another study limitation was lack of detailed demographic information, such as race, income, and education, which might affect its generalizability.
Concerns and questions
Pouya Movahed Rad, MD, PhD, senior consultant and researcher in psychiatry, Lund (Sweden) University, noted several concerns, including that the clinics treating the study participants with ketamine profited from it.
He also speculated about who can afford the treatment because only a few patients in the study were reimbursed through insurance.
Dr. Movahed Rad was not involved with the current research but was principal investigator for a recent study that compared intravenous ketamine to ECT.
He questioned whether the patient population in the new study really was “real world.” Well-designed randomized controlled trials have been carried out in a “naturalistic setting, [which] get closer to real-life patients,” he said.
He also noted that the median dose after clinician titration (0.93 mg/kg over 40 minutes) “may be considered very high.”
With regard to doses being titrated to achieve symptoms of partial dissociation, “there is no obvious evidence to my knowledge that patients need to develop dissociative symptoms in order to have antidepressant effect,” said Dr. Movahed Rad.
Finally, he noted that the finding that 28% of the participants were using illegal drugs “is worrying” and wondered what drugs they were taking; he also questioned why 81% of the study population needed to take antidepressants.
The study did not receive outside funding. Dr. Oliver is the founder of MindPeace Clinics, which specialize in ketamine therapeutics. Dr. Movahed Rad has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a retrospective chart review analysis, which included more than 400 participants with TRD, illustrate that ketamine is a safe and rapid treatment in a real-world patient population, lead author Patrick A. Oliver, MD, founder and medical director, MindPeace Clinics, Richmond, Va., told this news organization.
The effect was perhaps most notable for reducing suicidal ideation, he said.
“In 2 weeks, we can take somebody from being suicidal to nonsuicidal. It’s a total game changer,” Dr. Oliver added.
Every year in the United States, about 12 million individuals think about suicide, 3.2 million make a plan to kill themselves, and more than 46,000 succeed, the investigators note.
The findings were published online in the Journal of Clinical Psychiatry.
Molecule mixture
Primarily used as an anesthetic in hospitals, ketamine is also taken illegally as a recreational drug. Users may aim for an intense high or feeling of dissociation, or an out-of-body–type experience.
Ketamine is a mixture of two mirror-image molecules. An intranasal version of one of these molecules (esketamine) is approved by the U.S. Food and Drug Administration for TRD. Both esketamine and ketamine are believed to increase neurotrophic signaling that affects synaptic function.
The study included 424 patients (mean age, 41.7 years) with major depressive disorder or another mood disorder and who received at least one ketamine infusion at a specialty clinic. Most participants had failed prior medication trials.
Patients in the study were typically started on 0.5 mg/kg of ketamine, with the dose titrated to achieve symptoms of partial dissociation. The median dose administered after titration was 0.93 mg/kg over 40 minutes.
The main treatment course of at least six infusions within 21 days was completed by 70% of the patients.
At each clinic visit, all participants completed the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7).
The primary outcome was PHQ-9 total scores, for which researchers looked at seven time periods: 1 week, 2-3 weeks, 4-6 weeks, 7-12 weeks, 13-24 weeks, 25-51 weeks, and 52+ weeks.
‘Blows it out of the water’
Results showed PHQ-9 total scores declined by 50% throughout the course of treatment, with much of the improvement gained within 4-6 weeks. There was a significant difference between week 1 and all later time periods (all P values < .001) and between weeks 2 and 3 and all later periods (all P values < .001).
Other measures included treatment response, defined as at least a 50% improvement on the PHQ-9, and depression remission, defined as a PHQ-9 score of less than 5. After three infusions, 14% of the patients responded and 7% were in remission. After 10 infusions, 72% responded and 38% were in remission.
These results compare favorably to other depression treatments, said Dr. Oliver. “Truthfully, with the exception of ECT [electroconvulsive therapy], this blows it all out of the water,” he added.
Dr. Oliver noted that the success rate for repetitive transcranial magnetic stimulation is 40%-60% depending on the modality; and for selective serotonin reuptake inhibitors, the success rate “is somewhere between the mid-20s and low-30s percent range.”
Another outcome measure was the self-harm/suicidal ideation item of the PHQ-9 questionnaire, which asks about “thoughts that you would be better off dead, or of hurting yourself in some way.” About 22% of the study participants no longer reported suicidal ideation after 3 infusions, 50% by 6 infusions, and 75% by 10 infusions.
By 15 infusions, 85% no longer reported these thoughts. “Nothing else has shown that, ever,” said Dr. Oliver.
Symptoms of generalized anxiety were also substantially improved. There was about a 30% reduction in the GAD-7 score during treatment and, again, most of the response occurred by 4-6 weeks.
Study limitations
Sex, age, and other demographic characteristics did not predict response or remission, but suicide planning trended toward higher response rates (P = .083). This suggests that a more depressed subgroup can achieve greater benefit from the treatment than can less symptomatic patients, the investigators note.
A history of psychosis also trended toward better response to treatment (P = .086) but not remission.
The researchers note that study limitations include that it was retrospective, lacked a control group, and did not require patients to be hospitalized – so the study sample may have been less severely ill than in other studies.
In addition, most patients paid out of pocket for the treatment at $495 per infusion, and they self-reported their symptoms.
As well, the researchers did not assess adverse events, although nurses made follow-up calls to patients. Dr. Oliver noted the most common side effects of ketamine are nausea, vomiting, and anxiety.
Previous research has suggested that ketamine therapy is not linked to long-term side effects, such as sexual dysfunction, weight gain, lethargy, or cognitive issues, said Dr. Oliver.
The investigators point out another study limitation was lack of detailed demographic information, such as race, income, and education, which might affect its generalizability.
Concerns and questions
Pouya Movahed Rad, MD, PhD, senior consultant and researcher in psychiatry, Lund (Sweden) University, noted several concerns, including that the clinics treating the study participants with ketamine profited from it.
He also speculated about who can afford the treatment because only a few patients in the study were reimbursed through insurance.
Dr. Movahed Rad was not involved with the current research but was principal investigator for a recent study that compared intravenous ketamine to ECT.
He questioned whether the patient population in the new study really was “real world.” Well-designed randomized controlled trials have been carried out in a “naturalistic setting, [which] get closer to real-life patients,” he said.
He also noted that the median dose after clinician titration (0.93 mg/kg over 40 minutes) “may be considered very high.”
With regard to doses being titrated to achieve symptoms of partial dissociation, “there is no obvious evidence to my knowledge that patients need to develop dissociative symptoms in order to have antidepressant effect,” said Dr. Movahed Rad.
Finally, he noted that the finding that 28% of the participants were using illegal drugs “is worrying” and wondered what drugs they were taking; he also questioned why 81% of the study population needed to take antidepressants.
The study did not receive outside funding. Dr. Oliver is the founder of MindPeace Clinics, which specialize in ketamine therapeutics. Dr. Movahed Rad has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF CLINICAL PSYCHIATRY
A history of head trauma may predict Parkinson’s disease progression
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a longitudinal online study, among patients with Parkinson’s disease who had a history of head injury, motor impairment developed 25% faster and cognitive impairment developed 45% faster than among those without such a history.
In addition, severe head injuries were associated with an even more rapid onset of impairment. The results give weight to the idea that “it’s head injuries themselves” prior to the development of Parkinson’s disease that might exacerbate motor and cognitive symptoms, said study investigator Ethan Brown, MD, assistant professor, Weill Institute of Neurosciences, department of neurology, University of California, San Francisco.
The findings emphasize the importance of “doing everything we can” to prevent falls and head injuries for patients with Parkinson’s disease, Dr. Brown said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Reverse causality concerns
Head injury is a risk factor for Parkinson’s disease, but its relationship to Parkinson’s disease progression is not well established. “There has always been this concern in Parkinson’s disease that maybe it’s problems with motor impairment that lead to head injuries, so reverse causality is an issue,” said Dr. Brown. “We wanted to look at whether risk factors we know relate to the development of Parkinson’s disease can also have a bearing on its progression,” he added.
The analysis was part of the online Fox Insight study that is evaluating motor and nonmotor symptoms in individuals with and those without Parkinson’s disease. The study included participants who had completed questionnaires on such things as head trauma.
The study included 1,065 patients (47% women; mean age, 63 years) with Parkinson’s disease who reported having had a head injury at least 5 years prior to their diagnosis. Among the participants, the mean duration of Parkinson’s disease was 7.5 years.
The investigators employed a 5-year lag time in their study to exclude head injuries caused by early motor dysfunction, they noted. “We wanted to look at people who had these head injuries we think might be part of the cause of Parkinson’s disease as opposed to a result of them,” Dr. Brown said.
In this head injury group, 51% had received one head injury, 28% had received two injuries, and 22% had received more than two injuries.
The study also included 1,457 participants (56% women; mean age, 65 years) with Parkinson’s disease who had not had a head injury prior to their diagnosis. Of these patients, the mean time with a Parkinson’s disease diagnosis was 8 years.
Dr. Brown noted that the age and sex distribution of the study group was “probably representative” of the general Parkinson’s disease population. However, because the participants had to be able to go online and complete questionnaires, it is unlikely that, among these patients, Parkinson’s disease was far advanced, he said.
The investigators adjusted for age, sex, years of education, and Parkinson’s disease duration.
Two-hit hypothesis?
The researchers compared time from diagnosis to the development of significant motor impairment, such as the need for assistance with walking, and cognitive impairment, such as having a score of less than 43 on the Penn Daily Activities Questionnaire.
They also examined the role of more severe head injuries. In the head injury group, over half (54%) had had a severe head injury, including 543 who had lost consciousness and others who had suffered a fracture or had had a seizure.
Results showed that the adjusted hazard ratio for developing motor impairment among those with a head injury, compared with those who had not had a head injury was 1.24 (95% confidence interval, 1.01-1.53; P = .037). For severe injuries, the aHR for motor impairment was 1.44 (95% CI, 1.13-1.83; P = .003).
For cognitive impairment, the aHR for those with versus without head injuries was 1.45 (95% CI, 1.14-1.86; P = .003); and for severe injuries, the aHR was 1.49 (95% CI, 1.11-2.0; P = .008).
Aside from severity, the researchers did not examine subgroups. However, Dr. Brown reported that his team would like to stratify results by sex and other variables in the future.
He noted that various mechanisms may explain why Parkinson’s disease progression is faster for patients who have a history of head injury, compared with others. Chronic inflammation due to the injury and “co-pathology” might play some role, he said. He noted that head injuries are associated with cognitive impairment in other conditions, including Alzheimer’s disease.
There is also the “two hit” hypothesis, Dr. Brown said. “A head injury could cause such broad damage that once people develop Parkinson’s disease, it’s harder for them to compensate.”
Dr. Brown also noted there might have been a “higher magnitude” of a difference between groups had the study captured participants with more severe symptoms.
‘Provocative’ findings
Michael S. Okun, MD, medical advisor at the Parkinson’s Foundation and professor and director at the Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, said the new data are “provocative.”
“The idea that a head injury may be important in predicting how quickly and how severely deficits will manifest could be important to the treating clinician,” said Dr. Okun, who was not involved with the research.
He noted that the results suggest clinicians should elicit more information from patients about head trauma. “They should be seeking more than a binary ‘yes or no’ answer to head injury when questioning patients,” he added.
Dr. Okun reiterated that head injury is a “known and important risk factor” not only for Parkinson’s disease but also for other neurodegenerative diseases. “It’s important to counsel patients about the association,” he said.
The study was supported by the Michael J. Fox Foundation. Dr. Brown reports having received grant support from the Michael J. Fox Foundation. Dr. Okun has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From MDS 2022
Dignity
Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.
I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.
She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.
The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.
Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” . There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.
Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.
The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.
I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.
She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.
The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.
Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” . There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.
Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.
The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.
I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.
She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.
The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.
Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” . There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.
Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.
The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Tralokinumab earns EU recommendation to expand age range for atopic dermatitis to include adolescents
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Thoracic Oncology & Chest Imaging Network
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Lung Cancer Section
What is comprehensive biomarker testing and who should order it? For non–small cell lung cancer, comprehensive biomarker testing is generally defined as testing eligible patients for all biomarkers that direct the use of FDA-approved therapies (Mileham KF, et al. Cancer Med. 2022;11[2]:530. What comprises comprehensive testing has changed over time and will likely continue to change as advances in biomarkers, therapies, and indications for their use continue to evolve. There are also some potential benefits to testing biomarkers without FDA-approved therapies, such as assessing eligibility for treatment as part of a clinical trial or for identifying treatment options that gain FDA-approval in the future. As for who should be responsible for biomarker test ordering, this remains unclear and variable between institutions and practices (Fox AH, et al. Chest. 2021;160[6]:2293). All subspecialties involved, including pulmonology, pathology, interventional radiology, surgery, and oncology, have the potential for knowledge gaps surrounding biomarker testing (Gregg JP, et al. Transl Lung Cancer Res. 2019;8[3]:286; Smeltzer MP, et al. J Thorac Oncol. 2020;15[9]:1434). Those obtaining diagnostic tissue, including pulmonologists, surgeons, and interventional radiologists may not appreciate the downstream use of each biomarker but are in the place to order testing as soon as the time of biopsy. Pathologists may be unaware of clinical aspects to the patient’s case, such as the suspected clinical stage of disease. Oncologists arguably have the best chance of having the expertise to order testing but, ideally, biomarker results would be available by the time a patient meets with an oncologist to discuss treatment options. There is no perfect solution to this question at present, but if you are involved with the diagnosis of lung cancer, you should collaborate with your multidisciplinary team to streamline testing and strategize how to best serve patients.
Adam Fox, MD
Section Fellow-in-Training
Chest Infections & Disaster Response Network
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Chest Infections Section
An evolving diagnostic tool: Microbial cell-free DNA
The diagnosis of the microbial etiology of pneumonia remains a significant challenge with <50% yield of blood and sputum cultures in most studies. More reliable samples, like bronchoalveolar lavage, require invasive procedures. Undifferentiated pneumonia hampers antimicrobial stewardship and increases the risk of suboptimal treatment. New diagnostic tools that detect degraded microbial DNA in plasma, known as microbial cell-free DNA (cfDNA), may offer improved diagnostic yield. Through metagenomic next-generation approaches, these tools sequence DNA fragments to identify viral, bacterial, and fungal sequences.
Earlier studies of cfDNA in pneumonia have been mixed, correctly identifying the pathogen in 55% to 86% of cases – though notably cfDNA was superior to PCR and cultures and provided early detection of VAP in some cases (Farnaes L, et al. Diagn Microbiol Infect Dis. 2019;94:188; Langelier C, et al. Am J Respir Crit Care Med. 2020;201:491). However, a recent study of cfDNA in severe complicated pediatric pneumonia had promising results with significant clinical impact. cfDNA provided an accurate microbial diagnosis in 89% of cases, with it being the only positive study in 70% of cases. Further, cfDNA narrowed the antimicrobial regimen in 81% of cases (Dworsky ZD, et al. Hosp Pediatr. 2022;12:377).
The use of cfDNA is still in its infancy. Limitations, such as a lack of validated thresholds to differentiate colonization vs infection are noted given its detection sensitivity. Its utility, including ideal timing and patient population, needs further investigation. However, diagnostic cfDNA may soon provide earlier and less invasive microbial diagnostics in patients with chest infections and beyond.
Gregory Wigger, MD
Section Fellow-in-Training
Employers’ self-funded health plans can leave rheumatology patients vulnerable
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Health care costs are skyrocketing for everyone! For employers, the cost of health insurance is second only to their payroll expense. Per person spending in employer plans grew by 22% between 2015 and 2019. This outpaced inflation and economic growth. Affording health insurance for business owners has become more and more difficult, bordering on desperation for some. Consequently, they are looking for ways to be more efficient in their health care spending. One way is through self-funding their employees’ health care costs. This means that the employer directly pays for the care of their employees. While it has always been thought this was just for very large employers, it is becoming more common with smaller businesses. There is more flexibility and oversight with self-funded plans, and the employer can dictate exactly what benefits are covered within the bounds of the law. While this can make it easier to exclude certain therapies and even institute site-of-care restrictions, it also can make the employer vulnerable to health insurance companies, pharmacy benefit managers (PBMs), and third-party administrators (TPAs) that promise large discounts in plan and drug spending at the expense of their employees’ health.
Recently enacted state laws often don’t apply
Because employers who self-fund the health care for their employees are increasingly desperate to save money, they will often agree to plans that are less expensive but offer suboptimal care, particularly for patients with chronic diseases requiring expensive medicines. Many employers are not fully informed of the ramifications of these policies, so the Coalition of State Rheumatology Organizations is creating an educational employer tool kit that not only highlights the importance of disease control for their employees with rheumatic conditions but also outlines the pitfalls and misinformation that may be given to them by the insurance companies, PBMs, and other third parties that administer their health plan.
Policies that sacrifice patient care of course are not exclusive to certain self-funded health plans. The CSRO’s Payer Issue Response Team (PIRT) receives complaints daily from rheumatologists around the country regarding both the Employee Retirement Income Security Act and non-ERISA health plan policies that are harmful to their patients. Our PIRT team assesses these complaints and researches solutions that can include writing letters to the health insurance companies, employers, and departments of insurance, as well as applying enacted state legislation that overrides some of the detrimental policies. (Utilization management legislation, which has passed in many states, can be easily found on CSRO’s map tool.) These state laws can help patients with everything from harmful step therapy and nonmedical switching policies to accumulator adjustment programs denying application of copay card value to their deductibles. Unfortunately, these laws do not apply to most self-funded employer health plans, which are preempted by ERISA. Consequently, those employees are not protected from harmful changes in formularies and other policies.
Forced ‘white bagging’ in self-funded plans
Mandated “white bagging” has become a favorite for health plans covered by large insurance companies, which say that the practice is less expensive than what the physician would charge for the medication. White bagging takes away the ability of the physician to “buy and bill” infusibles that are given in their office. While some rheumatologists may accept this, there are many who do not accept infusible medications coming from another source. Often the health plan will tell the rheumatologist they must accept the white bagging or transfer the patient to another rheumatologist who will. Clearly, many health plans and TPAs do not understand the bonds that are created over the years between rheumatologists and their patients. Ironically, the price of the white-bagged medication charged to the employer has been shown often to be higher than what the physician would have charged.
Some TPAs also convince employers to carve out specialty medications from their policy entirely, leaving the employee uninsured for these meds. These TPAs then attempt to obtain the medications from the manufacturers, foundations, compounding pharmacies, and even other countries for free or highly discounted prices. Even if obtained at no cost, the TPA will charge the employer a percentage of the list price or fee for obtaining it. On the surface, this may seem like a good idea, but there are a number of issues with this, including some that are legally suspect. First of all, uninsuring employees for certain medications to take advantage of patient assistance programs from manufacturers and foundations could be viewed as perfectly legal and perfectly unethical. The legality of this practice is questionable when these companies pretend to be the patient when applying for the assistance or present compounded medication as coming from the manufacturer, or if the TPA obtains the medication from outside the country. Additionally, many employers end up paying 20% of the list price of a medication for a service that physicians provide at no cost for uninsured patients.
Educating employers
CSRO’s employer tool kit hopes to educate employers with self-funded health plans about the pitfalls of some of these policies and offers suggestions on how to best navigate these issues for employees with rheumatic diseases. We are hoping to launch this tool kit to small to medium business groups in the near future.
Advocacy is more than just contacting health insurers and those who make our laws and regulations. Although that is important, reaching out to those who employ our patients can be integral to ensuring they get the best care.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Online yoga program improves physical function in OA
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
Although pain did not significantly improve in the yoga group, participants only completed about two-thirds of the recommended sessions, suggesting that more benefit may be possible with greater adherence, wrote lead author Kim L. Bennell, PhD, of the University of Melbourne, and colleagues in the Annals of Internal Medicine.
“To date, an online yoga program specifically for people with knee osteoarthritis has not been investigated,” the investigators said. “The need for such evidence-based packaged online exercise programs is highlighted in the 2020 U.S. National Public Health Agenda for Osteoarthritis.”
Methods and results
The trial involved 212 adults aged 45 years or older with symptomatic knee osteoarthritis. All patients had access to online educational materials about managing osteoarthritis.
Half of the participants were randomized into the 12-week online yoga program. This self-directed, unsupervised course consisted of 12 prerecorded 30-minute instructional yoga sessions, each with a unique sequence of poses to be completed three times in one week before moving on to the next class the following week. After 12 weeks, these participants could choose to continue doing yoga via the online program for 12 additional weeks, if desired.
The primary outcomes were knee pain and physical function, gauged by a 10-point numerical rating scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. Adherence was defined as completion of at least 2 yoga sessions within the preceding week.
At the 12-week mark, the yoga group did not show any significant improvement in knee pain (–0.6; 95% confidence interval, –1.2 to 0.1), but they did achieve a mean 4-point reduction in WOMAC, suggesting significant improvement in knee function (–4.0; 95% CI, –6.8 to –1.3). Of note, however, this improvement was not enough to meet the threshold for minimal clinically important difference. At 24 weeks, the yoga group no longer showed significant improvement in knee function versus baseline.
“I don’t think a longer program would necessarily reduce knee pain, as benefits from a whole range of different types of exercise for knee osteoarthritis generally can show benefits within 8 weeks,” Dr. Bennell said in an interview.
Still, she noted that the average outcome in the trial may not represent what is possible if a patient commits to a regular yoga routine.
“I think it relates more to adherence [than duration], and I think benefits for knee pain would have been seen if a greater number of people had fully adhered to the program three times a week,” she said.
At 12 weeks, 68.8% of those in the yoga group were adherent, while just 28.4% were still adherent at week 24 after the optional extension period.
“As this was a self-directed program, adherence might be expected to be less than that of a supervised program,” Dr. Bennell noted.
Referring to unpublished data, Dr. Bennell said a sensitivity analysis showed that participants in the yoga group who completed yoga at least twice a week did show greater improvements in function and pain than those who did yoga less than twice per week.
“So it does suggest that adherence is important, as we might expect,” she said.
Another tool in the OA toolbox
Nick Trasolini, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., described the benefits in the trial as “modest” and noted that the improvement in function did not meet the threshold for minimal clinically important difference.
“Nevertheless,” he said in a written comment, “the [yoga] program was safe and associated with high participant satisfaction [mean satisfaction, 8 out of 10]. While this may not be the ‘silver bullet,’ it is another tool that we can offer to sufficiently motivated patients seeking non-operative solutions for knee osteoarthritis.”
Unfortunately, these tools remain “fraught with challenges,” Dr. Trasolini added.
“While multiple injection options are available (including corticosteroid, hyaluronic acid viscosupplementation, and biologic injections), the benefits of these injections can be short-lived,” he said. “This is frustrating to patients and physicians alike. Physical therapy is beneficial for knee osteoarthritis when deconditioning has led to decreased knee, hip, and core stability. However, physical therapy can be time consuming, painful, and cost prohibitive.”
In the present study, participants in the yoga group were somewhat willing (mean willingness, 5 out of 10) to pay for their 12-week yoga program. They reported that they would pay approximately $80 U.S. dollars for chance to do it all again.
The study was supported by grants from the National Health and Medical Research Council Program and the Centres of Research Excellence. The investigators disclosed additional relationships with Pfizer, Lilly, TLCBio, and others. Dr. Trasolini disclosed no relevant conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Is acetaminophen really safer than NSAIDs in heart disease?
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
New research calls into question the assumption that acetaminophen is safer than NSAIDs for patients with known cardiovascular disease (CVD) or CVD risk factors.
The analysis found a significant correlation between the use of acetaminophen and elevated systolic blood pressure.
While acetaminophen may still be safer than NSAIDs from a bleeding risk standpoint, or in patients with known kidney disease, “the gap may not be as large as once thought,” Rahul Gupta, MD, cardiologist with Lehigh Valley Health Network, Allentown, Pa., said in an interview.
“Cautious use is recommended over the long term, especially in patients with pre-existing hypertension or cardiovascular risk factors,” Dr. Gupta said.
The study was presented at the Hypertension Scientific Sessions, San Diego, sponsored by the American Heart Association.
Acetaminophen is one of the most widely used over-the-counter medications, as it is considered a safer medication for long-term use since it lacks the anti-inflammatory effects of NSAIDs, Dr. Gupta explained.
NSAIDs have been known to raise blood pressure, but the effect of acetaminophen in this regard has not been well studied. Observational studies have shown contradictory results in terms of its effect on blood pressure, he noted.
To investigate further, Dr. Gupta and colleagues did a meta-analysis of three studies that compared the effect of acetaminophen (3-4 g/day) versus placebo on systolic and diastolic ambulatory blood pressure in patients with heart disease or hypertension. Together, the studies included 172 adults (mean age, 60 years; 73% male).
They found that patients receiving acetaminophen had significantly higher systolic blood pressure, compared with those receiving placebo (standard mean difference [SMD] = 0.35; 95% confidence interval, 0.08-0.63; P = .01).
Subgroup analysis of the effect on hypertensive patients showed significant change in systolic blood pressure as well (SMD = 0.38; 95% CI, 0.05-0.71; P = .02).
“Interestingly, there was no significant difference in the effect on diastolic blood pressure,” Dr. Gupta commented.
Reached for comment, Timothy S. Anderson, MD, clinical investigator in the Division of General Medicine at Beth Israel Deaconess Medical Center and assistant professor of medicine at the Harvard Medical School, both in Boston, said this is “an interesting and not particularly well-known issue.”
“However, most of the trials look at very high doses of acetaminophen use (for example, six to eight of the 500 mg pills each day) so we don’t really know whether the more common patterns of using one to two acetaminophen pills every once in a while is problematic,” Dr. Anderson told this news organization.
“We also don’t have data showing a direct harm from these medications with regards to strokes or heart attacks or other downstream consequences of high blood pressure. Ideally we would need a head-to-head trial comparing ibuprofen-type medications to acetaminophen-type medications,” Dr. Anderson said.
The study had no specific funding. Dr. Gupta and Dr. Anderson reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION 2022
Me, my spouse, and COVID
Managing family conflict and cohesion
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.
Managing family conflict and cohesion
Managing family conflict and cohesion
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.
I watched you in the garage, with your wipes and your mask, your gloves and bottles of sprays and potions. I admired your fealty to CNN’s Dr. Sanjay Gupta as he demonstrated the proper technique for disinfecting groceries. I watched sterile protocol being broken and quietly closed the garage door.
I listened to your descriptions of the agility of the virus with each exhalation of breath, and how far the virus could travel with a tailwind and in cold dry air. I listen as closely and with the same intention as I listen to my yoga teacher’s explication of the benefits of attention to the breath.
Relatives and friends came prepared to be entertained outdoors. Even masked, you eschewed the world. Your version of science clashes with my laissez-faire attitude. We blow up as a couple. Then we settle down and learn how to cope with the stress, as a team, together.
The COVID factor
In the first few months of any stressor, family and couple functioning must reorganize to manage well.
During lockdown, social scientists accessed an eager public ready to participate in their studies. With nowhere to go, many people, especially women, completed online COVID surveys. Community-based tools such as the Centers for Disease Control and Prevention’s Social Vulnerability Index identified populations of high social vulnerability (as caused by external stresses on human health, such as unemployment, overcrowding, presence of an individual with caregiving needs, and low educational attainment). It is assumed that such populations will experience more stress and have more difficulty coping and adjusting.
In a study by a team at the University of Miami, social vulnerability was associated with more disrupted family functioning, except when households with children (n = 2,666) were compared to households without children (n = 1,456).1 What allowed these families with children to enjoy better functioning?
Looking more closely at the Miami study, what can we find? It is a large survey study (n = 4,122), disseminated through professional networks and social media via purchased Facebook and Instagram ads. Data were logged in REDCap, and participants had the option of taking the survey in English or Spanish. Most participants were female (93.5%), 55.7% responded in English, and 44.3% in Spanish. There were few differences between the women who had and did not have children, in terms of their age, employment status, and education level. The number of children in the household did not affect the results.
This study used a new tool called the COVID-19 Household Environment Scale. This tool has 25 items measuring individual and household characteristics, and associated COVID-19 stressors. This tool also includes two family functioning measures: conflict and cohesion, asking the respondent to reflect on the change in “conflict” or “togetherness,” as it relates to household experiences and activities, compared with the period before social distancing.
The surprising finding was that even though households with children reported more conflict than before the start of the pandemic, they also reported more cohesion. This syncs with my experience. My niece and nephew found that having their teenage children at home brought them closer as a family, cut down on some of the extracurricular activities they did not support, and generally “slowed the world down.”
However, in a study in Germany, survey respondents (n = 1,042) noted that having children up to 17 years old was associated with decreases in satisfaction with family life, although this was not related to changes in family demands. The study assessed changes over 6 months and underscores the fact that perceptions of family demands and family well-being are independent of each other.2
These findings also resonate with prior research that measured burden and reward in couples. High burden is not associated with low reward; these two constructs are independent of each other.3
What about couples?
It is no surprise that poor relationships begat poor coping. In an online Belgian survey of 1,491 cohabiting couples during the shutdown, both men and women felt significantly more stress than before, because they felt restricted in their relationship.4
However, only women reported significantly more stress during the lockdown than before, because of relationship conflicts, such as feeling neglected by their partner. These feelings had predated lockdown.
In another lockdown online survey of 782 U.S. adults (89.8% White, 84.5% female), cohabitating intimate partners reported that there were higher thoughts of separation if the participants were younger, or if there was higher verbal aggression, higher relationship invalidation, and lower relationship satisfaction. Higher relationship satisfaction was reported when there was lower money stress, higher sexual fulfillment, lower relationship invalidation, and higher perceived fairness of relationship power. High relationship satisfaction was also reported where there were no children in the home.5
It should be noted that none of these relationship variables was measured in the Miami study discussed above, and this study did not measure perceived conflict or perceived cohesion, so we know less about these aspects of the family unit.
What about teens?
The COVID-19 lockdown had a positive effect on the dynamics in some families, according to a naturalistic study of adolescents (n = 155) who completed surveys at two time periods (initial and 8 weeks).6
These adolescents reported a reduction in perceived psychological control by their mothers, and no change in autonomy support. The changes did not vary according to gender or the mother’s employment situation. The decrease in psychological control was greater with higher initial levels of satisfaction with the mother, and lower levels of the teens disobeying their parents.
What about hospital settings?
The worst of the COVID experience was in the hospital. The pain was displayed on the faces of the staff as they labored to figure out how to care for the dying patients who had no contact with their families. Hospitals, out of fear of contamination and viral dissemination, excluded visitors. In those early days of uncertainty, the stress among staff, patients, and family members was high.
In response to family members feeling disconnected from the health care team and the psychological and moral distress of the staff, Nadine J. Kaslow and colleagues revised policies and procedures at Emory University, Atlanta, facilities to reprioritize patient- and family-centered care.7
The guiding principles focus on providing safe yet compassionate and ethical care, balancing community health and the mitigation of viral transmission, while appreciating family members as essential partners in care; fostering communication between patients and their families; and promoting interactions and decision-making among health care providers, patients, and families.
COVID continues to intrude in many of our lives. Many people are mourning family members and friends who died after contracting the disease. Many people choose to ignore their risk and live their lives as before. Many people, like my spouse and me, continue to debate the merits of venturing into public spaces. Personally, COVID has given me time to read many more books than I could ever have imagined and allowed my spouse to explore the delicate nuances of cooking.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Chavez JV et al. Assessing the impact of COVID-19 social distancing and social vulnerability on family functioning in an international sample of households with and without children. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 233-48. doi: 10.1037/cfp0000166.
2. Rudolph CW, Zacher H. Family demands and satisfaction with family life during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 249-59. doi: 10.1037/cfp0000170.
3. Heru AM et al. Family functioning in the caregivers of patients with dementia. Int J Geriatr Psychiatry. 2004 Jun;19(6):533-7. doi: 10.1002/gps.1119.
4. Schokkenbroek JM et al. Partners in lockdown: Relationship stress in men and women during the COVID-19 pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 149-57. doi: 10.1037/cfp0000172.
5. Eubanks Fleming CJ, Franzese AT. Should I stay or should I go? Evaluating intimate relationship outcomes during the 2020 pandemic shutdown. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 158-67. doi: 10.1037/cfp0000169.
6. Bacikova-Sleskova M,et al. Did perceived parenting in adolescence change as a result of the COVID-19 lockdown? A natural experiment. Couple Fam Psychol: Res Pract. 2021 Dec;10(4): 271-80. doi: 10.1037/cfp0000167.
7. Kaslow NJ et al. A roadmap for patient- and family-centered care during the pandemic. Couple Fam Psychol: Res Pract. 2021 Sept;10(3): 223-32. doi: 10.1037/cfp0000176.