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Yoga is a good adjunct to migraine therapy
in Neurology.
The structured yoga program resulted in “remarkably improved” outcomes at 3 months of follow-up in CONTAIN, with both headache frequency and use of medications cut in half, compared with baseline, according to the investigators.
Compared with the control group on standard antimigraine medications alone, the yoga group demonstrated significantly greater reductions in pain intensity, headache frequency, pill counts, and validated measures of disability and headache impact on daily life (see graphic).
“The good news is that practicing something as simple and accessible as yoga may help much more than medications alone. And all you need is a mat,” observed Dr. Bhatia, professor of neurology at the All India Institute of Medical Sciences in New Delhi.
The single-center, open-label, blinded-assessment CONTAIN trial included 160 adult episodic migraine patients ages 18-50 years experiencing 4-14 headaches per month. They were randomized to prophylactic and acute rescue medications alone or in combination with yoga instruction by a qualified yoga therapist in a class that met at the medical center 3 days per week for 1 month. This was followed by practice of the hour-long yoga program at home 5 days per week for the next 2 months, with twice-monthly telephone calls from the yoga center to encourage adherence and encouragement to call if questions arose. Both groups received counseling about the importance of lifestyle changes that may help with migraine, including diet, physical activity, adequate sleep, and stress reduction. Outcomes were assessed in an intent-to-treat analysis.
The yoga program included specific relaxation exercises, breathing techniques, meditation, and yoga postures, or asanas. The migraine-tailored program was vetted by yoga experts at five renowned Indian yoga centers.
No safety issues arose with the yoga program.
The investigators noted that the 47% reduction in migraine medication pill count and 49% decrease in headache frequency over the course of 3 months in the adjunctive yoga group have important implications, not only in a limited-resource country such as India, but also in the United States, where Americans spend an estimated $3.2 billion annually on prescription and over the counter headache medications, and the indirect cost associated with lost productivity due to migraine has been put at $13 billion per year.
Dr. Bhatia and colleagues speculated that the observed benefits of add-on yoga in migraineurs may involve previously described improved vagal tone and parasympathetic drive coupled with decreased sympathetic tone, increased nitric oxide levels, and loosening of stiff muscles, which can trigger headaches.
Real-life goals
Commenting on the research, neurologist Holly Yancy, DO, a headache specialist at the Banner Health - University Medicine Neuroscience Institute in Phoenix, said she was impressed by the high quality of this well-designed, adequately powered study of a complementary and alternative therapy.
“The primary and secondary endpoints were real-life goals of migraine treatment that we strive to achieve in clinical practice – and they were met in the study,” she observed. “To start with a month of in-house yoga classes to instill a baseline competence in yoga prior to transitioning to home practice and to provide resources for ongoing assistance for questions were nice touches.”
She noted that the control group also experienced reductions in migraine frequency, severity, and disability scores, albeit of significantly lesser magnitude than in the yoga group. This underscores how important it is in clinical practice to spend time counseling migraine patients on lifestyle choices.
“A trial such as this provides neurologists and other health care providers with an accessible, evidence-based treatment for migraines that can be used with other preventive treatments to decrease the frequency and the amount of medication their patients are taking. In addition, it is a behavioral therapy that can decrease triggers and potentially help patients cope with pain,” Dr. Yancy said.
“I suspect I’ll not hesitate to recommend yoga as an adjunctive treatment for patients in my clinic that are physically capable. I think it would be logical to try to extrapolate the concept to a chronic migraine population as well, though it would be ideal to base that recommendation on another study conducted with a chronic migraine population.”
Dr. Bhatia and his coinvestigators reported having no financial conflicts regarding their study, funded by the Government of India and the All India Institute of Medical Sciences.
SOURCE: Kumar A et al. Neurology. 2020 May 6. doi: 10.1212/WNL.0000000000009473.
in Neurology.
The structured yoga program resulted in “remarkably improved” outcomes at 3 months of follow-up in CONTAIN, with both headache frequency and use of medications cut in half, compared with baseline, according to the investigators.
Compared with the control group on standard antimigraine medications alone, the yoga group demonstrated significantly greater reductions in pain intensity, headache frequency, pill counts, and validated measures of disability and headache impact on daily life (see graphic).
“The good news is that practicing something as simple and accessible as yoga may help much more than medications alone. And all you need is a mat,” observed Dr. Bhatia, professor of neurology at the All India Institute of Medical Sciences in New Delhi.
The single-center, open-label, blinded-assessment CONTAIN trial included 160 adult episodic migraine patients ages 18-50 years experiencing 4-14 headaches per month. They were randomized to prophylactic and acute rescue medications alone or in combination with yoga instruction by a qualified yoga therapist in a class that met at the medical center 3 days per week for 1 month. This was followed by practice of the hour-long yoga program at home 5 days per week for the next 2 months, with twice-monthly telephone calls from the yoga center to encourage adherence and encouragement to call if questions arose. Both groups received counseling about the importance of lifestyle changes that may help with migraine, including diet, physical activity, adequate sleep, and stress reduction. Outcomes were assessed in an intent-to-treat analysis.
The yoga program included specific relaxation exercises, breathing techniques, meditation, and yoga postures, or asanas. The migraine-tailored program was vetted by yoga experts at five renowned Indian yoga centers.
No safety issues arose with the yoga program.
The investigators noted that the 47% reduction in migraine medication pill count and 49% decrease in headache frequency over the course of 3 months in the adjunctive yoga group have important implications, not only in a limited-resource country such as India, but also in the United States, where Americans spend an estimated $3.2 billion annually on prescription and over the counter headache medications, and the indirect cost associated with lost productivity due to migraine has been put at $13 billion per year.
Dr. Bhatia and colleagues speculated that the observed benefits of add-on yoga in migraineurs may involve previously described improved vagal tone and parasympathetic drive coupled with decreased sympathetic tone, increased nitric oxide levels, and loosening of stiff muscles, which can trigger headaches.
Real-life goals
Commenting on the research, neurologist Holly Yancy, DO, a headache specialist at the Banner Health - University Medicine Neuroscience Institute in Phoenix, said she was impressed by the high quality of this well-designed, adequately powered study of a complementary and alternative therapy.
“The primary and secondary endpoints were real-life goals of migraine treatment that we strive to achieve in clinical practice – and they were met in the study,” she observed. “To start with a month of in-house yoga classes to instill a baseline competence in yoga prior to transitioning to home practice and to provide resources for ongoing assistance for questions were nice touches.”
She noted that the control group also experienced reductions in migraine frequency, severity, and disability scores, albeit of significantly lesser magnitude than in the yoga group. This underscores how important it is in clinical practice to spend time counseling migraine patients on lifestyle choices.
“A trial such as this provides neurologists and other health care providers with an accessible, evidence-based treatment for migraines that can be used with other preventive treatments to decrease the frequency and the amount of medication their patients are taking. In addition, it is a behavioral therapy that can decrease triggers and potentially help patients cope with pain,” Dr. Yancy said.
“I suspect I’ll not hesitate to recommend yoga as an adjunctive treatment for patients in my clinic that are physically capable. I think it would be logical to try to extrapolate the concept to a chronic migraine population as well, though it would be ideal to base that recommendation on another study conducted with a chronic migraine population.”
Dr. Bhatia and his coinvestigators reported having no financial conflicts regarding their study, funded by the Government of India and the All India Institute of Medical Sciences.
SOURCE: Kumar A et al. Neurology. 2020 May 6. doi: 10.1212/WNL.0000000000009473.
in Neurology.
The structured yoga program resulted in “remarkably improved” outcomes at 3 months of follow-up in CONTAIN, with both headache frequency and use of medications cut in half, compared with baseline, according to the investigators.
Compared with the control group on standard antimigraine medications alone, the yoga group demonstrated significantly greater reductions in pain intensity, headache frequency, pill counts, and validated measures of disability and headache impact on daily life (see graphic).
“The good news is that practicing something as simple and accessible as yoga may help much more than medications alone. And all you need is a mat,” observed Dr. Bhatia, professor of neurology at the All India Institute of Medical Sciences in New Delhi.
The single-center, open-label, blinded-assessment CONTAIN trial included 160 adult episodic migraine patients ages 18-50 years experiencing 4-14 headaches per month. They were randomized to prophylactic and acute rescue medications alone or in combination with yoga instruction by a qualified yoga therapist in a class that met at the medical center 3 days per week for 1 month. This was followed by practice of the hour-long yoga program at home 5 days per week for the next 2 months, with twice-monthly telephone calls from the yoga center to encourage adherence and encouragement to call if questions arose. Both groups received counseling about the importance of lifestyle changes that may help with migraine, including diet, physical activity, adequate sleep, and stress reduction. Outcomes were assessed in an intent-to-treat analysis.
The yoga program included specific relaxation exercises, breathing techniques, meditation, and yoga postures, or asanas. The migraine-tailored program was vetted by yoga experts at five renowned Indian yoga centers.
No safety issues arose with the yoga program.
The investigators noted that the 47% reduction in migraine medication pill count and 49% decrease in headache frequency over the course of 3 months in the adjunctive yoga group have important implications, not only in a limited-resource country such as India, but also in the United States, where Americans spend an estimated $3.2 billion annually on prescription and over the counter headache medications, and the indirect cost associated with lost productivity due to migraine has been put at $13 billion per year.
Dr. Bhatia and colleagues speculated that the observed benefits of add-on yoga in migraineurs may involve previously described improved vagal tone and parasympathetic drive coupled with decreased sympathetic tone, increased nitric oxide levels, and loosening of stiff muscles, which can trigger headaches.
Real-life goals
Commenting on the research, neurologist Holly Yancy, DO, a headache specialist at the Banner Health - University Medicine Neuroscience Institute in Phoenix, said she was impressed by the high quality of this well-designed, adequately powered study of a complementary and alternative therapy.
“The primary and secondary endpoints were real-life goals of migraine treatment that we strive to achieve in clinical practice – and they were met in the study,” she observed. “To start with a month of in-house yoga classes to instill a baseline competence in yoga prior to transitioning to home practice and to provide resources for ongoing assistance for questions were nice touches.”
She noted that the control group also experienced reductions in migraine frequency, severity, and disability scores, albeit of significantly lesser magnitude than in the yoga group. This underscores how important it is in clinical practice to spend time counseling migraine patients on lifestyle choices.
“A trial such as this provides neurologists and other health care providers with an accessible, evidence-based treatment for migraines that can be used with other preventive treatments to decrease the frequency and the amount of medication their patients are taking. In addition, it is a behavioral therapy that can decrease triggers and potentially help patients cope with pain,” Dr. Yancy said.
“I suspect I’ll not hesitate to recommend yoga as an adjunctive treatment for patients in my clinic that are physically capable. I think it would be logical to try to extrapolate the concept to a chronic migraine population as well, though it would be ideal to base that recommendation on another study conducted with a chronic migraine population.”
Dr. Bhatia and his coinvestigators reported having no financial conflicts regarding their study, funded by the Government of India and the All India Institute of Medical Sciences.
SOURCE: Kumar A et al. Neurology. 2020 May 6. doi: 10.1212/WNL.0000000000009473.
FROM NEUROLOGY
Satralizumab monotherapy reduces NMOSD relapse rate
according to trial results published in the Lancet Neurology.
The findings help confirm the role of interleukin-6 in the pathobiology of aquaporin-4 autoantibody (AQP4-IgG)–seropositive disease. For patients who are AQP4-IgG seronegative, however, “there is insufficient evidence to indicate a risk reduction” with this drug, the investigators wrote. In addition, satralizumab did not significantly affect pain or fatigue.
“The limitations of the study include the relatively small group sizes and low number of relapses. Despite these limitations, a significant treatment benefit was observed with satralizumab, compared with placebo in the study population, with efficacy and safety comparable to satralizumab used in combination with immunosuppressants,” reported lead author Anthony Traboulsee, MD, professor of neurology at the University of British Columbia, Vancouver, and colleagues.
Satralizumab is a humanized monoclonal antibody targeting the IL-6 receptor. A prior phase 3 study, SakuraSky, found that the drug reduces the risk of NMOSD relapse when added to immunosuppressant therapy. To assess the safety and efficacy of satralizumab monotherapy, Dr. Traboulsee and colleagues conducted SakuraStar, a randomized, double-blind, placebo-controlled trial.
Evaluating drug as monotherapy
The phase 3 trial enrolled 95 patients aged 18-74 years at 44 sites in 13 countries. The investigators included patients with AQP4-IgG–seropositive or –seronegative neuromyelitis optica using the 2006 Wingerchuk criteria or with AQP4-IgG–seropositive NMOSD with at least one event of longitudinally extensive myelitis or optic neuritis. The researchers limited the number of AQP4-IgG–seronegative patients to about 30% of the study population. Eligible participants had at least one NMOSD attack or relapse in the past 12 months and a score of 6.5 or less on the Expanded Disability Status Scale (EDSS). The investigators excluded patients with a clinical relapse in the 30 days before study baseline. Participants were randomly assigned 2:1 to receive satralizumab 120 mg or placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Concomitant immunosuppressant use was prohibited, although corticosteroids and intravenous immunoglobulin were permitted as rescue therapy for the treatment of relapse.
The primary endpoint was time to first relapse, and the trial was designed to continue until 44 relapses occurred or for 1.5 years after the last patient entered the trial, whichever occurred first.
“Because even one NMOSD attack can have serious neurological consequences, this design allowed patients who had an attack on placebo to enter the open-label phase and receive the active drug,” the researchers wrote. “The trial design used unequal randomization to minimize exposure to placebo; because patients were not permitted to receive concomitant immunosuppressant treatment in this trial, the design limited the number of patients not receiving any treatment for the disorder. Placebo was selected with the consideration that no drugs were approved for the treatment of NMOSD when the trial was designed.” Recent trials of eculizumab, inebilizumab, and satralizumab have found that the agents are effective treatments for NMOSD. In 2019, the Food and Drug Administration approved eculizumab, a complement inhibitor, for the treatment of AQP4-IgG–seropositive NMOSD.
For the primary endpoint of SakuraStar, the researchers defined relapses as new or worsening objective neurologic symptoms with at least one of the following:
- Increase of 1 or more EDSS points from a baseline EDSS score of more than 0, or increase of 2 or more EDSS points from a baseline EDSS score of 0
- Increase of 2 or more points on at least one appropriate symptom-specific functional system score for pyramidal, cerebellar, brain stem, sensory, bowel or bladder, or a single eye
- Increase of 1 or more points on more than one symptom-specific functional system score with a baseline of at least 1
- Increase of 1 or more points on a single-eye symptom-specific functional system score with a baseline score of at least 1
In addition, symptoms had to be attributable to NMOSD; persist for more than 24 hours; and not be attributable to confounding clinical factors such as fever, infection, injury, change in mood, or adverse reactions to medications. Researchers assessed EDSS and functional system scores within 7 days of a patient reporting symptoms.
The double-blind treatment period ended 1.5 years after the last enrolled patient was assigned to satralizumab or placebo. More than 80% of the participants were women, including 73% of the satralizumab group and 97% of the placebo group. In all, 95 participants were assigned to a treatment between 2014 and 2017 – 63 to satralizumab and 32 to placebo. Relapses occurred in 19 patients receiving satralizumab (30%) and 16 receiving placebo (50%). The hazard ratio was 0.45.
“Patients treated with placebo showed a shorter time to relapse and a higher withdrawal rate than did patients treated with satralizumab,” wrote Dr. Traboulsee and colleagues. The Kaplan-Meier method suggested that 76% of patients on satralizumab had not relapsed at 48 weeks, compared with 62% of patients on placebo. And at 96 weeks, 72% of patients on satralizumab had not relapsed, compared with 51% of patients on placebo.
Among patients who were AQP4-IgG seropositive, the proportion with protocol-defined relapse was 22% in the satralizumab group versus 57% in the placebo group. Among patients who were AQP4-IgG seronegative, the proportion with a protocol-defined relapse was 46% in the satralizumab group versus 33% in the placebo group.
The most common adverse events were urinary tract infection and upper respiratory tract infection, and most adverse events were mild to moderate. A higher rate of severe adverse events was reported in the satralizumab group than in the placebo group (32.1 vs. 9.9 events per 100 patient-years). The investigators considered most of the severe adverse events unrelated to the study treatment. “None of the severe adverse events led to discontinuation of the study drug except one severe event of pneumonia in the satralizumab group,” the researchers wrote.
Data confirm efficacy of IL-6 blockade
“Satralizumab was well tolerated and no meaningful adverse effects from the drug were reported and no deaths occurred,” said Michael Levy, MD, PhD, director of the NMO clinic and research laboratory at Massachusetts General Hospital, Boston, in an accompanying editorial. “This trial of satralizumab was done shortly after the completion of a parallel trial of satralizumab in patients with NMOSD in which the same dose of satralizumab reduced the risk of relapse by 62%, compared with placebo. The main difference between these two trials is that, in the first published study, participants were permitted to use background immunotherapy; otherwise, the trial designs were nearly identical, and the enrolled participants are comparable. Together, the findings from these studies suggest that background therapy seems to provide only a small additional benefit to satralizumab alone.”
Dr. Levy also discussed findings from a phase 2 study of tocilizumab for the prevention of relapse in patients with NMOSD published in the same issue of the Lancet Neurology. The satralizumab and tocilizumab data have “confirmed that IL-6 blockade reduces the risk of relapse in patients with NMOSD,” Dr. Levy said. “IL-6 is a crucial component of the immune system, but when IL-6 production is altered during autoimmune attacks and sepsis, there can be severe consequences.”
The phase 2 trial of tocilizumab, which was described at the 2019 annual congress of the European Committee for Treatment and Research in Multiple Sclerosis, included 118 patients, 87% of whom were AQP4-IgG seropositive. Patients received intravenous tocilizumab or oral azathioprine for up to 60 weeks. Overall, 14% of patients in the tocilizumab group relapsed, compared with 47% of patients in the azathioprine group.
“The main differences between this trial of tocilizumab and the two satralizumab trials are that the tocilizumab was administered intravenously, rather than subcutaneously, the study duration was approximately 1 year, and the investigators were not masked to the treatment allocation,” Dr. Levy said. “Similar to satralizumab, adverse effects with tocilizumab were mild, including asymptomatic elevations in liver enzymes and an increased incidence of respiratory and urinary infections, with no significant differences identified between the tocilizumab and azathioprine groups.”
Various immunopathologic mechanisms may influence outcomes in NMOSD. While satralizumab and tocilizumab target IL-6, eculizumab is a C5 complement inhibitor and inebilizumab is a CD19 B-cell depleting monoclonal antibody, Dr. Levy said. “The safety concerns regarding these approaches are all substantially outweighed by the benefit of preventing NMOSD relapses.”
A need to understand AQP4-IgG–seronegative disease
SakuraStar “provides convincing data for the efficacy of satralizumab monotherapy in NMOSD with subgroup analysis showing that the benefit was seen in AQP4-IgG seropositive patients,” commented Dean M. Wingerchuk, MD, director of the division of multiple sclerosis and autoimmune neurology at the Mayo Clinic in Phoenix. “The results help confirm the key role of IL-6 in the pathobiology of AQP4-IgG–seropositive disease.”
Questions about AQP4-IgG seronegative disease remain. “The results are quite similar to the SakuraSky trial, in which satralizumab was used in conjunction with other background immunosuppressive therapies, suggesting that the primary benefit may be derived primarily from satralizumab. Both trials also showed that satralizumab did not benefit the NMOSD without AQP4-IgG subgroup though the subject numbers are rather small. We need to know more about the clinical and laboratory characteristics of the seronegative patients as they likely comprise a heterogeneous group. For example, did any of them have other autoantibodies such as MOG-IgG? Depending on the results, those details may help us understand the relative role of IL-6 in AQP4-IgG–seronegative subgroups, an important area of further study.”
SakuraStar was funded by Chugai Pharmaceutical, a member of the Roche group. Dr. Traboulsee reported grants, personal fees, and nonfinancial support from Chugai Pharmaceutical during the study, and several coauthors were employees of Chugai Pharmaceutical. Additional coauthors reported personal fees from Chugai, Roche, and other companies. Dr. Levy has received consulting fees from Alexion, Viela Bio, Chugai Pharmaceutical, Quest Diagnostics, and UCB Pharmaceuticals.
SOURCE: Traboulsee A et al. Lancet Neurol. 2020;19(5):402-12.
according to trial results published in the Lancet Neurology.
The findings help confirm the role of interleukin-6 in the pathobiology of aquaporin-4 autoantibody (AQP4-IgG)–seropositive disease. For patients who are AQP4-IgG seronegative, however, “there is insufficient evidence to indicate a risk reduction” with this drug, the investigators wrote. In addition, satralizumab did not significantly affect pain or fatigue.
“The limitations of the study include the relatively small group sizes and low number of relapses. Despite these limitations, a significant treatment benefit was observed with satralizumab, compared with placebo in the study population, with efficacy and safety comparable to satralizumab used in combination with immunosuppressants,” reported lead author Anthony Traboulsee, MD, professor of neurology at the University of British Columbia, Vancouver, and colleagues.
Satralizumab is a humanized monoclonal antibody targeting the IL-6 receptor. A prior phase 3 study, SakuraSky, found that the drug reduces the risk of NMOSD relapse when added to immunosuppressant therapy. To assess the safety and efficacy of satralizumab monotherapy, Dr. Traboulsee and colleagues conducted SakuraStar, a randomized, double-blind, placebo-controlled trial.
Evaluating drug as monotherapy
The phase 3 trial enrolled 95 patients aged 18-74 years at 44 sites in 13 countries. The investigators included patients with AQP4-IgG–seropositive or –seronegative neuromyelitis optica using the 2006 Wingerchuk criteria or with AQP4-IgG–seropositive NMOSD with at least one event of longitudinally extensive myelitis or optic neuritis. The researchers limited the number of AQP4-IgG–seronegative patients to about 30% of the study population. Eligible participants had at least one NMOSD attack or relapse in the past 12 months and a score of 6.5 or less on the Expanded Disability Status Scale (EDSS). The investigators excluded patients with a clinical relapse in the 30 days before study baseline. Participants were randomly assigned 2:1 to receive satralizumab 120 mg or placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Concomitant immunosuppressant use was prohibited, although corticosteroids and intravenous immunoglobulin were permitted as rescue therapy for the treatment of relapse.
The primary endpoint was time to first relapse, and the trial was designed to continue until 44 relapses occurred or for 1.5 years after the last patient entered the trial, whichever occurred first.
“Because even one NMOSD attack can have serious neurological consequences, this design allowed patients who had an attack on placebo to enter the open-label phase and receive the active drug,” the researchers wrote. “The trial design used unequal randomization to minimize exposure to placebo; because patients were not permitted to receive concomitant immunosuppressant treatment in this trial, the design limited the number of patients not receiving any treatment for the disorder. Placebo was selected with the consideration that no drugs were approved for the treatment of NMOSD when the trial was designed.” Recent trials of eculizumab, inebilizumab, and satralizumab have found that the agents are effective treatments for NMOSD. In 2019, the Food and Drug Administration approved eculizumab, a complement inhibitor, for the treatment of AQP4-IgG–seropositive NMOSD.
For the primary endpoint of SakuraStar, the researchers defined relapses as new or worsening objective neurologic symptoms with at least one of the following:
- Increase of 1 or more EDSS points from a baseline EDSS score of more than 0, or increase of 2 or more EDSS points from a baseline EDSS score of 0
- Increase of 2 or more points on at least one appropriate symptom-specific functional system score for pyramidal, cerebellar, brain stem, sensory, bowel or bladder, or a single eye
- Increase of 1 or more points on more than one symptom-specific functional system score with a baseline of at least 1
- Increase of 1 or more points on a single-eye symptom-specific functional system score with a baseline score of at least 1
In addition, symptoms had to be attributable to NMOSD; persist for more than 24 hours; and not be attributable to confounding clinical factors such as fever, infection, injury, change in mood, or adverse reactions to medications. Researchers assessed EDSS and functional system scores within 7 days of a patient reporting symptoms.
The double-blind treatment period ended 1.5 years after the last enrolled patient was assigned to satralizumab or placebo. More than 80% of the participants were women, including 73% of the satralizumab group and 97% of the placebo group. In all, 95 participants were assigned to a treatment between 2014 and 2017 – 63 to satralizumab and 32 to placebo. Relapses occurred in 19 patients receiving satralizumab (30%) and 16 receiving placebo (50%). The hazard ratio was 0.45.
“Patients treated with placebo showed a shorter time to relapse and a higher withdrawal rate than did patients treated with satralizumab,” wrote Dr. Traboulsee and colleagues. The Kaplan-Meier method suggested that 76% of patients on satralizumab had not relapsed at 48 weeks, compared with 62% of patients on placebo. And at 96 weeks, 72% of patients on satralizumab had not relapsed, compared with 51% of patients on placebo.
Among patients who were AQP4-IgG seropositive, the proportion with protocol-defined relapse was 22% in the satralizumab group versus 57% in the placebo group. Among patients who were AQP4-IgG seronegative, the proportion with a protocol-defined relapse was 46% in the satralizumab group versus 33% in the placebo group.
The most common adverse events were urinary tract infection and upper respiratory tract infection, and most adverse events were mild to moderate. A higher rate of severe adverse events was reported in the satralizumab group than in the placebo group (32.1 vs. 9.9 events per 100 patient-years). The investigators considered most of the severe adverse events unrelated to the study treatment. “None of the severe adverse events led to discontinuation of the study drug except one severe event of pneumonia in the satralizumab group,” the researchers wrote.
Data confirm efficacy of IL-6 blockade
“Satralizumab was well tolerated and no meaningful adverse effects from the drug were reported and no deaths occurred,” said Michael Levy, MD, PhD, director of the NMO clinic and research laboratory at Massachusetts General Hospital, Boston, in an accompanying editorial. “This trial of satralizumab was done shortly after the completion of a parallel trial of satralizumab in patients with NMOSD in which the same dose of satralizumab reduced the risk of relapse by 62%, compared with placebo. The main difference between these two trials is that, in the first published study, participants were permitted to use background immunotherapy; otherwise, the trial designs were nearly identical, and the enrolled participants are comparable. Together, the findings from these studies suggest that background therapy seems to provide only a small additional benefit to satralizumab alone.”
Dr. Levy also discussed findings from a phase 2 study of tocilizumab for the prevention of relapse in patients with NMOSD published in the same issue of the Lancet Neurology. The satralizumab and tocilizumab data have “confirmed that IL-6 blockade reduces the risk of relapse in patients with NMOSD,” Dr. Levy said. “IL-6 is a crucial component of the immune system, but when IL-6 production is altered during autoimmune attacks and sepsis, there can be severe consequences.”
The phase 2 trial of tocilizumab, which was described at the 2019 annual congress of the European Committee for Treatment and Research in Multiple Sclerosis, included 118 patients, 87% of whom were AQP4-IgG seropositive. Patients received intravenous tocilizumab or oral azathioprine for up to 60 weeks. Overall, 14% of patients in the tocilizumab group relapsed, compared with 47% of patients in the azathioprine group.
“The main differences between this trial of tocilizumab and the two satralizumab trials are that the tocilizumab was administered intravenously, rather than subcutaneously, the study duration was approximately 1 year, and the investigators were not masked to the treatment allocation,” Dr. Levy said. “Similar to satralizumab, adverse effects with tocilizumab were mild, including asymptomatic elevations in liver enzymes and an increased incidence of respiratory and urinary infections, with no significant differences identified between the tocilizumab and azathioprine groups.”
Various immunopathologic mechanisms may influence outcomes in NMOSD. While satralizumab and tocilizumab target IL-6, eculizumab is a C5 complement inhibitor and inebilizumab is a CD19 B-cell depleting monoclonal antibody, Dr. Levy said. “The safety concerns regarding these approaches are all substantially outweighed by the benefit of preventing NMOSD relapses.”
A need to understand AQP4-IgG–seronegative disease
SakuraStar “provides convincing data for the efficacy of satralizumab monotherapy in NMOSD with subgroup analysis showing that the benefit was seen in AQP4-IgG seropositive patients,” commented Dean M. Wingerchuk, MD, director of the division of multiple sclerosis and autoimmune neurology at the Mayo Clinic in Phoenix. “The results help confirm the key role of IL-6 in the pathobiology of AQP4-IgG–seropositive disease.”
Questions about AQP4-IgG seronegative disease remain. “The results are quite similar to the SakuraSky trial, in which satralizumab was used in conjunction with other background immunosuppressive therapies, suggesting that the primary benefit may be derived primarily from satralizumab. Both trials also showed that satralizumab did not benefit the NMOSD without AQP4-IgG subgroup though the subject numbers are rather small. We need to know more about the clinical and laboratory characteristics of the seronegative patients as they likely comprise a heterogeneous group. For example, did any of them have other autoantibodies such as MOG-IgG? Depending on the results, those details may help us understand the relative role of IL-6 in AQP4-IgG–seronegative subgroups, an important area of further study.”
SakuraStar was funded by Chugai Pharmaceutical, a member of the Roche group. Dr. Traboulsee reported grants, personal fees, and nonfinancial support from Chugai Pharmaceutical during the study, and several coauthors were employees of Chugai Pharmaceutical. Additional coauthors reported personal fees from Chugai, Roche, and other companies. Dr. Levy has received consulting fees from Alexion, Viela Bio, Chugai Pharmaceutical, Quest Diagnostics, and UCB Pharmaceuticals.
SOURCE: Traboulsee A et al. Lancet Neurol. 2020;19(5):402-12.
according to trial results published in the Lancet Neurology.
The findings help confirm the role of interleukin-6 in the pathobiology of aquaporin-4 autoantibody (AQP4-IgG)–seropositive disease. For patients who are AQP4-IgG seronegative, however, “there is insufficient evidence to indicate a risk reduction” with this drug, the investigators wrote. In addition, satralizumab did not significantly affect pain or fatigue.
“The limitations of the study include the relatively small group sizes and low number of relapses. Despite these limitations, a significant treatment benefit was observed with satralizumab, compared with placebo in the study population, with efficacy and safety comparable to satralizumab used in combination with immunosuppressants,” reported lead author Anthony Traboulsee, MD, professor of neurology at the University of British Columbia, Vancouver, and colleagues.
Satralizumab is a humanized monoclonal antibody targeting the IL-6 receptor. A prior phase 3 study, SakuraSky, found that the drug reduces the risk of NMOSD relapse when added to immunosuppressant therapy. To assess the safety and efficacy of satralizumab monotherapy, Dr. Traboulsee and colleagues conducted SakuraStar, a randomized, double-blind, placebo-controlled trial.
Evaluating drug as monotherapy
The phase 3 trial enrolled 95 patients aged 18-74 years at 44 sites in 13 countries. The investigators included patients with AQP4-IgG–seropositive or –seronegative neuromyelitis optica using the 2006 Wingerchuk criteria or with AQP4-IgG–seropositive NMOSD with at least one event of longitudinally extensive myelitis or optic neuritis. The researchers limited the number of AQP4-IgG–seronegative patients to about 30% of the study population. Eligible participants had at least one NMOSD attack or relapse in the past 12 months and a score of 6.5 or less on the Expanded Disability Status Scale (EDSS). The investigators excluded patients with a clinical relapse in the 30 days before study baseline. Participants were randomly assigned 2:1 to receive satralizumab 120 mg or placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Concomitant immunosuppressant use was prohibited, although corticosteroids and intravenous immunoglobulin were permitted as rescue therapy for the treatment of relapse.
The primary endpoint was time to first relapse, and the trial was designed to continue until 44 relapses occurred or for 1.5 years after the last patient entered the trial, whichever occurred first.
“Because even one NMOSD attack can have serious neurological consequences, this design allowed patients who had an attack on placebo to enter the open-label phase and receive the active drug,” the researchers wrote. “The trial design used unequal randomization to minimize exposure to placebo; because patients were not permitted to receive concomitant immunosuppressant treatment in this trial, the design limited the number of patients not receiving any treatment for the disorder. Placebo was selected with the consideration that no drugs were approved for the treatment of NMOSD when the trial was designed.” Recent trials of eculizumab, inebilizumab, and satralizumab have found that the agents are effective treatments for NMOSD. In 2019, the Food and Drug Administration approved eculizumab, a complement inhibitor, for the treatment of AQP4-IgG–seropositive NMOSD.
For the primary endpoint of SakuraStar, the researchers defined relapses as new or worsening objective neurologic symptoms with at least one of the following:
- Increase of 1 or more EDSS points from a baseline EDSS score of more than 0, or increase of 2 or more EDSS points from a baseline EDSS score of 0
- Increase of 2 or more points on at least one appropriate symptom-specific functional system score for pyramidal, cerebellar, brain stem, sensory, bowel or bladder, or a single eye
- Increase of 1 or more points on more than one symptom-specific functional system score with a baseline of at least 1
- Increase of 1 or more points on a single-eye symptom-specific functional system score with a baseline score of at least 1
In addition, symptoms had to be attributable to NMOSD; persist for more than 24 hours; and not be attributable to confounding clinical factors such as fever, infection, injury, change in mood, or adverse reactions to medications. Researchers assessed EDSS and functional system scores within 7 days of a patient reporting symptoms.
The double-blind treatment period ended 1.5 years after the last enrolled patient was assigned to satralizumab or placebo. More than 80% of the participants were women, including 73% of the satralizumab group and 97% of the placebo group. In all, 95 participants were assigned to a treatment between 2014 and 2017 – 63 to satralizumab and 32 to placebo. Relapses occurred in 19 patients receiving satralizumab (30%) and 16 receiving placebo (50%). The hazard ratio was 0.45.
“Patients treated with placebo showed a shorter time to relapse and a higher withdrawal rate than did patients treated with satralizumab,” wrote Dr. Traboulsee and colleagues. The Kaplan-Meier method suggested that 76% of patients on satralizumab had not relapsed at 48 weeks, compared with 62% of patients on placebo. And at 96 weeks, 72% of patients on satralizumab had not relapsed, compared with 51% of patients on placebo.
Among patients who were AQP4-IgG seropositive, the proportion with protocol-defined relapse was 22% in the satralizumab group versus 57% in the placebo group. Among patients who were AQP4-IgG seronegative, the proportion with a protocol-defined relapse was 46% in the satralizumab group versus 33% in the placebo group.
The most common adverse events were urinary tract infection and upper respiratory tract infection, and most adverse events were mild to moderate. A higher rate of severe adverse events was reported in the satralizumab group than in the placebo group (32.1 vs. 9.9 events per 100 patient-years). The investigators considered most of the severe adverse events unrelated to the study treatment. “None of the severe adverse events led to discontinuation of the study drug except one severe event of pneumonia in the satralizumab group,” the researchers wrote.
Data confirm efficacy of IL-6 blockade
“Satralizumab was well tolerated and no meaningful adverse effects from the drug were reported and no deaths occurred,” said Michael Levy, MD, PhD, director of the NMO clinic and research laboratory at Massachusetts General Hospital, Boston, in an accompanying editorial. “This trial of satralizumab was done shortly after the completion of a parallel trial of satralizumab in patients with NMOSD in which the same dose of satralizumab reduced the risk of relapse by 62%, compared with placebo. The main difference between these two trials is that, in the first published study, participants were permitted to use background immunotherapy; otherwise, the trial designs were nearly identical, and the enrolled participants are comparable. Together, the findings from these studies suggest that background therapy seems to provide only a small additional benefit to satralizumab alone.”
Dr. Levy also discussed findings from a phase 2 study of tocilizumab for the prevention of relapse in patients with NMOSD published in the same issue of the Lancet Neurology. The satralizumab and tocilizumab data have “confirmed that IL-6 blockade reduces the risk of relapse in patients with NMOSD,” Dr. Levy said. “IL-6 is a crucial component of the immune system, but when IL-6 production is altered during autoimmune attacks and sepsis, there can be severe consequences.”
The phase 2 trial of tocilizumab, which was described at the 2019 annual congress of the European Committee for Treatment and Research in Multiple Sclerosis, included 118 patients, 87% of whom were AQP4-IgG seropositive. Patients received intravenous tocilizumab or oral azathioprine for up to 60 weeks. Overall, 14% of patients in the tocilizumab group relapsed, compared with 47% of patients in the azathioprine group.
“The main differences between this trial of tocilizumab and the two satralizumab trials are that the tocilizumab was administered intravenously, rather than subcutaneously, the study duration was approximately 1 year, and the investigators were not masked to the treatment allocation,” Dr. Levy said. “Similar to satralizumab, adverse effects with tocilizumab were mild, including asymptomatic elevations in liver enzymes and an increased incidence of respiratory and urinary infections, with no significant differences identified between the tocilizumab and azathioprine groups.”
Various immunopathologic mechanisms may influence outcomes in NMOSD. While satralizumab and tocilizumab target IL-6, eculizumab is a C5 complement inhibitor and inebilizumab is a CD19 B-cell depleting monoclonal antibody, Dr. Levy said. “The safety concerns regarding these approaches are all substantially outweighed by the benefit of preventing NMOSD relapses.”
A need to understand AQP4-IgG–seronegative disease
SakuraStar “provides convincing data for the efficacy of satralizumab monotherapy in NMOSD with subgroup analysis showing that the benefit was seen in AQP4-IgG seropositive patients,” commented Dean M. Wingerchuk, MD, director of the division of multiple sclerosis and autoimmune neurology at the Mayo Clinic in Phoenix. “The results help confirm the key role of IL-6 in the pathobiology of AQP4-IgG–seropositive disease.”
Questions about AQP4-IgG seronegative disease remain. “The results are quite similar to the SakuraSky trial, in which satralizumab was used in conjunction with other background immunosuppressive therapies, suggesting that the primary benefit may be derived primarily from satralizumab. Both trials also showed that satralizumab did not benefit the NMOSD without AQP4-IgG subgroup though the subject numbers are rather small. We need to know more about the clinical and laboratory characteristics of the seronegative patients as they likely comprise a heterogeneous group. For example, did any of them have other autoantibodies such as MOG-IgG? Depending on the results, those details may help us understand the relative role of IL-6 in AQP4-IgG–seronegative subgroups, an important area of further study.”
SakuraStar was funded by Chugai Pharmaceutical, a member of the Roche group. Dr. Traboulsee reported grants, personal fees, and nonfinancial support from Chugai Pharmaceutical during the study, and several coauthors were employees of Chugai Pharmaceutical. Additional coauthors reported personal fees from Chugai, Roche, and other companies. Dr. Levy has received consulting fees from Alexion, Viela Bio, Chugai Pharmaceutical, Quest Diagnostics, and UCB Pharmaceuticals.
SOURCE: Traboulsee A et al. Lancet Neurol. 2020;19(5):402-12.
FROM THE LANCET NEUROLOGY
Doctors advise asthmatics to continue therapy during pandemic
“In fact, there’s no data to support this at this time. Maintaining adequate asthma control is the current CDC recommendation,” said pediatric pulmonologist John Carl, MD, of Cleveland Clinic Children’s Hospital. Patients, he said, should be advised to “follow your asthma action plan as outlined by your primary care or specialty clinician and communicate about evolving symptoms, such as fever rather than just congestion, wheezing, and coughing, etc.”
Dr. Carl spoke in a May 7 webinar about asthma and COVID-19 with Lakiea Wright, M.D., a physician specializing in internal medicine and allergy and immunology at Brigham and Women’s Hospital in Boston and medical director of clinical affairs for Thermo Fisher Scientific’s ImmunoDiagnostics division. The webinar, sponsored by Thermo Fisher Scientific, included discussion of COVID-19 risks, disease management, and distinguishing between the virus and asthma.
In a follow-up interview, Dr. Wright said she’s hearing from patients and parents who are concerned about whether people with asthma face a higher risk of COVID-19 infection. There’s no evidence that they do, she said, but “the CDC states that individuals with moderate to severe asthma may be higher risk for moderate to severe disease from COVID-19 if they were to become infected.”
Indeed, she said, “it is well established that viruses can trigger asthma.” But, as she also noted, early research about the risk in patients with asthma is conflicting.
“Some studies suggest asthma may be a risk factor for hospitalization while other data suggests asthma is not a common risk factor for those hospitalized,” Dr. Wright said.
She highlighted a recent study that suggests people with allergic asthma have “a reduced ACE2 gene expression in airway cells and thus decreased susceptibility to infection” by the novel coronavirus (J Allergy Clin Immunol. 2020 Apr 22. doi: 10.1016/j.jaci.2020.04.009).
Dr. Wright cautioned, however, that “this is a hypothesis and will need to be studied more.”
For now, she said, patients “should follow their asthma action plan and take their inhalers, including inhaled corticosteroids, as prescribed by their health care providers.”
Most patients are reasonable and do comply when their physicians explain why they should take a medication,” she noted.
Dr. Carl agreed, and added that a short course of oral corticosteroids are also recommended to manage minor exacerbations and “prevent patients from having to arrive as inpatients in more acute settings and risk health system–related exposures to the current pandemic.”
He cautioned, however, that metered-dose inhalers are preferable to nebulizers, and side vent ports should be avoided since they can aerosolize infectious agents and put health care providers and family members at risk.
Unfortunately, he said, there’s been a shortage of short-acting beta agonist albuterol inhalers. This has been linked to hospitals trying to avoid the use of nebulizers.
Dr. Wright advised colleagues to focus on unique symptoms first, then address overlapping symptoms and other symptoms to differentiate between COVID-19 and asthma/allergy.
She noted that environmental allergy symptoms alone do not cause fever, a hallmark of COVID-19. Shortness of breath can be a distinguishing symptom for the virus, because this is not a common symptom of environmental allergies unless the patient has asthma, Dr. Wright said.
Cough can be an overlapping symptom because in environmental allergies, postnasal drip from allergic rhinitis can trigger cough, she explained. Nasal congestion and/or runny nose can develop with viral illnesses in general, but these are symptoms not included in the CDC’s list of the most common COVID-19 symptoms. Severe fatigue and body aches aren’t symptoms consistent with environmental allergies, Dr. Wright said.
Both Dr. Carl and Dr. Wright emphasized the importance of continuing routine asthma therapy during the pandemic.
“When discussing the importance of taking their inhaled steroids with patients, I also remind patients that asthma management is comprehensive,” Dr. Wright said. “I want them to take their medications, but I also want them avoid or minimize exposure to triggers. Allergic and nonallergic triggers such as environmental tobacco smoke can exacerbate asthma.”
In addition, she said, “it’s important to take a detailed medical history to identify triggers. And it’s important to conduct allergy testing to common environmental allergens to help identify allergic triggers and tailor environmental allergen control strategies based on the results. All of these strategies help patients keep their asthma well-controlled.”
Dr. Carl and Dr. Wright report having no relevant disclosures.
“In fact, there’s no data to support this at this time. Maintaining adequate asthma control is the current CDC recommendation,” said pediatric pulmonologist John Carl, MD, of Cleveland Clinic Children’s Hospital. Patients, he said, should be advised to “follow your asthma action plan as outlined by your primary care or specialty clinician and communicate about evolving symptoms, such as fever rather than just congestion, wheezing, and coughing, etc.”
Dr. Carl spoke in a May 7 webinar about asthma and COVID-19 with Lakiea Wright, M.D., a physician specializing in internal medicine and allergy and immunology at Brigham and Women’s Hospital in Boston and medical director of clinical affairs for Thermo Fisher Scientific’s ImmunoDiagnostics division. The webinar, sponsored by Thermo Fisher Scientific, included discussion of COVID-19 risks, disease management, and distinguishing between the virus and asthma.
In a follow-up interview, Dr. Wright said she’s hearing from patients and parents who are concerned about whether people with asthma face a higher risk of COVID-19 infection. There’s no evidence that they do, she said, but “the CDC states that individuals with moderate to severe asthma may be higher risk for moderate to severe disease from COVID-19 if they were to become infected.”
Indeed, she said, “it is well established that viruses can trigger asthma.” But, as she also noted, early research about the risk in patients with asthma is conflicting.
“Some studies suggest asthma may be a risk factor for hospitalization while other data suggests asthma is not a common risk factor for those hospitalized,” Dr. Wright said.
She highlighted a recent study that suggests people with allergic asthma have “a reduced ACE2 gene expression in airway cells and thus decreased susceptibility to infection” by the novel coronavirus (J Allergy Clin Immunol. 2020 Apr 22. doi: 10.1016/j.jaci.2020.04.009).
Dr. Wright cautioned, however, that “this is a hypothesis and will need to be studied more.”
For now, she said, patients “should follow their asthma action plan and take their inhalers, including inhaled corticosteroids, as prescribed by their health care providers.”
Most patients are reasonable and do comply when their physicians explain why they should take a medication,” she noted.
Dr. Carl agreed, and added that a short course of oral corticosteroids are also recommended to manage minor exacerbations and “prevent patients from having to arrive as inpatients in more acute settings and risk health system–related exposures to the current pandemic.”
He cautioned, however, that metered-dose inhalers are preferable to nebulizers, and side vent ports should be avoided since they can aerosolize infectious agents and put health care providers and family members at risk.
Unfortunately, he said, there’s been a shortage of short-acting beta agonist albuterol inhalers. This has been linked to hospitals trying to avoid the use of nebulizers.
Dr. Wright advised colleagues to focus on unique symptoms first, then address overlapping symptoms and other symptoms to differentiate between COVID-19 and asthma/allergy.
She noted that environmental allergy symptoms alone do not cause fever, a hallmark of COVID-19. Shortness of breath can be a distinguishing symptom for the virus, because this is not a common symptom of environmental allergies unless the patient has asthma, Dr. Wright said.
Cough can be an overlapping symptom because in environmental allergies, postnasal drip from allergic rhinitis can trigger cough, she explained. Nasal congestion and/or runny nose can develop with viral illnesses in general, but these are symptoms not included in the CDC’s list of the most common COVID-19 symptoms. Severe fatigue and body aches aren’t symptoms consistent with environmental allergies, Dr. Wright said.
Both Dr. Carl and Dr. Wright emphasized the importance of continuing routine asthma therapy during the pandemic.
“When discussing the importance of taking their inhaled steroids with patients, I also remind patients that asthma management is comprehensive,” Dr. Wright said. “I want them to take their medications, but I also want them avoid or minimize exposure to triggers. Allergic and nonallergic triggers such as environmental tobacco smoke can exacerbate asthma.”
In addition, she said, “it’s important to take a detailed medical history to identify triggers. And it’s important to conduct allergy testing to common environmental allergens to help identify allergic triggers and tailor environmental allergen control strategies based on the results. All of these strategies help patients keep their asthma well-controlled.”
Dr. Carl and Dr. Wright report having no relevant disclosures.
“In fact, there’s no data to support this at this time. Maintaining adequate asthma control is the current CDC recommendation,” said pediatric pulmonologist John Carl, MD, of Cleveland Clinic Children’s Hospital. Patients, he said, should be advised to “follow your asthma action plan as outlined by your primary care or specialty clinician and communicate about evolving symptoms, such as fever rather than just congestion, wheezing, and coughing, etc.”
Dr. Carl spoke in a May 7 webinar about asthma and COVID-19 with Lakiea Wright, M.D., a physician specializing in internal medicine and allergy and immunology at Brigham and Women’s Hospital in Boston and medical director of clinical affairs for Thermo Fisher Scientific’s ImmunoDiagnostics division. The webinar, sponsored by Thermo Fisher Scientific, included discussion of COVID-19 risks, disease management, and distinguishing between the virus and asthma.
In a follow-up interview, Dr. Wright said she’s hearing from patients and parents who are concerned about whether people with asthma face a higher risk of COVID-19 infection. There’s no evidence that they do, she said, but “the CDC states that individuals with moderate to severe asthma may be higher risk for moderate to severe disease from COVID-19 if they were to become infected.”
Indeed, she said, “it is well established that viruses can trigger asthma.” But, as she also noted, early research about the risk in patients with asthma is conflicting.
“Some studies suggest asthma may be a risk factor for hospitalization while other data suggests asthma is not a common risk factor for those hospitalized,” Dr. Wright said.
She highlighted a recent study that suggests people with allergic asthma have “a reduced ACE2 gene expression in airway cells and thus decreased susceptibility to infection” by the novel coronavirus (J Allergy Clin Immunol. 2020 Apr 22. doi: 10.1016/j.jaci.2020.04.009).
Dr. Wright cautioned, however, that “this is a hypothesis and will need to be studied more.”
For now, she said, patients “should follow their asthma action plan and take their inhalers, including inhaled corticosteroids, as prescribed by their health care providers.”
Most patients are reasonable and do comply when their physicians explain why they should take a medication,” she noted.
Dr. Carl agreed, and added that a short course of oral corticosteroids are also recommended to manage minor exacerbations and “prevent patients from having to arrive as inpatients in more acute settings and risk health system–related exposures to the current pandemic.”
He cautioned, however, that metered-dose inhalers are preferable to nebulizers, and side vent ports should be avoided since they can aerosolize infectious agents and put health care providers and family members at risk.
Unfortunately, he said, there’s been a shortage of short-acting beta agonist albuterol inhalers. This has been linked to hospitals trying to avoid the use of nebulizers.
Dr. Wright advised colleagues to focus on unique symptoms first, then address overlapping symptoms and other symptoms to differentiate between COVID-19 and asthma/allergy.
She noted that environmental allergy symptoms alone do not cause fever, a hallmark of COVID-19. Shortness of breath can be a distinguishing symptom for the virus, because this is not a common symptom of environmental allergies unless the patient has asthma, Dr. Wright said.
Cough can be an overlapping symptom because in environmental allergies, postnasal drip from allergic rhinitis can trigger cough, she explained. Nasal congestion and/or runny nose can develop with viral illnesses in general, but these are symptoms not included in the CDC’s list of the most common COVID-19 symptoms. Severe fatigue and body aches aren’t symptoms consistent with environmental allergies, Dr. Wright said.
Both Dr. Carl and Dr. Wright emphasized the importance of continuing routine asthma therapy during the pandemic.
“When discussing the importance of taking their inhaled steroids with patients, I also remind patients that asthma management is comprehensive,” Dr. Wright said. “I want them to take their medications, but I also want them avoid or minimize exposure to triggers. Allergic and nonallergic triggers such as environmental tobacco smoke can exacerbate asthma.”
In addition, she said, “it’s important to take a detailed medical history to identify triggers. And it’s important to conduct allergy testing to common environmental allergens to help identify allergic triggers and tailor environmental allergen control strategies based on the results. All of these strategies help patients keep their asthma well-controlled.”
Dr. Carl and Dr. Wright report having no relevant disclosures.
COVID-19 quarantine: Managing pediatric behavioral issues
We are living through unprecedented challenges, faced with profound uncertainties about the public health, the economy, the safety of our workplaces, the risks of gathering with friends and family, and even about the rhythm of the school year. Parents always have sought guidance from their pediatric providers when they are uncertain about their children’s health, behavior, and development. We want to share some guidance with you about several of the most common questions we have been hearing in the past few months, in the hope that it may prove useful in your conversations with patients and families.
What happens when we are so busy at home that our 2-year-old is ignored for much of the day?
If they are fortunate enough to be able to work from home, but have lost their child care, many parents are suddenly facing the sustained challenge of parenting while working. Even older children will have a tough time remembering that home is now a workplace, and they can’t interrupt their parents during a Zoom meeting. But older children will understand. Younger children (preschoolers) simply will not be able to understand that their parents are in sight but not fully available to them. They are exquisitely sensitive to their parents’ attention. If they are consistently ignored, behavioral problems can emerge. If both parents are at home, they should try to arrange a schedule taking turns so that one of them could turn their full attention to their kids if need be. If a working parent can be out of sight (i.e., in another room), it makes the situation easier for everyone.
If there is only one parent at home, that mom or dad should consider arranging a babysitter or sharing child care with a friend, with some reasonable safety provisions in place. The small risk of exposure to the virus is balanced by the risk of sustained invalidation in a developing child. Help parents set reasonable expectations for how productive they can be at home. If possible, they can manage their employer’s expectations, so that they do not find themselves in the impossible bind of choosing between a crying child and a crucial deadline. If they can work near the child (and be prepared for interruptions) when reading emails or writing, that may be enough availability for the child. And parents should not be discouraged when they have to repeatedly remind their children that they adore them, but also have to work while they are at home right now. Using age-appropriate screen time as a babysitter for a few hours each day is a perfectly acceptable part of a plan. Simply planning regular breaks when their children can have their attention will make the day easier for everyone at home.
What can I do about my 13-year-old who is lying around the house all day?
This is a time to pick your battles. If children can keep their regular sleep schedule, get their schoolwork done, and do some physical exercise every day, they are doing great. And if parents are continuously complaining that they are being lazy, it will probably cease to mean much to them. Instead, focus on clear, simple expectations, and parents should live by them, too. If parents can exercise with them, or try a new activity, that is a wonderful way to model self-care and trying new things. It is important to remember that the developmental task for a 13-year-old is to establish new avenues of independence that they will drive down further with each passing year. Give them some leeway to experiment and figure out their own way of handling this challenge, although it is bound to create some tension. Parents should always acknowledge how hard it is to stick with schoolwork without school, exercise without a team, practice music without a band, or do your work without an office!
What do we do about our 16-year-old who is staying up all night and sleeping until the late afternoon?
Adolescents naturally have their sleep cycle shift, so they are sleepy later and sleep longer. But staying up all night is usually about texting with friends or playing video games. The problem is that their sleep schedule can flip. They will not be able to participate in online class or enjoy exercise in the sun, and they rarely get enough sleep during the daytime, making them more irritable, anxious, inattentive, and tired. This will only make managing their schoolwork harder and increase the chances of conflict at home. So it is important to preserve rules around sleep. You might extend bedtime by an hour or so, but preserve rules and bedtime routines. Sleep is essential to health, well-being, and resilience, and all are critical during times of uncertainty and change.
We think our 17-year-old is using marijuana, and it might be a problem.
When parents think their children may have a problem with drugs, the children almost certainly do, as parents are typically the last to know about the extent of their use. Sheltering in place together may make their drug use much more apparent, and offer an opportunity for parents to respond. Talk with them about it. Let them know what you have noticed. See if they can tell you honestly about their drug use. Kids who are only experimenting socially are unlikely to be using drugs at home under quarantine. If you are truly calm and curious, they are more likely to be honest, and it could be a relief for them to discuss it with you. Find out what they think it helps, and what – if anything – they are worried about. Then share your concerns about marijuana use and the developing brain, and the risk of addiction. If they think it is “medical” use, remind them that anxiety or mood symptoms get better with therapy, whereas drugs (including marijuana) and alcohol actually worsen those problems. It is also a time to establish home rules, explain them, and enforce them. They will have your support while stopping and may learn that they are actually sleeping and feeling better after a few weeks without marijuana.
Parents should not hesitate to reach out to pediatric providers for guidance on local resources for assessment and treatment for substance abuse and addiction. These are medical problems, and they can become serious if untreated.
My 12-year-old perfectionist is very stressed about getting her work done well now that she is home schooling. How do I help her relax?
Some children, especially our anxious perfectionists, may respond to the switch to home school with great effort and organization. These kids usually are not the ones parents worry about. But they are very prone to expanding anxiety without the regular support and feedback of teachers. The school environment naturally encourages their taking chances and normalizes the setbacks and failures that are an essential part of learning something new. At home, parents are inclined to let these kids work independently. But they benefit from regular check-ins that are not focused on work completion or scores. Instead, ask about what they are doing that is hardest, and let them teach you about it. Model how you approach a new challenge, and how you regroup and try again when you don’t get it right. Finally, this is a good age to start discussing “reasonable expectations.” No one can “do their best” all the time; not parents, not professional athletes, not even machines can sustain long bursts of maximum speed without problems. Help them to start experimenting with different speeds and levels of effort, and see how it feels.
My 10-year-old is very anxious about catching coronavirus or one of us catching it. How do I help ease her anxiety when there is no certainty about how to prevent it?
Anxiety is a normal response to a situation with as much uncertainty as this one. But some are prone to more profound anxiety, and parents may find they are doing a lot of reassuring throughout the day. For especially anxious children (and adults), accommodating the anxiety by avoiding the stressful situation is a common response that provides temporary relief. But accommodation and avoidance actually fuel anxiety, and make it harder and harder to manage. It is important to talk about the “accommodations” we all are doing, how masks are recommended to protect others (not ourselves) and to slow down the spread of a new illness so our hospitals aren’t overwhelmed. It can seem counterintuitive, but rather than jumping to reassurance or dismissing their sense of risk, ask your children to play the full movie of what they are most worried about. What happens if they get sick? If you get sick? If they are worried about dying, go ahead and ask what they think happens then. You are demonstrating that you have confidence they can handle these feelings, and you are modeling curiosity – not avoidance – yourself. Correct any misunderstandings, check on facts together, acknowledge uncertainty. It also is very important for parents to assess whether their own anxiety level makes this task especially hard or may even be contributing to their children’s level of worry. Each of us is managing anxiety right now, and this moment presents an opportunity for all of us to learn about how we can face and bear it, learn to manage, and even master it.
We are all getting cabin fever at home and snapping at each other constantly. How do we keep the peace without just hiding in our rooms all day?
Cabin fever seems inevitable when a family is suddenly at home together all day every day with no end in sight. But if we establish some simple and realistic routines and preserve some structure without being rigid, it can go a long way to helping each member of a family to find their equilibrium in this new normal. Structure can be about preserving normal sleep and meal times. Ensuring everyone is getting adequate, restful sleep and is not hungry is probably the most powerful way to keep irritability and conflict low. It is also helpful to establish some new routines. These should be simple enough to be memorable and should be realistic. You might identify predictable blocks of time that are dedicated to school (or work), exercise, creative time, and family time. While much of the day may find each family member doing some independent activity, it helps when these “blocks” are the same for everybody. Try to consistently do one or two things together, like a walk after the family dinner or family game time. And also remember that everyone needs some alone time. Respect their need for this, and it will help you to explain when you need it. If someone wants to sit out the family Yahtzee tournament, don’t shame or punish them. Just invite them again the next night!
What are going to be the consequences of all this screen time?
The great majority of kids (and parents) will not suffer any adverse consequences from the increased amount of time spent in front of screens when these activities are varied and serve a useful purpose – including distraction, senseless fun, and social time. Beyond letter or email writing, screen and phone time are the only ways to stay socially connected while physically distant. But parents are the experts on their kids. Youth who are depressed and have in the past wanted to escape into long hours of video games or YouTube videos should not be allowed to do that now. Youth with attentional issues who have a hard time stopping video games will still have that difficulty. If they are getting adequate sleep and regular exercise, and are doing most of their school work and staying socially connected, screens are not dangerous. They are proving to be a wonderful tool to help us visit libraries and museums, take dance classes, learn new languages, follow the news, order groceries, or enjoy a movie together. If we stay connected to those we care about and to the world, then this time – although marked by profound suffering and loss – may prove to be a time when we were able to slow down and remember what truly matters in our lives.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
We are living through unprecedented challenges, faced with profound uncertainties about the public health, the economy, the safety of our workplaces, the risks of gathering with friends and family, and even about the rhythm of the school year. Parents always have sought guidance from their pediatric providers when they are uncertain about their children’s health, behavior, and development. We want to share some guidance with you about several of the most common questions we have been hearing in the past few months, in the hope that it may prove useful in your conversations with patients and families.
What happens when we are so busy at home that our 2-year-old is ignored for much of the day?
If they are fortunate enough to be able to work from home, but have lost their child care, many parents are suddenly facing the sustained challenge of parenting while working. Even older children will have a tough time remembering that home is now a workplace, and they can’t interrupt their parents during a Zoom meeting. But older children will understand. Younger children (preschoolers) simply will not be able to understand that their parents are in sight but not fully available to them. They are exquisitely sensitive to their parents’ attention. If they are consistently ignored, behavioral problems can emerge. If both parents are at home, they should try to arrange a schedule taking turns so that one of them could turn their full attention to their kids if need be. If a working parent can be out of sight (i.e., in another room), it makes the situation easier for everyone.
If there is only one parent at home, that mom or dad should consider arranging a babysitter or sharing child care with a friend, with some reasonable safety provisions in place. The small risk of exposure to the virus is balanced by the risk of sustained invalidation in a developing child. Help parents set reasonable expectations for how productive they can be at home. If possible, they can manage their employer’s expectations, so that they do not find themselves in the impossible bind of choosing between a crying child and a crucial deadline. If they can work near the child (and be prepared for interruptions) when reading emails or writing, that may be enough availability for the child. And parents should not be discouraged when they have to repeatedly remind their children that they adore them, but also have to work while they are at home right now. Using age-appropriate screen time as a babysitter for a few hours each day is a perfectly acceptable part of a plan. Simply planning regular breaks when their children can have their attention will make the day easier for everyone at home.
What can I do about my 13-year-old who is lying around the house all day?
This is a time to pick your battles. If children can keep their regular sleep schedule, get their schoolwork done, and do some physical exercise every day, they are doing great. And if parents are continuously complaining that they are being lazy, it will probably cease to mean much to them. Instead, focus on clear, simple expectations, and parents should live by them, too. If parents can exercise with them, or try a new activity, that is a wonderful way to model self-care and trying new things. It is important to remember that the developmental task for a 13-year-old is to establish new avenues of independence that they will drive down further with each passing year. Give them some leeway to experiment and figure out their own way of handling this challenge, although it is bound to create some tension. Parents should always acknowledge how hard it is to stick with schoolwork without school, exercise without a team, practice music without a band, or do your work without an office!
What do we do about our 16-year-old who is staying up all night and sleeping until the late afternoon?
Adolescents naturally have their sleep cycle shift, so they are sleepy later and sleep longer. But staying up all night is usually about texting with friends or playing video games. The problem is that their sleep schedule can flip. They will not be able to participate in online class or enjoy exercise in the sun, and they rarely get enough sleep during the daytime, making them more irritable, anxious, inattentive, and tired. This will only make managing their schoolwork harder and increase the chances of conflict at home. So it is important to preserve rules around sleep. You might extend bedtime by an hour or so, but preserve rules and bedtime routines. Sleep is essential to health, well-being, and resilience, and all are critical during times of uncertainty and change.
We think our 17-year-old is using marijuana, and it might be a problem.
When parents think their children may have a problem with drugs, the children almost certainly do, as parents are typically the last to know about the extent of their use. Sheltering in place together may make their drug use much more apparent, and offer an opportunity for parents to respond. Talk with them about it. Let them know what you have noticed. See if they can tell you honestly about their drug use. Kids who are only experimenting socially are unlikely to be using drugs at home under quarantine. If you are truly calm and curious, they are more likely to be honest, and it could be a relief for them to discuss it with you. Find out what they think it helps, and what – if anything – they are worried about. Then share your concerns about marijuana use and the developing brain, and the risk of addiction. If they think it is “medical” use, remind them that anxiety or mood symptoms get better with therapy, whereas drugs (including marijuana) and alcohol actually worsen those problems. It is also a time to establish home rules, explain them, and enforce them. They will have your support while stopping and may learn that they are actually sleeping and feeling better after a few weeks without marijuana.
Parents should not hesitate to reach out to pediatric providers for guidance on local resources for assessment and treatment for substance abuse and addiction. These are medical problems, and they can become serious if untreated.
My 12-year-old perfectionist is very stressed about getting her work done well now that she is home schooling. How do I help her relax?
Some children, especially our anxious perfectionists, may respond to the switch to home school with great effort and organization. These kids usually are not the ones parents worry about. But they are very prone to expanding anxiety without the regular support and feedback of teachers. The school environment naturally encourages their taking chances and normalizes the setbacks and failures that are an essential part of learning something new. At home, parents are inclined to let these kids work independently. But they benefit from regular check-ins that are not focused on work completion or scores. Instead, ask about what they are doing that is hardest, and let them teach you about it. Model how you approach a new challenge, and how you regroup and try again when you don’t get it right. Finally, this is a good age to start discussing “reasonable expectations.” No one can “do their best” all the time; not parents, not professional athletes, not even machines can sustain long bursts of maximum speed without problems. Help them to start experimenting with different speeds and levels of effort, and see how it feels.
My 10-year-old is very anxious about catching coronavirus or one of us catching it. How do I help ease her anxiety when there is no certainty about how to prevent it?
Anxiety is a normal response to a situation with as much uncertainty as this one. But some are prone to more profound anxiety, and parents may find they are doing a lot of reassuring throughout the day. For especially anxious children (and adults), accommodating the anxiety by avoiding the stressful situation is a common response that provides temporary relief. But accommodation and avoidance actually fuel anxiety, and make it harder and harder to manage. It is important to talk about the “accommodations” we all are doing, how masks are recommended to protect others (not ourselves) and to slow down the spread of a new illness so our hospitals aren’t overwhelmed. It can seem counterintuitive, but rather than jumping to reassurance or dismissing their sense of risk, ask your children to play the full movie of what they are most worried about. What happens if they get sick? If you get sick? If they are worried about dying, go ahead and ask what they think happens then. You are demonstrating that you have confidence they can handle these feelings, and you are modeling curiosity – not avoidance – yourself. Correct any misunderstandings, check on facts together, acknowledge uncertainty. It also is very important for parents to assess whether their own anxiety level makes this task especially hard or may even be contributing to their children’s level of worry. Each of us is managing anxiety right now, and this moment presents an opportunity for all of us to learn about how we can face and bear it, learn to manage, and even master it.
We are all getting cabin fever at home and snapping at each other constantly. How do we keep the peace without just hiding in our rooms all day?
Cabin fever seems inevitable when a family is suddenly at home together all day every day with no end in sight. But if we establish some simple and realistic routines and preserve some structure without being rigid, it can go a long way to helping each member of a family to find their equilibrium in this new normal. Structure can be about preserving normal sleep and meal times. Ensuring everyone is getting adequate, restful sleep and is not hungry is probably the most powerful way to keep irritability and conflict low. It is also helpful to establish some new routines. These should be simple enough to be memorable and should be realistic. You might identify predictable blocks of time that are dedicated to school (or work), exercise, creative time, and family time. While much of the day may find each family member doing some independent activity, it helps when these “blocks” are the same for everybody. Try to consistently do one or two things together, like a walk after the family dinner or family game time. And also remember that everyone needs some alone time. Respect their need for this, and it will help you to explain when you need it. If someone wants to sit out the family Yahtzee tournament, don’t shame or punish them. Just invite them again the next night!
What are going to be the consequences of all this screen time?
The great majority of kids (and parents) will not suffer any adverse consequences from the increased amount of time spent in front of screens when these activities are varied and serve a useful purpose – including distraction, senseless fun, and social time. Beyond letter or email writing, screen and phone time are the only ways to stay socially connected while physically distant. But parents are the experts on their kids. Youth who are depressed and have in the past wanted to escape into long hours of video games or YouTube videos should not be allowed to do that now. Youth with attentional issues who have a hard time stopping video games will still have that difficulty. If they are getting adequate sleep and regular exercise, and are doing most of their school work and staying socially connected, screens are not dangerous. They are proving to be a wonderful tool to help us visit libraries and museums, take dance classes, learn new languages, follow the news, order groceries, or enjoy a movie together. If we stay connected to those we care about and to the world, then this time – although marked by profound suffering and loss – may prove to be a time when we were able to slow down and remember what truly matters in our lives.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
We are living through unprecedented challenges, faced with profound uncertainties about the public health, the economy, the safety of our workplaces, the risks of gathering with friends and family, and even about the rhythm of the school year. Parents always have sought guidance from their pediatric providers when they are uncertain about their children’s health, behavior, and development. We want to share some guidance with you about several of the most common questions we have been hearing in the past few months, in the hope that it may prove useful in your conversations with patients and families.
What happens when we are so busy at home that our 2-year-old is ignored for much of the day?
If they are fortunate enough to be able to work from home, but have lost their child care, many parents are suddenly facing the sustained challenge of parenting while working. Even older children will have a tough time remembering that home is now a workplace, and they can’t interrupt their parents during a Zoom meeting. But older children will understand. Younger children (preschoolers) simply will not be able to understand that their parents are in sight but not fully available to them. They are exquisitely sensitive to their parents’ attention. If they are consistently ignored, behavioral problems can emerge. If both parents are at home, they should try to arrange a schedule taking turns so that one of them could turn their full attention to their kids if need be. If a working parent can be out of sight (i.e., in another room), it makes the situation easier for everyone.
If there is only one parent at home, that mom or dad should consider arranging a babysitter or sharing child care with a friend, with some reasonable safety provisions in place. The small risk of exposure to the virus is balanced by the risk of sustained invalidation in a developing child. Help parents set reasonable expectations for how productive they can be at home. If possible, they can manage their employer’s expectations, so that they do not find themselves in the impossible bind of choosing between a crying child and a crucial deadline. If they can work near the child (and be prepared for interruptions) when reading emails or writing, that may be enough availability for the child. And parents should not be discouraged when they have to repeatedly remind their children that they adore them, but also have to work while they are at home right now. Using age-appropriate screen time as a babysitter for a few hours each day is a perfectly acceptable part of a plan. Simply planning regular breaks when their children can have their attention will make the day easier for everyone at home.
What can I do about my 13-year-old who is lying around the house all day?
This is a time to pick your battles. If children can keep their regular sleep schedule, get their schoolwork done, and do some physical exercise every day, they are doing great. And if parents are continuously complaining that they are being lazy, it will probably cease to mean much to them. Instead, focus on clear, simple expectations, and parents should live by them, too. If parents can exercise with them, or try a new activity, that is a wonderful way to model self-care and trying new things. It is important to remember that the developmental task for a 13-year-old is to establish new avenues of independence that they will drive down further with each passing year. Give them some leeway to experiment and figure out their own way of handling this challenge, although it is bound to create some tension. Parents should always acknowledge how hard it is to stick with schoolwork without school, exercise without a team, practice music without a band, or do your work without an office!
What do we do about our 16-year-old who is staying up all night and sleeping until the late afternoon?
Adolescents naturally have their sleep cycle shift, so they are sleepy later and sleep longer. But staying up all night is usually about texting with friends or playing video games. The problem is that their sleep schedule can flip. They will not be able to participate in online class or enjoy exercise in the sun, and they rarely get enough sleep during the daytime, making them more irritable, anxious, inattentive, and tired. This will only make managing their schoolwork harder and increase the chances of conflict at home. So it is important to preserve rules around sleep. You might extend bedtime by an hour or so, but preserve rules and bedtime routines. Sleep is essential to health, well-being, and resilience, and all are critical during times of uncertainty and change.
We think our 17-year-old is using marijuana, and it might be a problem.
When parents think their children may have a problem with drugs, the children almost certainly do, as parents are typically the last to know about the extent of their use. Sheltering in place together may make their drug use much more apparent, and offer an opportunity for parents to respond. Talk with them about it. Let them know what you have noticed. See if they can tell you honestly about their drug use. Kids who are only experimenting socially are unlikely to be using drugs at home under quarantine. If you are truly calm and curious, they are more likely to be honest, and it could be a relief for them to discuss it with you. Find out what they think it helps, and what – if anything – they are worried about. Then share your concerns about marijuana use and the developing brain, and the risk of addiction. If they think it is “medical” use, remind them that anxiety or mood symptoms get better with therapy, whereas drugs (including marijuana) and alcohol actually worsen those problems. It is also a time to establish home rules, explain them, and enforce them. They will have your support while stopping and may learn that they are actually sleeping and feeling better after a few weeks without marijuana.
Parents should not hesitate to reach out to pediatric providers for guidance on local resources for assessment and treatment for substance abuse and addiction. These are medical problems, and they can become serious if untreated.
My 12-year-old perfectionist is very stressed about getting her work done well now that she is home schooling. How do I help her relax?
Some children, especially our anxious perfectionists, may respond to the switch to home school with great effort and organization. These kids usually are not the ones parents worry about. But they are very prone to expanding anxiety without the regular support and feedback of teachers. The school environment naturally encourages their taking chances and normalizes the setbacks and failures that are an essential part of learning something new. At home, parents are inclined to let these kids work independently. But they benefit from regular check-ins that are not focused on work completion or scores. Instead, ask about what they are doing that is hardest, and let them teach you about it. Model how you approach a new challenge, and how you regroup and try again when you don’t get it right. Finally, this is a good age to start discussing “reasonable expectations.” No one can “do their best” all the time; not parents, not professional athletes, not even machines can sustain long bursts of maximum speed without problems. Help them to start experimenting with different speeds and levels of effort, and see how it feels.
My 10-year-old is very anxious about catching coronavirus or one of us catching it. How do I help ease her anxiety when there is no certainty about how to prevent it?
Anxiety is a normal response to a situation with as much uncertainty as this one. But some are prone to more profound anxiety, and parents may find they are doing a lot of reassuring throughout the day. For especially anxious children (and adults), accommodating the anxiety by avoiding the stressful situation is a common response that provides temporary relief. But accommodation and avoidance actually fuel anxiety, and make it harder and harder to manage. It is important to talk about the “accommodations” we all are doing, how masks are recommended to protect others (not ourselves) and to slow down the spread of a new illness so our hospitals aren’t overwhelmed. It can seem counterintuitive, but rather than jumping to reassurance or dismissing their sense of risk, ask your children to play the full movie of what they are most worried about. What happens if they get sick? If you get sick? If they are worried about dying, go ahead and ask what they think happens then. You are demonstrating that you have confidence they can handle these feelings, and you are modeling curiosity – not avoidance – yourself. Correct any misunderstandings, check on facts together, acknowledge uncertainty. It also is very important for parents to assess whether their own anxiety level makes this task especially hard or may even be contributing to their children’s level of worry. Each of us is managing anxiety right now, and this moment presents an opportunity for all of us to learn about how we can face and bear it, learn to manage, and even master it.
We are all getting cabin fever at home and snapping at each other constantly. How do we keep the peace without just hiding in our rooms all day?
Cabin fever seems inevitable when a family is suddenly at home together all day every day with no end in sight. But if we establish some simple and realistic routines and preserve some structure without being rigid, it can go a long way to helping each member of a family to find their equilibrium in this new normal. Structure can be about preserving normal sleep and meal times. Ensuring everyone is getting adequate, restful sleep and is not hungry is probably the most powerful way to keep irritability and conflict low. It is also helpful to establish some new routines. These should be simple enough to be memorable and should be realistic. You might identify predictable blocks of time that are dedicated to school (or work), exercise, creative time, and family time. While much of the day may find each family member doing some independent activity, it helps when these “blocks” are the same for everybody. Try to consistently do one or two things together, like a walk after the family dinner or family game time. And also remember that everyone needs some alone time. Respect their need for this, and it will help you to explain when you need it. If someone wants to sit out the family Yahtzee tournament, don’t shame or punish them. Just invite them again the next night!
What are going to be the consequences of all this screen time?
The great majority of kids (and parents) will not suffer any adverse consequences from the increased amount of time spent in front of screens when these activities are varied and serve a useful purpose – including distraction, senseless fun, and social time. Beyond letter or email writing, screen and phone time are the only ways to stay socially connected while physically distant. But parents are the experts on their kids. Youth who are depressed and have in the past wanted to escape into long hours of video games or YouTube videos should not be allowed to do that now. Youth with attentional issues who have a hard time stopping video games will still have that difficulty. If they are getting adequate sleep and regular exercise, and are doing most of their school work and staying socially connected, screens are not dangerous. They are proving to be a wonderful tool to help us visit libraries and museums, take dance classes, learn new languages, follow the news, order groceries, or enjoy a movie together. If we stay connected to those we care about and to the world, then this time – although marked by profound suffering and loss – may prove to be a time when we were able to slow down and remember what truly matters in our lives.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
Consider COVID-19–associated multisystem hyperinflammatory syndrome
A 21-year-old young adult presented to the ED with a 1-week history of high fever, vomiting, diarrhea, and abdominal pain. His mother was SARS-CoV-2 positive by polymerase chain reaction approximately 3 weeks prior; his PCR was negative for SARS-CoV-2.
Following admission, he became hypotensive and tachycardic with evidence of myocarditis. His chest x-ray was normal and his O2 saturation was 100% on room air. His clinical presentation was initially suggestive of toxic shock syndrome without a rash, but despite aggressive fluid resuscitation and broad-spectrum antibiotics, he continued to clinically deteriorate with persistent high fever and increasing cardiac stress. Echocardiography revealed biventricular dysfunction. His laboratory abnormalities included rising inflammatory markers and troponin I and B-type natriuretic peptide (BNP). A repeat PCR for SARS-CoV-2 was negative on day 2 of illness. He was diagnosed as likely having macrophage-activation syndrome (MAS) despite the atypical features (myocarditis), and he received Anakinra with no apparent response. He also was given intravenous immunoglobulin (IVIg) for his myocarditis and subsequently high-dose steroids. He became afebrile, his blood pressure stabilized, his inflammatory markers declined, and over several days he returned to normal. His COVID-19 antibody test IgG was positive on day 4 of illness.
This case challenged us for several reasons. First, the PCR from his nasopharynx was negative on two occasions, which raises the issue of how sensitive and accurate these PCR tests are for SARS-CoV-2 or are patients with COVID-19–associated hyperinflammatory syndrome still PCR positive? Second, although we have seen many adult cases with a cytokine storm picture similar to this patient, nearly all of the prior cases had chest x-ray abnormalities and hypoxia. Third, the severity of the myocardial dysfunction and rising troponin and BNP also was unusual in our experience with COVID-19 infection. Lastly, the use of antibody detection to SARS-CoV-2 enabled us to confirm recent COIVD-19 disease and see his illness as part of the likely spectrum of clinical syndromes seen with this virus.
The Lancet reported eight children, aged 4-14 years, with a hyperinflammatory shock-like syndrome in early May.1 The cases had features similar to atypical Kawasaki disease, KD shock syndrome, and toxic shock syndrome. Each case had high fever for multiple days; diarrhea and abdominal pain was present in even children; elevated ferritin, C-reactive protein, d-dimer, increased troponins, and ventricular dysfunction also was present in seven. Most patients had no pulmonary involvement, and most tested negative for SARS-CoV-2 despite four of the eight having direct contact with a COVID-positive family member. All received IVIg and antibiotics; six received aspirin. Seven of the eight made a full recovery; one child died from a large cerebrovascular infarct.
Also in early May, the New York Times described a “mysterious” hyperinflammatory syndrome in children thought to be linked to COVID-19. A total of 76 suspected cases in children had been reported in New York state, three of whom died. The syndrome has been given the name pediatric multisystem inflammatory syndrome. The syndrome can resemble KD shock syndrome with rash; fever; conjunctivitis; hypotension; and redness in the lips, tongue and mucous membranes . It also can resemble toxic shock syndrome with abdominal pain, vomiting, and diarrhea. However, the degree of cardiac inflammation and dysfunction is substantial in many cases and usually beyond that seen in KD or toxic shock.
The syndrome is not limited to the United States. The Royal College of Pediatrics and Child Health has created a case definition:2
- A child presenting with persistent fever, inflammation (elevated C-reactive protein, neutrophilia, and lymphopenia) and evidence of single or multiorgan dysfunction (shock, cardiac, respiratory, renal, gastrointestinal, or neurologic) with additional features.
- Exclusion of any other microbial causes such as bacterial sepsis or staphylococcal or streptococcal shock syndromes, infections known to be associated with myocarditis (such as enterovirus).
- SARS-CoV-2 testing may or may not be positive.
As with our young adult, treatment is supportive, nonspecific, and aimed at quieting the inflammatory response. The current thinking is the syndrome is seen as antibody to SARS-CoV-2 appears and frequently the nasopharyngeal PCR is negative. It is hypothesized that the syndrome occurs in genetically predisposed hosts and potentially is a late-onset inflammatory process or potentially an antibody-triggered inflammatory process. The negative PCR from nasopharyngeal specimens reflects that the onset is later in the course of disease; whether fecal samples would be COVID positive is unknown. As with our case, antibody testing for IgG against SARS-CoV-2 is appropriate to confirm COVID-19 disease and may be positive as early as day 7.
The approach needs to be team oriented and include cardiology, rheumatology, infectious diseases, and intensive care specialists working collaboratively. Such cases should be considered COVID positive despite negative PCR tests, and full personal protective equipment should be used as we do not as yet know if live virus could be found in stool. We initiated treatment with Anakinra (an interleukin-1 type-1 receptor inhibitor) as part of our treatment protocol for MAS; we did not appreciate a response. He then received IVIg and high-dose steroids, and he recovered over several days with improved cardiac function and stable blood pressure.
What is the pathogenesis? Is SARS-CoV-2 causative or just an associated finding? Who are the at-risk children, adolescents, and adults? Is there a genetic predisposition? What therapies work best? The eight cases described in London all received IVIg, as did our case, and all but one improved and survived. In adults we have seen substantial inflammation with elevated C-reactive protein (often as high as 300), ferritin, lactate dehydrogenase, triglycerides, fibrinogen, and d-dimers, but nearly all have extensive pulmonary disease, hypoxia, and are SARS-CoV-2 positive by PCR. Influenza is also associated with a cytokine storm syndrome in adolescents and young adults.3 The mechanisms influenza virus uses to initiate a cytokine storm and strategies for immunomodulatory treatment may provide insights into COVID-19–associated multisystem hyperinflammatory syndrome.
Dr. Pelton is professor of pediatrics and epidemiology at Boston University and public health and senior attending physician in pediatric infectious diseases at Boston Medical Center. Dr. Camelo is a senior fellow in pediatric infectious diseases at Boston Medical Center. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
References
1. Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
2. Royal College of Paediatrics and Child Health Guidance: Paediatric multisystem inflammatory syndrome temporally associated with COVID-19.
3. Liu Q et al.Cell Mol Immunol. 2016 Jan;13(1):3-10.
A 21-year-old young adult presented to the ED with a 1-week history of high fever, vomiting, diarrhea, and abdominal pain. His mother was SARS-CoV-2 positive by polymerase chain reaction approximately 3 weeks prior; his PCR was negative for SARS-CoV-2.
Following admission, he became hypotensive and tachycardic with evidence of myocarditis. His chest x-ray was normal and his O2 saturation was 100% on room air. His clinical presentation was initially suggestive of toxic shock syndrome without a rash, but despite aggressive fluid resuscitation and broad-spectrum antibiotics, he continued to clinically deteriorate with persistent high fever and increasing cardiac stress. Echocardiography revealed biventricular dysfunction. His laboratory abnormalities included rising inflammatory markers and troponin I and B-type natriuretic peptide (BNP). A repeat PCR for SARS-CoV-2 was negative on day 2 of illness. He was diagnosed as likely having macrophage-activation syndrome (MAS) despite the atypical features (myocarditis), and he received Anakinra with no apparent response. He also was given intravenous immunoglobulin (IVIg) for his myocarditis and subsequently high-dose steroids. He became afebrile, his blood pressure stabilized, his inflammatory markers declined, and over several days he returned to normal. His COVID-19 antibody test IgG was positive on day 4 of illness.
This case challenged us for several reasons. First, the PCR from his nasopharynx was negative on two occasions, which raises the issue of how sensitive and accurate these PCR tests are for SARS-CoV-2 or are patients with COVID-19–associated hyperinflammatory syndrome still PCR positive? Second, although we have seen many adult cases with a cytokine storm picture similar to this patient, nearly all of the prior cases had chest x-ray abnormalities and hypoxia. Third, the severity of the myocardial dysfunction and rising troponin and BNP also was unusual in our experience with COVID-19 infection. Lastly, the use of antibody detection to SARS-CoV-2 enabled us to confirm recent COIVD-19 disease and see his illness as part of the likely spectrum of clinical syndromes seen with this virus.
The Lancet reported eight children, aged 4-14 years, with a hyperinflammatory shock-like syndrome in early May.1 The cases had features similar to atypical Kawasaki disease, KD shock syndrome, and toxic shock syndrome. Each case had high fever for multiple days; diarrhea and abdominal pain was present in even children; elevated ferritin, C-reactive protein, d-dimer, increased troponins, and ventricular dysfunction also was present in seven. Most patients had no pulmonary involvement, and most tested negative for SARS-CoV-2 despite four of the eight having direct contact with a COVID-positive family member. All received IVIg and antibiotics; six received aspirin. Seven of the eight made a full recovery; one child died from a large cerebrovascular infarct.
Also in early May, the New York Times described a “mysterious” hyperinflammatory syndrome in children thought to be linked to COVID-19. A total of 76 suspected cases in children had been reported in New York state, three of whom died. The syndrome has been given the name pediatric multisystem inflammatory syndrome. The syndrome can resemble KD shock syndrome with rash; fever; conjunctivitis; hypotension; and redness in the lips, tongue and mucous membranes . It also can resemble toxic shock syndrome with abdominal pain, vomiting, and diarrhea. However, the degree of cardiac inflammation and dysfunction is substantial in many cases and usually beyond that seen in KD or toxic shock.
The syndrome is not limited to the United States. The Royal College of Pediatrics and Child Health has created a case definition:2
- A child presenting with persistent fever, inflammation (elevated C-reactive protein, neutrophilia, and lymphopenia) and evidence of single or multiorgan dysfunction (shock, cardiac, respiratory, renal, gastrointestinal, or neurologic) with additional features.
- Exclusion of any other microbial causes such as bacterial sepsis or staphylococcal or streptococcal shock syndromes, infections known to be associated with myocarditis (such as enterovirus).
- SARS-CoV-2 testing may or may not be positive.
As with our young adult, treatment is supportive, nonspecific, and aimed at quieting the inflammatory response. The current thinking is the syndrome is seen as antibody to SARS-CoV-2 appears and frequently the nasopharyngeal PCR is negative. It is hypothesized that the syndrome occurs in genetically predisposed hosts and potentially is a late-onset inflammatory process or potentially an antibody-triggered inflammatory process. The negative PCR from nasopharyngeal specimens reflects that the onset is later in the course of disease; whether fecal samples would be COVID positive is unknown. As with our case, antibody testing for IgG against SARS-CoV-2 is appropriate to confirm COVID-19 disease and may be positive as early as day 7.
The approach needs to be team oriented and include cardiology, rheumatology, infectious diseases, and intensive care specialists working collaboratively. Such cases should be considered COVID positive despite negative PCR tests, and full personal protective equipment should be used as we do not as yet know if live virus could be found in stool. We initiated treatment with Anakinra (an interleukin-1 type-1 receptor inhibitor) as part of our treatment protocol for MAS; we did not appreciate a response. He then received IVIg and high-dose steroids, and he recovered over several days with improved cardiac function and stable blood pressure.
What is the pathogenesis? Is SARS-CoV-2 causative or just an associated finding? Who are the at-risk children, adolescents, and adults? Is there a genetic predisposition? What therapies work best? The eight cases described in London all received IVIg, as did our case, and all but one improved and survived. In adults we have seen substantial inflammation with elevated C-reactive protein (often as high as 300), ferritin, lactate dehydrogenase, triglycerides, fibrinogen, and d-dimers, but nearly all have extensive pulmonary disease, hypoxia, and are SARS-CoV-2 positive by PCR. Influenza is also associated with a cytokine storm syndrome in adolescents and young adults.3 The mechanisms influenza virus uses to initiate a cytokine storm and strategies for immunomodulatory treatment may provide insights into COVID-19–associated multisystem hyperinflammatory syndrome.
Dr. Pelton is professor of pediatrics and epidemiology at Boston University and public health and senior attending physician in pediatric infectious diseases at Boston Medical Center. Dr. Camelo is a senior fellow in pediatric infectious diseases at Boston Medical Center. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
References
1. Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
2. Royal College of Paediatrics and Child Health Guidance: Paediatric multisystem inflammatory syndrome temporally associated with COVID-19.
3. Liu Q et al.Cell Mol Immunol. 2016 Jan;13(1):3-10.
A 21-year-old young adult presented to the ED with a 1-week history of high fever, vomiting, diarrhea, and abdominal pain. His mother was SARS-CoV-2 positive by polymerase chain reaction approximately 3 weeks prior; his PCR was negative for SARS-CoV-2.
Following admission, he became hypotensive and tachycardic with evidence of myocarditis. His chest x-ray was normal and his O2 saturation was 100% on room air. His clinical presentation was initially suggestive of toxic shock syndrome without a rash, but despite aggressive fluid resuscitation and broad-spectrum antibiotics, he continued to clinically deteriorate with persistent high fever and increasing cardiac stress. Echocardiography revealed biventricular dysfunction. His laboratory abnormalities included rising inflammatory markers and troponin I and B-type natriuretic peptide (BNP). A repeat PCR for SARS-CoV-2 was negative on day 2 of illness. He was diagnosed as likely having macrophage-activation syndrome (MAS) despite the atypical features (myocarditis), and he received Anakinra with no apparent response. He also was given intravenous immunoglobulin (IVIg) for his myocarditis and subsequently high-dose steroids. He became afebrile, his blood pressure stabilized, his inflammatory markers declined, and over several days he returned to normal. His COVID-19 antibody test IgG was positive on day 4 of illness.
This case challenged us for several reasons. First, the PCR from his nasopharynx was negative on two occasions, which raises the issue of how sensitive and accurate these PCR tests are for SARS-CoV-2 or are patients with COVID-19–associated hyperinflammatory syndrome still PCR positive? Second, although we have seen many adult cases with a cytokine storm picture similar to this patient, nearly all of the prior cases had chest x-ray abnormalities and hypoxia. Third, the severity of the myocardial dysfunction and rising troponin and BNP also was unusual in our experience with COVID-19 infection. Lastly, the use of antibody detection to SARS-CoV-2 enabled us to confirm recent COIVD-19 disease and see his illness as part of the likely spectrum of clinical syndromes seen with this virus.
The Lancet reported eight children, aged 4-14 years, with a hyperinflammatory shock-like syndrome in early May.1 The cases had features similar to atypical Kawasaki disease, KD shock syndrome, and toxic shock syndrome. Each case had high fever for multiple days; diarrhea and abdominal pain was present in even children; elevated ferritin, C-reactive protein, d-dimer, increased troponins, and ventricular dysfunction also was present in seven. Most patients had no pulmonary involvement, and most tested negative for SARS-CoV-2 despite four of the eight having direct contact with a COVID-positive family member. All received IVIg and antibiotics; six received aspirin. Seven of the eight made a full recovery; one child died from a large cerebrovascular infarct.
Also in early May, the New York Times described a “mysterious” hyperinflammatory syndrome in children thought to be linked to COVID-19. A total of 76 suspected cases in children had been reported in New York state, three of whom died. The syndrome has been given the name pediatric multisystem inflammatory syndrome. The syndrome can resemble KD shock syndrome with rash; fever; conjunctivitis; hypotension; and redness in the lips, tongue and mucous membranes . It also can resemble toxic shock syndrome with abdominal pain, vomiting, and diarrhea. However, the degree of cardiac inflammation and dysfunction is substantial in many cases and usually beyond that seen in KD or toxic shock.
The syndrome is not limited to the United States. The Royal College of Pediatrics and Child Health has created a case definition:2
- A child presenting with persistent fever, inflammation (elevated C-reactive protein, neutrophilia, and lymphopenia) and evidence of single or multiorgan dysfunction (shock, cardiac, respiratory, renal, gastrointestinal, or neurologic) with additional features.
- Exclusion of any other microbial causes such as bacterial sepsis or staphylococcal or streptococcal shock syndromes, infections known to be associated with myocarditis (such as enterovirus).
- SARS-CoV-2 testing may or may not be positive.
As with our young adult, treatment is supportive, nonspecific, and aimed at quieting the inflammatory response. The current thinking is the syndrome is seen as antibody to SARS-CoV-2 appears and frequently the nasopharyngeal PCR is negative. It is hypothesized that the syndrome occurs in genetically predisposed hosts and potentially is a late-onset inflammatory process or potentially an antibody-triggered inflammatory process. The negative PCR from nasopharyngeal specimens reflects that the onset is later in the course of disease; whether fecal samples would be COVID positive is unknown. As with our case, antibody testing for IgG against SARS-CoV-2 is appropriate to confirm COVID-19 disease and may be positive as early as day 7.
The approach needs to be team oriented and include cardiology, rheumatology, infectious diseases, and intensive care specialists working collaboratively. Such cases should be considered COVID positive despite negative PCR tests, and full personal protective equipment should be used as we do not as yet know if live virus could be found in stool. We initiated treatment with Anakinra (an interleukin-1 type-1 receptor inhibitor) as part of our treatment protocol for MAS; we did not appreciate a response. He then received IVIg and high-dose steroids, and he recovered over several days with improved cardiac function and stable blood pressure.
What is the pathogenesis? Is SARS-CoV-2 causative or just an associated finding? Who are the at-risk children, adolescents, and adults? Is there a genetic predisposition? What therapies work best? The eight cases described in London all received IVIg, as did our case, and all but one improved and survived. In adults we have seen substantial inflammation with elevated C-reactive protein (often as high as 300), ferritin, lactate dehydrogenase, triglycerides, fibrinogen, and d-dimers, but nearly all have extensive pulmonary disease, hypoxia, and are SARS-CoV-2 positive by PCR. Influenza is also associated with a cytokine storm syndrome in adolescents and young adults.3 The mechanisms influenza virus uses to initiate a cytokine storm and strategies for immunomodulatory treatment may provide insights into COVID-19–associated multisystem hyperinflammatory syndrome.
Dr. Pelton is professor of pediatrics and epidemiology at Boston University and public health and senior attending physician in pediatric infectious diseases at Boston Medical Center. Dr. Camelo is a senior fellow in pediatric infectious diseases at Boston Medical Center. They have no relevant financial disclosures. Email them at pdnews@mdedge.com.
References
1. Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
2. Royal College of Paediatrics and Child Health Guidance: Paediatric multisystem inflammatory syndrome temporally associated with COVID-19.
3. Liu Q et al.Cell Mol Immunol. 2016 Jan;13(1):3-10.
COVID-19 fears tied to dangerous drop in child vaccinations
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Incidental finding on brain MRI seen in 5% of older patients
New research shows that Knowing the expected prevalence of such incidental findings in the older general population is “extremely useful” for both researchers and clinicians, said study co-author Sarah Elisabeth Keuss, MBChB, clinical research associate, Dementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
“In research, the knowledge helps to inform study protocols regarding how to manage incidental findings and enables study participants to be appropriately informed,” said Dr. Keuss. Greater awareness also helps clinicians make decisions about whether or not to scan a patient, she said, adding that imaging is increasingly available to them. It allows clinicians to counsel patients regarding the probability of an incidental finding and balance that risk against the potential benefits of having a test.
The research is being presented online as part of the American Academy of Neurology 2020 Science Highlights. The incidental findings also were published last year in BMJ Open.
The new findings are from the first wave of data collection for the Insight 46 study, a neuroimaging substudy of the MRC National Survey of Health and Development (NSHD) 1946 British birth cohort, a broadly representative sample of the population born in mainland Britain during 1946. The research uses detailed brain imaging, cognitive testing, and blood and other biomarkers to investigate genetic and life-course factors associated with Alzheimer’s disease and cerebrovascular disease.
The current study included 502 individuals, aged about 71 years at the time of the analysis, and 49% were women. Almost all (93.8%) participants underwent 1-day MRI scans. Some 4.5% of these participants had an incidental finding of brain abnormality as per a prespecified standardized protocol.
Suspected vascular malformations were present in 1.9%, and suspected intracranial mass lesions were present in 1.5%. The single most common vascular abnormality was a suspected cerebral aneurysm, which affected 1.1% of participants.
Suspected meningiomas were the most common intracranial lesion, affecting 0.6% of study participants.
Action plan
Participants and their primary care provider were informed of findings “that were deemed to be potentially serious, or life-threatening, or could have a major impact on quality of life,” said Dr. Keuss. Relevant experts “came up with a recommended clinical action plan to help the primary care provider decide what should be the next course of action with regard to investigation or referral to another specialist,” said Dr. Keuss.
The new results are important for clinical decision-making, said Dr. Keuss. “Clinicians should consider the possibility of detecting an incidental finding whenever they’re requesting a brain scan. They should balance that risk against the possible benefits of recommending a test.”
The prevalence of incidental findings on MRI reported in the literature varies because of different methods used to review scans. “However, comparing our study with similar studies, the prevalence of the key findings with regard to aneurysms and intracranial mass lesions are very similar,” said Dr. Keuss.
Dr. Keuss and colleagues do not recommend all elderly patients get a brain scan.
“We don’t know what the long-term consequences are of being informed you have an incidental finding of an abnormality; we don’t know if it improves their outcome, and it potentially could cause anxiety,” said Dr. Keuss.
Psychological impact
The researchers have not looked at the psychological impact of negative findings on study participants, but they could do so at a later date.
“It would be very important to look into that given the potential to cause anxiety,” said Dr. Keuss. “It’s important to find out the potential negative consequences to inform researchers in future about how best to manage these findings.”
From blood tests, the analysis found that more than a third (34.6%) of participants had at least one related abnormality. The most common of these were kidney impairment (about 9%), thyroid function abnormalities (between 4% and 5%), anemia (about 4%), and low vitamin B12 levels (about 3%).
However, few of these reached the prespecified threshold for urgent action, and Dr. Keuss noted these findings were not the focus of her AAN presentation.
A strength of the study was that participants were almost the exact same age.
Important issue
Commenting on the research, David S. Liebeskind, MD, professor of neurology and director, Neurovascular Imaging Research Core, University of California, Los Angeles, said it raises “a very interesting” and “important” public health issue.
“The question is whether we do things based around individual symptomatic status, or at a larger level in terms of public health, screening the larger population to figure out who is at risk for any particular disease or disorder.”
From the standpoint of imaging technologies like MRI that show details about brain structures, experts debate whether the population should be screened “before something occurs,” said Dr. Liebeskind. “Imaging has the capacity to tell us a tremendous amount; whether this implies we should therefore image everybody is a larger public health question.”
The issue is “fraught with a lot of difficulty and complexity” as treatment paradigms tend to be “built around symptomatic status,” he said. “When we sit in the office or with a patient at the bedside, we usually focus on that individual patient and not necessarily on the larger public.”
Dr. Liebeskind noted that the question of whether to put the emphasis on the individual patient or the public at large is also being discussed during the current COVID-19 pandemic.
He wasn’t surprised that the study uncovered incidental findings in almost 5% of the sample. “If you take an 80-year-old and study their brain, a good chunk, if not half or more, will have some abnormality,” he said.
Drs. Keuss and Liebeskind have reported no relevant financial relationships.
This article first appeared on Medscape.com.
New research shows that Knowing the expected prevalence of such incidental findings in the older general population is “extremely useful” for both researchers and clinicians, said study co-author Sarah Elisabeth Keuss, MBChB, clinical research associate, Dementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
“In research, the knowledge helps to inform study protocols regarding how to manage incidental findings and enables study participants to be appropriately informed,” said Dr. Keuss. Greater awareness also helps clinicians make decisions about whether or not to scan a patient, she said, adding that imaging is increasingly available to them. It allows clinicians to counsel patients regarding the probability of an incidental finding and balance that risk against the potential benefits of having a test.
The research is being presented online as part of the American Academy of Neurology 2020 Science Highlights. The incidental findings also were published last year in BMJ Open.
The new findings are from the first wave of data collection for the Insight 46 study, a neuroimaging substudy of the MRC National Survey of Health and Development (NSHD) 1946 British birth cohort, a broadly representative sample of the population born in mainland Britain during 1946. The research uses detailed brain imaging, cognitive testing, and blood and other biomarkers to investigate genetic and life-course factors associated with Alzheimer’s disease and cerebrovascular disease.
The current study included 502 individuals, aged about 71 years at the time of the analysis, and 49% were women. Almost all (93.8%) participants underwent 1-day MRI scans. Some 4.5% of these participants had an incidental finding of brain abnormality as per a prespecified standardized protocol.
Suspected vascular malformations were present in 1.9%, and suspected intracranial mass lesions were present in 1.5%. The single most common vascular abnormality was a suspected cerebral aneurysm, which affected 1.1% of participants.
Suspected meningiomas were the most common intracranial lesion, affecting 0.6% of study participants.
Action plan
Participants and their primary care provider were informed of findings “that were deemed to be potentially serious, or life-threatening, or could have a major impact on quality of life,” said Dr. Keuss. Relevant experts “came up with a recommended clinical action plan to help the primary care provider decide what should be the next course of action with regard to investigation or referral to another specialist,” said Dr. Keuss.
The new results are important for clinical decision-making, said Dr. Keuss. “Clinicians should consider the possibility of detecting an incidental finding whenever they’re requesting a brain scan. They should balance that risk against the possible benefits of recommending a test.”
The prevalence of incidental findings on MRI reported in the literature varies because of different methods used to review scans. “However, comparing our study with similar studies, the prevalence of the key findings with regard to aneurysms and intracranial mass lesions are very similar,” said Dr. Keuss.
Dr. Keuss and colleagues do not recommend all elderly patients get a brain scan.
“We don’t know what the long-term consequences are of being informed you have an incidental finding of an abnormality; we don’t know if it improves their outcome, and it potentially could cause anxiety,” said Dr. Keuss.
Psychological impact
The researchers have not looked at the psychological impact of negative findings on study participants, but they could do so at a later date.
“It would be very important to look into that given the potential to cause anxiety,” said Dr. Keuss. “It’s important to find out the potential negative consequences to inform researchers in future about how best to manage these findings.”
From blood tests, the analysis found that more than a third (34.6%) of participants had at least one related abnormality. The most common of these were kidney impairment (about 9%), thyroid function abnormalities (between 4% and 5%), anemia (about 4%), and low vitamin B12 levels (about 3%).
However, few of these reached the prespecified threshold for urgent action, and Dr. Keuss noted these findings were not the focus of her AAN presentation.
A strength of the study was that participants were almost the exact same age.
Important issue
Commenting on the research, David S. Liebeskind, MD, professor of neurology and director, Neurovascular Imaging Research Core, University of California, Los Angeles, said it raises “a very interesting” and “important” public health issue.
“The question is whether we do things based around individual symptomatic status, or at a larger level in terms of public health, screening the larger population to figure out who is at risk for any particular disease or disorder.”
From the standpoint of imaging technologies like MRI that show details about brain structures, experts debate whether the population should be screened “before something occurs,” said Dr. Liebeskind. “Imaging has the capacity to tell us a tremendous amount; whether this implies we should therefore image everybody is a larger public health question.”
The issue is “fraught with a lot of difficulty and complexity” as treatment paradigms tend to be “built around symptomatic status,” he said. “When we sit in the office or with a patient at the bedside, we usually focus on that individual patient and not necessarily on the larger public.”
Dr. Liebeskind noted that the question of whether to put the emphasis on the individual patient or the public at large is also being discussed during the current COVID-19 pandemic.
He wasn’t surprised that the study uncovered incidental findings in almost 5% of the sample. “If you take an 80-year-old and study their brain, a good chunk, if not half or more, will have some abnormality,” he said.
Drs. Keuss and Liebeskind have reported no relevant financial relationships.
This article first appeared on Medscape.com.
New research shows that Knowing the expected prevalence of such incidental findings in the older general population is “extremely useful” for both researchers and clinicians, said study co-author Sarah Elisabeth Keuss, MBChB, clinical research associate, Dementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
“In research, the knowledge helps to inform study protocols regarding how to manage incidental findings and enables study participants to be appropriately informed,” said Dr. Keuss. Greater awareness also helps clinicians make decisions about whether or not to scan a patient, she said, adding that imaging is increasingly available to them. It allows clinicians to counsel patients regarding the probability of an incidental finding and balance that risk against the potential benefits of having a test.
The research is being presented online as part of the American Academy of Neurology 2020 Science Highlights. The incidental findings also were published last year in BMJ Open.
The new findings are from the first wave of data collection for the Insight 46 study, a neuroimaging substudy of the MRC National Survey of Health and Development (NSHD) 1946 British birth cohort, a broadly representative sample of the population born in mainland Britain during 1946. The research uses detailed brain imaging, cognitive testing, and blood and other biomarkers to investigate genetic and life-course factors associated with Alzheimer’s disease and cerebrovascular disease.
The current study included 502 individuals, aged about 71 years at the time of the analysis, and 49% were women. Almost all (93.8%) participants underwent 1-day MRI scans. Some 4.5% of these participants had an incidental finding of brain abnormality as per a prespecified standardized protocol.
Suspected vascular malformations were present in 1.9%, and suspected intracranial mass lesions were present in 1.5%. The single most common vascular abnormality was a suspected cerebral aneurysm, which affected 1.1% of participants.
Suspected meningiomas were the most common intracranial lesion, affecting 0.6% of study participants.
Action plan
Participants and their primary care provider were informed of findings “that were deemed to be potentially serious, or life-threatening, or could have a major impact on quality of life,” said Dr. Keuss. Relevant experts “came up with a recommended clinical action plan to help the primary care provider decide what should be the next course of action with regard to investigation or referral to another specialist,” said Dr. Keuss.
The new results are important for clinical decision-making, said Dr. Keuss. “Clinicians should consider the possibility of detecting an incidental finding whenever they’re requesting a brain scan. They should balance that risk against the possible benefits of recommending a test.”
The prevalence of incidental findings on MRI reported in the literature varies because of different methods used to review scans. “However, comparing our study with similar studies, the prevalence of the key findings with regard to aneurysms and intracranial mass lesions are very similar,” said Dr. Keuss.
Dr. Keuss and colleagues do not recommend all elderly patients get a brain scan.
“We don’t know what the long-term consequences are of being informed you have an incidental finding of an abnormality; we don’t know if it improves their outcome, and it potentially could cause anxiety,” said Dr. Keuss.
Psychological impact
The researchers have not looked at the psychological impact of negative findings on study participants, but they could do so at a later date.
“It would be very important to look into that given the potential to cause anxiety,” said Dr. Keuss. “It’s important to find out the potential negative consequences to inform researchers in future about how best to manage these findings.”
From blood tests, the analysis found that more than a third (34.6%) of participants had at least one related abnormality. The most common of these were kidney impairment (about 9%), thyroid function abnormalities (between 4% and 5%), anemia (about 4%), and low vitamin B12 levels (about 3%).
However, few of these reached the prespecified threshold for urgent action, and Dr. Keuss noted these findings were not the focus of her AAN presentation.
A strength of the study was that participants were almost the exact same age.
Important issue
Commenting on the research, David S. Liebeskind, MD, professor of neurology and director, Neurovascular Imaging Research Core, University of California, Los Angeles, said it raises “a very interesting” and “important” public health issue.
“The question is whether we do things based around individual symptomatic status, or at a larger level in terms of public health, screening the larger population to figure out who is at risk for any particular disease or disorder.”
From the standpoint of imaging technologies like MRI that show details about brain structures, experts debate whether the population should be screened “before something occurs,” said Dr. Liebeskind. “Imaging has the capacity to tell us a tremendous amount; whether this implies we should therefore image everybody is a larger public health question.”
The issue is “fraught with a lot of difficulty and complexity” as treatment paradigms tend to be “built around symptomatic status,” he said. “When we sit in the office or with a patient at the bedside, we usually focus on that individual patient and not necessarily on the larger public.”
Dr. Liebeskind noted that the question of whether to put the emphasis on the individual patient or the public at large is also being discussed during the current COVID-19 pandemic.
He wasn’t surprised that the study uncovered incidental findings in almost 5% of the sample. “If you take an 80-year-old and study their brain, a good chunk, if not half or more, will have some abnormality,” he said.
Drs. Keuss and Liebeskind have reported no relevant financial relationships.
This article first appeared on Medscape.com.
The third surge: Are we prepared for the non-COVID crisis?
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
Depression linked to neuro dysfunction, brain lesions in MS
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
COVID-19 experiences from the pediatrician front line
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.