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Nilotinib is safe in moderate and advanced Parkinson’s disease
according to investigators. Nevertheless, other drugs that – like nilotinib – inhibit tyrosine kinase (c-Abl) may have a neuroprotective effect, they added. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Research using preclinical models of Parkinson’s disease has indicated that nilotinib offers neuroprotection. Tanya Simuni, MD, the Arthur C. Nielsen Jr., Research Professor of Parkinson’s Disease and Movement Disorders at Northwestern University in Chicago, and colleagues conducted a prospective study to evaluate the safety and tolerability of oral nilotinib in patients with moderate or advanced Parkinson’s disease. The investigators also sought to examine nilotinib’s symptomatic effect, as measured by the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III. In addition, Dr. Simuni and colleagues analyzed the drug’s effect on progression of disability, as measured by various other Parkinson’s disease scales. The study’s exploratory outcomes included cognitive function, quality of life, pharmacokinetic profile, and a battery of serum and spinal fluid biomarkers.
The researchers conducted their randomized, double-blind, placebo-controlled, parallel-group study at 25 sites in the United States. They randomized 76 patients with Parkinson’s disease in approximately equal groups to a daily dose of placebo, 150 mg of nilotinib, or 300 mg of nilotinib. Safety visits occurred monthly. Patient assessments occurred at 3 months and at 6 months, which was the end of the treatment period. Patients presented off study medication at 1 month and 2 months after the end of the treatment period.
Treatment did not change dopamine levels
Baseline demographics and disease characteristics were balanced between groups. Mean age was about 66 years in the placebo group, 61 years in the 150-mg group, and 67 years in the 300-mg group. The proportion of male participants was 64% in the placebo group, 60% in the 150-mg group, and 81% in the 300-mg group. Disease duration was 9 years in the placebo group, approximately 9 years in the 150-mg group, and approximately 12 years in the 300-mg group. Mean MDS-UPDRS total on score was 46 in the placebo group, 47 in the 150-mg group, and 52 in the 300-mg group.
Tolerability was 84% in the placebo group, 76% in the in the 150-mg group, and 77% in the 300-mg group. The sole treatment-related serious adverse event, arrhythmia, occurred in one patient in the 300-mg group. The rate of any adverse event was 88% in the placebo group, 92% in the 150-mg group, and 88% in the 300-mg group. The rate of any serious adverse event was 8% in the placebo group and 4% in each nilotinib group.
From baseline to 1 month, MDS-UPDRS part III on scores decreased by 0.49 points in the placebo group, increased by 2.08 in the 150-mg group, and increased by 4.67 in the 300-mg group. Differences in other secondary measures (e.g., change in MDS-UPDRS part III on scores from baseline to 6 months and change in MDS-UPDRS part III off score from baseline to 6 months) were not statistically significant.
At 3 months, CSF levels of nilotinib were well below the threshold for c-Abl inhibition (approximately 11 ng/mL). The arithmetic mean levels were 0.91 ng/mL in the 150-mg group and 1.69 ng/mL in the 300-mg group. Nilotinib also failed to alter CSF levels of dopamine or its metabolites at 3 months. Dr. Simuni and colleagues did not see significant differences between treatment groups in the exploratory outcomes of cognitive function and quality of life.
“Nilotinib is not an optimal molecule to assess the therapeutic potential of c-Abl inhibition for Parkinson’s disease,” the investigators concluded.
Nilotinib may be an inappropriate candidate
The data “suggest that the hypothesis wasn’t tested, since the CSF and serum concentration of the drug were insufficient for enzyme inhibition,” said Peter LeWitt, MD, Sastry Foundation Endowed Chair in Neurology and professor of neurology at Wayne State University, Detroit. “A higher dose or a more CNS-penetrant drug would be needed for adequate testing of the hypothesis that c-Abl inhibition could provide disease modification.”
Nilotinib might not be an appropriate drug for this investigation, he continued. “There may be better choices among c-Abl inhibitors for penetration into the CNS, such as dasatinib, or for increased potency of effect, such as imatinib.”
Sun Pharma Advanced Research Company is conducting a clinical trial of KO706, another c-Abl inhibitor, added Dr. LeWitt, who is a researcher in that trial and an editorial adviser to Neurology Reviews. “The studies published recently in JAMA Neurology by Pagan et al. claiming target engagement with nilotinib in Parkinson’s disease patients need to be contrasted with the results of the current investigation. Disease modification with c-Abl inhibition continues to be a promising therapeutic avenue, but both positive and negative study results need careful reassessment and validation.”
The Michael J. Fox Foundation, the Cure Parkinson’s Trust, and Van Andel Research Institute funded the study. Novartis provided the study drug and placebo. The investigators reported no conflicts of interest.
SOURCE: Simuni T et al. AAN 2020. Abstract 43617.
according to investigators. Nevertheless, other drugs that – like nilotinib – inhibit tyrosine kinase (c-Abl) may have a neuroprotective effect, they added. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Research using preclinical models of Parkinson’s disease has indicated that nilotinib offers neuroprotection. Tanya Simuni, MD, the Arthur C. Nielsen Jr., Research Professor of Parkinson’s Disease and Movement Disorders at Northwestern University in Chicago, and colleagues conducted a prospective study to evaluate the safety and tolerability of oral nilotinib in patients with moderate or advanced Parkinson’s disease. The investigators also sought to examine nilotinib’s symptomatic effect, as measured by the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III. In addition, Dr. Simuni and colleagues analyzed the drug’s effect on progression of disability, as measured by various other Parkinson’s disease scales. The study’s exploratory outcomes included cognitive function, quality of life, pharmacokinetic profile, and a battery of serum and spinal fluid biomarkers.
The researchers conducted their randomized, double-blind, placebo-controlled, parallel-group study at 25 sites in the United States. They randomized 76 patients with Parkinson’s disease in approximately equal groups to a daily dose of placebo, 150 mg of nilotinib, or 300 mg of nilotinib. Safety visits occurred monthly. Patient assessments occurred at 3 months and at 6 months, which was the end of the treatment period. Patients presented off study medication at 1 month and 2 months after the end of the treatment period.
Treatment did not change dopamine levels
Baseline demographics and disease characteristics were balanced between groups. Mean age was about 66 years in the placebo group, 61 years in the 150-mg group, and 67 years in the 300-mg group. The proportion of male participants was 64% in the placebo group, 60% in the 150-mg group, and 81% in the 300-mg group. Disease duration was 9 years in the placebo group, approximately 9 years in the 150-mg group, and approximately 12 years in the 300-mg group. Mean MDS-UPDRS total on score was 46 in the placebo group, 47 in the 150-mg group, and 52 in the 300-mg group.
Tolerability was 84% in the placebo group, 76% in the in the 150-mg group, and 77% in the 300-mg group. The sole treatment-related serious adverse event, arrhythmia, occurred in one patient in the 300-mg group. The rate of any adverse event was 88% in the placebo group, 92% in the 150-mg group, and 88% in the 300-mg group. The rate of any serious adverse event was 8% in the placebo group and 4% in each nilotinib group.
From baseline to 1 month, MDS-UPDRS part III on scores decreased by 0.49 points in the placebo group, increased by 2.08 in the 150-mg group, and increased by 4.67 in the 300-mg group. Differences in other secondary measures (e.g., change in MDS-UPDRS part III on scores from baseline to 6 months and change in MDS-UPDRS part III off score from baseline to 6 months) were not statistically significant.
At 3 months, CSF levels of nilotinib were well below the threshold for c-Abl inhibition (approximately 11 ng/mL). The arithmetic mean levels were 0.91 ng/mL in the 150-mg group and 1.69 ng/mL in the 300-mg group. Nilotinib also failed to alter CSF levels of dopamine or its metabolites at 3 months. Dr. Simuni and colleagues did not see significant differences between treatment groups in the exploratory outcomes of cognitive function and quality of life.
“Nilotinib is not an optimal molecule to assess the therapeutic potential of c-Abl inhibition for Parkinson’s disease,” the investigators concluded.
Nilotinib may be an inappropriate candidate
The data “suggest that the hypothesis wasn’t tested, since the CSF and serum concentration of the drug were insufficient for enzyme inhibition,” said Peter LeWitt, MD, Sastry Foundation Endowed Chair in Neurology and professor of neurology at Wayne State University, Detroit. “A higher dose or a more CNS-penetrant drug would be needed for adequate testing of the hypothesis that c-Abl inhibition could provide disease modification.”
Nilotinib might not be an appropriate drug for this investigation, he continued. “There may be better choices among c-Abl inhibitors for penetration into the CNS, such as dasatinib, or for increased potency of effect, such as imatinib.”
Sun Pharma Advanced Research Company is conducting a clinical trial of KO706, another c-Abl inhibitor, added Dr. LeWitt, who is a researcher in that trial and an editorial adviser to Neurology Reviews. “The studies published recently in JAMA Neurology by Pagan et al. claiming target engagement with nilotinib in Parkinson’s disease patients need to be contrasted with the results of the current investigation. Disease modification with c-Abl inhibition continues to be a promising therapeutic avenue, but both positive and negative study results need careful reassessment and validation.”
The Michael J. Fox Foundation, the Cure Parkinson’s Trust, and Van Andel Research Institute funded the study. Novartis provided the study drug and placebo. The investigators reported no conflicts of interest.
SOURCE: Simuni T et al. AAN 2020. Abstract 43617.
according to investigators. Nevertheless, other drugs that – like nilotinib – inhibit tyrosine kinase (c-Abl) may have a neuroprotective effect, they added. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Research using preclinical models of Parkinson’s disease has indicated that nilotinib offers neuroprotection. Tanya Simuni, MD, the Arthur C. Nielsen Jr., Research Professor of Parkinson’s Disease and Movement Disorders at Northwestern University in Chicago, and colleagues conducted a prospective study to evaluate the safety and tolerability of oral nilotinib in patients with moderate or advanced Parkinson’s disease. The investigators also sought to examine nilotinib’s symptomatic effect, as measured by the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III. In addition, Dr. Simuni and colleagues analyzed the drug’s effect on progression of disability, as measured by various other Parkinson’s disease scales. The study’s exploratory outcomes included cognitive function, quality of life, pharmacokinetic profile, and a battery of serum and spinal fluid biomarkers.
The researchers conducted their randomized, double-blind, placebo-controlled, parallel-group study at 25 sites in the United States. They randomized 76 patients with Parkinson’s disease in approximately equal groups to a daily dose of placebo, 150 mg of nilotinib, or 300 mg of nilotinib. Safety visits occurred monthly. Patient assessments occurred at 3 months and at 6 months, which was the end of the treatment period. Patients presented off study medication at 1 month and 2 months after the end of the treatment period.
Treatment did not change dopamine levels
Baseline demographics and disease characteristics were balanced between groups. Mean age was about 66 years in the placebo group, 61 years in the 150-mg group, and 67 years in the 300-mg group. The proportion of male participants was 64% in the placebo group, 60% in the 150-mg group, and 81% in the 300-mg group. Disease duration was 9 years in the placebo group, approximately 9 years in the 150-mg group, and approximately 12 years in the 300-mg group. Mean MDS-UPDRS total on score was 46 in the placebo group, 47 in the 150-mg group, and 52 in the 300-mg group.
Tolerability was 84% in the placebo group, 76% in the in the 150-mg group, and 77% in the 300-mg group. The sole treatment-related serious adverse event, arrhythmia, occurred in one patient in the 300-mg group. The rate of any adverse event was 88% in the placebo group, 92% in the 150-mg group, and 88% in the 300-mg group. The rate of any serious adverse event was 8% in the placebo group and 4% in each nilotinib group.
From baseline to 1 month, MDS-UPDRS part III on scores decreased by 0.49 points in the placebo group, increased by 2.08 in the 150-mg group, and increased by 4.67 in the 300-mg group. Differences in other secondary measures (e.g., change in MDS-UPDRS part III on scores from baseline to 6 months and change in MDS-UPDRS part III off score from baseline to 6 months) were not statistically significant.
At 3 months, CSF levels of nilotinib were well below the threshold for c-Abl inhibition (approximately 11 ng/mL). The arithmetic mean levels were 0.91 ng/mL in the 150-mg group and 1.69 ng/mL in the 300-mg group. Nilotinib also failed to alter CSF levels of dopamine or its metabolites at 3 months. Dr. Simuni and colleagues did not see significant differences between treatment groups in the exploratory outcomes of cognitive function and quality of life.
“Nilotinib is not an optimal molecule to assess the therapeutic potential of c-Abl inhibition for Parkinson’s disease,” the investigators concluded.
Nilotinib may be an inappropriate candidate
The data “suggest that the hypothesis wasn’t tested, since the CSF and serum concentration of the drug were insufficient for enzyme inhibition,” said Peter LeWitt, MD, Sastry Foundation Endowed Chair in Neurology and professor of neurology at Wayne State University, Detroit. “A higher dose or a more CNS-penetrant drug would be needed for adequate testing of the hypothesis that c-Abl inhibition could provide disease modification.”
Nilotinib might not be an appropriate drug for this investigation, he continued. “There may be better choices among c-Abl inhibitors for penetration into the CNS, such as dasatinib, or for increased potency of effect, such as imatinib.”
Sun Pharma Advanced Research Company is conducting a clinical trial of KO706, another c-Abl inhibitor, added Dr. LeWitt, who is a researcher in that trial and an editorial adviser to Neurology Reviews. “The studies published recently in JAMA Neurology by Pagan et al. claiming target engagement with nilotinib in Parkinson’s disease patients need to be contrasted with the results of the current investigation. Disease modification with c-Abl inhibition continues to be a promising therapeutic avenue, but both positive and negative study results need careful reassessment and validation.”
The Michael J. Fox Foundation, the Cure Parkinson’s Trust, and Van Andel Research Institute funded the study. Novartis provided the study drug and placebo. The investigators reported no conflicts of interest.
SOURCE: Simuni T et al. AAN 2020. Abstract 43617.
FROM AAN 2020
Ofatumumab shows high elimination of disease activity in MS
, a new study shows.
The drug, which is already approved for the treatment of chronic lymphocytic leukemia, is currently under review for relapsing MS as a once-per-month self-injected therapy that could offer a convenient alternative to DMTs that require in-office infusion.
The new findings are from a pooled analysis from the phase 3 ASCLEPIOS I/II trials of the use of ofatumumab for patients with relapsing MS. There were 927 patients in the ASCLEPIOS I trial and 955 in the ASCLEPIOS II trial. The trials were conducted in 37 countries and involved patients aged 18-55 years.
The late-breaking research was presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
The studies compared patients who were treated with subcutaneous ofatumumab 20 mg with patients treated with oral teriflunomide 14 mg once daily for up to 30 months. The average duration of follow-up was 18 months.
NEDA-3, commonly used to determine treatment outcomes for patients with relapsing MS, was defined as a composite of having no worsening of disability over a 6-month period (6mCDW), no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing T1 lesions.
The pooled results showed that the odds of achieving NEDA-3 during the first 12 months were three times greater with ofatumumab than with teriflunomide (47.0% vs. 24.5%; odds ratio [OR], 3.36; P < .001) and were more than eight times greater from months 12 to 24 (87.8% vs. 48.2%; OR, 8.09; P < .001).
In addition, compared with patients who received teriflunomide, a higher proportion of patients who received ofatumumab were free from 6mCDW over 2 years (91.9% vs. 88.9%), as well as from relapses (82.3% vs 69.2%) and lesion activity (54.1% vs. 27.5%).
There was a significantly greater reduction in annualized relapse rate with ofatumumab compared with teriflunomide at all cumulative time intervals, including months 0 to 3 (P = .011), and at all subsequent time intervals from month 0 to 27 (P < .001).
The pooled findings further showed that ofatumumab reduced the mean number of gadolinium-enhancing T1 lesions per scan by 95.9% compared with teriflunomide (P < .001).
“Ofatumumab increased the probability of achieving NEDA-3 and demonstrated superior efficacy vs teriflunomide in patients with relapsing MS,” said the authors, led by Stephen L. Hauser, MD, of the department of neurology, UCSF Weill Institute for Neurosciences, University of California, San Francisco.
Ofatumumab superior in primary, secondary outcomes
As previously reported, subcutaneous ofatumumab also demonstrated superior efficacy over oral teriflunomide in the primary and secondary endpoints in the ASCLEPIOS I/II trials. The annualized relapse rate was reduced by 0.22 in the teriflunomide group, vs 0.11 in the ofatumumab group (50.5% relative reduction; P < .001) in the ASCLEPIOS I trial, and by 0.25 vs. 0.10 (58.5% relative reduction P < .001) in ASCLEPIOS II.
Ofatumumab also reduced the number of gadolinium-enhancing T1 lesions and new or enlarging T2 lesions compared with teriflunomide (all P < .001). It reduced the risk for disability progression by 34.4% over 3 months and by 32.5% over 6 months.
In the studies, the rate of serious infection with ofatumumab was 2.5%, compared with 1.8% with teriflunomide. Rates of malignancies were 0.5% and 0.3%, respectively.
“Ofatumumab demonstrated superior efficacy versus teriflunomide, with an acceptable safety profile, in patients with relapsing MS,” the authors reported.
Adherence rates with self-injection encouraging
An additional analysis from the two trials presented virtually in a separate abstract at the CMSC showed greater adherence to the self-administered regimen.
The analysis shows that in the ASCLEPIOS I study, 86.0% patients who were randomly assigned to receive ofatumumab and 77.7% who received teriflunomide completed the study on the assigned study drug. The proportion of patients who received ofatumumab and who discontinued treatment was 14.0%, versus 21.2% for those in the teriflunomide group. The most common reasons for discontinuation were patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), adverse event (ofatumumab, 5.2%; teriflunomide, 5.0%), and physician decision (ofatumumab, 2.2%; teriflunomide, 6.5%).
In the ASCLEPIOS II study, the rates were similar in all measures.
“In ASCLEPIOS trials, compliance with home-administered subcutaneous ofatumumab was high, and fewer patients discontinued ofatumumab as compared to teriflunomide,” the authors concluded.
Comparator drug a weak choice?
In commenting on the research, Stephen Kamin, MD, professor, vice chair, and chief of service, department of neurology, New Jersey Medical School, in Newark, noted that a limitation of the ASCLEPIOS trials is the comparison with teriflunomide.
“The comparator drug, teriflunomide, is one of the least effective DMTs, and one that some clinicians, including myself, don’t use,” he said.
Previously, when asked in an interview about the choice of teriflunomide as the comparator, Dr. Hauser noted that considerable discussion had gone into the decision. “The rationale was that we wanted to have a comparator that would be present not only against focal disease activity but also potentially against progression, and we were also able to blind the study successfully,” he said at the time.
Dr. Kamin said that ofatumumab will nevertheless likely represent a welcome addition to the tool kit of treatment options for MS. “Any new drug is helpful in adding to our choices as a general rule,” he said. “Subcutaneous injection does have increased convenience.”
It is not likely that the drug will be a game changer, he added, although the treatment’s efficacy compared with other drugs remains to be seen. “It all depends upon the relative efficacy of ofatumumab versus ocrelizumab or siponimod,” Dr. Kamin said.
“There has been another subcutaneous monoclonal for MS, daclizumab, although this was withdrawn from the market due to severe adverse effects not related to route of administration,” he added.
Dr. Hauser has relationships with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix, and F. Hoffmann-La Roche. Dr. Kamin has received research support from Biogen, Novartis and CMSC.
A version of this article originally appeared on Medscape.com.
, a new study shows.
The drug, which is already approved for the treatment of chronic lymphocytic leukemia, is currently under review for relapsing MS as a once-per-month self-injected therapy that could offer a convenient alternative to DMTs that require in-office infusion.
The new findings are from a pooled analysis from the phase 3 ASCLEPIOS I/II trials of the use of ofatumumab for patients with relapsing MS. There were 927 patients in the ASCLEPIOS I trial and 955 in the ASCLEPIOS II trial. The trials were conducted in 37 countries and involved patients aged 18-55 years.
The late-breaking research was presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
The studies compared patients who were treated with subcutaneous ofatumumab 20 mg with patients treated with oral teriflunomide 14 mg once daily for up to 30 months. The average duration of follow-up was 18 months.
NEDA-3, commonly used to determine treatment outcomes for patients with relapsing MS, was defined as a composite of having no worsening of disability over a 6-month period (6mCDW), no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing T1 lesions.
The pooled results showed that the odds of achieving NEDA-3 during the first 12 months were three times greater with ofatumumab than with teriflunomide (47.0% vs. 24.5%; odds ratio [OR], 3.36; P < .001) and were more than eight times greater from months 12 to 24 (87.8% vs. 48.2%; OR, 8.09; P < .001).
In addition, compared with patients who received teriflunomide, a higher proportion of patients who received ofatumumab were free from 6mCDW over 2 years (91.9% vs. 88.9%), as well as from relapses (82.3% vs 69.2%) and lesion activity (54.1% vs. 27.5%).
There was a significantly greater reduction in annualized relapse rate with ofatumumab compared with teriflunomide at all cumulative time intervals, including months 0 to 3 (P = .011), and at all subsequent time intervals from month 0 to 27 (P < .001).
The pooled findings further showed that ofatumumab reduced the mean number of gadolinium-enhancing T1 lesions per scan by 95.9% compared with teriflunomide (P < .001).
“Ofatumumab increased the probability of achieving NEDA-3 and demonstrated superior efficacy vs teriflunomide in patients with relapsing MS,” said the authors, led by Stephen L. Hauser, MD, of the department of neurology, UCSF Weill Institute for Neurosciences, University of California, San Francisco.
Ofatumumab superior in primary, secondary outcomes
As previously reported, subcutaneous ofatumumab also demonstrated superior efficacy over oral teriflunomide in the primary and secondary endpoints in the ASCLEPIOS I/II trials. The annualized relapse rate was reduced by 0.22 in the teriflunomide group, vs 0.11 in the ofatumumab group (50.5% relative reduction; P < .001) in the ASCLEPIOS I trial, and by 0.25 vs. 0.10 (58.5% relative reduction P < .001) in ASCLEPIOS II.
Ofatumumab also reduced the number of gadolinium-enhancing T1 lesions and new or enlarging T2 lesions compared with teriflunomide (all P < .001). It reduced the risk for disability progression by 34.4% over 3 months and by 32.5% over 6 months.
In the studies, the rate of serious infection with ofatumumab was 2.5%, compared with 1.8% with teriflunomide. Rates of malignancies were 0.5% and 0.3%, respectively.
“Ofatumumab demonstrated superior efficacy versus teriflunomide, with an acceptable safety profile, in patients with relapsing MS,” the authors reported.
Adherence rates with self-injection encouraging
An additional analysis from the two trials presented virtually in a separate abstract at the CMSC showed greater adherence to the self-administered regimen.
The analysis shows that in the ASCLEPIOS I study, 86.0% patients who were randomly assigned to receive ofatumumab and 77.7% who received teriflunomide completed the study on the assigned study drug. The proportion of patients who received ofatumumab and who discontinued treatment was 14.0%, versus 21.2% for those in the teriflunomide group. The most common reasons for discontinuation were patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), adverse event (ofatumumab, 5.2%; teriflunomide, 5.0%), and physician decision (ofatumumab, 2.2%; teriflunomide, 6.5%).
In the ASCLEPIOS II study, the rates were similar in all measures.
“In ASCLEPIOS trials, compliance with home-administered subcutaneous ofatumumab was high, and fewer patients discontinued ofatumumab as compared to teriflunomide,” the authors concluded.
Comparator drug a weak choice?
In commenting on the research, Stephen Kamin, MD, professor, vice chair, and chief of service, department of neurology, New Jersey Medical School, in Newark, noted that a limitation of the ASCLEPIOS trials is the comparison with teriflunomide.
“The comparator drug, teriflunomide, is one of the least effective DMTs, and one that some clinicians, including myself, don’t use,” he said.
Previously, when asked in an interview about the choice of teriflunomide as the comparator, Dr. Hauser noted that considerable discussion had gone into the decision. “The rationale was that we wanted to have a comparator that would be present not only against focal disease activity but also potentially against progression, and we were also able to blind the study successfully,” he said at the time.
Dr. Kamin said that ofatumumab will nevertheless likely represent a welcome addition to the tool kit of treatment options for MS. “Any new drug is helpful in adding to our choices as a general rule,” he said. “Subcutaneous injection does have increased convenience.”
It is not likely that the drug will be a game changer, he added, although the treatment’s efficacy compared with other drugs remains to be seen. “It all depends upon the relative efficacy of ofatumumab versus ocrelizumab or siponimod,” Dr. Kamin said.
“There has been another subcutaneous monoclonal for MS, daclizumab, although this was withdrawn from the market due to severe adverse effects not related to route of administration,” he added.
Dr. Hauser has relationships with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix, and F. Hoffmann-La Roche. Dr. Kamin has received research support from Biogen, Novartis and CMSC.
A version of this article originally appeared on Medscape.com.
, a new study shows.
The drug, which is already approved for the treatment of chronic lymphocytic leukemia, is currently under review for relapsing MS as a once-per-month self-injected therapy that could offer a convenient alternative to DMTs that require in-office infusion.
The new findings are from a pooled analysis from the phase 3 ASCLEPIOS I/II trials of the use of ofatumumab for patients with relapsing MS. There were 927 patients in the ASCLEPIOS I trial and 955 in the ASCLEPIOS II trial. The trials were conducted in 37 countries and involved patients aged 18-55 years.
The late-breaking research was presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
The studies compared patients who were treated with subcutaneous ofatumumab 20 mg with patients treated with oral teriflunomide 14 mg once daily for up to 30 months. The average duration of follow-up was 18 months.
NEDA-3, commonly used to determine treatment outcomes for patients with relapsing MS, was defined as a composite of having no worsening of disability over a 6-month period (6mCDW), no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing T1 lesions.
The pooled results showed that the odds of achieving NEDA-3 during the first 12 months were three times greater with ofatumumab than with teriflunomide (47.0% vs. 24.5%; odds ratio [OR], 3.36; P < .001) and were more than eight times greater from months 12 to 24 (87.8% vs. 48.2%; OR, 8.09; P < .001).
In addition, compared with patients who received teriflunomide, a higher proportion of patients who received ofatumumab were free from 6mCDW over 2 years (91.9% vs. 88.9%), as well as from relapses (82.3% vs 69.2%) and lesion activity (54.1% vs. 27.5%).
There was a significantly greater reduction in annualized relapse rate with ofatumumab compared with teriflunomide at all cumulative time intervals, including months 0 to 3 (P = .011), and at all subsequent time intervals from month 0 to 27 (P < .001).
The pooled findings further showed that ofatumumab reduced the mean number of gadolinium-enhancing T1 lesions per scan by 95.9% compared with teriflunomide (P < .001).
“Ofatumumab increased the probability of achieving NEDA-3 and demonstrated superior efficacy vs teriflunomide in patients with relapsing MS,” said the authors, led by Stephen L. Hauser, MD, of the department of neurology, UCSF Weill Institute for Neurosciences, University of California, San Francisco.
Ofatumumab superior in primary, secondary outcomes
As previously reported, subcutaneous ofatumumab also demonstrated superior efficacy over oral teriflunomide in the primary and secondary endpoints in the ASCLEPIOS I/II trials. The annualized relapse rate was reduced by 0.22 in the teriflunomide group, vs 0.11 in the ofatumumab group (50.5% relative reduction; P < .001) in the ASCLEPIOS I trial, and by 0.25 vs. 0.10 (58.5% relative reduction P < .001) in ASCLEPIOS II.
Ofatumumab also reduced the number of gadolinium-enhancing T1 lesions and new or enlarging T2 lesions compared with teriflunomide (all P < .001). It reduced the risk for disability progression by 34.4% over 3 months and by 32.5% over 6 months.
In the studies, the rate of serious infection with ofatumumab was 2.5%, compared with 1.8% with teriflunomide. Rates of malignancies were 0.5% and 0.3%, respectively.
“Ofatumumab demonstrated superior efficacy versus teriflunomide, with an acceptable safety profile, in patients with relapsing MS,” the authors reported.
Adherence rates with self-injection encouraging
An additional analysis from the two trials presented virtually in a separate abstract at the CMSC showed greater adherence to the self-administered regimen.
The analysis shows that in the ASCLEPIOS I study, 86.0% patients who were randomly assigned to receive ofatumumab and 77.7% who received teriflunomide completed the study on the assigned study drug. The proportion of patients who received ofatumumab and who discontinued treatment was 14.0%, versus 21.2% for those in the teriflunomide group. The most common reasons for discontinuation were patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), adverse event (ofatumumab, 5.2%; teriflunomide, 5.0%), and physician decision (ofatumumab, 2.2%; teriflunomide, 6.5%).
In the ASCLEPIOS II study, the rates were similar in all measures.
“In ASCLEPIOS trials, compliance with home-administered subcutaneous ofatumumab was high, and fewer patients discontinued ofatumumab as compared to teriflunomide,” the authors concluded.
Comparator drug a weak choice?
In commenting on the research, Stephen Kamin, MD, professor, vice chair, and chief of service, department of neurology, New Jersey Medical School, in Newark, noted that a limitation of the ASCLEPIOS trials is the comparison with teriflunomide.
“The comparator drug, teriflunomide, is one of the least effective DMTs, and one that some clinicians, including myself, don’t use,” he said.
Previously, when asked in an interview about the choice of teriflunomide as the comparator, Dr. Hauser noted that considerable discussion had gone into the decision. “The rationale was that we wanted to have a comparator that would be present not only against focal disease activity but also potentially against progression, and we were also able to blind the study successfully,” he said at the time.
Dr. Kamin said that ofatumumab will nevertheless likely represent a welcome addition to the tool kit of treatment options for MS. “Any new drug is helpful in adding to our choices as a general rule,” he said. “Subcutaneous injection does have increased convenience.”
It is not likely that the drug will be a game changer, he added, although the treatment’s efficacy compared with other drugs remains to be seen. “It all depends upon the relative efficacy of ofatumumab versus ocrelizumab or siponimod,” Dr. Kamin said.
“There has been another subcutaneous monoclonal for MS, daclizumab, although this was withdrawn from the market due to severe adverse effects not related to route of administration,” he added.
Dr. Hauser has relationships with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix, and F. Hoffmann-La Roche. Dr. Kamin has received research support from Biogen, Novartis and CMSC.
A version of this article originally appeared on Medscape.com.
From CMSC 2020
High levels of air pollution linked to increased MS risk
, new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.
The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.
“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.
The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
Toxic pollutants
Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.
Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM2.5) to 10 microns (PM10) in diameter.
The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.
The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.
Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM10 levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.
The current investigators assessed the association between PM2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
Peculiar features
Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.
The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.
Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM2.5.
Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.
After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)
Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
Vitamin D’s role?
Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.
Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.
Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.
However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.
Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.
Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.
“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.
Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
, new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.
The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.
“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.
The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
Toxic pollutants
Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.
Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM2.5) to 10 microns (PM10) in diameter.
The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.
The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.
Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM10 levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.
The current investigators assessed the association between PM2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
Peculiar features
Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.
The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.
Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM2.5.
Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.
After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)
Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
Vitamin D’s role?
Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.
Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.
Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.
However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.
Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.
Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.
“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.
Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
, new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.
The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.
“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.
The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
Toxic pollutants
Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.
Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM2.5) to 10 microns (PM10) in diameter.
The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.
The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.
Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM10 levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.
The current investigators assessed the association between PM2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
Peculiar features
Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.
The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.
Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM2.5.
Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.
After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)
Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
Vitamin D’s role?
Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.
Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.
Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.
However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.
Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.
Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.
“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.
Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
FROM EAN 2020
Mixed results for aducanumab in two phase 3 trials for Alzheimer’s disease
Aducanumab was associated with favorable changes in activities of daily living and in Alzheimer’s disease biomarkers.
The EMERGE and ENGAGE studies compared low-dose and high-dose aducanumab and placebo over 78 weeks. The high-dose EMERGE cohort experienced a 22% improvement in the primary outcome – adjusted mean Clinical Dementia Rating Sum of Box (CDR-SB) scores – compared with baseline.
“We have with EMERGE, in the high-dose group, a positive result,” said lead author Samantha Budd Haeberlein, PhD, who presented this research online as part of the 2020 American Academy of Neurology Science Highlights.
In contrast, the low-dose EMERGE group, as well as the low-dose and high-dose cohorts in the ENGAGE study, experienced no statistically significant change in CDR-SB outcomes.
Clinical benefit was associated with the degree of exposure to aducanumab. For example, a protocol adjustment during the study increased the mean dose of aducanumab, a move associated with better outcomes.
“We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” Dr. Haerberlein, senior vice president and head of the neurodegeneration development unit at Biogen in Cambridge, Mass., said in an interview.
Although the studies shared an identical design, “because ENGAGE began enrolling first and recruitment remained ahead of EMERGE, more patients in EMERGE were impacted by the protocol amendments, which we believe resulted in a higher number of patients exposed to the highest dose in EMERGE versus ENGAGE,” Dr. Haerberlein added.
The EMERGE and ENGAGE studies were conducted at 348 sites in 20 countries. The research included a total of 3,285 participants with mild cognitive impairment caused by Alzheimer’s disease or mild Alzheimer’s disease dementia.
The mean age was 70 years, about 52% were women, and slightly more than half had a history of taking medication for Alzheimer’s disease. The mean Mini-Mental State Exam (MMSE) score was 26 at baseline.
Key findings
Dr. Haerberlein and colleagues reported that the 22% decrease in CDR-SB scores in the high-dose EMERGE participants was significant (P = .01). No significant difference emerged, however, in the ENGAGE study, where high-dose participants had a 2% decrease at 78 weeks in CDR-SB scores (P = .83).
The high-dose EMERGE regimen was also associated with an 18% improvement in MMSE scores (P < .05). In the ENGAGE study, the high-dose MMSE scores increased a nonsignificant 3% (P = .81).
The researchers reported no significant differences in the low-dose cohorts in both studies regarding CDR-SB or MMSE scores at week 78, compared with baseline.
They also assessed amyloid using PET scans. Levels remained essentially the same throughout both studies in the placebo participants. In contrast, there was a statistically significant, dose- and time-dependent reduction associated with both low- and high-dose aducanumab.
Aducanumab treatment was associated with significant benefits on measures of cognition and function such as memory, orientation, and language, Dr. Haeberlein said. “Patients also experienced benefits on activities of daily living including conducting personal finances; performing household chores such as cleaning, shopping, and doing laundry; and independently traveling out of the home.”
Furthermore, reductions in the CSF biomarker phospho-tau in the high-dose EMERGE and ENGAGE cohorts were statistically significant. In contrast, changes in total tau were not significant.
The proportion of patients who experienced an adverse event during EMERGE was similar across groups – 92% of the high-dose group, 88% of the low-dose group, and 87% of the placebo cohort. Similar rates were reported in the ENGAGE high-dose, 90%; low-dose, 90%; and placebo cohorts, 86%.
Adverse events reported in more than 10% of participants included headache, nasopharyngitis, and two forms of amyloid-related imaging abnormalities (ARIA), one of which related to edema (ARIA-E) and the other to hemosiderosis (ARIA-H).
Future plans
Going forward, the researchers are conducting a redosing study to offer aducanumab to all participants in the clinical trials. Also, Biogen is completing the filing of a Biologics License Application with the Food and Drug Administration and with regulatory agencies in other countries.
Early identification and treatment of Alzheimer’s disease remains a priority, Dr. Haeberlein said, because it offers an opportunity to begin health measures like exercise, mental activity, and social engagement; allows people more time to plan for the future; and gives families and loved ones’ time to prepare and support each other. From a research perspective, early identification of this population can maximize chances of participation in a clinical trial as well.
Unanswered questions
“Briefly, while both [studies] were looking at aducanumab’s effect on rate of decline across a variety of measures, one statistically showed a positive impact in a subset and the other did not,” Richard J. Caselli, MD, said when asked to comment on the EMERGE and ENGAGE findings. “The subset were the mildest affected patients on the highest dose for the longest time.”
The main difference between the two studies was that one was adequately powered for this subanalysis and the other was not. Even the underpowered subanalysis showed a beneficial trend, added Dr. Caselli, a neurologist at the Mayo Clinic in Phoenix, Arizona.
Dr. Caselli said these findings raise a number of unanswered questions. For example, is a subanalysis valid? Is the degree of improvement clinically meaningful or meaningful enough to justify the anticipated cost of the drug itself – “likely to be very expensive” plus the “cost and hassle” of monthly IV infusions? Is there enough provider and infusion center capacity going forward? What will the reimbursement from third party payers be like?
Biogen sponsored the EMERGE and ENGAGE studies. Dr. Haeberlein is a Biogen employee. Dr. Caselli had no relevant disclosures.
SOURCE: Haeberlein SB et al. AAN 2020, Abstract 46977.
Aducanumab was associated with favorable changes in activities of daily living and in Alzheimer’s disease biomarkers.
The EMERGE and ENGAGE studies compared low-dose and high-dose aducanumab and placebo over 78 weeks. The high-dose EMERGE cohort experienced a 22% improvement in the primary outcome – adjusted mean Clinical Dementia Rating Sum of Box (CDR-SB) scores – compared with baseline.
“We have with EMERGE, in the high-dose group, a positive result,” said lead author Samantha Budd Haeberlein, PhD, who presented this research online as part of the 2020 American Academy of Neurology Science Highlights.
In contrast, the low-dose EMERGE group, as well as the low-dose and high-dose cohorts in the ENGAGE study, experienced no statistically significant change in CDR-SB outcomes.
Clinical benefit was associated with the degree of exposure to aducanumab. For example, a protocol adjustment during the study increased the mean dose of aducanumab, a move associated with better outcomes.
“We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” Dr. Haerberlein, senior vice president and head of the neurodegeneration development unit at Biogen in Cambridge, Mass., said in an interview.
Although the studies shared an identical design, “because ENGAGE began enrolling first and recruitment remained ahead of EMERGE, more patients in EMERGE were impacted by the protocol amendments, which we believe resulted in a higher number of patients exposed to the highest dose in EMERGE versus ENGAGE,” Dr. Haerberlein added.
The EMERGE and ENGAGE studies were conducted at 348 sites in 20 countries. The research included a total of 3,285 participants with mild cognitive impairment caused by Alzheimer’s disease or mild Alzheimer’s disease dementia.
The mean age was 70 years, about 52% were women, and slightly more than half had a history of taking medication for Alzheimer’s disease. The mean Mini-Mental State Exam (MMSE) score was 26 at baseline.
Key findings
Dr. Haerberlein and colleagues reported that the 22% decrease in CDR-SB scores in the high-dose EMERGE participants was significant (P = .01). No significant difference emerged, however, in the ENGAGE study, where high-dose participants had a 2% decrease at 78 weeks in CDR-SB scores (P = .83).
The high-dose EMERGE regimen was also associated with an 18% improvement in MMSE scores (P < .05). In the ENGAGE study, the high-dose MMSE scores increased a nonsignificant 3% (P = .81).
The researchers reported no significant differences in the low-dose cohorts in both studies regarding CDR-SB or MMSE scores at week 78, compared with baseline.
They also assessed amyloid using PET scans. Levels remained essentially the same throughout both studies in the placebo participants. In contrast, there was a statistically significant, dose- and time-dependent reduction associated with both low- and high-dose aducanumab.
Aducanumab treatment was associated with significant benefits on measures of cognition and function such as memory, orientation, and language, Dr. Haeberlein said. “Patients also experienced benefits on activities of daily living including conducting personal finances; performing household chores such as cleaning, shopping, and doing laundry; and independently traveling out of the home.”
Furthermore, reductions in the CSF biomarker phospho-tau in the high-dose EMERGE and ENGAGE cohorts were statistically significant. In contrast, changes in total tau were not significant.
The proportion of patients who experienced an adverse event during EMERGE was similar across groups – 92% of the high-dose group, 88% of the low-dose group, and 87% of the placebo cohort. Similar rates were reported in the ENGAGE high-dose, 90%; low-dose, 90%; and placebo cohorts, 86%.
Adverse events reported in more than 10% of participants included headache, nasopharyngitis, and two forms of amyloid-related imaging abnormalities (ARIA), one of which related to edema (ARIA-E) and the other to hemosiderosis (ARIA-H).
Future plans
Going forward, the researchers are conducting a redosing study to offer aducanumab to all participants in the clinical trials. Also, Biogen is completing the filing of a Biologics License Application with the Food and Drug Administration and with regulatory agencies in other countries.
Early identification and treatment of Alzheimer’s disease remains a priority, Dr. Haeberlein said, because it offers an opportunity to begin health measures like exercise, mental activity, and social engagement; allows people more time to plan for the future; and gives families and loved ones’ time to prepare and support each other. From a research perspective, early identification of this population can maximize chances of participation in a clinical trial as well.
Unanswered questions
“Briefly, while both [studies] were looking at aducanumab’s effect on rate of decline across a variety of measures, one statistically showed a positive impact in a subset and the other did not,” Richard J. Caselli, MD, said when asked to comment on the EMERGE and ENGAGE findings. “The subset were the mildest affected patients on the highest dose for the longest time.”
The main difference between the two studies was that one was adequately powered for this subanalysis and the other was not. Even the underpowered subanalysis showed a beneficial trend, added Dr. Caselli, a neurologist at the Mayo Clinic in Phoenix, Arizona.
Dr. Caselli said these findings raise a number of unanswered questions. For example, is a subanalysis valid? Is the degree of improvement clinically meaningful or meaningful enough to justify the anticipated cost of the drug itself – “likely to be very expensive” plus the “cost and hassle” of monthly IV infusions? Is there enough provider and infusion center capacity going forward? What will the reimbursement from third party payers be like?
Biogen sponsored the EMERGE and ENGAGE studies. Dr. Haeberlein is a Biogen employee. Dr. Caselli had no relevant disclosures.
SOURCE: Haeberlein SB et al. AAN 2020, Abstract 46977.
Aducanumab was associated with favorable changes in activities of daily living and in Alzheimer’s disease biomarkers.
The EMERGE and ENGAGE studies compared low-dose and high-dose aducanumab and placebo over 78 weeks. The high-dose EMERGE cohort experienced a 22% improvement in the primary outcome – adjusted mean Clinical Dementia Rating Sum of Box (CDR-SB) scores – compared with baseline.
“We have with EMERGE, in the high-dose group, a positive result,” said lead author Samantha Budd Haeberlein, PhD, who presented this research online as part of the 2020 American Academy of Neurology Science Highlights.
In contrast, the low-dose EMERGE group, as well as the low-dose and high-dose cohorts in the ENGAGE study, experienced no statistically significant change in CDR-SB outcomes.
Clinical benefit was associated with the degree of exposure to aducanumab. For example, a protocol adjustment during the study increased the mean dose of aducanumab, a move associated with better outcomes.
“We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” Dr. Haerberlein, senior vice president and head of the neurodegeneration development unit at Biogen in Cambridge, Mass., said in an interview.
Although the studies shared an identical design, “because ENGAGE began enrolling first and recruitment remained ahead of EMERGE, more patients in EMERGE were impacted by the protocol amendments, which we believe resulted in a higher number of patients exposed to the highest dose in EMERGE versus ENGAGE,” Dr. Haerberlein added.
The EMERGE and ENGAGE studies were conducted at 348 sites in 20 countries. The research included a total of 3,285 participants with mild cognitive impairment caused by Alzheimer’s disease or mild Alzheimer’s disease dementia.
The mean age was 70 years, about 52% were women, and slightly more than half had a history of taking medication for Alzheimer’s disease. The mean Mini-Mental State Exam (MMSE) score was 26 at baseline.
Key findings
Dr. Haerberlein and colleagues reported that the 22% decrease in CDR-SB scores in the high-dose EMERGE participants was significant (P = .01). No significant difference emerged, however, in the ENGAGE study, where high-dose participants had a 2% decrease at 78 weeks in CDR-SB scores (P = .83).
The high-dose EMERGE regimen was also associated with an 18% improvement in MMSE scores (P < .05). In the ENGAGE study, the high-dose MMSE scores increased a nonsignificant 3% (P = .81).
The researchers reported no significant differences in the low-dose cohorts in both studies regarding CDR-SB or MMSE scores at week 78, compared with baseline.
They also assessed amyloid using PET scans. Levels remained essentially the same throughout both studies in the placebo participants. In contrast, there was a statistically significant, dose- and time-dependent reduction associated with both low- and high-dose aducanumab.
Aducanumab treatment was associated with significant benefits on measures of cognition and function such as memory, orientation, and language, Dr. Haeberlein said. “Patients also experienced benefits on activities of daily living including conducting personal finances; performing household chores such as cleaning, shopping, and doing laundry; and independently traveling out of the home.”
Furthermore, reductions in the CSF biomarker phospho-tau in the high-dose EMERGE and ENGAGE cohorts were statistically significant. In contrast, changes in total tau were not significant.
The proportion of patients who experienced an adverse event during EMERGE was similar across groups – 92% of the high-dose group, 88% of the low-dose group, and 87% of the placebo cohort. Similar rates were reported in the ENGAGE high-dose, 90%; low-dose, 90%; and placebo cohorts, 86%.
Adverse events reported in more than 10% of participants included headache, nasopharyngitis, and two forms of amyloid-related imaging abnormalities (ARIA), one of which related to edema (ARIA-E) and the other to hemosiderosis (ARIA-H).
Future plans
Going forward, the researchers are conducting a redosing study to offer aducanumab to all participants in the clinical trials. Also, Biogen is completing the filing of a Biologics License Application with the Food and Drug Administration and with regulatory agencies in other countries.
Early identification and treatment of Alzheimer’s disease remains a priority, Dr. Haeberlein said, because it offers an opportunity to begin health measures like exercise, mental activity, and social engagement; allows people more time to plan for the future; and gives families and loved ones’ time to prepare and support each other. From a research perspective, early identification of this population can maximize chances of participation in a clinical trial as well.
Unanswered questions
“Briefly, while both [studies] were looking at aducanumab’s effect on rate of decline across a variety of measures, one statistically showed a positive impact in a subset and the other did not,” Richard J. Caselli, MD, said when asked to comment on the EMERGE and ENGAGE findings. “The subset were the mildest affected patients on the highest dose for the longest time.”
The main difference between the two studies was that one was adequately powered for this subanalysis and the other was not. Even the underpowered subanalysis showed a beneficial trend, added Dr. Caselli, a neurologist at the Mayo Clinic in Phoenix, Arizona.
Dr. Caselli said these findings raise a number of unanswered questions. For example, is a subanalysis valid? Is the degree of improvement clinically meaningful or meaningful enough to justify the anticipated cost of the drug itself – “likely to be very expensive” plus the “cost and hassle” of monthly IV infusions? Is there enough provider and infusion center capacity going forward? What will the reimbursement from third party payers be like?
Biogen sponsored the EMERGE and ENGAGE studies. Dr. Haeberlein is a Biogen employee. Dr. Caselli had no relevant disclosures.
SOURCE: Haeberlein SB et al. AAN 2020, Abstract 46977.
FROM AAN 2020
Galcanezumab looks promising for treatment-resistant migraine
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
FROM AAN 2020
COVID-19: Psychiatrists assess geriatric harm from social distancing
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
Social isolation tied to higher risk of cardiovascular events, death
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
FROM EAN 2020
An eConsults Program to Improve Patient Access to Specialty Care in an Academic Health System
From the Department of Medicine, University of California, Irvine, Orange, CA.
Abstract
Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.
Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.
Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.
Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.
Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.
Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.
Orange County’s growing, aging, and diverse population is driving an increased demand for health care.1 But with the county’s high cost of living and worsening shortage of physicians,1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,7-9 and avoid the time and costs associated with a visit to the specialist,10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.8,12
Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.
Setting
UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.
eConsults Program
We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.
To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.
Implementation
The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.
The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).
Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.
Measurement/Analysis
The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.
Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.
Results
Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).
The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.
As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.
Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).
Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.
Discussion
Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.
We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.8,12-16
We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,8,9,13,14,17-19 though some reported that the level of satisfaction among specialists was more varied.18-21
Lessons Learned
The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.
Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.
We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.
Applicability
Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.
Current Status and Future Directions
Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.
Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.
Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; anamin@uci.edu.
Financial disclosures: None.
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19. McAdams M, Cannavo L, Orlander JD. A medical specialty e-consult program in a VA health care system. Fed Pract. 2014; 31:26–31.
20. Keely E, Williams R, Epstein G, et al. Specialist perspectives on Ontario Provincial electronic consultation services. Telemed J E Health. 2019;25:3-10.
21. Kim-Hwang JE, Chen AH, Bell DS, et al. Evaluating electronic referrals for specialty care at a public hospital. J Gen Intern Med. 2010;25:1123-1128.
From the Department of Medicine, University of California, Irvine, Orange, CA.
Abstract
Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.
Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.
Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.
Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.
Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.
Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.
Orange County’s growing, aging, and diverse population is driving an increased demand for health care.1 But with the county’s high cost of living and worsening shortage of physicians,1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,7-9 and avoid the time and costs associated with a visit to the specialist,10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.8,12
Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.
Setting
UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.
eConsults Program
We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.
To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.
Implementation
The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.
The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).
Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.
Measurement/Analysis
The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.
Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.
Results
Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).
The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.
As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.
Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).
Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.
Discussion
Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.
We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.8,12-16
We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,8,9,13,14,17-19 though some reported that the level of satisfaction among specialists was more varied.18-21
Lessons Learned
The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.
Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.
We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.
Applicability
Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.
Current Status and Future Directions
Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.
Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.
Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; anamin@uci.edu.
Financial disclosures: None.
From the Department of Medicine, University of California, Irvine, Orange, CA.
Abstract
Background: Orange County’s residents have difficulty accessing timely, quality, affordable specialty care services. As the county’s only academic health system, the University of California, Irvine (UCI) aimed to improve specialty care access for the communities it serves by implementing an electronic consultations (eConsults) program that allows primary care providers (PCPs) to efficiently receive specialist recommendations on referral problems that do not require an in-person evaluation.
Objective: To implement an eConsults program at the UCI that enhances access to and the delivery of coordinated specialty care for lower-complexity referral problems.
Methods: We developed custom solutions to integrate eConsults into UCI’s 2 electronic health record platforms. The impact of the eConsults program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of submitted eConsult requests per PCP, the number of completed responses per specialty, and the response time for eConsult requests. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback.
Results: Over 4.5 years, more than 1400 successful eConsults have been completed, and the program has expanded to 17 specialties. The average turnaround time for an eConsult response across all specialties was 1 business day. Moreover, more than 50% of the eConsults received specialty responses within the same day of the eConsult request. Most important, about 80% of eConsult requests were addressed without the need for an in-office visit with a specialist.
Conclusion: The enhanced access to and the delivery of coordinated specialty care provided by eConsults resulted in improved efficiency and specialty access, while likely reducing costs and improving patient satisfaction. The improved communication and collaboration among providers with eConsults has also led to overwhelmingly positive feedback from both PCPs and specialists.
Keywords: electronic consultation; access to care; primary care; specialty referral; telehealth.
Orange County’s growing, aging, and diverse population is driving an increased demand for health care.1 But with the county’s high cost of living and worsening shortage of physicians,1-3 many of its residents are struggling to access timely, quality, affordable care. Access to specialty care services is especially frustrating for many patients and their providers, both primary care providers (PCPs) and specialists, due to problems with the referral process. Many patients experience increased wait times for a visit with a specialist due to poor communication between providers, insufficient guidance on the information or diagnostic results needed by specialists, and lack of care coordination.4-6 One promising approach to overcome these challenges is the use of an electronic consultation, or eConsult, in place of a standard in-person referral. An eConsult is an asynchronous, non-face-to-face, provider-to-provider exchange using a secure electronic communication platform. For appropriate referral problems, the patient is able to receive timely access to specialist expertise through electronic referral by their PCP,7-9 and avoid the time and costs associated with a visit to the specialist,10,11 such as travel, missed work, co-pays, and child-care expenses. Clinical questions addressed using an eConsult system subsequently free up office visit appointment slots, improving access for patients requiring in-office evaluation.8,12
Orange County’s only academic health system, the University of California, Irvine (UCI), serves a population of 3.5 million, and its principal priority is providing the communities in the county (which is the sixth largest in United States) and the surrounding region with the highest quality health care possible. Thus, UCI aimed to improve its referral processes and provide timely access to specialty care for its patients by implementing an eConsults program that allows PCPs to efficiently receive specialist recommendations on referral problems that do not require the specialist to evaluate the patient in person. This report describes our experiences with developing and implementing a custom-built eConsults workflow in UCI’s prior electronic health record (EHR) platform, Allscripts, and subsequently transitioning our mature eConsults program to a new EHR system when UCI adopted Epic. UCI is likely the only academic medical center to have experience in successfully implementing eConsults into 2 different EHR systems.
Setting
UCI’s medical center is a 417-bed acute care hospital providing tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health care, and rehabilitation services. It is located in Orange, CA, and serves a diverse population of 3.5 million persons with broad health care needs. With more than 400 specialty and primary care physicians, UCI offers a full scope of acute and general care services. It is also the primary teaching location for UCI medical and nursing students, medical residents, and fellows, and is home to Orange County’s only adult Level I and pediatric Level II trauma centers and the regional burn center.
eConsults Program
We designed the initial eConsults program within UCI’s Allscripts EHR platform. Our information technology (IT) build team developed unique “documents-based” eConsults workflows that simplified the process of initiating requests directly from the EHR and facilitated rapid responses from participating specialties. The requesting provider’s eConsults interface was user-friendly, and referring providers were able to initiate an eConsult easily by selecting the customized eConsult icon from the Allscripts main toolbar. To ensure that all relevant information is provided to the specialists, condition-specific templates are embedded in the requesting provider’s eConsults workflow that allow PCPs to enter a focused, patient-specific clinical question and provide guidance on recommended patient information (eg, health history, laboratory results, and digital images) that may help the specialist provide an informed response. The eConsult templates were adapted from standardized forms developed by partner University of California Health Systems in an initiative funded by the University of California Center for Health Quality and Innovation.
To facilitate timely responses from specialists, an innovative notification system was created in the responding provider’s eConsults workflow to automatically send an email to participating specialists when a new eConsult is requested. The responding provider’s workflow also includes an option for the specialist to decline the eConsult if the case is deemed too complex to be addressed electronically. For every completed eConsult that does not result in an in-person patient evaluation, the requesting provider and responding specialist each receives a modest reimbursement, which was initially paid by UCI Health System funds.
Implementation
The design and implementation of the eConsults program began in November 2014, and was guided by a steering committee that included the chair of the department of medicine, chief medical information officer, primary care and specialty physician leads, IT build team, and a project manager. Early on, members of this committee engaged UCI leadership to affirm support for the program and obtain the IT resources needed to build the eConsults workflow. Regular steering committee meetings were established to discuss the design of the workflow, adapt the clinical content of the referral templates, and develop a provider reimbursement plan. After completion of the workflow build, the eConsults system was tested to identify failure points and obtain feedback from users. Prior to going live, the eConsults program was publicized by members of the steering committee through meetings with primary care groups and email communications. Committee members also hosted in-person training and orientation sessions with PCPs and participating specialists, and distributed tip sheets summarizing the steps to complete the PCP and specialist eConsult workflows.
The eConsults workflow build, testing, and launch were completed within 5 months (April 2015; Figure 1). eConsults went live in the 3 initial specialties (endocrinology, cardiology, and rheumatology) that were interested in participating in the first wave of the program. UCI’s eConsults service has subsequently expanded to 17 total specialties (allergy, cardiology, dermatology, endocrinology, gastroenterology, geriatrics, gynecology, hematology, hepatology, infectious disease, nephrology, neurology, palliative care, psychiatry, pulmonary, rheumatology, and sports medicine).
Two and half years after the eConsults program was implemented in Allscripts, UCI adopted a new EHR platform, Epic. By this time, the eConsults service had grown into a mature program with greater numbers of PCP users and submitted eConsults (Figure 2). Using our experience with the Allscripts build, our IT team was able to efficiently transition the eConsults service to the new EHR system. In contrast to the “documents-based” eConsult workflows on Allscripts, our IT team utilized an “orders-based” strategy on Epic, which followed a more traditional approach to requesting a consultation. We re-launched the service in Epic within 3 months (February 2018). However, both platforms utilized user-friendly workflows to achieve similar goals, and the program has continued to grow with respect to the number of users and eConsults.
Measurement/Analysis
The impact of the program was assessed by continuously evaluating usage and outcomes. Measures used to track usage included the number of PCP users, the number of submitted eConsult requests per PCP, and the number of requests per specialty. The response time for eConsult requests and the self-reported amount of time spent by specialists on the response were also tracked. Outcome measures included the specialist recommendation (eg, in-office visit, consultation avoided) and physician feedback. Provider satisfaction was primarily obtained by soliciting feedback from individual eConsult users.
Implementation of this eConsults program constituted a quality improvement activity and did not require Institutional Review Board review.
Results
Since the program was launched in April 2015, more than 1400 eConsults have been completed across 17 specialties (Figure 3). There were 654 completed eConsults on the Allscripts platform, and 808 eConsults have been completed using the Epic platform to date. The busiest eConsult specialties were endocrinology (receiving 276, or 19%, of the eConsults requests), hematology (receiving 249 requests, or 17%), infectious disease (receiving 244 requests, or 17% ), and cardiology (receiving 148 requests, or 10%).
The self-reported amount of time specialists spent on the response was different between the 2 EHR systems (Figure 4). On Allscripts, specialists reported that 23% of eConsults took 10 minutes or less to complete, 47% took 11 to 20 minutes, 23% took 21 to 30 minutes, and 7% took more than 30 minutes. On Epic, specialists reported that 42% of eConsults took 10 minutes or less to complete, 44% took 11 to 20 minutes, 12% took 21 to 30 minutes, and 2% took more than 30 minutes. This difference in time spent fielding eConsults likely represents the subtle nuances between Allscripts’ “documents-based” and Epic’s “orders-based” workflows.
As a result of the automated notification system that was introduced early in the eConsults implementation process on Allscripts, the specialty response times were much faster than the expected 3 business days’ turnaround goal instituted by the Center for Health Quality and Innovation initiative, regardless of the EHR platform used. In fact, the average turnaround time for an eConsult response across all specialties was 1 business day, which was similar for both EHR systems (Figure 5). Furthermore, more than 50% of the eConsults on both EHR systems received specialist responses within the same day of the eConsult request (63% on Allscripts, 54% on Epic). There was a small decrease in the percentage of same-day responses when we transitioned to Epic, likely because the functionality of an automated notification email could not be restored in Epic. Regardless, the specialty response times on Epic remained expeditious, likely because the automated notifications on Allscripts instilled good practices for the specialists, and regularly checking for new eConsult requests became an ingrained behavior.
Our most important finding was that approximately 80% of eConsult requests were addressed without the need for an in-office visit with a specialist. This measure was similar for both EHR platforms (83% on Allscripts and 78% on Epic).
Provider feedback has been overwhelmingly positive. PCPs are impressed with the robust educational content of the eConsult responses, since the goal for specialists is to justify their recommendations. Specialists appreciate the convenience and efficiency that eConsults offer, as well as the improved communication and collaboration among physicians. eConsults have been especially beneficial to PCPs at UCI’s Family Health Centers, who are now able to receive subspecialty consultations from UCI specialists despite insurance barriers.
Discussion
Our eConsults program uniquely contrasts with other programs because UCI is likely the only academic medical center to have experience in successfully incorporating eConsults into 2 different EHR systems: initial development of the eConsults workflow in UCI’s existing Allscripts EHR platform, and subsequently transitioning a mature eConsults program to a new EHR system when the institution adopted Epic.
We measured the impact of the eConsults program on access to care by the response time for eConsult requests and the percentage of eConsults that averted an in-office visit with a specialist. We found that the eConsults program at UCI provided our PCPs access to specialist consultations in a timely manner, with much shorter response times than standard in-person referrals. The average turnaround time for an eConsult response we reported is consistent with findings from other studies.12-15 Additionally, our program was able to address about 80% of its eConsults electronically, helping to reduce unnecessary in-person specialist referrals. In the literature, the percentage of eConsults that avoided an in-person specialist visit varies widely.8,12-16
We reported very positive feedback from both PCPs and specialists on UCI’s eConsults service. Similarly, other studies described PCP satisfaction with their respective eConsults programs to be uniformly high,8,9,13,14,17-19 though some reported that the level of satisfaction among specialists was more varied.18-21
Lessons Learned
The successful design and implementation of our eConsults program began with assembling the right clinical champions and technology partners for our steering committee. Establishing regular steering committee meetings helped maintain an appropriate timeline for completion of different aspects of the project. Engaging support from UCI’s leadership also provided us with a dedicated IT team that helped us with the build, training resources, troubleshooting issues, and reporting for the project.
Our experience with implementing the eConsults program on 2 different EHR systems highlighted the importance of creating efficient, user-friendly workflows to foster provider adoption and achieve sustainability. Allscripts’ open platform gave our IT team the ability to create a homegrown solution to implementing an eConsult model that was simple and easy to use. The Epic platform’s interoperability allowed us to leverage our learnings from the Allscripts build to efficiently implement eConsults in Epic.
We also found that providing modest incentive payments or reimbursements to both PCPs and specialists for each completed eConsult helps with both adoption and program sustainability. Initially, credit for the eConsult work was paid by internal UCI Health System funds. Two payers, UC Care (a preferred provider organization plan created just for the University of California) and more recently, the Centers for Medicare & Medicaid Services, have agreed to reimburse for outpatient eConsults. Securing additional payers for reimbursement of the eConsult service will not only ensure the program’s long-term sustainability, but also represents an acknowledgment of the value of eConsults in supporting access to care.
Applicability
Other health care settings that are experiencing issues with specialty care access can successfully implement their own eConsults program by employing strategies similar to those described in this report—assembling the right team, creating user-friendly workflows, and providing incentives. Our advice for successful implementation is to clearly communicate your goals to all involved, including primary care, specialists, leadership, and IT partners, and establish with these stakeholders the appropriate support and resources needed to facilitate the development of the program and overcome any barriers to adoption.
Current Status and Future Directions
Our future plans include continuing to optimize the Epic eConsult backend build and workflows using our experience in Allscripts. We have implemented eConsult workflows for use by graduate medical education trainees and advanced practice providers, with attending supervision. Further work is in progress to optimize these workflows, which will allow for appropriate education and supervision without delaying care. Furthermore, we plan to expand the program to include inpatient-to-inpatient and emergency department-to-inpatient eConsults. We will continue to expand the eConsults program by offering additional specialties, engage providers to encourage ongoing participation, and maximize PCP use by continuing to market the program through regular newsletters and email communications. Finally, the eConsults has served as an effective, important resource in the current era of COVID-19 in several ways: it allows for optimization of specialty input in patient care delivery without subjecting more health care workers to unnecessary exposure; saves on utilization of precious personal protective equipment; and enhances our ability to deal with a potential surge by providing access to specialists remotely and electronically all hours of the day, thus expanding care to the evening and weekend hours.
Acknowledgment: The authors thank our steering committee members (Dr. Ralph Cygan, Dr. Andrew Reikes, Dr. Byron Allen, Dr. George Lawry) and IT build team (Lori Bocchicchio, Meghan van Witsen, Jaymee Zillgitt, Tanya Sickles, Dennis Hoang, Jeanette Lisak-Phillips) for their contributions in the design and implementation of our eConsults program. We also thank additional team members Kurt McArthur and Neaktisia Lee for their assistance with generating reports, and Kathy LaPierre, Jennifer Rios, and Debra Webb Torres for their guidance with compliance and billing issues.
Corresponding author: Alpesh N. Amin, MD, MBA, University of California, Irvine, 101 The City Drive South, Building 26, Room 1000, ZC-4076H, Orange, CA 92868; anamin@uci.edu.
Financial disclosures: None.
1. County of Orange, Health Care Agency, Public Health Services. Orange County Health Profile 2013.
2. Coffman JM, Fix M Ko, M. California physician supply and distribution: headed for a drought? California Health Care Foundation, June 2018.
3. Spetz J, Coffman J, Geyn I. California’s primary care workforce: forecasted supply, demand, and pipeline of trainees, 2016-2030. Healthforce Center at the University of California, San Francisco, August 2017.
4. Gandhi TK, Sittig DF, Franklin M, et al. Communication breakdown in the outpatient referral process. J Gen Intern Med. 2000;15:626-631.
5. McPhee SJ, Lo B, Saika GY, Meltzer R. How good is communication between primary care physicians and subspecialty consultants? Arch Intern Med. 1984;144:1265-1268.
6. Mehrotra A, Forrest CB, Lin CY. Dropping the baton: specialty referrals in the United States. Milbank Q. 2011;89:39-68.
7. Wrenn K, Catschegn S, Cruz M, et al. Analysis of an electronic consultation program at an academic medical centre: Primary care provider questions, specialist responses, and primary care provider actions. J Telemed Telecare. 2017;23: 217-224.
8. Gleason N, Prasad PA, Ackerman S, et al. Adoption and impact of an eConsult system in a fee-for-service setting. Healthc (Amst). 2017;5(1-2):40-45.
9. Stoves J, Connolly J, Cheung CK, et al. Electronic consultation as an alternative to hospital referral for patients with chronic kidney disease: a novel application for networked electronic health records to improve the accessibility and efficiency of healthcare. Qual Saf Health Care. 2010;19: e54.
10. Datta SK, Warshaw EM, Edison KE, et al. Cost and utility analysis of a store-and-forward teledermatology referral system: a randomized clinical trial. JAMA Dermatol. 2015;151:1323-1329.
11. Liddy C, Drosinis P, Deri Armstrong C, et al. What are the cost savings associated with providing access to specialist care through the Champlain BASE eConsult service? A costing evaluation. BMJ Open. 2016;6:e010920.
12. Barnett ML, Yee HF Jr, Mehrotra A, Giboney P. Los Angeles safety-net program eConsult system was rapidly adopted and decreased wait times to see specialists. Health Aff. 2017;36:492-499.
13. Malagrino GD, Chaudhry R, Gardner M, et al. A study of 6,000 electronic specialty consultations for person-centered care at The Mayo Clinic. Int J Person Centered Med. 2012;2:458-466.
14. Keely E, Liddy C, Afkham A. Utilization, benefits, and impact of an e-consultation service across diverse specialties and primary care providers. Telemed J E Health. 2013;19:733-738.
15. Scherpbier-de Haan ND, van Gelder VA, Van Weel C, et al. Initial implementation of a web-based consultation process for patients with chronic kidney disease. Ann Fam Med. 2013;11:151-156.
16. Palen TE, Price D, Shetterly S, Wallace KB. Comparing virtual consults to traditional consults using an electronic health record: an observational case-control study. BMC Med Inform Decis Mak. 2012;12:65.
17. Liddy C, Afkham A, Drosinis P, et al. Impact of and satisfaction with a new eConsult service: a mixed methods study of primary care providers. J Am Board Fam Med. 2015;28:394-403.
18. Angstman KB, Adamson SC, Furst JW, et al. Provider satisfaction with virtual specialist consultations in a family medicine department. Health Care Manag (Frederick). 2009;28:14-18.
19. McAdams M, Cannavo L, Orlander JD. A medical specialty e-consult program in a VA health care system. Fed Pract. 2014; 31:26–31.
20. Keely E, Williams R, Epstein G, et al. Specialist perspectives on Ontario Provincial electronic consultation services. Telemed J E Health. 2019;25:3-10.
21. Kim-Hwang JE, Chen AH, Bell DS, et al. Evaluating electronic referrals for specialty care at a public hospital. J Gen Intern Med. 2010;25:1123-1128.
1. County of Orange, Health Care Agency, Public Health Services. Orange County Health Profile 2013.
2. Coffman JM, Fix M Ko, M. California physician supply and distribution: headed for a drought? California Health Care Foundation, June 2018.
3. Spetz J, Coffman J, Geyn I. California’s primary care workforce: forecasted supply, demand, and pipeline of trainees, 2016-2030. Healthforce Center at the University of California, San Francisco, August 2017.
4. Gandhi TK, Sittig DF, Franklin M, et al. Communication breakdown in the outpatient referral process. J Gen Intern Med. 2000;15:626-631.
5. McPhee SJ, Lo B, Saika GY, Meltzer R. How good is communication between primary care physicians and subspecialty consultants? Arch Intern Med. 1984;144:1265-1268.
6. Mehrotra A, Forrest CB, Lin CY. Dropping the baton: specialty referrals in the United States. Milbank Q. 2011;89:39-68.
7. Wrenn K, Catschegn S, Cruz M, et al. Analysis of an electronic consultation program at an academic medical centre: Primary care provider questions, specialist responses, and primary care provider actions. J Telemed Telecare. 2017;23: 217-224.
8. Gleason N, Prasad PA, Ackerman S, et al. Adoption and impact of an eConsult system in a fee-for-service setting. Healthc (Amst). 2017;5(1-2):40-45.
9. Stoves J, Connolly J, Cheung CK, et al. Electronic consultation as an alternative to hospital referral for patients with chronic kidney disease: a novel application for networked electronic health records to improve the accessibility and efficiency of healthcare. Qual Saf Health Care. 2010;19: e54.
10. Datta SK, Warshaw EM, Edison KE, et al. Cost and utility analysis of a store-and-forward teledermatology referral system: a randomized clinical trial. JAMA Dermatol. 2015;151:1323-1329.
11. Liddy C, Drosinis P, Deri Armstrong C, et al. What are the cost savings associated with providing access to specialist care through the Champlain BASE eConsult service? A costing evaluation. BMJ Open. 2016;6:e010920.
12. Barnett ML, Yee HF Jr, Mehrotra A, Giboney P. Los Angeles safety-net program eConsult system was rapidly adopted and decreased wait times to see specialists. Health Aff. 2017;36:492-499.
13. Malagrino GD, Chaudhry R, Gardner M, et al. A study of 6,000 electronic specialty consultations for person-centered care at The Mayo Clinic. Int J Person Centered Med. 2012;2:458-466.
14. Keely E, Liddy C, Afkham A. Utilization, benefits, and impact of an e-consultation service across diverse specialties and primary care providers. Telemed J E Health. 2013;19:733-738.
15. Scherpbier-de Haan ND, van Gelder VA, Van Weel C, et al. Initial implementation of a web-based consultation process for patients with chronic kidney disease. Ann Fam Med. 2013;11:151-156.
16. Palen TE, Price D, Shetterly S, Wallace KB. Comparing virtual consults to traditional consults using an electronic health record: an observational case-control study. BMC Med Inform Decis Mak. 2012;12:65.
17. Liddy C, Afkham A, Drosinis P, et al. Impact of and satisfaction with a new eConsult service: a mixed methods study of primary care providers. J Am Board Fam Med. 2015;28:394-403.
18. Angstman KB, Adamson SC, Furst JW, et al. Provider satisfaction with virtual specialist consultations in a family medicine department. Health Care Manag (Frederick). 2009;28:14-18.
19. McAdams M, Cannavo L, Orlander JD. A medical specialty e-consult program in a VA health care system. Fed Pract. 2014; 31:26–31.
20. Keely E, Williams R, Epstein G, et al. Specialist perspectives on Ontario Provincial electronic consultation services. Telemed J E Health. 2019;25:3-10.
21. Kim-Hwang JE, Chen AH, Bell DS, et al. Evaluating electronic referrals for specialty care at a public hospital. J Gen Intern Med. 2010;25:1123-1128.
Framingham risk score may also predict cognitive decline
“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.
“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”
Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.
The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
Assessing cardiovascular risk and cognition
The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).
Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.
A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.
Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.
At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.
Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.
The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.
Bringing dementia prevention into the exam room early
Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.
“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.
“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”
Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.
Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.
Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.
Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.
The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.
Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.
Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.
This article appeared on Medscape.com.
“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.
“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”
Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.
The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
Assessing cardiovascular risk and cognition
The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).
Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.
A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.
Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.
At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.
Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.
The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.
Bringing dementia prevention into the exam room early
Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.
“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.
“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”
Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.
Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.
Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.
Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.
The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.
Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.
Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.
This article appeared on Medscape.com.
“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.
“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”
Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.
The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
Assessing cardiovascular risk and cognition
The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).
Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.
A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.
Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.
At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.
Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.
The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.
Bringing dementia prevention into the exam room early
Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.
“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.
“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”
Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.
Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.
Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.
Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.
The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.
Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.
Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.
This article appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
AHA offers advice on prehospital acute stroke triage amid COVID-19
A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.
“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)
“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.
“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
A new layer of complexity
The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.
“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.
The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.
The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.
They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.
“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.
The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.
“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.
This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.
This article first appeared on Medscape.com.
A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.
“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)
“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.
“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
A new layer of complexity
The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.
“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.
The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.
The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.
They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.
“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.
The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.
“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.
This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.
This article first appeared on Medscape.com.
A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.
“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)
“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.
“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
A new layer of complexity
The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.
“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.
The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.
The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.
They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.
“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.
The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.
“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.
This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.
This article first appeared on Medscape.com.