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Medicaid coverage decreased in Arkansas following work requirements
WASHINGTON – Early analysis of the implementation of Medicaid work requirements suggests administrative burden on beneficiaries is leading to decreased coverage.
according to state reports.
A study of the early months after Arkansas put its work requirement into effect in June 2018 found those most affected were people already working but unaware of or unable to meet the administrative requirements to demonstrate they were working. These people lost coverage.
Researchers identified “lots of confusion,” Anna Goldman, MD, of Harvard University, Boston, told attendees at the annual meeting of the Society of General Internal Medicine 2019 conference. “People didn’t know if they should report, or if they thought they should, they didn’t know how.”
Additionally, there is no evidence that the implementation of the work rules caused an increase of employment within the Medicaid-eligible population in Arkansas within the first 6 months of the law going into effect.
Arkansas’s rules required individuals aged 30-49 years (applied during the first 6 months of the rollout) to work at least 80 hours a month in a job or doing something equivalent to a job, such as job skills training. Exemptions were available to those who were disabled, pregnant, or caregiving; had student status; or were receiving treatment for substance abuse. Individuals were required to report their work hours each month. Failure to do so for 3 months in a year would cause Medicaid benefits to be suspended for the balance of the year.
Dr. Goldman noted that phone surveys were done in four states (Arkansas, Kentucky, Louisiana, and Texas) of low-income adults earning up to 138% of the federal poverty limit. About 6,000 people were surveyed across the four states, with half coming from 2016 and the other from a survey in 2018. In both years, the surveys were conducted in November and December of survey years. She acknowledged a low response rate of 14%, but she said that weighting was used to minimize nonresponse bias.
With the introduction of the work requirements, researchers found a 13.2% decrease in Medicaid or marketplace insurance and a 7.1% increase in the uninsured rate. No change in employment rates were found.
She noted that the findings that employment didn’t change were not surprising “given that 95% of people were either exempt or working, according to our survey results.”
Dr. Goldman said the survey completed for this study was consistent with studies done in Arkansas that showed most people that would be covered by the work rule were either working or would be exempt from the work requirements laid forth by state regulation.
“Those studies had raised an initial concern that most of the coverage losses would be related to nonreporting and administrative issues as opposed to just removing people who were healthy and didn’t want to get a job,” she explained.
Dr. Goldman noted that this newer study found that of the people required to report their work activities to the state, half didn’t because they either had no Internet access or were confused and could not figure out how to use the reporting system, even though they met the work requirements necessary to keep their Medicaid coverage.
In general, about 52% of the Arkansas population surveyed had heard something about the work requirements, but of those in the age range targeted by the rules, only 22% thought they were subject to the work requirements. Of those informed by the state that they needed to report, only half said they were doing so, Dr. Goldman added.
The survey results were consistent with state reports on the number of people experiencing coverage loss after the rollout, she said.
“One important thing to take away is that information barriers and administrative hassles are key reasons why people are losing coverage. ... Therefore, anything that states can do to automatically exempt people using state data that they already have can possibly reduce unnecessary coverage losses,” Dr. Goldman concluded.
Arkansas’s Medicaid work requirements were blocked by a federal judge in March 2019. Appeals are ongoing.
The authors reported no disclosures.
WASHINGTON – Early analysis of the implementation of Medicaid work requirements suggests administrative burden on beneficiaries is leading to decreased coverage.
according to state reports.
A study of the early months after Arkansas put its work requirement into effect in June 2018 found those most affected were people already working but unaware of or unable to meet the administrative requirements to demonstrate they were working. These people lost coverage.
Researchers identified “lots of confusion,” Anna Goldman, MD, of Harvard University, Boston, told attendees at the annual meeting of the Society of General Internal Medicine 2019 conference. “People didn’t know if they should report, or if they thought they should, they didn’t know how.”
Additionally, there is no evidence that the implementation of the work rules caused an increase of employment within the Medicaid-eligible population in Arkansas within the first 6 months of the law going into effect.
Arkansas’s rules required individuals aged 30-49 years (applied during the first 6 months of the rollout) to work at least 80 hours a month in a job or doing something equivalent to a job, such as job skills training. Exemptions were available to those who were disabled, pregnant, or caregiving; had student status; or were receiving treatment for substance abuse. Individuals were required to report their work hours each month. Failure to do so for 3 months in a year would cause Medicaid benefits to be suspended for the balance of the year.
Dr. Goldman noted that phone surveys were done in four states (Arkansas, Kentucky, Louisiana, and Texas) of low-income adults earning up to 138% of the federal poverty limit. About 6,000 people were surveyed across the four states, with half coming from 2016 and the other from a survey in 2018. In both years, the surveys were conducted in November and December of survey years. She acknowledged a low response rate of 14%, but she said that weighting was used to minimize nonresponse bias.
With the introduction of the work requirements, researchers found a 13.2% decrease in Medicaid or marketplace insurance and a 7.1% increase in the uninsured rate. No change in employment rates were found.
She noted that the findings that employment didn’t change were not surprising “given that 95% of people were either exempt or working, according to our survey results.”
Dr. Goldman said the survey completed for this study was consistent with studies done in Arkansas that showed most people that would be covered by the work rule were either working or would be exempt from the work requirements laid forth by state regulation.
“Those studies had raised an initial concern that most of the coverage losses would be related to nonreporting and administrative issues as opposed to just removing people who were healthy and didn’t want to get a job,” she explained.
Dr. Goldman noted that this newer study found that of the people required to report their work activities to the state, half didn’t because they either had no Internet access or were confused and could not figure out how to use the reporting system, even though they met the work requirements necessary to keep their Medicaid coverage.
In general, about 52% of the Arkansas population surveyed had heard something about the work requirements, but of those in the age range targeted by the rules, only 22% thought they were subject to the work requirements. Of those informed by the state that they needed to report, only half said they were doing so, Dr. Goldman added.
The survey results were consistent with state reports on the number of people experiencing coverage loss after the rollout, she said.
“One important thing to take away is that information barriers and administrative hassles are key reasons why people are losing coverage. ... Therefore, anything that states can do to automatically exempt people using state data that they already have can possibly reduce unnecessary coverage losses,” Dr. Goldman concluded.
Arkansas’s Medicaid work requirements were blocked by a federal judge in March 2019. Appeals are ongoing.
The authors reported no disclosures.
WASHINGTON – Early analysis of the implementation of Medicaid work requirements suggests administrative burden on beneficiaries is leading to decreased coverage.
according to state reports.
A study of the early months after Arkansas put its work requirement into effect in June 2018 found those most affected were people already working but unaware of or unable to meet the administrative requirements to demonstrate they were working. These people lost coverage.
Researchers identified “lots of confusion,” Anna Goldman, MD, of Harvard University, Boston, told attendees at the annual meeting of the Society of General Internal Medicine 2019 conference. “People didn’t know if they should report, or if they thought they should, they didn’t know how.”
Additionally, there is no evidence that the implementation of the work rules caused an increase of employment within the Medicaid-eligible population in Arkansas within the first 6 months of the law going into effect.
Arkansas’s rules required individuals aged 30-49 years (applied during the first 6 months of the rollout) to work at least 80 hours a month in a job or doing something equivalent to a job, such as job skills training. Exemptions were available to those who were disabled, pregnant, or caregiving; had student status; or were receiving treatment for substance abuse. Individuals were required to report their work hours each month. Failure to do so for 3 months in a year would cause Medicaid benefits to be suspended for the balance of the year.
Dr. Goldman noted that phone surveys were done in four states (Arkansas, Kentucky, Louisiana, and Texas) of low-income adults earning up to 138% of the federal poverty limit. About 6,000 people were surveyed across the four states, with half coming from 2016 and the other from a survey in 2018. In both years, the surveys were conducted in November and December of survey years. She acknowledged a low response rate of 14%, but she said that weighting was used to minimize nonresponse bias.
With the introduction of the work requirements, researchers found a 13.2% decrease in Medicaid or marketplace insurance and a 7.1% increase in the uninsured rate. No change in employment rates were found.
She noted that the findings that employment didn’t change were not surprising “given that 95% of people were either exempt or working, according to our survey results.”
Dr. Goldman said the survey completed for this study was consistent with studies done in Arkansas that showed most people that would be covered by the work rule were either working or would be exempt from the work requirements laid forth by state regulation.
“Those studies had raised an initial concern that most of the coverage losses would be related to nonreporting and administrative issues as opposed to just removing people who were healthy and didn’t want to get a job,” she explained.
Dr. Goldman noted that this newer study found that of the people required to report their work activities to the state, half didn’t because they either had no Internet access or were confused and could not figure out how to use the reporting system, even though they met the work requirements necessary to keep their Medicaid coverage.
In general, about 52% of the Arkansas population surveyed had heard something about the work requirements, but of those in the age range targeted by the rules, only 22% thought they were subject to the work requirements. Of those informed by the state that they needed to report, only half said they were doing so, Dr. Goldman added.
The survey results were consistent with state reports on the number of people experiencing coverage loss after the rollout, she said.
“One important thing to take away is that information barriers and administrative hassles are key reasons why people are losing coverage. ... Therefore, anything that states can do to automatically exempt people using state data that they already have can possibly reduce unnecessary coverage losses,” Dr. Goldman concluded.
Arkansas’s Medicaid work requirements were blocked by a federal judge in March 2019. Appeals are ongoing.
The authors reported no disclosures.
REPORTING FROM SGIM 2019
Atypical case of cutaneous MCL mimics SPTCL
An atypical case of cutaneous mantle cell lymphoma (MCL) with histomorphological features mimicking subcutaneous panniculitis-like T-cell lymphoma (SPTCL) highlights a “potential pitfall,” according to investigators.
This unusual case stresses the importance of molecular cytogenetics and/or immunohistochemistry for panniculitis-type lymphomas, reported lead author Caroline Laggis, MD of the University of Utah, Salt Lake City, and colleagues.
“While morphologic features of SPTCL, specifically rimming of adipocytes by neoplastic lymphoid cells, have been documented in other types of lymphomas, this case is exceptional in that the morphologic features of SPTCL are showed in secondary cutaneous involvement by MCL,” the investigators wrote. Their report is in Journal of Cutaneous Pathology.
The patient was a 69-year-old man who presented with 2-year history of night sweats and fever of unknown origin, and, closer to presentation, weight loss and tender bumps under the skin of his pelvic region.
Subsequent computed tomography and excisional lymph node biopsy led to a diagnosis of MCL, with a Mantle Cell Lymphoma International Prognostic Index of 5, suggesting aggressive, intermediate-risk disease. Further imaging showed involvement of the nasopharynx, and cervical and mediastinal lymph nodes.
Bendamustine and rituximab chemotherapy was given unremarkably until the final cycle, at which point the patient presented with tender subcutaneous nodules on his lower legs. Histopathology from punch biopsies revealed “a dense infiltrate of monomorphic, mitotically active lymphoid cells with infiltration between the deep dermal collagen and the adipocytes in subcutaneous fat,” the investigators wrote, noting that the infiltrative cells were blastoid and 70% expressed cyclin D1, supporting cutaneous involvement of his systemic MCL.
Treatment was switched to ibrutinib and selinexor via a clinical trial, which led to temporary improvement of leg lesions; when the lesions returned, biopsy was performed with the same histopathological result. Lenalidomide and rituximab were started, but without success, and disease spread to the central nervous system.
Another biopsy of the skin lesions again supported cutaneous MCL, with tumor cells rimming individual adipocytes.
Because of this atypical morphology, fluorescence in situ hybridization (FISH) was conducted, revealing t(11;14)(q13:32) positivity, thereby “confirming the diagnosis of cutaneous involvement by systemic MCL,” the investigators wrote.
Genomic sequencing revealed abnormalities of “ataxia-telangiectasia mutated, mechanistic target of rapamycin kinase (mTOR), BCL6 corepressor, and FAS-associated factor 1, as well as the expected mutation in IGH-CCND1, leading to cyclin D1 upregulation.”
Subsequent treatment was unsuccessful, and the patient died from his disease.
“The complex and central role that mTOR plays in adipose homeostasis may link our tumor to its preference to the adipose tissue, although further investigation is warranted regarding specific genomic alterations in lymphomas and the implications these mutations have in the involvement of tumor cells with cutaneous and adipose environments,” the investigators wrote.
The investigators did not report conflicts of interest.
SOURCE: Laggis C et al. 2019 Apr 8. doi:10.1111/cup.13471.
An atypical case of cutaneous mantle cell lymphoma (MCL) with histomorphological features mimicking subcutaneous panniculitis-like T-cell lymphoma (SPTCL) highlights a “potential pitfall,” according to investigators.
This unusual case stresses the importance of molecular cytogenetics and/or immunohistochemistry for panniculitis-type lymphomas, reported lead author Caroline Laggis, MD of the University of Utah, Salt Lake City, and colleagues.
“While morphologic features of SPTCL, specifically rimming of adipocytes by neoplastic lymphoid cells, have been documented in other types of lymphomas, this case is exceptional in that the morphologic features of SPTCL are showed in secondary cutaneous involvement by MCL,” the investigators wrote. Their report is in Journal of Cutaneous Pathology.
The patient was a 69-year-old man who presented with 2-year history of night sweats and fever of unknown origin, and, closer to presentation, weight loss and tender bumps under the skin of his pelvic region.
Subsequent computed tomography and excisional lymph node biopsy led to a diagnosis of MCL, with a Mantle Cell Lymphoma International Prognostic Index of 5, suggesting aggressive, intermediate-risk disease. Further imaging showed involvement of the nasopharynx, and cervical and mediastinal lymph nodes.
Bendamustine and rituximab chemotherapy was given unremarkably until the final cycle, at which point the patient presented with tender subcutaneous nodules on his lower legs. Histopathology from punch biopsies revealed “a dense infiltrate of monomorphic, mitotically active lymphoid cells with infiltration between the deep dermal collagen and the adipocytes in subcutaneous fat,” the investigators wrote, noting that the infiltrative cells were blastoid and 70% expressed cyclin D1, supporting cutaneous involvement of his systemic MCL.
Treatment was switched to ibrutinib and selinexor via a clinical trial, which led to temporary improvement of leg lesions; when the lesions returned, biopsy was performed with the same histopathological result. Lenalidomide and rituximab were started, but without success, and disease spread to the central nervous system.
Another biopsy of the skin lesions again supported cutaneous MCL, with tumor cells rimming individual adipocytes.
Because of this atypical morphology, fluorescence in situ hybridization (FISH) was conducted, revealing t(11;14)(q13:32) positivity, thereby “confirming the diagnosis of cutaneous involvement by systemic MCL,” the investigators wrote.
Genomic sequencing revealed abnormalities of “ataxia-telangiectasia mutated, mechanistic target of rapamycin kinase (mTOR), BCL6 corepressor, and FAS-associated factor 1, as well as the expected mutation in IGH-CCND1, leading to cyclin D1 upregulation.”
Subsequent treatment was unsuccessful, and the patient died from his disease.
“The complex and central role that mTOR plays in adipose homeostasis may link our tumor to its preference to the adipose tissue, although further investigation is warranted regarding specific genomic alterations in lymphomas and the implications these mutations have in the involvement of tumor cells with cutaneous and adipose environments,” the investigators wrote.
The investigators did not report conflicts of interest.
SOURCE: Laggis C et al. 2019 Apr 8. doi:10.1111/cup.13471.
An atypical case of cutaneous mantle cell lymphoma (MCL) with histomorphological features mimicking subcutaneous panniculitis-like T-cell lymphoma (SPTCL) highlights a “potential pitfall,” according to investigators.
This unusual case stresses the importance of molecular cytogenetics and/or immunohistochemistry for panniculitis-type lymphomas, reported lead author Caroline Laggis, MD of the University of Utah, Salt Lake City, and colleagues.
“While morphologic features of SPTCL, specifically rimming of adipocytes by neoplastic lymphoid cells, have been documented in other types of lymphomas, this case is exceptional in that the morphologic features of SPTCL are showed in secondary cutaneous involvement by MCL,” the investigators wrote. Their report is in Journal of Cutaneous Pathology.
The patient was a 69-year-old man who presented with 2-year history of night sweats and fever of unknown origin, and, closer to presentation, weight loss and tender bumps under the skin of his pelvic region.
Subsequent computed tomography and excisional lymph node biopsy led to a diagnosis of MCL, with a Mantle Cell Lymphoma International Prognostic Index of 5, suggesting aggressive, intermediate-risk disease. Further imaging showed involvement of the nasopharynx, and cervical and mediastinal lymph nodes.
Bendamustine and rituximab chemotherapy was given unremarkably until the final cycle, at which point the patient presented with tender subcutaneous nodules on his lower legs. Histopathology from punch biopsies revealed “a dense infiltrate of monomorphic, mitotically active lymphoid cells with infiltration between the deep dermal collagen and the adipocytes in subcutaneous fat,” the investigators wrote, noting that the infiltrative cells were blastoid and 70% expressed cyclin D1, supporting cutaneous involvement of his systemic MCL.
Treatment was switched to ibrutinib and selinexor via a clinical trial, which led to temporary improvement of leg lesions; when the lesions returned, biopsy was performed with the same histopathological result. Lenalidomide and rituximab were started, but without success, and disease spread to the central nervous system.
Another biopsy of the skin lesions again supported cutaneous MCL, with tumor cells rimming individual adipocytes.
Because of this atypical morphology, fluorescence in situ hybridization (FISH) was conducted, revealing t(11;14)(q13:32) positivity, thereby “confirming the diagnosis of cutaneous involvement by systemic MCL,” the investigators wrote.
Genomic sequencing revealed abnormalities of “ataxia-telangiectasia mutated, mechanistic target of rapamycin kinase (mTOR), BCL6 corepressor, and FAS-associated factor 1, as well as the expected mutation in IGH-CCND1, leading to cyclin D1 upregulation.”
Subsequent treatment was unsuccessful, and the patient died from his disease.
“The complex and central role that mTOR plays in adipose homeostasis may link our tumor to its preference to the adipose tissue, although further investigation is warranted regarding specific genomic alterations in lymphomas and the implications these mutations have in the involvement of tumor cells with cutaneous and adipose environments,” the investigators wrote.
The investigators did not report conflicts of interest.
SOURCE: Laggis C et al. 2019 Apr 8. doi:10.1111/cup.13471.
FROM JOURNAL OF CUTANEOUS PATHOLOGY
Insomnia symptoms correlate with seizure frequency
PHILADELPHIA – . Insomnia symptoms are not associated with epilepsy type, number of antiepileptic drugs (AEDs), or AED standardized dose, however.
“Given the potential benefits of sleep therapies on epilepsy outcomes, routine screening of insomnia symptoms is warranted,” said lead study author Thapanee Somboon, MD, a researcher at the sleep disorders center at Cleveland Clinic Neurological Institute in Ohio and at Prasat Neurological Institute in Bangkok.
Insomnia is common and associated with depression in patients with epilepsy, but prior studies that looked at the relationship between insomnia and epilepsy-related characteristics yielded limited and conflicting results, according to Dr. Somboon.
To evaluate potential associations between insomnia and epilepsy, Dr. Somboon and colleagues conducted a prospective analysis of data from 270 patients with epilepsy who presented to the Cleveland Clinic Epilepsy Center for an initial evaluation between January and August 2018. The patients completed the Insomnia Severity Index (ISI). An ISI score of 8 or greater indicated clinical insomnia symptoms, and an ISI score of 15 or greater indicated moderate or severe insomnia symptoms.
The researchers used Spearman’s correlation and the Kruskal-Wallis test to evaluate associations among insomnia symptoms and AED standardized dose, monthly seizure frequency, Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Questionnaire (GAD-7), and Quality of Life in Epilepsy-10 (QOLIE10).
Among the 270 patients, the average age was 43.5 years, 58% were female, 74% had focal epilepsy, and 26% had one or more seizures per month. The population’s median ISI score was 7. Nearly half had an ISI score of 8 or greater, and 23% had an ISI score of 15 or greater.
“A positive correlation was found between ISI and PHQ-9 (r = 0.64, P less than .001), GAD-7 (r = 0.68, P less than .001), QOLIE (r = 0.55, P less than .001), and monthly seizure frequency (r = 0.31, P less than .001),” the researchers reported. Insomnia symptoms had a significantly stronger correlation with PHQ-9 and GAD-7 than with seizure frequency.
Dr. Somboon had no disclosures. A coinvestigator has received research support from Jazz Pharmaceuticals.
SOURCE: Somboon T et al. AAN 2019, Abstract P3.6-026.
PHILADELPHIA – . Insomnia symptoms are not associated with epilepsy type, number of antiepileptic drugs (AEDs), or AED standardized dose, however.
“Given the potential benefits of sleep therapies on epilepsy outcomes, routine screening of insomnia symptoms is warranted,” said lead study author Thapanee Somboon, MD, a researcher at the sleep disorders center at Cleveland Clinic Neurological Institute in Ohio and at Prasat Neurological Institute in Bangkok.
Insomnia is common and associated with depression in patients with epilepsy, but prior studies that looked at the relationship between insomnia and epilepsy-related characteristics yielded limited and conflicting results, according to Dr. Somboon.
To evaluate potential associations between insomnia and epilepsy, Dr. Somboon and colleagues conducted a prospective analysis of data from 270 patients with epilepsy who presented to the Cleveland Clinic Epilepsy Center for an initial evaluation between January and August 2018. The patients completed the Insomnia Severity Index (ISI). An ISI score of 8 or greater indicated clinical insomnia symptoms, and an ISI score of 15 or greater indicated moderate or severe insomnia symptoms.
The researchers used Spearman’s correlation and the Kruskal-Wallis test to evaluate associations among insomnia symptoms and AED standardized dose, monthly seizure frequency, Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Questionnaire (GAD-7), and Quality of Life in Epilepsy-10 (QOLIE10).
Among the 270 patients, the average age was 43.5 years, 58% were female, 74% had focal epilepsy, and 26% had one or more seizures per month. The population’s median ISI score was 7. Nearly half had an ISI score of 8 or greater, and 23% had an ISI score of 15 or greater.
“A positive correlation was found between ISI and PHQ-9 (r = 0.64, P less than .001), GAD-7 (r = 0.68, P less than .001), QOLIE (r = 0.55, P less than .001), and monthly seizure frequency (r = 0.31, P less than .001),” the researchers reported. Insomnia symptoms had a significantly stronger correlation with PHQ-9 and GAD-7 than with seizure frequency.
Dr. Somboon had no disclosures. A coinvestigator has received research support from Jazz Pharmaceuticals.
SOURCE: Somboon T et al. AAN 2019, Abstract P3.6-026.
PHILADELPHIA – . Insomnia symptoms are not associated with epilepsy type, number of antiepileptic drugs (AEDs), or AED standardized dose, however.
“Given the potential benefits of sleep therapies on epilepsy outcomes, routine screening of insomnia symptoms is warranted,” said lead study author Thapanee Somboon, MD, a researcher at the sleep disorders center at Cleveland Clinic Neurological Institute in Ohio and at Prasat Neurological Institute in Bangkok.
Insomnia is common and associated with depression in patients with epilepsy, but prior studies that looked at the relationship between insomnia and epilepsy-related characteristics yielded limited and conflicting results, according to Dr. Somboon.
To evaluate potential associations between insomnia and epilepsy, Dr. Somboon and colleagues conducted a prospective analysis of data from 270 patients with epilepsy who presented to the Cleveland Clinic Epilepsy Center for an initial evaluation between January and August 2018. The patients completed the Insomnia Severity Index (ISI). An ISI score of 8 or greater indicated clinical insomnia symptoms, and an ISI score of 15 or greater indicated moderate or severe insomnia symptoms.
The researchers used Spearman’s correlation and the Kruskal-Wallis test to evaluate associations among insomnia symptoms and AED standardized dose, monthly seizure frequency, Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Questionnaire (GAD-7), and Quality of Life in Epilepsy-10 (QOLIE10).
Among the 270 patients, the average age was 43.5 years, 58% were female, 74% had focal epilepsy, and 26% had one or more seizures per month. The population’s median ISI score was 7. Nearly half had an ISI score of 8 or greater, and 23% had an ISI score of 15 or greater.
“A positive correlation was found between ISI and PHQ-9 (r = 0.64, P less than .001), GAD-7 (r = 0.68, P less than .001), QOLIE (r = 0.55, P less than .001), and monthly seizure frequency (r = 0.31, P less than .001),” the researchers reported. Insomnia symptoms had a significantly stronger correlation with PHQ-9 and GAD-7 than with seizure frequency.
Dr. Somboon had no disclosures. A coinvestigator has received research support from Jazz Pharmaceuticals.
SOURCE: Somboon T et al. AAN 2019, Abstract P3.6-026.
REPORTING FROM AAN 2019
Inebilizumab reduces the risk of NMOSD attacks
PHILADELPHIA – , according to results presented at the annual meeting of the American Academy of Neurology. The antibody also reduces the risks of disability worsening, MRI lesion activity, and hospitalization.
No approved therapies are available for NMOSD, which is thought to be a B-cell-mediated disorder. Research suggests that CD19 is a potential therapeutic target in NMOSD. Inebilizumab has a high affinity for CD19 and reliably depleted B cells in preclinical and clinical studies.
Participants did not receive concomitant immunosuppressants
Bruce Cree, MD, PhD, clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and colleagues conducted a phase 3 study to evaluate the safety and efficacy of inebilizumab in NMOSD. Eligible participants were older than 18 years, had NMOSD, and were seropositive for aquaporin-4 (AQP4) antibodies. Seronegative patients were allowed to participate, provided that they met the 2006 Wingerchuk criteria for neuromyelitis optica. Participants were required to have had one attack in the previous year or two attacks in the 2 previous years. Participants had a wide range of disability. No background use of immune suppressants was permitted.
The trial was conducted at 99 centers in 24 countries. After a 4-week screening period, investigators randomized patients in a 3:1 ratio to inebilizumab or placebo. Treatment was administered on days 1 and 15 by IV infusion. The randomized, controlled period lasted for 197 days. If a participant did not have a relapse by the end of this period, he or she was given the choice of participating in a yearlong open-label study, in which he or she would receive 300 mg of inebilizumab every 6 months. Participants who had an attack were treated for the attack.
An independent eligibility committee reviewed and confirmed the diagnostic criteria for AQP4 seronegative participants. A masked attack-adjudication committee provided real-time assessment of NMOSD attacks. An independent data monitoring committee reviewed patient safety and ensured the ethical conduct of the study.
The trial’s primary endpoint was the time from randomization to first attack. Secondary endpoints included a measure of disability, a measure of visual acuity, cumulative lesions on MRI, and NMOSD-related inpatient hospitalizations.
Treatment reduced the risk of hospitalization
Dr. Cree and colleagues screened 467 subjects and randomized 231. Among those patients, 175 received inebilizumab, and 56 received placebo. The population’s mean age was 43 years. About 90% were women, and 72% were white or Asian. The median baseline disability score was 3.5, indicating moderate disability. More than 90% of patients were AQP4 seropositive. The mean number of attacks at entry was 4.3. About 60% of participants had had prior exposure to immune suppressants.
Enrollment into the randomized, controlled period was stopped at 231 patients after 43 attacks had occurred, based on the recommendation of the independent data monitoring committee, which concluded that further recruitment into the placebo arm would not be ethical. The committee also recommended that all participants be shifted into the open-label period.
Among AQP4 seropositive patients, 88% of the inebilizumab group did not have an attack, compared with 57% of the control group. This result represents a 77% reduction in the risk of a relapse following inebilizumab treatment. The number needed to treat was 3.23. In the population overall, 87% of patients treated with inebilizumab did not have an attack, compared with 60% of controls, which corresponded to a 73% reduction in risk of an attack and a number needed to treat of 3.7.
In addition, Dr. Cree and colleagues found that inebilizumab was associated with a 63% reduction in risk of disability, a 43% reduction in risk of developing new lesions, and a 71% reduction in NMOSD-related hospitalizations. These results were statistically significant and clinically meaningful, he said. The only secondary endpoint that was not met was the difference in binocular low-contrast visual acuity scores. “This [result] may be due to the low frequency of optic neuritis events, a floor effect within the placebo arm (many of those patients had profound visual loss at baseline), or selection of a binocular acuity test that diluted the impact of monocular events,” said Dr. Cree.
Adverse events and serious adverse events were well balanced between the two treatment arms. The rate of infusion-related reactions was low in both arms and was “perhaps slightly lower in the inebilizumab treatment arm,” said Dr. Cree. No deaths occurred during the randomized, controlled period, and the researchers found no pattern of serious adverse events. Two deaths occurred in the open-label period: one related to a severe attack, and the other related to a brain event of unclear etiology without definite diagnosis.
B cells were depleted within approximately 4 weeks of treatment, and this depletion was sustained throughout the randomized, controlled period.
This study was funded by Viela Bio and MedImmune. Dr. Cree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities from Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019. Abstract Plen02.001.
PHILADELPHIA – , according to results presented at the annual meeting of the American Academy of Neurology. The antibody also reduces the risks of disability worsening, MRI lesion activity, and hospitalization.
No approved therapies are available for NMOSD, which is thought to be a B-cell-mediated disorder. Research suggests that CD19 is a potential therapeutic target in NMOSD. Inebilizumab has a high affinity for CD19 and reliably depleted B cells in preclinical and clinical studies.
Participants did not receive concomitant immunosuppressants
Bruce Cree, MD, PhD, clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and colleagues conducted a phase 3 study to evaluate the safety and efficacy of inebilizumab in NMOSD. Eligible participants were older than 18 years, had NMOSD, and were seropositive for aquaporin-4 (AQP4) antibodies. Seronegative patients were allowed to participate, provided that they met the 2006 Wingerchuk criteria for neuromyelitis optica. Participants were required to have had one attack in the previous year or two attacks in the 2 previous years. Participants had a wide range of disability. No background use of immune suppressants was permitted.
The trial was conducted at 99 centers in 24 countries. After a 4-week screening period, investigators randomized patients in a 3:1 ratio to inebilizumab or placebo. Treatment was administered on days 1 and 15 by IV infusion. The randomized, controlled period lasted for 197 days. If a participant did not have a relapse by the end of this period, he or she was given the choice of participating in a yearlong open-label study, in which he or she would receive 300 mg of inebilizumab every 6 months. Participants who had an attack were treated for the attack.
An independent eligibility committee reviewed and confirmed the diagnostic criteria for AQP4 seronegative participants. A masked attack-adjudication committee provided real-time assessment of NMOSD attacks. An independent data monitoring committee reviewed patient safety and ensured the ethical conduct of the study.
The trial’s primary endpoint was the time from randomization to first attack. Secondary endpoints included a measure of disability, a measure of visual acuity, cumulative lesions on MRI, and NMOSD-related inpatient hospitalizations.
Treatment reduced the risk of hospitalization
Dr. Cree and colleagues screened 467 subjects and randomized 231. Among those patients, 175 received inebilizumab, and 56 received placebo. The population’s mean age was 43 years. About 90% were women, and 72% were white or Asian. The median baseline disability score was 3.5, indicating moderate disability. More than 90% of patients were AQP4 seropositive. The mean number of attacks at entry was 4.3. About 60% of participants had had prior exposure to immune suppressants.
Enrollment into the randomized, controlled period was stopped at 231 patients after 43 attacks had occurred, based on the recommendation of the independent data monitoring committee, which concluded that further recruitment into the placebo arm would not be ethical. The committee also recommended that all participants be shifted into the open-label period.
Among AQP4 seropositive patients, 88% of the inebilizumab group did not have an attack, compared with 57% of the control group. This result represents a 77% reduction in the risk of a relapse following inebilizumab treatment. The number needed to treat was 3.23. In the population overall, 87% of patients treated with inebilizumab did not have an attack, compared with 60% of controls, which corresponded to a 73% reduction in risk of an attack and a number needed to treat of 3.7.
In addition, Dr. Cree and colleagues found that inebilizumab was associated with a 63% reduction in risk of disability, a 43% reduction in risk of developing new lesions, and a 71% reduction in NMOSD-related hospitalizations. These results were statistically significant and clinically meaningful, he said. The only secondary endpoint that was not met was the difference in binocular low-contrast visual acuity scores. “This [result] may be due to the low frequency of optic neuritis events, a floor effect within the placebo arm (many of those patients had profound visual loss at baseline), or selection of a binocular acuity test that diluted the impact of monocular events,” said Dr. Cree.
Adverse events and serious adverse events were well balanced between the two treatment arms. The rate of infusion-related reactions was low in both arms and was “perhaps slightly lower in the inebilizumab treatment arm,” said Dr. Cree. No deaths occurred during the randomized, controlled period, and the researchers found no pattern of serious adverse events. Two deaths occurred in the open-label period: one related to a severe attack, and the other related to a brain event of unclear etiology without definite diagnosis.
B cells were depleted within approximately 4 weeks of treatment, and this depletion was sustained throughout the randomized, controlled period.
This study was funded by Viela Bio and MedImmune. Dr. Cree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities from Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019. Abstract Plen02.001.
PHILADELPHIA – , according to results presented at the annual meeting of the American Academy of Neurology. The antibody also reduces the risks of disability worsening, MRI lesion activity, and hospitalization.
No approved therapies are available for NMOSD, which is thought to be a B-cell-mediated disorder. Research suggests that CD19 is a potential therapeutic target in NMOSD. Inebilizumab has a high affinity for CD19 and reliably depleted B cells in preclinical and clinical studies.
Participants did not receive concomitant immunosuppressants
Bruce Cree, MD, PhD, clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and colleagues conducted a phase 3 study to evaluate the safety and efficacy of inebilizumab in NMOSD. Eligible participants were older than 18 years, had NMOSD, and were seropositive for aquaporin-4 (AQP4) antibodies. Seronegative patients were allowed to participate, provided that they met the 2006 Wingerchuk criteria for neuromyelitis optica. Participants were required to have had one attack in the previous year or two attacks in the 2 previous years. Participants had a wide range of disability. No background use of immune suppressants was permitted.
The trial was conducted at 99 centers in 24 countries. After a 4-week screening period, investigators randomized patients in a 3:1 ratio to inebilizumab or placebo. Treatment was administered on days 1 and 15 by IV infusion. The randomized, controlled period lasted for 197 days. If a participant did not have a relapse by the end of this period, he or she was given the choice of participating in a yearlong open-label study, in which he or she would receive 300 mg of inebilizumab every 6 months. Participants who had an attack were treated for the attack.
An independent eligibility committee reviewed and confirmed the diagnostic criteria for AQP4 seronegative participants. A masked attack-adjudication committee provided real-time assessment of NMOSD attacks. An independent data monitoring committee reviewed patient safety and ensured the ethical conduct of the study.
The trial’s primary endpoint was the time from randomization to first attack. Secondary endpoints included a measure of disability, a measure of visual acuity, cumulative lesions on MRI, and NMOSD-related inpatient hospitalizations.
Treatment reduced the risk of hospitalization
Dr. Cree and colleagues screened 467 subjects and randomized 231. Among those patients, 175 received inebilizumab, and 56 received placebo. The population’s mean age was 43 years. About 90% were women, and 72% were white or Asian. The median baseline disability score was 3.5, indicating moderate disability. More than 90% of patients were AQP4 seropositive. The mean number of attacks at entry was 4.3. About 60% of participants had had prior exposure to immune suppressants.
Enrollment into the randomized, controlled period was stopped at 231 patients after 43 attacks had occurred, based on the recommendation of the independent data monitoring committee, which concluded that further recruitment into the placebo arm would not be ethical. The committee also recommended that all participants be shifted into the open-label period.
Among AQP4 seropositive patients, 88% of the inebilizumab group did not have an attack, compared with 57% of the control group. This result represents a 77% reduction in the risk of a relapse following inebilizumab treatment. The number needed to treat was 3.23. In the population overall, 87% of patients treated with inebilizumab did not have an attack, compared with 60% of controls, which corresponded to a 73% reduction in risk of an attack and a number needed to treat of 3.7.
In addition, Dr. Cree and colleagues found that inebilizumab was associated with a 63% reduction in risk of disability, a 43% reduction in risk of developing new lesions, and a 71% reduction in NMOSD-related hospitalizations. These results were statistically significant and clinically meaningful, he said. The only secondary endpoint that was not met was the difference in binocular low-contrast visual acuity scores. “This [result] may be due to the low frequency of optic neuritis events, a floor effect within the placebo arm (many of those patients had profound visual loss at baseline), or selection of a binocular acuity test that diluted the impact of monocular events,” said Dr. Cree.
Adverse events and serious adverse events were well balanced between the two treatment arms. The rate of infusion-related reactions was low in both arms and was “perhaps slightly lower in the inebilizumab treatment arm,” said Dr. Cree. No deaths occurred during the randomized, controlled period, and the researchers found no pattern of serious adverse events. Two deaths occurred in the open-label period: one related to a severe attack, and the other related to a brain event of unclear etiology without definite diagnosis.
B cells were depleted within approximately 4 weeks of treatment, and this depletion was sustained throughout the randomized, controlled period.
This study was funded by Viela Bio and MedImmune. Dr. Cree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities from Abbvie, Akili, Biogen, EMD Serono, GeNeuro and Novartis.
SOURCE: Cree B et al. AAN 2019. Abstract Plen02.001.
REPORTING FROM AAN 2019
Unit-based models of care
A tool for ensuring patient safety
“To me, teamwork is the beauty of our sport, where you have five acting as one. You become selfless.” – Mike Krzyzewski
High-performing teams plan, communicate, reflect, and take action together. Teamwork can transform seemingly impossible tasks into opportunities for people to come together and create value.
The increasing complexity of health care makes team-based care necessary to achieve successful health outcomes for patients. At the Brooklyn (N.Y.) Hospital Center, a 464-bed care center, we transformed the model of care on the medical wards into a geographic, unit-based team model. Here we describe our journey – the successes, the challenges, and the opportunities for growth.
Previous model
In the previous care model on our medical wards, no set structures were in place. Teams would travel to multiple wards throughout the hospital to see the patients they were rounding on. Each floor had its own set of social workers and case managers, therefore a hospital medicine team routinely dealt with more than eight social workers and case managers to address their patients’ needs in a single day.
Multidisciplinary rounds for all medical patients were held at 11 a.m. in a room located a significant distance away from the medical wards. All case managers and social workers would sit in this room from 11 a.m. until noon, and teams would travel to that room to discuss their patients.
Many challenges were identified in this model, including a lack of communication, a de-emphasis on teamwork, and a design that did not take physician workflows into account resulting in low efficiency. Thus, these challenges sparked a desire to create a more effective and team-based methodology of accomplishing excellence in delivery of clinical care. Dr. Pendharkar, having worked primarily in centers with unit-based care, determined that a geographic, unit-based model of care could transform care delivery at the Brooklyn Hospital Center.
Looking ahead
The efforts for transforming the vision of geographic, unit-based teams into a reality started by gathering all stakeholders together to unite for a common mission. Initial meetings were held with all parties including social workers, case managers, residents, nursing staff, bed board and attending physicians in internal medicine, and the emergency department.
The vision of a geographic, unit-based team was shared and explained to all team members. Exercises in LEAN methodology were conducted, including one-piece flow exercises, to highlight the possibilities of what could be accomplished through teamwork. Once support for the vision was in place from all parties, the logistics were addressed.
The biggest challenge to overcome was how to place all of one team’s patients on a singular medical ward. In our hospital, a medical ward holds anywhere from 30 to 33 patients. Each hospital medicine team, of which there are many, typically carries 20-23 patients. We created a blueprint to map out the floor to which each team and attending would be assigned. Next, we partnered with both IT and bed board to design an admission order set that specified the particular geographic location that a team and attending were associated with so that patients could be placed accordingly from the ED.
It was important for the ED doctors, bed board, and the internal medicine residents to understand these changes because all of these parties were involved in the initial admitting process. Dr. Pendharkar and Dr. Malieckal provided all groups with in-person training on how the logistics of the system would unfold. Noon conference lectures were also held to explain the vision to residents.
Over 3 weeks, the first ward we chose to implement our model on slowly accumulated the patients of one team – this was the gradual trickle phase. We then selected a “re-set” date. On the re-set date, it was determined that all patients would go to the team that was assigned to that floor, with the exception of any private attendings’ patients.
On the day before the re-set date, time was spent ensuring that all hand-offs were safe. Dr. Pendharkar and Dr. Malieckal spoke with every intern and team that would be handing off and/or receiving patients as a result of the re-set policy. The goal was to ensure that on that date a ward had close to 100% of its patients belonging to the team/attending that was assigned to that area.
The good
Once we began our geographic, unit-based model, our rounding process was transformed.
Now, our morning rounds were joined by the bedside nurse, case manager, social worker, clinical pharmacy, and nutrition in addition to the core team. The entire team went from room to room on one ward rounding on all 20 to 25 patients back to back, which created an unparalleled level of efficiency and a forum for effective communication lasting throughout the day.
We also added workstations on wheels (WOWS) to the rounding process so that labs, radiology, and more could be reviewed on rounds with the entire team. A standard script was developed so that each patient was introduced to all members of the team, and the care plan was disclosed and highlighted. One patient noted, “I feel so cared for, knowing I have this entire team taking care of me.” We also rounded in the afternoon with the case managers and social workers to follow up tasks that were to be completed that day.
Our first few weeks utilizing the geographic, unit-based model of rounding was largely successful. The residents, now able to round on all of their patients in one location with one case manager and one social worker, noted, “This model of rounding makes my life so much easier, I feel like I can focus on the patient rather than running around. … and I know the social worker and case manager will help me.”
Provider satisfaction had improved, from residents to physicians to nurses, case managers, social workers, and more. Our case manager also noted her satisfaction with the new model, stating that her communication with the medical team was much easier. As the attending, I witnessed firsthand how working together with the team moved care forward much more quickly, compared with the previous model, because of the simple factor of increased ease of communication.
Now all team members were together in the patient room and discussion was much easier. There was less confusion, fewer delays, and better communication – I think unit-based teams can even be described as a lifesaving measure that reduces harm to patients. An additional benefit is the relationship that now developed between doctors, social workers, and case managers – they spent more time together and really got to know one another, creating a feeling of shared success and a deeper drive to help one another succeed.
In our model, 87% of surveyed residents said they felt less burned out in the new geographic, unit-based model of care, and 91% of physicians surveyed said it was easier to talk with team members to coordinate care. Additionally, our HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores saw a drastic increase in many domains. Nursing communication improved by more than 42% on domain 7B; doctor communication improved by more than 31%. Additionally, all other domains saw at least 10% improvement. We are now 5 months out from our initial rollout of the model and continue to see sustained improvements in quality measures.
The bad
The biggest challenges that we are working through with this model are hand-offs and transfer of patients from one team to another. Sometimes, it happens that one team’s patient will wind up on a floor that is the designated floor of another team because of bed availability. We continue to work with bed board to address this issue. We want to minimize transfers and hand-offs to promote continuity and have to balance that with the need for geographic location. With clear communication, hospital collaboration from bed board and safe hand-off methods, this problem can be safely addressed.
Conclusions
The experience of implementing the unit-based team model has been an eye-opening journey. One thing that stands out is that, in an increasingly complex health care system, design thinking is critical.
Design thinking takes into consideration the needs of those who are using a system. In this case, patients and health care workers including doctors, nurses, case managers, and social workers are the end users of the health care system. All parties are utilizing the health care system to optimize patient health. Therefore, we must create systems that are easy to navigate and use by patients and health care workers so that they can ensure the success of patients.
Unit-based teams offer a basic framework to optimize the inpatient system to facilitate better workflow. In our system, it allowed us to optimize communications between health care workers and also between health care workers and patients. It allowed team members to work in close proximity to better share ideas with each other.
We spent a significant amount of time upfront earning the support of all of the disciplines for this effort. We had support from all leaders within the organization and continue to make our case for this model by sharing metrics and holding forums to discuss the process.
Initial data show a marked improvement in many domains of HCAHPS scores. Our frontline staff, including attendings, residents, nursing, case managers, and social workers, also continue to support this effort since it has a positive impact on their workflow and improves their workday quality. One nurse mentioned specifically, “in my 30 years at this hospital I have never seen people work together so well.”
To sustain this effort, we continue to have regular meetings, and there are new features that we would like to add to the program. For example, we are working with our IT group to ensure that each unit-based team will have dashboards available to incorporate real time, actionable data into daily workflows.
We are excited by the potential of our high-performing teams to highlight the patient experience, placing the patient at the center for care, decision making, and rounding. Health care is a team sport, and anytime you build something where all teams are playing together and approaching the finish line as a unit, you will never go wrong!
Dr. Pendharkar is division chief of hospital medicine at the Brooklyn (N.Y.) Hospital Center, medical director of inpatient services and director of quality for the department of medicine at the Brooklyn Hospital Center and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York. Dr. Malieckal is chief resident, internal medicine, at the Brooklyn Hospital Center. Dr. Gasperino is chair, department of medicine; vice president for critical care, perioperative, and hospital medicine; and associate chief medical officer at the Brooklyn Hospital Center.
A tool for ensuring patient safety
A tool for ensuring patient safety
“To me, teamwork is the beauty of our sport, where you have five acting as one. You become selfless.” – Mike Krzyzewski
High-performing teams plan, communicate, reflect, and take action together. Teamwork can transform seemingly impossible tasks into opportunities for people to come together and create value.
The increasing complexity of health care makes team-based care necessary to achieve successful health outcomes for patients. At the Brooklyn (N.Y.) Hospital Center, a 464-bed care center, we transformed the model of care on the medical wards into a geographic, unit-based team model. Here we describe our journey – the successes, the challenges, and the opportunities for growth.
Previous model
In the previous care model on our medical wards, no set structures were in place. Teams would travel to multiple wards throughout the hospital to see the patients they were rounding on. Each floor had its own set of social workers and case managers, therefore a hospital medicine team routinely dealt with more than eight social workers and case managers to address their patients’ needs in a single day.
Multidisciplinary rounds for all medical patients were held at 11 a.m. in a room located a significant distance away from the medical wards. All case managers and social workers would sit in this room from 11 a.m. until noon, and teams would travel to that room to discuss their patients.
Many challenges were identified in this model, including a lack of communication, a de-emphasis on teamwork, and a design that did not take physician workflows into account resulting in low efficiency. Thus, these challenges sparked a desire to create a more effective and team-based methodology of accomplishing excellence in delivery of clinical care. Dr. Pendharkar, having worked primarily in centers with unit-based care, determined that a geographic, unit-based model of care could transform care delivery at the Brooklyn Hospital Center.
Looking ahead
The efforts for transforming the vision of geographic, unit-based teams into a reality started by gathering all stakeholders together to unite for a common mission. Initial meetings were held with all parties including social workers, case managers, residents, nursing staff, bed board and attending physicians in internal medicine, and the emergency department.
The vision of a geographic, unit-based team was shared and explained to all team members. Exercises in LEAN methodology were conducted, including one-piece flow exercises, to highlight the possibilities of what could be accomplished through teamwork. Once support for the vision was in place from all parties, the logistics were addressed.
The biggest challenge to overcome was how to place all of one team’s patients on a singular medical ward. In our hospital, a medical ward holds anywhere from 30 to 33 patients. Each hospital medicine team, of which there are many, typically carries 20-23 patients. We created a blueprint to map out the floor to which each team and attending would be assigned. Next, we partnered with both IT and bed board to design an admission order set that specified the particular geographic location that a team and attending were associated with so that patients could be placed accordingly from the ED.
It was important for the ED doctors, bed board, and the internal medicine residents to understand these changes because all of these parties were involved in the initial admitting process. Dr. Pendharkar and Dr. Malieckal provided all groups with in-person training on how the logistics of the system would unfold. Noon conference lectures were also held to explain the vision to residents.
Over 3 weeks, the first ward we chose to implement our model on slowly accumulated the patients of one team – this was the gradual trickle phase. We then selected a “re-set” date. On the re-set date, it was determined that all patients would go to the team that was assigned to that floor, with the exception of any private attendings’ patients.
On the day before the re-set date, time was spent ensuring that all hand-offs were safe. Dr. Pendharkar and Dr. Malieckal spoke with every intern and team that would be handing off and/or receiving patients as a result of the re-set policy. The goal was to ensure that on that date a ward had close to 100% of its patients belonging to the team/attending that was assigned to that area.
The good
Once we began our geographic, unit-based model, our rounding process was transformed.
Now, our morning rounds were joined by the bedside nurse, case manager, social worker, clinical pharmacy, and nutrition in addition to the core team. The entire team went from room to room on one ward rounding on all 20 to 25 patients back to back, which created an unparalleled level of efficiency and a forum for effective communication lasting throughout the day.
We also added workstations on wheels (WOWS) to the rounding process so that labs, radiology, and more could be reviewed on rounds with the entire team. A standard script was developed so that each patient was introduced to all members of the team, and the care plan was disclosed and highlighted. One patient noted, “I feel so cared for, knowing I have this entire team taking care of me.” We also rounded in the afternoon with the case managers and social workers to follow up tasks that were to be completed that day.
Our first few weeks utilizing the geographic, unit-based model of rounding was largely successful. The residents, now able to round on all of their patients in one location with one case manager and one social worker, noted, “This model of rounding makes my life so much easier, I feel like I can focus on the patient rather than running around. … and I know the social worker and case manager will help me.”
Provider satisfaction had improved, from residents to physicians to nurses, case managers, social workers, and more. Our case manager also noted her satisfaction with the new model, stating that her communication with the medical team was much easier. As the attending, I witnessed firsthand how working together with the team moved care forward much more quickly, compared with the previous model, because of the simple factor of increased ease of communication.
Now all team members were together in the patient room and discussion was much easier. There was less confusion, fewer delays, and better communication – I think unit-based teams can even be described as a lifesaving measure that reduces harm to patients. An additional benefit is the relationship that now developed between doctors, social workers, and case managers – they spent more time together and really got to know one another, creating a feeling of shared success and a deeper drive to help one another succeed.
In our model, 87% of surveyed residents said they felt less burned out in the new geographic, unit-based model of care, and 91% of physicians surveyed said it was easier to talk with team members to coordinate care. Additionally, our HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores saw a drastic increase in many domains. Nursing communication improved by more than 42% on domain 7B; doctor communication improved by more than 31%. Additionally, all other domains saw at least 10% improvement. We are now 5 months out from our initial rollout of the model and continue to see sustained improvements in quality measures.
The bad
The biggest challenges that we are working through with this model are hand-offs and transfer of patients from one team to another. Sometimes, it happens that one team’s patient will wind up on a floor that is the designated floor of another team because of bed availability. We continue to work with bed board to address this issue. We want to minimize transfers and hand-offs to promote continuity and have to balance that with the need for geographic location. With clear communication, hospital collaboration from bed board and safe hand-off methods, this problem can be safely addressed.
Conclusions
The experience of implementing the unit-based team model has been an eye-opening journey. One thing that stands out is that, in an increasingly complex health care system, design thinking is critical.
Design thinking takes into consideration the needs of those who are using a system. In this case, patients and health care workers including doctors, nurses, case managers, and social workers are the end users of the health care system. All parties are utilizing the health care system to optimize patient health. Therefore, we must create systems that are easy to navigate and use by patients and health care workers so that they can ensure the success of patients.
Unit-based teams offer a basic framework to optimize the inpatient system to facilitate better workflow. In our system, it allowed us to optimize communications between health care workers and also between health care workers and patients. It allowed team members to work in close proximity to better share ideas with each other.
We spent a significant amount of time upfront earning the support of all of the disciplines for this effort. We had support from all leaders within the organization and continue to make our case for this model by sharing metrics and holding forums to discuss the process.
Initial data show a marked improvement in many domains of HCAHPS scores. Our frontline staff, including attendings, residents, nursing, case managers, and social workers, also continue to support this effort since it has a positive impact on their workflow and improves their workday quality. One nurse mentioned specifically, “in my 30 years at this hospital I have never seen people work together so well.”
To sustain this effort, we continue to have regular meetings, and there are new features that we would like to add to the program. For example, we are working with our IT group to ensure that each unit-based team will have dashboards available to incorporate real time, actionable data into daily workflows.
We are excited by the potential of our high-performing teams to highlight the patient experience, placing the patient at the center for care, decision making, and rounding. Health care is a team sport, and anytime you build something where all teams are playing together and approaching the finish line as a unit, you will never go wrong!
Dr. Pendharkar is division chief of hospital medicine at the Brooklyn (N.Y.) Hospital Center, medical director of inpatient services and director of quality for the department of medicine at the Brooklyn Hospital Center and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York. Dr. Malieckal is chief resident, internal medicine, at the Brooklyn Hospital Center. Dr. Gasperino is chair, department of medicine; vice president for critical care, perioperative, and hospital medicine; and associate chief medical officer at the Brooklyn Hospital Center.
“To me, teamwork is the beauty of our sport, where you have five acting as one. You become selfless.” – Mike Krzyzewski
High-performing teams plan, communicate, reflect, and take action together. Teamwork can transform seemingly impossible tasks into opportunities for people to come together and create value.
The increasing complexity of health care makes team-based care necessary to achieve successful health outcomes for patients. At the Brooklyn (N.Y.) Hospital Center, a 464-bed care center, we transformed the model of care on the medical wards into a geographic, unit-based team model. Here we describe our journey – the successes, the challenges, and the opportunities for growth.
Previous model
In the previous care model on our medical wards, no set structures were in place. Teams would travel to multiple wards throughout the hospital to see the patients they were rounding on. Each floor had its own set of social workers and case managers, therefore a hospital medicine team routinely dealt with more than eight social workers and case managers to address their patients’ needs in a single day.
Multidisciplinary rounds for all medical patients were held at 11 a.m. in a room located a significant distance away from the medical wards. All case managers and social workers would sit in this room from 11 a.m. until noon, and teams would travel to that room to discuss their patients.
Many challenges were identified in this model, including a lack of communication, a de-emphasis on teamwork, and a design that did not take physician workflows into account resulting in low efficiency. Thus, these challenges sparked a desire to create a more effective and team-based methodology of accomplishing excellence in delivery of clinical care. Dr. Pendharkar, having worked primarily in centers with unit-based care, determined that a geographic, unit-based model of care could transform care delivery at the Brooklyn Hospital Center.
Looking ahead
The efforts for transforming the vision of geographic, unit-based teams into a reality started by gathering all stakeholders together to unite for a common mission. Initial meetings were held with all parties including social workers, case managers, residents, nursing staff, bed board and attending physicians in internal medicine, and the emergency department.
The vision of a geographic, unit-based team was shared and explained to all team members. Exercises in LEAN methodology were conducted, including one-piece flow exercises, to highlight the possibilities of what could be accomplished through teamwork. Once support for the vision was in place from all parties, the logistics were addressed.
The biggest challenge to overcome was how to place all of one team’s patients on a singular medical ward. In our hospital, a medical ward holds anywhere from 30 to 33 patients. Each hospital medicine team, of which there are many, typically carries 20-23 patients. We created a blueprint to map out the floor to which each team and attending would be assigned. Next, we partnered with both IT and bed board to design an admission order set that specified the particular geographic location that a team and attending were associated with so that patients could be placed accordingly from the ED.
It was important for the ED doctors, bed board, and the internal medicine residents to understand these changes because all of these parties were involved in the initial admitting process. Dr. Pendharkar and Dr. Malieckal provided all groups with in-person training on how the logistics of the system would unfold. Noon conference lectures were also held to explain the vision to residents.
Over 3 weeks, the first ward we chose to implement our model on slowly accumulated the patients of one team – this was the gradual trickle phase. We then selected a “re-set” date. On the re-set date, it was determined that all patients would go to the team that was assigned to that floor, with the exception of any private attendings’ patients.
On the day before the re-set date, time was spent ensuring that all hand-offs were safe. Dr. Pendharkar and Dr. Malieckal spoke with every intern and team that would be handing off and/or receiving patients as a result of the re-set policy. The goal was to ensure that on that date a ward had close to 100% of its patients belonging to the team/attending that was assigned to that area.
The good
Once we began our geographic, unit-based model, our rounding process was transformed.
Now, our morning rounds were joined by the bedside nurse, case manager, social worker, clinical pharmacy, and nutrition in addition to the core team. The entire team went from room to room on one ward rounding on all 20 to 25 patients back to back, which created an unparalleled level of efficiency and a forum for effective communication lasting throughout the day.
We also added workstations on wheels (WOWS) to the rounding process so that labs, radiology, and more could be reviewed on rounds with the entire team. A standard script was developed so that each patient was introduced to all members of the team, and the care plan was disclosed and highlighted. One patient noted, “I feel so cared for, knowing I have this entire team taking care of me.” We also rounded in the afternoon with the case managers and social workers to follow up tasks that were to be completed that day.
Our first few weeks utilizing the geographic, unit-based model of rounding was largely successful. The residents, now able to round on all of their patients in one location with one case manager and one social worker, noted, “This model of rounding makes my life so much easier, I feel like I can focus on the patient rather than running around. … and I know the social worker and case manager will help me.”
Provider satisfaction had improved, from residents to physicians to nurses, case managers, social workers, and more. Our case manager also noted her satisfaction with the new model, stating that her communication with the medical team was much easier. As the attending, I witnessed firsthand how working together with the team moved care forward much more quickly, compared with the previous model, because of the simple factor of increased ease of communication.
Now all team members were together in the patient room and discussion was much easier. There was less confusion, fewer delays, and better communication – I think unit-based teams can even be described as a lifesaving measure that reduces harm to patients. An additional benefit is the relationship that now developed between doctors, social workers, and case managers – they spent more time together and really got to know one another, creating a feeling of shared success and a deeper drive to help one another succeed.
In our model, 87% of surveyed residents said they felt less burned out in the new geographic, unit-based model of care, and 91% of physicians surveyed said it was easier to talk with team members to coordinate care. Additionally, our HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores saw a drastic increase in many domains. Nursing communication improved by more than 42% on domain 7B; doctor communication improved by more than 31%. Additionally, all other domains saw at least 10% improvement. We are now 5 months out from our initial rollout of the model and continue to see sustained improvements in quality measures.
The bad
The biggest challenges that we are working through with this model are hand-offs and transfer of patients from one team to another. Sometimes, it happens that one team’s patient will wind up on a floor that is the designated floor of another team because of bed availability. We continue to work with bed board to address this issue. We want to minimize transfers and hand-offs to promote continuity and have to balance that with the need for geographic location. With clear communication, hospital collaboration from bed board and safe hand-off methods, this problem can be safely addressed.
Conclusions
The experience of implementing the unit-based team model has been an eye-opening journey. One thing that stands out is that, in an increasingly complex health care system, design thinking is critical.
Design thinking takes into consideration the needs of those who are using a system. In this case, patients and health care workers including doctors, nurses, case managers, and social workers are the end users of the health care system. All parties are utilizing the health care system to optimize patient health. Therefore, we must create systems that are easy to navigate and use by patients and health care workers so that they can ensure the success of patients.
Unit-based teams offer a basic framework to optimize the inpatient system to facilitate better workflow. In our system, it allowed us to optimize communications between health care workers and also between health care workers and patients. It allowed team members to work in close proximity to better share ideas with each other.
We spent a significant amount of time upfront earning the support of all of the disciplines for this effort. We had support from all leaders within the organization and continue to make our case for this model by sharing metrics and holding forums to discuss the process.
Initial data show a marked improvement in many domains of HCAHPS scores. Our frontline staff, including attendings, residents, nursing, case managers, and social workers, also continue to support this effort since it has a positive impact on their workflow and improves their workday quality. One nurse mentioned specifically, “in my 30 years at this hospital I have never seen people work together so well.”
To sustain this effort, we continue to have regular meetings, and there are new features that we would like to add to the program. For example, we are working with our IT group to ensure that each unit-based team will have dashboards available to incorporate real time, actionable data into daily workflows.
We are excited by the potential of our high-performing teams to highlight the patient experience, placing the patient at the center for care, decision making, and rounding. Health care is a team sport, and anytime you build something where all teams are playing together and approaching the finish line as a unit, you will never go wrong!
Dr. Pendharkar is division chief of hospital medicine at the Brooklyn (N.Y.) Hospital Center, medical director of inpatient services and director of quality for the department of medicine at the Brooklyn Hospital Center and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York. Dr. Malieckal is chief resident, internal medicine, at the Brooklyn Hospital Center. Dr. Gasperino is chair, department of medicine; vice president for critical care, perioperative, and hospital medicine; and associate chief medical officer at the Brooklyn Hospital Center.
Inhibitor may overcome ibrutinib resistance in MCL
Investigators have identified a mechanism of ibrutinib resistance in mantle cell lymphoma (MCL) and showed that a small molecule can overcome that resistance in vitro and in vivo.
The team found that ibrutinib-resistant MCL cells rely on oxidative phosphorylation (OXPHOS) and glutaminolysis to survive.
Targeting the OXPHOS pathway with a small molecule, IACS-010759, inhibited the proliferation of ibrutinib-resistant cells in vitro.
IACS-010759 also decreased tumor volume and improved survival in mouse models of ibrutinib-resistant MCL and double-hit B-cell lymphoma.
Now, IACS-10759 is being tested in phase 1 trials of lymphoma and solid tumors (NCT03291938) as well as acute myeloid leukemia (NCT02882321).
Liang Zhang, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues conducted the preclinical research and described their findings in Science Translational Medicine.
The investigators sequenced samples from MCL patients with ibrutinib-sensitive and -resistant disease and found that “glutamine-fueled OXPHOS appears to be a prominent energy metabolism pathway in ibrutinib-resistant MCL cells.”
This finding prompted the team to test IACS-010759, an inhibitor of ETC complex I, in ibrutinib-resistant MCL. They theorized that the inhibitor would be effective because, during OXPHOS, electrons are transferred from electron donors to acceptors through the ETC in redox reactions that release energy to form ATP, and OXPHOS generates ATP to meet requirements for cell growth.
In experiments, IACS-010759 inhibited the proliferation of two ibrutinib-resistant MCL cell lines, Z-138 and Maver-1, in a dose-dependent manner.
The investigators also tested IACS-010759 in two mouse models of ibrutinib-resistant MCL. In both models, mice treated with IACS-010759 had a significant reduction in tumor volume, compared with controls. In one model, IACS-010759 extended survival by a median of 11 days.
Finally, the team tested IACS-010759 in a model of ibrutinib-resistant, double-hit (MYC and BCL-2) B-cell lymphoma with central nervous system involvement. Again, IACS-010759 significantly inhibited tumor growth. Compared to ibrutinib and vehicle control, IACS-010759 provided a median survival benefit of more than 20 days.
There were no toxicities associated with IACS-010759 treatment, according to the investigators.
This research was supported by the MD Anderson B Cell Lymphoma Moon Shot Project, Gary Rogers Foundation, Kinder Foundation, Cullen Foundation, Cancer Prevention Research Institute of Texas, and the National Institutes of Health. Most investigators reported having no competing interests, but two reported a patent (WO/2015/130790).
SOURCE: Zhang L et al. Sci Transl Med. 2019 May 8. doi: 10.1126/scitranslmed.aau1167.
Investigators have identified a mechanism of ibrutinib resistance in mantle cell lymphoma (MCL) and showed that a small molecule can overcome that resistance in vitro and in vivo.
The team found that ibrutinib-resistant MCL cells rely on oxidative phosphorylation (OXPHOS) and glutaminolysis to survive.
Targeting the OXPHOS pathway with a small molecule, IACS-010759, inhibited the proliferation of ibrutinib-resistant cells in vitro.
IACS-010759 also decreased tumor volume and improved survival in mouse models of ibrutinib-resistant MCL and double-hit B-cell lymphoma.
Now, IACS-10759 is being tested in phase 1 trials of lymphoma and solid tumors (NCT03291938) as well as acute myeloid leukemia (NCT02882321).
Liang Zhang, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues conducted the preclinical research and described their findings in Science Translational Medicine.
The investigators sequenced samples from MCL patients with ibrutinib-sensitive and -resistant disease and found that “glutamine-fueled OXPHOS appears to be a prominent energy metabolism pathway in ibrutinib-resistant MCL cells.”
This finding prompted the team to test IACS-010759, an inhibitor of ETC complex I, in ibrutinib-resistant MCL. They theorized that the inhibitor would be effective because, during OXPHOS, electrons are transferred from electron donors to acceptors through the ETC in redox reactions that release energy to form ATP, and OXPHOS generates ATP to meet requirements for cell growth.
In experiments, IACS-010759 inhibited the proliferation of two ibrutinib-resistant MCL cell lines, Z-138 and Maver-1, in a dose-dependent manner.
The investigators also tested IACS-010759 in two mouse models of ibrutinib-resistant MCL. In both models, mice treated with IACS-010759 had a significant reduction in tumor volume, compared with controls. In one model, IACS-010759 extended survival by a median of 11 days.
Finally, the team tested IACS-010759 in a model of ibrutinib-resistant, double-hit (MYC and BCL-2) B-cell lymphoma with central nervous system involvement. Again, IACS-010759 significantly inhibited tumor growth. Compared to ibrutinib and vehicle control, IACS-010759 provided a median survival benefit of more than 20 days.
There were no toxicities associated with IACS-010759 treatment, according to the investigators.
This research was supported by the MD Anderson B Cell Lymphoma Moon Shot Project, Gary Rogers Foundation, Kinder Foundation, Cullen Foundation, Cancer Prevention Research Institute of Texas, and the National Institutes of Health. Most investigators reported having no competing interests, but two reported a patent (WO/2015/130790).
SOURCE: Zhang L et al. Sci Transl Med. 2019 May 8. doi: 10.1126/scitranslmed.aau1167.
Investigators have identified a mechanism of ibrutinib resistance in mantle cell lymphoma (MCL) and showed that a small molecule can overcome that resistance in vitro and in vivo.
The team found that ibrutinib-resistant MCL cells rely on oxidative phosphorylation (OXPHOS) and glutaminolysis to survive.
Targeting the OXPHOS pathway with a small molecule, IACS-010759, inhibited the proliferation of ibrutinib-resistant cells in vitro.
IACS-010759 also decreased tumor volume and improved survival in mouse models of ibrutinib-resistant MCL and double-hit B-cell lymphoma.
Now, IACS-10759 is being tested in phase 1 trials of lymphoma and solid tumors (NCT03291938) as well as acute myeloid leukemia (NCT02882321).
Liang Zhang, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues conducted the preclinical research and described their findings in Science Translational Medicine.
The investigators sequenced samples from MCL patients with ibrutinib-sensitive and -resistant disease and found that “glutamine-fueled OXPHOS appears to be a prominent energy metabolism pathway in ibrutinib-resistant MCL cells.”
This finding prompted the team to test IACS-010759, an inhibitor of ETC complex I, in ibrutinib-resistant MCL. They theorized that the inhibitor would be effective because, during OXPHOS, electrons are transferred from electron donors to acceptors through the ETC in redox reactions that release energy to form ATP, and OXPHOS generates ATP to meet requirements for cell growth.
In experiments, IACS-010759 inhibited the proliferation of two ibrutinib-resistant MCL cell lines, Z-138 and Maver-1, in a dose-dependent manner.
The investigators also tested IACS-010759 in two mouse models of ibrutinib-resistant MCL. In both models, mice treated with IACS-010759 had a significant reduction in tumor volume, compared with controls. In one model, IACS-010759 extended survival by a median of 11 days.
Finally, the team tested IACS-010759 in a model of ibrutinib-resistant, double-hit (MYC and BCL-2) B-cell lymphoma with central nervous system involvement. Again, IACS-010759 significantly inhibited tumor growth. Compared to ibrutinib and vehicle control, IACS-010759 provided a median survival benefit of more than 20 days.
There were no toxicities associated with IACS-010759 treatment, according to the investigators.
This research was supported by the MD Anderson B Cell Lymphoma Moon Shot Project, Gary Rogers Foundation, Kinder Foundation, Cullen Foundation, Cancer Prevention Research Institute of Texas, and the National Institutes of Health. Most investigators reported having no competing interests, but two reported a patent (WO/2015/130790).
SOURCE: Zhang L et al. Sci Transl Med. 2019 May 8. doi: 10.1126/scitranslmed.aau1167.
FROM SCIENCE TRANSLATIONAL MEDICINE
Perplexing text messages may be the sole sign of stroke
PHILADELPHIA – described at the annual meeting of the American Academy of Neurology. The phenomenon, dubbed “dystextia” and characterized by confusing interpersonal electronic communications, is not new but is increasingly relevant to clinical practice now that smartphones are essentially ubiquitous, said the case report authors.
In fact, time to intervention may be positively impacted if access to a patient’s texts and emails can be obtained, said lead author Taylor R. Anderson, a medical student at Wayne State University, Detroit.
The findings sparked interest in further research into the underlying causes and implications of dystextia: “It will be interesting to see if there are specific regions of the brain that are responsible for texting, and how they relate to other forms of communication such as handwriting and typing,” the authors said in their poster presentation.
Mr. Anderson and colleagues described two patients evaluated at Ascension St. John Hospital and Medical Center in Detroit who had stroke presenting as difficulty in typing text messages.
One case was a 43-year-old woman who experienced headache consistent with her usual migraine and spelling errors in her texts and posts on Facebook. She had visuospatial anomalies and left facial droop on evaluation. A brain MRI revealed acute embolic infarcts in the parietal and right frontal lobes, according to Mr. Anderson and coauthors.
The second case was a 66-year-old woman who had difficulty writing texts and typed notes. A head CT done in an urgent care facility showed a left frontal subacute infarct, which, according to the authors, was likely related to risk factors including hypertension, diabetes, and dyslipidemia.
These cases show that dystextia can arise after lesions in either hemisphere, the authors said. However, they emphasized that both cases involved the dominant cerebral hemisphere, while by contrast, there have not been previous reports of dystextia due to nondominant hemispheric infarct.
It stands to reason that stroke would affect the ability to text, a multipurpose task that involves use of motor, language, and vision skills, the authors said. Strokes could affect not only skills needed to type, read, and express thoughts, but also visuospatial memory mapping to letters on the device’s keyboard, they noted.
The left frontal and superior parietal regions have been implicated in handwriting in neuroimaging experiments, the authors said, while the operculum and left second frontal convolution are involved in typing.
The authors had nothing to disclose.
SOURCE: Anderson T et al. AAN 2019. Abstract P5.3-062.
PHILADELPHIA – described at the annual meeting of the American Academy of Neurology. The phenomenon, dubbed “dystextia” and characterized by confusing interpersonal electronic communications, is not new but is increasingly relevant to clinical practice now that smartphones are essentially ubiquitous, said the case report authors.
In fact, time to intervention may be positively impacted if access to a patient’s texts and emails can be obtained, said lead author Taylor R. Anderson, a medical student at Wayne State University, Detroit.
The findings sparked interest in further research into the underlying causes and implications of dystextia: “It will be interesting to see if there are specific regions of the brain that are responsible for texting, and how they relate to other forms of communication such as handwriting and typing,” the authors said in their poster presentation.
Mr. Anderson and colleagues described two patients evaluated at Ascension St. John Hospital and Medical Center in Detroit who had stroke presenting as difficulty in typing text messages.
One case was a 43-year-old woman who experienced headache consistent with her usual migraine and spelling errors in her texts and posts on Facebook. She had visuospatial anomalies and left facial droop on evaluation. A brain MRI revealed acute embolic infarcts in the parietal and right frontal lobes, according to Mr. Anderson and coauthors.
The second case was a 66-year-old woman who had difficulty writing texts and typed notes. A head CT done in an urgent care facility showed a left frontal subacute infarct, which, according to the authors, was likely related to risk factors including hypertension, diabetes, and dyslipidemia.
These cases show that dystextia can arise after lesions in either hemisphere, the authors said. However, they emphasized that both cases involved the dominant cerebral hemisphere, while by contrast, there have not been previous reports of dystextia due to nondominant hemispheric infarct.
It stands to reason that stroke would affect the ability to text, a multipurpose task that involves use of motor, language, and vision skills, the authors said. Strokes could affect not only skills needed to type, read, and express thoughts, but also visuospatial memory mapping to letters on the device’s keyboard, they noted.
The left frontal and superior parietal regions have been implicated in handwriting in neuroimaging experiments, the authors said, while the operculum and left second frontal convolution are involved in typing.
The authors had nothing to disclose.
SOURCE: Anderson T et al. AAN 2019. Abstract P5.3-062.
PHILADELPHIA – described at the annual meeting of the American Academy of Neurology. The phenomenon, dubbed “dystextia” and characterized by confusing interpersonal electronic communications, is not new but is increasingly relevant to clinical practice now that smartphones are essentially ubiquitous, said the case report authors.
In fact, time to intervention may be positively impacted if access to a patient’s texts and emails can be obtained, said lead author Taylor R. Anderson, a medical student at Wayne State University, Detroit.
The findings sparked interest in further research into the underlying causes and implications of dystextia: “It will be interesting to see if there are specific regions of the brain that are responsible for texting, and how they relate to other forms of communication such as handwriting and typing,” the authors said in their poster presentation.
Mr. Anderson and colleagues described two patients evaluated at Ascension St. John Hospital and Medical Center in Detroit who had stroke presenting as difficulty in typing text messages.
One case was a 43-year-old woman who experienced headache consistent with her usual migraine and spelling errors in her texts and posts on Facebook. She had visuospatial anomalies and left facial droop on evaluation. A brain MRI revealed acute embolic infarcts in the parietal and right frontal lobes, according to Mr. Anderson and coauthors.
The second case was a 66-year-old woman who had difficulty writing texts and typed notes. A head CT done in an urgent care facility showed a left frontal subacute infarct, which, according to the authors, was likely related to risk factors including hypertension, diabetes, and dyslipidemia.
These cases show that dystextia can arise after lesions in either hemisphere, the authors said. However, they emphasized that both cases involved the dominant cerebral hemisphere, while by contrast, there have not been previous reports of dystextia due to nondominant hemispheric infarct.
It stands to reason that stroke would affect the ability to text, a multipurpose task that involves use of motor, language, and vision skills, the authors said. Strokes could affect not only skills needed to type, read, and express thoughts, but also visuospatial memory mapping to letters on the device’s keyboard, they noted.
The left frontal and superior parietal regions have been implicated in handwriting in neuroimaging experiments, the authors said, while the operculum and left second frontal convolution are involved in typing.
The authors had nothing to disclose.
SOURCE: Anderson T et al. AAN 2019. Abstract P5.3-062.
REPORTING FROM AAN 2019
BTK inhibitor reduces MS enhancing lesions
. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).
We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.
. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).
We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.
. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).
We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Survey: High costs lead to skipped or postponed health care
Half of all Americans with employer-sponsored health benefits say that they or someone in their family has skipped or postponed care because of the cost, according to a survey by the Kaiser Family Foundation and the Los Angeles Times.
That number changes, however, when chronic conditions are considered. In the survey of Americans covered by employer-sponsored health insurance, 60% of those with a family member who had a chronic condition said that cost had altered the care of someone in the family over the previous 12 months, compared with 40% of those who had no chronic condition in their family, the KFF and L.A. Times noted in their report.
More specifically, families with an individual who had a chronic condition were more likely to put off or postpone needed care (42% vs. 23%) and to rely on home remedies or OTC drugs instead of visiting a physician (41% vs. 28%) than were families without chronic conditions, the report’s authors said.
When asked about the affordability of their health care, 49% of those in families with a chronic health condition said they had a problem paying for their coverage in the past year, compared with 29% of respondents in families with no chronic condition.
“Drilling down into the consequences of these affordability problems reveals more about the financial burden of health care on families with chronic conditions,” compared with those without chronic conditions: cut back spending on food, clothes, household items (35% vs. 16%); used up all or most of their savings (26% vs. 11%); and borrowed money from friends or family (14% vs. 6%), according to the researchers.
Although respondents felt “that the cost of health care for people like them is too high, more say the current U.S. health insurance system works well for people with employer coverage than say it works well for people on Medicare or Medicaid or those who purchase their own insurance. Asked who is to blame for high costs, majorities point the finger at pharmaceutical and insurance companies, while fewer see hospitals, doctors, or employers as deserving of blame,” the KFF and L.A. Times investigators wrote.
The survey involved a sample of 1,407 adults aged 18-64 years and was conducted from Sept. 25 through Oct. 9, 2018. The margin of the sampling error is ±3 percentage points.
Half of all Americans with employer-sponsored health benefits say that they or someone in their family has skipped or postponed care because of the cost, according to a survey by the Kaiser Family Foundation and the Los Angeles Times.
That number changes, however, when chronic conditions are considered. In the survey of Americans covered by employer-sponsored health insurance, 60% of those with a family member who had a chronic condition said that cost had altered the care of someone in the family over the previous 12 months, compared with 40% of those who had no chronic condition in their family, the KFF and L.A. Times noted in their report.
More specifically, families with an individual who had a chronic condition were more likely to put off or postpone needed care (42% vs. 23%) and to rely on home remedies or OTC drugs instead of visiting a physician (41% vs. 28%) than were families without chronic conditions, the report’s authors said.
When asked about the affordability of their health care, 49% of those in families with a chronic health condition said they had a problem paying for their coverage in the past year, compared with 29% of respondents in families with no chronic condition.
“Drilling down into the consequences of these affordability problems reveals more about the financial burden of health care on families with chronic conditions,” compared with those without chronic conditions: cut back spending on food, clothes, household items (35% vs. 16%); used up all or most of their savings (26% vs. 11%); and borrowed money from friends or family (14% vs. 6%), according to the researchers.
Although respondents felt “that the cost of health care for people like them is too high, more say the current U.S. health insurance system works well for people with employer coverage than say it works well for people on Medicare or Medicaid or those who purchase their own insurance. Asked who is to blame for high costs, majorities point the finger at pharmaceutical and insurance companies, while fewer see hospitals, doctors, or employers as deserving of blame,” the KFF and L.A. Times investigators wrote.
The survey involved a sample of 1,407 adults aged 18-64 years and was conducted from Sept. 25 through Oct. 9, 2018. The margin of the sampling error is ±3 percentage points.
Half of all Americans with employer-sponsored health benefits say that they or someone in their family has skipped or postponed care because of the cost, according to a survey by the Kaiser Family Foundation and the Los Angeles Times.
That number changes, however, when chronic conditions are considered. In the survey of Americans covered by employer-sponsored health insurance, 60% of those with a family member who had a chronic condition said that cost had altered the care of someone in the family over the previous 12 months, compared with 40% of those who had no chronic condition in their family, the KFF and L.A. Times noted in their report.
More specifically, families with an individual who had a chronic condition were more likely to put off or postpone needed care (42% vs. 23%) and to rely on home remedies or OTC drugs instead of visiting a physician (41% vs. 28%) than were families without chronic conditions, the report’s authors said.
When asked about the affordability of their health care, 49% of those in families with a chronic health condition said they had a problem paying for their coverage in the past year, compared with 29% of respondents in families with no chronic condition.
“Drilling down into the consequences of these affordability problems reveals more about the financial burden of health care on families with chronic conditions,” compared with those without chronic conditions: cut back spending on food, clothes, household items (35% vs. 16%); used up all or most of their savings (26% vs. 11%); and borrowed money from friends or family (14% vs. 6%), according to the researchers.
Although respondents felt “that the cost of health care for people like them is too high, more say the current U.S. health insurance system works well for people with employer coverage than say it works well for people on Medicare or Medicaid or those who purchase their own insurance. Asked who is to blame for high costs, majorities point the finger at pharmaceutical and insurance companies, while fewer see hospitals, doctors, or employers as deserving of blame,” the KFF and L.A. Times investigators wrote.
The survey involved a sample of 1,407 adults aged 18-64 years and was conducted from Sept. 25 through Oct. 9, 2018. The margin of the sampling error is ±3 percentage points.
Renal denervation boosts effectiveness of AFib catheter ablation
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
REPORTING FROM HEART RHYTHM 2019