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Automatic reenrollment helps keep people insured
appearing in JAMA Internal Medicine
Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.
The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.
“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).
“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.
Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.
“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”
SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.
appearing in JAMA Internal Medicine
Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.
The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.
“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).
“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.
Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.
“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”
SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.
appearing in JAMA Internal Medicine
Researchers looked at 123,244 households in California that were enrolled in marketplace plans that exited the state in 2015. Of the 781 households that were not automatically reenrolled in other plans, the unadjusted and adjusted enrollment rates were 21.4% and 21.5%, respectively. Researchers adjusted for a variety of household characteristics, including age of the oldest household member, household size, receipt of tax credit subsidy, and other factors. Of the 122,463 with the option to reenroll, unadjusted and adjusted enrollment was 51.2%.
The research comes as the Centers for Medicare & Medicaid Services is contemplating the elimination of automatic reenrollment in marketplace plans.
“Elimination of automatic reenrollment would likely be associated with decreases in the number of enrollees who remain insured through the marketplaces,” research authors Coleman Drake, PhD, University of Pittsburgh, and David Anderson, Duke Univeristy, Durham, N.C., wrote in a letter (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717).
“As an opt-out policy similar to that used in other health insurance markets such as Medicaid, automatic reenrollment may be associated with increases in continuity of coverage in the marketplaces by reducing administrative barriers to reenrollment,” the authors continued.
Dr. Drake and Mr. Anderson noted that losing automatic reenrollment was associated with a decrease in enrollment, but more study is needed particularly because the group that lost reenrollment was small.
“Households with different demographics or different experiences may have behaved differently if they had lost the option to automatically reenroll,” they state. “Losing automatic reenrollment because of a policy change rather than an insurer exit also may be associated with households behaving differently. Given the magnitude of our findings, it is critical that future studies continue investigating the association between automatic reenrollment and continuity of coverage.”
SOURCE: Coleman D, Anderson A. JAMA Inter Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3717.
FROM JAMA INTERNAL MEDICINE
Business case for interoperability remains elusive
In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”
That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.
“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.
“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”
But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.
“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.
Rather, he sees two key components that will drive interoperability.
First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.
“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.
The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.
“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”
And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.
“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.
The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.
Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.
But overall, it would appear that getting to an interoperable point is going to be a challenge.
The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”
SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”
In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”
That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.
“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.
“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”
But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.
“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.
Rather, he sees two key components that will drive interoperability.
First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.
“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.
The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.
“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”
And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.
“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.
The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.
Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.
But overall, it would appear that getting to an interoperable point is going to be a challenge.
The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”
SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”
In a recent survey issued by the Center for Connected Medicine that asked, “What is needed most to push interoperability forward in health care?” 53% of the 100 IT and business leader participants at hospitals and health systems answered “senior leadership commitment to interoperability as a top strategic priority.”
That interoperability continues to be an elusive target despite being a regulatory emphasis for more than a decade comes as no surprise.
“You have to put interoperability into the context of the challenges of being a leader in health care delivery organization or a hospital,” Robert Bart, MD, chief medical information officer of the Health Services Division at the University of Pittsburgh Medical Center, said in an interview. UPMC operates the Center for Connected Medicine in partnership with GE Healthcare and Nokia.
“For many health care delivery systems, the operational margin is extremely small,” he continued. “From a strategic perspective, they may be prioritizing things or opportunities that directly contribute to the bottom line and the financial success or even financial viability of the organization. “Interoperability certainly helps health care overall in the U.S., but whether it contributes directly to the financial bottom line of any given specific organization might vary significantly.”
But Dr. Bart said it really is not the financial incentives, a staple in the early days of the meaningful use program to spur adoption, that will get electronic health records and other health IT into a more interoperable space.
“I am not sure that financial incentives – unless they are significantly different in amounts than they currently are – are going to be the sole single reason why organizations prioritize interoperability higher,” he said.
Rather, he sees two key components that will drive interoperability.
First, he cited efforts by the Centers for Medicare & Medicaid Services to bring ownership of health data to the individual as an important driver.
“I think that is a better direction to push as opposed to financial incentives because I think that is really where we philosophically and then therefore operationally need to get to,” Dr. Bart said.
The second would take a lot more involvement from government that likely is more difficult to achieve: getting a more clear definition of health IT standards.
“We have accomplished some forward movement in interoperability, but we probably have far more road in front of us than we have left behind us as it relates to interoperability,” he said. “A fair amount of that is related to standards which, unfortunately, oftentimes are left up to interpretation. So when it comes to operationalizing these standards between different vendors or different health care systems, they sometimes don’t match up and add even more challenge to the exchange of information.”
And with industry not taking an active lead in solving some of the problems related to the standardization of data needed to drive interoperability, he suggested government should play a bigger role.
“I would like the government to take a stronger hand in helping health care define the standards so the standards are actually much more executable and there is a lot less interpretation, which I think would ease the ability for interoperability to flourish a lot more,” he said.
The move to value-based care could also provide added incentive to drive interoperability, Dr. Bart said.
Value-based care is “certainly not going to raise more barriers toward interoperability and potentially could lower some as organizations recognize that it may be a path to decreasing the costs of repeating tests that will not improve the quality of care delivered,” he said.
But overall, it would appear that getting to an interoperable point is going to be a challenge.
The report notes that “beyond tasks required by regulation or related to basic functioning (such as sharing data within their own system), interoperability still presents a challenge to organizations. Fewer than 4 in 10 report success with sharing data with other health systems, effectiveness in tapping into unstructured data, and effectiveness in reducing the cost of care.”
SOURCE: A report issued by the Center for Connected Medicine called “Improving Health Care Interoperability: Are We Making Progress?”
Adult insomnia associated with childhood behavioral problems
Yohannes Adama Melaku, MPH, PhD, of the Adelaide (Australia) Institute for Sleep Health at Flinders University and coauthors drew data from the 1970 UK Birth Cohort Study. This study followed an initial cohort of 16,571 babies who were born during a single week, with follow-up at ages 5, 10, 16, 26, 30, 38, 42, and 46 years. For the purposes of this study, the investigators looked at participants who, at 42 years of age, were alive and not lost to follow-up and who responded to an invitation to be interviewed; the sample sizes in the analysis were 8,050 participants aged 5 years, 9,090 participants aged 10 years, 9,653 participants aged 16 years, and 9,841 participants aged 42 years.
Behavior was measured at ages 5 years and 16 years using the Rutter Behavioral Scale (RBS) and at age 10 years using a visual analog scale, and insomnia symptoms were assessed through interviewing participants in adulthood about duration of sleep, difficulty initiating sleep, difficulty maintaining sleep, and not feeling rested on waking. Participants were organized into normal behavior (less than or equal to 80th percentile on RBS), moderate behavioral problems (greater than the 80th percentile but less than or equal to the 95th percentile), and severe behavioral problems (above 95th percentile). The investigators then devised two models for their analysis: Model 1 adjusted for sex, parent’s social class and educational level, marital status, educational status, and social class, and model 2 adjusted for physical activity level and body mass index (BMI) trajectory (from 10 to 42 years), perceived health status, and number of noncommunicable diseases, although this latter model yielded fewer statistically significant results in some analyses.
Odds for difficulty initiating or maintaining sleep as an adult was increased among participants with severe behavioral problems at age 5 years in model 1 (adjusted odds ratio, 1.50; 95% confidence interval, 1.14-1.96; P = .004), as well as for those with severe problems at 10 years (aOR, 1.30; 95% CI, 1.14-1.63; P = .001), and at 16 years (aOR, 2.17; 95% CI, 1.59-2.91; P less than .001). The aORs also were higher individually for difficulty initiating sleep and for difficulty maintaining sleep in all age groups.
The association with adulthood insomnia was stronger in participants with externalizing behavioral problems such as lying, bullying, restlessness, and fighting than it was in those with internalizing behavioral problems such as worry, fearfulness, and solitariness.
“Although early sleep problems should be identified, we should additionally identify children with moderate to severe behavioral problems that persist throughout childhood as potential beneficiaries of early intervention with a sleep health focus,” the authors wrote.
One of the study’s limitations was a lack of standardized insomnia measures in the cohort study; however, the researchers suggested that the symptoms included reflect those of standardized measures and diagnostic criteria.
“This study is the first, to our knowledge, to suggest an unfavorable association of early-life behavioral problems with adulthood sleep health, underlining the importance of treating behavioral problems in children and addressing insomnia from a life-course perspective,” they concluded.
No study sponsor was identified. The authors reported no relevant financial disclosures.
SOURCE: Melaku YA et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10861.
Yohannes Adama Melaku, MPH, PhD, of the Adelaide (Australia) Institute for Sleep Health at Flinders University and coauthors drew data from the 1970 UK Birth Cohort Study. This study followed an initial cohort of 16,571 babies who were born during a single week, with follow-up at ages 5, 10, 16, 26, 30, 38, 42, and 46 years. For the purposes of this study, the investigators looked at participants who, at 42 years of age, were alive and not lost to follow-up and who responded to an invitation to be interviewed; the sample sizes in the analysis were 8,050 participants aged 5 years, 9,090 participants aged 10 years, 9,653 participants aged 16 years, and 9,841 participants aged 42 years.
Behavior was measured at ages 5 years and 16 years using the Rutter Behavioral Scale (RBS) and at age 10 years using a visual analog scale, and insomnia symptoms were assessed through interviewing participants in adulthood about duration of sleep, difficulty initiating sleep, difficulty maintaining sleep, and not feeling rested on waking. Participants were organized into normal behavior (less than or equal to 80th percentile on RBS), moderate behavioral problems (greater than the 80th percentile but less than or equal to the 95th percentile), and severe behavioral problems (above 95th percentile). The investigators then devised two models for their analysis: Model 1 adjusted for sex, parent’s social class and educational level, marital status, educational status, and social class, and model 2 adjusted for physical activity level and body mass index (BMI) trajectory (from 10 to 42 years), perceived health status, and number of noncommunicable diseases, although this latter model yielded fewer statistically significant results in some analyses.
Odds for difficulty initiating or maintaining sleep as an adult was increased among participants with severe behavioral problems at age 5 years in model 1 (adjusted odds ratio, 1.50; 95% confidence interval, 1.14-1.96; P = .004), as well as for those with severe problems at 10 years (aOR, 1.30; 95% CI, 1.14-1.63; P = .001), and at 16 years (aOR, 2.17; 95% CI, 1.59-2.91; P less than .001). The aORs also were higher individually for difficulty initiating sleep and for difficulty maintaining sleep in all age groups.
The association with adulthood insomnia was stronger in participants with externalizing behavioral problems such as lying, bullying, restlessness, and fighting than it was in those with internalizing behavioral problems such as worry, fearfulness, and solitariness.
“Although early sleep problems should be identified, we should additionally identify children with moderate to severe behavioral problems that persist throughout childhood as potential beneficiaries of early intervention with a sleep health focus,” the authors wrote.
One of the study’s limitations was a lack of standardized insomnia measures in the cohort study; however, the researchers suggested that the symptoms included reflect those of standardized measures and diagnostic criteria.
“This study is the first, to our knowledge, to suggest an unfavorable association of early-life behavioral problems with adulthood sleep health, underlining the importance of treating behavioral problems in children and addressing insomnia from a life-course perspective,” they concluded.
No study sponsor was identified. The authors reported no relevant financial disclosures.
SOURCE: Melaku YA et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10861.
Yohannes Adama Melaku, MPH, PhD, of the Adelaide (Australia) Institute for Sleep Health at Flinders University and coauthors drew data from the 1970 UK Birth Cohort Study. This study followed an initial cohort of 16,571 babies who were born during a single week, with follow-up at ages 5, 10, 16, 26, 30, 38, 42, and 46 years. For the purposes of this study, the investigators looked at participants who, at 42 years of age, were alive and not lost to follow-up and who responded to an invitation to be interviewed; the sample sizes in the analysis were 8,050 participants aged 5 years, 9,090 participants aged 10 years, 9,653 participants aged 16 years, and 9,841 participants aged 42 years.
Behavior was measured at ages 5 years and 16 years using the Rutter Behavioral Scale (RBS) and at age 10 years using a visual analog scale, and insomnia symptoms were assessed through interviewing participants in adulthood about duration of sleep, difficulty initiating sleep, difficulty maintaining sleep, and not feeling rested on waking. Participants were organized into normal behavior (less than or equal to 80th percentile on RBS), moderate behavioral problems (greater than the 80th percentile but less than or equal to the 95th percentile), and severe behavioral problems (above 95th percentile). The investigators then devised two models for their analysis: Model 1 adjusted for sex, parent’s social class and educational level, marital status, educational status, and social class, and model 2 adjusted for physical activity level and body mass index (BMI) trajectory (from 10 to 42 years), perceived health status, and number of noncommunicable diseases, although this latter model yielded fewer statistically significant results in some analyses.
Odds for difficulty initiating or maintaining sleep as an adult was increased among participants with severe behavioral problems at age 5 years in model 1 (adjusted odds ratio, 1.50; 95% confidence interval, 1.14-1.96; P = .004), as well as for those with severe problems at 10 years (aOR, 1.30; 95% CI, 1.14-1.63; P = .001), and at 16 years (aOR, 2.17; 95% CI, 1.59-2.91; P less than .001). The aORs also were higher individually for difficulty initiating sleep and for difficulty maintaining sleep in all age groups.
The association with adulthood insomnia was stronger in participants with externalizing behavioral problems such as lying, bullying, restlessness, and fighting than it was in those with internalizing behavioral problems such as worry, fearfulness, and solitariness.
“Although early sleep problems should be identified, we should additionally identify children with moderate to severe behavioral problems that persist throughout childhood as potential beneficiaries of early intervention with a sleep health focus,” the authors wrote.
One of the study’s limitations was a lack of standardized insomnia measures in the cohort study; however, the researchers suggested that the symptoms included reflect those of standardized measures and diagnostic criteria.
“This study is the first, to our knowledge, to suggest an unfavorable association of early-life behavioral problems with adulthood sleep health, underlining the importance of treating behavioral problems in children and addressing insomnia from a life-course perspective,” they concluded.
No study sponsor was identified. The authors reported no relevant financial disclosures.
SOURCE: Melaku YA et al. JAMA Netw Open. 2019 Sep 6. doi: 10.1001/jamanetworkopen.2019.10861.
FROM JAMA NETWORK OPEN
Early infusion of mononuclear cells may benefit stroke patients
, results from a single-arm, phase I trial demonstrated. Unlike autologous mesenchymal stem cells, mononuclear cells (MNCs) do not require passage in culture, which allows for testing in the early poststroke time therapy window.
Bone marrow MNCs are attractive in regenerative medicine studies because they can be rapidly isolated; are enriched with hematopoietic, mesenchymal, and endothelial progenitor cells; and permit autologous applications. “The regenerative potential of bone marrow–derived MNCs is attributed to various mechanisms that impact stroke recovery,” researchers led by Sean I. Savitz, MD, wrote in a study published online Sept. 17 in Stem Cells. “These cells migrate to the site of injury, release cytokines and other trophic factors, decrease proinflammatory and upregulate anti-inflammatory pathways, and enhance angiogenesis, neurogenesis, and synaptogenesis.”
For the trial, Dr. Savitz, MD, director of the Institute for Stroke and Cerebrovascular Disease at UTHealth, Houston, and colleagues recruited 25 patients to receive an IV dose of their own bone marrow mononuclear cells within 72 hours after stroke onset, a time frame supported by previous preclinical studies. They followed the patients for 1 year and compared the results with a control group of 185 patients who received conventional poststroke treatment. Primary outcomes were study-related serious adverse events and the proportion of patients successfully completing study intervention.
The researchers reported results from 25 patients who received bone marrow MNCs. The mean age of patients in the MNC and control groups were 61 and 63 years, respectively, 53% were female, and 69% were white. No study-related adverse events were observed in the MNC group, but three (12%) had infarct expansion between enrollment and harvest and underwent elective hemicraniectomy after cell infusion.
Advanced magnetic resonance imaging revealed that the average mean fractional anisotropy (FA), a measure of structural integrity and directional coherence of axonal fibers, within the ipsilesional pons was decreased between 1 and 3 months after stroke, “which translated to a relative FA [rFA] comparable with prior reports at this time point,” the researchers wrote. “However, by 6 months, mean rFA began to increase and by 2 years it was significantly higher than at 1 month. This increasing trend in rFA may imply an increase in axonal and fiber coherence as well as thickness in myelin sheets, suggesting microstructural repair. However, without a comparable group of stroke patients not treated with MNCs, we cannot directly ascribe the white matter changes to MNC treatment.”
In light of the findings, the researchers concluded that MNCs “pose no additional harm in ischemic stroke patients when given during the acute phase, doses up to 10 million cells per kilogram are tolerated, and it is feasible to perform a bone marrow harvest and reinfusion of MNCs for a wide range of stroke patients. Well-designed RCTs are needed to further assess safety and efficacy of this novel investigational approach to enhance stroke recovery.”
The study was supported by grants from the National Institutes of Health. Dr. Savitz and many of his coauthors disclosed having numerous financial ties to the pharmaceutical and biotechnology industries.
, results from a single-arm, phase I trial demonstrated. Unlike autologous mesenchymal stem cells, mononuclear cells (MNCs) do not require passage in culture, which allows for testing in the early poststroke time therapy window.
Bone marrow MNCs are attractive in regenerative medicine studies because they can be rapidly isolated; are enriched with hematopoietic, mesenchymal, and endothelial progenitor cells; and permit autologous applications. “The regenerative potential of bone marrow–derived MNCs is attributed to various mechanisms that impact stroke recovery,” researchers led by Sean I. Savitz, MD, wrote in a study published online Sept. 17 in Stem Cells. “These cells migrate to the site of injury, release cytokines and other trophic factors, decrease proinflammatory and upregulate anti-inflammatory pathways, and enhance angiogenesis, neurogenesis, and synaptogenesis.”
For the trial, Dr. Savitz, MD, director of the Institute for Stroke and Cerebrovascular Disease at UTHealth, Houston, and colleagues recruited 25 patients to receive an IV dose of their own bone marrow mononuclear cells within 72 hours after stroke onset, a time frame supported by previous preclinical studies. They followed the patients for 1 year and compared the results with a control group of 185 patients who received conventional poststroke treatment. Primary outcomes were study-related serious adverse events and the proportion of patients successfully completing study intervention.
The researchers reported results from 25 patients who received bone marrow MNCs. The mean age of patients in the MNC and control groups were 61 and 63 years, respectively, 53% were female, and 69% were white. No study-related adverse events were observed in the MNC group, but three (12%) had infarct expansion between enrollment and harvest and underwent elective hemicraniectomy after cell infusion.
Advanced magnetic resonance imaging revealed that the average mean fractional anisotropy (FA), a measure of structural integrity and directional coherence of axonal fibers, within the ipsilesional pons was decreased between 1 and 3 months after stroke, “which translated to a relative FA [rFA] comparable with prior reports at this time point,” the researchers wrote. “However, by 6 months, mean rFA began to increase and by 2 years it was significantly higher than at 1 month. This increasing trend in rFA may imply an increase in axonal and fiber coherence as well as thickness in myelin sheets, suggesting microstructural repair. However, without a comparable group of stroke patients not treated with MNCs, we cannot directly ascribe the white matter changes to MNC treatment.”
In light of the findings, the researchers concluded that MNCs “pose no additional harm in ischemic stroke patients when given during the acute phase, doses up to 10 million cells per kilogram are tolerated, and it is feasible to perform a bone marrow harvest and reinfusion of MNCs for a wide range of stroke patients. Well-designed RCTs are needed to further assess safety and efficacy of this novel investigational approach to enhance stroke recovery.”
The study was supported by grants from the National Institutes of Health. Dr. Savitz and many of his coauthors disclosed having numerous financial ties to the pharmaceutical and biotechnology industries.
, results from a single-arm, phase I trial demonstrated. Unlike autologous mesenchymal stem cells, mononuclear cells (MNCs) do not require passage in culture, which allows for testing in the early poststroke time therapy window.
Bone marrow MNCs are attractive in regenerative medicine studies because they can be rapidly isolated; are enriched with hematopoietic, mesenchymal, and endothelial progenitor cells; and permit autologous applications. “The regenerative potential of bone marrow–derived MNCs is attributed to various mechanisms that impact stroke recovery,” researchers led by Sean I. Savitz, MD, wrote in a study published online Sept. 17 in Stem Cells. “These cells migrate to the site of injury, release cytokines and other trophic factors, decrease proinflammatory and upregulate anti-inflammatory pathways, and enhance angiogenesis, neurogenesis, and synaptogenesis.”
For the trial, Dr. Savitz, MD, director of the Institute for Stroke and Cerebrovascular Disease at UTHealth, Houston, and colleagues recruited 25 patients to receive an IV dose of their own bone marrow mononuclear cells within 72 hours after stroke onset, a time frame supported by previous preclinical studies. They followed the patients for 1 year and compared the results with a control group of 185 patients who received conventional poststroke treatment. Primary outcomes were study-related serious adverse events and the proportion of patients successfully completing study intervention.
The researchers reported results from 25 patients who received bone marrow MNCs. The mean age of patients in the MNC and control groups were 61 and 63 years, respectively, 53% were female, and 69% were white. No study-related adverse events were observed in the MNC group, but three (12%) had infarct expansion between enrollment and harvest and underwent elective hemicraniectomy after cell infusion.
Advanced magnetic resonance imaging revealed that the average mean fractional anisotropy (FA), a measure of structural integrity and directional coherence of axonal fibers, within the ipsilesional pons was decreased between 1 and 3 months after stroke, “which translated to a relative FA [rFA] comparable with prior reports at this time point,” the researchers wrote. “However, by 6 months, mean rFA began to increase and by 2 years it was significantly higher than at 1 month. This increasing trend in rFA may imply an increase in axonal and fiber coherence as well as thickness in myelin sheets, suggesting microstructural repair. However, without a comparable group of stroke patients not treated with MNCs, we cannot directly ascribe the white matter changes to MNC treatment.”
In light of the findings, the researchers concluded that MNCs “pose no additional harm in ischemic stroke patients when given during the acute phase, doses up to 10 million cells per kilogram are tolerated, and it is feasible to perform a bone marrow harvest and reinfusion of MNCs for a wide range of stroke patients. Well-designed RCTs are needed to further assess safety and efficacy of this novel investigational approach to enhance stroke recovery.”
The study was supported by grants from the National Institutes of Health. Dr. Savitz and many of his coauthors disclosed having numerous financial ties to the pharmaceutical and biotechnology industries.
FROM STEM CELLS
Gastrostomy tube placement associated with higher pneumonia recurrence in children with neurologic impairment
according to findings published in Pediatrics.
Five of the remaining seven strategies – gastrostomy tube placement, chest physiotherapy, outpatient antibiotics before hospitalization, and clinic visit before and after index hospitalization – were associated with increased recurrence, Jody L. Lin, MD, of the department of pediatrics at Stanford (Calif.) University, and colleagues reported. Oral secretion management and gastric acid suppression were associated with increased risk, but to a lesser extent.
The researchers examined the outcomes of the prevention strategies because, although children with neurologic impairment are more susceptible to community-acquired pneumonia, current guidelines are based mostly on expert opinion. The study included 3,632 children aged 21 years or younger with neurologic impairment and at least one hospitalization for pneumonia, who were enrolled in the California Children’s Services program between July 1, 2009, and June 30, 2014.
Propensity-score matching based on factors such as age, sex, household income, as well as characteristics of index hospitalization, showed decreased odds of recurrence only with receipt of dental care (adjusted odds ratio, 0.64; 95% confidence interval, 0.49-0.85), whereas increased odds were seen with other recommended prevention strategies, such as chest physiotherapy (aOR, 2.03; 95% CI, 1.29-3.20), receipt of antibiotics before hospitalization (aOR, 1.42; 95% CI, 1.06-1.92), and clinic visit before (aOR, 1.30; 95% CI, 1.11-1.52) and after index hospitalization (aOR, 1.72; 95% CI, 1.35-2.20).
The greatest increased odds, however, were seen with new gastrostomy tube placement (aOR, 2.15; 95% CI, 1.63-2.85).
The investigators noted that the biggest limitation of this study was the potential for residual confounding by indication even after adjustment, whereby certain interventions were provided to patients deemed more clinically severe to begin with. A strength of the study is its longitudinal nature.
“Our results suggest that more attention should be paid to dental health for children with [neurologic impairment],” the researchers wrote, although they noted that dental care “remains the most common unmet health care need” for children with special health care needs.
The findings also “support a clinical trial of dental care for prevention of severe pneumonia in children with [neurologic impairment] and do not support the widespread use of gastrostomy tubes for that purpose,” they added.
The study was funded by the National Institutes of Health. Dr. Lin received support from the NIH and the Clinical Excellence Research Center. The authors reported that they had no conflicts of interest.
cpalmer@mdedge.com
SOURCE: Lin JL et al. Pediatrics. 2019 Sep 19. doi: 10.1542/peds.2019-0543.
according to findings published in Pediatrics.
Five of the remaining seven strategies – gastrostomy tube placement, chest physiotherapy, outpatient antibiotics before hospitalization, and clinic visit before and after index hospitalization – were associated with increased recurrence, Jody L. Lin, MD, of the department of pediatrics at Stanford (Calif.) University, and colleagues reported. Oral secretion management and gastric acid suppression were associated with increased risk, but to a lesser extent.
The researchers examined the outcomes of the prevention strategies because, although children with neurologic impairment are more susceptible to community-acquired pneumonia, current guidelines are based mostly on expert opinion. The study included 3,632 children aged 21 years or younger with neurologic impairment and at least one hospitalization for pneumonia, who were enrolled in the California Children’s Services program between July 1, 2009, and June 30, 2014.
Propensity-score matching based on factors such as age, sex, household income, as well as characteristics of index hospitalization, showed decreased odds of recurrence only with receipt of dental care (adjusted odds ratio, 0.64; 95% confidence interval, 0.49-0.85), whereas increased odds were seen with other recommended prevention strategies, such as chest physiotherapy (aOR, 2.03; 95% CI, 1.29-3.20), receipt of antibiotics before hospitalization (aOR, 1.42; 95% CI, 1.06-1.92), and clinic visit before (aOR, 1.30; 95% CI, 1.11-1.52) and after index hospitalization (aOR, 1.72; 95% CI, 1.35-2.20).
The greatest increased odds, however, were seen with new gastrostomy tube placement (aOR, 2.15; 95% CI, 1.63-2.85).
The investigators noted that the biggest limitation of this study was the potential for residual confounding by indication even after adjustment, whereby certain interventions were provided to patients deemed more clinically severe to begin with. A strength of the study is its longitudinal nature.
“Our results suggest that more attention should be paid to dental health for children with [neurologic impairment],” the researchers wrote, although they noted that dental care “remains the most common unmet health care need” for children with special health care needs.
The findings also “support a clinical trial of dental care for prevention of severe pneumonia in children with [neurologic impairment] and do not support the widespread use of gastrostomy tubes for that purpose,” they added.
The study was funded by the National Institutes of Health. Dr. Lin received support from the NIH and the Clinical Excellence Research Center. The authors reported that they had no conflicts of interest.
cpalmer@mdedge.com
SOURCE: Lin JL et al. Pediatrics. 2019 Sep 19. doi: 10.1542/peds.2019-0543.
according to findings published in Pediatrics.
Five of the remaining seven strategies – gastrostomy tube placement, chest physiotherapy, outpatient antibiotics before hospitalization, and clinic visit before and after index hospitalization – were associated with increased recurrence, Jody L. Lin, MD, of the department of pediatrics at Stanford (Calif.) University, and colleagues reported. Oral secretion management and gastric acid suppression were associated with increased risk, but to a lesser extent.
The researchers examined the outcomes of the prevention strategies because, although children with neurologic impairment are more susceptible to community-acquired pneumonia, current guidelines are based mostly on expert opinion. The study included 3,632 children aged 21 years or younger with neurologic impairment and at least one hospitalization for pneumonia, who were enrolled in the California Children’s Services program between July 1, 2009, and June 30, 2014.
Propensity-score matching based on factors such as age, sex, household income, as well as characteristics of index hospitalization, showed decreased odds of recurrence only with receipt of dental care (adjusted odds ratio, 0.64; 95% confidence interval, 0.49-0.85), whereas increased odds were seen with other recommended prevention strategies, such as chest physiotherapy (aOR, 2.03; 95% CI, 1.29-3.20), receipt of antibiotics before hospitalization (aOR, 1.42; 95% CI, 1.06-1.92), and clinic visit before (aOR, 1.30; 95% CI, 1.11-1.52) and after index hospitalization (aOR, 1.72; 95% CI, 1.35-2.20).
The greatest increased odds, however, were seen with new gastrostomy tube placement (aOR, 2.15; 95% CI, 1.63-2.85).
The investigators noted that the biggest limitation of this study was the potential for residual confounding by indication even after adjustment, whereby certain interventions were provided to patients deemed more clinically severe to begin with. A strength of the study is its longitudinal nature.
“Our results suggest that more attention should be paid to dental health for children with [neurologic impairment],” the researchers wrote, although they noted that dental care “remains the most common unmet health care need” for children with special health care needs.
The findings also “support a clinical trial of dental care for prevention of severe pneumonia in children with [neurologic impairment] and do not support the widespread use of gastrostomy tubes for that purpose,” they added.
The study was funded by the National Institutes of Health. Dr. Lin received support from the NIH and the Clinical Excellence Research Center. The authors reported that they had no conflicts of interest.
cpalmer@mdedge.com
SOURCE: Lin JL et al. Pediatrics. 2019 Sep 19. doi: 10.1542/peds.2019-0543.
FROM PEDIATRICS
Key clinical point: Gastrostomy tube placement is associated with higher pneumonia recurrence in children with neurologic impairment, and dental care is linked to decreased recurrence.
Major finding: There was an increased odds of pneumonia recurrence with new gastrostomy tube placement (adjusted odds ratio, 2.15; 95% confidence interval, 1.63-2.85) and decreased odds with dental care (aOR, 0.64; 95% CI, 0.49-0.85).
Study details: A comparative effectiveness study of a retrospective cohort of 3,632 children with neurologic impairment and at least one hospitalization for pneumonia, enrolled in California Children’s Services from July 1, 2009, to June 30, 2014.
Disclosures: The study was funded by the National Institutes of Health. Dr. Lin received support from the NIH and the Clinical Excellence Research Center. The authors reported that they had no conflicts of interest.
Source: Lin JL et al. Pediatrics. 2019 Sep 19. doi: 10.1542/peds.2019-0543.
Most practices not screening for five social needs
that are associated with health outcomes, a study found.
Lead author Taressa K. Fraze, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., and colleagues conducted a cross-sectional survey analysis of responses by physician practices and hospitals that participated in the 2017-2018 National Survey of Healthcare Organizations and Systems. The investigators evaluated how many practices and hospitals reported screening of patients for five social needs: food insecurity, housing instability, utility needs, transportation needs, and experience with interpersonal violence. The final analysis included 2,190 physician practices and 739 hospitals.
Of physician practices, 56% reported screening for interpersonal violence, 35% screened for transportation needs, 30% for food insecurity, 28% for housing instability, and 23% for utility needs, according to the study published in JAMA Network Open.
Among hospitals, 75% reported screening for interpersonal violence, 74% for transportation needs, 60% for housing instability, 40% for food insecurity, and 36% for utility needs. Only 16% of physician practices and 24% of hospitals screened for all five social needs, the study found, while 33% of physician practices and 8% of hospitals reported screening for no social needs. The majority of the overall screening activity was driven by interpersonal violence screenings.
Physician practices that served more disadvantaged patients, including federally qualified health centers and those with more Medicaid revenue were more likely to screen for all five social needs. Practices in Medicaid accountable care organization contracts and those in Medicaid expansion states also had higher screening rates. Regionally, practices in the West had the highest screening rates, while practices in the Midwest had the lowest rates.
Among hospitals, the investigators found few significant screening differences based on hospital characteristics. Ownership, critical access status, delivery reform participation, rural status, region, and Medicaid expansion had no significant effects on screening rates, although academic medical centers were more likely to screen patients for all needs compared with nonacademic medical centers.
The study authors wrote that doctors and hospitals may need more resources and additional processes to screen for and/or to address the social needs of patients. They noted that practices and hospitals that did not screen for social needs were more likely to report a lack of financial resources, time, and incentives as major barriers.
To implement better screening protocols and address patients’ needs, the investigators wrote that doctors and hospitals will need financial support. For example, the Centers for Medicare & Medicaid Services should consider expanding care management billing to include managing care for patients who are both at risk or have clinically complex conditions in addition to social needs.
Dr. Fraze and three coauthors reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study. Dr. Fraze also reported receiving grants from the Robert Wood Johnson Foundation during the conduct of the study and receiving grants as an investigator from the 6 Foundation Collaborative, Commonwealth Fund, and Centers for Disease Control and Prevention. One coauthor reported receiving grants from the National Institute on Aging/National Institutes of Health during the conduct of the study.
SOURCE: Fraze TK et al. JAMA Netw Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11514.
While momentum for social risk screening is growing nationally, the recent study by Fraze et al. illustrates that screening across multiple domains is not yet common in clinical settings, wrote Rachel Gold, PhD, of Kaiser Permanente Center for Health Research Northwest in Portland, Ore.
In an editorial accompanying the study, Dr. Gold and coauthor Laura Gottlieb, MD, an associate professor of family and community medicine at the University of California, San Francisco, wrote that a critical finding of the study is that reimbursement is associated with uptake of social risk screening (JAMA Network Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11513). Specifically, the analysis found that screening for social risks is more common in care settings that receive some form of payment to support such efforts, directly or indirectly.
“This finding aligns with other research showing that altering incentive structures may enhance the adoption of social risk screening in health care settings,” Dr. Gold and Dr. Gottlieb wrote. “But these findings are just a beginning. Disseminating and sustaining social risk screening will require a deep understanding of how best to structure financial and other incentives to optimally support social risk screening; high-quality research is needed to help design reimbursement models that reliably influence adoption.”
Further research is needed not only to explain challenges to the implementation of social risk screening, but also to reveal the best evidence-based methods for overcoming them, the authors wrote. Such methods will likely require a range of support strategies targeted to the needs of various health care settings.
“Documenting social risk data in health care settings requires identifying ways to implement such screening effectively and sustainably,” Dr. Gold and Dr. Gottlieb wrote. “These findings underscore how much we still have to learn about the types of support needed to implement and sustain these practices.”
Dr. Gold reported receiving grants from the National Institutes of Health during the conduct of the study. Dr. Gottlieb reported receiving grants from the Robert Wood Johnson Foundation, the Commonwealth Fund, Kaiser Permanente, Episcopal Health Foundation, the Agency for Healthcare Research and Quality, St. David’s Foundation, the Pritzker Family Fund, and the Harvard Research Network on Toxic Stress outside the submitted work.
While momentum for social risk screening is growing nationally, the recent study by Fraze et al. illustrates that screening across multiple domains is not yet common in clinical settings, wrote Rachel Gold, PhD, of Kaiser Permanente Center for Health Research Northwest in Portland, Ore.
In an editorial accompanying the study, Dr. Gold and coauthor Laura Gottlieb, MD, an associate professor of family and community medicine at the University of California, San Francisco, wrote that a critical finding of the study is that reimbursement is associated with uptake of social risk screening (JAMA Network Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11513). Specifically, the analysis found that screening for social risks is more common in care settings that receive some form of payment to support such efforts, directly or indirectly.
“This finding aligns with other research showing that altering incentive structures may enhance the adoption of social risk screening in health care settings,” Dr. Gold and Dr. Gottlieb wrote. “But these findings are just a beginning. Disseminating and sustaining social risk screening will require a deep understanding of how best to structure financial and other incentives to optimally support social risk screening; high-quality research is needed to help design reimbursement models that reliably influence adoption.”
Further research is needed not only to explain challenges to the implementation of social risk screening, but also to reveal the best evidence-based methods for overcoming them, the authors wrote. Such methods will likely require a range of support strategies targeted to the needs of various health care settings.
“Documenting social risk data in health care settings requires identifying ways to implement such screening effectively and sustainably,” Dr. Gold and Dr. Gottlieb wrote. “These findings underscore how much we still have to learn about the types of support needed to implement and sustain these practices.”
Dr. Gold reported receiving grants from the National Institutes of Health during the conduct of the study. Dr. Gottlieb reported receiving grants from the Robert Wood Johnson Foundation, the Commonwealth Fund, Kaiser Permanente, Episcopal Health Foundation, the Agency for Healthcare Research and Quality, St. David’s Foundation, the Pritzker Family Fund, and the Harvard Research Network on Toxic Stress outside the submitted work.
While momentum for social risk screening is growing nationally, the recent study by Fraze et al. illustrates that screening across multiple domains is not yet common in clinical settings, wrote Rachel Gold, PhD, of Kaiser Permanente Center for Health Research Northwest in Portland, Ore.
In an editorial accompanying the study, Dr. Gold and coauthor Laura Gottlieb, MD, an associate professor of family and community medicine at the University of California, San Francisco, wrote that a critical finding of the study is that reimbursement is associated with uptake of social risk screening (JAMA Network Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11513). Specifically, the analysis found that screening for social risks is more common in care settings that receive some form of payment to support such efforts, directly or indirectly.
“This finding aligns with other research showing that altering incentive structures may enhance the adoption of social risk screening in health care settings,” Dr. Gold and Dr. Gottlieb wrote. “But these findings are just a beginning. Disseminating and sustaining social risk screening will require a deep understanding of how best to structure financial and other incentives to optimally support social risk screening; high-quality research is needed to help design reimbursement models that reliably influence adoption.”
Further research is needed not only to explain challenges to the implementation of social risk screening, but also to reveal the best evidence-based methods for overcoming them, the authors wrote. Such methods will likely require a range of support strategies targeted to the needs of various health care settings.
“Documenting social risk data in health care settings requires identifying ways to implement such screening effectively and sustainably,” Dr. Gold and Dr. Gottlieb wrote. “These findings underscore how much we still have to learn about the types of support needed to implement and sustain these practices.”
Dr. Gold reported receiving grants from the National Institutes of Health during the conduct of the study. Dr. Gottlieb reported receiving grants from the Robert Wood Johnson Foundation, the Commonwealth Fund, Kaiser Permanente, Episcopal Health Foundation, the Agency for Healthcare Research and Quality, St. David’s Foundation, the Pritzker Family Fund, and the Harvard Research Network on Toxic Stress outside the submitted work.
that are associated with health outcomes, a study found.
Lead author Taressa K. Fraze, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., and colleagues conducted a cross-sectional survey analysis of responses by physician practices and hospitals that participated in the 2017-2018 National Survey of Healthcare Organizations and Systems. The investigators evaluated how many practices and hospitals reported screening of patients for five social needs: food insecurity, housing instability, utility needs, transportation needs, and experience with interpersonal violence. The final analysis included 2,190 physician practices and 739 hospitals.
Of physician practices, 56% reported screening for interpersonal violence, 35% screened for transportation needs, 30% for food insecurity, 28% for housing instability, and 23% for utility needs, according to the study published in JAMA Network Open.
Among hospitals, 75% reported screening for interpersonal violence, 74% for transportation needs, 60% for housing instability, 40% for food insecurity, and 36% for utility needs. Only 16% of physician practices and 24% of hospitals screened for all five social needs, the study found, while 33% of physician practices and 8% of hospitals reported screening for no social needs. The majority of the overall screening activity was driven by interpersonal violence screenings.
Physician practices that served more disadvantaged patients, including federally qualified health centers and those with more Medicaid revenue were more likely to screen for all five social needs. Practices in Medicaid accountable care organization contracts and those in Medicaid expansion states also had higher screening rates. Regionally, practices in the West had the highest screening rates, while practices in the Midwest had the lowest rates.
Among hospitals, the investigators found few significant screening differences based on hospital characteristics. Ownership, critical access status, delivery reform participation, rural status, region, and Medicaid expansion had no significant effects on screening rates, although academic medical centers were more likely to screen patients for all needs compared with nonacademic medical centers.
The study authors wrote that doctors and hospitals may need more resources and additional processes to screen for and/or to address the social needs of patients. They noted that practices and hospitals that did not screen for social needs were more likely to report a lack of financial resources, time, and incentives as major barriers.
To implement better screening protocols and address patients’ needs, the investigators wrote that doctors and hospitals will need financial support. For example, the Centers for Medicare & Medicaid Services should consider expanding care management billing to include managing care for patients who are both at risk or have clinically complex conditions in addition to social needs.
Dr. Fraze and three coauthors reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study. Dr. Fraze also reported receiving grants from the Robert Wood Johnson Foundation during the conduct of the study and receiving grants as an investigator from the 6 Foundation Collaborative, Commonwealth Fund, and Centers for Disease Control and Prevention. One coauthor reported receiving grants from the National Institute on Aging/National Institutes of Health during the conduct of the study.
SOURCE: Fraze TK et al. JAMA Netw Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11514.
that are associated with health outcomes, a study found.
Lead author Taressa K. Fraze, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., and colleagues conducted a cross-sectional survey analysis of responses by physician practices and hospitals that participated in the 2017-2018 National Survey of Healthcare Organizations and Systems. The investigators evaluated how many practices and hospitals reported screening of patients for five social needs: food insecurity, housing instability, utility needs, transportation needs, and experience with interpersonal violence. The final analysis included 2,190 physician practices and 739 hospitals.
Of physician practices, 56% reported screening for interpersonal violence, 35% screened for transportation needs, 30% for food insecurity, 28% for housing instability, and 23% for utility needs, according to the study published in JAMA Network Open.
Among hospitals, 75% reported screening for interpersonal violence, 74% for transportation needs, 60% for housing instability, 40% for food insecurity, and 36% for utility needs. Only 16% of physician practices and 24% of hospitals screened for all five social needs, the study found, while 33% of physician practices and 8% of hospitals reported screening for no social needs. The majority of the overall screening activity was driven by interpersonal violence screenings.
Physician practices that served more disadvantaged patients, including federally qualified health centers and those with more Medicaid revenue were more likely to screen for all five social needs. Practices in Medicaid accountable care organization contracts and those in Medicaid expansion states also had higher screening rates. Regionally, practices in the West had the highest screening rates, while practices in the Midwest had the lowest rates.
Among hospitals, the investigators found few significant screening differences based on hospital characteristics. Ownership, critical access status, delivery reform participation, rural status, region, and Medicaid expansion had no significant effects on screening rates, although academic medical centers were more likely to screen patients for all needs compared with nonacademic medical centers.
The study authors wrote that doctors and hospitals may need more resources and additional processes to screen for and/or to address the social needs of patients. They noted that practices and hospitals that did not screen for social needs were more likely to report a lack of financial resources, time, and incentives as major barriers.
To implement better screening protocols and address patients’ needs, the investigators wrote that doctors and hospitals will need financial support. For example, the Centers for Medicare & Medicaid Services should consider expanding care management billing to include managing care for patients who are both at risk or have clinically complex conditions in addition to social needs.
Dr. Fraze and three coauthors reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study. Dr. Fraze also reported receiving grants from the Robert Wood Johnson Foundation during the conduct of the study and receiving grants as an investigator from the 6 Foundation Collaborative, Commonwealth Fund, and Centers for Disease Control and Prevention. One coauthor reported receiving grants from the National Institute on Aging/National Institutes of Health during the conduct of the study.
SOURCE: Fraze TK et al. JAMA Netw Open. 2019 Sep 18. doi: 10.1001/jamanetworkopen.2019.11514.
FROM JAMA NETWORK OPEN
‘Fast MRI’ may be option in TBI screening for children
“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.
The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”
Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.
The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.
The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.
CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.
While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”
In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”
However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”
And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”
Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”
The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.
SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.
“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.
The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”
Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.
The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.
The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.
CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.
While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”
In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”
However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”
And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”
Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”
The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.
SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.
“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.
The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”
Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.
The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.
The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.
CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.
While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”
In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”
However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”
And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”
Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”
The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.
SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.
FROM PEDIATRICS
Drug abuse–linked infective endocarditis spiking in U.S.
Hospitalizations for infective endocarditis associated with drug abuse doubled in the United States from 2002 to 2016, in a trend investigators call “alarming,” and link to a concurrent rise in opioid abuse.
Patients tend to be younger, poorer white males, according to findings published online in the Journal of the American Heart Association.
For their research, Amer N. Kadri, MD, of the Cleveland Clinic and colleagues looked at records for nearly a million hospitalizations for infective endocarditis (IE) in the National Inpatient Sample registry. All U.S. regions saw increases in drug abuse–linked cases of IE as a share of IE hospitalizations. Incidence of drug abuse–associated IC rose from 48 cases/100,000 population in 2002 to 79/100,000 in 2016. The Midwest saw the highest rate of change, with an annual percent increase of 4.9%.
While most IE hospitalizations in the study cohort were of white men (including 68% for drug-linked cases), the drug abuse–related cases were younger (median age, 38 vs. 70 years for nondrug-related IE), and more likely male (55.5% vs. 50%). About 45% of the drug-related cases were in people receiving Medicaid, and 42% were in the lowest quartile of median household income.
The drug abuse cases had fewer renal and cardiovascular comorbidities, compared with the nondrug cases, but were significantly more likely to present with HIV, hepatitis C, alcohol abuse, and liver disease. Inpatient mortality was lower among the drug-linked cases – 6% vs. 9% – but the drug cases saw significantly more cardiac or valve surgeries, longer hospital stays, and higher costs.
“Hospitalizations for IE have been increasing side by side with the opioid epidemic,” the investigators wrote in their analysis. “The opioid crisis has reached epidemic levels, and now drug overdoses have been the leading cause of injury-related death in the U.S. Heroin deaths had remained relatively low from 1999 until 2010 whereas it then increased threefold from 2010-2015.” The analysis showed a rise in drug abuse–associated IE “that corresponds to this general period.” The findings argue, the investigators said, for better treatment for opioid addiction after hospitalization and greater efforts to make drug rehabilitation available after discharge. The researchers described as a limitation of their study the use of billing codes that changed late in the study period, increasing detection of drug abuse cases after 2015. They reported no outside funding or conflicts of interest.
SOURCE: Kadri AN et al. J Am Heart Assoc. 2019 Sep 18.
Hospitalizations for infective endocarditis associated with drug abuse doubled in the United States from 2002 to 2016, in a trend investigators call “alarming,” and link to a concurrent rise in opioid abuse.
Patients tend to be younger, poorer white males, according to findings published online in the Journal of the American Heart Association.
For their research, Amer N. Kadri, MD, of the Cleveland Clinic and colleagues looked at records for nearly a million hospitalizations for infective endocarditis (IE) in the National Inpatient Sample registry. All U.S. regions saw increases in drug abuse–linked cases of IE as a share of IE hospitalizations. Incidence of drug abuse–associated IC rose from 48 cases/100,000 population in 2002 to 79/100,000 in 2016. The Midwest saw the highest rate of change, with an annual percent increase of 4.9%.
While most IE hospitalizations in the study cohort were of white men (including 68% for drug-linked cases), the drug abuse–related cases were younger (median age, 38 vs. 70 years for nondrug-related IE), and more likely male (55.5% vs. 50%). About 45% of the drug-related cases were in people receiving Medicaid, and 42% were in the lowest quartile of median household income.
The drug abuse cases had fewer renal and cardiovascular comorbidities, compared with the nondrug cases, but were significantly more likely to present with HIV, hepatitis C, alcohol abuse, and liver disease. Inpatient mortality was lower among the drug-linked cases – 6% vs. 9% – but the drug cases saw significantly more cardiac or valve surgeries, longer hospital stays, and higher costs.
“Hospitalizations for IE have been increasing side by side with the opioid epidemic,” the investigators wrote in their analysis. “The opioid crisis has reached epidemic levels, and now drug overdoses have been the leading cause of injury-related death in the U.S. Heroin deaths had remained relatively low from 1999 until 2010 whereas it then increased threefold from 2010-2015.” The analysis showed a rise in drug abuse–associated IE “that corresponds to this general period.” The findings argue, the investigators said, for better treatment for opioid addiction after hospitalization and greater efforts to make drug rehabilitation available after discharge. The researchers described as a limitation of their study the use of billing codes that changed late in the study period, increasing detection of drug abuse cases after 2015. They reported no outside funding or conflicts of interest.
SOURCE: Kadri AN et al. J Am Heart Assoc. 2019 Sep 18.
Hospitalizations for infective endocarditis associated with drug abuse doubled in the United States from 2002 to 2016, in a trend investigators call “alarming,” and link to a concurrent rise in opioid abuse.
Patients tend to be younger, poorer white males, according to findings published online in the Journal of the American Heart Association.
For their research, Amer N. Kadri, MD, of the Cleveland Clinic and colleagues looked at records for nearly a million hospitalizations for infective endocarditis (IE) in the National Inpatient Sample registry. All U.S. regions saw increases in drug abuse–linked cases of IE as a share of IE hospitalizations. Incidence of drug abuse–associated IC rose from 48 cases/100,000 population in 2002 to 79/100,000 in 2016. The Midwest saw the highest rate of change, with an annual percent increase of 4.9%.
While most IE hospitalizations in the study cohort were of white men (including 68% for drug-linked cases), the drug abuse–related cases were younger (median age, 38 vs. 70 years for nondrug-related IE), and more likely male (55.5% vs. 50%). About 45% of the drug-related cases were in people receiving Medicaid, and 42% were in the lowest quartile of median household income.
The drug abuse cases had fewer renal and cardiovascular comorbidities, compared with the nondrug cases, but were significantly more likely to present with HIV, hepatitis C, alcohol abuse, and liver disease. Inpatient mortality was lower among the drug-linked cases – 6% vs. 9% – but the drug cases saw significantly more cardiac or valve surgeries, longer hospital stays, and higher costs.
“Hospitalizations for IE have been increasing side by side with the opioid epidemic,” the investigators wrote in their analysis. “The opioid crisis has reached epidemic levels, and now drug overdoses have been the leading cause of injury-related death in the U.S. Heroin deaths had remained relatively low from 1999 until 2010 whereas it then increased threefold from 2010-2015.” The analysis showed a rise in drug abuse–associated IE “that corresponds to this general period.” The findings argue, the investigators said, for better treatment for opioid addiction after hospitalization and greater efforts to make drug rehabilitation available after discharge. The researchers described as a limitation of their study the use of billing codes that changed late in the study period, increasing detection of drug abuse cases after 2015. They reported no outside funding or conflicts of interest.
SOURCE: Kadri AN et al. J Am Heart Assoc. 2019 Sep 18.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point:
Major finding: Incidence of drug abuse–associated IC increased from 48 cases/100,000 in 2002 to 79/100,000 in 2016.
Study details: A retrospective cohort study identifying about a more than 950,000 cases of IC from the National Inpatient Sample registry.
Disclosures: None.
Source: Kadri AN et al. J Am Heart Assoc. 2019 Sep 18.
Even with no disease activity, recurrence risk near 50% when stopping DMTs for MS
STOCKHOLM – according to data presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
Of 49 patients who had been on DMT for at least 5 years and had shown no evidence of disease activity (NEDA) during that time, 26 continued to have NEDA through at least 5 years of follow-up, explained Tobias Monschein, MD, of the department of neurology at the Medical University of Vienna.
The cohort of patients had all been taking either interferon beta or glatiramer acetate after a first clinical episode leading to an initial diagnosis of MS. Patients all met Barkhof criteria for MS diagnosis on MRI, and all but six patients had oligoclonal bands found on examination of cerebrospinal fluid.
All patients in the cohort thus met criteria for clinically isolated syndrome (CIS) and MS under the 2017 revisions to the McDonald diagnostic criteria. “To our knowledge, this is the first study determining the risk of disease recurrence in a homogenous cohort of patients with CIS,” reported Dr. Monschein and collaborators.
Before stopping DMT, patients had to show at least 5 years of NEDA status; at that point, patients were offered the opportunity to discontinue medication. The decision to stop or continue taking a DMT was left to individual patient choice, Dr. Monschein said in an interview.
The cohort of patients who decided to discontinue DMT was seen yearly; they received a clinical examination that included expanded disability status scale (EDSS) rating. Patients also received an annual MRI.
Age at DMT discontinuation was predictive of remaining disease free, found Dr. Monschein and collaborators. The 26 patients who continued disease free after DMT discontinuation were a mean 29.7 years old, while patients who had disease recurrence were a mean 22.7 years old.
Looking at age as a dichotomous variable, the investigators found that the 16 patients who were 40 years or older when they stopped DMT had an 18.8% risk of MS recurrence, while the 33 patients younger than 40 years at the time of ceasing DMT had a 60.6% risk of recurrence.
Age, in fact, was the only patient, disease, or therapy characteristic that Dr. Monschein and colleagues found predictive of relapse: “Gender, type of DMT, treatment duration, and CIS symptom did not differ significantly between groups,” they reported.
The data “should not encourage patients to generally stop DMTs after a long NEDA period,” they noted.
In the context of shared patient decision-making, though, the data can inform discussion with patients who wish to discontinue DMTS after long disease-free periods, Dr. Monschein said.
“Physicians should encourage younger people to stay on DMTS despite long lasting NEDA status while in patients [older than] 40 years stopping DMTs together with regular clinical and radiological monitoring could be a reasonable option,” he and his colleagues advised.
Dr. Monschein reported no outside sources of funding and no conflicts of interest.
SOURCE: Monschein T et al. ECTRIMS 2019, Abstract P654.
STOCKHOLM – according to data presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
Of 49 patients who had been on DMT for at least 5 years and had shown no evidence of disease activity (NEDA) during that time, 26 continued to have NEDA through at least 5 years of follow-up, explained Tobias Monschein, MD, of the department of neurology at the Medical University of Vienna.
The cohort of patients had all been taking either interferon beta or glatiramer acetate after a first clinical episode leading to an initial diagnosis of MS. Patients all met Barkhof criteria for MS diagnosis on MRI, and all but six patients had oligoclonal bands found on examination of cerebrospinal fluid.
All patients in the cohort thus met criteria for clinically isolated syndrome (CIS) and MS under the 2017 revisions to the McDonald diagnostic criteria. “To our knowledge, this is the first study determining the risk of disease recurrence in a homogenous cohort of patients with CIS,” reported Dr. Monschein and collaborators.
Before stopping DMT, patients had to show at least 5 years of NEDA status; at that point, patients were offered the opportunity to discontinue medication. The decision to stop or continue taking a DMT was left to individual patient choice, Dr. Monschein said in an interview.
The cohort of patients who decided to discontinue DMT was seen yearly; they received a clinical examination that included expanded disability status scale (EDSS) rating. Patients also received an annual MRI.
Age at DMT discontinuation was predictive of remaining disease free, found Dr. Monschein and collaborators. The 26 patients who continued disease free after DMT discontinuation were a mean 29.7 years old, while patients who had disease recurrence were a mean 22.7 years old.
Looking at age as a dichotomous variable, the investigators found that the 16 patients who were 40 years or older when they stopped DMT had an 18.8% risk of MS recurrence, while the 33 patients younger than 40 years at the time of ceasing DMT had a 60.6% risk of recurrence.
Age, in fact, was the only patient, disease, or therapy characteristic that Dr. Monschein and colleagues found predictive of relapse: “Gender, type of DMT, treatment duration, and CIS symptom did not differ significantly between groups,” they reported.
The data “should not encourage patients to generally stop DMTs after a long NEDA period,” they noted.
In the context of shared patient decision-making, though, the data can inform discussion with patients who wish to discontinue DMTS after long disease-free periods, Dr. Monschein said.
“Physicians should encourage younger people to stay on DMTS despite long lasting NEDA status while in patients [older than] 40 years stopping DMTs together with regular clinical and radiological monitoring could be a reasonable option,” he and his colleagues advised.
Dr. Monschein reported no outside sources of funding and no conflicts of interest.
SOURCE: Monschein T et al. ECTRIMS 2019, Abstract P654.
STOCKHOLM – according to data presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
Of 49 patients who had been on DMT for at least 5 years and had shown no evidence of disease activity (NEDA) during that time, 26 continued to have NEDA through at least 5 years of follow-up, explained Tobias Monschein, MD, of the department of neurology at the Medical University of Vienna.
The cohort of patients had all been taking either interferon beta or glatiramer acetate after a first clinical episode leading to an initial diagnosis of MS. Patients all met Barkhof criteria for MS diagnosis on MRI, and all but six patients had oligoclonal bands found on examination of cerebrospinal fluid.
All patients in the cohort thus met criteria for clinically isolated syndrome (CIS) and MS under the 2017 revisions to the McDonald diagnostic criteria. “To our knowledge, this is the first study determining the risk of disease recurrence in a homogenous cohort of patients with CIS,” reported Dr. Monschein and collaborators.
Before stopping DMT, patients had to show at least 5 years of NEDA status; at that point, patients were offered the opportunity to discontinue medication. The decision to stop or continue taking a DMT was left to individual patient choice, Dr. Monschein said in an interview.
The cohort of patients who decided to discontinue DMT was seen yearly; they received a clinical examination that included expanded disability status scale (EDSS) rating. Patients also received an annual MRI.
Age at DMT discontinuation was predictive of remaining disease free, found Dr. Monschein and collaborators. The 26 patients who continued disease free after DMT discontinuation were a mean 29.7 years old, while patients who had disease recurrence were a mean 22.7 years old.
Looking at age as a dichotomous variable, the investigators found that the 16 patients who were 40 years or older when they stopped DMT had an 18.8% risk of MS recurrence, while the 33 patients younger than 40 years at the time of ceasing DMT had a 60.6% risk of recurrence.
Age, in fact, was the only patient, disease, or therapy characteristic that Dr. Monschein and colleagues found predictive of relapse: “Gender, type of DMT, treatment duration, and CIS symptom did not differ significantly between groups,” they reported.
The data “should not encourage patients to generally stop DMTs after a long NEDA period,” they noted.
In the context of shared patient decision-making, though, the data can inform discussion with patients who wish to discontinue DMTS after long disease-free periods, Dr. Monschein said.
“Physicians should encourage younger people to stay on DMTS despite long lasting NEDA status while in patients [older than] 40 years stopping DMTs together with regular clinical and radiological monitoring could be a reasonable option,” he and his colleagues advised.
Dr. Monschein reported no outside sources of funding and no conflicts of interest.
SOURCE: Monschein T et al. ECTRIMS 2019, Abstract P654.
REPORTING FROM ECTRIMS 2019
Plasma exchange in natalizumab-related PML shows no benefit, possible harm
STOCKHOLM – Christopher McGuigan, MD, and colleagues reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
“This is a very important issue for us as neurologists. I think this data suggests that plasma exchange does not seem to confer an advantage to our patients when it comes to mortality and – albeit with caveats – it actually seems to be associated with worsening of the disability level in survivors,” according to Dr. McGuigan, consultant neurologist at St. Vincent’s University Hospital in Dublin and clinical professor at University College Dublin.
Natalizumab is an effective treatment for patients with highly active MS, but its use is limited by the feared complication of PML. Plasma exchange to clear the drug from the patient’s system is a popular and biologically plausible therapy, but its impact on clinical outcomes had not been formally studied until now.
Examining a database of confirmed PML cases
Dr. McGuigan presented a retrospective study of 723 patients with confirmed PML included in the natalizumab pharmacovigilance database run by Biogen, which markets the drug. A total of 85% (616 patients) underwent plasma exchange. The study’s primary outcome was the survival rate 2 years after PML diagnosis in patients who received plasma exchange, compared with those who did not.
Since the viral load of John Cunningham (JC) virus is known to influence outcome in PML, Dr. McGuigan and coinvestigators stratified the primary outcome based on tertiles of baseline viral copy number (VCN). The key study finding was that, across the range of viral loads, plasma exchange was consistently associated with a numerically worse 2-year survival rate, although the difference did not reach statistical significance. Among patients with less than a log5 baseline JC virus VCN, 2-year survival was 88.2% in the plasma exchange group, compared with 89.3% in the patients who did not undergo plasma exchange. For patients with a JC virus VCN greater than log5 but not more than log7, the survival rate was 89.3% without plasma exchange versus 73.8% with the intervention. In the group with greater than a log7 VCN, the 2-year survival was 78.9% without plasma exchange and 68.2% with it.
Statistically significant covariates
In a multivariate Cox proportional hazards analysis, plasma exchange was associated with a statistically nonsignificant 44% increased risk of mortality at 2 years post PML diagnosis. However, several other covariates emerged as statistically significant independent predictors of 2-year mortality. These included age greater than 50 years at diagnosis of PML, with an associated hazard ratio of 1.56, compared with younger patients; male gender (HR, 1.48); a JC virus VCN greater than log 7, compared with log 5 or less (HR, 2.86); a VCN greater than log5 but not more than log7, compared with a VCN of log5 or less (HR, 2.11); and widespread as opposed to localized MRI brain lesions of PML (HR, 1.61). In contrast, an asymptomatic presentation of PML was protective, with an HR of 0.38, compared with patients with a symptomatic presentation.
The likelihood of survival at 2 years was not affected by the number of plasma exchange cycles utilized, the number of natalizumab infusions received prior to diagnosis of PML, or the time from the last natalizumab infusion to starting plasma exchange.
Additional analyses focused on functional ability and disability
A secondary analysis addressed the question of whether plasma exchange has a favorable impact on functional ability. This is an important issue because many MS patients who remain alive 2 years after diagnosis of PML are left with marked permanent disability. This analysis was restricted to the 523 MS patients with PML for whom Expanded Disability Status Scale (EDSS) scores were available 6 months or more after PML diagnosis. The key finding here was that, at 2 years, 62% of the plasma exchange group, but only 38% of non–plasma exchange controls, were either dead or had an EDSS score of 7 or greater, which is a degree of disability likely to render a patient unable to live independently.
Of note, the median EDSS score 6 months before diagnosis of PML was 3.5 in both groups. Moreover, the median EDSS score at the time of diagnosis was similar in the two groups as well: 4.0 in those who underwent plasma exchange and 4.5 in those who did not. So the physician decision to employ plasma exchange clearly was not driven by more-severe disability.
In a multivariate analysis, plasma exchange was independently associated with a 168% increased likelihood of death or an EDSS score of 7 or more at 2 years. A sensitivity analysis restricted to patients who fell into that category was supportive of the main analysis: it concluded that such patients were 159% more likely to have received plasma exchange than not.
Dr. McGuigan cited several study limitations, including possible selection bias, inability to assess the potential impact of other disease-modifying therapies utilized after PML diagnosis, the lack of baseline EDSS scores in a fair number of patients, and the necessity to evaluate all-cause mortality rather than death attributable to PML.
He made a plea for neurologists to diligently submit their own cases of natalizumab-associated PML in MS patients to the Biogen pharmacovigilance database, which is totally dependent upon voluntary physician reporting.
“This is the only tool by which we can get this information at present. It’s the best data we’re likely to be able to get,” he observed.
The study was funded by Biogen. Dr. McGuigan reported receiving research grants from and serving as an advisor to that company and several other pharmaceutical companies.
SOURCE: McGuigan C et al. ECTRIMS 2019, Abstract 63.
STOCKHOLM – Christopher McGuigan, MD, and colleagues reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
“This is a very important issue for us as neurologists. I think this data suggests that plasma exchange does not seem to confer an advantage to our patients when it comes to mortality and – albeit with caveats – it actually seems to be associated with worsening of the disability level in survivors,” according to Dr. McGuigan, consultant neurologist at St. Vincent’s University Hospital in Dublin and clinical professor at University College Dublin.
Natalizumab is an effective treatment for patients with highly active MS, but its use is limited by the feared complication of PML. Plasma exchange to clear the drug from the patient’s system is a popular and biologically plausible therapy, but its impact on clinical outcomes had not been formally studied until now.
Examining a database of confirmed PML cases
Dr. McGuigan presented a retrospective study of 723 patients with confirmed PML included in the natalizumab pharmacovigilance database run by Biogen, which markets the drug. A total of 85% (616 patients) underwent plasma exchange. The study’s primary outcome was the survival rate 2 years after PML diagnosis in patients who received plasma exchange, compared with those who did not.
Since the viral load of John Cunningham (JC) virus is known to influence outcome in PML, Dr. McGuigan and coinvestigators stratified the primary outcome based on tertiles of baseline viral copy number (VCN). The key study finding was that, across the range of viral loads, plasma exchange was consistently associated with a numerically worse 2-year survival rate, although the difference did not reach statistical significance. Among patients with less than a log5 baseline JC virus VCN, 2-year survival was 88.2% in the plasma exchange group, compared with 89.3% in the patients who did not undergo plasma exchange. For patients with a JC virus VCN greater than log5 but not more than log7, the survival rate was 89.3% without plasma exchange versus 73.8% with the intervention. In the group with greater than a log7 VCN, the 2-year survival was 78.9% without plasma exchange and 68.2% with it.
Statistically significant covariates
In a multivariate Cox proportional hazards analysis, plasma exchange was associated with a statistically nonsignificant 44% increased risk of mortality at 2 years post PML diagnosis. However, several other covariates emerged as statistically significant independent predictors of 2-year mortality. These included age greater than 50 years at diagnosis of PML, with an associated hazard ratio of 1.56, compared with younger patients; male gender (HR, 1.48); a JC virus VCN greater than log 7, compared with log 5 or less (HR, 2.86); a VCN greater than log5 but not more than log7, compared with a VCN of log5 or less (HR, 2.11); and widespread as opposed to localized MRI brain lesions of PML (HR, 1.61). In contrast, an asymptomatic presentation of PML was protective, with an HR of 0.38, compared with patients with a symptomatic presentation.
The likelihood of survival at 2 years was not affected by the number of plasma exchange cycles utilized, the number of natalizumab infusions received prior to diagnosis of PML, or the time from the last natalizumab infusion to starting plasma exchange.
Additional analyses focused on functional ability and disability
A secondary analysis addressed the question of whether plasma exchange has a favorable impact on functional ability. This is an important issue because many MS patients who remain alive 2 years after diagnosis of PML are left with marked permanent disability. This analysis was restricted to the 523 MS patients with PML for whom Expanded Disability Status Scale (EDSS) scores were available 6 months or more after PML diagnosis. The key finding here was that, at 2 years, 62% of the plasma exchange group, but only 38% of non–plasma exchange controls, were either dead or had an EDSS score of 7 or greater, which is a degree of disability likely to render a patient unable to live independently.
Of note, the median EDSS score 6 months before diagnosis of PML was 3.5 in both groups. Moreover, the median EDSS score at the time of diagnosis was similar in the two groups as well: 4.0 in those who underwent plasma exchange and 4.5 in those who did not. So the physician decision to employ plasma exchange clearly was not driven by more-severe disability.
In a multivariate analysis, plasma exchange was independently associated with a 168% increased likelihood of death or an EDSS score of 7 or more at 2 years. A sensitivity analysis restricted to patients who fell into that category was supportive of the main analysis: it concluded that such patients were 159% more likely to have received plasma exchange than not.
Dr. McGuigan cited several study limitations, including possible selection bias, inability to assess the potential impact of other disease-modifying therapies utilized after PML diagnosis, the lack of baseline EDSS scores in a fair number of patients, and the necessity to evaluate all-cause mortality rather than death attributable to PML.
He made a plea for neurologists to diligently submit their own cases of natalizumab-associated PML in MS patients to the Biogen pharmacovigilance database, which is totally dependent upon voluntary physician reporting.
“This is the only tool by which we can get this information at present. It’s the best data we’re likely to be able to get,” he observed.
The study was funded by Biogen. Dr. McGuigan reported receiving research grants from and serving as an advisor to that company and several other pharmaceutical companies.
SOURCE: McGuigan C et al. ECTRIMS 2019, Abstract 63.
STOCKHOLM – Christopher McGuigan, MD, and colleagues reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.
“This is a very important issue for us as neurologists. I think this data suggests that plasma exchange does not seem to confer an advantage to our patients when it comes to mortality and – albeit with caveats – it actually seems to be associated with worsening of the disability level in survivors,” according to Dr. McGuigan, consultant neurologist at St. Vincent’s University Hospital in Dublin and clinical professor at University College Dublin.
Natalizumab is an effective treatment for patients with highly active MS, but its use is limited by the feared complication of PML. Plasma exchange to clear the drug from the patient’s system is a popular and biologically plausible therapy, but its impact on clinical outcomes had not been formally studied until now.
Examining a database of confirmed PML cases
Dr. McGuigan presented a retrospective study of 723 patients with confirmed PML included in the natalizumab pharmacovigilance database run by Biogen, which markets the drug. A total of 85% (616 patients) underwent plasma exchange. The study’s primary outcome was the survival rate 2 years after PML diagnosis in patients who received plasma exchange, compared with those who did not.
Since the viral load of John Cunningham (JC) virus is known to influence outcome in PML, Dr. McGuigan and coinvestigators stratified the primary outcome based on tertiles of baseline viral copy number (VCN). The key study finding was that, across the range of viral loads, plasma exchange was consistently associated with a numerically worse 2-year survival rate, although the difference did not reach statistical significance. Among patients with less than a log5 baseline JC virus VCN, 2-year survival was 88.2% in the plasma exchange group, compared with 89.3% in the patients who did not undergo plasma exchange. For patients with a JC virus VCN greater than log5 but not more than log7, the survival rate was 89.3% without plasma exchange versus 73.8% with the intervention. In the group with greater than a log7 VCN, the 2-year survival was 78.9% without plasma exchange and 68.2% with it.
Statistically significant covariates
In a multivariate Cox proportional hazards analysis, plasma exchange was associated with a statistically nonsignificant 44% increased risk of mortality at 2 years post PML diagnosis. However, several other covariates emerged as statistically significant independent predictors of 2-year mortality. These included age greater than 50 years at diagnosis of PML, with an associated hazard ratio of 1.56, compared with younger patients; male gender (HR, 1.48); a JC virus VCN greater than log 7, compared with log 5 or less (HR, 2.86); a VCN greater than log5 but not more than log7, compared with a VCN of log5 or less (HR, 2.11); and widespread as opposed to localized MRI brain lesions of PML (HR, 1.61). In contrast, an asymptomatic presentation of PML was protective, with an HR of 0.38, compared with patients with a symptomatic presentation.
The likelihood of survival at 2 years was not affected by the number of plasma exchange cycles utilized, the number of natalizumab infusions received prior to diagnosis of PML, or the time from the last natalizumab infusion to starting plasma exchange.
Additional analyses focused on functional ability and disability
A secondary analysis addressed the question of whether plasma exchange has a favorable impact on functional ability. This is an important issue because many MS patients who remain alive 2 years after diagnosis of PML are left with marked permanent disability. This analysis was restricted to the 523 MS patients with PML for whom Expanded Disability Status Scale (EDSS) scores were available 6 months or more after PML diagnosis. The key finding here was that, at 2 years, 62% of the plasma exchange group, but only 38% of non–plasma exchange controls, were either dead or had an EDSS score of 7 or greater, which is a degree of disability likely to render a patient unable to live independently.
Of note, the median EDSS score 6 months before diagnosis of PML was 3.5 in both groups. Moreover, the median EDSS score at the time of diagnosis was similar in the two groups as well: 4.0 in those who underwent plasma exchange and 4.5 in those who did not. So the physician decision to employ plasma exchange clearly was not driven by more-severe disability.
In a multivariate analysis, plasma exchange was independently associated with a 168% increased likelihood of death or an EDSS score of 7 or more at 2 years. A sensitivity analysis restricted to patients who fell into that category was supportive of the main analysis: it concluded that such patients were 159% more likely to have received plasma exchange than not.
Dr. McGuigan cited several study limitations, including possible selection bias, inability to assess the potential impact of other disease-modifying therapies utilized after PML diagnosis, the lack of baseline EDSS scores in a fair number of patients, and the necessity to evaluate all-cause mortality rather than death attributable to PML.
He made a plea for neurologists to diligently submit their own cases of natalizumab-associated PML in MS patients to the Biogen pharmacovigilance database, which is totally dependent upon voluntary physician reporting.
“This is the only tool by which we can get this information at present. It’s the best data we’re likely to be able to get,” he observed.
The study was funded by Biogen. Dr. McGuigan reported receiving research grants from and serving as an advisor to that company and several other pharmaceutical companies.
SOURCE: McGuigan C et al. ECTRIMS 2019, Abstract 63.
REPORTING FROM ECTRIMS 2019
Key clinical point: Plasma exchange has no clinical benefit in natalizumab-associated progressive multifocal leukoencephalopathy (PML).
Major finding: The risk of composite endpoint of death or an Expanded Disability Status Scale of 7.0 or more at follow-up 2 years after a natalizumab-associated PML diagnosis was an adjusted 168% greater in multiple sclerosis patients who underwent plasma exchange than in those who did not.
Study details: A retrospective analysis of the records of 723 multiple sclerosis patients with confirmed natalizumab-associated PML.
Disclosures: The study was funded by Biogen. The presenter reported receiving research grants from and serving as an advisor to Biogen and several other pharmaceutical companies.
Source: McGuigan C et al. ECTRIMS 2019, Abstract 63.