VIDEO: PML prevention is possible, even when treating patients with aggressive MS

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– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.
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– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.

– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.
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Inside the complex, surprising world of MS comorbidities

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– Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

 

 


Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

 

 


Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

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– Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

 

 


Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

 

 


Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

– Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

 

 


Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

 

 


Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

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Value-based care spawns new challenges for MS physicians

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– Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

 

 


Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.



Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

 

 


“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

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– Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

 

 


Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.



Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

 

 


“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

– Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

 

 


Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.



Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

 

 


“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

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REPORTING FROM THE CMSC ANNUAL MEETING

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Teaching opportunities of live surgery broadcasts debated

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– Two thoracic societies are being challenged to review their rejection of live broadcasts of surgical procedures at medical meetings.

The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”

Dr. Joseph E. Bavaria
Dr. Bavaria, a former president of the Society of Thoracic Surgeon, spoke during a series of talks on ethics at the annual meeting of the American Association for Thoracic Surgery.

Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.

In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”

Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”

The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
 

 


He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).

A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.

Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).

The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”

Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.

Dr. Bavaria reports no relevant disclosures.

Body

 

Dr. Peter Angelos
Although I do not agree with the suggestion that surgical meetings such as AATS and STS should reverse their ban on live surgery broadcasts, Dr. Bavaria’s suggestion certainly brings attention to an important question about how to maintain the safety of patients in the operating room, while still allowing for optimal teaching opportunities. Most surgeons have accepted that in a live surgical broadcast, the surgeon’s primary attention on the well-being of the patient in the operating room is potentially distracted by the audience viewing the procedure from afar. Although I cannot cite evidence that patient safety is actually compromised from such live broadcasts, self-reflection certainly suggests that there is a potential risk for the surgeon to have competing concerns during surgery, potentially at the expense of safety. In a similar context, I wonder where are the data that previously recorded videos of surgical procedures have less educational value than live operations. I am concerned that the fascination with live broadcasts has much to do with the sense that a complication might occur and that this fascination has little to do with educational value. Although I disagree with Dr. Bavaria’s conclusions on live broadcasting of operations, I commend his refocusing of attention on the educational value for students of viewing surgery in real time. Simulations are good teaching tools, but firsthand observation remains essential.

Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.

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Dr. Peter Angelos
Although I do not agree with the suggestion that surgical meetings such as AATS and STS should reverse their ban on live surgery broadcasts, Dr. Bavaria’s suggestion certainly brings attention to an important question about how to maintain the safety of patients in the operating room, while still allowing for optimal teaching opportunities. Most surgeons have accepted that in a live surgical broadcast, the surgeon’s primary attention on the well-being of the patient in the operating room is potentially distracted by the audience viewing the procedure from afar. Although I cannot cite evidence that patient safety is actually compromised from such live broadcasts, self-reflection certainly suggests that there is a potential risk for the surgeon to have competing concerns during surgery, potentially at the expense of safety. In a similar context, I wonder where are the data that previously recorded videos of surgical procedures have less educational value than live operations. I am concerned that the fascination with live broadcasts has much to do with the sense that a complication might occur and that this fascination has little to do with educational value. Although I disagree with Dr. Bavaria’s conclusions on live broadcasting of operations, I commend his refocusing of attention on the educational value for students of viewing surgery in real time. Simulations are good teaching tools, but firsthand observation remains essential.

Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.

Body

 

Dr. Peter Angelos
Although I do not agree with the suggestion that surgical meetings such as AATS and STS should reverse their ban on live surgery broadcasts, Dr. Bavaria’s suggestion certainly brings attention to an important question about how to maintain the safety of patients in the operating room, while still allowing for optimal teaching opportunities. Most surgeons have accepted that in a live surgical broadcast, the surgeon’s primary attention on the well-being of the patient in the operating room is potentially distracted by the audience viewing the procedure from afar. Although I cannot cite evidence that patient safety is actually compromised from such live broadcasts, self-reflection certainly suggests that there is a potential risk for the surgeon to have competing concerns during surgery, potentially at the expense of safety. In a similar context, I wonder where are the data that previously recorded videos of surgical procedures have less educational value than live operations. I am concerned that the fascination with live broadcasts has much to do with the sense that a complication might occur and that this fascination has little to do with educational value. Although I disagree with Dr. Bavaria’s conclusions on live broadcasting of operations, I commend his refocusing of attention on the educational value for students of viewing surgery in real time. Simulations are good teaching tools, but firsthand observation remains essential.

Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.

Title
Potential for distraction is an issue.
Potential for distraction is an issue.

 

– Two thoracic societies are being challenged to review their rejection of live broadcasts of surgical procedures at medical meetings.

The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”

Dr. Joseph E. Bavaria
Dr. Bavaria, a former president of the Society of Thoracic Surgeon, spoke during a series of talks on ethics at the annual meeting of the American Association for Thoracic Surgery.

Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.

In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”

Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”

The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
 

 


He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).

A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.

Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).

The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”

Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.

Dr. Bavaria reports no relevant disclosures.

 

– Two thoracic societies are being challenged to review their rejection of live broadcasts of surgical procedures at medical meetings.

The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”

Dr. Joseph E. Bavaria
Dr. Bavaria, a former president of the Society of Thoracic Surgeon, spoke during a series of talks on ethics at the annual meeting of the American Association for Thoracic Surgery.

Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.

In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”

Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”

The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
 

 


He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).

A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.

Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).

The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”

Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.

Dr. Bavaria reports no relevant disclosures.

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CMSC looks to increase advocacy efforts to address looming concerns

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As patients with multiple sclerosis and their caregivers face various challenges in the American health care system, the Consortium of Multiple Sclerosis Centers (CMSC) is re-energizing its focus on advocacy. The 2018 annual meeting in Nashville, Tenn., will feature programming designed to teach MS professionals and researchers how to speak up and let their voices be heard.

“CMSC has re-engaged in advocacy, in a more focused and energized way, because of mounting concerns that there is inadequate advocacy pressure on some of the critical issues negatively impacting the quality and comprehensive nature of MS care required of people living with MS,” said Lisa Taylor Skutnik, a physical therapist and chief operating officer of the CMSC. “Both people living with MS and the clinicians dedicated to treating them are increasingly frustrated and powerless in attempts to facilitate the right care and resources for people living with MS. Our members are facing significant barriers and obstacles to ensure timely and seamless comprehensive care.”

Lisa Taylor Skutnik
Specifically, she said, the MS community is concerned about topics such as “the shortage of health care professionals engaged in MS care; the future of the MS workforce; limited/compromised access to MS neurology clinicians, mental health professionals, and rehabilitation professionals trained in MS care; and drug pricing/utilization management challenges.”

The development of quality measures in MS is also a “huge concern,” she said, referring to the federal government’s efforts to develop new ways to measure whether health professionals are providing high-quality care. Physicians have expressed widespread concern about the measures, which are being linked to reimbursement from Medicare and Medicaid.

Among the highlights of the CMSC meeting will be an educational session that “will focus on the available resources within the MS community for MS professionals and researchers to access advocacy efforts and get involved,” Ms. Skutnik said.

Another educational session “will focus on helping MS clinicians and researchers to understand all of the various stakeholders and their respective perspectives related to access to comprehensive care services for those living with MS,” such as pharmacy benefit managers and insurers, she said.
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As patients with multiple sclerosis and their caregivers face various challenges in the American health care system, the Consortium of Multiple Sclerosis Centers (CMSC) is re-energizing its focus on advocacy. The 2018 annual meeting in Nashville, Tenn., will feature programming designed to teach MS professionals and researchers how to speak up and let their voices be heard.

“CMSC has re-engaged in advocacy, in a more focused and energized way, because of mounting concerns that there is inadequate advocacy pressure on some of the critical issues negatively impacting the quality and comprehensive nature of MS care required of people living with MS,” said Lisa Taylor Skutnik, a physical therapist and chief operating officer of the CMSC. “Both people living with MS and the clinicians dedicated to treating them are increasingly frustrated and powerless in attempts to facilitate the right care and resources for people living with MS. Our members are facing significant barriers and obstacles to ensure timely and seamless comprehensive care.”

Lisa Taylor Skutnik
Specifically, she said, the MS community is concerned about topics such as “the shortage of health care professionals engaged in MS care; the future of the MS workforce; limited/compromised access to MS neurology clinicians, mental health professionals, and rehabilitation professionals trained in MS care; and drug pricing/utilization management challenges.”

The development of quality measures in MS is also a “huge concern,” she said, referring to the federal government’s efforts to develop new ways to measure whether health professionals are providing high-quality care. Physicians have expressed widespread concern about the measures, which are being linked to reimbursement from Medicare and Medicaid.

Among the highlights of the CMSC meeting will be an educational session that “will focus on the available resources within the MS community for MS professionals and researchers to access advocacy efforts and get involved,” Ms. Skutnik said.

Another educational session “will focus on helping MS clinicians and researchers to understand all of the various stakeholders and their respective perspectives related to access to comprehensive care services for those living with MS,” such as pharmacy benefit managers and insurers, she said.

 

As patients with multiple sclerosis and their caregivers face various challenges in the American health care system, the Consortium of Multiple Sclerosis Centers (CMSC) is re-energizing its focus on advocacy. The 2018 annual meeting in Nashville, Tenn., will feature programming designed to teach MS professionals and researchers how to speak up and let their voices be heard.

“CMSC has re-engaged in advocacy, in a more focused and energized way, because of mounting concerns that there is inadequate advocacy pressure on some of the critical issues negatively impacting the quality and comprehensive nature of MS care required of people living with MS,” said Lisa Taylor Skutnik, a physical therapist and chief operating officer of the CMSC. “Both people living with MS and the clinicians dedicated to treating them are increasingly frustrated and powerless in attempts to facilitate the right care and resources for people living with MS. Our members are facing significant barriers and obstacles to ensure timely and seamless comprehensive care.”

Lisa Taylor Skutnik
Specifically, she said, the MS community is concerned about topics such as “the shortage of health care professionals engaged in MS care; the future of the MS workforce; limited/compromised access to MS neurology clinicians, mental health professionals, and rehabilitation professionals trained in MS care; and drug pricing/utilization management challenges.”

The development of quality measures in MS is also a “huge concern,” she said, referring to the federal government’s efforts to develop new ways to measure whether health professionals are providing high-quality care. Physicians have expressed widespread concern about the measures, which are being linked to reimbursement from Medicare and Medicaid.

Among the highlights of the CMSC meeting will be an educational session that “will focus on the available resources within the MS community for MS professionals and researchers to access advocacy efforts and get involved,” Ms. Skutnik said.

Another educational session “will focus on helping MS clinicians and researchers to understand all of the various stakeholders and their respective perspectives related to access to comprehensive care services for those living with MS,” such as pharmacy benefit managers and insurers, she said.
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Rehabilitation in MS is hot topic at CMSC 2018

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This year’s annual meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tenn., will feature an intense focus on rehabilitation in MS. The topic is often a priority for patients but not necessarily at top of mind for health care providers, said rehabilitation therapist Patty Bobryk, secretary of the CMSC.

“This year, some of the Rehab Track topics include addressing respiratory issues in MS, exploring the impact of visual impairments on rehab, and recommending the proper orthotics, as well as discussing treatments that focus on mind-body understanding,” said Ms. Bobryk of MS Comprehensive Care Center of Central Florida, Orlando. She serves as cochair of the International Organization of MS Rehabilitation Therapists.

Patty Bobryk


Rehabilitation in MS is a controversial topic. Two years ago, the CMSC endorsed a statement criticizing a 2015 report by the American Academy of Neurology that found limited evidence supporting MS rehabilitation (Neurology. 2015 Nov 24;85[21]:1896-903). The statement, also supported by the International Organization of MS Nurses and International Organization of MS Rehabilitation Therapists, declared that the AAN report “presents an incomplete review of the evidence published” (Neurol Clin Pract. 2016 Dec;6[6]:475-9).

However, the statement acknowledged that “larger studies with better research methodologies and higher-quality evidence are needed in rehabilitation.”

More recently, a 2017 systematic review of systematic reviews of rehabilitation in MS found that “strong” evidence only exists “for physical therapy for improved activity and participation, and for exercise-based educational programs for the reduction of patient-reported fatigue.” The review of reviews also found there’s “ ‘moderate’ evidence for multidisciplinary rehabilitation for longer-term gains at the levels of activity (disability) and participation, for cognitive-behavior therapy for the treatment of depression, and for information-provision interventions for improved patient knowledge” (Arch Phys Med Rehabil. 2017 Feb;98[2]:353-67).

In an interview, Ms. Bobryk said the MS rehabilitation community is evolving toward “a better understanding of neuroplasticity and the impact that rehab can have on maintaining and improving functional skills.”

In addition, she said, “more emphasis is being placed on early intervention and preventing the secondary effects of the disease versus providing only compensatory strategies.”
 

 

Highlights of this year’s rehab sessions at the CMSC conference include a 3-hour course on imbalance in MS that will “provide an intensive review of the anatomy of the balance system and educate the audience on evaluation and treatment interventions specific to retraining the balance system,” Ms. Bobryk said.

Another highlight: A half-day course that will “provide the rationale for including rehabilitation in a comprehensive model of care for people with severe MS,” she said. “Unique interventions such as the use of functional electrical stimulation cycling and body weight-supported treadmill training will be discussed.”

In the big picture, “clinicians who are working in the field of MS realize the benefits of rehab, but more education is needed to spread the word to the broader scope of health care providers,” Ms. Bobryk said. “Patients are often the ones that bring up rehab to their physicians to initiate a referral.”
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This year’s annual meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tenn., will feature an intense focus on rehabilitation in MS. The topic is often a priority for patients but not necessarily at top of mind for health care providers, said rehabilitation therapist Patty Bobryk, secretary of the CMSC.

“This year, some of the Rehab Track topics include addressing respiratory issues in MS, exploring the impact of visual impairments on rehab, and recommending the proper orthotics, as well as discussing treatments that focus on mind-body understanding,” said Ms. Bobryk of MS Comprehensive Care Center of Central Florida, Orlando. She serves as cochair of the International Organization of MS Rehabilitation Therapists.

Patty Bobryk


Rehabilitation in MS is a controversial topic. Two years ago, the CMSC endorsed a statement criticizing a 2015 report by the American Academy of Neurology that found limited evidence supporting MS rehabilitation (Neurology. 2015 Nov 24;85[21]:1896-903). The statement, also supported by the International Organization of MS Nurses and International Organization of MS Rehabilitation Therapists, declared that the AAN report “presents an incomplete review of the evidence published” (Neurol Clin Pract. 2016 Dec;6[6]:475-9).

However, the statement acknowledged that “larger studies with better research methodologies and higher-quality evidence are needed in rehabilitation.”

More recently, a 2017 systematic review of systematic reviews of rehabilitation in MS found that “strong” evidence only exists “for physical therapy for improved activity and participation, and for exercise-based educational programs for the reduction of patient-reported fatigue.” The review of reviews also found there’s “ ‘moderate’ evidence for multidisciplinary rehabilitation for longer-term gains at the levels of activity (disability) and participation, for cognitive-behavior therapy for the treatment of depression, and for information-provision interventions for improved patient knowledge” (Arch Phys Med Rehabil. 2017 Feb;98[2]:353-67).

In an interview, Ms. Bobryk said the MS rehabilitation community is evolving toward “a better understanding of neuroplasticity and the impact that rehab can have on maintaining and improving functional skills.”

In addition, she said, “more emphasis is being placed on early intervention and preventing the secondary effects of the disease versus providing only compensatory strategies.”
 

 

Highlights of this year’s rehab sessions at the CMSC conference include a 3-hour course on imbalance in MS that will “provide an intensive review of the anatomy of the balance system and educate the audience on evaluation and treatment interventions specific to retraining the balance system,” Ms. Bobryk said.

Another highlight: A half-day course that will “provide the rationale for including rehabilitation in a comprehensive model of care for people with severe MS,” she said. “Unique interventions such as the use of functional electrical stimulation cycling and body weight-supported treadmill training will be discussed.”

In the big picture, “clinicians who are working in the field of MS realize the benefits of rehab, but more education is needed to spread the word to the broader scope of health care providers,” Ms. Bobryk said. “Patients are often the ones that bring up rehab to their physicians to initiate a referral.”


This year’s annual meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tenn., will feature an intense focus on rehabilitation in MS. The topic is often a priority for patients but not necessarily at top of mind for health care providers, said rehabilitation therapist Patty Bobryk, secretary of the CMSC.

“This year, some of the Rehab Track topics include addressing respiratory issues in MS, exploring the impact of visual impairments on rehab, and recommending the proper orthotics, as well as discussing treatments that focus on mind-body understanding,” said Ms. Bobryk of MS Comprehensive Care Center of Central Florida, Orlando. She serves as cochair of the International Organization of MS Rehabilitation Therapists.

Patty Bobryk


Rehabilitation in MS is a controversial topic. Two years ago, the CMSC endorsed a statement criticizing a 2015 report by the American Academy of Neurology that found limited evidence supporting MS rehabilitation (Neurology. 2015 Nov 24;85[21]:1896-903). The statement, also supported by the International Organization of MS Nurses and International Organization of MS Rehabilitation Therapists, declared that the AAN report “presents an incomplete review of the evidence published” (Neurol Clin Pract. 2016 Dec;6[6]:475-9).

However, the statement acknowledged that “larger studies with better research methodologies and higher-quality evidence are needed in rehabilitation.”

More recently, a 2017 systematic review of systematic reviews of rehabilitation in MS found that “strong” evidence only exists “for physical therapy for improved activity and participation, and for exercise-based educational programs for the reduction of patient-reported fatigue.” The review of reviews also found there’s “ ‘moderate’ evidence for multidisciplinary rehabilitation for longer-term gains at the levels of activity (disability) and participation, for cognitive-behavior therapy for the treatment of depression, and for information-provision interventions for improved patient knowledge” (Arch Phys Med Rehabil. 2017 Feb;98[2]:353-67).

In an interview, Ms. Bobryk said the MS rehabilitation community is evolving toward “a better understanding of neuroplasticity and the impact that rehab can have on maintaining and improving functional skills.”

In addition, she said, “more emphasis is being placed on early intervention and preventing the secondary effects of the disease versus providing only compensatory strategies.”
 

 

Highlights of this year’s rehab sessions at the CMSC conference include a 3-hour course on imbalance in MS that will “provide an intensive review of the anatomy of the balance system and educate the audience on evaluation and treatment interventions specific to retraining the balance system,” Ms. Bobryk said.

Another highlight: A half-day course that will “provide the rationale for including rehabilitation in a comprehensive model of care for people with severe MS,” she said. “Unique interventions such as the use of functional electrical stimulation cycling and body weight-supported treadmill training will be discussed.”

In the big picture, “clinicians who are working in the field of MS realize the benefits of rehab, but more education is needed to spread the word to the broader scope of health care providers,” Ms. Bobryk said. “Patients are often the ones that bring up rehab to their physicians to initiate a referral.”
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Wide variety of MS topics on tap at CMSC 2018

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More than 2,000 members of the multiple sclerosis care, advocacy, research, and patient communities will gather in Nashville, Tenn., May 30–June 2 for the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dozens of topics will be discussed, ranging from complementary/alternative therapies, ethics, and neuropsychiatry to neuroimmunology and disease models, relapse management, and self-care. Clinicians also will tackle sensitive topics such as suicide, depression, and cognitive impairment.

“Accredited continuing education will be offered for MDs, registered nurses, pharmacists, occupational therapists, physical therapists, social workers, and psychologists,” said Gary Cutter, PhD, president of the CMSC. “Our offerings include beginner courses, advanced science sessions, rehab and mental health tracks, platform and poster sessions, and roundtables.”

Dr. Gary Cutter
Special areas of focus this year include the use of stem cells, evolving knowledge about MS drugs and disease-modifying treatments, disease pathology, and neuroimaging, Dr. Cutter, professor of biostatistics at the University of Alabama at Birmingham, said in an interview.

“We’ll discuss meds for progressive forms of MS as well as targeted therapies based on new information from genetics,” Dr. Cutter said. Participants will also gain insight from registries and other data sources, he added.

Lecture topics will include the use of computerized screening for cognitive dysfunction in the MS clinic and new research into MS pathology.

Other sessions will explore the use of cannabis, infusion therapies, respiratory enhancement, and a new class of medications for blocking lipid metabolism. Rehabilitation will also be a major focus.
 

 


One session will examine MS in patients before conception, during pregnancy, and in the postpartum period. Another session will explore suicide in MS and discuss how clinics can identify and help patients at risk.

The annual CMSC conference stands apart because it’s a “relatively unique meeting where the entire MS treatment team, researchers, and persons with MS can interact and discuss the complex issues in MS care,” Dr. Cutter said. “Much of this takes place outside of the formal program but can still have major impact on all of us. The enthusiasm of the young attendees is always amazing. They are supported, involved, and encouraged.”
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More than 2,000 members of the multiple sclerosis care, advocacy, research, and patient communities will gather in Nashville, Tenn., May 30–June 2 for the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dozens of topics will be discussed, ranging from complementary/alternative therapies, ethics, and neuropsychiatry to neuroimmunology and disease models, relapse management, and self-care. Clinicians also will tackle sensitive topics such as suicide, depression, and cognitive impairment.

“Accredited continuing education will be offered for MDs, registered nurses, pharmacists, occupational therapists, physical therapists, social workers, and psychologists,” said Gary Cutter, PhD, president of the CMSC. “Our offerings include beginner courses, advanced science sessions, rehab and mental health tracks, platform and poster sessions, and roundtables.”

Dr. Gary Cutter
Special areas of focus this year include the use of stem cells, evolving knowledge about MS drugs and disease-modifying treatments, disease pathology, and neuroimaging, Dr. Cutter, professor of biostatistics at the University of Alabama at Birmingham, said in an interview.

“We’ll discuss meds for progressive forms of MS as well as targeted therapies based on new information from genetics,” Dr. Cutter said. Participants will also gain insight from registries and other data sources, he added.

Lecture topics will include the use of computerized screening for cognitive dysfunction in the MS clinic and new research into MS pathology.

Other sessions will explore the use of cannabis, infusion therapies, respiratory enhancement, and a new class of medications for blocking lipid metabolism. Rehabilitation will also be a major focus.
 

 


One session will examine MS in patients before conception, during pregnancy, and in the postpartum period. Another session will explore suicide in MS and discuss how clinics can identify and help patients at risk.

The annual CMSC conference stands apart because it’s a “relatively unique meeting where the entire MS treatment team, researchers, and persons with MS can interact and discuss the complex issues in MS care,” Dr. Cutter said. “Much of this takes place outside of the formal program but can still have major impact on all of us. The enthusiasm of the young attendees is always amazing. They are supported, involved, and encouraged.”


More than 2,000 members of the multiple sclerosis care, advocacy, research, and patient communities will gather in Nashville, Tenn., May 30–June 2 for the annual meeting of the Consortium of Multiple Sclerosis Centers.

Dozens of topics will be discussed, ranging from complementary/alternative therapies, ethics, and neuropsychiatry to neuroimmunology and disease models, relapse management, and self-care. Clinicians also will tackle sensitive topics such as suicide, depression, and cognitive impairment.

“Accredited continuing education will be offered for MDs, registered nurses, pharmacists, occupational therapists, physical therapists, social workers, and psychologists,” said Gary Cutter, PhD, president of the CMSC. “Our offerings include beginner courses, advanced science sessions, rehab and mental health tracks, platform and poster sessions, and roundtables.”

Dr. Gary Cutter
Special areas of focus this year include the use of stem cells, evolving knowledge about MS drugs and disease-modifying treatments, disease pathology, and neuroimaging, Dr. Cutter, professor of biostatistics at the University of Alabama at Birmingham, said in an interview.

“We’ll discuss meds for progressive forms of MS as well as targeted therapies based on new information from genetics,” Dr. Cutter said. Participants will also gain insight from registries and other data sources, he added.

Lecture topics will include the use of computerized screening for cognitive dysfunction in the MS clinic and new research into MS pathology.

Other sessions will explore the use of cannabis, infusion therapies, respiratory enhancement, and a new class of medications for blocking lipid metabolism. Rehabilitation will also be a major focus.
 

 


One session will examine MS in patients before conception, during pregnancy, and in the postpartum period. Another session will explore suicide in MS and discuss how clinics can identify and help patients at risk.

The annual CMSC conference stands apart because it’s a “relatively unique meeting where the entire MS treatment team, researchers, and persons with MS can interact and discuss the complex issues in MS care,” Dr. Cutter said. “Much of this takes place outside of the formal program but can still have major impact on all of us. The enthusiasm of the young attendees is always amazing. They are supported, involved, and encouraged.”
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Hefty rewards pay off in smoking-cessation study

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A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com
The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com
The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

 

A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com
The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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FROM NEW ENGLAND JOURNAL OF MEDICINE

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Key clinical point: Smokers are more likely to sustain cessation if they receive incentives worth $600.

Major finding: Cessation rates for 6 months past target quit date reached as high as 2.9% in smokers who had the opportunity to gain rewards, while they didn’t top 1% in those who received free cessation aids or free e-cigarettes.

Study details: A randomized, prospective study of 6,006 smokers (employees of 54 companies and spouses) who were assigned to usual care or one of four intervention groups.

Disclosures: The study received grant support from the Vitality Institute. Most of the study authors reported no relevant disclosures. One reported serving on the scientific advisory board of VAL Health, and another reported various grants and personal fees.

Source: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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Malignant pleural mesothelioma guidelines often are ignored

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SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.

Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.

Dr. Harmik Soukiasian

Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”

Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).

Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”

For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.

 

 

“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”

In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”

But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.

During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
 

 

“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”

Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.

How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”

No disclosures and no study funding were reported.
 

SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.

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SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.

Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.

Dr. Harmik Soukiasian

Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”

Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).

Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”

For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.

 

 

“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”

In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”

But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.

During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
 

 

“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”

Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.

How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”

No disclosures and no study funding were reported.
 

SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.

SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.

Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.

Dr. Harmik Soukiasian

Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”

Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).

Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”

For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.

 

 

“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”

In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”

But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.

During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
 

 

“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”

Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.

How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”

No disclosures and no study funding were reported.
 

SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.

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REPORTING FROM THE AATS ANNUAL MEETING

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Key clinical point: Patients with malignant pleural mesothelioma (MPM) often don’t receive recommended treatment.

Major finding: Guidelines recommend surgery in epithelioid MPM, but only 30% of patients received it.

Study details: Analysis of 3,834 patients diagnosed with MPM clinical stages I-III during 2004-2014.

Disclosures: No disclosures and no study funding were reported.

Source: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.

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Delay of NSCLC surgery can lead to worse prognosis

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– Delaying surgery in certain cases of non–small cell lung cancer (NSCLC) can mean patients will be upstaged and consequently have worse prognoses, a study suggests.

“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”

Dr. Harmik Soukiasian
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.

“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”

For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.

Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
 

 

Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.

“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”

The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.

In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”

No disclosures and no study funding are reported.

SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.

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– Delaying surgery in certain cases of non–small cell lung cancer (NSCLC) can mean patients will be upstaged and consequently have worse prognoses, a study suggests.

“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”

Dr. Harmik Soukiasian
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.

“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”

For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.

Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
 

 

Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.

“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”

The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.

In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”

No disclosures and no study funding are reported.

SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.

 

– Delaying surgery in certain cases of non–small cell lung cancer (NSCLC) can mean patients will be upstaged and consequently have worse prognoses, a study suggests.

“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”

Dr. Harmik Soukiasian
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.

An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.

“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”

For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.

Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
 

 

Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.

“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”

The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.

In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”

No disclosures and no study funding are reported.

SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.

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Key clinical point: Clinical staging levels worsen in each successive surgery-free week after initial staging in certain NSCLC patients.

Major finding: There was a 1.3% increase per week of upstaging to stage IIIA.

Study details: Analysis of 52,406 patients with stage I NSCLC who were tracked for up to 12 weeks.

Disclosures: No disclosures and no funding were reported.

Source: Soukiasian HJ et al. AATS 2018, Abstract 67.

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