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FDA: Some blood lead tests have reported falsely low levels since 2014
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
AGA recognizes 52 investigators with research funding
The AGA Research Foundation is thrilled to award 52 researchers with research funding in the 2017 award year.
“The AGA Research Foundation has a proven track record of funding young investigators who subsequently achieve great success in research. We are confident that the 2017 class will be no exception,” said Robert S. Sandler, MD, MPH, AGAF, chair, AGA Research Foundation. “AGA is honored to invest in this year’s award recipients and looks forward to seeing how each research project contributes to advancing the field of gastroenterology.”
The AGA Research Award Program serves to support talented investigators who are pursuing careers in digestive disease research. A grant from the AGA Research Foundation ensures that a major proportion of the recipient’s time is protected for research.
The awards program is made possible thanks to generous donors and funders contributing to the AGA Research Foundation. Show your support for GI research.
To learn about upcoming research funding opportunities, and to view the list of this years’ winners, visit www.gastro.org/awards.
This year’s honorees were recognized during several AGA Research Foundation events at Digestive Disease Week® 2017, which took place May 6-9 in Chicago, IL.
The AGA Research Foundation is thrilled to award 52 researchers with research funding in the 2017 award year.
“The AGA Research Foundation has a proven track record of funding young investigators who subsequently achieve great success in research. We are confident that the 2017 class will be no exception,” said Robert S. Sandler, MD, MPH, AGAF, chair, AGA Research Foundation. “AGA is honored to invest in this year’s award recipients and looks forward to seeing how each research project contributes to advancing the field of gastroenterology.”
The AGA Research Award Program serves to support talented investigators who are pursuing careers in digestive disease research. A grant from the AGA Research Foundation ensures that a major proportion of the recipient’s time is protected for research.
The awards program is made possible thanks to generous donors and funders contributing to the AGA Research Foundation. Show your support for GI research.
To learn about upcoming research funding opportunities, and to view the list of this years’ winners, visit www.gastro.org/awards.
This year’s honorees were recognized during several AGA Research Foundation events at Digestive Disease Week® 2017, which took place May 6-9 in Chicago, IL.
The AGA Research Foundation is thrilled to award 52 researchers with research funding in the 2017 award year.
“The AGA Research Foundation has a proven track record of funding young investigators who subsequently achieve great success in research. We are confident that the 2017 class will be no exception,” said Robert S. Sandler, MD, MPH, AGAF, chair, AGA Research Foundation. “AGA is honored to invest in this year’s award recipients and looks forward to seeing how each research project contributes to advancing the field of gastroenterology.”
The AGA Research Award Program serves to support talented investigators who are pursuing careers in digestive disease research. A grant from the AGA Research Foundation ensures that a major proportion of the recipient’s time is protected for research.
The awards program is made possible thanks to generous donors and funders contributing to the AGA Research Foundation. Show your support for GI research.
To learn about upcoming research funding opportunities, and to view the list of this years’ winners, visit www.gastro.org/awards.
This year’s honorees were recognized during several AGA Research Foundation events at Digestive Disease Week® 2017, which took place May 6-9 in Chicago, IL.
Nausea with pediatric functional abdominal pain may mean depression, anxiety
(FAP), reported Alexandra C. Russell, MD, and her associates at Vanderbilt University, Nashville.
In a study of 398 children with FAP and nausea and 479 with FAP alone, those with comorbid nausea had significantly more GI symptoms and depression symptoms. Anxiety symptoms were not studied. Mean age at baseline was 12 years.
The FAP plus nausea patients were 1.79-times more likely to meet criteria for a current DSM-IV anxiety disorder and 2.61-times more likely to meet DSM-IV diagnostic criteria for generalized anxiety disorder than were FAP-only patients. The FAP and nausea patients were 1.81 times more likely to meet criteria for a DSM-IV for a major depressive disorder in their lifetime than were FAP-only patients.
The suggestion that nausea may be an independent risk factor for later anxiety and depression in children with FAP “may be owing to chronic nausea being a distressing symptom that permeates multiple areas of physical and psychosocial functioning,” Dr. Russell and her colleagues surmised.
“It may be difficult for these patients to maintain good nutrition, sleep habits, exercise, and resiliency when they frequently are nauseated,” the study authors noted. “Alternatively, FAP patients with comorbid nausea may represent a phenotype with autonomic nervous system dysfunction that contributes to both nausea and emotional distress.”
Read more in Clinical Gastroenterology and Hepatology (2017 May;15[5]:706-11).
(FAP), reported Alexandra C. Russell, MD, and her associates at Vanderbilt University, Nashville.
In a study of 398 children with FAP and nausea and 479 with FAP alone, those with comorbid nausea had significantly more GI symptoms and depression symptoms. Anxiety symptoms were not studied. Mean age at baseline was 12 years.
The FAP plus nausea patients were 1.79-times more likely to meet criteria for a current DSM-IV anxiety disorder and 2.61-times more likely to meet DSM-IV diagnostic criteria for generalized anxiety disorder than were FAP-only patients. The FAP and nausea patients were 1.81 times more likely to meet criteria for a DSM-IV for a major depressive disorder in their lifetime than were FAP-only patients.
The suggestion that nausea may be an independent risk factor for later anxiety and depression in children with FAP “may be owing to chronic nausea being a distressing symptom that permeates multiple areas of physical and psychosocial functioning,” Dr. Russell and her colleagues surmised.
“It may be difficult for these patients to maintain good nutrition, sleep habits, exercise, and resiliency when they frequently are nauseated,” the study authors noted. “Alternatively, FAP patients with comorbid nausea may represent a phenotype with autonomic nervous system dysfunction that contributes to both nausea and emotional distress.”
Read more in Clinical Gastroenterology and Hepatology (2017 May;15[5]:706-11).
(FAP), reported Alexandra C. Russell, MD, and her associates at Vanderbilt University, Nashville.
In a study of 398 children with FAP and nausea and 479 with FAP alone, those with comorbid nausea had significantly more GI symptoms and depression symptoms. Anxiety symptoms were not studied. Mean age at baseline was 12 years.
The FAP plus nausea patients were 1.79-times more likely to meet criteria for a current DSM-IV anxiety disorder and 2.61-times more likely to meet DSM-IV diagnostic criteria for generalized anxiety disorder than were FAP-only patients. The FAP and nausea patients were 1.81 times more likely to meet criteria for a DSM-IV for a major depressive disorder in their lifetime than were FAP-only patients.
The suggestion that nausea may be an independent risk factor for later anxiety and depression in children with FAP “may be owing to chronic nausea being a distressing symptom that permeates multiple areas of physical and psychosocial functioning,” Dr. Russell and her colleagues surmised.
“It may be difficult for these patients to maintain good nutrition, sleep habits, exercise, and resiliency when they frequently are nauseated,” the study authors noted. “Alternatively, FAP patients with comorbid nausea may represent a phenotype with autonomic nervous system dysfunction that contributes to both nausea and emotional distress.”
Read more in Clinical Gastroenterology and Hepatology (2017 May;15[5]:706-11).
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Intravenous tPA ups mortality in children with acute ischemic stroke
BOSTON – Intravenous thrombolysis with tissue plasminogen activator (tPA) is associated with adverse outcomes, including an increased risk of death, in children with acute ischemic stroke, based on a review of cases from the 2006-2010 Nationwide Inpatient Survey.
Of 20,587 patients aged 0-17 years who were included in the survey, 198 received an intervention, including tPA in 169 patients, intra-arterial thrombectomy (IAT) in 5 patients, and both tPA and IAT in 24 patients. The overall mortality was 7.8%, but in those who received tPA it was 13.8%, compared with 7.7% in those who did not, Kathryn Ess, MD, reported at the annual meeting of the American Academy of Neurology.
Other outcomes were also worse in those who received tPA. For example, untreated patients were more likely to be discharged home than were tPA-treated patients (67.8% vs. 47.5%), and intracerebral hemorrhage was more common in treated vs. untreated patients (10.1% vs. 3.8%). Costs for treated patients averaged $200,346 vs. $123,015 for untreated patients.
Children included in the review had a mean age of 6 years, 43.9% were girls, and 47.7% were white. Treated patients were older (10 years vs. 5.9 years), and comorbidities included Moyamoya disease in 12.4% of patients, cardiac valvular disease in 6.6%, and sickle cell disease in 6.5%. Those who received tPA had a higher prevalence of procoagulable conditions (15.2% vs. 2%). Of note, the higher prevalence of intracerebral hemorrhage in treated patients was not explained by Moyamoya or sickle cell disease, as patients with those comorbidities were less likely than those without those conditions to receive treatment, Dr. Ess said.
Though limited by the retrospective study design, small numbers of treated patients, a lack of data on stroke severity or functional outcomes, and the inclusion of data from years before newer thrombectomy devices became available, the findings highlight concerns about the safety and efficacy of tPA in children with ischemic stroke, she said, noting that few studies have looked at the utility of tPA with or without IAT in the pediatric population.
“Studies of the efficacy of ischemic stroke treatment in adults can’t necessarily be extrapolated to children,” she said, adding that this is especially true given the difference in etiologies of pediatric acute ischemic stroke.
Indeed, the findings underscore “the age-old adage that children are not just little adults,” said Andrew Southerland, MD, of the University of Virginia, Charlottesville, who was the discussant for the session.
“We need prospective clinical trials in children,” he said.
Dr. Ess and Dr. Southerland reported having no relevant financial disclosures.
BOSTON – Intravenous thrombolysis with tissue plasminogen activator (tPA) is associated with adverse outcomes, including an increased risk of death, in children with acute ischemic stroke, based on a review of cases from the 2006-2010 Nationwide Inpatient Survey.
Of 20,587 patients aged 0-17 years who were included in the survey, 198 received an intervention, including tPA in 169 patients, intra-arterial thrombectomy (IAT) in 5 patients, and both tPA and IAT in 24 patients. The overall mortality was 7.8%, but in those who received tPA it was 13.8%, compared with 7.7% in those who did not, Kathryn Ess, MD, reported at the annual meeting of the American Academy of Neurology.
Other outcomes were also worse in those who received tPA. For example, untreated patients were more likely to be discharged home than were tPA-treated patients (67.8% vs. 47.5%), and intracerebral hemorrhage was more common in treated vs. untreated patients (10.1% vs. 3.8%). Costs for treated patients averaged $200,346 vs. $123,015 for untreated patients.
Children included in the review had a mean age of 6 years, 43.9% were girls, and 47.7% were white. Treated patients were older (10 years vs. 5.9 years), and comorbidities included Moyamoya disease in 12.4% of patients, cardiac valvular disease in 6.6%, and sickle cell disease in 6.5%. Those who received tPA had a higher prevalence of procoagulable conditions (15.2% vs. 2%). Of note, the higher prevalence of intracerebral hemorrhage in treated patients was not explained by Moyamoya or sickle cell disease, as patients with those comorbidities were less likely than those without those conditions to receive treatment, Dr. Ess said.
Though limited by the retrospective study design, small numbers of treated patients, a lack of data on stroke severity or functional outcomes, and the inclusion of data from years before newer thrombectomy devices became available, the findings highlight concerns about the safety and efficacy of tPA in children with ischemic stroke, she said, noting that few studies have looked at the utility of tPA with or without IAT in the pediatric population.
“Studies of the efficacy of ischemic stroke treatment in adults can’t necessarily be extrapolated to children,” she said, adding that this is especially true given the difference in etiologies of pediatric acute ischemic stroke.
Indeed, the findings underscore “the age-old adage that children are not just little adults,” said Andrew Southerland, MD, of the University of Virginia, Charlottesville, who was the discussant for the session.
“We need prospective clinical trials in children,” he said.
Dr. Ess and Dr. Southerland reported having no relevant financial disclosures.
BOSTON – Intravenous thrombolysis with tissue plasminogen activator (tPA) is associated with adverse outcomes, including an increased risk of death, in children with acute ischemic stroke, based on a review of cases from the 2006-2010 Nationwide Inpatient Survey.
Of 20,587 patients aged 0-17 years who were included in the survey, 198 received an intervention, including tPA in 169 patients, intra-arterial thrombectomy (IAT) in 5 patients, and both tPA and IAT in 24 patients. The overall mortality was 7.8%, but in those who received tPA it was 13.8%, compared with 7.7% in those who did not, Kathryn Ess, MD, reported at the annual meeting of the American Academy of Neurology.
Other outcomes were also worse in those who received tPA. For example, untreated patients were more likely to be discharged home than were tPA-treated patients (67.8% vs. 47.5%), and intracerebral hemorrhage was more common in treated vs. untreated patients (10.1% vs. 3.8%). Costs for treated patients averaged $200,346 vs. $123,015 for untreated patients.
Children included in the review had a mean age of 6 years, 43.9% were girls, and 47.7% were white. Treated patients were older (10 years vs. 5.9 years), and comorbidities included Moyamoya disease in 12.4% of patients, cardiac valvular disease in 6.6%, and sickle cell disease in 6.5%. Those who received tPA had a higher prevalence of procoagulable conditions (15.2% vs. 2%). Of note, the higher prevalence of intracerebral hemorrhage in treated patients was not explained by Moyamoya or sickle cell disease, as patients with those comorbidities were less likely than those without those conditions to receive treatment, Dr. Ess said.
Though limited by the retrospective study design, small numbers of treated patients, a lack of data on stroke severity or functional outcomes, and the inclusion of data from years before newer thrombectomy devices became available, the findings highlight concerns about the safety and efficacy of tPA in children with ischemic stroke, she said, noting that few studies have looked at the utility of tPA with or without IAT in the pediatric population.
“Studies of the efficacy of ischemic stroke treatment in adults can’t necessarily be extrapolated to children,” she said, adding that this is especially true given the difference in etiologies of pediatric acute ischemic stroke.
Indeed, the findings underscore “the age-old adage that children are not just little adults,” said Andrew Southerland, MD, of the University of Virginia, Charlottesville, who was the discussant for the session.
“We need prospective clinical trials in children,” he said.
Dr. Ess and Dr. Southerland reported having no relevant financial disclosures.
AT AAN 2017
Key clinical point:
Major finding: Mortality for pediatric acute ischemic stroke was 7.8% overall, 7.7% in those who did not receive tPA, and 13.8% in those who did receive tPA.
Data source: A retrospective review of cases from the 2006-2010 Nationwide Inpatient Sample.
Disclosures: Dr. Ess and Dr. Southerland reported having no relevant financial disclosures.
Screen for comorbidities in pyoderma gangrenosum
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized. 
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized.
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized.
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
AT SID 2017
Key clinical point: Carefully screen for comorbidities when patients have pyoderma gangrenosum (PG).
Major finding: The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%).
Data source: A single-center retrospective study of 130 patients seen for pyoderma gangrenosum between 2006 and 2015.
Disclosures: Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
VIDEO: Sutureless aortic valve shows promise in IDE trial
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
Chronic GVHD linked to fivefold increase in squamous cell skin carcinomas
PORTLAND – Chronic graft versus host disease (GVHD) was associated with a fivefold increase in risk of squamous cell carcinoma and a nearly twofold rise in the rate of basal cell carcinoma, based on a meta-analysis of eight studies.
Acute GVHD was not tied to an increase in secondary nonmelanoma skin cancers, Pooja H. Rambhia and her associates reported in a poster presented at the annual meeting of the Society for Investigative Dermatology. The findings highlight the need for multidisciplinary consults to distinguish malignancies from the cutaneous manifestations of chronic GVHD and for vigorous surveillance for skin cancer even years after hematopoietic stem cell transplantation.
GVHS has been linked to secondary nonmelanoma skin cancers in previous studies, but few have quantified the risk, according to the reviewers, who are from the department of dermatology and dermatopathology at the Cleveland Clinic Foundation. The increased risk may be related to the heavy immunosuppression needed to treat chronic GVHD.
For the meta-analysis, the researchers identified 1,411 studies recorded in academic databases and reviewed those that reported both cases of skin cancers and GVHD. Seven retrospective, and one prospective, studies published between 1997 and 2012 measured both variables in all patients.
The studies included more than 56,000 patients followed for up to 36 years after undergoing allogeneic or syngeneic transplantation, the reviewers reported. During follow-up, between 17% and 73% of patients developed chronic GVHD, and 29% to 67% developed acute GVHD. There were 98 cases of basal cell carcinoma, 49 cases of squamous cell carcinoma, and 34 cases of malignant melanoma. Chronic GVHD was significantly associated with both squamous cell carcinoma (risk ratio, 5.3; 95% confidence interval, 2.4-11.8; P less than .001) and basal cell carcinoma (RR, 2.0; 95% CI, 1.3-3.0; P = .002). In contrast, chronic GVHD showed a nonsignificant trend toward an inverse correlation with the risk of secondary melanoma. Acute GVHD was not linked with squamous cell carcinoma, basal cell carcinoma, or melanoma.
GVHD develops, up to half the time, after hematopoietic stem cell transplantation and often becomes chronic, the reviewers noted. Catching skin cancer early is crucial, and transplant patients should undergo regular skin checks with multidisciplinary consults to promptly, accurately distinguish malignancies from the cutaneous manifestations of GVHD, they added.
The researchers did not report external funding sources. They had no relevant financial conflicts of interest.
PORTLAND – Chronic graft versus host disease (GVHD) was associated with a fivefold increase in risk of squamous cell carcinoma and a nearly twofold rise in the rate of basal cell carcinoma, based on a meta-analysis of eight studies.
Acute GVHD was not tied to an increase in secondary nonmelanoma skin cancers, Pooja H. Rambhia and her associates reported in a poster presented at the annual meeting of the Society for Investigative Dermatology. The findings highlight the need for multidisciplinary consults to distinguish malignancies from the cutaneous manifestations of chronic GVHD and for vigorous surveillance for skin cancer even years after hematopoietic stem cell transplantation.
GVHS has been linked to secondary nonmelanoma skin cancers in previous studies, but few have quantified the risk, according to the reviewers, who are from the department of dermatology and dermatopathology at the Cleveland Clinic Foundation. The increased risk may be related to the heavy immunosuppression needed to treat chronic GVHD.
For the meta-analysis, the researchers identified 1,411 studies recorded in academic databases and reviewed those that reported both cases of skin cancers and GVHD. Seven retrospective, and one prospective, studies published between 1997 and 2012 measured both variables in all patients.
The studies included more than 56,000 patients followed for up to 36 years after undergoing allogeneic or syngeneic transplantation, the reviewers reported. During follow-up, between 17% and 73% of patients developed chronic GVHD, and 29% to 67% developed acute GVHD. There were 98 cases of basal cell carcinoma, 49 cases of squamous cell carcinoma, and 34 cases of malignant melanoma. Chronic GVHD was significantly associated with both squamous cell carcinoma (risk ratio, 5.3; 95% confidence interval, 2.4-11.8; P less than .001) and basal cell carcinoma (RR, 2.0; 95% CI, 1.3-3.0; P = .002). In contrast, chronic GVHD showed a nonsignificant trend toward an inverse correlation with the risk of secondary melanoma. Acute GVHD was not linked with squamous cell carcinoma, basal cell carcinoma, or melanoma.
GVHD develops, up to half the time, after hematopoietic stem cell transplantation and often becomes chronic, the reviewers noted. Catching skin cancer early is crucial, and transplant patients should undergo regular skin checks with multidisciplinary consults to promptly, accurately distinguish malignancies from the cutaneous manifestations of GVHD, they added.
The researchers did not report external funding sources. They had no relevant financial conflicts of interest.
PORTLAND – Chronic graft versus host disease (GVHD) was associated with a fivefold increase in risk of squamous cell carcinoma and a nearly twofold rise in the rate of basal cell carcinoma, based on a meta-analysis of eight studies.
Acute GVHD was not tied to an increase in secondary nonmelanoma skin cancers, Pooja H. Rambhia and her associates reported in a poster presented at the annual meeting of the Society for Investigative Dermatology. The findings highlight the need for multidisciplinary consults to distinguish malignancies from the cutaneous manifestations of chronic GVHD and for vigorous surveillance for skin cancer even years after hematopoietic stem cell transplantation.
GVHS has been linked to secondary nonmelanoma skin cancers in previous studies, but few have quantified the risk, according to the reviewers, who are from the department of dermatology and dermatopathology at the Cleveland Clinic Foundation. The increased risk may be related to the heavy immunosuppression needed to treat chronic GVHD.
For the meta-analysis, the researchers identified 1,411 studies recorded in academic databases and reviewed those that reported both cases of skin cancers and GVHD. Seven retrospective, and one prospective, studies published between 1997 and 2012 measured both variables in all patients.
The studies included more than 56,000 patients followed for up to 36 years after undergoing allogeneic or syngeneic transplantation, the reviewers reported. During follow-up, between 17% and 73% of patients developed chronic GVHD, and 29% to 67% developed acute GVHD. There were 98 cases of basal cell carcinoma, 49 cases of squamous cell carcinoma, and 34 cases of malignant melanoma. Chronic GVHD was significantly associated with both squamous cell carcinoma (risk ratio, 5.3; 95% confidence interval, 2.4-11.8; P less than .001) and basal cell carcinoma (RR, 2.0; 95% CI, 1.3-3.0; P = .002). In contrast, chronic GVHD showed a nonsignificant trend toward an inverse correlation with the risk of secondary melanoma. Acute GVHD was not linked with squamous cell carcinoma, basal cell carcinoma, or melanoma.
GVHD develops, up to half the time, after hematopoietic stem cell transplantation and often becomes chronic, the reviewers noted. Catching skin cancer early is crucial, and transplant patients should undergo regular skin checks with multidisciplinary consults to promptly, accurately distinguish malignancies from the cutaneous manifestations of GVHD, they added.
The researchers did not report external funding sources. They had no relevant financial conflicts of interest.
AT SID 2017
Key clinical point: Chronic graft versus host disease was associated with a significantly increased risk of squamous cell and basal cell carcinomas.
Major finding: Chronic GVHD was associated with a fivefold increase in squamous cell carcinoma (risk ratio, 5.3; 95% confidence interval, 2.4 to 11.8; P less than .001).
Data source: A meta-analysis of eight cohort studies of 56,000 patients who underwent hematopoietic stem cell transplantation.
Disclosures: The researchers did not report external funding sources. They had no conflicts of interest.
Topical tretinoin resolves inflammatory symptoms in rosacea, in small study
SYDNEY, AUSTRALIA – Treatment with topical tretinoin resulted in complete resolution of rosacea symptoms in a significant number of patients, in a small retrospective study presented at the annual meeting of the Australasian College of Dermatologists.
“As an intermediary step between topical antibiotics and oral isotretinoin, we propose that topical tretinoin may be effective in the management and reduction of rosacea symptoms,” Emily Forward, MD, of the University of Sydney, said at the meeting. There has been recent discussion regarding the use of low-dose isotretinoin in the treatment of rosacea, but safety with long-term use is an issue, she noted.
More than 80% of patients had complete or excellent resolution of papules and pustules, with only one patient showing no benefit. Of the patients with erythema as the primary feature of their rosacea, 42% achieved complete resolution, 33% achieved excellent resolution, 17% achieved a good response, and 8% showed no benefit, Dr. Forward reported.
Among patients with telangiectasia, 40% achieved complete resolution, while 37% of those with flushing achieved complete resolution.
Topical tretinoin should be considered among the treatment options for rosacea “as it is effective, well tolerated, and has synergistic benefits in the prevention of photoaging,” Dr. Forward said. The ideal patient candidate would be someone with inflammatory features such as papules, pustules, or erythema, she added.
No patients experienced worsening of their symptoms with treatment, although one patient stopped treatment because of adverse effects. Dr. Forward also stressed that tretinoin is a known teratogen, so it should not be used during pregnancy or breastfeeding, or in patients trying to conceive.
In an interview, Dr. Forward said that she and her associates were surprised at the degree of improvement with topical tretinoin, particularly for erythema symptoms. However, she said it was important to educate patients about how to use topical tretinoin. “You use a pea-sized amount, at night, and in the beginning we advise them to use it every second or third day, and if they tolerate it they can increase the amount,” she said.
No conflicts of interest were declared.
SYDNEY, AUSTRALIA – Treatment with topical tretinoin resulted in complete resolution of rosacea symptoms in a significant number of patients, in a small retrospective study presented at the annual meeting of the Australasian College of Dermatologists.
“As an intermediary step between topical antibiotics and oral isotretinoin, we propose that topical tretinoin may be effective in the management and reduction of rosacea symptoms,” Emily Forward, MD, of the University of Sydney, said at the meeting. There has been recent discussion regarding the use of low-dose isotretinoin in the treatment of rosacea, but safety with long-term use is an issue, she noted.
More than 80% of patients had complete or excellent resolution of papules and pustules, with only one patient showing no benefit. Of the patients with erythema as the primary feature of their rosacea, 42% achieved complete resolution, 33% achieved excellent resolution, 17% achieved a good response, and 8% showed no benefit, Dr. Forward reported.
Among patients with telangiectasia, 40% achieved complete resolution, while 37% of those with flushing achieved complete resolution.
Topical tretinoin should be considered among the treatment options for rosacea “as it is effective, well tolerated, and has synergistic benefits in the prevention of photoaging,” Dr. Forward said. The ideal patient candidate would be someone with inflammatory features such as papules, pustules, or erythema, she added.
No patients experienced worsening of their symptoms with treatment, although one patient stopped treatment because of adverse effects. Dr. Forward also stressed that tretinoin is a known teratogen, so it should not be used during pregnancy or breastfeeding, or in patients trying to conceive.
In an interview, Dr. Forward said that she and her associates were surprised at the degree of improvement with topical tretinoin, particularly for erythema symptoms. However, she said it was important to educate patients about how to use topical tretinoin. “You use a pea-sized amount, at night, and in the beginning we advise them to use it every second or third day, and if they tolerate it they can increase the amount,” she said.
No conflicts of interest were declared.
SYDNEY, AUSTRALIA – Treatment with topical tretinoin resulted in complete resolution of rosacea symptoms in a significant number of patients, in a small retrospective study presented at the annual meeting of the Australasian College of Dermatologists.
“As an intermediary step between topical antibiotics and oral isotretinoin, we propose that topical tretinoin may be effective in the management and reduction of rosacea symptoms,” Emily Forward, MD, of the University of Sydney, said at the meeting. There has been recent discussion regarding the use of low-dose isotretinoin in the treatment of rosacea, but safety with long-term use is an issue, she noted.
More than 80% of patients had complete or excellent resolution of papules and pustules, with only one patient showing no benefit. Of the patients with erythema as the primary feature of their rosacea, 42% achieved complete resolution, 33% achieved excellent resolution, 17% achieved a good response, and 8% showed no benefit, Dr. Forward reported.
Among patients with telangiectasia, 40% achieved complete resolution, while 37% of those with flushing achieved complete resolution.
Topical tretinoin should be considered among the treatment options for rosacea “as it is effective, well tolerated, and has synergistic benefits in the prevention of photoaging,” Dr. Forward said. The ideal patient candidate would be someone with inflammatory features such as papules, pustules, or erythema, she added.
No patients experienced worsening of their symptoms with treatment, although one patient stopped treatment because of adverse effects. Dr. Forward also stressed that tretinoin is a known teratogen, so it should not be used during pregnancy or breastfeeding, or in patients trying to conceive.
In an interview, Dr. Forward said that she and her associates were surprised at the degree of improvement with topical tretinoin, particularly for erythema symptoms. However, she said it was important to educate patients about how to use topical tretinoin. “You use a pea-sized amount, at night, and in the beginning we advise them to use it every second or third day, and if they tolerate it they can increase the amount,” she said.
No conflicts of interest were declared.
AT ACDASM 2017
Key clinical point: Topical tretinoin may be useful in treating erythema and the inflammatory symptoms of rosacea.
Major finding: More than 80% of patients with rosacea had complete or excellent resolution of papules and pustules with topical tretinoin 0.05%.
Data source: A retrospective study of 25 patients with mild to severe rosacea.
Disclosures: No conflicts of interest were declared.
My mundane genetic testing results
I’ve never been particularly curious about my genetic background. We have a pretty clear family history that I’m of central European and Russian descent, with my ancestors coming over in groups between 1900 and 1938.
Recently, my mother decided she wanted more genetic information on us, so she paid $99 for us to send saliva samples to a company that advertises such services.
A few weeks went by. You read about people who find out they have a genetic background that’s quite surprising. I began to wonder: Would there be some giant family history shocker when the results came in?
I’ve since spoken to others who had paid for this service and found most had the same experience. The test confirmed what was already well known, except for one friend whose results suggested a trace of Polynesian blood somewhere in his background. He believes this was likely artefactual, though he enjoys the idea that somewhere in history a Tongan warrior was blown off course at sea and somehow ended up in Odessa, Ukraine.
Of course, as I’ve now learned, that’s only the start of things. These days, I get emails advertising a more detailed panel (for an additional fee), looking for genetic markers for disease and more obscure traits. I also receive the occasional one from someone who, through the company’s anonymous servers, thinks they may be related to me.
I don’t answer either of those. I have no desire to expand my family circle beyond what it already is.
As for the disease testing? Not interested. Yes, some genetic tests may be helpful in making better choices, but the majority, at least to me, are still a work in progress. We deal with both false negatives and false positives in medicine. I routinely discourage my patients from spending money on unproven testing and treatments and have no desire to do the same myself. Maybe someday it will be worth the additional dollars, but I’m not convinced it’s there.
Money is, for better or worse, the driving force for all technologies, medical and otherwise. Maybe my $99 investment will help pay dividends down the road for someone, but today it only resulted in a shoulder shrug and chuckle at what I already knew.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve never been particularly curious about my genetic background. We have a pretty clear family history that I’m of central European and Russian descent, with my ancestors coming over in groups between 1900 and 1938.
Recently, my mother decided she wanted more genetic information on us, so she paid $99 for us to send saliva samples to a company that advertises such services.
A few weeks went by. You read about people who find out they have a genetic background that’s quite surprising. I began to wonder: Would there be some giant family history shocker when the results came in?
I’ve since spoken to others who had paid for this service and found most had the same experience. The test confirmed what was already well known, except for one friend whose results suggested a trace of Polynesian blood somewhere in his background. He believes this was likely artefactual, though he enjoys the idea that somewhere in history a Tongan warrior was blown off course at sea and somehow ended up in Odessa, Ukraine.
Of course, as I’ve now learned, that’s only the start of things. These days, I get emails advertising a more detailed panel (for an additional fee), looking for genetic markers for disease and more obscure traits. I also receive the occasional one from someone who, through the company’s anonymous servers, thinks they may be related to me.
I don’t answer either of those. I have no desire to expand my family circle beyond what it already is.
As for the disease testing? Not interested. Yes, some genetic tests may be helpful in making better choices, but the majority, at least to me, are still a work in progress. We deal with both false negatives and false positives in medicine. I routinely discourage my patients from spending money on unproven testing and treatments and have no desire to do the same myself. Maybe someday it will be worth the additional dollars, but I’m not convinced it’s there.
Money is, for better or worse, the driving force for all technologies, medical and otherwise. Maybe my $99 investment will help pay dividends down the road for someone, but today it only resulted in a shoulder shrug and chuckle at what I already knew.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve never been particularly curious about my genetic background. We have a pretty clear family history that I’m of central European and Russian descent, with my ancestors coming over in groups between 1900 and 1938.
Recently, my mother decided she wanted more genetic information on us, so she paid $99 for us to send saliva samples to a company that advertises such services.
A few weeks went by. You read about people who find out they have a genetic background that’s quite surprising. I began to wonder: Would there be some giant family history shocker when the results came in?
I’ve since spoken to others who had paid for this service and found most had the same experience. The test confirmed what was already well known, except for one friend whose results suggested a trace of Polynesian blood somewhere in his background. He believes this was likely artefactual, though he enjoys the idea that somewhere in history a Tongan warrior was blown off course at sea and somehow ended up in Odessa, Ukraine.
Of course, as I’ve now learned, that’s only the start of things. These days, I get emails advertising a more detailed panel (for an additional fee), looking for genetic markers for disease and more obscure traits. I also receive the occasional one from someone who, through the company’s anonymous servers, thinks they may be related to me.
I don’t answer either of those. I have no desire to expand my family circle beyond what it already is.
As for the disease testing? Not interested. Yes, some genetic tests may be helpful in making better choices, but the majority, at least to me, are still a work in progress. We deal with both false negatives and false positives in medicine. I routinely discourage my patients from spending money on unproven testing and treatments and have no desire to do the same myself. Maybe someday it will be worth the additional dollars, but I’m not convinced it’s there.
Money is, for better or worse, the driving force for all technologies, medical and otherwise. Maybe my $99 investment will help pay dividends down the road for someone, but today it only resulted in a shoulder shrug and chuckle at what I already knew.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
How to work with specialists in value-based care
The typical primary care physician has a patient base that consumes $10 million of health care a year. Yet the PCP receives only 6%-7% of those payments, with the rest of the costs resulting largely from the PCP’s referrals or lack of PCP care management of that patient.
The average PCP makes 1,000 referrals a year. Often, the referee specialist or facility not only does not coordinate with the PCP’s patient-centered medical home, they make their own downstream referrals.
A revolution in your compensation is underway. Under MACRA and other accountable care models, providers across the continuum of care are now being held responsible for the overall costs of those patients, not just their charges.
This is still hard to grasp, isn’t it? I was recently talking to a preeminent primary care physician who was an active member of an accountable care organization board of directors. I was fairly excited about the new impact this highly professional community leader could have on patients, now that he was in the PCP-driven ACO, not to mention his shared savings payment opportunities.
I was on a roll until he said, “But Bo, I’m already as efficient in treating patients as I can get.” He was still fighting the barriers you all face to do the best he could under the circumstances for the patients in his office each day.
Later, however, on a better day for me, we were working together on a cardiac care white paper. The physician leader told me, “I get it now – the biggest value-adding impact I might have is for the patient I don’t ever see.”
The above statistics show just what an opportunity you have in the new value care.
You can legally control referrals and patient care coordination with specialists. They don’t have to be in your ACO. You don’t even need to be in an ACO to take advantage of high-value referrals under the Medicare Merit-based Incentive Payment System (MIPS) program under MACRA. But how?
Let’s start by assuming the specialist you need to refer to is not in your ACO. You might be able to do this without an ACO, but it’s hard to get the critical mass of primary care physicians. If you’re under the Medicare Shared Savings Program or Next Gen initiative, there are important Stark Law and antikickback liability waivers that would benefit you by being in an ACO.
Otherwise, you should consider a high-value referral affiliation agreement.
If a critical mass of primary care physicians can access data that create a short list of high-value specialists, they can put them on the high-value specialist list. Specialists do not need to get part of the shared savings pool or other financial incentives – just referrals because of their high-quality and high-efficiency care. A superstar specialist or acute care or post–acute care facility may ultimately be invited into the ACO as a full participant.
The specialist/facility basically agrees to coordinate all care with the medical home and comanage that care with you. The agreement specifies that they will observe the care protocols of the ACO for that disease state. The provider will share data and agree to be monitored.
What is a high-value specialist/facility? The current common approach is to look at the insurance companies’ top tiers, but they are often too weighted to allowed charges. It’s really about being care coordinators and about readmission and complication rates.
For example, some bundled-payment specialists are selected solely based on the surgeons’ and anesthesiologists’ complication rates. If fees are mentioned at all, they are well down the list.
Of course, if the specialist is in the ACO with the primary care physician, this can be done internally.
How do you find value-added protocols involving specialists? I was lucky to be on a multiyear grant program whereby I worked with many primary care physicians and specialists to create white papers setting out high-value, practical initiatives. There are also guides for internists and family physicians. A condition of the grant was that they all can be accessed free of charge; they’re available at www.tac-consortium.org/resources.
This is a new day. Primary care is being asked to lead health care delivery today and be paid to do it. You are being rewarded or punished financially now based on the overall costs of your patients. You must have specialists and facilities coordinate with you in this new health care model. We have attempted to provide a road map to assist you on your journey.
Mr. Bobbitt is head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.
The typical primary care physician has a patient base that consumes $10 million of health care a year. Yet the PCP receives only 6%-7% of those payments, with the rest of the costs resulting largely from the PCP’s referrals or lack of PCP care management of that patient.
The average PCP makes 1,000 referrals a year. Often, the referee specialist or facility not only does not coordinate with the PCP’s patient-centered medical home, they make their own downstream referrals.
A revolution in your compensation is underway. Under MACRA and other accountable care models, providers across the continuum of care are now being held responsible for the overall costs of those patients, not just their charges.
This is still hard to grasp, isn’t it? I was recently talking to a preeminent primary care physician who was an active member of an accountable care organization board of directors. I was fairly excited about the new impact this highly professional community leader could have on patients, now that he was in the PCP-driven ACO, not to mention his shared savings payment opportunities.
I was on a roll until he said, “But Bo, I’m already as efficient in treating patients as I can get.” He was still fighting the barriers you all face to do the best he could under the circumstances for the patients in his office each day.
Later, however, on a better day for me, we were working together on a cardiac care white paper. The physician leader told me, “I get it now – the biggest value-adding impact I might have is for the patient I don’t ever see.”
The above statistics show just what an opportunity you have in the new value care.
You can legally control referrals and patient care coordination with specialists. They don’t have to be in your ACO. You don’t even need to be in an ACO to take advantage of high-value referrals under the Medicare Merit-based Incentive Payment System (MIPS) program under MACRA. But how?
Let’s start by assuming the specialist you need to refer to is not in your ACO. You might be able to do this without an ACO, but it’s hard to get the critical mass of primary care physicians. If you’re under the Medicare Shared Savings Program or Next Gen initiative, there are important Stark Law and antikickback liability waivers that would benefit you by being in an ACO.
Otherwise, you should consider a high-value referral affiliation agreement.
If a critical mass of primary care physicians can access data that create a short list of high-value specialists, they can put them on the high-value specialist list. Specialists do not need to get part of the shared savings pool or other financial incentives – just referrals because of their high-quality and high-efficiency care. A superstar specialist or acute care or post–acute care facility may ultimately be invited into the ACO as a full participant.
The specialist/facility basically agrees to coordinate all care with the medical home and comanage that care with you. The agreement specifies that they will observe the care protocols of the ACO for that disease state. The provider will share data and agree to be monitored.
What is a high-value specialist/facility? The current common approach is to look at the insurance companies’ top tiers, but they are often too weighted to allowed charges. It’s really about being care coordinators and about readmission and complication rates.
For example, some bundled-payment specialists are selected solely based on the surgeons’ and anesthesiologists’ complication rates. If fees are mentioned at all, they are well down the list.
Of course, if the specialist is in the ACO with the primary care physician, this can be done internally.
How do you find value-added protocols involving specialists? I was lucky to be on a multiyear grant program whereby I worked with many primary care physicians and specialists to create white papers setting out high-value, practical initiatives. There are also guides for internists and family physicians. A condition of the grant was that they all can be accessed free of charge; they’re available at www.tac-consortium.org/resources.
This is a new day. Primary care is being asked to lead health care delivery today and be paid to do it. You are being rewarded or punished financially now based on the overall costs of your patients. You must have specialists and facilities coordinate with you in this new health care model. We have attempted to provide a road map to assist you on your journey.
Mr. Bobbitt is head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.
The typical primary care physician has a patient base that consumes $10 million of health care a year. Yet the PCP receives only 6%-7% of those payments, with the rest of the costs resulting largely from the PCP’s referrals or lack of PCP care management of that patient.
The average PCP makes 1,000 referrals a year. Often, the referee specialist or facility not only does not coordinate with the PCP’s patient-centered medical home, they make their own downstream referrals.
A revolution in your compensation is underway. Under MACRA and other accountable care models, providers across the continuum of care are now being held responsible for the overall costs of those patients, not just their charges.
This is still hard to grasp, isn’t it? I was recently talking to a preeminent primary care physician who was an active member of an accountable care organization board of directors. I was fairly excited about the new impact this highly professional community leader could have on patients, now that he was in the PCP-driven ACO, not to mention his shared savings payment opportunities.
I was on a roll until he said, “But Bo, I’m already as efficient in treating patients as I can get.” He was still fighting the barriers you all face to do the best he could under the circumstances for the patients in his office each day.
Later, however, on a better day for me, we were working together on a cardiac care white paper. The physician leader told me, “I get it now – the biggest value-adding impact I might have is for the patient I don’t ever see.”
The above statistics show just what an opportunity you have in the new value care.
You can legally control referrals and patient care coordination with specialists. They don’t have to be in your ACO. You don’t even need to be in an ACO to take advantage of high-value referrals under the Medicare Merit-based Incentive Payment System (MIPS) program under MACRA. But how?
Let’s start by assuming the specialist you need to refer to is not in your ACO. You might be able to do this without an ACO, but it’s hard to get the critical mass of primary care physicians. If you’re under the Medicare Shared Savings Program or Next Gen initiative, there are important Stark Law and antikickback liability waivers that would benefit you by being in an ACO.
Otherwise, you should consider a high-value referral affiliation agreement.
If a critical mass of primary care physicians can access data that create a short list of high-value specialists, they can put them on the high-value specialist list. Specialists do not need to get part of the shared savings pool or other financial incentives – just referrals because of their high-quality and high-efficiency care. A superstar specialist or acute care or post–acute care facility may ultimately be invited into the ACO as a full participant.
The specialist/facility basically agrees to coordinate all care with the medical home and comanage that care with you. The agreement specifies that they will observe the care protocols of the ACO for that disease state. The provider will share data and agree to be monitored.
What is a high-value specialist/facility? The current common approach is to look at the insurance companies’ top tiers, but they are often too weighted to allowed charges. It’s really about being care coordinators and about readmission and complication rates.
For example, some bundled-payment specialists are selected solely based on the surgeons’ and anesthesiologists’ complication rates. If fees are mentioned at all, they are well down the list.
Of course, if the specialist is in the ACO with the primary care physician, this can be done internally.
How do you find value-added protocols involving specialists? I was lucky to be on a multiyear grant program whereby I worked with many primary care physicians and specialists to create white papers setting out high-value, practical initiatives. There are also guides for internists and family physicians. A condition of the grant was that they all can be accessed free of charge; they’re available at www.tac-consortium.org/resources.
This is a new day. Primary care is being asked to lead health care delivery today and be paid to do it. You are being rewarded or punished financially now based on the overall costs of your patients. You must have specialists and facilities coordinate with you in this new health care model. We have attempted to provide a road map to assist you on your journey.
Mr. Bobbitt is head of the health law group at the Smith Anderson law firm in Raleigh, N.C. He is president of Value Health Partners, LLC, a health care strategic consulting company. He has years of experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.