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40% of top-rated sunscreens fall short of AAD guidelines
Customer satisfaction ratings of sunscreens do not always reflect the products’ effectiveness, as 40% of the 65 top-rated sunscreens available on Amazon.com did not adhere to all three of the American Academy of Dermatology’s recommended criteria.
The AAD recommends the following for all sunscreens: sun protection factor (SPF) of 30 more, broad-spectrum protection, and water and/or sweat resistance. Of those criteria, water/sweat resistance was missing in 19 (29%), compared with SPF less than 30 in 7 (11%) products and lack of broad-spectrum protection in 4 (6%). Some products missed more than one criterion, said Shuai Xu, MD, of Northwestern University, Chicago, and his associates (JAMA Dermatolol. 2016 Jul 6. doi: 10.1001/jamadermatol.2016.2344).

Of the qualities besides performance that were analyzed, “cosmetic elegance,” which the investigators “defined as any feature associated with skin sensation on application, color, or scent,” was the positive feature most often mentioned in the customer reviews. On the other hand, they noted, “dermatologist recommendations were not a significantly cited positive feature.”
The sunscreens in the analysis represented the top 1 percentile by customer rating of the 6,500 products categorized as sunscreens on Amazon as of December 2015. The 65 products included in the study had more than 24,400 customer reviews and a median rating of 4.5 out of 5 stars, Dr. Xu and his associates said.
The investigators did not report any conflicts of interest.
Customer satisfaction ratings of sunscreens do not always reflect the products’ effectiveness, as 40% of the 65 top-rated sunscreens available on Amazon.com did not adhere to all three of the American Academy of Dermatology’s recommended criteria.
The AAD recommends the following for all sunscreens: sun protection factor (SPF) of 30 more, broad-spectrum protection, and water and/or sweat resistance. Of those criteria, water/sweat resistance was missing in 19 (29%), compared with SPF less than 30 in 7 (11%) products and lack of broad-spectrum protection in 4 (6%). Some products missed more than one criterion, said Shuai Xu, MD, of Northwestern University, Chicago, and his associates (JAMA Dermatolol. 2016 Jul 6. doi: 10.1001/jamadermatol.2016.2344).

Of the qualities besides performance that were analyzed, “cosmetic elegance,” which the investigators “defined as any feature associated with skin sensation on application, color, or scent,” was the positive feature most often mentioned in the customer reviews. On the other hand, they noted, “dermatologist recommendations were not a significantly cited positive feature.”
The sunscreens in the analysis represented the top 1 percentile by customer rating of the 6,500 products categorized as sunscreens on Amazon as of December 2015. The 65 products included in the study had more than 24,400 customer reviews and a median rating of 4.5 out of 5 stars, Dr. Xu and his associates said.
The investigators did not report any conflicts of interest.
Customer satisfaction ratings of sunscreens do not always reflect the products’ effectiveness, as 40% of the 65 top-rated sunscreens available on Amazon.com did not adhere to all three of the American Academy of Dermatology’s recommended criteria.
The AAD recommends the following for all sunscreens: sun protection factor (SPF) of 30 more, broad-spectrum protection, and water and/or sweat resistance. Of those criteria, water/sweat resistance was missing in 19 (29%), compared with SPF less than 30 in 7 (11%) products and lack of broad-spectrum protection in 4 (6%). Some products missed more than one criterion, said Shuai Xu, MD, of Northwestern University, Chicago, and his associates (JAMA Dermatolol. 2016 Jul 6. doi: 10.1001/jamadermatol.2016.2344).

Of the qualities besides performance that were analyzed, “cosmetic elegance,” which the investigators “defined as any feature associated with skin sensation on application, color, or scent,” was the positive feature most often mentioned in the customer reviews. On the other hand, they noted, “dermatologist recommendations were not a significantly cited positive feature.”
The sunscreens in the analysis represented the top 1 percentile by customer rating of the 6,500 products categorized as sunscreens on Amazon as of December 2015. The 65 products included in the study had more than 24,400 customer reviews and a median rating of 4.5 out of 5 stars, Dr. Xu and his associates said.
The investigators did not report any conflicts of interest.
FROM JAMA DERMATOLOGY
Incident to billing
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
Sex-mismatched RBCs associated with increased mortality after cardiac surgery
Transfusing sex-mismatched red blood cells (RBCs) was associated with an increased risk of death in people undergoing heart bypass surgery or aortic valve replacement, based on results of a retrospective single-center study of almost 10,000 transfusions in cardiac surgery patients.
Each unit of sex-mismatched red blood cells (RBCs) transfused was associated with an increased risk of death (hazard ratio, 1.083; 95% confidence interval, 1.028-1.140; P = .003). In addition, transfusing 1-2 units of non–leukocyte depleted RBCs was associated with a significant increase in the risk of death during the first year after surgery (HR, 1.426; 95% CI, 1.004-2.024; P = .047).
Transfusion of 1-2 units of leukocyte-depleted RBCs and the age of blood products was not associated with increased mortality (J Thorac Cardiovasc Surg. 2016;152:223-32.e1).
“Factors such as ABO group, Rh profile and sex of the PRBC [packed RBC] donor generally have been overlooked, as has the variation in postdonation treatment of blood,” in the outcomes of cardiac surgery patients, researchers led by Henrik Bjursten, MD, PhD, of Lund (Sweden) University, reported.
The study involved 9,907 patients at Lund University from 2002 to 2012: 7,696 had coronary artery bypass grafting (CABG); 1,216 had aortic valve replacement (AVR); and 995 concomitantly had both procedures. PRBC transfusions were given to nearly 51% of the patients. Compared with the group that did not receive PRBC transfusions, the transfused group had significantly higher rates of heart attack after surgery (1.5% vs. 0.6%), infection (0.6% vs. 0.3%), reoperation for bleeding (4.3% vs. 0.2%), 30-day death (0.7% vs. 0.2%), and overall death (25.9% vs. 12.6%).
Based on an analysis that factored in 24 different variables, transfusion of 1-2 units of non–leukocyte depleted PRBCs was associated with a HR of 1.426, but the same amount of leukocyte-depleted PRBCs did not increase risk (HR, 0.981). However, transfusion of 5-7 units of leukocyte-depleted RBCs was associated with decreased survival, as was transfusion of sex-mismatched PRBCs, associated with a HR of 1.046-1.133 per unit, Dr. Bjursten and colleagues wrote. “In this cohort, 58% of transfusions were sex mismatched, and thus we interpret the result as relatively robust and clinically relevant.”
Patients having combined CABG and AVR were more likely to have PRBC transfusions than patients who had a single procedure. Additionally, the increased death rate in the PRBC transfusion group may have been related to age and comorbidities such as diabetes, chronic obstructive pulmonary disease, and cardiac insufficiency. “Blood transfusion in part is a biomarker for advanced disease,” Dr. Bjursten and coauthors said. While patient who received PRBC transfusions may have been sicker, they did not require greater use of the ICU than patients who did not receive transfusions.
Dr. Bjursten disclosed receiving consulting fees from Boston Scientific. Coauthor Lars Algotsson, MD, PhD, disclosed receiving lecture fees from Abbott. All other authors had no financial disclosures.
The study results expand on the knowledge of potential sex-mismatch risks and reiterates the potential benefits of limiting transfusion to leukocyte-depleted PRBC.
Strengths of the study are its size and its use of the Swedish national tax registry to accurately count deaths. Weaknesses include its retrospective design and inherent issues with advanced statistical analysis, and the failure to address secondary morbidity outcomes. Cardiac surgery’s mortality is multifactorial and secondary outcomes would have strengthened the results.
Unlike previous studies, this study showed that 1 or 2 units of leukocyte-depleted PRBCs did not increase mortality.
This study suggests that sex-mismatched blood transfusions may create a high enough risk to necessitate a change in transfusion protocols. Further, many countries already have universal strategies to use leukocyte-depleted PRBC, and perhaps this study should call for the United States to pursue the same policy.
Jennifer Banayan, MD, and Mark Chaney, MD, of the University of Chicago made their remarks in a commentary (J Thorac Cardiovasc Surg. 2016;152:18-9) that accompanied the study.
The study results expand on the knowledge of potential sex-mismatch risks and reiterates the potential benefits of limiting transfusion to leukocyte-depleted PRBC.
Strengths of the study are its size and its use of the Swedish national tax registry to accurately count deaths. Weaknesses include its retrospective design and inherent issues with advanced statistical analysis, and the failure to address secondary morbidity outcomes. Cardiac surgery’s mortality is multifactorial and secondary outcomes would have strengthened the results.
Unlike previous studies, this study showed that 1 or 2 units of leukocyte-depleted PRBCs did not increase mortality.
This study suggests that sex-mismatched blood transfusions may create a high enough risk to necessitate a change in transfusion protocols. Further, many countries already have universal strategies to use leukocyte-depleted PRBC, and perhaps this study should call for the United States to pursue the same policy.
Jennifer Banayan, MD, and Mark Chaney, MD, of the University of Chicago made their remarks in a commentary (J Thorac Cardiovasc Surg. 2016;152:18-9) that accompanied the study.
The study results expand on the knowledge of potential sex-mismatch risks and reiterates the potential benefits of limiting transfusion to leukocyte-depleted PRBC.
Strengths of the study are its size and its use of the Swedish national tax registry to accurately count deaths. Weaknesses include its retrospective design and inherent issues with advanced statistical analysis, and the failure to address secondary morbidity outcomes. Cardiac surgery’s mortality is multifactorial and secondary outcomes would have strengthened the results.
Unlike previous studies, this study showed that 1 or 2 units of leukocyte-depleted PRBCs did not increase mortality.
This study suggests that sex-mismatched blood transfusions may create a high enough risk to necessitate a change in transfusion protocols. Further, many countries already have universal strategies to use leukocyte-depleted PRBC, and perhaps this study should call for the United States to pursue the same policy.
Jennifer Banayan, MD, and Mark Chaney, MD, of the University of Chicago made their remarks in a commentary (J Thorac Cardiovasc Surg. 2016;152:18-9) that accompanied the study.
Transfusing sex-mismatched red blood cells (RBCs) was associated with an increased risk of death in people undergoing heart bypass surgery or aortic valve replacement, based on results of a retrospective single-center study of almost 10,000 transfusions in cardiac surgery patients.
Each unit of sex-mismatched red blood cells (RBCs) transfused was associated with an increased risk of death (hazard ratio, 1.083; 95% confidence interval, 1.028-1.140; P = .003). In addition, transfusing 1-2 units of non–leukocyte depleted RBCs was associated with a significant increase in the risk of death during the first year after surgery (HR, 1.426; 95% CI, 1.004-2.024; P = .047).
Transfusion of 1-2 units of leukocyte-depleted RBCs and the age of blood products was not associated with increased mortality (J Thorac Cardiovasc Surg. 2016;152:223-32.e1).
“Factors such as ABO group, Rh profile and sex of the PRBC [packed RBC] donor generally have been overlooked, as has the variation in postdonation treatment of blood,” in the outcomes of cardiac surgery patients, researchers led by Henrik Bjursten, MD, PhD, of Lund (Sweden) University, reported.
The study involved 9,907 patients at Lund University from 2002 to 2012: 7,696 had coronary artery bypass grafting (CABG); 1,216 had aortic valve replacement (AVR); and 995 concomitantly had both procedures. PRBC transfusions were given to nearly 51% of the patients. Compared with the group that did not receive PRBC transfusions, the transfused group had significantly higher rates of heart attack after surgery (1.5% vs. 0.6%), infection (0.6% vs. 0.3%), reoperation for bleeding (4.3% vs. 0.2%), 30-day death (0.7% vs. 0.2%), and overall death (25.9% vs. 12.6%).
Based on an analysis that factored in 24 different variables, transfusion of 1-2 units of non–leukocyte depleted PRBCs was associated with a HR of 1.426, but the same amount of leukocyte-depleted PRBCs did not increase risk (HR, 0.981). However, transfusion of 5-7 units of leukocyte-depleted RBCs was associated with decreased survival, as was transfusion of sex-mismatched PRBCs, associated with a HR of 1.046-1.133 per unit, Dr. Bjursten and colleagues wrote. “In this cohort, 58% of transfusions were sex mismatched, and thus we interpret the result as relatively robust and clinically relevant.”
Patients having combined CABG and AVR were more likely to have PRBC transfusions than patients who had a single procedure. Additionally, the increased death rate in the PRBC transfusion group may have been related to age and comorbidities such as diabetes, chronic obstructive pulmonary disease, and cardiac insufficiency. “Blood transfusion in part is a biomarker for advanced disease,” Dr. Bjursten and coauthors said. While patient who received PRBC transfusions may have been sicker, they did not require greater use of the ICU than patients who did not receive transfusions.
Dr. Bjursten disclosed receiving consulting fees from Boston Scientific. Coauthor Lars Algotsson, MD, PhD, disclosed receiving lecture fees from Abbott. All other authors had no financial disclosures.
Transfusing sex-mismatched red blood cells (RBCs) was associated with an increased risk of death in people undergoing heart bypass surgery or aortic valve replacement, based on results of a retrospective single-center study of almost 10,000 transfusions in cardiac surgery patients.
Each unit of sex-mismatched red blood cells (RBCs) transfused was associated with an increased risk of death (hazard ratio, 1.083; 95% confidence interval, 1.028-1.140; P = .003). In addition, transfusing 1-2 units of non–leukocyte depleted RBCs was associated with a significant increase in the risk of death during the first year after surgery (HR, 1.426; 95% CI, 1.004-2.024; P = .047).
Transfusion of 1-2 units of leukocyte-depleted RBCs and the age of blood products was not associated with increased mortality (J Thorac Cardiovasc Surg. 2016;152:223-32.e1).
“Factors such as ABO group, Rh profile and sex of the PRBC [packed RBC] donor generally have been overlooked, as has the variation in postdonation treatment of blood,” in the outcomes of cardiac surgery patients, researchers led by Henrik Bjursten, MD, PhD, of Lund (Sweden) University, reported.
The study involved 9,907 patients at Lund University from 2002 to 2012: 7,696 had coronary artery bypass grafting (CABG); 1,216 had aortic valve replacement (AVR); and 995 concomitantly had both procedures. PRBC transfusions were given to nearly 51% of the patients. Compared with the group that did not receive PRBC transfusions, the transfused group had significantly higher rates of heart attack after surgery (1.5% vs. 0.6%), infection (0.6% vs. 0.3%), reoperation for bleeding (4.3% vs. 0.2%), 30-day death (0.7% vs. 0.2%), and overall death (25.9% vs. 12.6%).
Based on an analysis that factored in 24 different variables, transfusion of 1-2 units of non–leukocyte depleted PRBCs was associated with a HR of 1.426, but the same amount of leukocyte-depleted PRBCs did not increase risk (HR, 0.981). However, transfusion of 5-7 units of leukocyte-depleted RBCs was associated with decreased survival, as was transfusion of sex-mismatched PRBCs, associated with a HR of 1.046-1.133 per unit, Dr. Bjursten and colleagues wrote. “In this cohort, 58% of transfusions were sex mismatched, and thus we interpret the result as relatively robust and clinically relevant.”
Patients having combined CABG and AVR were more likely to have PRBC transfusions than patients who had a single procedure. Additionally, the increased death rate in the PRBC transfusion group may have been related to age and comorbidities such as diabetes, chronic obstructive pulmonary disease, and cardiac insufficiency. “Blood transfusion in part is a biomarker for advanced disease,” Dr. Bjursten and coauthors said. While patient who received PRBC transfusions may have been sicker, they did not require greater use of the ICU than patients who did not receive transfusions.
Dr. Bjursten disclosed receiving consulting fees from Boston Scientific. Coauthor Lars Algotsson, MD, PhD, disclosed receiving lecture fees from Abbott. All other authors had no financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Transfusion of sex-mismatched and non–leukocyte depleted PRBCs may impact survival after cardiac surgery.
Major finding: Transfusion of 1-2 units of non–leukocyte depleted PRBCs has a hazard ratio of 1.426.
Data source: Single-center, retrospective study of 9,007 patients who had CABG or AVR, or both, from 2002 to 2012. The study used the Swedish national tax registry to track deaths.
Disclosures: Lead author Dr. Bjursten disclosed receiving consulting fees from Boston Scientific. Coauthor Lars Algotsson, MD, PhD, disclosed receiving lecture fees from Abbott. All other authors have nothing to disclose with regard to commercial support.
Therapeutic alliance is paramount
As psychologists at the Veterans Affairs Medical Center and the Baylor College of Medicine, both in Houston, we agree with many points raised in a recent article about Dr. Harold Kudler’s presentation at the American Psychiatric Association meeting about the mental health care program at the Department of Veterans Affairs (See at left Related Content: “Greater focus on therapeutic relationship could improve VAMC outcomes”). However, we think the article inaccurately characterizes the role of the therapeutic relationship in evidence-based psychotherapy training and delivery within the VA.
The article states that evidence-based psychotherapy (EBP) training in the VA “typically focuses on mastering specific skills and maintaining adherence to the manuals rather than [emphasis added] on the strength and nature of the therapeutic relationship.” This is an unfortunate yet enduring myth. All of the 15 VA-sponsored EBP training programs specifically focus on the development of a strong working alliance as a necessary component of delivering these treatments. As a demonstration of this focus, the therapeutic alliance is measured as part of ongoing program evaluation efforts.
The VA EBP training programs that treat depression, insomnia, posttraumatic stress disorder (PTSD), and chronic pain all have published results demonstrating that VA-licensed therapists in EBP training are able to build strong initial alliances with their veteran patients that continue to improve over the course of treatment (average Cohen’s d = 0.56) (J Consult Clin Psychol. 2012;80[5];707-18), (J Consult Clin Psychcol. 2014;82[6];1201-6), (Clin J Pain. 2015;31[8]722-9) (Behav Res Ther. 2013 Sep;51[9]555-63), (Int J Geriatr Psychiatry. 2015;30(3):308-15), and (Am Psychol. 2014 Jan;69[1]:19-33).
The article goes on to note that clinical practice guidelines should address therapist behaviors and qualities that promote a facilitative therapy relationship. As Dr. Kudler and his colleagues have noted elsewhere (JAMA Psychiatry. 2016 May 18. doi: 10.1001/jamapsychiatry.2016.0746), the VA/Department of Defense Clinical Practice Guideline (CPG for Posttraumatic Stress Disorder) explicitly states: “A supportive and collaborative treatment relationship or therapeutic alliance should be developed and maintained with patients with PTSD.” (http://www.healthquality.va.gov/PTSD-Full-2010c.pdf: p. 92, accessed on May 30, 2016.)
Similarly, the VA/DOD CPG for the Management of Substance Use Disorders (SUDs) states that the therapeutic alliance “is at least as important as the specific treatment approach selected.” (http://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGRevised22216.pdf: p. 15.)
In short, VA EBP training has a strong emphasis on the development of the therapeutic alliance as a necessary condition for effective treatment and published results demonstrating the strength of those alliances as well as robust symptom reductions among our veteran patients. We agree with the authors as well as various task forces that the therapeutic relationship should be included in mental health CPGs beyond those mentioned for PTSD and SUD.
Tracey L. Smith, Ph.D.
Houston
Natalie Hundt, Ph.D.
Houston
As psychologists at the Veterans Affairs Medical Center and the Baylor College of Medicine, both in Houston, we agree with many points raised in a recent article about Dr. Harold Kudler’s presentation at the American Psychiatric Association meeting about the mental health care program at the Department of Veterans Affairs (See at left Related Content: “Greater focus on therapeutic relationship could improve VAMC outcomes”). However, we think the article inaccurately characterizes the role of the therapeutic relationship in evidence-based psychotherapy training and delivery within the VA.
The article states that evidence-based psychotherapy (EBP) training in the VA “typically focuses on mastering specific skills and maintaining adherence to the manuals rather than [emphasis added] on the strength and nature of the therapeutic relationship.” This is an unfortunate yet enduring myth. All of the 15 VA-sponsored EBP training programs specifically focus on the development of a strong working alliance as a necessary component of delivering these treatments. As a demonstration of this focus, the therapeutic alliance is measured as part of ongoing program evaluation efforts.
The VA EBP training programs that treat depression, insomnia, posttraumatic stress disorder (PTSD), and chronic pain all have published results demonstrating that VA-licensed therapists in EBP training are able to build strong initial alliances with their veteran patients that continue to improve over the course of treatment (average Cohen’s d = 0.56) (J Consult Clin Psychol. 2012;80[5];707-18), (J Consult Clin Psychcol. 2014;82[6];1201-6), (Clin J Pain. 2015;31[8]722-9) (Behav Res Ther. 2013 Sep;51[9]555-63), (Int J Geriatr Psychiatry. 2015;30(3):308-15), and (Am Psychol. 2014 Jan;69[1]:19-33).
The article goes on to note that clinical practice guidelines should address therapist behaviors and qualities that promote a facilitative therapy relationship. As Dr. Kudler and his colleagues have noted elsewhere (JAMA Psychiatry. 2016 May 18. doi: 10.1001/jamapsychiatry.2016.0746), the VA/Department of Defense Clinical Practice Guideline (CPG for Posttraumatic Stress Disorder) explicitly states: “A supportive and collaborative treatment relationship or therapeutic alliance should be developed and maintained with patients with PTSD.” (http://www.healthquality.va.gov/PTSD-Full-2010c.pdf: p. 92, accessed on May 30, 2016.)
Similarly, the VA/DOD CPG for the Management of Substance Use Disorders (SUDs) states that the therapeutic alliance “is at least as important as the specific treatment approach selected.” (http://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGRevised22216.pdf: p. 15.)
In short, VA EBP training has a strong emphasis on the development of the therapeutic alliance as a necessary condition for effective treatment and published results demonstrating the strength of those alliances as well as robust symptom reductions among our veteran patients. We agree with the authors as well as various task forces that the therapeutic relationship should be included in mental health CPGs beyond those mentioned for PTSD and SUD.
Tracey L. Smith, Ph.D.
Houston
Natalie Hundt, Ph.D.
Houston
As psychologists at the Veterans Affairs Medical Center and the Baylor College of Medicine, both in Houston, we agree with many points raised in a recent article about Dr. Harold Kudler’s presentation at the American Psychiatric Association meeting about the mental health care program at the Department of Veterans Affairs (See at left Related Content: “Greater focus on therapeutic relationship could improve VAMC outcomes”). However, we think the article inaccurately characterizes the role of the therapeutic relationship in evidence-based psychotherapy training and delivery within the VA.
The article states that evidence-based psychotherapy (EBP) training in the VA “typically focuses on mastering specific skills and maintaining adherence to the manuals rather than [emphasis added] on the strength and nature of the therapeutic relationship.” This is an unfortunate yet enduring myth. All of the 15 VA-sponsored EBP training programs specifically focus on the development of a strong working alliance as a necessary component of delivering these treatments. As a demonstration of this focus, the therapeutic alliance is measured as part of ongoing program evaluation efforts.
The VA EBP training programs that treat depression, insomnia, posttraumatic stress disorder (PTSD), and chronic pain all have published results demonstrating that VA-licensed therapists in EBP training are able to build strong initial alliances with their veteran patients that continue to improve over the course of treatment (average Cohen’s d = 0.56) (J Consult Clin Psychol. 2012;80[5];707-18), (J Consult Clin Psychcol. 2014;82[6];1201-6), (Clin J Pain. 2015;31[8]722-9) (Behav Res Ther. 2013 Sep;51[9]555-63), (Int J Geriatr Psychiatry. 2015;30(3):308-15), and (Am Psychol. 2014 Jan;69[1]:19-33).
The article goes on to note that clinical practice guidelines should address therapist behaviors and qualities that promote a facilitative therapy relationship. As Dr. Kudler and his colleagues have noted elsewhere (JAMA Psychiatry. 2016 May 18. doi: 10.1001/jamapsychiatry.2016.0746), the VA/Department of Defense Clinical Practice Guideline (CPG for Posttraumatic Stress Disorder) explicitly states: “A supportive and collaborative treatment relationship or therapeutic alliance should be developed and maintained with patients with PTSD.” (http://www.healthquality.va.gov/PTSD-Full-2010c.pdf: p. 92, accessed on May 30, 2016.)
Similarly, the VA/DOD CPG for the Management of Substance Use Disorders (SUDs) states that the therapeutic alliance “is at least as important as the specific treatment approach selected.” (http://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGRevised22216.pdf: p. 15.)
In short, VA EBP training has a strong emphasis on the development of the therapeutic alliance as a necessary condition for effective treatment and published results demonstrating the strength of those alliances as well as robust symptom reductions among our veteran patients. We agree with the authors as well as various task forces that the therapeutic relationship should be included in mental health CPGs beyond those mentioned for PTSD and SUD.
Tracey L. Smith, Ph.D.
Houston
Natalie Hundt, Ph.D.
Houston
HHS issues guidance on ransomware attacks
The U.S. Department of Health & Human Services’ Office of Civil Rights has issued new guidance to help physicians and their practices combat a ransomware attack.
Ransomware – a type of malicious software designed to block access to a computer system until a sum of money is paid – is becoming a bigger problem for U.S. businesses in general. Daily ransomware attacks against all types of computer systems increased 300% in early 2016 to 4,000, from 1,000 daily attacks in 2015, according to the Department of Justice.
The HHS fact sheet offers information on how HIPAA compliance can help protect and recover infected systems; how to detect if systems are infected; and what to do if a system becomes infected, including what is reportable.
There are “measures known to be effective to prevent the introduction of ransomware and to recover from a ransomware attack,” according to HHS.
The U.S. Department of Health & Human Services’ Office of Civil Rights has issued new guidance to help physicians and their practices combat a ransomware attack.
Ransomware – a type of malicious software designed to block access to a computer system until a sum of money is paid – is becoming a bigger problem for U.S. businesses in general. Daily ransomware attacks against all types of computer systems increased 300% in early 2016 to 4,000, from 1,000 daily attacks in 2015, according to the Department of Justice.
The HHS fact sheet offers information on how HIPAA compliance can help protect and recover infected systems; how to detect if systems are infected; and what to do if a system becomes infected, including what is reportable.
There are “measures known to be effective to prevent the introduction of ransomware and to recover from a ransomware attack,” according to HHS.
The U.S. Department of Health & Human Services’ Office of Civil Rights has issued new guidance to help physicians and their practices combat a ransomware attack.
Ransomware – a type of malicious software designed to block access to a computer system until a sum of money is paid – is becoming a bigger problem for U.S. businesses in general. Daily ransomware attacks against all types of computer systems increased 300% in early 2016 to 4,000, from 1,000 daily attacks in 2015, according to the Department of Justice.
The HHS fact sheet offers information on how HIPAA compliance can help protect and recover infected systems; how to detect if systems are infected; and what to do if a system becomes infected, including what is reportable.
There are “measures known to be effective to prevent the introduction of ransomware and to recover from a ransomware attack,” according to HHS.
Dexlansoprazole Approved to Treat Heartburn in Younger Patients
The Food and Drug Administration has approved dexlansoprazole (Dexilant) for gastroesophageal reflux disease patients aged 12-17 years, according to a press release from Takeda Pharmaceuticals.
FDA approval of dexlansoprazole for this age group is based on adequate and well controlled studies proving its efficacy in adults, as well data on safety, pharmacokinetics, and efficacy in children 12-17 years. Dexlansoprazole is approved for younger patients to maintain healing of erosive esophagus and heartburn relief for 16 weeks, healing all grades of EE for 8 weeks, and treating heartburn associated with GERD for 4 weeks.
Ddexlansoprazole is a proton pump inhibitor, prescribed to relieve heartburn associated with GERD and maintain healed erosive esophagus. The most common side effects seen in individuals aged 12-17 were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD. This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” noted Thomas Gibbs, senior vice president of general medicine at Takeda.
Find the full press release on the Takeda Pharmaceuticals website.
The Food and Drug Administration has approved dexlansoprazole (Dexilant) for gastroesophageal reflux disease patients aged 12-17 years, according to a press release from Takeda Pharmaceuticals.
FDA approval of dexlansoprazole for this age group is based on adequate and well controlled studies proving its efficacy in adults, as well data on safety, pharmacokinetics, and efficacy in children 12-17 years. Dexlansoprazole is approved for younger patients to maintain healing of erosive esophagus and heartburn relief for 16 weeks, healing all grades of EE for 8 weeks, and treating heartburn associated with GERD for 4 weeks.
Ddexlansoprazole is a proton pump inhibitor, prescribed to relieve heartburn associated with GERD and maintain healed erosive esophagus. The most common side effects seen in individuals aged 12-17 were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD. This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” noted Thomas Gibbs, senior vice president of general medicine at Takeda.
Find the full press release on the Takeda Pharmaceuticals website.
The Food and Drug Administration has approved dexlansoprazole (Dexilant) for gastroesophageal reflux disease patients aged 12-17 years, according to a press release from Takeda Pharmaceuticals.
FDA approval of dexlansoprazole for this age group is based on adequate and well controlled studies proving its efficacy in adults, as well data on safety, pharmacokinetics, and efficacy in children 12-17 years. Dexlansoprazole is approved for younger patients to maintain healing of erosive esophagus and heartburn relief for 16 weeks, healing all grades of EE for 8 weeks, and treating heartburn associated with GERD for 4 weeks.
Ddexlansoprazole is a proton pump inhibitor, prescribed to relieve heartburn associated with GERD and maintain healed erosive esophagus. The most common side effects seen in individuals aged 12-17 were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD. This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” noted Thomas Gibbs, senior vice president of general medicine at Takeda.
Find the full press release on the Takeda Pharmaceuticals website.
CDC forecasts low chance of mosquito-borne Zika infection at Olympics
With only a few weeks left until the 2016 Olympic Games get underway in Rio de Janeiro, officials at the Centers for Disease Control and Prevention are urging anyone traveling to the Olympics to take precautions to avoid contracting Zika virus infection or spreading it when they return home.
But the CDC estimates that there is a low probability of mosquito-borne Zika virus infections during the Olympics because Rio will be experiencing cooler, drier weather then, which typically reduces the mosquito population.
Along with lower mosquito activity, the CDC said that the number of visitors expected in Brazil for the Olympics represents only a fraction of the total travel volume to Zika-affected countries during 2015. The Brazilian Tourism Board is expecting anywhere between 350,000 and 500,000 visitors for the Olympic Games, coming from 207 countries. That represents less than 0.25% of the total travel volume to Zika-affected countries during the entirety of 2015, according to the CDC.
There are 19 countries that the CDC deems susceptible to sustained mosquito-borne transmission of the Zika virus, should the virus enter the country via an attendee of the Olympics (MMWR. 2016 Jul 13. doi: 10.15585/mmwr.mm6528e1).
Of these 19 – none of which are currently experiencing a Zika outbreak – 15 are “not estimated to increase substantially the level of risk above that incurred by the usual aviation travel baseline for these countries.” This leaves Chad, Djibouti, Eritrea, and Yemen at an elevated risk for a Zika outbreak. These four countries “are unique in that they do not have a substantial number of travelers to any country with local Zika virus transmission, except for anticipated travel to the Games,” according to the CDC.
The CDC is urging travelers to take protective measures for their entire stay in Rio and for at least 3 weeks after returning home. The measures include applying mosquito repellent, wearing long-sleeved shirts and long pants, staying in rooms that are air conditioned, and using either screen doors or a mosquito net for additional protection. Additionally, all travelers should take measures to prevent sexual transmission. The CDC continues to advise pregnant women not to travel to the Olympics.
With only a few weeks left until the 2016 Olympic Games get underway in Rio de Janeiro, officials at the Centers for Disease Control and Prevention are urging anyone traveling to the Olympics to take precautions to avoid contracting Zika virus infection or spreading it when they return home.
But the CDC estimates that there is a low probability of mosquito-borne Zika virus infections during the Olympics because Rio will be experiencing cooler, drier weather then, which typically reduces the mosquito population.
Along with lower mosquito activity, the CDC said that the number of visitors expected in Brazil for the Olympics represents only a fraction of the total travel volume to Zika-affected countries during 2015. The Brazilian Tourism Board is expecting anywhere between 350,000 and 500,000 visitors for the Olympic Games, coming from 207 countries. That represents less than 0.25% of the total travel volume to Zika-affected countries during the entirety of 2015, according to the CDC.
There are 19 countries that the CDC deems susceptible to sustained mosquito-borne transmission of the Zika virus, should the virus enter the country via an attendee of the Olympics (MMWR. 2016 Jul 13. doi: 10.15585/mmwr.mm6528e1).
Of these 19 – none of which are currently experiencing a Zika outbreak – 15 are “not estimated to increase substantially the level of risk above that incurred by the usual aviation travel baseline for these countries.” This leaves Chad, Djibouti, Eritrea, and Yemen at an elevated risk for a Zika outbreak. These four countries “are unique in that they do not have a substantial number of travelers to any country with local Zika virus transmission, except for anticipated travel to the Games,” according to the CDC.
The CDC is urging travelers to take protective measures for their entire stay in Rio and for at least 3 weeks after returning home. The measures include applying mosquito repellent, wearing long-sleeved shirts and long pants, staying in rooms that are air conditioned, and using either screen doors or a mosquito net for additional protection. Additionally, all travelers should take measures to prevent sexual transmission. The CDC continues to advise pregnant women not to travel to the Olympics.
With only a few weeks left until the 2016 Olympic Games get underway in Rio de Janeiro, officials at the Centers for Disease Control and Prevention are urging anyone traveling to the Olympics to take precautions to avoid contracting Zika virus infection or spreading it when they return home.
But the CDC estimates that there is a low probability of mosquito-borne Zika virus infections during the Olympics because Rio will be experiencing cooler, drier weather then, which typically reduces the mosquito population.
Along with lower mosquito activity, the CDC said that the number of visitors expected in Brazil for the Olympics represents only a fraction of the total travel volume to Zika-affected countries during 2015. The Brazilian Tourism Board is expecting anywhere between 350,000 and 500,000 visitors for the Olympic Games, coming from 207 countries. That represents less than 0.25% of the total travel volume to Zika-affected countries during the entirety of 2015, according to the CDC.
There are 19 countries that the CDC deems susceptible to sustained mosquito-borne transmission of the Zika virus, should the virus enter the country via an attendee of the Olympics (MMWR. 2016 Jul 13. doi: 10.15585/mmwr.mm6528e1).
Of these 19 – none of which are currently experiencing a Zika outbreak – 15 are “not estimated to increase substantially the level of risk above that incurred by the usual aviation travel baseline for these countries.” This leaves Chad, Djibouti, Eritrea, and Yemen at an elevated risk for a Zika outbreak. These four countries “are unique in that they do not have a substantial number of travelers to any country with local Zika virus transmission, except for anticipated travel to the Games,” according to the CDC.
The CDC is urging travelers to take protective measures for their entire stay in Rio and for at least 3 weeks after returning home. The measures include applying mosquito repellent, wearing long-sleeved shirts and long pants, staying in rooms that are air conditioned, and using either screen doors or a mosquito net for additional protection. Additionally, all travelers should take measures to prevent sexual transmission. The CDC continues to advise pregnant women not to travel to the Olympics.
FROM MMWR
White House to Advance Obama's Precision Medicine Initiative
WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.
The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.
The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.
"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.
A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.
"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.
The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."
As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.
Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.
"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."
WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.
The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.
The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.
"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.
A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.
"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.
The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."
As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.
Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.
"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."
WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.
The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.
The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.
"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.
A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.
"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.
The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."
As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.
Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.
"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."
Looking for a grant? Now accepting 2016 applications
Four $1,000 grants will be awarded to help awardees develop mentorship programs, course or curricular materials, or teaching tools related to gastroenterology and hepatology. The grants also may be used to help develop innovative assessment tools or to do research projects in GI and hepatology education.
The deadline to apply for the 2016 awards is Aug. 31, 2016, and the awardees will be notified by Oct. 10, 2016. Members of the Academy of Educators are invited to submit applications to [email protected]. Not a member yet? Join today for consideration.
Learn more and apply today at www.gastro.org/about/initiatives/aga-academy-of-educators. Please contact Paula Dorfman with any questions [email protected].
Four $1,000 grants will be awarded to help awardees develop mentorship programs, course or curricular materials, or teaching tools related to gastroenterology and hepatology. The grants also may be used to help develop innovative assessment tools or to do research projects in GI and hepatology education.
The deadline to apply for the 2016 awards is Aug. 31, 2016, and the awardees will be notified by Oct. 10, 2016. Members of the Academy of Educators are invited to submit applications to [email protected]. Not a member yet? Join today for consideration.
Learn more and apply today at www.gastro.org/about/initiatives/aga-academy-of-educators. Please contact Paula Dorfman with any questions [email protected].
Four $1,000 grants will be awarded to help awardees develop mentorship programs, course or curricular materials, or teaching tools related to gastroenterology and hepatology. The grants also may be used to help develop innovative assessment tools or to do research projects in GI and hepatology education.
The deadline to apply for the 2016 awards is Aug. 31, 2016, and the awardees will be notified by Oct. 10, 2016. Members of the Academy of Educators are invited to submit applications to [email protected]. Not a member yet? Join today for consideration.
Learn more and apply today at www.gastro.org/about/initiatives/aga-academy-of-educators. Please contact Paula Dorfman with any questions [email protected].
AGA and Takeda Pharmaceuticals announce new grants for IBD researchers
Thanks to a generous grant from Takeda Pharmaceuticals U.S.A., the AGA Research Foundation is thrilled to announce three new research grants to fund young investigators working on inflammatory bowel disease (IBD) projects. This funding will provide qualified scientists with the opportunity to make discoveries that will lead to improvements in patient care.
The AGA-Takeda Pharmaceuticals Research Scholar Awards in Inflammatory Bowel Disease will provide $90,000 per year for 3 years (total $270,000) to three young investigators working toward independent research careers with a focus on IBD.
“The AGA Research Foundation is very grateful to have Takeda’s support for promising young researchers at a very vulnerable stage in their careers,” said Robert S. Sandler, M.D., MPH, AGAF, chair of the AGA Research Foundation. “Inflammatory bowel disease offers exciting opportunities for research, and we look forward to seeing how these three award recipients will advance our understanding of this serious digestive disease.”
“Takeda is proud to partner with the AGA Research Foundation to present three research scholar awards in IBD,” said Karen Lasch, MD, executive medical director, gastroenterology, Takeda. “As we look to the future, there is great promise with significant IBD research underway, but a strong need still exists for further scientific and clinical understanding. Providing young research investigators with the support they need to drive innovation and discovery is critical.”
Interested researchers can learn more by visiting the AGA website. The deadline for applications is Aug. 26, 2016, for funding beginning July 1, 2017. The AGA Research Awards Panel is looking for individuals in the beginning years of their careers who have demonstrated exceptional promise and have some record of accomplishment in research.
The overall objective of the AGA Research Scholar Award (RSA) is to enable young investigators, instructors, research associates or equivalents to develop independent and productive research careers in digestive diseases by ensuring that a major proportion of their time is protected for research.
Thanks to a generous grant from Takeda Pharmaceuticals U.S.A., the AGA Research Foundation is thrilled to announce three new research grants to fund young investigators working on inflammatory bowel disease (IBD) projects. This funding will provide qualified scientists with the opportunity to make discoveries that will lead to improvements in patient care.
The AGA-Takeda Pharmaceuticals Research Scholar Awards in Inflammatory Bowel Disease will provide $90,000 per year for 3 years (total $270,000) to three young investigators working toward independent research careers with a focus on IBD.
“The AGA Research Foundation is very grateful to have Takeda’s support for promising young researchers at a very vulnerable stage in their careers,” said Robert S. Sandler, M.D., MPH, AGAF, chair of the AGA Research Foundation. “Inflammatory bowel disease offers exciting opportunities for research, and we look forward to seeing how these three award recipients will advance our understanding of this serious digestive disease.”
“Takeda is proud to partner with the AGA Research Foundation to present three research scholar awards in IBD,” said Karen Lasch, MD, executive medical director, gastroenterology, Takeda. “As we look to the future, there is great promise with significant IBD research underway, but a strong need still exists for further scientific and clinical understanding. Providing young research investigators with the support they need to drive innovation and discovery is critical.”
Interested researchers can learn more by visiting the AGA website. The deadline for applications is Aug. 26, 2016, for funding beginning July 1, 2017. The AGA Research Awards Panel is looking for individuals in the beginning years of their careers who have demonstrated exceptional promise and have some record of accomplishment in research.
The overall objective of the AGA Research Scholar Award (RSA) is to enable young investigators, instructors, research associates or equivalents to develop independent and productive research careers in digestive diseases by ensuring that a major proportion of their time is protected for research.
Thanks to a generous grant from Takeda Pharmaceuticals U.S.A., the AGA Research Foundation is thrilled to announce three new research grants to fund young investigators working on inflammatory bowel disease (IBD) projects. This funding will provide qualified scientists with the opportunity to make discoveries that will lead to improvements in patient care.
The AGA-Takeda Pharmaceuticals Research Scholar Awards in Inflammatory Bowel Disease will provide $90,000 per year for 3 years (total $270,000) to three young investigators working toward independent research careers with a focus on IBD.
“The AGA Research Foundation is very grateful to have Takeda’s support for promising young researchers at a very vulnerable stage in their careers,” said Robert S. Sandler, M.D., MPH, AGAF, chair of the AGA Research Foundation. “Inflammatory bowel disease offers exciting opportunities for research, and we look forward to seeing how these three award recipients will advance our understanding of this serious digestive disease.”
“Takeda is proud to partner with the AGA Research Foundation to present three research scholar awards in IBD,” said Karen Lasch, MD, executive medical director, gastroenterology, Takeda. “As we look to the future, there is great promise with significant IBD research underway, but a strong need still exists for further scientific and clinical understanding. Providing young research investigators with the support they need to drive innovation and discovery is critical.”
Interested researchers can learn more by visiting the AGA website. The deadline for applications is Aug. 26, 2016, for funding beginning July 1, 2017. The AGA Research Awards Panel is looking for individuals in the beginning years of their careers who have demonstrated exceptional promise and have some record of accomplishment in research.
The overall objective of the AGA Research Scholar Award (RSA) is to enable young investigators, instructors, research associates or equivalents to develop independent and productive research careers in digestive diseases by ensuring that a major proportion of their time is protected for research.