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Do you answer patient emails?
Recently I received a lengthy email from a woman who claimed to have once been a patient, though her name did not come up in my EHR system. She asked numerous questions about a self-diagnosed skin disorder.
I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.
Responses varied all over the map – from “I never answer patient emails” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between. I decided to look at what has been published on the subject.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/do-you-answer-patient-emails-take-our-poll?iframe=1"}]It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it (JAMA. 1998 Oct 21;280[15]:1333-5). Posing as a fictitious patient, they sent emails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.
As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: 50% responded to the fictitious patient’s email; of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answered each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”
Indeed. But my own unscientific survey suggests that, almost 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the American Medical Association have proposed guidelines; but none have been generally accepted. Until such time as that happens, it seems prudent for each individual practice to adopt its own. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.
Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy; but all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and of course, confidentiality.
Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit email communication with patients, nor does it require that it be encrypted. The HIPAA website specifically says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”
Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Enli, Sigaba, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)
Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.
Web-based messaging services can be freestanding or incorporated into existing secure web sites. Medfusion and RelayHealth are among the leading vendors of secure messaging services.
And now, I’m writing my guidelines.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Recently I received a lengthy email from a woman who claimed to have once been a patient, though her name did not come up in my EHR system. She asked numerous questions about a self-diagnosed skin disorder.
I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.
Responses varied all over the map – from “I never answer patient emails” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between. I decided to look at what has been published on the subject.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/do-you-answer-patient-emails-take-our-poll?iframe=1"}]It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it (JAMA. 1998 Oct 21;280[15]:1333-5). Posing as a fictitious patient, they sent emails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.
As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: 50% responded to the fictitious patient’s email; of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answered each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”
Indeed. But my own unscientific survey suggests that, almost 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the American Medical Association have proposed guidelines; but none have been generally accepted. Until such time as that happens, it seems prudent for each individual practice to adopt its own. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.
Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy; but all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and of course, confidentiality.
Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit email communication with patients, nor does it require that it be encrypted. The HIPAA website specifically says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”
Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Enli, Sigaba, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)
Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.
Web-based messaging services can be freestanding or incorporated into existing secure web sites. Medfusion and RelayHealth are among the leading vendors of secure messaging services.
And now, I’m writing my guidelines.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Recently I received a lengthy email from a woman who claimed to have once been a patient, though her name did not come up in my EHR system. She asked numerous questions about a self-diagnosed skin disorder.
I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.
Responses varied all over the map – from “I never answer patient emails” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between. I decided to look at what has been published on the subject.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/do-you-answer-patient-emails-take-our-poll?iframe=1"}]It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it (JAMA. 1998 Oct 21;280[15]:1333-5). Posing as a fictitious patient, they sent emails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.
As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: 50% responded to the fictitious patient’s email; of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answered each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”
Indeed. But my own unscientific survey suggests that, almost 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the American Medical Association have proposed guidelines; but none have been generally accepted. Until such time as that happens, it seems prudent for each individual practice to adopt its own. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.
Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy; but all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and of course, confidentiality.
Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit email communication with patients, nor does it require that it be encrypted. The HIPAA website specifically says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”
Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Enli, Sigaba, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)
Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.
Web-based messaging services can be freestanding or incorporated into existing secure web sites. Medfusion and RelayHealth are among the leading vendors of secure messaging services.
And now, I’m writing my guidelines.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Female physicians can face breastfeeding challenges at work
CHICAGO – Physician mothers who breastfeed and wish to pump milk during work hours can face many of the same challenges as other working mothers, as well as some issues unique to the profession, a new survey revealed.
“Although physician mothers have high rates of intention to breastfeed while they are pregnant, and initiation of breastfeeding at birth, we unfortunately have low rates of continuing to breastfeed and even meeting the [6 month] recommendations for exclusive breastfeeding,” Rebecca Cantu, MD, MPH said at the annual meeting of the American Academy of Pediatrics.
Dr. Cantu and her colleagues surveyed providers affiliated with the University of Arkansas for Medical Sciences in Little Rock in 2016. The 3-item, Web-based survey was anonymous and assessed role [trainee (medical student, resident physician, fellow) or faculty physician], breastfeeding experience, and perceived barriers to successful breastfeeding.
Common barriers identified
Of the 223 responses, 38% were from medical students, 31% from faculty, 24% from residents, and 7% from fellows. Of the 97 physicians who had breastfed at some point, 97% identified at least one barrier they felt inhibited their breastfeeding goals, said Dr. Cantu, a pediatric hospitalist at Arkansas Children’s Hospital in Little Rock. The survey revealed a total 397 barriers, for an average of 3.7 per person. Being faced with barriers could lead to early unintentional weaning and other consequences like mastitis, decreased milk supply, or anxiety, she added.
“We did find trainees identified a significantly higher median number of barriers, five, versus three for faculty [P less than .01],” Dr. Cantu said. Only one respondent said she faced no barriers.
Lack of time and place to pump breast milk, an unpredictable schedule, short maternity leave, and long working hours were among the most common barriers cited.
“For physicians, we don’t have time. I don’t have a protected lunch break. I’m a hospitalist rounding for hours in the morning,” Dr. Cantu said. “Also, residents don’t always feel comfortable asking for time to leave, and we don’t have people identified to cover our patients. So, depending on the institution, there can be many areas that need to be addressed.”
“The last place I worked had many lactation rooms scattered throughout the hospital, some for physicians only,” she said. “Where I work now we have one room for breastfeeding with two chairs for the entire medical center. So space is a problem.”
A little over half (56%) of respondents had never breastfed. Another 30% had previously breastfed and weaned and 14% were currently breastfeeding at the time of the survey. Of those who had never breastfed, 87% indicated that they planned to at some point in the future. “This emphasizes that the current problem is something we need to continue to work on. We need to address these barriers, and find ways to decrease the impact these barriers have on breastfeeding physicians.”
Future research will investigate association between these barriers and breastfeeding duration and other outcomes, Dr. Cantu said.
Potential solutions
“Policy can play a role here. Plenty of studies have shown that supporting physicians who breastfeed is associated with better patient outcomes, and institutions that support breastfeeding can have a financial benefit,” she said, adding, “If the hospitals cannot even support breastfeeding mothers, how do we expect other places to?”
During the Q&A after Dr. Cantu’s presentation, a meeting attendee suggested using a Freemie pump.* It’s a smaller and more discreet pump that can be used “at an airport, restaurant or while charting in the emergency department.” Dr. Cantu agreed that Freemie pumps could help.
Dr. Cantu also recommended the Dr. Milk support group website and Facebook pages. “I refer a lot of trainees there because you can post a question and get tons of peer advice and support, and find out what’s worked for other people.:
Dr. Cantu had no relevant financial disclosures.
* This article was updated on 1/11/18.
CHICAGO – Physician mothers who breastfeed and wish to pump milk during work hours can face many of the same challenges as other working mothers, as well as some issues unique to the profession, a new survey revealed.
“Although physician mothers have high rates of intention to breastfeed while they are pregnant, and initiation of breastfeeding at birth, we unfortunately have low rates of continuing to breastfeed and even meeting the [6 month] recommendations for exclusive breastfeeding,” Rebecca Cantu, MD, MPH said at the annual meeting of the American Academy of Pediatrics.
Dr. Cantu and her colleagues surveyed providers affiliated with the University of Arkansas for Medical Sciences in Little Rock in 2016. The 3-item, Web-based survey was anonymous and assessed role [trainee (medical student, resident physician, fellow) or faculty physician], breastfeeding experience, and perceived barriers to successful breastfeeding.
Common barriers identified
Of the 223 responses, 38% were from medical students, 31% from faculty, 24% from residents, and 7% from fellows. Of the 97 physicians who had breastfed at some point, 97% identified at least one barrier they felt inhibited their breastfeeding goals, said Dr. Cantu, a pediatric hospitalist at Arkansas Children’s Hospital in Little Rock. The survey revealed a total 397 barriers, for an average of 3.7 per person. Being faced with barriers could lead to early unintentional weaning and other consequences like mastitis, decreased milk supply, or anxiety, she added.
“We did find trainees identified a significantly higher median number of barriers, five, versus three for faculty [P less than .01],” Dr. Cantu said. Only one respondent said she faced no barriers.
Lack of time and place to pump breast milk, an unpredictable schedule, short maternity leave, and long working hours were among the most common barriers cited.
“For physicians, we don’t have time. I don’t have a protected lunch break. I’m a hospitalist rounding for hours in the morning,” Dr. Cantu said. “Also, residents don’t always feel comfortable asking for time to leave, and we don’t have people identified to cover our patients. So, depending on the institution, there can be many areas that need to be addressed.”
“The last place I worked had many lactation rooms scattered throughout the hospital, some for physicians only,” she said. “Where I work now we have one room for breastfeeding with two chairs for the entire medical center. So space is a problem.”
A little over half (56%) of respondents had never breastfed. Another 30% had previously breastfed and weaned and 14% were currently breastfeeding at the time of the survey. Of those who had never breastfed, 87% indicated that they planned to at some point in the future. “This emphasizes that the current problem is something we need to continue to work on. We need to address these barriers, and find ways to decrease the impact these barriers have on breastfeeding physicians.”
Future research will investigate association between these barriers and breastfeeding duration and other outcomes, Dr. Cantu said.
Potential solutions
“Policy can play a role here. Plenty of studies have shown that supporting physicians who breastfeed is associated with better patient outcomes, and institutions that support breastfeeding can have a financial benefit,” she said, adding, “If the hospitals cannot even support breastfeeding mothers, how do we expect other places to?”
During the Q&A after Dr. Cantu’s presentation, a meeting attendee suggested using a Freemie pump.* It’s a smaller and more discreet pump that can be used “at an airport, restaurant or while charting in the emergency department.” Dr. Cantu agreed that Freemie pumps could help.
Dr. Cantu also recommended the Dr. Milk support group website and Facebook pages. “I refer a lot of trainees there because you can post a question and get tons of peer advice and support, and find out what’s worked for other people.:
Dr. Cantu had no relevant financial disclosures.
* This article was updated on 1/11/18.
CHICAGO – Physician mothers who breastfeed and wish to pump milk during work hours can face many of the same challenges as other working mothers, as well as some issues unique to the profession, a new survey revealed.
“Although physician mothers have high rates of intention to breastfeed while they are pregnant, and initiation of breastfeeding at birth, we unfortunately have low rates of continuing to breastfeed and even meeting the [6 month] recommendations for exclusive breastfeeding,” Rebecca Cantu, MD, MPH said at the annual meeting of the American Academy of Pediatrics.
Dr. Cantu and her colleagues surveyed providers affiliated with the University of Arkansas for Medical Sciences in Little Rock in 2016. The 3-item, Web-based survey was anonymous and assessed role [trainee (medical student, resident physician, fellow) or faculty physician], breastfeeding experience, and perceived barriers to successful breastfeeding.
Common barriers identified
Of the 223 responses, 38% were from medical students, 31% from faculty, 24% from residents, and 7% from fellows. Of the 97 physicians who had breastfed at some point, 97% identified at least one barrier they felt inhibited their breastfeeding goals, said Dr. Cantu, a pediatric hospitalist at Arkansas Children’s Hospital in Little Rock. The survey revealed a total 397 barriers, for an average of 3.7 per person. Being faced with barriers could lead to early unintentional weaning and other consequences like mastitis, decreased milk supply, or anxiety, she added.
“We did find trainees identified a significantly higher median number of barriers, five, versus three for faculty [P less than .01],” Dr. Cantu said. Only one respondent said she faced no barriers.
Lack of time and place to pump breast milk, an unpredictable schedule, short maternity leave, and long working hours were among the most common barriers cited.
“For physicians, we don’t have time. I don’t have a protected lunch break. I’m a hospitalist rounding for hours in the morning,” Dr. Cantu said. “Also, residents don’t always feel comfortable asking for time to leave, and we don’t have people identified to cover our patients. So, depending on the institution, there can be many areas that need to be addressed.”
“The last place I worked had many lactation rooms scattered throughout the hospital, some for physicians only,” she said. “Where I work now we have one room for breastfeeding with two chairs for the entire medical center. So space is a problem.”
A little over half (56%) of respondents had never breastfed. Another 30% had previously breastfed and weaned and 14% were currently breastfeeding at the time of the survey. Of those who had never breastfed, 87% indicated that they planned to at some point in the future. “This emphasizes that the current problem is something we need to continue to work on. We need to address these barriers, and find ways to decrease the impact these barriers have on breastfeeding physicians.”
Future research will investigate association between these barriers and breastfeeding duration and other outcomes, Dr. Cantu said.
Potential solutions
“Policy can play a role here. Plenty of studies have shown that supporting physicians who breastfeed is associated with better patient outcomes, and institutions that support breastfeeding can have a financial benefit,” she said, adding, “If the hospitals cannot even support breastfeeding mothers, how do we expect other places to?”
During the Q&A after Dr. Cantu’s presentation, a meeting attendee suggested using a Freemie pump.* It’s a smaller and more discreet pump that can be used “at an airport, restaurant or while charting in the emergency department.” Dr. Cantu agreed that Freemie pumps could help.
Dr. Cantu also recommended the Dr. Milk support group website and Facebook pages. “I refer a lot of trainees there because you can post a question and get tons of peer advice and support, and find out what’s worked for other people.:
Dr. Cantu had no relevant financial disclosures.
* This article was updated on 1/11/18.
AT AAP 2017
Key clinical point: .
Major finding: Of 97 physicians who had ever breastfed, 97% perceived at least one barrier at work that inhibited meeting their breastfeeding goals.
Data source: Survey responses from 223 physicians and medical students affiliated with the University of Arkansas.
Disclosures: Dr. Cantu had no relevant financial disclosures.
Hepatitis C falls as barrier to heart transplantation
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Eight of nine patients who developed HCV infection had it eradicated by a direct-acting antiviral regimen.
Data source: A series of 13 patients treated at one U.S. center.
Disclosures: Dr. Schlendorf had no disclosures.
Mitotic rate not tied to SLN biopsy results in thin melanomas
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
SAN FRANCISCO –
The finding supports the 2017 revision in the American Joint Committee on Cancer guideline, which dropped mitotic rate from its criteria for upstaging thin melanomas.
An earlier version of the guideline, published in 2010, had called for upgrading thin (less than 1 mm), nonulcerated melanomas with a mitotic rate (MR) of at least 1/mm2 to T1B, which could then trigger an SLN biopsy.
SLN biopsy is controversial in thin melanomas, because there is no evidence that it has a survival benefit in these populations, though it is useful as a prognostic measure. However, the procedure carries a risk of complications.
“This makes judicious selection of patients for the procedures even more important,” Heidi Wat, MD, of the division of dermatology at the University of Alberta, Edmonton, said during her presentation of the research at the annual meeting of the Pacific Dermatologic Association.
The researchers set out to determine the predictive value of mitotic rate (the number of cells undergoing cell division) on SLN status, particularly when stratified by tumor thickness. They analyzed 990 SLN biopsy procedures performed in Alberta from January 2007 through December 2013, which were pulled from the Cancer Surgery Alberta tumor database and provincial pathology records. The mean age of the patients was 57 years (range, 15-93 years), and 55% were male; 171 records involved thin melanomas.
Overall, 25.4% of SLN biopsies came back positive, including 8.8% of thin melanomas. Among all cases, there was a statistically significant association between a mitotic rate of 1 or higher and a positive SLN biopsy.
However, when the researchers stratified the results by thickness, they found a statistically significant association only between mitotic rate and SLN biopsy positivity in thicker tumors (1-2 mm, P = .01).
Further analysis of factors including age, ulceration, and tumor location showed that MR and thickness measures were not independent, and the potential for MR to predict SLN biopsy positivity declined at lower thickness values.
“Performing sentinel lymph node biopsy in thin melanomas upstaged purely because of the finding of a single mitotic (event) has questionable clinical value,” said Dr. Wat.
The 2010 AJCC guidelines called for upgrading thin tumors with an MR of 1 or higher, or ulceration, to T1b. The new AJCC guidelines restrict the definition of T1b to tumors 0.8-1.0 mm in size with or without ulceration, or tumors 0.8 mm or smaller with ulceration.
“The results really confirm the latest recommendations,” said Nina Botto, MD, of the department of dermatology at the University of California, San Francisco, who chaired the session in which the research was presented.
SLN status remains a useful prognostic indicator, Dr. Wat said, and MR may still be useful for intermediate and thick melanomas.
Dr. Wat and Dr. Botto reported no relevant financial disclosures.
AT PDA 2017
Key clinical point: The results support the latest guidelines, which exclude mitotic rate in the criteria for upstaging thin melanomas.
Major finding: There was no association between mitotic rate and positive sentinel lymph node biopsy results.
Data source: A retrospective analysis of 990 patient records in Alberta, Canada.
Disclosures: Dr. Wat and Dr. Botto reported no relevant financial disclosures.
Lobectomy shown safe after concurrent chemo and radiation
Lobectomy can be done safely after concurrent chemotherapy and high-dose radiation in patients with resectable N2-positive stage IIIA non–small cell lung cancer, according to study findings presented by Jessica S. Donington, MD.
Dr. Donington of New York University and her colleagues presented analysis of two prospective trials conducted by NRG Oncology, RTOG 0229 and RTOG 0839 at the AATS Annual Meeting. Both trials’ primary endpoints were mediastinal node sterilization after concurrent chemotherapy and full-dose radiation and those results were previously reported.
Dr. Donington and her fellow investigators specifically examined short-term surgical outcomes, given the significant controversy regarding the safety of resection after full-dose thoracic radiation. In both trials, patients received weekly carboplatin and paclitaxel. Those in the 0229 trial underwent 61.2 Gy of radiation in 34 fractions, while patients in the 0839 trial underwent 60 Gy in 30 fractions. In addition, patients in the 0839 trial were randomized 2:1 to receive weekly panitumumab, an EGFR monoclonal antibody, with their induction therapy.
Surgical expertise was considered essential to this treatment strategy. Therefore, all surgeons were certified by RTOG prior to enrolling patients, and all patients were surgically evaluated before beginning induction therapy to determine resectability and appropriateness for trimodality therapy. Of 125 eligible patients enrolled in the two trials, 93 patients (74%) underwent anatomic resection. A total of 77 patients underwent lobectomy, 8 underwent pneumonectomy, 6 underwent bilobectomy, and 2 patients had sleeve lobectomy.
Medical contraindication and persistent nodal disease found during post-induction invasive staging were the most common reasons patients didn’t undergo resection. Eighty-five of the 93 surgical patients had R0 resections (91%). Surgeons attempted 14 minimally invasive resections (15%), 2 of which uneventfully converted to open resection. Just over one-quarter (28%) of patients suffered greater than Grade 3 adverse events (AEs) related to surgery, the majority of which were pulmonary in nature.
The 30-day mortality rate was 4%, and all four deaths were linked to pulmonary adverse events, including acute respiratory distress syndrome, bronchopleural fistula, pulmonary artery hemorrhage, and respiratory failure. Multivariable analysis for mortality identified the addition of panitumumab and use of an extended resection to be associated with an increased risk for operative mortality.
In the patients undergoing lobectomy, rates for greater than Grade 3 adverse events and 30-day mortality were 26%, and 1.3%, respectively. Those are similar to rates reported for lobectomy without induction therapy in the National Inpatient Sample (NIS) and the STS General Thoracic Surgery Database over the same time period.
These two RTOG trials are the first to prospectively demonstrate that trimodality therapy with full-dose neoadjuvant radiation therapy is safe in a multi-institutional setting, Dr. Donington said.
As her conclusions, she listed that “we have demonstrated the safety of resection following full-dose concurrent CRT in a multi-insitutional setting, that EGFR-AB and T2/T3 stage was associated with decreased nonfatal morbidity, but that extended resection and EGFR-AB were associated with excessive surgical mortality.” Dr. Donington added that the morbidity and mortality for lobectomy compared favorably with large national databases.She pointed out several limitations of the study, which included the relatively small size, and the unexpected toxicity of the EGFR antibody, “which severely limited our ability to assess trimodality therapy.”
She added that “our short-term outcomes tell us nothing about the long-term oncologic benefit.
Dr. David R. Jones, chief of thoracic surgery at the Memorial Sloan-Kettering Cancer Center, New York, was the invited discussant of the paper. “Despite combining these [2] trials, there are still only 93 patients in the analysis and 77 of these had a lobectomy,” Dr. Jones stated. He pointed out that “there was a significant increase in 30- and 90-day mortality in the 16 patients who had more than a straightforward lobectomy,” and asked whether this increased mortality could be due to the use of radiation in the induction therapy.
Dr. Donington replied that there was a wide variation in causes of death, but that “the fact that these patients had induction therapy, be that radiation or chemo, and then went on to this bigger operation, it was overall a difficult thing for them to overcome.” Dr. Donington also agreed with a comment by Dr. Jones that it would be important to follow predicted postoperative diffusion capacity in these patients to potentially help determine the amount of lung to be taken and would be a valuable preoperative consideration.
Dr. Donington reported that two of her coauthors received grant support from NCI and AMGen for the work she was reporting, but that there were no other related disclosures. Dr. Jones reported that he had no disclosures.
Lobectomy can be done safely after concurrent chemotherapy and high-dose radiation in patients with resectable N2-positive stage IIIA non–small cell lung cancer, according to study findings presented by Jessica S. Donington, MD.
Dr. Donington of New York University and her colleagues presented analysis of two prospective trials conducted by NRG Oncology, RTOG 0229 and RTOG 0839 at the AATS Annual Meeting. Both trials’ primary endpoints were mediastinal node sterilization after concurrent chemotherapy and full-dose radiation and those results were previously reported.
Dr. Donington and her fellow investigators specifically examined short-term surgical outcomes, given the significant controversy regarding the safety of resection after full-dose thoracic radiation. In both trials, patients received weekly carboplatin and paclitaxel. Those in the 0229 trial underwent 61.2 Gy of radiation in 34 fractions, while patients in the 0839 trial underwent 60 Gy in 30 fractions. In addition, patients in the 0839 trial were randomized 2:1 to receive weekly panitumumab, an EGFR monoclonal antibody, with their induction therapy.
Surgical expertise was considered essential to this treatment strategy. Therefore, all surgeons were certified by RTOG prior to enrolling patients, and all patients were surgically evaluated before beginning induction therapy to determine resectability and appropriateness for trimodality therapy. Of 125 eligible patients enrolled in the two trials, 93 patients (74%) underwent anatomic resection. A total of 77 patients underwent lobectomy, 8 underwent pneumonectomy, 6 underwent bilobectomy, and 2 patients had sleeve lobectomy.
Medical contraindication and persistent nodal disease found during post-induction invasive staging were the most common reasons patients didn’t undergo resection. Eighty-five of the 93 surgical patients had R0 resections (91%). Surgeons attempted 14 minimally invasive resections (15%), 2 of which uneventfully converted to open resection. Just over one-quarter (28%) of patients suffered greater than Grade 3 adverse events (AEs) related to surgery, the majority of which were pulmonary in nature.
The 30-day mortality rate was 4%, and all four deaths were linked to pulmonary adverse events, including acute respiratory distress syndrome, bronchopleural fistula, pulmonary artery hemorrhage, and respiratory failure. Multivariable analysis for mortality identified the addition of panitumumab and use of an extended resection to be associated with an increased risk for operative mortality.
In the patients undergoing lobectomy, rates for greater than Grade 3 adverse events and 30-day mortality were 26%, and 1.3%, respectively. Those are similar to rates reported for lobectomy without induction therapy in the National Inpatient Sample (NIS) and the STS General Thoracic Surgery Database over the same time period.
These two RTOG trials are the first to prospectively demonstrate that trimodality therapy with full-dose neoadjuvant radiation therapy is safe in a multi-institutional setting, Dr. Donington said.
As her conclusions, she listed that “we have demonstrated the safety of resection following full-dose concurrent CRT in a multi-insitutional setting, that EGFR-AB and T2/T3 stage was associated with decreased nonfatal morbidity, but that extended resection and EGFR-AB were associated with excessive surgical mortality.” Dr. Donington added that the morbidity and mortality for lobectomy compared favorably with large national databases.She pointed out several limitations of the study, which included the relatively small size, and the unexpected toxicity of the EGFR antibody, “which severely limited our ability to assess trimodality therapy.”
She added that “our short-term outcomes tell us nothing about the long-term oncologic benefit.
Dr. David R. Jones, chief of thoracic surgery at the Memorial Sloan-Kettering Cancer Center, New York, was the invited discussant of the paper. “Despite combining these [2] trials, there are still only 93 patients in the analysis and 77 of these had a lobectomy,” Dr. Jones stated. He pointed out that “there was a significant increase in 30- and 90-day mortality in the 16 patients who had more than a straightforward lobectomy,” and asked whether this increased mortality could be due to the use of radiation in the induction therapy.
Dr. Donington replied that there was a wide variation in causes of death, but that “the fact that these patients had induction therapy, be that radiation or chemo, and then went on to this bigger operation, it was overall a difficult thing for them to overcome.” Dr. Donington also agreed with a comment by Dr. Jones that it would be important to follow predicted postoperative diffusion capacity in these patients to potentially help determine the amount of lung to be taken and would be a valuable preoperative consideration.
Dr. Donington reported that two of her coauthors received grant support from NCI and AMGen for the work she was reporting, but that there were no other related disclosures. Dr. Jones reported that he had no disclosures.
Lobectomy can be done safely after concurrent chemotherapy and high-dose radiation in patients with resectable N2-positive stage IIIA non–small cell lung cancer, according to study findings presented by Jessica S. Donington, MD.
Dr. Donington of New York University and her colleagues presented analysis of two prospective trials conducted by NRG Oncology, RTOG 0229 and RTOG 0839 at the AATS Annual Meeting. Both trials’ primary endpoints were mediastinal node sterilization after concurrent chemotherapy and full-dose radiation and those results were previously reported.
Dr. Donington and her fellow investigators specifically examined short-term surgical outcomes, given the significant controversy regarding the safety of resection after full-dose thoracic radiation. In both trials, patients received weekly carboplatin and paclitaxel. Those in the 0229 trial underwent 61.2 Gy of radiation in 34 fractions, while patients in the 0839 trial underwent 60 Gy in 30 fractions. In addition, patients in the 0839 trial were randomized 2:1 to receive weekly panitumumab, an EGFR monoclonal antibody, with their induction therapy.
Surgical expertise was considered essential to this treatment strategy. Therefore, all surgeons were certified by RTOG prior to enrolling patients, and all patients were surgically evaluated before beginning induction therapy to determine resectability and appropriateness for trimodality therapy. Of 125 eligible patients enrolled in the two trials, 93 patients (74%) underwent anatomic resection. A total of 77 patients underwent lobectomy, 8 underwent pneumonectomy, 6 underwent bilobectomy, and 2 patients had sleeve lobectomy.
Medical contraindication and persistent nodal disease found during post-induction invasive staging were the most common reasons patients didn’t undergo resection. Eighty-five of the 93 surgical patients had R0 resections (91%). Surgeons attempted 14 minimally invasive resections (15%), 2 of which uneventfully converted to open resection. Just over one-quarter (28%) of patients suffered greater than Grade 3 adverse events (AEs) related to surgery, the majority of which were pulmonary in nature.
The 30-day mortality rate was 4%, and all four deaths were linked to pulmonary adverse events, including acute respiratory distress syndrome, bronchopleural fistula, pulmonary artery hemorrhage, and respiratory failure. Multivariable analysis for mortality identified the addition of panitumumab and use of an extended resection to be associated with an increased risk for operative mortality.
In the patients undergoing lobectomy, rates for greater than Grade 3 adverse events and 30-day mortality were 26%, and 1.3%, respectively. Those are similar to rates reported for lobectomy without induction therapy in the National Inpatient Sample (NIS) and the STS General Thoracic Surgery Database over the same time period.
These two RTOG trials are the first to prospectively demonstrate that trimodality therapy with full-dose neoadjuvant radiation therapy is safe in a multi-institutional setting, Dr. Donington said.
As her conclusions, she listed that “we have demonstrated the safety of resection following full-dose concurrent CRT in a multi-insitutional setting, that EGFR-AB and T2/T3 stage was associated with decreased nonfatal morbidity, but that extended resection and EGFR-AB were associated with excessive surgical mortality.” Dr. Donington added that the morbidity and mortality for lobectomy compared favorably with large national databases.She pointed out several limitations of the study, which included the relatively small size, and the unexpected toxicity of the EGFR antibody, “which severely limited our ability to assess trimodality therapy.”
She added that “our short-term outcomes tell us nothing about the long-term oncologic benefit.
Dr. David R. Jones, chief of thoracic surgery at the Memorial Sloan-Kettering Cancer Center, New York, was the invited discussant of the paper. “Despite combining these [2] trials, there are still only 93 patients in the analysis and 77 of these had a lobectomy,” Dr. Jones stated. He pointed out that “there was a significant increase in 30- and 90-day mortality in the 16 patients who had more than a straightforward lobectomy,” and asked whether this increased mortality could be due to the use of radiation in the induction therapy.
Dr. Donington replied that there was a wide variation in causes of death, but that “the fact that these patients had induction therapy, be that radiation or chemo, and then went on to this bigger operation, it was overall a difficult thing for them to overcome.” Dr. Donington also agreed with a comment by Dr. Jones that it would be important to follow predicted postoperative diffusion capacity in these patients to potentially help determine the amount of lung to be taken and would be a valuable preoperative consideration.
Dr. Donington reported that two of her coauthors received grant support from NCI and AMGen for the work she was reporting, but that there were no other related disclosures. Dr. Jones reported that he had no disclosures.
FROM THE AMERICAN ASSOCIATION FOR THORACIC SURGERY ANNUAL MEETING
Hospital-led interventions cut pediatric asthma hospitalizations
Hospital-driven interventions designed to improve management of asthma in children achieved significant reductions in monthly asthma-related hospitalizations and emergency department visits, according to a paper published online Sept. 18 in JAMA Pediatrics.
Long-term management of pediatric asthma is challenging, and around 40% of children and adolescents hospitalized with the disease tend to be rehospitalized or revisit the emergency department (ED) within 12 months, according to Carolyn M. Kercsmar, MD, of Children’s Hospital Medical Center in Cincinnati, and her coauthors.
“Traditional care models do not adequately address underlying risk factors, propagating disparities and costly health care use,” they wrote (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2600).
This study, initiated by Cincinnati Children’s Hospital Medical Center, involved a range of interventions implemented with inpatients and outpatients and through the community setting, targeting the region’s more than 36,000 children and adolescents with asthma, approximately 13,000 of whom were Medicaid insured.
Over the 5-year study, researchers saw a 41.8% relative reduction in asthma-related hospitalizations – from 8.1 to 4.7 per 10,000 Medicaid patients per month. Asthma-related visits to the ED decreased by 42.4%, from 21.5 to 12.4 per 10,000 Medicaid patients per month, and the percentage of patients rehospitalized or who returned to the ED for asthma within 30 days declined from 12% to 7%, “within 3 years of implementation of the inpatient care interventions,” the researchers noted.
There was also a significant increase in the percentage of patients discharged with a 30-day supply of inhaled controller medications, from 50% in May 2008 to 90% in May 2010, and the percentage of patients discharged with a short course of oral corticosteroids increased from 0% to 70% by March 2011.
Outpatient processes ensured that Asthma Control Test scores were collected and that patients were provided with asthma action plans. This was associated with an increase in the percentage of patients with well-controlled asthma from 48% to 54%.
“Implementation of an integrated, multilevel approach focused on enhancing availability and accessibility of treatments, removing barriers to adherence, mitigating risks related to adverse exposures, and augmenting self-management and collaborative relationships between the family and the health care system was associated with improved asthma outcomes,” the authors wrote.
Noting that previous research has found 38%-70% of patients do not get their prescribed medications at hospital discharge, the authors said they believed giving a 30-day supply of all daily asthma medications at discharge was a key part of their success.
The study was supported by the Cincinnati Children’s Hospital Medical Center and one author received a grant from the National Institutes of Health. One author declared compensation for a committee role on a study of asthma treatments in children. No other conflicts of interest were declared.
Of importance, any future efforts to replicate this work in a patient-centered way should include consideration of how information on asthma management is communicated to and understood by patients. Standard tools such as asthma action plans often contain language and other information that is inaccessible to populations with low health literacy levels.
After years of elevated morbidity, the work of Kercsmar et al. is a demonstration of how interdisciplinary care focused within a biopsychosocial model can improve outcomes for vulnerable children. Future efforts to replicate these results in other communities should continue to emphasize this patient-centered, biopsychosocial philosophy, with heightened attention to the challenges that remain for children and families.
Dr. Sean M. Frey and Dr. Jill S. Halterman are in the department of pediatrics at the University of Rochester (N.Y.) School of Medicine and Dentistry. These comments are taken from an accompanying editorial (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2609). No conflicts of interest were declared.
Of importance, any future efforts to replicate this work in a patient-centered way should include consideration of how information on asthma management is communicated to and understood by patients. Standard tools such as asthma action plans often contain language and other information that is inaccessible to populations with low health literacy levels.
After years of elevated morbidity, the work of Kercsmar et al. is a demonstration of how interdisciplinary care focused within a biopsychosocial model can improve outcomes for vulnerable children. Future efforts to replicate these results in other communities should continue to emphasize this patient-centered, biopsychosocial philosophy, with heightened attention to the challenges that remain for children and families.
Dr. Sean M. Frey and Dr. Jill S. Halterman are in the department of pediatrics at the University of Rochester (N.Y.) School of Medicine and Dentistry. These comments are taken from an accompanying editorial (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2609). No conflicts of interest were declared.
Of importance, any future efforts to replicate this work in a patient-centered way should include consideration of how information on asthma management is communicated to and understood by patients. Standard tools such as asthma action plans often contain language and other information that is inaccessible to populations with low health literacy levels.
After years of elevated morbidity, the work of Kercsmar et al. is a demonstration of how interdisciplinary care focused within a biopsychosocial model can improve outcomes for vulnerable children. Future efforts to replicate these results in other communities should continue to emphasize this patient-centered, biopsychosocial philosophy, with heightened attention to the challenges that remain for children and families.
Dr. Sean M. Frey and Dr. Jill S. Halterman are in the department of pediatrics at the University of Rochester (N.Y.) School of Medicine and Dentistry. These comments are taken from an accompanying editorial (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2609). No conflicts of interest were declared.
Hospital-driven interventions designed to improve management of asthma in children achieved significant reductions in monthly asthma-related hospitalizations and emergency department visits, according to a paper published online Sept. 18 in JAMA Pediatrics.
Long-term management of pediatric asthma is challenging, and around 40% of children and adolescents hospitalized with the disease tend to be rehospitalized or revisit the emergency department (ED) within 12 months, according to Carolyn M. Kercsmar, MD, of Children’s Hospital Medical Center in Cincinnati, and her coauthors.
“Traditional care models do not adequately address underlying risk factors, propagating disparities and costly health care use,” they wrote (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2600).
This study, initiated by Cincinnati Children’s Hospital Medical Center, involved a range of interventions implemented with inpatients and outpatients and through the community setting, targeting the region’s more than 36,000 children and adolescents with asthma, approximately 13,000 of whom were Medicaid insured.
Over the 5-year study, researchers saw a 41.8% relative reduction in asthma-related hospitalizations – from 8.1 to 4.7 per 10,000 Medicaid patients per month. Asthma-related visits to the ED decreased by 42.4%, from 21.5 to 12.4 per 10,000 Medicaid patients per month, and the percentage of patients rehospitalized or who returned to the ED for asthma within 30 days declined from 12% to 7%, “within 3 years of implementation of the inpatient care interventions,” the researchers noted.
There was also a significant increase in the percentage of patients discharged with a 30-day supply of inhaled controller medications, from 50% in May 2008 to 90% in May 2010, and the percentage of patients discharged with a short course of oral corticosteroids increased from 0% to 70% by March 2011.
Outpatient processes ensured that Asthma Control Test scores were collected and that patients were provided with asthma action plans. This was associated with an increase in the percentage of patients with well-controlled asthma from 48% to 54%.
“Implementation of an integrated, multilevel approach focused on enhancing availability and accessibility of treatments, removing barriers to adherence, mitigating risks related to adverse exposures, and augmenting self-management and collaborative relationships between the family and the health care system was associated with improved asthma outcomes,” the authors wrote.
Noting that previous research has found 38%-70% of patients do not get their prescribed medications at hospital discharge, the authors said they believed giving a 30-day supply of all daily asthma medications at discharge was a key part of their success.
The study was supported by the Cincinnati Children’s Hospital Medical Center and one author received a grant from the National Institutes of Health. One author declared compensation for a committee role on a study of asthma treatments in children. No other conflicts of interest were declared.
Hospital-driven interventions designed to improve management of asthma in children achieved significant reductions in monthly asthma-related hospitalizations and emergency department visits, according to a paper published online Sept. 18 in JAMA Pediatrics.
Long-term management of pediatric asthma is challenging, and around 40% of children and adolescents hospitalized with the disease tend to be rehospitalized or revisit the emergency department (ED) within 12 months, according to Carolyn M. Kercsmar, MD, of Children’s Hospital Medical Center in Cincinnati, and her coauthors.
“Traditional care models do not adequately address underlying risk factors, propagating disparities and costly health care use,” they wrote (JAMA Pediatrics 2017, Sep 18. doi: 10.1001/jamapediatrics.2017.2600).
This study, initiated by Cincinnati Children’s Hospital Medical Center, involved a range of interventions implemented with inpatients and outpatients and through the community setting, targeting the region’s more than 36,000 children and adolescents with asthma, approximately 13,000 of whom were Medicaid insured.
Over the 5-year study, researchers saw a 41.8% relative reduction in asthma-related hospitalizations – from 8.1 to 4.7 per 10,000 Medicaid patients per month. Asthma-related visits to the ED decreased by 42.4%, from 21.5 to 12.4 per 10,000 Medicaid patients per month, and the percentage of patients rehospitalized or who returned to the ED for asthma within 30 days declined from 12% to 7%, “within 3 years of implementation of the inpatient care interventions,” the researchers noted.
There was also a significant increase in the percentage of patients discharged with a 30-day supply of inhaled controller medications, from 50% in May 2008 to 90% in May 2010, and the percentage of patients discharged with a short course of oral corticosteroids increased from 0% to 70% by March 2011.
Outpatient processes ensured that Asthma Control Test scores were collected and that patients were provided with asthma action plans. This was associated with an increase in the percentage of patients with well-controlled asthma from 48% to 54%.
“Implementation of an integrated, multilevel approach focused on enhancing availability and accessibility of treatments, removing barriers to adherence, mitigating risks related to adverse exposures, and augmenting self-management and collaborative relationships between the family and the health care system was associated with improved asthma outcomes,” the authors wrote.
Noting that previous research has found 38%-70% of patients do not get their prescribed medications at hospital discharge, the authors said they believed giving a 30-day supply of all daily asthma medications at discharge was a key part of their success.
The study was supported by the Cincinnati Children’s Hospital Medical Center and one author received a grant from the National Institutes of Health. One author declared compensation for a committee role on a study of asthma treatments in children. No other conflicts of interest were declared.
FROM JAMA PEDIATRICS
Key clinical point: A hospital-driven intervention to improve management of asthma in children has achieved significant reductions in asthma-related hospitalizations and emergency department visits and increased medication uptake.
Major finding: A multifactorial intervention to improve asthma management in children was associated with a 41.8% relative reduction in asthma-related hospitalizations and a 42.4% reduction in emergency department visits.
Data source: A hospital-based intervention.
Disclosures: The study was supported by the Cincinnati Children’s Hospital Medical Center and one author received a grant from the National Institutes of Health. One author declared compensation for a committee role on a study of asthma treatments in children. No other conflicts of interest were declared.
Breastfeeding practices have improved, but some attitudes are concerning
Pediatricians’ recommendations and practices for breastfeeding have become more closely aligned with American Academy of Pediatrics policy since 1995, but attitudes toward breastfeeding show cause for concern, according to a study.
The percentage of surveyed pediatricians who advise exclusive breastfeeding during the first month rose from 66% in 1995 to 75% in 2014 (P less than .05), reported Lori Feldman-Winter, MD, MPH, of Rowan University, Camden, N.J., and her coauthors (Pediatrics. 2017. doi: 10.1542/peds.2017-1229).
Physicians also were less likely to recommend formula supplementation (12% in 1995; 4.5% in 2014; P less than .05).
In addition, pediatricians in 2014 were significantly more likely to report that their affiliated hospitals had applied to be a baby-friendly hospital (56%), compared with results for 1995 (12%) and 2004 (22%) (P less than .05), the investigators said. The physicians also were more likely to report that their practices were more in line with the “Ten Steps to Successful Breastfeeding” policy.
Despite this general trend toward AAP recommendation–compliant practices, many pediatricians doubt the likelihood of breastfeeding success. Although in 1995, 70% of pediatricians reported that almost any mother can be successful at breastfeeding if she keeps trying, only 56% reported the same in 2014 (P less than .05), Dr. Feldman-Winter and her coauthors said. Similarly, only 50% reported that the benefits of breastfeeding outweigh the difficulties in 2014, compared with 70% in 1995 (P less than .05). This may be in part because younger pediatricians reported less confidence in managing common breastfeeding problems and being able to adequately address parents’ questions about breastfeeding; there was a statistically significant difference between pediatricians younger than 45 years and those 45 years and older (P less than .01).
“Pediatricians have demonstrated a modest decline in attitudes about the potential for breastfeeding success,” the investigators wrote. “Lack of resident support for breastfeeding is apparent among many programs and may set the stage for attitudes about breastfeeding for years to come. There are continued opportunities to enhance training in breastfeeding and participate in breastfeeding management and support.”
The study was funded by the American Academy of Pediatrics and the Maternal and Child Health Bureau, Health Resources and Services Administration, and Department of Health and Human Services. None of the authors reported any financial disclosures.
Despite changes in breastfeeding recommendations and practices as well as numerous initiatives from organizations such as the Centers for Disease Control and Prevention and the Department of Health and Human Services, residency training for breastfeeding is not universal.
The study by Feldman et al. shows some concerning trends toward a lack of belief among pediatricians that the benefits of breastfeeding outweigh the difficulties or inconveniences and toward less confidence in managing breastfeeding. They also indicate that baby-friendly hospitals are providing the required breastfeeding education, but this is only a start.
As the trend toward staffing hospitals with pediatric hospitalists increases, it is essential to remember that ambulatory pediatricians also need breastfeeding education because they are responsible for ongoing follow-up care. Maintenance of certification should include breastfeeding as a “core competency” for general pediatricians as well.
Although this analysis shows progress, “the importance of routine integration of breastfeeding into all aspects of medical education cannot be overstated. Breastfeeding education should be as routine in the curriculum as other preventive health strategies, such as immunization.” Hopefully, future studies will show that pediatricians have the skills, attitudes, and confidence necessary to provide competent support to their patients.
Joan Younger Meek, MD, is the associate dean for graduate medical education and a professor at Florida State University in Tallahassee. Her comments were with the Feldman-Winter et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-2509). She reported no relevant financial disclosures or external funding.
Despite changes in breastfeeding recommendations and practices as well as numerous initiatives from organizations such as the Centers for Disease Control and Prevention and the Department of Health and Human Services, residency training for breastfeeding is not universal.
The study by Feldman et al. shows some concerning trends toward a lack of belief among pediatricians that the benefits of breastfeeding outweigh the difficulties or inconveniences and toward less confidence in managing breastfeeding. They also indicate that baby-friendly hospitals are providing the required breastfeeding education, but this is only a start.
As the trend toward staffing hospitals with pediatric hospitalists increases, it is essential to remember that ambulatory pediatricians also need breastfeeding education because they are responsible for ongoing follow-up care. Maintenance of certification should include breastfeeding as a “core competency” for general pediatricians as well.
Although this analysis shows progress, “the importance of routine integration of breastfeeding into all aspects of medical education cannot be overstated. Breastfeeding education should be as routine in the curriculum as other preventive health strategies, such as immunization.” Hopefully, future studies will show that pediatricians have the skills, attitudes, and confidence necessary to provide competent support to their patients.
Joan Younger Meek, MD, is the associate dean for graduate medical education and a professor at Florida State University in Tallahassee. Her comments were with the Feldman-Winter et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-2509). She reported no relevant financial disclosures or external funding.
Despite changes in breastfeeding recommendations and practices as well as numerous initiatives from organizations such as the Centers for Disease Control and Prevention and the Department of Health and Human Services, residency training for breastfeeding is not universal.
The study by Feldman et al. shows some concerning trends toward a lack of belief among pediatricians that the benefits of breastfeeding outweigh the difficulties or inconveniences and toward less confidence in managing breastfeeding. They also indicate that baby-friendly hospitals are providing the required breastfeeding education, but this is only a start.
As the trend toward staffing hospitals with pediatric hospitalists increases, it is essential to remember that ambulatory pediatricians also need breastfeeding education because they are responsible for ongoing follow-up care. Maintenance of certification should include breastfeeding as a “core competency” for general pediatricians as well.
Although this analysis shows progress, “the importance of routine integration of breastfeeding into all aspects of medical education cannot be overstated. Breastfeeding education should be as routine in the curriculum as other preventive health strategies, such as immunization.” Hopefully, future studies will show that pediatricians have the skills, attitudes, and confidence necessary to provide competent support to their patients.
Joan Younger Meek, MD, is the associate dean for graduate medical education and a professor at Florida State University in Tallahassee. Her comments were with the Feldman-Winter et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-2509). She reported no relevant financial disclosures or external funding.
Pediatricians’ recommendations and practices for breastfeeding have become more closely aligned with American Academy of Pediatrics policy since 1995, but attitudes toward breastfeeding show cause for concern, according to a study.
The percentage of surveyed pediatricians who advise exclusive breastfeeding during the first month rose from 66% in 1995 to 75% in 2014 (P less than .05), reported Lori Feldman-Winter, MD, MPH, of Rowan University, Camden, N.J., and her coauthors (Pediatrics. 2017. doi: 10.1542/peds.2017-1229).
Physicians also were less likely to recommend formula supplementation (12% in 1995; 4.5% in 2014; P less than .05).
In addition, pediatricians in 2014 were significantly more likely to report that their affiliated hospitals had applied to be a baby-friendly hospital (56%), compared with results for 1995 (12%) and 2004 (22%) (P less than .05), the investigators said. The physicians also were more likely to report that their practices were more in line with the “Ten Steps to Successful Breastfeeding” policy.
Despite this general trend toward AAP recommendation–compliant practices, many pediatricians doubt the likelihood of breastfeeding success. Although in 1995, 70% of pediatricians reported that almost any mother can be successful at breastfeeding if she keeps trying, only 56% reported the same in 2014 (P less than .05), Dr. Feldman-Winter and her coauthors said. Similarly, only 50% reported that the benefits of breastfeeding outweigh the difficulties in 2014, compared with 70% in 1995 (P less than .05). This may be in part because younger pediatricians reported less confidence in managing common breastfeeding problems and being able to adequately address parents’ questions about breastfeeding; there was a statistically significant difference between pediatricians younger than 45 years and those 45 years and older (P less than .01).
“Pediatricians have demonstrated a modest decline in attitudes about the potential for breastfeeding success,” the investigators wrote. “Lack of resident support for breastfeeding is apparent among many programs and may set the stage for attitudes about breastfeeding for years to come. There are continued opportunities to enhance training in breastfeeding and participate in breastfeeding management and support.”
The study was funded by the American Academy of Pediatrics and the Maternal and Child Health Bureau, Health Resources and Services Administration, and Department of Health and Human Services. None of the authors reported any financial disclosures.
Pediatricians’ recommendations and practices for breastfeeding have become more closely aligned with American Academy of Pediatrics policy since 1995, but attitudes toward breastfeeding show cause for concern, according to a study.
The percentage of surveyed pediatricians who advise exclusive breastfeeding during the first month rose from 66% in 1995 to 75% in 2014 (P less than .05), reported Lori Feldman-Winter, MD, MPH, of Rowan University, Camden, N.J., and her coauthors (Pediatrics. 2017. doi: 10.1542/peds.2017-1229).
Physicians also were less likely to recommend formula supplementation (12% in 1995; 4.5% in 2014; P less than .05).
In addition, pediatricians in 2014 were significantly more likely to report that their affiliated hospitals had applied to be a baby-friendly hospital (56%), compared with results for 1995 (12%) and 2004 (22%) (P less than .05), the investigators said. The physicians also were more likely to report that their practices were more in line with the “Ten Steps to Successful Breastfeeding” policy.
Despite this general trend toward AAP recommendation–compliant practices, many pediatricians doubt the likelihood of breastfeeding success. Although in 1995, 70% of pediatricians reported that almost any mother can be successful at breastfeeding if she keeps trying, only 56% reported the same in 2014 (P less than .05), Dr. Feldman-Winter and her coauthors said. Similarly, only 50% reported that the benefits of breastfeeding outweigh the difficulties in 2014, compared with 70% in 1995 (P less than .05). This may be in part because younger pediatricians reported less confidence in managing common breastfeeding problems and being able to adequately address parents’ questions about breastfeeding; there was a statistically significant difference between pediatricians younger than 45 years and those 45 years and older (P less than .01).
“Pediatricians have demonstrated a modest decline in attitudes about the potential for breastfeeding success,” the investigators wrote. “Lack of resident support for breastfeeding is apparent among many programs and may set the stage for attitudes about breastfeeding for years to come. There are continued opportunities to enhance training in breastfeeding and participate in breastfeeding management and support.”
The study was funded by the American Academy of Pediatrics and the Maternal and Child Health Bureau, Health Resources and Services Administration, and Department of Health and Human Services. None of the authors reported any financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: The percentage of surveyed physicians who advise exclusive breastfeeding during the first month rose from 66% in 1995 to 75% in 2014 (P less than .05).
Data source: An analysis of data from three AAP Periodic Surveys of Fellows.
Disclosures: The study was funded by the American Academy of Pediatrics and the Maternal and Child Health Bureau, Health Resources and Services Administration, and Department of Health and Human Services. None of the authors reported any financial disclosures.
Subtle hearing loss after concussion could impair learning
CHICAGO – Children who experience concussion can develop deficits in auditory processing that could impair long-term academic performance and carry implications for return-to-play strategies, according to a study.
Investigators assessed 40 children aged 8-15 years, half of whom experienced concussion. The postconcussion group of 20 children had slower and smaller neural responses to speech, compared with 20 control children, on the noninvasive frequency-following response measure.
“The ability to hear in noise following concussion is impaired in the pediatric population, based on our results, which suggests it might pose additional challenges for classroom learning,” Ms. Thompson said. The study also suggests that auditory function should be considered part of acute and long-term assessment of children post concussion.
Importantly, all participants in the study had normal hearing. “It’s important to know these are very subtle auditory deficits that only emerge if you’re looking for them,” Ms. Thompson said at the annual meeting of the American Academy of Pediatrics.
Children in the concussion group were recruited from the concussion clinic at the Ann and Robert H. Lurie Children’s Hospital of Chicago. Patients were assessed an average of 27 days post injury, with most still symptomatic. The children in the control group had been treated for musculoskeletal injuries. The concussed and control groups were matched for sex and gender.
“We think that these results have implications beyond the classroom,” Ms. Thompson said. “Auditory deficits might increase risk of reinjury if sports are being played in loud, noisy gymnasiums or crowded soccer fields. So this is important to consider with return-to-play strategies.” She added, “There is hope. Auditory processing is a malleable skill, and it can be a useful target for rehabilitation and recovery.”
Ms. Thompson had no relevant financial disclosures. The study was supported by the Knowles Hearing Center.
CHICAGO – Children who experience concussion can develop deficits in auditory processing that could impair long-term academic performance and carry implications for return-to-play strategies, according to a study.
Investigators assessed 40 children aged 8-15 years, half of whom experienced concussion. The postconcussion group of 20 children had slower and smaller neural responses to speech, compared with 20 control children, on the noninvasive frequency-following response measure.
“The ability to hear in noise following concussion is impaired in the pediatric population, based on our results, which suggests it might pose additional challenges for classroom learning,” Ms. Thompson said. The study also suggests that auditory function should be considered part of acute and long-term assessment of children post concussion.
Importantly, all participants in the study had normal hearing. “It’s important to know these are very subtle auditory deficits that only emerge if you’re looking for them,” Ms. Thompson said at the annual meeting of the American Academy of Pediatrics.
Children in the concussion group were recruited from the concussion clinic at the Ann and Robert H. Lurie Children’s Hospital of Chicago. Patients were assessed an average of 27 days post injury, with most still symptomatic. The children in the control group had been treated for musculoskeletal injuries. The concussed and control groups were matched for sex and gender.
“We think that these results have implications beyond the classroom,” Ms. Thompson said. “Auditory deficits might increase risk of reinjury if sports are being played in loud, noisy gymnasiums or crowded soccer fields. So this is important to consider with return-to-play strategies.” She added, “There is hope. Auditory processing is a malleable skill, and it can be a useful target for rehabilitation and recovery.”
Ms. Thompson had no relevant financial disclosures. The study was supported by the Knowles Hearing Center.
CHICAGO – Children who experience concussion can develop deficits in auditory processing that could impair long-term academic performance and carry implications for return-to-play strategies, according to a study.
Investigators assessed 40 children aged 8-15 years, half of whom experienced concussion. The postconcussion group of 20 children had slower and smaller neural responses to speech, compared with 20 control children, on the noninvasive frequency-following response measure.
“The ability to hear in noise following concussion is impaired in the pediatric population, based on our results, which suggests it might pose additional challenges for classroom learning,” Ms. Thompson said. The study also suggests that auditory function should be considered part of acute and long-term assessment of children post concussion.
Importantly, all participants in the study had normal hearing. “It’s important to know these are very subtle auditory deficits that only emerge if you’re looking for them,” Ms. Thompson said at the annual meeting of the American Academy of Pediatrics.
Children in the concussion group were recruited from the concussion clinic at the Ann and Robert H. Lurie Children’s Hospital of Chicago. Patients were assessed an average of 27 days post injury, with most still symptomatic. The children in the control group had been treated for musculoskeletal injuries. The concussed and control groups were matched for sex and gender.
“We think that these results have implications beyond the classroom,” Ms. Thompson said. “Auditory deficits might increase risk of reinjury if sports are being played in loud, noisy gymnasiums or crowded soccer fields. So this is important to consider with return-to-play strategies.” She added, “There is hope. Auditory processing is a malleable skill, and it can be a useful target for rehabilitation and recovery.”
Ms. Thompson had no relevant financial disclosures. The study was supported by the Knowles Hearing Center.
AT AAP 2017
Key clinical point:
Major finding: Children with concussion symptoms performed significantly poorer on the Hearing in Noise Test, compared with nonconcussed peers (P = .001).
Data source: Study of 40 children in a sports medicine tertiary clinic: half experienced concussion and half served as controls.
Disclosures: Ms. Thompson had no relevant financial disclosures. The study was supported by the Knowles Hearing Center.
Combo vaccines improve compliance
, reported Samantha K. Kurosky of RTI Health Solutions, Research Triangle Park, N.C., and her colleagues.
Data from the 2012 National Immunization Survey was used to assess vaccination completion and compliance in 11,561 children age 24-35 months. Most children had providers who were in private practice (58%); about half of the children were enrolled in Medicaid or the Children’s Health Insurance Program (CHIP).
Completion of the full 4:3:1:3:3:1:4 vaccine series (4 DTaP, 3 inactivated polio vaccine [IPV], 1 MMR, 3 or 4 Haemophilus influenzae type b [Hib], 3 hepatitis B, 1 varicella, and 4 pneumococcal conjugate vaccine) was better among those who received combination vaccines, at 69%, compared with children who received single-antigen vaccine only (50%).
Children receiving combination vaccines also had a significantly higher compliance rate for the 4:3:1:3:3:1:4 series, at 24%, compared with those receiving single-antigen vaccines only, at 13% (P less than .001). Of children who received at least one vaccine by 24 months, 86% received at least one combo vaccine.
Children getting at least one combo vaccine were 2.2 times more likely to get all vaccines on time, and 2.4 times more likely to spend less time undervaccinated (less than 7 months), compared with those receiving single-antigen vaccines only, Ms. Kurosky and her associates said.
Previous studies have found that parents who refuse or intentionally delay vaccines often have higher income and are married mothers with college educations. In this study, parents with these demographics tended to have children who received single-antigen–only vaccines – that is, children who were less likely to complete a full vaccine series or have a high compliance rate, they said.
GlaxoSmithKline funded the research.
Read more at Human Vaccines & Immunotherapeutics (2017 Sep 7. doi: 10.1080/21645515.2017.1362515).
, reported Samantha K. Kurosky of RTI Health Solutions, Research Triangle Park, N.C., and her colleagues.
Data from the 2012 National Immunization Survey was used to assess vaccination completion and compliance in 11,561 children age 24-35 months. Most children had providers who were in private practice (58%); about half of the children were enrolled in Medicaid or the Children’s Health Insurance Program (CHIP).
Completion of the full 4:3:1:3:3:1:4 vaccine series (4 DTaP, 3 inactivated polio vaccine [IPV], 1 MMR, 3 or 4 Haemophilus influenzae type b [Hib], 3 hepatitis B, 1 varicella, and 4 pneumococcal conjugate vaccine) was better among those who received combination vaccines, at 69%, compared with children who received single-antigen vaccine only (50%).
Children receiving combination vaccines also had a significantly higher compliance rate for the 4:3:1:3:3:1:4 series, at 24%, compared with those receiving single-antigen vaccines only, at 13% (P less than .001). Of children who received at least one vaccine by 24 months, 86% received at least one combo vaccine.
Children getting at least one combo vaccine were 2.2 times more likely to get all vaccines on time, and 2.4 times more likely to spend less time undervaccinated (less than 7 months), compared with those receiving single-antigen vaccines only, Ms. Kurosky and her associates said.
Previous studies have found that parents who refuse or intentionally delay vaccines often have higher income and are married mothers with college educations. In this study, parents with these demographics tended to have children who received single-antigen–only vaccines – that is, children who were less likely to complete a full vaccine series or have a high compliance rate, they said.
GlaxoSmithKline funded the research.
Read more at Human Vaccines & Immunotherapeutics (2017 Sep 7. doi: 10.1080/21645515.2017.1362515).
, reported Samantha K. Kurosky of RTI Health Solutions, Research Triangle Park, N.C., and her colleagues.
Data from the 2012 National Immunization Survey was used to assess vaccination completion and compliance in 11,561 children age 24-35 months. Most children had providers who were in private practice (58%); about half of the children were enrolled in Medicaid or the Children’s Health Insurance Program (CHIP).
Completion of the full 4:3:1:3:3:1:4 vaccine series (4 DTaP, 3 inactivated polio vaccine [IPV], 1 MMR, 3 or 4 Haemophilus influenzae type b [Hib], 3 hepatitis B, 1 varicella, and 4 pneumococcal conjugate vaccine) was better among those who received combination vaccines, at 69%, compared with children who received single-antigen vaccine only (50%).
Children receiving combination vaccines also had a significantly higher compliance rate for the 4:3:1:3:3:1:4 series, at 24%, compared with those receiving single-antigen vaccines only, at 13% (P less than .001). Of children who received at least one vaccine by 24 months, 86% received at least one combo vaccine.
Children getting at least one combo vaccine were 2.2 times more likely to get all vaccines on time, and 2.4 times more likely to spend less time undervaccinated (less than 7 months), compared with those receiving single-antigen vaccines only, Ms. Kurosky and her associates said.
Previous studies have found that parents who refuse or intentionally delay vaccines often have higher income and are married mothers with college educations. In this study, parents with these demographics tended to have children who received single-antigen–only vaccines – that is, children who were less likely to complete a full vaccine series or have a high compliance rate, they said.
GlaxoSmithKline funded the research.
Read more at Human Vaccines & Immunotherapeutics (2017 Sep 7. doi: 10.1080/21645515.2017.1362515).
FROM HUMAN VACCINES & IMMUNOTHERAPEUTICS
CHMP recommends approval of generic imatinib
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Imatinib Teva B.V., a generic of Glivec.
The recommendation is that Imatinib Teva B.V. be approved to treat chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPNs), gastrointestinal stromal tumors (GIST), and dermatofibrosarcoma protuberans (DFSP).
The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.
The European Commission’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.
If approved, Imatinib Teva B.V. will be available as capsules and film-coated tablets (100 mg and 400 mg). And it will be authorized:
- As monotherapy for pediatric patients with newly diagnosed, Philadelphia-chromosome-positive (Ph+) CML for whom bone marrow transplant is not considered the first line of treatment.
- As monotherapy for pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis.
- As monotherapy for adults with Ph+ CML in blast crisis.
- Integrated with chemotherapy to treat adult and pediatric patients with newly diagnosed, Ph+ ALL.
- As monotherapy for adults with relapsed or refractory Ph+ ALL.
- As monotherapy for adults with MDS/MPNs associated with platelet-derived growth factor receptor gene re-arrangements.
- As monotherapy for adults with advanced HES and/or CEL with FIP1L1-PDGFRα rearrangement.
- As monotherapy for adults with Kit- (CD117-) positive, unresectable and/or metastatic malignant GISTs.
- For the adjuvant treatment of adults who are at significant risk of relapse following resection of Kit-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
- As monotherapy for adults with unresectable DFSP and adults with recurrent and/or metastatic DFSP who are not eligible for surgery.
The CHMP said studies have demonstrated the satisfactory quality of Imatinib Teva B.V. and its bioequivalence to the reference product, Glivec.
In adult and pediatric patients, the effectiveness of imatinib is based on:
- Overall hematologic and cytogenetic response rates and progression-free survival in CML
- Hematologic and cytogenetic response rates in Ph+ ALL and MDS/MPNs
- Hematologic response rates in HES/CEL
- Objective response rates in adults with unresectable and/or metastatic GIST and DFSP
- Recurrence-free survival in adjuvant GIST.
The experience with imatinib in patients with MDS/MPNs associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. 
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Imatinib Teva B.V., a generic of Glivec.
The recommendation is that Imatinib Teva B.V. be approved to treat chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPNs), gastrointestinal stromal tumors (GIST), and dermatofibrosarcoma protuberans (DFSP).
The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.
The European Commission’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.
If approved, Imatinib Teva B.V. will be available as capsules and film-coated tablets (100 mg and 400 mg). And it will be authorized:
- As monotherapy for pediatric patients with newly diagnosed, Philadelphia-chromosome-positive (Ph+) CML for whom bone marrow transplant is not considered the first line of treatment.
- As monotherapy for pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis.
- As monotherapy for adults with Ph+ CML in blast crisis.
- Integrated with chemotherapy to treat adult and pediatric patients with newly diagnosed, Ph+ ALL.
- As monotherapy for adults with relapsed or refractory Ph+ ALL.
- As monotherapy for adults with MDS/MPNs associated with platelet-derived growth factor receptor gene re-arrangements.
- As monotherapy for adults with advanced HES and/or CEL with FIP1L1-PDGFRα rearrangement.
- As monotherapy for adults with Kit- (CD117-) positive, unresectable and/or metastatic malignant GISTs.
- For the adjuvant treatment of adults who are at significant risk of relapse following resection of Kit-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
- As monotherapy for adults with unresectable DFSP and adults with recurrent and/or metastatic DFSP who are not eligible for surgery.
The CHMP said studies have demonstrated the satisfactory quality of Imatinib Teva B.V. and its bioequivalence to the reference product, Glivec.
In adult and pediatric patients, the effectiveness of imatinib is based on:
- Overall hematologic and cytogenetic response rates and progression-free survival in CML
- Hematologic and cytogenetic response rates in Ph+ ALL and MDS/MPNs
- Hematologic response rates in HES/CEL
- Objective response rates in adults with unresectable and/or metastatic GIST and DFSP
- Recurrence-free survival in adjuvant GIST.
The experience with imatinib in patients with MDS/MPNs associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Imatinib Teva B.V., a generic of Glivec.
The recommendation is that Imatinib Teva B.V. be approved to treat chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPNs), gastrointestinal stromal tumors (GIST), and dermatofibrosarcoma protuberans (DFSP).
The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.
The European Commission’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.
If approved, Imatinib Teva B.V. will be available as capsules and film-coated tablets (100 mg and 400 mg). And it will be authorized:
- As monotherapy for pediatric patients with newly diagnosed, Philadelphia-chromosome-positive (Ph+) CML for whom bone marrow transplant is not considered the first line of treatment.
- As monotherapy for pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis.
- As monotherapy for adults with Ph+ CML in blast crisis.
- Integrated with chemotherapy to treat adult and pediatric patients with newly diagnosed, Ph+ ALL.
- As monotherapy for adults with relapsed or refractory Ph+ ALL.
- As monotherapy for adults with MDS/MPNs associated with platelet-derived growth factor receptor gene re-arrangements.
- As monotherapy for adults with advanced HES and/or CEL with FIP1L1-PDGFRα rearrangement.
- As monotherapy for adults with Kit- (CD117-) positive, unresectable and/or metastatic malignant GISTs.
- For the adjuvant treatment of adults who are at significant risk of relapse following resection of Kit-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
- As monotherapy for adults with unresectable DFSP and adults with recurrent and/or metastatic DFSP who are not eligible for surgery.
The CHMP said studies have demonstrated the satisfactory quality of Imatinib Teva B.V. and its bioequivalence to the reference product, Glivec.
In adult and pediatric patients, the effectiveness of imatinib is based on:
- Overall hematologic and cytogenetic response rates and progression-free survival in CML
- Hematologic and cytogenetic response rates in Ph+ ALL and MDS/MPNs
- Hematologic response rates in HES/CEL
- Objective response rates in adults with unresectable and/or metastatic GIST and DFSP
- Recurrence-free survival in adjuvant GIST.
The experience with imatinib in patients with MDS/MPNs associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.