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Don’t Miss the Celebration: AATS Centennial
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Improving the Quality of Life and Care for Cancer Survivors
As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.
Related: Putting the Focus on Quality of Life in Cancer Care
The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.
A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.
For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.
Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.
Related: Cancer Survivorship Care
Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.
As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.
Related: Putting the Focus on Quality of Life in Cancer Care
The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.
A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.
For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.
Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.
Related: Cancer Survivorship Care
Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.
As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.
Related: Putting the Focus on Quality of Life in Cancer Care
The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.
A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.
For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.
Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.
Related: Cancer Survivorship Care
Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.
Service can help lymphoma patients find clinical trials
The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.
Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.
Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.
The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.
At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.
At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.
Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.
The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.
“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.
“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”
A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.
“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”
Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year. 
*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.
The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.
Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.
Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.
The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.
At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.
At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.
Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.
The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.
“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.
“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”
A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.
“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”
Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year.
*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.
The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.
Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.
Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.
The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.
At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.
At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.
Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.
The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.
“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.
“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”
A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.
“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”
Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year.
*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.
Study shows RT underused in developing countries
Photo courtesy of ASTRO
BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.
Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.
These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).
“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.
“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”
Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.
The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.
An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).
In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.
Results
The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.
The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.
The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).
Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.
The median level of unmet need was 47% for all countries combined.
Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.
The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.
The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.
“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.
“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”
Photo courtesy of ASTRO
BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.
Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.
These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).
“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.
“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”
Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.
The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.
An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).
In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.
Results
The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.
The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.
The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).
Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.
The median level of unmet need was 47% for all countries combined.
Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.
The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.
The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.
“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.
“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”
Photo courtesy of ASTRO
BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.
Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.
These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).
“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.
“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”
Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.
The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.
An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).
In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.
Results
The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.
The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.
The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).
Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.
The median level of unmet need was 47% for all countries combined.
Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.
The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.
The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.
“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.
“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”
NCCN releases guidelines for managing MF
The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).
The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.
The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.
The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.
Treatment of low-risk MF
The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.
Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.
If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.
Intermediate-1-risk MF
Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).
Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.
If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.
Intermediate-2- or high-risk MF
Patients who are transplant candidates should receive allogeneic HSCT.
Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.
Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.
If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.
If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.
If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.
For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.
“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.
“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”
Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”
The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).
The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.
The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.
The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.
Treatment of low-risk MF
The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.
Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.
If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.
Intermediate-1-risk MF
Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).
Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.
If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.
Intermediate-2- or high-risk MF
Patients who are transplant candidates should receive allogeneic HSCT.
Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.
Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.
If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.
If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.
If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.
For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.
“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.
“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”
Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”
The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).
The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.
The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.
The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.
Treatment of low-risk MF
The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.
Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.
If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.
Intermediate-1-risk MF
Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).
Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.
If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.
Intermediate-2- or high-risk MF
Patients who are transplant candidates should receive allogeneic HSCT.
Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.
Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.
If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.
If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.
If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.
For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.
“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.
“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”
Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”
OSC calls for further review of allegations about Zika test
Photo by Graham Colm
The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.
A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.
The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)
Allegations
The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.
Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.
Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.
He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.
The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.
Investigation
The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.
HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.
The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.
The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.
The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”
The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.
Response
Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”
He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.
Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”
Reassignment
Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.
In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.
After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.
OSC assessment
In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”
On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.
“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.
“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”
Photo by Graham Colm
The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.
A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.
The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)
Allegations
The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.
Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.
Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.
He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.
The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.
Investigation
The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.
HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.
The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.
The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.
The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”
The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.
Response
Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”
He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.
Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”
Reassignment
Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.
In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.
After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.
OSC assessment
In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”
On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.
“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.
“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”
Photo by Graham Colm
The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.
A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.
The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)
Allegations
The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.
Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.
Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.
He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.
The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.
Investigation
The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.
HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.
The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.
The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.
The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”
The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.
Response
Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”
He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.
Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”
Reassignment
Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.
In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.
After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.
OSC assessment
In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”
On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.
“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.
“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”
Hair loss on scalp
The FP noted patchy alopecia with scaling of the scalp and made the presumptive diagnosis of tinea capitis. A woods lamp examination did not demonstrate fluorescence. The child was very cooperative and the doctor was able to perform a potassium hydroxide (KOH) preparation by scraping the areas of alopecia with the edge of one glass slide while catching the scale on another slide. Microscopic examination revealed branching hyphae and some broken hairs with fungal elements within the hair shaft. (See video on how to perform a KOH preparation.) This microscopic picture was consistent with Trichophyton tonsurans, the most common cause of tinea capitis in the United States. The reason that the infected area did not fluoresce was that the dermatophyte was within the hair shaft (endothrix) rather than external to the hair (exothrix).
Topical antifungal therapy is not adequate for tinea capitis; oral treatment is needed. Oral antifungal choices include griseofulvin, terbinafine, and fluconazole. Griseofulvin comes in an oral suspension making it a desirable option for children who can’t swallow pills. However, at least 6 to 8 weeks of treatment (20 mg/kg/d) is required. Oral terbinafine tablets are less expensive and shorter courses of therapy may be used. Tablets of 250 mg terbinafine (most affordable of all the choices) can be broken in half for younger children and the dose should always be calculated based on weight. Fluconazole comes in various tablets, strengths, and liquid formulations and can be prescribed for 3 to 6 weeks, as needed.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Yao C. Tinea capitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill;2013:782-787.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP noted patchy alopecia with scaling of the scalp and made the presumptive diagnosis of tinea capitis. A woods lamp examination did not demonstrate fluorescence. The child was very cooperative and the doctor was able to perform a potassium hydroxide (KOH) preparation by scraping the areas of alopecia with the edge of one glass slide while catching the scale on another slide. Microscopic examination revealed branching hyphae and some broken hairs with fungal elements within the hair shaft. (See video on how to perform a KOH preparation.) This microscopic picture was consistent with Trichophyton tonsurans, the most common cause of tinea capitis in the United States. The reason that the infected area did not fluoresce was that the dermatophyte was within the hair shaft (endothrix) rather than external to the hair (exothrix).
Topical antifungal therapy is not adequate for tinea capitis; oral treatment is needed. Oral antifungal choices include griseofulvin, terbinafine, and fluconazole. Griseofulvin comes in an oral suspension making it a desirable option for children who can’t swallow pills. However, at least 6 to 8 weeks of treatment (20 mg/kg/d) is required. Oral terbinafine tablets are less expensive and shorter courses of therapy may be used. Tablets of 250 mg terbinafine (most affordable of all the choices) can be broken in half for younger children and the dose should always be calculated based on weight. Fluconazole comes in various tablets, strengths, and liquid formulations and can be prescribed for 3 to 6 weeks, as needed.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Yao C. Tinea capitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill;2013:782-787.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP noted patchy alopecia with scaling of the scalp and made the presumptive diagnosis of tinea capitis. A woods lamp examination did not demonstrate fluorescence. The child was very cooperative and the doctor was able to perform a potassium hydroxide (KOH) preparation by scraping the areas of alopecia with the edge of one glass slide while catching the scale on another slide. Microscopic examination revealed branching hyphae and some broken hairs with fungal elements within the hair shaft. (See video on how to perform a KOH preparation.) This microscopic picture was consistent with Trichophyton tonsurans, the most common cause of tinea capitis in the United States. The reason that the infected area did not fluoresce was that the dermatophyte was within the hair shaft (endothrix) rather than external to the hair (exothrix).
Topical antifungal therapy is not adequate for tinea capitis; oral treatment is needed. Oral antifungal choices include griseofulvin, terbinafine, and fluconazole. Griseofulvin comes in an oral suspension making it a desirable option for children who can’t swallow pills. However, at least 6 to 8 weeks of treatment (20 mg/kg/d) is required. Oral terbinafine tablets are less expensive and shorter courses of therapy may be used. Tablets of 250 mg terbinafine (most affordable of all the choices) can be broken in half for younger children and the dose should always be calculated based on weight. Fluconazole comes in various tablets, strengths, and liquid formulations and can be prescribed for 3 to 6 weeks, as needed.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Yao C. Tinea capitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill;2013:782-787.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Heart failure risk with individual NSAIDs examined in study
Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
This report provides additional weight backing the association between increased risk of heart failure with NSAID use and gives better insight on the dose-response relationship between individual NSAIDs and heart failure. However, beyond that, its clinical impact is hurt by the lack of data on the magnitude of excess absolute risk of heart failure with NSAID use, which varies according to baseline cardiovascular risk.
Even though the risk of heart failure associated with NSAID use in the study occurred independent of a history of heart failure, it still is prudent to restrict NSAID use in patients with heart failure because of the high risk noted in this group in other studies.
The widespread use and ease of access to NSAIDs fuels the common misconception that NSAIDs are harmless drugs that are safe for everyone, and this warrants a more restrictive policy by regulatory authorities on the availability of NSAIDs and requirements for health care professionals providing advice on their use.
Gunnar H. Gislason, MD, PhD, is a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte, Denmark, and Christian Torp-Pedersen, MD, is a professor of cardiology at Aalborg (Denmark) University. Dr. Gislason had no disclosures and Dr. Torp-Pedersen advises Bayer on anticoagulation for atrial fibrillation. Their remarks are taken from an editorial accompanying the study by Mr. Arfè and his colleagues (BMJ. 2016 Sep;354:i5163 doi: 10.1136/bmj.i5163).
Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
Nine popular painkillers – including traditional NSAIDs and cyclo-oxygenase-2 (COX-2) inhibitors – are associated with an increased risk of hospitalization for heart failure in adults, based on data from a case-control study of approximately 92,000 hospital admissions. The findings were published online Sept. 28 in BMJ.
Although data from previous large studies suggest that high doses of NSAIDs as well as COX-2 inhibitors increase the risk of hospital admission for heart failure, “there is still limited information on the risk of heart failure associated with the use of individual NSAIDs in clinical practice,” wrote Andrea Arfè of the University of Milano-Bicocca, Milan, and his colleagues (BMJ. 2016 Sep;354:i4857 doi: 10.1136/bmj.i4857).
The researchers reviewed data from five electronic health databases in the Netherlands, Italy, Germany, and the United Kingdom as part of the SOS (Safety of Non-Steroidal Anti-Inflammatory Drugs) project and conducted a nested, case-control study including 92,163 hospital admissions for heart failure and 8,246,403 controls matched for age, sex, and year of study entry. The study included 23 traditional NSAIDs and four selective COX-2 inhibitors.
Overall, individual use of any of nine different NSAIDs within 14 days was associated with a nearly 20% higher likelihood of hospital admission for heart failure, compared with NSAID use more than 183 days in the past (odds ratio, 1.19). For seven traditional NSAIDS (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, and piroxicam) and the COX-2 inhibitors etoricoxib and rofecoxib, the odds ratios for heart failure with current use ranged from 1.16 for naproxen to 1.83 for ketorolac, compared with past use.
In addition, the odds of hospitalization for heart failure doubled for diclofenac, etoricoxib, indomethacin, piroxicam, and rofecoxib when dosed at two or more daily dose equivalents, the researchers noted. There was no increase in the odds of hospitalization for heart failure with celecoxib when dosed at standard levels, but “indomethacin and etoricoxib seemed to increase the risk of hospital admission for heart failure, even if used at medium doses,” they said. Other lesser-used NSAIDs were associated with an increased risk, but it was not statistically significant.
“The effect of individual NSAIDs could depend on a complex interaction of pharmacological properties, including duration and extent of platelet inhibition, extent of blood pressure increase, and properties possibly unique to the molecule,” the researchers said.
The findings were limited by several factors including misclassification of outcomes and the observational nature of the study, which prevents conclusions about cause and effect, the researchers noted. However, “Because any potential increased risk could have a considerable impact on public health, the risk effect estimates provided by this study may help inform both clinical practice and regulatory activities,” they said.
The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
FROM BMJ
Key clinical point: Patients taking high doses of certain NSAIDS had significantly higher odds of hospital admission for heart failure, compared with controls not currently taking the medications.
Major finding: The odds of hospitalization for heart failure increased by 19% overall for adults currently using certain NSAIDS and doubled for users of certain NSAIDs at high doses.
Data source: The data come from approximately 10 million hospital admissions taken from databases in the Netherlands, Italy, Germany, and the United Kingdom.
Disclosures: The study was funded in part by the European Community’s seventh Framework Programme. Mr. Arfè had no financial conflicts to disclose. Several study coauthors disclosed relationships with multiple companies including AstraZeneca, Bayer, Celgene, GlaxoSmithKline, Schwabe, and Novartis.
Cognitive Behavioral Therapy Eases Postconcussive Symptoms in Teens
Adolescents who underwent cognitive behavioral therapy (CBT) as part of postconcussion care reported significantly lower levels of postconcussive and depressive symptoms, according to the results of a randomized trial published online ahead of print September 12 in Pediatrics.
“Affective symptoms, including depression and anxiety, commonly co-occur with cognitive and somatic symptoms and may prolong recovery from postconcussive symptoms, wrote Carolyn A. McCarty, PhD, Research Associate Professor of Pediatrics and Adjunct Research Associate Professor of Psychology at Seattle Children’s Hospital Center for Child Health Behavior and Development in Seattle, and her colleagues.
“The complexities of managing persistent postconcussive symptoms in conjunction with comorbid psychological symptoms create a significant burden for injured children and adolescents, their families, and schools.”
To determine the impact of CBT on persistent symptoms in adolescents with concussions, the researchers randomized 49 patients, ages 11 to 17, to usual care or a collaborative care plan that included usual care plus CBT.
Concussions were diagnosed by sports medicine or rehabilitative medicine specialists. The patients assigned to CBT received usual care management, CBT, and possible psychopharmacologic consultation. Control patients received usual concussion care, generally defined as an initial visit with a sports medicine physician and assessments at one, three, and six months. Usual care also could include MRI, sleep medication, and subthreshold exercise, depending on the patient. No serious adverse events were reported. The average age of the patients was 15, approximately 65% were girls, and 76% were white.
After six months, approximately 13% of the teens in the CBT group reported high levels of postconcussive symptoms, compared with 42% of controls. In addition, 78% of patients receiving CBT reported a depressive symptom reduction of more than 50%, compared with 46% of controls.
Overall, 83% of the patients receiving CBT and 87% of their parents were “very satisfied” with their care, compared with 46% of patients and 29% of parents in the control group.
“Although patients in both groups showed symptom reduction in the first three months, only those who received collaborative care demonstrated sustained improvements through six months of follow-up,” Dr. McCarty and her colleagues wrote.
The results were limited by several factors, including the small size of the study, the researchers said. However, the findings “prompt more investigation into the role of affective symptoms in perpetuating physical symptoms secondary to prolonged recovery from sports-related concussion” and also suggest that collaborative care can help improve persistent postconcussive symptoms in teens.The Seattle Sports Concussion Research Collaborative supported the study.
—Heidi Splete
Suggested Reading
McCarty CA, Zatzick D, Stein E, et al. Collaborative care for adolescents with persistent postconcussive symptoms: a randomized trial. Pediatrics. 2016 Sept 13 [Epub ahead of print].
Cordingley D, Girardin R, Reimer K, et al. Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. J Neurosurg Pediatr. 2016 September 13 [Epub ahead of print].
Adolescents who underwent cognitive behavioral therapy (CBT) as part of postconcussion care reported significantly lower levels of postconcussive and depressive symptoms, according to the results of a randomized trial published online ahead of print September 12 in Pediatrics.
“Affective symptoms, including depression and anxiety, commonly co-occur with cognitive and somatic symptoms and may prolong recovery from postconcussive symptoms, wrote Carolyn A. McCarty, PhD, Research Associate Professor of Pediatrics and Adjunct Research Associate Professor of Psychology at Seattle Children’s Hospital Center for Child Health Behavior and Development in Seattle, and her colleagues.
“The complexities of managing persistent postconcussive symptoms in conjunction with comorbid psychological symptoms create a significant burden for injured children and adolescents, their families, and schools.”
To determine the impact of CBT on persistent symptoms in adolescents with concussions, the researchers randomized 49 patients, ages 11 to 17, to usual care or a collaborative care plan that included usual care plus CBT.
Concussions were diagnosed by sports medicine or rehabilitative medicine specialists. The patients assigned to CBT received usual care management, CBT, and possible psychopharmacologic consultation. Control patients received usual concussion care, generally defined as an initial visit with a sports medicine physician and assessments at one, three, and six months. Usual care also could include MRI, sleep medication, and subthreshold exercise, depending on the patient. No serious adverse events were reported. The average age of the patients was 15, approximately 65% were girls, and 76% were white.
After six months, approximately 13% of the teens in the CBT group reported high levels of postconcussive symptoms, compared with 42% of controls. In addition, 78% of patients receiving CBT reported a depressive symptom reduction of more than 50%, compared with 46% of controls.
Overall, 83% of the patients receiving CBT and 87% of their parents were “very satisfied” with their care, compared with 46% of patients and 29% of parents in the control group.
“Although patients in both groups showed symptom reduction in the first three months, only those who received collaborative care demonstrated sustained improvements through six months of follow-up,” Dr. McCarty and her colleagues wrote.
The results were limited by several factors, including the small size of the study, the researchers said. However, the findings “prompt more investigation into the role of affective symptoms in perpetuating physical symptoms secondary to prolonged recovery from sports-related concussion” and also suggest that collaborative care can help improve persistent postconcussive symptoms in teens.The Seattle Sports Concussion Research Collaborative supported the study.
—Heidi Splete
Suggested Reading
McCarty CA, Zatzick D, Stein E, et al. Collaborative care for adolescents with persistent postconcussive symptoms: a randomized trial. Pediatrics. 2016 Sept 13 [Epub ahead of print].
Cordingley D, Girardin R, Reimer K, et al. Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. J Neurosurg Pediatr. 2016 September 13 [Epub ahead of print].
Adolescents who underwent cognitive behavioral therapy (CBT) as part of postconcussion care reported significantly lower levels of postconcussive and depressive symptoms, according to the results of a randomized trial published online ahead of print September 12 in Pediatrics.
“Affective symptoms, including depression and anxiety, commonly co-occur with cognitive and somatic symptoms and may prolong recovery from postconcussive symptoms, wrote Carolyn A. McCarty, PhD, Research Associate Professor of Pediatrics and Adjunct Research Associate Professor of Psychology at Seattle Children’s Hospital Center for Child Health Behavior and Development in Seattle, and her colleagues.
“The complexities of managing persistent postconcussive symptoms in conjunction with comorbid psychological symptoms create a significant burden for injured children and adolescents, their families, and schools.”
To determine the impact of CBT on persistent symptoms in adolescents with concussions, the researchers randomized 49 patients, ages 11 to 17, to usual care or a collaborative care plan that included usual care plus CBT.
Concussions were diagnosed by sports medicine or rehabilitative medicine specialists. The patients assigned to CBT received usual care management, CBT, and possible psychopharmacologic consultation. Control patients received usual concussion care, generally defined as an initial visit with a sports medicine physician and assessments at one, three, and six months. Usual care also could include MRI, sleep medication, and subthreshold exercise, depending on the patient. No serious adverse events were reported. The average age of the patients was 15, approximately 65% were girls, and 76% were white.
After six months, approximately 13% of the teens in the CBT group reported high levels of postconcussive symptoms, compared with 42% of controls. In addition, 78% of patients receiving CBT reported a depressive symptom reduction of more than 50%, compared with 46% of controls.
Overall, 83% of the patients receiving CBT and 87% of their parents were “very satisfied” with their care, compared with 46% of patients and 29% of parents in the control group.
“Although patients in both groups showed symptom reduction in the first three months, only those who received collaborative care demonstrated sustained improvements through six months of follow-up,” Dr. McCarty and her colleagues wrote.
The results were limited by several factors, including the small size of the study, the researchers said. However, the findings “prompt more investigation into the role of affective symptoms in perpetuating physical symptoms secondary to prolonged recovery from sports-related concussion” and also suggest that collaborative care can help improve persistent postconcussive symptoms in teens.The Seattle Sports Concussion Research Collaborative supported the study.
—Heidi Splete
Suggested Reading
McCarty CA, Zatzick D, Stein E, et al. Collaborative care for adolescents with persistent postconcussive symptoms: a randomized trial. Pediatrics. 2016 Sept 13 [Epub ahead of print].
Cordingley D, Girardin R, Reimer K, et al. Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. J Neurosurg Pediatr. 2016 September 13 [Epub ahead of print].
Adjunctive azithromycin cuts postcesarean infection
Adding a single intravenous dose of azithromycin to standard antibiotic prophylaxis further reduces maternal infections without increasing neonatal adverse outcomes after nonelective cesarean delivery, according to a report published in the New England Journal of Medicine.
The adjunctive azithromycin also significantly decreased rates of postpartum fever and of readmission or unscheduled office visits, wrote Alan T.N. Tita, MD, PhD, of the University of Alabama at Birmingham, and his colleagues.
Recent studies have suggested that extended-spectrum prophylaxis using azithromycin, when added to standard cephalosporin prophylaxis, would further reduce the incidence of post-cesarean infection, chiefly because of azithromycin’s coverage of ureaplasma species that are frequently associated with these infections. The C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial tested this hypothesis in 2,013 women who underwent nonelective cesarean delivery of singleton neonates at 14 U.S. hospitals during a 3.5-year period.
All the women received standard antibiotic prophylaxis (usually with cefazolin) and were randomly assigned to receive either a 500-mg dose of azithromycin (1,019 participants) or a matching placebo (994 participants) before surgical incision.
The primary outcome measure – a composite of endometritis; wound infection; or other infections such as abdominopelvic abscess, maternal sepsis, pelvic septic thrombophlebitis, pyelonephritis, pneumonia, or meningitis occurring up to 6 weeks after surgery – developed in half as many women in the azithromycin group (6.1%) as in the placebo group (12.0%). The relative risk (RR) was 0.51 (P less than .001).
Azithromycin, in particular, was associated with significantly lower rates of endometritis (3.8% vs. 6.1%; RR, 0.62; P = .02) and wound infection (2.4% vs. 6.6%; RR, 0.35; P less than .001). This benefit extended across all subgroups of patients regardless of study site, maternal obesity status, the presence or absence of membrane rupture at randomization, preterm or term delivery, or maternal diabetes status.
The number of patients who would need to be treated to prevent one study outcome was 17 for the primary outcome, 43 for endometritis, and 24 for wound infections, the researchers reported (N Engl J Med. 2016 Sep 29;375:1231-41).
Serious maternal adverse events also were less common with azithromycin (1.5%) than with placebo (2.9%). Neonatal outcomes did not differ between the study groups. The rate of combined neonatal death or complications was 14.3% with azithromycin and 13.6% with placebo, a nonsignificant difference.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Pfizer donated the azithromycin used in the trial. Dr. Tita reported having no relevant financial disclosures; his colleagues reported ties to numerous industry sources.
This well-designed, pragmatic, multicenter trial shows that a single adjunctive dose of azithromycin likely would reduce the number of infectious complications for women undergoing nonelective cesarean section.
The addition of azithromycin may have been particularly effective for the 73% of this study population who had a body mass index of 30 kg/m2 or more. Obesity is known to double the risk of infectious complications, and previous studies have suggested that cefazolin may be underdosed in women with increased BMI values. It appears that azithromycin improved outcomes on the basis of the additive effects of the two drugs against common surgical pathogens, such as staphylococcus species. Information provided in the Supplementary Appendix accompanying the article indicates that routine bacterial cultures, when done, were much-less-frequently positive in the azithromycin group.
Robert A. Weinstein, MD, and Kenneth M. Boyer, MD, are at Rush University Medical Center and Cook County Health and Hospital System, both in Chicago. Dr. Weinstein reported receiving support from Merck outside of this work, and Dr. Boyer reported having no relevant financial disclosures. These remarks are adapted from an accompanying editorial (N Engl J Med. 2016 Sept 29. doi: 10.1056/NEJMe1610010).
This well-designed, pragmatic, multicenter trial shows that a single adjunctive dose of azithromycin likely would reduce the number of infectious complications for women undergoing nonelective cesarean section.
The addition of azithromycin may have been particularly effective for the 73% of this study population who had a body mass index of 30 kg/m2 or more. Obesity is known to double the risk of infectious complications, and previous studies have suggested that cefazolin may be underdosed in women with increased BMI values. It appears that azithromycin improved outcomes on the basis of the additive effects of the two drugs against common surgical pathogens, such as staphylococcus species. Information provided in the Supplementary Appendix accompanying the article indicates that routine bacterial cultures, when done, were much-less-frequently positive in the azithromycin group.
Robert A. Weinstein, MD, and Kenneth M. Boyer, MD, are at Rush University Medical Center and Cook County Health and Hospital System, both in Chicago. Dr. Weinstein reported receiving support from Merck outside of this work, and Dr. Boyer reported having no relevant financial disclosures. These remarks are adapted from an accompanying editorial (N Engl J Med. 2016 Sept 29. doi: 10.1056/NEJMe1610010).
This well-designed, pragmatic, multicenter trial shows that a single adjunctive dose of azithromycin likely would reduce the number of infectious complications for women undergoing nonelective cesarean section.
The addition of azithromycin may have been particularly effective for the 73% of this study population who had a body mass index of 30 kg/m2 or more. Obesity is known to double the risk of infectious complications, and previous studies have suggested that cefazolin may be underdosed in women with increased BMI values. It appears that azithromycin improved outcomes on the basis of the additive effects of the two drugs against common surgical pathogens, such as staphylococcus species. Information provided in the Supplementary Appendix accompanying the article indicates that routine bacterial cultures, when done, were much-less-frequently positive in the azithromycin group.
Robert A. Weinstein, MD, and Kenneth M. Boyer, MD, are at Rush University Medical Center and Cook County Health and Hospital System, both in Chicago. Dr. Weinstein reported receiving support from Merck outside of this work, and Dr. Boyer reported having no relevant financial disclosures. These remarks are adapted from an accompanying editorial (N Engl J Med. 2016 Sept 29. doi: 10.1056/NEJMe1610010).
Adding a single intravenous dose of azithromycin to standard antibiotic prophylaxis further reduces maternal infections without increasing neonatal adverse outcomes after nonelective cesarean delivery, according to a report published in the New England Journal of Medicine.
The adjunctive azithromycin also significantly decreased rates of postpartum fever and of readmission or unscheduled office visits, wrote Alan T.N. Tita, MD, PhD, of the University of Alabama at Birmingham, and his colleagues.
Recent studies have suggested that extended-spectrum prophylaxis using azithromycin, when added to standard cephalosporin prophylaxis, would further reduce the incidence of post-cesarean infection, chiefly because of azithromycin’s coverage of ureaplasma species that are frequently associated with these infections. The C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial tested this hypothesis in 2,013 women who underwent nonelective cesarean delivery of singleton neonates at 14 U.S. hospitals during a 3.5-year period.
All the women received standard antibiotic prophylaxis (usually with cefazolin) and were randomly assigned to receive either a 500-mg dose of azithromycin (1,019 participants) or a matching placebo (994 participants) before surgical incision.
The primary outcome measure – a composite of endometritis; wound infection; or other infections such as abdominopelvic abscess, maternal sepsis, pelvic septic thrombophlebitis, pyelonephritis, pneumonia, or meningitis occurring up to 6 weeks after surgery – developed in half as many women in the azithromycin group (6.1%) as in the placebo group (12.0%). The relative risk (RR) was 0.51 (P less than .001).
Azithromycin, in particular, was associated with significantly lower rates of endometritis (3.8% vs. 6.1%; RR, 0.62; P = .02) and wound infection (2.4% vs. 6.6%; RR, 0.35; P less than .001). This benefit extended across all subgroups of patients regardless of study site, maternal obesity status, the presence or absence of membrane rupture at randomization, preterm or term delivery, or maternal diabetes status.
The number of patients who would need to be treated to prevent one study outcome was 17 for the primary outcome, 43 for endometritis, and 24 for wound infections, the researchers reported (N Engl J Med. 2016 Sep 29;375:1231-41).
Serious maternal adverse events also were less common with azithromycin (1.5%) than with placebo (2.9%). Neonatal outcomes did not differ between the study groups. The rate of combined neonatal death or complications was 14.3% with azithromycin and 13.6% with placebo, a nonsignificant difference.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Pfizer donated the azithromycin used in the trial. Dr. Tita reported having no relevant financial disclosures; his colleagues reported ties to numerous industry sources.
Adding a single intravenous dose of azithromycin to standard antibiotic prophylaxis further reduces maternal infections without increasing neonatal adverse outcomes after nonelective cesarean delivery, according to a report published in the New England Journal of Medicine.
The adjunctive azithromycin also significantly decreased rates of postpartum fever and of readmission or unscheduled office visits, wrote Alan T.N. Tita, MD, PhD, of the University of Alabama at Birmingham, and his colleagues.
Recent studies have suggested that extended-spectrum prophylaxis using azithromycin, when added to standard cephalosporin prophylaxis, would further reduce the incidence of post-cesarean infection, chiefly because of azithromycin’s coverage of ureaplasma species that are frequently associated with these infections. The C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial tested this hypothesis in 2,013 women who underwent nonelective cesarean delivery of singleton neonates at 14 U.S. hospitals during a 3.5-year period.
All the women received standard antibiotic prophylaxis (usually with cefazolin) and were randomly assigned to receive either a 500-mg dose of azithromycin (1,019 participants) or a matching placebo (994 participants) before surgical incision.
The primary outcome measure – a composite of endometritis; wound infection; or other infections such as abdominopelvic abscess, maternal sepsis, pelvic septic thrombophlebitis, pyelonephritis, pneumonia, or meningitis occurring up to 6 weeks after surgery – developed in half as many women in the azithromycin group (6.1%) as in the placebo group (12.0%). The relative risk (RR) was 0.51 (P less than .001).
Azithromycin, in particular, was associated with significantly lower rates of endometritis (3.8% vs. 6.1%; RR, 0.62; P = .02) and wound infection (2.4% vs. 6.6%; RR, 0.35; P less than .001). This benefit extended across all subgroups of patients regardless of study site, maternal obesity status, the presence or absence of membrane rupture at randomization, preterm or term delivery, or maternal diabetes status.
The number of patients who would need to be treated to prevent one study outcome was 17 for the primary outcome, 43 for endometritis, and 24 for wound infections, the researchers reported (N Engl J Med. 2016 Sep 29;375:1231-41).
Serious maternal adverse events also were less common with azithromycin (1.5%) than with placebo (2.9%). Neonatal outcomes did not differ between the study groups. The rate of combined neonatal death or complications was 14.3% with azithromycin and 13.6% with placebo, a nonsignificant difference.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Pfizer donated the azithromycin used in the trial. Dr. Tita reported having no relevant financial disclosures; his colleagues reported ties to numerous industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
