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Caution urged over real-world bleeding risk with ibrutinib
The Bruton tyrosine kinase inhibitor ibrutinib has been linked to an almost 20-fold increased risk of major bleeding in blood cancer patients taking concomitant antiplatelet and anticoagulation therapy in a clinical setting.
Caution should be used when weighing the risks and benefits of ibrutinib for patients already taking antiplatelet or anticoagulation therapy, or both, wrote Paul R. Kunk, MD, of University of Virginia, Charlottesville, and his colleagues. Their report is in Clinical Lymphoma, Myeloma & Leukemia.
Ibrutinib had been associated with an increased risk of bleeding, albeit low, in the clinical trial setting but the authors suggested that this rate could be higher in everyday clinical practice.
“Much of the information [from clinical trials] on the bleeding risk with ibrutinib, included pooled analyses, was from patients exclusively treated in clinical trials with specific exclusion criteria. These criteria have generally excluded patients with significant comorbidities. However, these patients are seen in clinical practice,” the researchers wrote.
They conducted a review of patients attending their center and associated regional clinics between January 2012 and May 2016. They identified 70 patients, average age 72, who were taking ibrutinib for chronic lymphocytic leukemia (64%) and mantle cell lymphoma (27%), diffuse large B-cell lymphoma (4%), lymphoblastic lymphoma (3%), and Waldenström macroglobulinemia (1%).
The analysis showed that bleeding of any grade occurred in 56% of patients, mostly grade 1-2 bruising and epistaxis. However, major bleeding, defined as grade 3, occurred in 13 patients (19%), a figure that the authors noted was greater than the rate of around 7% reported by clinical trials.
Of these patients, seven were taking combined antiplatelet and anticoagulant therapy, four were taking antiplatelets alone, one was taking an anticoagulant agent alone, and one was taking only ibrutinib.
Univariate analysis showed that the factors associated with an increased risk of major bleeding included antiplatelet or anticoagulant medication, the combination of the two medications or interacting medications, anemia (hemoglobin less than 12 g/dL) and an elevated international normalized ratio (greater than 1.5).
However, in a multivariate analysis, only combined antiplatelet and anticoagulant use (hazard ratio, 20.0; 95% confidence interval, 2.1-200.0; P less than .01) and an elevated INR (HR, 4.6; 95% CI, 1.1-19.6; P less than .01) remained statistically significant.
The researchers said the risk of major bleeding in patients taking both antiplatelet and anticoagulant therapy was “unacceptably high” and “medications other than ibrutinib should be considered” in this patient population.
Overall, they said their findings confirmed “the increasingly recognized risk of major bleeding complications with ibrutinib compared with what was originally reported in the clinical trial setting.
“As ibrutinib increases in use, it is paramount to increase awareness of the known adverse events. This is especially important given the association of ibrutinib use with atrial fibrillation,” they wrote.
They noted that their trial was limited by the relatively small population size. Their finding that platelet count was not associated with bleeding risk was also “counterintuitive,” they noted.
SOURCE: Kunk PR et al. Clin Lymphoma Myeloma Leuk. 2018 Jul 15. doi: 10.1016/j.clml.2018.07.287.
The Bruton tyrosine kinase inhibitor ibrutinib has been linked to an almost 20-fold increased risk of major bleeding in blood cancer patients taking concomitant antiplatelet and anticoagulation therapy in a clinical setting.
Caution should be used when weighing the risks and benefits of ibrutinib for patients already taking antiplatelet or anticoagulation therapy, or both, wrote Paul R. Kunk, MD, of University of Virginia, Charlottesville, and his colleagues. Their report is in Clinical Lymphoma, Myeloma & Leukemia.
Ibrutinib had been associated with an increased risk of bleeding, albeit low, in the clinical trial setting but the authors suggested that this rate could be higher in everyday clinical practice.
“Much of the information [from clinical trials] on the bleeding risk with ibrutinib, included pooled analyses, was from patients exclusively treated in clinical trials with specific exclusion criteria. These criteria have generally excluded patients with significant comorbidities. However, these patients are seen in clinical practice,” the researchers wrote.
They conducted a review of patients attending their center and associated regional clinics between January 2012 and May 2016. They identified 70 patients, average age 72, who were taking ibrutinib for chronic lymphocytic leukemia (64%) and mantle cell lymphoma (27%), diffuse large B-cell lymphoma (4%), lymphoblastic lymphoma (3%), and Waldenström macroglobulinemia (1%).
The analysis showed that bleeding of any grade occurred in 56% of patients, mostly grade 1-2 bruising and epistaxis. However, major bleeding, defined as grade 3, occurred in 13 patients (19%), a figure that the authors noted was greater than the rate of around 7% reported by clinical trials.
Of these patients, seven were taking combined antiplatelet and anticoagulant therapy, four were taking antiplatelets alone, one was taking an anticoagulant agent alone, and one was taking only ibrutinib.
Univariate analysis showed that the factors associated with an increased risk of major bleeding included antiplatelet or anticoagulant medication, the combination of the two medications or interacting medications, anemia (hemoglobin less than 12 g/dL) and an elevated international normalized ratio (greater than 1.5).
However, in a multivariate analysis, only combined antiplatelet and anticoagulant use (hazard ratio, 20.0; 95% confidence interval, 2.1-200.0; P less than .01) and an elevated INR (HR, 4.6; 95% CI, 1.1-19.6; P less than .01) remained statistically significant.
The researchers said the risk of major bleeding in patients taking both antiplatelet and anticoagulant therapy was “unacceptably high” and “medications other than ibrutinib should be considered” in this patient population.
Overall, they said their findings confirmed “the increasingly recognized risk of major bleeding complications with ibrutinib compared with what was originally reported in the clinical trial setting.
“As ibrutinib increases in use, it is paramount to increase awareness of the known adverse events. This is especially important given the association of ibrutinib use with atrial fibrillation,” they wrote.
They noted that their trial was limited by the relatively small population size. Their finding that platelet count was not associated with bleeding risk was also “counterintuitive,” they noted.
SOURCE: Kunk PR et al. Clin Lymphoma Myeloma Leuk. 2018 Jul 15. doi: 10.1016/j.clml.2018.07.287.
The Bruton tyrosine kinase inhibitor ibrutinib has been linked to an almost 20-fold increased risk of major bleeding in blood cancer patients taking concomitant antiplatelet and anticoagulation therapy in a clinical setting.
Caution should be used when weighing the risks and benefits of ibrutinib for patients already taking antiplatelet or anticoagulation therapy, or both, wrote Paul R. Kunk, MD, of University of Virginia, Charlottesville, and his colleagues. Their report is in Clinical Lymphoma, Myeloma & Leukemia.
Ibrutinib had been associated with an increased risk of bleeding, albeit low, in the clinical trial setting but the authors suggested that this rate could be higher in everyday clinical practice.
“Much of the information [from clinical trials] on the bleeding risk with ibrutinib, included pooled analyses, was from patients exclusively treated in clinical trials with specific exclusion criteria. These criteria have generally excluded patients with significant comorbidities. However, these patients are seen in clinical practice,” the researchers wrote.
They conducted a review of patients attending their center and associated regional clinics between January 2012 and May 2016. They identified 70 patients, average age 72, who were taking ibrutinib for chronic lymphocytic leukemia (64%) and mantle cell lymphoma (27%), diffuse large B-cell lymphoma (4%), lymphoblastic lymphoma (3%), and Waldenström macroglobulinemia (1%).
The analysis showed that bleeding of any grade occurred in 56% of patients, mostly grade 1-2 bruising and epistaxis. However, major bleeding, defined as grade 3, occurred in 13 patients (19%), a figure that the authors noted was greater than the rate of around 7% reported by clinical trials.
Of these patients, seven were taking combined antiplatelet and anticoagulant therapy, four were taking antiplatelets alone, one was taking an anticoagulant agent alone, and one was taking only ibrutinib.
Univariate analysis showed that the factors associated with an increased risk of major bleeding included antiplatelet or anticoagulant medication, the combination of the two medications or interacting medications, anemia (hemoglobin less than 12 g/dL) and an elevated international normalized ratio (greater than 1.5).
However, in a multivariate analysis, only combined antiplatelet and anticoagulant use (hazard ratio, 20.0; 95% confidence interval, 2.1-200.0; P less than .01) and an elevated INR (HR, 4.6; 95% CI, 1.1-19.6; P less than .01) remained statistically significant.
The researchers said the risk of major bleeding in patients taking both antiplatelet and anticoagulant therapy was “unacceptably high” and “medications other than ibrutinib should be considered” in this patient population.
Overall, they said their findings confirmed “the increasingly recognized risk of major bleeding complications with ibrutinib compared with what was originally reported in the clinical trial setting.
“As ibrutinib increases in use, it is paramount to increase awareness of the known adverse events. This is especially important given the association of ibrutinib use with atrial fibrillation,” they wrote.
They noted that their trial was limited by the relatively small population size. Their finding that platelet count was not associated with bleeding risk was also “counterintuitive,” they noted.
SOURCE: Kunk PR et al. Clin Lymphoma Myeloma Leuk. 2018 Jul 15. doi: 10.1016/j.clml.2018.07.287.
FROM CLINICAL LYMPHOMA, MYELOMA & LEUKEMIA
Key clinical point: Clinicians should exercise caution when prescribing antiplatelet and anticoagulant medications in people taking the Bruton tyrosine kinase inhibitor ibrutinib.
Major finding: The use of both antiplatelet and anticoagulant therapy significantly increased the risk of a major bleed event (HR, 19.2; 95% CI, 2.3-166.7; P less than .01) in patients also taking ibrutinib.
Study details: A retrospective analysis of prescription data from 70 patients seen at a single U.S. cancer center and its regional clinics between January 2012 and May 2016.
Disclosures: Two of the authors reported receiving clinical trial support from Acerta and Abbvie.
Source: Kunk PR et al. Clin Lymphoma Myeloma Leuk. 2018 Jul 15. doi: 10.1016/j.clml.2018.07.287.
Make The Diagnosis - September 2018
Some have postulated an infectious agent as the cause. Atopic dermatitis may confer an increased risk because of the chronic stimulation of T cells. Males are more commonly affected than females by a 2:1 ratio. A worse prognosis is associated with advanced age. Children and adolescents may be affected as well.
With mycosis fungoides, there are three main types of skin lesions: patch, plaque, and tumor. Patients will progress from patch to plaque to tumor stage in classic MF. Often, lesions begin as scaly, erythematous patches that resemble eczema. Because of the nonspecific nature of early lesions, the median duration from the onset of skin lesions to the diagnosis of MF is 4-6 years. Patch stage lesions may be pruritic or asymptomatic. Commonly, they present in non–sun-exposed areas, such as the buttocks. Annular, infiltrated, red-brown or violaceous plaques can develop, which represent malignant T-cell infiltration. Many patients never progress past the plaque stage. Tumor stage MF is more aggressive, with nodules that may undergo necrosis and ulceration.
The leukemic form of MF is Sézary syndrome. Patients present with pruritic erythroderma and lymphadenopathy. Nail dystrophy, scaling of palms and soles, and alopecia may be present. A peripheral blood smear reveals Sézary cells, which are large, hyperconvoluted lymphocytes. The count of Sézary cells is usually greater than 1000 cells/mm3.
Histology of early lesions may not be diagnostic for CTCL. Often, biopsies will be read as eczematous or psoriasiform for years before the diagnosis of MF is made. Classically, epidermotropism (single-cell exocytosis of lymphocytes into the epidermis) is present. Advanced stages may show a dense infiltrate of lymphocytes in the dermis. Groups of lymphocytes in the epidermis form Pautrier’s microabscesses. Mycosis cells may exhibit cerebriform nuclei. Neoplastic cells in MF are CD3+, CD4+, CD45RO+, CD8–. Tissue can be sent for T-cell gene rearrangement polymerase chain reaction. The presence of monoclonal T-cell gene receptor rearrangements can aid in the diagnosis of MF.
Treatment includes topical steroids, mechlorethamine (nitrogen mustard) or bexarotene gel, PUVA therapy, and narrow-band UVB light for limited and/or patch disease. Localized radiotherapy can be used for more resistant lesions. Topical therapies are preferred in the early stages in MF. Systemic treatments for patients who do not respond to local therapy, or in more advanced disease include methotrexate, interferon-alpha, oral bexarotene, denileukin diftitox, and combination chemotherapy. Photopheresis is reserved for erythrodermic disease.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
Some have postulated an infectious agent as the cause. Atopic dermatitis may confer an increased risk because of the chronic stimulation of T cells. Males are more commonly affected than females by a 2:1 ratio. A worse prognosis is associated with advanced age. Children and adolescents may be affected as well.
With mycosis fungoides, there are three main types of skin lesions: patch, plaque, and tumor. Patients will progress from patch to plaque to tumor stage in classic MF. Often, lesions begin as scaly, erythematous patches that resemble eczema. Because of the nonspecific nature of early lesions, the median duration from the onset of skin lesions to the diagnosis of MF is 4-6 years. Patch stage lesions may be pruritic or asymptomatic. Commonly, they present in non–sun-exposed areas, such as the buttocks. Annular, infiltrated, red-brown or violaceous plaques can develop, which represent malignant T-cell infiltration. Many patients never progress past the plaque stage. Tumor stage MF is more aggressive, with nodules that may undergo necrosis and ulceration.
The leukemic form of MF is Sézary syndrome. Patients present with pruritic erythroderma and lymphadenopathy. Nail dystrophy, scaling of palms and soles, and alopecia may be present. A peripheral blood smear reveals Sézary cells, which are large, hyperconvoluted lymphocytes. The count of Sézary cells is usually greater than 1000 cells/mm3.
Histology of early lesions may not be diagnostic for CTCL. Often, biopsies will be read as eczematous or psoriasiform for years before the diagnosis of MF is made. Classically, epidermotropism (single-cell exocytosis of lymphocytes into the epidermis) is present. Advanced stages may show a dense infiltrate of lymphocytes in the dermis. Groups of lymphocytes in the epidermis form Pautrier’s microabscesses. Mycosis cells may exhibit cerebriform nuclei. Neoplastic cells in MF are CD3+, CD4+, CD45RO+, CD8–. Tissue can be sent for T-cell gene rearrangement polymerase chain reaction. The presence of monoclonal T-cell gene receptor rearrangements can aid in the diagnosis of MF.
Treatment includes topical steroids, mechlorethamine (nitrogen mustard) or bexarotene gel, PUVA therapy, and narrow-band UVB light for limited and/or patch disease. Localized radiotherapy can be used for more resistant lesions. Topical therapies are preferred in the early stages in MF. Systemic treatments for patients who do not respond to local therapy, or in more advanced disease include methotrexate, interferon-alpha, oral bexarotene, denileukin diftitox, and combination chemotherapy. Photopheresis is reserved for erythrodermic disease.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
Some have postulated an infectious agent as the cause. Atopic dermatitis may confer an increased risk because of the chronic stimulation of T cells. Males are more commonly affected than females by a 2:1 ratio. A worse prognosis is associated with advanced age. Children and adolescents may be affected as well.
With mycosis fungoides, there are three main types of skin lesions: patch, plaque, and tumor. Patients will progress from patch to plaque to tumor stage in classic MF. Often, lesions begin as scaly, erythematous patches that resemble eczema. Because of the nonspecific nature of early lesions, the median duration from the onset of skin lesions to the diagnosis of MF is 4-6 years. Patch stage lesions may be pruritic or asymptomatic. Commonly, they present in non–sun-exposed areas, such as the buttocks. Annular, infiltrated, red-brown or violaceous plaques can develop, which represent malignant T-cell infiltration. Many patients never progress past the plaque stage. Tumor stage MF is more aggressive, with nodules that may undergo necrosis and ulceration.
The leukemic form of MF is Sézary syndrome. Patients present with pruritic erythroderma and lymphadenopathy. Nail dystrophy, scaling of palms and soles, and alopecia may be present. A peripheral blood smear reveals Sézary cells, which are large, hyperconvoluted lymphocytes. The count of Sézary cells is usually greater than 1000 cells/mm3.
Histology of early lesions may not be diagnostic for CTCL. Often, biopsies will be read as eczematous or psoriasiform for years before the diagnosis of MF is made. Classically, epidermotropism (single-cell exocytosis of lymphocytes into the epidermis) is present. Advanced stages may show a dense infiltrate of lymphocytes in the dermis. Groups of lymphocytes in the epidermis form Pautrier’s microabscesses. Mycosis cells may exhibit cerebriform nuclei. Neoplastic cells in MF are CD3+, CD4+, CD45RO+, CD8–. Tissue can be sent for T-cell gene rearrangement polymerase chain reaction. The presence of monoclonal T-cell gene receptor rearrangements can aid in the diagnosis of MF.
Treatment includes topical steroids, mechlorethamine (nitrogen mustard) or bexarotene gel, PUVA therapy, and narrow-band UVB light for limited and/or patch disease. Localized radiotherapy can be used for more resistant lesions. Topical therapies are preferred in the early stages in MF. Systemic treatments for patients who do not respond to local therapy, or in more advanced disease include methotrexate, interferon-alpha, oral bexarotene, denileukin diftitox, and combination chemotherapy. Photopheresis is reserved for erythrodermic disease.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
Crystal ball: The future of hospital medicine
Profound changes on the horizon
At HM18 in Orlando, the Society of Hospital Medicine’s CEO Larry Wellikson, MD, MHM, challenged our thinking by sharing a slide with the attendees that effectively and accurately captured the current environment. Today’s largest retailer, Amazon, owns no inventory; today’s largest taxi company, Uber, owns no cars; and today’s largest provider of accommodations, Airbnb, owns no real estate.
This powerful statement captures a transformative way of thinking, functioning, and thriving that has rapidly evolved over the past decade in the United States. And yet, health care fundamentally functions very similarly to how it did 10 years ago. I think we can all acknowledge that this is not a sustainable way to advance.
With megamergers dominating the health care landscape in 2017, the industry has become consolidated to weather the economic challenges ahead. Hospital contribution margins have been declining, forcing systems to critically evaluate how they deliver value-based care. In addition, the joining of forces between Amazon, Berkshire Hathaway, and JPMorgan further illustrates the pressures employers are experiencing with costs in the market.
What can we in hospital medicine do to proactively respond to, and shape, the evolving U.S. health care landscape?
If I had a crystal ball and could predict the future, I would say hospital medicine will be functioning very differently in 10 years to respond to today’s challenges.
The acute becomes more acute
When I started working as a hospitalist more than a decade ago, in a tertiary/quaternary academic medical center, the patients were severely ill with multiple comorbidities. Yet, in the span of 10 years, we care for many of those diagnoses in the ambulatory setting.
Reflecting on the severity of illness in my patients when I was recently on the medicine wards, I have to admit the patients now have a significantly higher burden of disease with twice as many comorbidities. As medicine has advanced and we have become more skilled at caring for patients, the acuity of patients has exponentially increased.
As this trend continues, hospitalists will need greater training in critical care components of hospital-based care. While we may comanage some of these patients with critical care, our skill sets need to intensify to address the growing needs of our patient population.
“Bread and butter” moves to lower-acuity settings and home
As our ability to manage patients advances, and the existing inpatient beds are occupied by sicker patients, the common hospital medicine diagnoses will move to skilled nursing facilities, long-term acute care settings, and ultimately home.
Delivery systems will have to create robust networks of home health and home services to actively manage patients with accountability. This provides an opportunity for hospitalists to manage acutely ill patients in less intense settings of care, and the emergence of telehealth will help facilitate this.
In a Feb. 6, 2018 article in JAMA – “Is it Time for a New Medical Specialty?” – Dr. Michael Nochomovitz and Dr. Rahul Sharma argue that, with rapid advances in technology and the establishment of telemedicine, a new specialty – the virtualist – will need to formally emerge (JAMA. 2018;319[5]:437-8. While telehealth has been successfully utilized for the delivery of acute care in remote regions, as well as the delivery of basic services for common diagnoses, it is not robustly and broadly integrated into all aspects of care delivery.
As we move from the hospital setting to less acute settings of care and home-based care, providers need specific training and skill sets in how to manage and deliver care without the patient in front of them. This includes knowledge of how to remotely manage acutely ill patients who are stable and do not require a hospitalization, as well as effectively managing day-to-day issues that arise with patients.
Translating our role in population health management
I have written previously about the expanding role of hospitalists in population health management. In addition to the transitions of care work that we are all involved in, hospitalists must actively partner with our ambulatory colleagues to identify and communicate key barriers to care.
Hospitalists are already instrumental in a number of institutions providing inpatient and ambulatory care for a select group of patients with high utilization. We have the ability to care for high utilizers and partner with ambulatory providers who can ensure we care for patients with high burdens of disease in the most appropriate settings of care. In the fall of 2018, SHM is convening a group of experts in population health to discuss the role of hospitalists in this area.
While I don’t have a crystal ball to predict the future, sadly, SHM is committed to proactively defining and advancing our specialty. I am confident that together we can find the solutions that will successfully advance us towards the future.
Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.
Profound changes on the horizon
Profound changes on the horizon
At HM18 in Orlando, the Society of Hospital Medicine’s CEO Larry Wellikson, MD, MHM, challenged our thinking by sharing a slide with the attendees that effectively and accurately captured the current environment. Today’s largest retailer, Amazon, owns no inventory; today’s largest taxi company, Uber, owns no cars; and today’s largest provider of accommodations, Airbnb, owns no real estate.
This powerful statement captures a transformative way of thinking, functioning, and thriving that has rapidly evolved over the past decade in the United States. And yet, health care fundamentally functions very similarly to how it did 10 years ago. I think we can all acknowledge that this is not a sustainable way to advance.
With megamergers dominating the health care landscape in 2017, the industry has become consolidated to weather the economic challenges ahead. Hospital contribution margins have been declining, forcing systems to critically evaluate how they deliver value-based care. In addition, the joining of forces between Amazon, Berkshire Hathaway, and JPMorgan further illustrates the pressures employers are experiencing with costs in the market.
What can we in hospital medicine do to proactively respond to, and shape, the evolving U.S. health care landscape?
If I had a crystal ball and could predict the future, I would say hospital medicine will be functioning very differently in 10 years to respond to today’s challenges.
The acute becomes more acute
When I started working as a hospitalist more than a decade ago, in a tertiary/quaternary academic medical center, the patients were severely ill with multiple comorbidities. Yet, in the span of 10 years, we care for many of those diagnoses in the ambulatory setting.
Reflecting on the severity of illness in my patients when I was recently on the medicine wards, I have to admit the patients now have a significantly higher burden of disease with twice as many comorbidities. As medicine has advanced and we have become more skilled at caring for patients, the acuity of patients has exponentially increased.
As this trend continues, hospitalists will need greater training in critical care components of hospital-based care. While we may comanage some of these patients with critical care, our skill sets need to intensify to address the growing needs of our patient population.
“Bread and butter” moves to lower-acuity settings and home
As our ability to manage patients advances, and the existing inpatient beds are occupied by sicker patients, the common hospital medicine diagnoses will move to skilled nursing facilities, long-term acute care settings, and ultimately home.
Delivery systems will have to create robust networks of home health and home services to actively manage patients with accountability. This provides an opportunity for hospitalists to manage acutely ill patients in less intense settings of care, and the emergence of telehealth will help facilitate this.
In a Feb. 6, 2018 article in JAMA – “Is it Time for a New Medical Specialty?” – Dr. Michael Nochomovitz and Dr. Rahul Sharma argue that, with rapid advances in technology and the establishment of telemedicine, a new specialty – the virtualist – will need to formally emerge (JAMA. 2018;319[5]:437-8. While telehealth has been successfully utilized for the delivery of acute care in remote regions, as well as the delivery of basic services for common diagnoses, it is not robustly and broadly integrated into all aspects of care delivery.
As we move from the hospital setting to less acute settings of care and home-based care, providers need specific training and skill sets in how to manage and deliver care without the patient in front of them. This includes knowledge of how to remotely manage acutely ill patients who are stable and do not require a hospitalization, as well as effectively managing day-to-day issues that arise with patients.
Translating our role in population health management
I have written previously about the expanding role of hospitalists in population health management. In addition to the transitions of care work that we are all involved in, hospitalists must actively partner with our ambulatory colleagues to identify and communicate key barriers to care.
Hospitalists are already instrumental in a number of institutions providing inpatient and ambulatory care for a select group of patients with high utilization. We have the ability to care for high utilizers and partner with ambulatory providers who can ensure we care for patients with high burdens of disease in the most appropriate settings of care. In the fall of 2018, SHM is convening a group of experts in population health to discuss the role of hospitalists in this area.
While I don’t have a crystal ball to predict the future, sadly, SHM is committed to proactively defining and advancing our specialty. I am confident that together we can find the solutions that will successfully advance us towards the future.
Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.
At HM18 in Orlando, the Society of Hospital Medicine’s CEO Larry Wellikson, MD, MHM, challenged our thinking by sharing a slide with the attendees that effectively and accurately captured the current environment. Today’s largest retailer, Amazon, owns no inventory; today’s largest taxi company, Uber, owns no cars; and today’s largest provider of accommodations, Airbnb, owns no real estate.
This powerful statement captures a transformative way of thinking, functioning, and thriving that has rapidly evolved over the past decade in the United States. And yet, health care fundamentally functions very similarly to how it did 10 years ago. I think we can all acknowledge that this is not a sustainable way to advance.
With megamergers dominating the health care landscape in 2017, the industry has become consolidated to weather the economic challenges ahead. Hospital contribution margins have been declining, forcing systems to critically evaluate how they deliver value-based care. In addition, the joining of forces between Amazon, Berkshire Hathaway, and JPMorgan further illustrates the pressures employers are experiencing with costs in the market.
What can we in hospital medicine do to proactively respond to, and shape, the evolving U.S. health care landscape?
If I had a crystal ball and could predict the future, I would say hospital medicine will be functioning very differently in 10 years to respond to today’s challenges.
The acute becomes more acute
When I started working as a hospitalist more than a decade ago, in a tertiary/quaternary academic medical center, the patients were severely ill with multiple comorbidities. Yet, in the span of 10 years, we care for many of those diagnoses in the ambulatory setting.
Reflecting on the severity of illness in my patients when I was recently on the medicine wards, I have to admit the patients now have a significantly higher burden of disease with twice as many comorbidities. As medicine has advanced and we have become more skilled at caring for patients, the acuity of patients has exponentially increased.
As this trend continues, hospitalists will need greater training in critical care components of hospital-based care. While we may comanage some of these patients with critical care, our skill sets need to intensify to address the growing needs of our patient population.
“Bread and butter” moves to lower-acuity settings and home
As our ability to manage patients advances, and the existing inpatient beds are occupied by sicker patients, the common hospital medicine diagnoses will move to skilled nursing facilities, long-term acute care settings, and ultimately home.
Delivery systems will have to create robust networks of home health and home services to actively manage patients with accountability. This provides an opportunity for hospitalists to manage acutely ill patients in less intense settings of care, and the emergence of telehealth will help facilitate this.
In a Feb. 6, 2018 article in JAMA – “Is it Time for a New Medical Specialty?” – Dr. Michael Nochomovitz and Dr. Rahul Sharma argue that, with rapid advances in technology and the establishment of telemedicine, a new specialty – the virtualist – will need to formally emerge (JAMA. 2018;319[5]:437-8. While telehealth has been successfully utilized for the delivery of acute care in remote regions, as well as the delivery of basic services for common diagnoses, it is not robustly and broadly integrated into all aspects of care delivery.
As we move from the hospital setting to less acute settings of care and home-based care, providers need specific training and skill sets in how to manage and deliver care without the patient in front of them. This includes knowledge of how to remotely manage acutely ill patients who are stable and do not require a hospitalization, as well as effectively managing day-to-day issues that arise with patients.
Translating our role in population health management
I have written previously about the expanding role of hospitalists in population health management. In addition to the transitions of care work that we are all involved in, hospitalists must actively partner with our ambulatory colleagues to identify and communicate key barriers to care.
Hospitalists are already instrumental in a number of institutions providing inpatient and ambulatory care for a select group of patients with high utilization. We have the ability to care for high utilizers and partner with ambulatory providers who can ensure we care for patients with high burdens of disease in the most appropriate settings of care. In the fall of 2018, SHM is convening a group of experts in population health to discuss the role of hospitalists in this area.
While I don’t have a crystal ball to predict the future, sadly, SHM is committed to proactively defining and advancing our specialty. I am confident that together we can find the solutions that will successfully advance us towards the future.
Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.
ADA underscores distinctions in youth, adult T1DM
Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.
The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.
With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.
The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).
In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.
Because the current method of using HbA1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.
The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA1c should be measured at 3-month intervals to assess glycemic control, with a target HbA1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.
The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.
Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.
Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.
The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.
Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.
“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”
The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.
SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.
Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.
The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.
With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.
The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).
In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.
Because the current method of using HbA1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.
The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA1c should be measured at 3-month intervals to assess glycemic control, with a target HbA1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.
The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.
Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.
Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.
The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.
Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.
“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”
The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.
SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.
Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.
The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.
With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.
The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).
In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.
Because the current method of using HbA1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.
The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA1c should be measured at 3-month intervals to assess glycemic control, with a target HbA1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.
The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.
Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.
Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.
The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.
Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.
“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”
The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.
SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.
FROM DIABETES CARE
Key clinical point: Management of type 1 diabetes in children and adolescents should take into account the unique challenges of disease management in that age group, and facilitate an effective transition to adult care.
Major finding: The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and the importance of integrating an exercise and nutrition plan.
Study details: An analysis of numerous diabetes studies and clinical trials.
Disclosures: The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.
Source: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.
Variants in five genes signal TNBC risk
Women with germline pathogenic variants in five genes are at high risk for developing triple-negative breast cancer, and have a greater than 20% lifetime risk for breast cancer in general, results of a large study suggest.
Multigene testing of nearly 11,000 women with triple-negative breast cancer (TNBC; lacking estrogen, progesterone, and human epidermal growth factor receptors) showed that germline pathogenic variants in BARD1, BRCA1, BRCA2, PALB2, and RAD51D were associated with risk for clinical TNBC ranging from nearly sixfold to more than 16-fold higher than that of women without the genetic variants, reported Fergus J. Couch, PhD, of the Mayo Clinic, Rochester, Minn., and his colleagues.
“The results suggest that all TNBC patients should undergo multigene panel testing, regardless of age at diagnosis or family history of cancer, for improved cancer risk assessment and because of the ongoing development of targeted therapeutic approaches for TNBC patients with mutations in predisposition genes,” they wrote. Their report is in the Journal of the National Cancer Institute.
Although National Comprehensive Cancer Network guidelines recommend testing for the cancer predisposition genes BRCA1 and BRCA2 in women with a TNBC diagnosis at age 60 or younger or those with a family history of breast and/or ovarian cancer, the picture is less clear regarding genetic predisposition to TNBC, the authors noted.
“[R]ecommendations for testing of other genes are not fully established because the risks of TNBC associated with mutations in cancer predisposition genes have not been established. Thus, a better understanding of gene-specific risks for TNBC is needed to identify the genes that should be tested in the setting of TNBC,” they wrote.
The investigators looked for associations between deleterious mutations in cancer predisposition genes and TNBC among 8,753 patients with TNBC testing with a 21-gene assay, and among 2,148 women tested for 17 genes in studies conducted by the Triple Negative Breast Cancer Consortium.
They found that among white women, germline pathogenic variants were associated with the following odds ratios (OR) for TNBC (all P values less than .0001):
- BRCA2 = 5.42
- BARD1 = 5.92
- RAD51D = 6.97
- PALB2 = 14.41
- BRCA1 = 16.27
Although there were insufficient data on the risks for African American women, an exploratory analysis showed that risks for TNBC associated with specific pathogenic variants were similar to those for white women, the authors said.
The pathogenic variants were detected in 12% of all patients in the study.
“Continued study of gene-specific risks for breast cancer subtypes may lead to tailored medical management recommendations for PV [pathogenic variant] carriers. Consistent with this hypothesis, initial studies evaluating intensified screening in high-risk women have suggested that a decrease in mortality from TNBC can be achieved,” they wrote.
The study was supported in part by the National Institutes of Health and the Breast Cancer Research Foundation, and was sponsored by Ambry Genetics Inc. The authors reported having no conflicts of interest.
SOURCE: Shimelis H et al. J Natl Cancer Inst. 2018 Aug 7. doi: 10.1093/jnci/djy106.
Women with germline pathogenic variants in five genes are at high risk for developing triple-negative breast cancer, and have a greater than 20% lifetime risk for breast cancer in general, results of a large study suggest.
Multigene testing of nearly 11,000 women with triple-negative breast cancer (TNBC; lacking estrogen, progesterone, and human epidermal growth factor receptors) showed that germline pathogenic variants in BARD1, BRCA1, BRCA2, PALB2, and RAD51D were associated with risk for clinical TNBC ranging from nearly sixfold to more than 16-fold higher than that of women without the genetic variants, reported Fergus J. Couch, PhD, of the Mayo Clinic, Rochester, Minn., and his colleagues.
“The results suggest that all TNBC patients should undergo multigene panel testing, regardless of age at diagnosis or family history of cancer, for improved cancer risk assessment and because of the ongoing development of targeted therapeutic approaches for TNBC patients with mutations in predisposition genes,” they wrote. Their report is in the Journal of the National Cancer Institute.
Although National Comprehensive Cancer Network guidelines recommend testing for the cancer predisposition genes BRCA1 and BRCA2 in women with a TNBC diagnosis at age 60 or younger or those with a family history of breast and/or ovarian cancer, the picture is less clear regarding genetic predisposition to TNBC, the authors noted.
“[R]ecommendations for testing of other genes are not fully established because the risks of TNBC associated with mutations in cancer predisposition genes have not been established. Thus, a better understanding of gene-specific risks for TNBC is needed to identify the genes that should be tested in the setting of TNBC,” they wrote.
The investigators looked for associations between deleterious mutations in cancer predisposition genes and TNBC among 8,753 patients with TNBC testing with a 21-gene assay, and among 2,148 women tested for 17 genes in studies conducted by the Triple Negative Breast Cancer Consortium.
They found that among white women, germline pathogenic variants were associated with the following odds ratios (OR) for TNBC (all P values less than .0001):
- BRCA2 = 5.42
- BARD1 = 5.92
- RAD51D = 6.97
- PALB2 = 14.41
- BRCA1 = 16.27
Although there were insufficient data on the risks for African American women, an exploratory analysis showed that risks for TNBC associated with specific pathogenic variants were similar to those for white women, the authors said.
The pathogenic variants were detected in 12% of all patients in the study.
“Continued study of gene-specific risks for breast cancer subtypes may lead to tailored medical management recommendations for PV [pathogenic variant] carriers. Consistent with this hypothesis, initial studies evaluating intensified screening in high-risk women have suggested that a decrease in mortality from TNBC can be achieved,” they wrote.
The study was supported in part by the National Institutes of Health and the Breast Cancer Research Foundation, and was sponsored by Ambry Genetics Inc. The authors reported having no conflicts of interest.
SOURCE: Shimelis H et al. J Natl Cancer Inst. 2018 Aug 7. doi: 10.1093/jnci/djy106.
Women with germline pathogenic variants in five genes are at high risk for developing triple-negative breast cancer, and have a greater than 20% lifetime risk for breast cancer in general, results of a large study suggest.
Multigene testing of nearly 11,000 women with triple-negative breast cancer (TNBC; lacking estrogen, progesterone, and human epidermal growth factor receptors) showed that germline pathogenic variants in BARD1, BRCA1, BRCA2, PALB2, and RAD51D were associated with risk for clinical TNBC ranging from nearly sixfold to more than 16-fold higher than that of women without the genetic variants, reported Fergus J. Couch, PhD, of the Mayo Clinic, Rochester, Minn., and his colleagues.
“The results suggest that all TNBC patients should undergo multigene panel testing, regardless of age at diagnosis or family history of cancer, for improved cancer risk assessment and because of the ongoing development of targeted therapeutic approaches for TNBC patients with mutations in predisposition genes,” they wrote. Their report is in the Journal of the National Cancer Institute.
Although National Comprehensive Cancer Network guidelines recommend testing for the cancer predisposition genes BRCA1 and BRCA2 in women with a TNBC diagnosis at age 60 or younger or those with a family history of breast and/or ovarian cancer, the picture is less clear regarding genetic predisposition to TNBC, the authors noted.
“[R]ecommendations for testing of other genes are not fully established because the risks of TNBC associated with mutations in cancer predisposition genes have not been established. Thus, a better understanding of gene-specific risks for TNBC is needed to identify the genes that should be tested in the setting of TNBC,” they wrote.
The investigators looked for associations between deleterious mutations in cancer predisposition genes and TNBC among 8,753 patients with TNBC testing with a 21-gene assay, and among 2,148 women tested for 17 genes in studies conducted by the Triple Negative Breast Cancer Consortium.
They found that among white women, germline pathogenic variants were associated with the following odds ratios (OR) for TNBC (all P values less than .0001):
- BRCA2 = 5.42
- BARD1 = 5.92
- RAD51D = 6.97
- PALB2 = 14.41
- BRCA1 = 16.27
Although there were insufficient data on the risks for African American women, an exploratory analysis showed that risks for TNBC associated with specific pathogenic variants were similar to those for white women, the authors said.
The pathogenic variants were detected in 12% of all patients in the study.
“Continued study of gene-specific risks for breast cancer subtypes may lead to tailored medical management recommendations for PV [pathogenic variant] carriers. Consistent with this hypothesis, initial studies evaluating intensified screening in high-risk women have suggested that a decrease in mortality from TNBC can be achieved,” they wrote.
The study was supported in part by the National Institutes of Health and the Breast Cancer Research Foundation, and was sponsored by Ambry Genetics Inc. The authors reported having no conflicts of interest.
SOURCE: Shimelis H et al. J Natl Cancer Inst. 2018 Aug 7. doi: 10.1093/jnci/djy106.
FROM JOURNAL OF THE NATIONAL CANCER INSTITUTE
Key clinical point: Pathogenic variants in five cancer predisposition genes are associated with significantly increased risk for triple negative breast cancer (TNBC).
Major finding: Pathogenic variants in BRCA1 were associated with a more than 16-fold risk for TNBC.
Study details: Retrospective review of multigene assay testing in 10,901 women with TNBC.
Disclosures: The study was supported in part by the National Institutes of Health and the Breast Cancer Research Foundation, and was sponsored by Ambry Genetics Inc. The authors reported having no conflicts of interest.
Source: Shimelis H et al. J Natl Cancer Inst. 2018 Aug 7. doi: 10.1093/jnci/djy106.
Docs push back on step therapy in Medicare Advantage
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
Key clinical point: Medicare Advantage plans will now be able to implement step therapy on Part B drugs.
Major finding: Only new prescriptions will be eligible for step therapy; existing treatments will not be disrupted.
Study details: CMS made the decision to reverse previously existing policy on step therapy as part of an ongoing effort to help lower the cost of prescription drugs.
Disclosures: There were no relevant disclosures.
Source: Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage;
Lung ultrasound predicts need for first-dose surfactant in neonates
Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.
Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.
The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.
In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.
“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.
Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.
At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.
Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.
The authors had no relevant financial disclosures.
SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.
Point-of-care ultrasound (POCUS) has been recognized for years for its value in assessing sick neonates, but a recent survey showed that less than one-third of U.S. neonatal-perinatal medicine programs actually use bedside ultrasound for health care diagnosis and management. Although its use historically has been confined to pediatric cardiology and radiology, it has gained more of a foothold in acute pediatric care settings, and its use in evaluating neonate lungs is a “relatively new and potentially revolutionary approach,” Maria V. Fraga, MD, and her associates wrote in an accompanying editorial.
A growing body of data over the past 2 decades is available to help radiologists and bedside providers to better understand the applications and limitations of POCUS. Findings in similar studies looking at the use of LUS in neonates “make the article by De Martino et al. so important,” Dr. Fraga and her associates emphasized. Dr. De Martino and her colleagues were able to use POCUS of the lung “to develop reliable predictive models for the need for surfactant treatment and re-dosing” in a group of preterm infants.
Although it would seem reasonable to expect the potential benefits of POCUS to have worldwide application, implementation is inconsistent. Clinicians in Australia, New Zealand, and Canada are trained and use POCUS daily, but this is not the case in other countries such as the United States. Concern over legal risks and training, as well as turf disputes with cardiology and radiology, the lack of clinicians actively using ultrasound, and scarce evidence showing benefit of its use could be to blame.
“The development of a POCUS program requires an accessible dedicated ultrasound machine kept in close proximity to clinical areas, a core group of interested clinicians, and a training and accreditation program with a commitment to continuing professional development,” advised Dr. Fraga and her associates.
“It is important to understand the limitation of bedside ultrasound, which should always be performed for a specific clinical purpose and to answer a clinical question and does not always mandate a full comprehensive study,” they added.
Dr. Fraga and her associates are affiliated with the department of pediatrics at the University of Pennsylvania, Philadelphia. There was no external funding and the authors had no relevant financial disclosures. These comments are adapted from an editorial accompanying the article by De Martino et al. (Pediatrics. 2018. doi: 10.1542/peds.2018-1621).
Point-of-care ultrasound (POCUS) has been recognized for years for its value in assessing sick neonates, but a recent survey showed that less than one-third of U.S. neonatal-perinatal medicine programs actually use bedside ultrasound for health care diagnosis and management. Although its use historically has been confined to pediatric cardiology and radiology, it has gained more of a foothold in acute pediatric care settings, and its use in evaluating neonate lungs is a “relatively new and potentially revolutionary approach,” Maria V. Fraga, MD, and her associates wrote in an accompanying editorial.
A growing body of data over the past 2 decades is available to help radiologists and bedside providers to better understand the applications and limitations of POCUS. Findings in similar studies looking at the use of LUS in neonates “make the article by De Martino et al. so important,” Dr. Fraga and her associates emphasized. Dr. De Martino and her colleagues were able to use POCUS of the lung “to develop reliable predictive models for the need for surfactant treatment and re-dosing” in a group of preterm infants.
Although it would seem reasonable to expect the potential benefits of POCUS to have worldwide application, implementation is inconsistent. Clinicians in Australia, New Zealand, and Canada are trained and use POCUS daily, but this is not the case in other countries such as the United States. Concern over legal risks and training, as well as turf disputes with cardiology and radiology, the lack of clinicians actively using ultrasound, and scarce evidence showing benefit of its use could be to blame.
“The development of a POCUS program requires an accessible dedicated ultrasound machine kept in close proximity to clinical areas, a core group of interested clinicians, and a training and accreditation program with a commitment to continuing professional development,” advised Dr. Fraga and her associates.
“It is important to understand the limitation of bedside ultrasound, which should always be performed for a specific clinical purpose and to answer a clinical question and does not always mandate a full comprehensive study,” they added.
Dr. Fraga and her associates are affiliated with the department of pediatrics at the University of Pennsylvania, Philadelphia. There was no external funding and the authors had no relevant financial disclosures. These comments are adapted from an editorial accompanying the article by De Martino et al. (Pediatrics. 2018. doi: 10.1542/peds.2018-1621).
Point-of-care ultrasound (POCUS) has been recognized for years for its value in assessing sick neonates, but a recent survey showed that less than one-third of U.S. neonatal-perinatal medicine programs actually use bedside ultrasound for health care diagnosis and management. Although its use historically has been confined to pediatric cardiology and radiology, it has gained more of a foothold in acute pediatric care settings, and its use in evaluating neonate lungs is a “relatively new and potentially revolutionary approach,” Maria V. Fraga, MD, and her associates wrote in an accompanying editorial.
A growing body of data over the past 2 decades is available to help radiologists and bedside providers to better understand the applications and limitations of POCUS. Findings in similar studies looking at the use of LUS in neonates “make the article by De Martino et al. so important,” Dr. Fraga and her associates emphasized. Dr. De Martino and her colleagues were able to use POCUS of the lung “to develop reliable predictive models for the need for surfactant treatment and re-dosing” in a group of preterm infants.
Although it would seem reasonable to expect the potential benefits of POCUS to have worldwide application, implementation is inconsistent. Clinicians in Australia, New Zealand, and Canada are trained and use POCUS daily, but this is not the case in other countries such as the United States. Concern over legal risks and training, as well as turf disputes with cardiology and radiology, the lack of clinicians actively using ultrasound, and scarce evidence showing benefit of its use could be to blame.
“The development of a POCUS program requires an accessible dedicated ultrasound machine kept in close proximity to clinical areas, a core group of interested clinicians, and a training and accreditation program with a commitment to continuing professional development,” advised Dr. Fraga and her associates.
“It is important to understand the limitation of bedside ultrasound, which should always be performed for a specific clinical purpose and to answer a clinical question and does not always mandate a full comprehensive study,” they added.
Dr. Fraga and her associates are affiliated with the department of pediatrics at the University of Pennsylvania, Philadelphia. There was no external funding and the authors had no relevant financial disclosures. These comments are adapted from an editorial accompanying the article by De Martino et al. (Pediatrics. 2018. doi: 10.1542/peds.2018-1621).
Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.
Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.
The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.
In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.
“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.
Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.
At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.
Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.
The authors had no relevant financial disclosures.
SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.
Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.
Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.
The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.
In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.
“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.
Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.
At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.
Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.
The authors had no relevant financial disclosures.
SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.
FROM PEDIATRICS
Key clinical point:
Major finding: A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose.
Study details: Prospective cohort diagnostic accuracy study that included 133 infants.
Disclosures: The authors had no relevant financial disclosures.
Source: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.
NIMH urged to shift priorities toward children’s mental health
ROCKVILLE, MD. – A researcher is calling for a major shift in funding and priorities within the National Institute of Mental Health to seize on ripe opportunities to better understand how social and environmental factors affect the development of children’s brains.
“This new agenda that I’m suggesting would prioritize child and family health over other populations,” Kimberly E. Hoagwood, PhD, of NYU Langone Health, said at a National Institute of Mental Health conference on mental health services research. “But if we want science to maximize the public health impact and we want our services implementation research to have the biggest impact, then I think we have to think about rebalancing the portfolio.”
Dr. Hoagwood made her argument during a well-received presentation at the meeting. In an interview afterward, Dr. Hoagwood confirmed that she’s advocating for a potential shifting of funds from basic neuroscience.
She previously argued a case for rebalancing priorities within mental health research in a paper published in the Journal of the American Academy of Child and Adolescent Psychiatry (2018 Jan;57[1]:10-3). In the paper, Dr. Hoagwood and her coauthors said the NIMH’s annual funding for child and adolescent services and intervention research decreased 42%, to $30.2 million, from fiscal 2005 to fiscal 2015.
“The NIMH made an explicit decision to invest in basic neuroscience in part because of concerns about the inadequacy of the diagnostic classification systems and limited understanding of the etiology of mental illness,” Dr. Hoagwood and her colleagues wrote in the paper. “This investment could well pay off in the future. However, at least 20% of children now suffer from mental health problems. They cannot be ignored.”
The share of NIMH’s annual budget dedicated to child and adolescent services and intervention research has hovered around 2%-3% in recent years, according to Dr. Hoagwood.
She argued that increased investment in child and adolescent services and intervention research is needed in part because of a flourishing atmosphere outside of the NIMH. At least two dozen notable initiatives looking at social and environmental factors are underway that could contribute greatly to the understanding of factors outside of genetics that influence early brain development, Dr. Hoagwood said.
Those initiatives include about a dozen Medicaid accountable care organizations that are identifying social risks such as poverty, homelessness, food insecurity, and unemployment. Efforts aimed at addressing the effects of poverty through the adoption of strategies such as living wage laws also are underway, she said.
Dr. Hoagwood highlighted the importance of work on the exposome, which the NIMH has described as a new approach to understanding the mechanisms by which environmental factors alter brain and behavior – starting from prenatal development. Dr. Hoagwood said this approach would collect samples to systematically monitor a range of broad-spectrum environmental exposures. She described it as the “complement to the genomic sequencing.”
She called for launching multisite studies to look at how such factors affect brain development, and where and how early interventions can improve children’s healthy development. Data from community efforts and some of those experiments might, at least initially, be “messy beyond belief,” she said.
“We have to not shy away from it. The genomic sequencing has not shied away from messy data,” Dr. Hoagwood said. “We don’t need to do that, either. We need new methods. We need small experiments of novel payment approaches. We need to use our data systems better.”
Dr. Hoagwood had no financial disclosures to report.
ROCKVILLE, MD. – A researcher is calling for a major shift in funding and priorities within the National Institute of Mental Health to seize on ripe opportunities to better understand how social and environmental factors affect the development of children’s brains.
“This new agenda that I’m suggesting would prioritize child and family health over other populations,” Kimberly E. Hoagwood, PhD, of NYU Langone Health, said at a National Institute of Mental Health conference on mental health services research. “But if we want science to maximize the public health impact and we want our services implementation research to have the biggest impact, then I think we have to think about rebalancing the portfolio.”
Dr. Hoagwood made her argument during a well-received presentation at the meeting. In an interview afterward, Dr. Hoagwood confirmed that she’s advocating for a potential shifting of funds from basic neuroscience.
She previously argued a case for rebalancing priorities within mental health research in a paper published in the Journal of the American Academy of Child and Adolescent Psychiatry (2018 Jan;57[1]:10-3). In the paper, Dr. Hoagwood and her coauthors said the NIMH’s annual funding for child and adolescent services and intervention research decreased 42%, to $30.2 million, from fiscal 2005 to fiscal 2015.
“The NIMH made an explicit decision to invest in basic neuroscience in part because of concerns about the inadequacy of the diagnostic classification systems and limited understanding of the etiology of mental illness,” Dr. Hoagwood and her colleagues wrote in the paper. “This investment could well pay off in the future. However, at least 20% of children now suffer from mental health problems. They cannot be ignored.”
The share of NIMH’s annual budget dedicated to child and adolescent services and intervention research has hovered around 2%-3% in recent years, according to Dr. Hoagwood.
She argued that increased investment in child and adolescent services and intervention research is needed in part because of a flourishing atmosphere outside of the NIMH. At least two dozen notable initiatives looking at social and environmental factors are underway that could contribute greatly to the understanding of factors outside of genetics that influence early brain development, Dr. Hoagwood said.
Those initiatives include about a dozen Medicaid accountable care organizations that are identifying social risks such as poverty, homelessness, food insecurity, and unemployment. Efforts aimed at addressing the effects of poverty through the adoption of strategies such as living wage laws also are underway, she said.
Dr. Hoagwood highlighted the importance of work on the exposome, which the NIMH has described as a new approach to understanding the mechanisms by which environmental factors alter brain and behavior – starting from prenatal development. Dr. Hoagwood said this approach would collect samples to systematically monitor a range of broad-spectrum environmental exposures. She described it as the “complement to the genomic sequencing.”
She called for launching multisite studies to look at how such factors affect brain development, and where and how early interventions can improve children’s healthy development. Data from community efforts and some of those experiments might, at least initially, be “messy beyond belief,” she said.
“We have to not shy away from it. The genomic sequencing has not shied away from messy data,” Dr. Hoagwood said. “We don’t need to do that, either. We need new methods. We need small experiments of novel payment approaches. We need to use our data systems better.”
Dr. Hoagwood had no financial disclosures to report.
ROCKVILLE, MD. – A researcher is calling for a major shift in funding and priorities within the National Institute of Mental Health to seize on ripe opportunities to better understand how social and environmental factors affect the development of children’s brains.
“This new agenda that I’m suggesting would prioritize child and family health over other populations,” Kimberly E. Hoagwood, PhD, of NYU Langone Health, said at a National Institute of Mental Health conference on mental health services research. “But if we want science to maximize the public health impact and we want our services implementation research to have the biggest impact, then I think we have to think about rebalancing the portfolio.”
Dr. Hoagwood made her argument during a well-received presentation at the meeting. In an interview afterward, Dr. Hoagwood confirmed that she’s advocating for a potential shifting of funds from basic neuroscience.
She previously argued a case for rebalancing priorities within mental health research in a paper published in the Journal of the American Academy of Child and Adolescent Psychiatry (2018 Jan;57[1]:10-3). In the paper, Dr. Hoagwood and her coauthors said the NIMH’s annual funding for child and adolescent services and intervention research decreased 42%, to $30.2 million, from fiscal 2005 to fiscal 2015.
“The NIMH made an explicit decision to invest in basic neuroscience in part because of concerns about the inadequacy of the diagnostic classification systems and limited understanding of the etiology of mental illness,” Dr. Hoagwood and her colleagues wrote in the paper. “This investment could well pay off in the future. However, at least 20% of children now suffer from mental health problems. They cannot be ignored.”
The share of NIMH’s annual budget dedicated to child and adolescent services and intervention research has hovered around 2%-3% in recent years, according to Dr. Hoagwood.
She argued that increased investment in child and adolescent services and intervention research is needed in part because of a flourishing atmosphere outside of the NIMH. At least two dozen notable initiatives looking at social and environmental factors are underway that could contribute greatly to the understanding of factors outside of genetics that influence early brain development, Dr. Hoagwood said.
Those initiatives include about a dozen Medicaid accountable care organizations that are identifying social risks such as poverty, homelessness, food insecurity, and unemployment. Efforts aimed at addressing the effects of poverty through the adoption of strategies such as living wage laws also are underway, she said.
Dr. Hoagwood highlighted the importance of work on the exposome, which the NIMH has described as a new approach to understanding the mechanisms by which environmental factors alter brain and behavior – starting from prenatal development. Dr. Hoagwood said this approach would collect samples to systematically monitor a range of broad-spectrum environmental exposures. She described it as the “complement to the genomic sequencing.”
She called for launching multisite studies to look at how such factors affect brain development, and where and how early interventions can improve children’s healthy development. Data from community efforts and some of those experiments might, at least initially, be “messy beyond belief,” she said.
“We have to not shy away from it. The genomic sequencing has not shied away from messy data,” Dr. Hoagwood said. “We don’t need to do that, either. We need new methods. We need small experiments of novel payment approaches. We need to use our data systems better.”
Dr. Hoagwood had no financial disclosures to report.
REPORTING FROM AN NIMH CONFERENCE
Sexual minorities seeking abortion report high levels of male violence
Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.
Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.
“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.
Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.
For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.
Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.
Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.
Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).
Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).
“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”
The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.
Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.
The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.
SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.
Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.
Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.
“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.
Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.
For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.
Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.
Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.
Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).
Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).
“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”
The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.
Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.
The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.
SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.
Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.
Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.
“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.
Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.
For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.
Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.
Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.
Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).
Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).
“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”
The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.
Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.
The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.
SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point:
Major finding: Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals (P less than .001), and 3% of bisexuals. Lesbians (33%) were more likely than were heterosexuals (4%) to say the man who impregnated them had physically and/or sexually abused them.
Study details: A 2014 survey of 8,380 women seeking abortions at 87 U.S. nonhospital facilities.
Disclosures: The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.
Source: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.
Three Clinical Studies Demonstrating Safety and Efficacy of Treatment for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) in Adults
In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.
Topics include:
- IBS-D diagnosis and treatment challenges
- The role of microbial imbalance and altered gut microbiota
- A treatment option for relief of IBS-D symptoms
XIFI.0273.USA.18
In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.
Topics include:
- IBS-D diagnosis and treatment challenges
- The role of microbial imbalance and altered gut microbiota
- A treatment option for relief of IBS-D symptoms
XIFI.0273.USA.18
In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.
Topics include:
- IBS-D diagnosis and treatment challenges
- The role of microbial imbalance and altered gut microbiota
- A treatment option for relief of IBS-D symptoms
XIFI.0273.USA.18