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Promising phase 3 results for ixazomib in multiple myeloma
who had responded to high-dose therapy and autologous stem cell transplant.
The drug’s sponsor, Takeda, announced that the oral proteasome inhibitor had met the primary endpoint – progression-free survival versus placebo – in the randomized, phase 3 TOURMALINE-MM3 study. They also reported that adverse events were consistent with previously reported results for single-agent use of ixazomib and that there were no new safety signals.
Full study results will be presented at the annual meeting of the American Society of Hematology. Company officials plan to submit the trial data to the Food and Drug Administration and regulatory agencies around the world to gain approval of ixazomib as a single-agent maintenance therapy, according to a Takeda announcement.
The TOURMALINE-MM3 study is a double-blind study of 656 patients with multiple myeloma who have had complete response, very good partial response, or partial response to induction therapy followed by high-dose therapy and autologous stem cell transplant. In addition to progression-free survival, the trial assessed overall survival.
who had responded to high-dose therapy and autologous stem cell transplant.
The drug’s sponsor, Takeda, announced that the oral proteasome inhibitor had met the primary endpoint – progression-free survival versus placebo – in the randomized, phase 3 TOURMALINE-MM3 study. They also reported that adverse events were consistent with previously reported results for single-agent use of ixazomib and that there were no new safety signals.
Full study results will be presented at the annual meeting of the American Society of Hematology. Company officials plan to submit the trial data to the Food and Drug Administration and regulatory agencies around the world to gain approval of ixazomib as a single-agent maintenance therapy, according to a Takeda announcement.
The TOURMALINE-MM3 study is a double-blind study of 656 patients with multiple myeloma who have had complete response, very good partial response, or partial response to induction therapy followed by high-dose therapy and autologous stem cell transplant. In addition to progression-free survival, the trial assessed overall survival.
who had responded to high-dose therapy and autologous stem cell transplant.
The drug’s sponsor, Takeda, announced that the oral proteasome inhibitor had met the primary endpoint – progression-free survival versus placebo – in the randomized, phase 3 TOURMALINE-MM3 study. They also reported that adverse events were consistent with previously reported results for single-agent use of ixazomib and that there were no new safety signals.
Full study results will be presented at the annual meeting of the American Society of Hematology. Company officials plan to submit the trial data to the Food and Drug Administration and regulatory agencies around the world to gain approval of ixazomib as a single-agent maintenance therapy, according to a Takeda announcement.
The TOURMALINE-MM3 study is a double-blind study of 656 patients with multiple myeloma who have had complete response, very good partial response, or partial response to induction therapy followed by high-dose therapy and autologous stem cell transplant. In addition to progression-free survival, the trial assessed overall survival.
Benefits, drawbacks when hospitalists expand roles
Hospitalists can’t ‘fill all the cracks’ in primary care
As vice chair of the hospital medicine service at Northwell Health, Nick Fitterman, MD, FACP, SFHM, oversees 16 HM groups at 15 hospitals in New York. He says the duties of his hospitalist staff, like those of most U.S. hospitalists, are similar to what they have traditionally been – clinical care on the wards, teaching, comanagement of surgery, quality improvement, committee work, and research. But he has noticed a trend of late: rapid expansion of the hospitalist’s role.
Speaking at an education session at HM18 in Orlando, Dr. Fitterman said the role of the hospitalist is growing to include tasks that might not be as common, but are becoming more familiar all the time: working at infusion centers, caring for patients in skilled nursing facilities, specializing in electronic health record use, colocating in psychiatric hospitals, even being deployed to natural disasters. His list went on, and it was much longer than the list of traditional hospitalist responsibilities.
“Where do we draw the line and say, ‘Wait a minute, our primary site is going to suffer if we continue to get spread this thin. Can we really do it all?” Dr. Fitterman said. As the number of hats hospitalists wear grows ever bigger, he said more thought must be placed into how expansion happens.
The preop clinic
Efren Manjarrez, MD, SFHM, former chief of hospital medicine at the University of Miami, told a cautionary tale about a preoperative clinic staffed by hospitalists that appeared to provide a financial benefit to a hospital – helping to avoid costly last-minute cancellations of surgeries – but that ultimately was shuttered. The hospital, he said, loses $8,000-$10,000 for each case that gets canceled on the same day.
“Think about that just for a minute,” Dr. Manjarrez said. “If 100 cases are canceled during the year at the last minute, that’s a lot of money.”
A preoperative clinic seemed like a worthwhile role for hospitalists – the program was started in Miami by the same doctor who initiated a similar program at Cleveland Clinic. “Surgical cases are what support the hospital [financially], and we’re here to help them along,” Dr. Manjarrez said. “The purpose of hospitalists is to make sure that patients are medically optimized.”
The preop program concept, used in U.S. medicine since the 1990s, was originally started by anesthesiologists, but they may not always be the best fit to staff such programs.
“Anesthesiologists do not manage all beta blockers,” Dr. Manjarrez said. “They don’t manage ACE inhibitors by mouth. They don’t manage all oral diabetes agents, and they sure as heck don’t manage pills that are anticoagulants. That’s the domain of internal medicine. And as patients have become more complex, that’s where hospitalists who [work in] preop clinics have stepped in.”
Studies have found that hospitalists staffing preop clinics have improved quality metrics and some clinical outcomes, including lowering cancellation rates and more appropriate use of beta blockers, he said.
In the Miami program described by Dr. Manjarrez, hospitalists in the preop clinic at first saw only patients who’d been financially cleared as able to pay. But ultimately, a tiered system was developed, and hospitalists saw only patients who were higher risk – those with COPD or stroke patients, for example – without regard to ability to pay.
“The hospital would have to make up any financial deficit at the very end,” Dr. Manjarrez said. This meant there were no longer efficient 5-minute encounters with patients. Instead, visits lasted about 45 minutes, so fewer patients were seen.
The program was successful, in that the same-day cancellation rate for surgeries dropped to less than 0.1% – fewer than 1 in 1,000 – with the preop clinic up and running, Dr. Manjarrez. Still, the hospital decided to end the program. “The hospital no longer wanted to reimburse us,” he said.
A takeaway from this experience for Dr. Manjarrez was that hospitalists need to do a better job of showing the financial benefits in their expanding roles, if they want them to endure.
“At the end of the day, hospitalists do provide value in preoperative clinics,” he said. “But unfortunately, we’re not doing a great job of publishing our data and showing our value.”
At-home care
At Brigham and Women’s Hospital in Boston, hospitalists have demonstrated good results with a program to provide care at home rather than in the hospital.
David Levine, MD, MPH, MA, clinician and investigator at Brigham and Women’s and an instructor in medicine at Harvard Medical School, said that the structure of inpatient care has generally not changed much over decades, despite advances in technology.
“We round on them once a day – if they’re lucky, twice,” he said. “The medicines have changed and imaging has changed, but we really haven’t changed the structure of how we take care of acutely ill adults for almost a hundred years.”
Hospitalizing patients brings unintended consequences. Twenty percent of older adults will become delirious during their stay, 1 out of 3 will lose a level of functional status in the hospital that they’ll never regain, and 1 out of 10 hospitalized patients will experience an adverse event, like an infection or a medication error.
Brigham and Women’s program of at-home care involves “admitting” patients to their homes after being treated in the emergency department. The goal is to reduce costs by 20%, while maintaining quality and safety and improving patients’ quality of life and experience.
Researchers are studying their results. They randomized patients, after the ED determined they required admission, either to admission to the hospital or to their home. The decision on whether to admit was made before the study investigators became involved with the patients, Dr. Levine said.
The program is also intended to improve access to hospitals. Brigham and Women’s is often over 100% capacity in the general medical ward.
Patients in the study needed to live within a 5-mile radius of either Brigham and Women’s Hospital, or Brigham and Women’s Faulkner Hospital, a nearby community hospital. A physician and a registered nurse form the core team; they assess patient needs and ratchet care either up or down, perhaps adding a home health aide or social worker.
The home care team takes advantage of technology: Portable equipment allows a basic metabolic panel to be performed on the spot – for example, a hemoglobin and hematocrit can be produced within 2 minutes. Also, portable ultrasounds and x-rays are used. Doctors keep a “tackle box” of urgent medications such as antibiotics and diuretics.
“We showed a direct cost reduction taking care of patients at home,” Dr. Levine said. There was also a reduction in utilization of care, and an increase in patient activity, with patients taking about 1,800 steps at home, compared with 180 in the hospital. There were no significant changes in safety, quality, or patient experience, he said.
Postdischarge clinics
Lauren Doctoroff, MD, FHM – a hospitalist at Beth Israel Deaconness Medical Center in Boston and assistant professor of medicine at Harvard Medical School – explained another hospitalist-staffed project meant to improve access to care: her center’s postdischarge clinic, which was started in 2009 but is no longer operating.
The clinic tackled the problem of what to do with patients when you discharge them, Dr. Doctoroff said, and its goal was to foster more cooperation between hospitalists and the faculty primary care practice, as well as to improve postdischarge access for patients from that practice.
A dedicated group of hospitalists staffed the clinics, handling medication reconciliation, symptom management, pending tests, and other services the patients were supposed to be getting after discharge, Dr. Doctoroff said.
“We greatly improved access so that when you came to see us you generally saw a hospitalist a week before you would have seen your primary care doctor,” she said. “And that was mostly because we created open access in a clinic that did not have open access. So if a doctor discharging a patient really thought that the patient needed to be seen after discharge, they would often see us.”
Hospitalists considering starting such a clinic have several key questions to consider, Dr. Doctoroff said.
“You need to focus on who the patient population is, the clinic structure, how you plan to staff the clinic, and what your outcomes are – mainly how you will measure performance,” she said.
Dr. Doctoroff said hospitalists are good for this role because “we’re very comfortable with patients who are complicated, and we are very adept at accessing information from the hospitalization. I think, as a hospitalist who spent 5 years seeing patients in a discharge clinic, it greatly enhances my understanding of patients and their challenges at discharge.”
The clinic was closed, she said, in part because it was largely an extension of primary care, and the patient volume wasn’t big enough to justify continuing it.
“Postdischarge clinics are, in a very narrow sense, a bit of a Band-Aid for a really dysfunctional primary care system,” Dr. Doctoroff said. “Ideally, if all you’re doing is providing a postdischarge physician visit, then you really want primary care to be able to do that in order to reengage with their patient. I think this is because postdischarge clinics are construed in a very narrow way to address the simple need to see a patient after discharge. And this may lead to the failure of these clinics, or make them easy to replace. Also, often what patients really need is more than just a physician visit, so a discharge clinic may need to be designed to provide an enhanced array of services.”
Dr. Fitterman said that these stories show that not all role expansion in hospital medicine is good role expansion. The experiences described by Dr. Manjarrez, Dr. Levine, and Dr. Doctoroff demonstrate the challenges hospitalists face as they attempt expansions into new roles, he said.
“We can’t be expected to fill all the cracks in primary care,” Dr. Fitterman said. “As a country we need to really prop up primary care. This all can’t come under the roof of hospital medicine. We need to be part of a patient-centered medical home – but we are not the patient-centered medical home.”
He said the experience with the preop clinic described by Dr. Manjarrez also shows the need for buy-in from hospital or health system administration.
“While most of us are employed by hospitals and want to help meet their needs, we have to be more cautious. We have to look, I think, with a more critical eye, for the value; it may not always be in the dollars coming back in,” he said. “It might be in cost avoidance, such as reducing readmissions, or reducing same-day cancellations in an OR. Unless the C-suite appreciates that value, such programs will be short-lived.”
Hospitalists can’t ‘fill all the cracks’ in primary care
Hospitalists can’t ‘fill all the cracks’ in primary care
As vice chair of the hospital medicine service at Northwell Health, Nick Fitterman, MD, FACP, SFHM, oversees 16 HM groups at 15 hospitals in New York. He says the duties of his hospitalist staff, like those of most U.S. hospitalists, are similar to what they have traditionally been – clinical care on the wards, teaching, comanagement of surgery, quality improvement, committee work, and research. But he has noticed a trend of late: rapid expansion of the hospitalist’s role.
Speaking at an education session at HM18 in Orlando, Dr. Fitterman said the role of the hospitalist is growing to include tasks that might not be as common, but are becoming more familiar all the time: working at infusion centers, caring for patients in skilled nursing facilities, specializing in electronic health record use, colocating in psychiatric hospitals, even being deployed to natural disasters. His list went on, and it was much longer than the list of traditional hospitalist responsibilities.
“Where do we draw the line and say, ‘Wait a minute, our primary site is going to suffer if we continue to get spread this thin. Can we really do it all?” Dr. Fitterman said. As the number of hats hospitalists wear grows ever bigger, he said more thought must be placed into how expansion happens.
The preop clinic
Efren Manjarrez, MD, SFHM, former chief of hospital medicine at the University of Miami, told a cautionary tale about a preoperative clinic staffed by hospitalists that appeared to provide a financial benefit to a hospital – helping to avoid costly last-minute cancellations of surgeries – but that ultimately was shuttered. The hospital, he said, loses $8,000-$10,000 for each case that gets canceled on the same day.
“Think about that just for a minute,” Dr. Manjarrez said. “If 100 cases are canceled during the year at the last minute, that’s a lot of money.”
A preoperative clinic seemed like a worthwhile role for hospitalists – the program was started in Miami by the same doctor who initiated a similar program at Cleveland Clinic. “Surgical cases are what support the hospital [financially], and we’re here to help them along,” Dr. Manjarrez said. “The purpose of hospitalists is to make sure that patients are medically optimized.”
The preop program concept, used in U.S. medicine since the 1990s, was originally started by anesthesiologists, but they may not always be the best fit to staff such programs.
“Anesthesiologists do not manage all beta blockers,” Dr. Manjarrez said. “They don’t manage ACE inhibitors by mouth. They don’t manage all oral diabetes agents, and they sure as heck don’t manage pills that are anticoagulants. That’s the domain of internal medicine. And as patients have become more complex, that’s where hospitalists who [work in] preop clinics have stepped in.”
Studies have found that hospitalists staffing preop clinics have improved quality metrics and some clinical outcomes, including lowering cancellation rates and more appropriate use of beta blockers, he said.
In the Miami program described by Dr. Manjarrez, hospitalists in the preop clinic at first saw only patients who’d been financially cleared as able to pay. But ultimately, a tiered system was developed, and hospitalists saw only patients who were higher risk – those with COPD or stroke patients, for example – without regard to ability to pay.
“The hospital would have to make up any financial deficit at the very end,” Dr. Manjarrez said. This meant there were no longer efficient 5-minute encounters with patients. Instead, visits lasted about 45 minutes, so fewer patients were seen.
The program was successful, in that the same-day cancellation rate for surgeries dropped to less than 0.1% – fewer than 1 in 1,000 – with the preop clinic up and running, Dr. Manjarrez. Still, the hospital decided to end the program. “The hospital no longer wanted to reimburse us,” he said.
A takeaway from this experience for Dr. Manjarrez was that hospitalists need to do a better job of showing the financial benefits in their expanding roles, if they want them to endure.
“At the end of the day, hospitalists do provide value in preoperative clinics,” he said. “But unfortunately, we’re not doing a great job of publishing our data and showing our value.”
At-home care
At Brigham and Women’s Hospital in Boston, hospitalists have demonstrated good results with a program to provide care at home rather than in the hospital.
David Levine, MD, MPH, MA, clinician and investigator at Brigham and Women’s and an instructor in medicine at Harvard Medical School, said that the structure of inpatient care has generally not changed much over decades, despite advances in technology.
“We round on them once a day – if they’re lucky, twice,” he said. “The medicines have changed and imaging has changed, but we really haven’t changed the structure of how we take care of acutely ill adults for almost a hundred years.”
Hospitalizing patients brings unintended consequences. Twenty percent of older adults will become delirious during their stay, 1 out of 3 will lose a level of functional status in the hospital that they’ll never regain, and 1 out of 10 hospitalized patients will experience an adverse event, like an infection or a medication error.
Brigham and Women’s program of at-home care involves “admitting” patients to their homes after being treated in the emergency department. The goal is to reduce costs by 20%, while maintaining quality and safety and improving patients’ quality of life and experience.
Researchers are studying their results. They randomized patients, after the ED determined they required admission, either to admission to the hospital or to their home. The decision on whether to admit was made before the study investigators became involved with the patients, Dr. Levine said.
The program is also intended to improve access to hospitals. Brigham and Women’s is often over 100% capacity in the general medical ward.
Patients in the study needed to live within a 5-mile radius of either Brigham and Women’s Hospital, or Brigham and Women’s Faulkner Hospital, a nearby community hospital. A physician and a registered nurse form the core team; they assess patient needs and ratchet care either up or down, perhaps adding a home health aide or social worker.
The home care team takes advantage of technology: Portable equipment allows a basic metabolic panel to be performed on the spot – for example, a hemoglobin and hematocrit can be produced within 2 minutes. Also, portable ultrasounds and x-rays are used. Doctors keep a “tackle box” of urgent medications such as antibiotics and diuretics.
“We showed a direct cost reduction taking care of patients at home,” Dr. Levine said. There was also a reduction in utilization of care, and an increase in patient activity, with patients taking about 1,800 steps at home, compared with 180 in the hospital. There were no significant changes in safety, quality, or patient experience, he said.
Postdischarge clinics
Lauren Doctoroff, MD, FHM – a hospitalist at Beth Israel Deaconness Medical Center in Boston and assistant professor of medicine at Harvard Medical School – explained another hospitalist-staffed project meant to improve access to care: her center’s postdischarge clinic, which was started in 2009 but is no longer operating.
The clinic tackled the problem of what to do with patients when you discharge them, Dr. Doctoroff said, and its goal was to foster more cooperation between hospitalists and the faculty primary care practice, as well as to improve postdischarge access for patients from that practice.
A dedicated group of hospitalists staffed the clinics, handling medication reconciliation, symptom management, pending tests, and other services the patients were supposed to be getting after discharge, Dr. Doctoroff said.
“We greatly improved access so that when you came to see us you generally saw a hospitalist a week before you would have seen your primary care doctor,” she said. “And that was mostly because we created open access in a clinic that did not have open access. So if a doctor discharging a patient really thought that the patient needed to be seen after discharge, they would often see us.”
Hospitalists considering starting such a clinic have several key questions to consider, Dr. Doctoroff said.
“You need to focus on who the patient population is, the clinic structure, how you plan to staff the clinic, and what your outcomes are – mainly how you will measure performance,” she said.
Dr. Doctoroff said hospitalists are good for this role because “we’re very comfortable with patients who are complicated, and we are very adept at accessing information from the hospitalization. I think, as a hospitalist who spent 5 years seeing patients in a discharge clinic, it greatly enhances my understanding of patients and their challenges at discharge.”
The clinic was closed, she said, in part because it was largely an extension of primary care, and the patient volume wasn’t big enough to justify continuing it.
“Postdischarge clinics are, in a very narrow sense, a bit of a Band-Aid for a really dysfunctional primary care system,” Dr. Doctoroff said. “Ideally, if all you’re doing is providing a postdischarge physician visit, then you really want primary care to be able to do that in order to reengage with their patient. I think this is because postdischarge clinics are construed in a very narrow way to address the simple need to see a patient after discharge. And this may lead to the failure of these clinics, or make them easy to replace. Also, often what patients really need is more than just a physician visit, so a discharge clinic may need to be designed to provide an enhanced array of services.”
Dr. Fitterman said that these stories show that not all role expansion in hospital medicine is good role expansion. The experiences described by Dr. Manjarrez, Dr. Levine, and Dr. Doctoroff demonstrate the challenges hospitalists face as they attempt expansions into new roles, he said.
“We can’t be expected to fill all the cracks in primary care,” Dr. Fitterman said. “As a country we need to really prop up primary care. This all can’t come under the roof of hospital medicine. We need to be part of a patient-centered medical home – but we are not the patient-centered medical home.”
He said the experience with the preop clinic described by Dr. Manjarrez also shows the need for buy-in from hospital or health system administration.
“While most of us are employed by hospitals and want to help meet their needs, we have to be more cautious. We have to look, I think, with a more critical eye, for the value; it may not always be in the dollars coming back in,” he said. “It might be in cost avoidance, such as reducing readmissions, or reducing same-day cancellations in an OR. Unless the C-suite appreciates that value, such programs will be short-lived.”
As vice chair of the hospital medicine service at Northwell Health, Nick Fitterman, MD, FACP, SFHM, oversees 16 HM groups at 15 hospitals in New York. He says the duties of his hospitalist staff, like those of most U.S. hospitalists, are similar to what they have traditionally been – clinical care on the wards, teaching, comanagement of surgery, quality improvement, committee work, and research. But he has noticed a trend of late: rapid expansion of the hospitalist’s role.
Speaking at an education session at HM18 in Orlando, Dr. Fitterman said the role of the hospitalist is growing to include tasks that might not be as common, but are becoming more familiar all the time: working at infusion centers, caring for patients in skilled nursing facilities, specializing in electronic health record use, colocating in psychiatric hospitals, even being deployed to natural disasters. His list went on, and it was much longer than the list of traditional hospitalist responsibilities.
“Where do we draw the line and say, ‘Wait a minute, our primary site is going to suffer if we continue to get spread this thin. Can we really do it all?” Dr. Fitterman said. As the number of hats hospitalists wear grows ever bigger, he said more thought must be placed into how expansion happens.
The preop clinic
Efren Manjarrez, MD, SFHM, former chief of hospital medicine at the University of Miami, told a cautionary tale about a preoperative clinic staffed by hospitalists that appeared to provide a financial benefit to a hospital – helping to avoid costly last-minute cancellations of surgeries – but that ultimately was shuttered. The hospital, he said, loses $8,000-$10,000 for each case that gets canceled on the same day.
“Think about that just for a minute,” Dr. Manjarrez said. “If 100 cases are canceled during the year at the last minute, that’s a lot of money.”
A preoperative clinic seemed like a worthwhile role for hospitalists – the program was started in Miami by the same doctor who initiated a similar program at Cleveland Clinic. “Surgical cases are what support the hospital [financially], and we’re here to help them along,” Dr. Manjarrez said. “The purpose of hospitalists is to make sure that patients are medically optimized.”
The preop program concept, used in U.S. medicine since the 1990s, was originally started by anesthesiologists, but they may not always be the best fit to staff such programs.
“Anesthesiologists do not manage all beta blockers,” Dr. Manjarrez said. “They don’t manage ACE inhibitors by mouth. They don’t manage all oral diabetes agents, and they sure as heck don’t manage pills that are anticoagulants. That’s the domain of internal medicine. And as patients have become more complex, that’s where hospitalists who [work in] preop clinics have stepped in.”
Studies have found that hospitalists staffing preop clinics have improved quality metrics and some clinical outcomes, including lowering cancellation rates and more appropriate use of beta blockers, he said.
In the Miami program described by Dr. Manjarrez, hospitalists in the preop clinic at first saw only patients who’d been financially cleared as able to pay. But ultimately, a tiered system was developed, and hospitalists saw only patients who were higher risk – those with COPD or stroke patients, for example – without regard to ability to pay.
“The hospital would have to make up any financial deficit at the very end,” Dr. Manjarrez said. This meant there were no longer efficient 5-minute encounters with patients. Instead, visits lasted about 45 minutes, so fewer patients were seen.
The program was successful, in that the same-day cancellation rate for surgeries dropped to less than 0.1% – fewer than 1 in 1,000 – with the preop clinic up and running, Dr. Manjarrez. Still, the hospital decided to end the program. “The hospital no longer wanted to reimburse us,” he said.
A takeaway from this experience for Dr. Manjarrez was that hospitalists need to do a better job of showing the financial benefits in their expanding roles, if they want them to endure.
“At the end of the day, hospitalists do provide value in preoperative clinics,” he said. “But unfortunately, we’re not doing a great job of publishing our data and showing our value.”
At-home care
At Brigham and Women’s Hospital in Boston, hospitalists have demonstrated good results with a program to provide care at home rather than in the hospital.
David Levine, MD, MPH, MA, clinician and investigator at Brigham and Women’s and an instructor in medicine at Harvard Medical School, said that the structure of inpatient care has generally not changed much over decades, despite advances in technology.
“We round on them once a day – if they’re lucky, twice,” he said. “The medicines have changed and imaging has changed, but we really haven’t changed the structure of how we take care of acutely ill adults for almost a hundred years.”
Hospitalizing patients brings unintended consequences. Twenty percent of older adults will become delirious during their stay, 1 out of 3 will lose a level of functional status in the hospital that they’ll never regain, and 1 out of 10 hospitalized patients will experience an adverse event, like an infection or a medication error.
Brigham and Women’s program of at-home care involves “admitting” patients to their homes after being treated in the emergency department. The goal is to reduce costs by 20%, while maintaining quality and safety and improving patients’ quality of life and experience.
Researchers are studying their results. They randomized patients, after the ED determined they required admission, either to admission to the hospital or to their home. The decision on whether to admit was made before the study investigators became involved with the patients, Dr. Levine said.
The program is also intended to improve access to hospitals. Brigham and Women’s is often over 100% capacity in the general medical ward.
Patients in the study needed to live within a 5-mile radius of either Brigham and Women’s Hospital, or Brigham and Women’s Faulkner Hospital, a nearby community hospital. A physician and a registered nurse form the core team; they assess patient needs and ratchet care either up or down, perhaps adding a home health aide or social worker.
The home care team takes advantage of technology: Portable equipment allows a basic metabolic panel to be performed on the spot – for example, a hemoglobin and hematocrit can be produced within 2 minutes. Also, portable ultrasounds and x-rays are used. Doctors keep a “tackle box” of urgent medications such as antibiotics and diuretics.
“We showed a direct cost reduction taking care of patients at home,” Dr. Levine said. There was also a reduction in utilization of care, and an increase in patient activity, with patients taking about 1,800 steps at home, compared with 180 in the hospital. There were no significant changes in safety, quality, or patient experience, he said.
Postdischarge clinics
Lauren Doctoroff, MD, FHM – a hospitalist at Beth Israel Deaconness Medical Center in Boston and assistant professor of medicine at Harvard Medical School – explained another hospitalist-staffed project meant to improve access to care: her center’s postdischarge clinic, which was started in 2009 but is no longer operating.
The clinic tackled the problem of what to do with patients when you discharge them, Dr. Doctoroff said, and its goal was to foster more cooperation between hospitalists and the faculty primary care practice, as well as to improve postdischarge access for patients from that practice.
A dedicated group of hospitalists staffed the clinics, handling medication reconciliation, symptom management, pending tests, and other services the patients were supposed to be getting after discharge, Dr. Doctoroff said.
“We greatly improved access so that when you came to see us you generally saw a hospitalist a week before you would have seen your primary care doctor,” she said. “And that was mostly because we created open access in a clinic that did not have open access. So if a doctor discharging a patient really thought that the patient needed to be seen after discharge, they would often see us.”
Hospitalists considering starting such a clinic have several key questions to consider, Dr. Doctoroff said.
“You need to focus on who the patient population is, the clinic structure, how you plan to staff the clinic, and what your outcomes are – mainly how you will measure performance,” she said.
Dr. Doctoroff said hospitalists are good for this role because “we’re very comfortable with patients who are complicated, and we are very adept at accessing information from the hospitalization. I think, as a hospitalist who spent 5 years seeing patients in a discharge clinic, it greatly enhances my understanding of patients and their challenges at discharge.”
The clinic was closed, she said, in part because it was largely an extension of primary care, and the patient volume wasn’t big enough to justify continuing it.
“Postdischarge clinics are, in a very narrow sense, a bit of a Band-Aid for a really dysfunctional primary care system,” Dr. Doctoroff said. “Ideally, if all you’re doing is providing a postdischarge physician visit, then you really want primary care to be able to do that in order to reengage with their patient. I think this is because postdischarge clinics are construed in a very narrow way to address the simple need to see a patient after discharge. And this may lead to the failure of these clinics, or make them easy to replace. Also, often what patients really need is more than just a physician visit, so a discharge clinic may need to be designed to provide an enhanced array of services.”
Dr. Fitterman said that these stories show that not all role expansion in hospital medicine is good role expansion. The experiences described by Dr. Manjarrez, Dr. Levine, and Dr. Doctoroff demonstrate the challenges hospitalists face as they attempt expansions into new roles, he said.
“We can’t be expected to fill all the cracks in primary care,” Dr. Fitterman said. “As a country we need to really prop up primary care. This all can’t come under the roof of hospital medicine. We need to be part of a patient-centered medical home – but we are not the patient-centered medical home.”
He said the experience with the preop clinic described by Dr. Manjarrez also shows the need for buy-in from hospital or health system administration.
“While most of us are employed by hospitals and want to help meet their needs, we have to be more cautious. We have to look, I think, with a more critical eye, for the value; it may not always be in the dollars coming back in,” he said. “It might be in cost avoidance, such as reducing readmissions, or reducing same-day cancellations in an OR. Unless the C-suite appreciates that value, such programs will be short-lived.”
SHM: My home as a pediatric hospitalist
As I began my career in pediatric hospital medicine at the Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn., I knew that I wanted a way to continue my education and to network with other hospitalists with interests in academics and pediatrics.
In 2010, I decided to attend a pre-course to the Society of Hospital Medicine’s annual conference that focused on academic hospital medicine, and my career has never been the same! I am thrilled to say I have found my professional home in SHM.
Here’s a quick list of the reasons SHM has been such a warm, welcoming home for me. I’ve highlighted the few options that stood out to me, but rest assured there is so much more from which to choose:
- Leadership opportunities in our Pediatrics Special Interest Group.
- Representation on the Annual Conference Committee to select pediatric-specific content as well as workshops on leadership, education, patient experience, and quality improvement.
- The Academic Hospitalist Academy, first as a pre-course before the SHM annual conference, and now as its own amazing meeting for academic pediatric hospital medicine providers.
- SHM’s Leadership Academy, a wonderful opportunity to learn leadership skills and network with other leaders. This year, it is in Vancouver!
- Participation in quality improvement initiatives like Pedi-BOOST, a care transitions program that specializes in pediatric patients.
- Traveling to Abu Dhabi and the Middle East Update in Hospital Medicine this March – being able to spread the latest trends in hospital medicine in the USA is one of the best experiences I have had with SHM!
Another reason SHM truly made me feel welcomed was the opportunity to attend the Pediatric Hospital Medicine (PHM) meeting. Each July, SHM helps to put on the largest gathering of pediatric hospital medicine providers. This year, it will be held in Atlanta from July 19-22.
This meeting is organized and supported by SHM, the American Academy of Pediatrics (AAP), and the Academic Pediatric Association (APA), and offers spectacular content in many tracks, including quality improvement, education, research, and the incredibly popular “Top Articles” presentation at lunch on Saturday. This session provides teaching materials that can span the year for Journal Clubs and resident and student education. The abstracts and poster sessions are top-notch and provide an opportunity for young and experienced providers to share their work.
The fourth annual Knowledge Café will be a highlight for me as well, as it allows collaboration and networking experiences in hot topics for early career hospitalists. How to strive for work/life balance, how to get the most out of your first meeting, and techniques for talking with your boss about difficult issues are some of the topics we plan to cover this year.
On top of this, networking and participation on various committees and work groups afforded me the opportunity to join the SHM Board of Directors in May of 2017. Having completed my first year on the Board, I have an even deeper appreciation for the progressive thinking of our leadership team and the amazing work that the staff of SHM does behind the scenes to help us maximize our memberships. I love the continuous process improvement that is happening with every Board meeting.
As a member of the Board, it’s important to keep tabs on the pulse of SHM members and their evolving needs. One way I have really enjoyed getting to learn about our membership is by attending local chapter meetings. I recently traveled to West Virginia and Connecticut, both of which have active, engaged chapters working to improve care in their local communities – it was so inspiring to have the opportunity to represent the organization, and I look forward to more meetings just like this. For our local chapter in Nashville, I have the honor of picking the venue for our meetings, which keeps me on my toes as I look for the latest hot spots in an incredibly happening city!
Last summer, the benefits of membership in SHM and my career choice of hospital medicine took on a whole new meaning. In July, just before PHM 2017, a meeting that I was lucky enough to chair, my husband started to feel the pain of a recurrent kidney stone as he was traveling with our four sons and their three friends. Can you imagine being on an airplane with seven elementary school–age boys when the worst pain EVER strikes?
I was home in Nashville thinking, “Who can I call to help him in Minneapolis?” My first thought was of fellow members of SHM with whom I’ve developed friendships over the years – other hospitalists like you and me. Many people came to mind, all of whom practice hospital medicine! A huge thank-you to our friend Dr. Shaun Frost, who rescued my husband, drove him to a local ED, AND took the seven boys out for lunch. I truly have never been so grateful!
My task for you is simple: Engage with the Society of Hospital Medicine! Come to a meeting, join a special interest group, connect with your local chapter, and make friends who can support you through your career – and, as evidenced by my husband’s experience – even in your personal life. It’s truly a special organization, and I can’t wait to share some experiences just like these with you.
Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.
As I began my career in pediatric hospital medicine at the Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn., I knew that I wanted a way to continue my education and to network with other hospitalists with interests in academics and pediatrics.
In 2010, I decided to attend a pre-course to the Society of Hospital Medicine’s annual conference that focused on academic hospital medicine, and my career has never been the same! I am thrilled to say I have found my professional home in SHM.
Here’s a quick list of the reasons SHM has been such a warm, welcoming home for me. I’ve highlighted the few options that stood out to me, but rest assured there is so much more from which to choose:
- Leadership opportunities in our Pediatrics Special Interest Group.
- Representation on the Annual Conference Committee to select pediatric-specific content as well as workshops on leadership, education, patient experience, and quality improvement.
- The Academic Hospitalist Academy, first as a pre-course before the SHM annual conference, and now as its own amazing meeting for academic pediatric hospital medicine providers.
- SHM’s Leadership Academy, a wonderful opportunity to learn leadership skills and network with other leaders. This year, it is in Vancouver!
- Participation in quality improvement initiatives like Pedi-BOOST, a care transitions program that specializes in pediatric patients.
- Traveling to Abu Dhabi and the Middle East Update in Hospital Medicine this March – being able to spread the latest trends in hospital medicine in the USA is one of the best experiences I have had with SHM!
Another reason SHM truly made me feel welcomed was the opportunity to attend the Pediatric Hospital Medicine (PHM) meeting. Each July, SHM helps to put on the largest gathering of pediatric hospital medicine providers. This year, it will be held in Atlanta from July 19-22.
This meeting is organized and supported by SHM, the American Academy of Pediatrics (AAP), and the Academic Pediatric Association (APA), and offers spectacular content in many tracks, including quality improvement, education, research, and the incredibly popular “Top Articles” presentation at lunch on Saturday. This session provides teaching materials that can span the year for Journal Clubs and resident and student education. The abstracts and poster sessions are top-notch and provide an opportunity for young and experienced providers to share their work.
The fourth annual Knowledge Café will be a highlight for me as well, as it allows collaboration and networking experiences in hot topics for early career hospitalists. How to strive for work/life balance, how to get the most out of your first meeting, and techniques for talking with your boss about difficult issues are some of the topics we plan to cover this year.
On top of this, networking and participation on various committees and work groups afforded me the opportunity to join the SHM Board of Directors in May of 2017. Having completed my first year on the Board, I have an even deeper appreciation for the progressive thinking of our leadership team and the amazing work that the staff of SHM does behind the scenes to help us maximize our memberships. I love the continuous process improvement that is happening with every Board meeting.
As a member of the Board, it’s important to keep tabs on the pulse of SHM members and their evolving needs. One way I have really enjoyed getting to learn about our membership is by attending local chapter meetings. I recently traveled to West Virginia and Connecticut, both of which have active, engaged chapters working to improve care in their local communities – it was so inspiring to have the opportunity to represent the organization, and I look forward to more meetings just like this. For our local chapter in Nashville, I have the honor of picking the venue for our meetings, which keeps me on my toes as I look for the latest hot spots in an incredibly happening city!
Last summer, the benefits of membership in SHM and my career choice of hospital medicine took on a whole new meaning. In July, just before PHM 2017, a meeting that I was lucky enough to chair, my husband started to feel the pain of a recurrent kidney stone as he was traveling with our four sons and their three friends. Can you imagine being on an airplane with seven elementary school–age boys when the worst pain EVER strikes?
I was home in Nashville thinking, “Who can I call to help him in Minneapolis?” My first thought was of fellow members of SHM with whom I’ve developed friendships over the years – other hospitalists like you and me. Many people came to mind, all of whom practice hospital medicine! A huge thank-you to our friend Dr. Shaun Frost, who rescued my husband, drove him to a local ED, AND took the seven boys out for lunch. I truly have never been so grateful!
My task for you is simple: Engage with the Society of Hospital Medicine! Come to a meeting, join a special interest group, connect with your local chapter, and make friends who can support you through your career – and, as evidenced by my husband’s experience – even in your personal life. It’s truly a special organization, and I can’t wait to share some experiences just like these with you.
Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.
As I began my career in pediatric hospital medicine at the Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn., I knew that I wanted a way to continue my education and to network with other hospitalists with interests in academics and pediatrics.
In 2010, I decided to attend a pre-course to the Society of Hospital Medicine’s annual conference that focused on academic hospital medicine, and my career has never been the same! I am thrilled to say I have found my professional home in SHM.
Here’s a quick list of the reasons SHM has been such a warm, welcoming home for me. I’ve highlighted the few options that stood out to me, but rest assured there is so much more from which to choose:
- Leadership opportunities in our Pediatrics Special Interest Group.
- Representation on the Annual Conference Committee to select pediatric-specific content as well as workshops on leadership, education, patient experience, and quality improvement.
- The Academic Hospitalist Academy, first as a pre-course before the SHM annual conference, and now as its own amazing meeting for academic pediatric hospital medicine providers.
- SHM’s Leadership Academy, a wonderful opportunity to learn leadership skills and network with other leaders. This year, it is in Vancouver!
- Participation in quality improvement initiatives like Pedi-BOOST, a care transitions program that specializes in pediatric patients.
- Traveling to Abu Dhabi and the Middle East Update in Hospital Medicine this March – being able to spread the latest trends in hospital medicine in the USA is one of the best experiences I have had with SHM!
Another reason SHM truly made me feel welcomed was the opportunity to attend the Pediatric Hospital Medicine (PHM) meeting. Each July, SHM helps to put on the largest gathering of pediatric hospital medicine providers. This year, it will be held in Atlanta from July 19-22.
This meeting is organized and supported by SHM, the American Academy of Pediatrics (AAP), and the Academic Pediatric Association (APA), and offers spectacular content in many tracks, including quality improvement, education, research, and the incredibly popular “Top Articles” presentation at lunch on Saturday. This session provides teaching materials that can span the year for Journal Clubs and resident and student education. The abstracts and poster sessions are top-notch and provide an opportunity for young and experienced providers to share their work.
The fourth annual Knowledge Café will be a highlight for me as well, as it allows collaboration and networking experiences in hot topics for early career hospitalists. How to strive for work/life balance, how to get the most out of your first meeting, and techniques for talking with your boss about difficult issues are some of the topics we plan to cover this year.
On top of this, networking and participation on various committees and work groups afforded me the opportunity to join the SHM Board of Directors in May of 2017. Having completed my first year on the Board, I have an even deeper appreciation for the progressive thinking of our leadership team and the amazing work that the staff of SHM does behind the scenes to help us maximize our memberships. I love the continuous process improvement that is happening with every Board meeting.
As a member of the Board, it’s important to keep tabs on the pulse of SHM members and their evolving needs. One way I have really enjoyed getting to learn about our membership is by attending local chapter meetings. I recently traveled to West Virginia and Connecticut, both of which have active, engaged chapters working to improve care in their local communities – it was so inspiring to have the opportunity to represent the organization, and I look forward to more meetings just like this. For our local chapter in Nashville, I have the honor of picking the venue for our meetings, which keeps me on my toes as I look for the latest hot spots in an incredibly happening city!
Last summer, the benefits of membership in SHM and my career choice of hospital medicine took on a whole new meaning. In July, just before PHM 2017, a meeting that I was lucky enough to chair, my husband started to feel the pain of a recurrent kidney stone as he was traveling with our four sons and their three friends. Can you imagine being on an airplane with seven elementary school–age boys when the worst pain EVER strikes?
I was home in Nashville thinking, “Who can I call to help him in Minneapolis?” My first thought was of fellow members of SHM with whom I’ve developed friendships over the years – other hospitalists like you and me. Many people came to mind, all of whom practice hospital medicine! A huge thank-you to our friend Dr. Shaun Frost, who rescued my husband, drove him to a local ED, AND took the seven boys out for lunch. I truly have never been so grateful!
My task for you is simple: Engage with the Society of Hospital Medicine! Come to a meeting, join a special interest group, connect with your local chapter, and make friends who can support you through your career – and, as evidenced by my husband’s experience – even in your personal life. It’s truly a special organization, and I can’t wait to share some experiences just like these with you.
Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.
Device impresses for chronic cluster headache attacks
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
REPORTING FROM THE AHS ANNUAL MEETING
Key clinical point: Sphenopalatine ganglion stimulation aborts chronic cluster headache attacks and reduces their frequency.
Major finding: Seventy-one percent of patients with longstanding chronic cluster headaches achieved at least a 75% reduction in either attack frequency or severity by using a sphenopalatine ganglion stimulation device.
Study details: This was a prospective multicenter study in which 93 chronic cluster headache patients were randomized to sphenopalatine ganglion stimulation or sham stimulation.
Disclosures: The presenter serves as a consultant to Autonomic Technologies Inc., which funded the study, and numerous other companies.
Source: Dodick DW. AHS 2018 Abstract PS112LB.
Sweeping reductions to documentation included in Medicare fee schedule proposal
Doctors could spend less time with their EHRs under Medicare’s proposed physician fee schedule for 2019.
The sweeping proposal also would improve Medicare telemedicine opportunities and update portions of the Quality Payment Program and the Medicare Shared Savings Program, according to documents posted online July 12. There would also be more opportunities to be paid for telemedicine services under the proposed rule, released by the Centers for Medicare & Medicaid Services online July 12 and scheduled for publication July 27 in the Federal Register.
“We are streamlining the system of office E&M codes and reducing the requirements for documentation,” CMS Administrator Seema Verma said during a July 12 press conference.
The proposal would condense all four levels of E&M coding to one level, with one payment – there would no longer be higher payments provided for high levels.
While the change could reduce payments to specialists who generally bill only at the highest level for E&M visits, that difference should be made up in the additional time physicians should have to see patients, according to a fact sheet on the proposed physician fee schedule.
“We estimate that this proposal would save approximately 51 hours of clinic time per clinician per year,” Ms. Verma said, or an additional 500 years of time available for patient care across the system.
The proposed schedule also would expand the list of services that qualify for telemedicine payments and would add payments for virtual check-ins via phone or other communication technologies such as Skype, paying clinicians for time spent reviewing patient photos submitted via text or e-mail.
More time savings could come from proposed reductions to the documentation required to qualify for bonus payments under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
CMS proposes to remove 34 process measures that are considered to be low-value or low-priority, Ms. Verma said, noting that most physicians are doing these measures but seeing no meaningful difference in the performance that would differentiate payment under the program.
The proposed update continues on with the MyHealthEData initiative by supporting greater patient access to their individual health records. Ms. Verma said that the agency will “reward providers that offer interoperability and provide patients access to their health information.”
While the proposal would not change most of the thresholds for participating MIPS – physicians still would be exempted if they bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients – they also would be exempted if they perform 200 or fewer services under Medicare fee schedule. However, the agency is proposing for the first time to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements, according to a fact sheet on the proposed changes to QPP.
CMS also is proposing changes to how it pays for new drugs administered in the physician office under Medicare Part B. The proposal would reduce reimbursement for drugs that have not yet been on the market long enough to establish an average sales price from wholesale acquisition cost (WAC) plus 6% to WAC plus 3%, potentially saving money for both patients and Medicare.
The agency also asked for information related to price transparency as part of the proposal. It is looking for perspectives on whether providers and suppliers can and should be required to provide charge and payments information, for health care services and out-of-pocket costs, as well as what data elements would be most useful to consumers to promote price shopping.
Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.
Doctors could spend less time with their EHRs under Medicare’s proposed physician fee schedule for 2019.
The sweeping proposal also would improve Medicare telemedicine opportunities and update portions of the Quality Payment Program and the Medicare Shared Savings Program, according to documents posted online July 12. There would also be more opportunities to be paid for telemedicine services under the proposed rule, released by the Centers for Medicare & Medicaid Services online July 12 and scheduled for publication July 27 in the Federal Register.
“We are streamlining the system of office E&M codes and reducing the requirements for documentation,” CMS Administrator Seema Verma said during a July 12 press conference.
The proposal would condense all four levels of E&M coding to one level, with one payment – there would no longer be higher payments provided for high levels.
While the change could reduce payments to specialists who generally bill only at the highest level for E&M visits, that difference should be made up in the additional time physicians should have to see patients, according to a fact sheet on the proposed physician fee schedule.
“We estimate that this proposal would save approximately 51 hours of clinic time per clinician per year,” Ms. Verma said, or an additional 500 years of time available for patient care across the system.
The proposed schedule also would expand the list of services that qualify for telemedicine payments and would add payments for virtual check-ins via phone or other communication technologies such as Skype, paying clinicians for time spent reviewing patient photos submitted via text or e-mail.
More time savings could come from proposed reductions to the documentation required to qualify for bonus payments under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
CMS proposes to remove 34 process measures that are considered to be low-value or low-priority, Ms. Verma said, noting that most physicians are doing these measures but seeing no meaningful difference in the performance that would differentiate payment under the program.
The proposed update continues on with the MyHealthEData initiative by supporting greater patient access to their individual health records. Ms. Verma said that the agency will “reward providers that offer interoperability and provide patients access to their health information.”
While the proposal would not change most of the thresholds for participating MIPS – physicians still would be exempted if they bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients – they also would be exempted if they perform 200 or fewer services under Medicare fee schedule. However, the agency is proposing for the first time to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements, according to a fact sheet on the proposed changes to QPP.
CMS also is proposing changes to how it pays for new drugs administered in the physician office under Medicare Part B. The proposal would reduce reimbursement for drugs that have not yet been on the market long enough to establish an average sales price from wholesale acquisition cost (WAC) plus 6% to WAC plus 3%, potentially saving money for both patients and Medicare.
The agency also asked for information related to price transparency as part of the proposal. It is looking for perspectives on whether providers and suppliers can and should be required to provide charge and payments information, for health care services and out-of-pocket costs, as well as what data elements would be most useful to consumers to promote price shopping.
Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.
Doctors could spend less time with their EHRs under Medicare’s proposed physician fee schedule for 2019.
The sweeping proposal also would improve Medicare telemedicine opportunities and update portions of the Quality Payment Program and the Medicare Shared Savings Program, according to documents posted online July 12. There would also be more opportunities to be paid for telemedicine services under the proposed rule, released by the Centers for Medicare & Medicaid Services online July 12 and scheduled for publication July 27 in the Federal Register.
“We are streamlining the system of office E&M codes and reducing the requirements for documentation,” CMS Administrator Seema Verma said during a July 12 press conference.
The proposal would condense all four levels of E&M coding to one level, with one payment – there would no longer be higher payments provided for high levels.
While the change could reduce payments to specialists who generally bill only at the highest level for E&M visits, that difference should be made up in the additional time physicians should have to see patients, according to a fact sheet on the proposed physician fee schedule.
“We estimate that this proposal would save approximately 51 hours of clinic time per clinician per year,” Ms. Verma said, or an additional 500 years of time available for patient care across the system.
The proposed schedule also would expand the list of services that qualify for telemedicine payments and would add payments for virtual check-ins via phone or other communication technologies such as Skype, paying clinicians for time spent reviewing patient photos submitted via text or e-mail.
More time savings could come from proposed reductions to the documentation required to qualify for bonus payments under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
CMS proposes to remove 34 process measures that are considered to be low-value or low-priority, Ms. Verma said, noting that most physicians are doing these measures but seeing no meaningful difference in the performance that would differentiate payment under the program.
The proposed update continues on with the MyHealthEData initiative by supporting greater patient access to their individual health records. Ms. Verma said that the agency will “reward providers that offer interoperability and provide patients access to their health information.”
While the proposal would not change most of the thresholds for participating MIPS – physicians still would be exempted if they bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients – they also would be exempted if they perform 200 or fewer services under Medicare fee schedule. However, the agency is proposing for the first time to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements, according to a fact sheet on the proposed changes to QPP.
CMS also is proposing changes to how it pays for new drugs administered in the physician office under Medicare Part B. The proposal would reduce reimbursement for drugs that have not yet been on the market long enough to establish an average sales price from wholesale acquisition cost (WAC) plus 6% to WAC plus 3%, potentially saving money for both patients and Medicare.
The agency also asked for information related to price transparency as part of the proposal. It is looking for perspectives on whether providers and suppliers can and should be required to provide charge and payments information, for health care services and out-of-pocket costs, as well as what data elements would be most useful to consumers to promote price shopping.
Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.
New analysis improves understanding of PHACE syndrome
LAKE TAHOE, CALIF. –
In addition, children with isolated S2 or parotid hemangiomas should be recognized as having lower risk for PHACE, and specifics of evaluation should be discussed with parents on a case-by-case basis.
Those are key findings from a retrospective cohort study presented by Colleen Cotton, MD, at the annual meeting of the Society for Pediatric Dermatology.
An association between large facial hemangiomas and multiple abnormalities was described as early as 1978, but it wasn’t until 1996 that researchers first proposed the term PHACE to describe the association (Arch Dermatol. 1996;132[3]:307-11). As the National Institutes of Health explain, “PHACE is an acronym for a neurocutaneous syndrome encompassing the following features: posterior fossa brain malformations, hemangiomas of the face, arterial anomalies, cardiac anomalies, and eye abnormalities.” Official diagnostic criteria for PHACE were not established until 2009 (Pediatrics. 2009;124[5]:1447-56) and were updated in 2016 (J Pediatr. 2016;178:24-33.e2).
“A multicenter, prospective, cohort study published in 2010 estimated the incidence of PHACE to be 31% in patients with large facial hemangiomas, while a retrospective study published in 2017 estimated the incidence to be as high as 58%,” Dr. Cotton, chief dermatology resident at the University of Arizona, Tucson, said in an interview in advance of the meeting. “With the current understanding of risk for PHACE, any child with a facial hemangioma of greater than or equal to 5 cm in diameter receives a full work-up for the syndrome. However, there has been anecdotal evidence that patients with certain subtypes of hemangiomas (such as parotid hemangiomas) may not carry this same risk.”
In what is believed to be the largest study of its kind, Dr. Cotton and her associates retrospectively analyzed data from 244 patients from 13 pediatric dermatology centers who were fully evaluated for PHACE between August 2009 and December 2014. The investigators also performed subgroup analyses on different hemangioma characteristics, including parotid hemangiomas and specific facial segments of involvement. All patients underwent magnetic resonance imaging/magnetic resonance angiography of the head and neck, and the researchers collected data on age at diagnosis; gender; patterns of hemangioma presentation, including location, size, and depth; diagnostic procedures and results; and type and number of associated anomalies. An expert reviewed photographs or diagrams to confirm facial segment locations.
Of the 244 patients, 34.7% met criteria for PHACE syndrome. On multivariate analysis, the following factors were found to be independently and significantly associated with a risk for PHACE: bilateral location (positive predictive value, 54.9%), S1 involvement (PPV, 49.5%), S3 involvement (PPV, 39.5%), and area greater than 25cm2 (PPV, 44.8%), with a P value less than .05 for all associations.
Risk of PHACE also increased with the number of locations involved, with a sharp increase observed at three or more locations (PPV, 65.5%; P less than .001). In patients with one unilateral segment involved, S2 and S3 carried a significantly lower risk (P less than .03). Parotid hemangiomas had a negative predictive value of 80.4% (P = .035).
“While we found that patients with parotid hemangiomas had a lower risk of PHACE, 10 patients with parotid hemangiomas did have PHACE, and 90% of those patients had cerebral arterial anomalies,” Dr. Cotton said. “However, only one of these patients had an isolated unilateral parotid hemangioma without other facial segment involvement. Additionally, two patients with isolated involvement of the midcheek below the eye [the S2 location, which was another low risk segment] also had PHACE, both of whom would have been missed without MRI/MRA [magnetic resonance angiography].”
She acknowledged certain limitations of the study, including its retrospective design. “Additionally, many of the very large hemangiomas were not measured in size, and so, estimated sizes needed to be used in calculating relationship of hemangioma size with risk of PHACE,” she said.
The study was funded in part by a grant from the Pediatric Dermatology Research Alliance.* Dr. Cotton reported having no relevant financial disclosures.
Correction, 7/20/18: An earlier version of this article misstated the name of the Pediatric Dermatology Research Alliance.
LAKE TAHOE, CALIF. –
In addition, children with isolated S2 or parotid hemangiomas should be recognized as having lower risk for PHACE, and specifics of evaluation should be discussed with parents on a case-by-case basis.
Those are key findings from a retrospective cohort study presented by Colleen Cotton, MD, at the annual meeting of the Society for Pediatric Dermatology.
An association between large facial hemangiomas and multiple abnormalities was described as early as 1978, but it wasn’t until 1996 that researchers first proposed the term PHACE to describe the association (Arch Dermatol. 1996;132[3]:307-11). As the National Institutes of Health explain, “PHACE is an acronym for a neurocutaneous syndrome encompassing the following features: posterior fossa brain malformations, hemangiomas of the face, arterial anomalies, cardiac anomalies, and eye abnormalities.” Official diagnostic criteria for PHACE were not established until 2009 (Pediatrics. 2009;124[5]:1447-56) and were updated in 2016 (J Pediatr. 2016;178:24-33.e2).
“A multicenter, prospective, cohort study published in 2010 estimated the incidence of PHACE to be 31% in patients with large facial hemangiomas, while a retrospective study published in 2017 estimated the incidence to be as high as 58%,” Dr. Cotton, chief dermatology resident at the University of Arizona, Tucson, said in an interview in advance of the meeting. “With the current understanding of risk for PHACE, any child with a facial hemangioma of greater than or equal to 5 cm in diameter receives a full work-up for the syndrome. However, there has been anecdotal evidence that patients with certain subtypes of hemangiomas (such as parotid hemangiomas) may not carry this same risk.”
In what is believed to be the largest study of its kind, Dr. Cotton and her associates retrospectively analyzed data from 244 patients from 13 pediatric dermatology centers who were fully evaluated for PHACE between August 2009 and December 2014. The investigators also performed subgroup analyses on different hemangioma characteristics, including parotid hemangiomas and specific facial segments of involvement. All patients underwent magnetic resonance imaging/magnetic resonance angiography of the head and neck, and the researchers collected data on age at diagnosis; gender; patterns of hemangioma presentation, including location, size, and depth; diagnostic procedures and results; and type and number of associated anomalies. An expert reviewed photographs or diagrams to confirm facial segment locations.
Of the 244 patients, 34.7% met criteria for PHACE syndrome. On multivariate analysis, the following factors were found to be independently and significantly associated with a risk for PHACE: bilateral location (positive predictive value, 54.9%), S1 involvement (PPV, 49.5%), S3 involvement (PPV, 39.5%), and area greater than 25cm2 (PPV, 44.8%), with a P value less than .05 for all associations.
Risk of PHACE also increased with the number of locations involved, with a sharp increase observed at three or more locations (PPV, 65.5%; P less than .001). In patients with one unilateral segment involved, S2 and S3 carried a significantly lower risk (P less than .03). Parotid hemangiomas had a negative predictive value of 80.4% (P = .035).
“While we found that patients with parotid hemangiomas had a lower risk of PHACE, 10 patients with parotid hemangiomas did have PHACE, and 90% of those patients had cerebral arterial anomalies,” Dr. Cotton said. “However, only one of these patients had an isolated unilateral parotid hemangioma without other facial segment involvement. Additionally, two patients with isolated involvement of the midcheek below the eye [the S2 location, which was another low risk segment] also had PHACE, both of whom would have been missed without MRI/MRA [magnetic resonance angiography].”
She acknowledged certain limitations of the study, including its retrospective design. “Additionally, many of the very large hemangiomas were not measured in size, and so, estimated sizes needed to be used in calculating relationship of hemangioma size with risk of PHACE,” she said.
The study was funded in part by a grant from the Pediatric Dermatology Research Alliance.* Dr. Cotton reported having no relevant financial disclosures.
Correction, 7/20/18: An earlier version of this article misstated the name of the Pediatric Dermatology Research Alliance.
LAKE TAHOE, CALIF. –
In addition, children with isolated S2 or parotid hemangiomas should be recognized as having lower risk for PHACE, and specifics of evaluation should be discussed with parents on a case-by-case basis.
Those are key findings from a retrospective cohort study presented by Colleen Cotton, MD, at the annual meeting of the Society for Pediatric Dermatology.
An association between large facial hemangiomas and multiple abnormalities was described as early as 1978, but it wasn’t until 1996 that researchers first proposed the term PHACE to describe the association (Arch Dermatol. 1996;132[3]:307-11). As the National Institutes of Health explain, “PHACE is an acronym for a neurocutaneous syndrome encompassing the following features: posterior fossa brain malformations, hemangiomas of the face, arterial anomalies, cardiac anomalies, and eye abnormalities.” Official diagnostic criteria for PHACE were not established until 2009 (Pediatrics. 2009;124[5]:1447-56) and were updated in 2016 (J Pediatr. 2016;178:24-33.e2).
“A multicenter, prospective, cohort study published in 2010 estimated the incidence of PHACE to be 31% in patients with large facial hemangiomas, while a retrospective study published in 2017 estimated the incidence to be as high as 58%,” Dr. Cotton, chief dermatology resident at the University of Arizona, Tucson, said in an interview in advance of the meeting. “With the current understanding of risk for PHACE, any child with a facial hemangioma of greater than or equal to 5 cm in diameter receives a full work-up for the syndrome. However, there has been anecdotal evidence that patients with certain subtypes of hemangiomas (such as parotid hemangiomas) may not carry this same risk.”
In what is believed to be the largest study of its kind, Dr. Cotton and her associates retrospectively analyzed data from 244 patients from 13 pediatric dermatology centers who were fully evaluated for PHACE between August 2009 and December 2014. The investigators also performed subgroup analyses on different hemangioma characteristics, including parotid hemangiomas and specific facial segments of involvement. All patients underwent magnetic resonance imaging/magnetic resonance angiography of the head and neck, and the researchers collected data on age at diagnosis; gender; patterns of hemangioma presentation, including location, size, and depth; diagnostic procedures and results; and type and number of associated anomalies. An expert reviewed photographs or diagrams to confirm facial segment locations.
Of the 244 patients, 34.7% met criteria for PHACE syndrome. On multivariate analysis, the following factors were found to be independently and significantly associated with a risk for PHACE: bilateral location (positive predictive value, 54.9%), S1 involvement (PPV, 49.5%), S3 involvement (PPV, 39.5%), and area greater than 25cm2 (PPV, 44.8%), with a P value less than .05 for all associations.
Risk of PHACE also increased with the number of locations involved, with a sharp increase observed at three or more locations (PPV, 65.5%; P less than .001). In patients with one unilateral segment involved, S2 and S3 carried a significantly lower risk (P less than .03). Parotid hemangiomas had a negative predictive value of 80.4% (P = .035).
“While we found that patients with parotid hemangiomas had a lower risk of PHACE, 10 patients with parotid hemangiomas did have PHACE, and 90% of those patients had cerebral arterial anomalies,” Dr. Cotton said. “However, only one of these patients had an isolated unilateral parotid hemangioma without other facial segment involvement. Additionally, two patients with isolated involvement of the midcheek below the eye [the S2 location, which was another low risk segment] also had PHACE, both of whom would have been missed without MRI/MRA [magnetic resonance angiography].”
She acknowledged certain limitations of the study, including its retrospective design. “Additionally, many of the very large hemangiomas were not measured in size, and so, estimated sizes needed to be used in calculating relationship of hemangioma size with risk of PHACE,” she said.
The study was funded in part by a grant from the Pediatric Dermatology Research Alliance.* Dr. Cotton reported having no relevant financial disclosures.
Correction, 7/20/18: An earlier version of this article misstated the name of the Pediatric Dermatology Research Alliance.
FROM SPD 2018
Key clinical point: Children with large, high-risk facial hemangiomas should be prioritized for PHACE syndrome work-up.
Major finding: On multivariate analysis, the following factors were found to be independently and significantly associated with a risk for PHACE: bilateral location (positive predictive value, 54.9%), S1 involvement (PPV, 49.5%), S3 involvement (PPV, 39.5%), and area greater than 25 cm2 (PPV, 44.8%; P less than .05 for all associations).
Study details: A retrospective evaluation of 244 patients from 13 pediatric dermatology who were fully evaluated for PHACE between August 2009 and December 2014.
Disclosures: The study was funded in part by a grant from the Pediatric Dermatology Research Association. Dr. Cotton reported having no financial disclosures.
DOACs found safer than warfarin in the real world
The safety of direct oral anticoagulants is affirmed in a real-world study; a wearable ECG boosts atrial fibrillation detection by a factor of 8; new pediatric guidelines catch more hypertension cases in children; and nontraditional cardiovascular risk factors are not ready for prime time, says a federal task force. Listen to MDedge Cardiocast for all the details on the week’s top news, and subscribe on iTunes.
The safety of direct oral anticoagulants is affirmed in a real-world study; a wearable ECG boosts atrial fibrillation detection by a factor of 8; new pediatric guidelines catch more hypertension cases in children; and nontraditional cardiovascular risk factors are not ready for prime time, says a federal task force. Listen to MDedge Cardiocast for all the details on the week’s top news, and subscribe on iTunes.
The safety of direct oral anticoagulants is affirmed in a real-world study; a wearable ECG boosts atrial fibrillation detection by a factor of 8; new pediatric guidelines catch more hypertension cases in children; and nontraditional cardiovascular risk factors are not ready for prime time, says a federal task force. Listen to MDedge Cardiocast for all the details on the week’s top news, and subscribe on iTunes.
Genentech submits sNDA for venetoclax in untreated AML
A supplemental new drug application (sNDA) for venetoclax (Venclexta) used in combination with either a hypomethylating agent or low-dose cytarabine (LDAC) for previously untreated acute myeloid leukemia has been submitted to the Food and Drug Administration by Genentech, which developed it.
Specifically, the sNDA is for these drug combinations in the treatment of AML patients ineligible for intensive chemotherapy, according to the announcement from Genentech.
The sNDA is based on results of two trials that included patients in this population. In the phase 1b M14-358 (NCT02203773), venetoclax was combined with either azacitidine or decitabine; patients treated with 400 mg of venetoclax had a complete remission rate of 73%, and the median overall survival across all doses of venetoclax was 17.5 months. Low white blood cell count with fever, low white blood cell count, anemia, low platelet count, and decreased potassium levels were the most common grade 3/4 adverse events (occurring in 10% or more of patients). In the phase 1b/2 study M14-387 (NCT02287233), venetoclax was used in combination with LDAC; patients treated with a 600-mg dose of venetoclax showed a complete response rate of 62%, and a median overall survival of 11.4 months. Low white blood cell count with fever, decreased potassium levels, pneumonia, disease progression, decreased phosphate levels, high blood pressure, and sepsis were the most common grade 3/4 adverse events seen in this study.
This sNDA follows FDA breakthrough therapy designations, based on these same trials, for these uses of venetoclax with either hypomethylating agents or LDAC. The FDA also recently approved venetoclax in combination with rituximab (Rituxan) for treatment of patients who have chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p depletion, and have been treated with at least one prior therapy.
“AML is an aggressive disease with the lowest survival rate of all leukemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible,” said Sandra Horning, MD, chief medical officer at Genentech.
More information is included in the full release.
A supplemental new drug application (sNDA) for venetoclax (Venclexta) used in combination with either a hypomethylating agent or low-dose cytarabine (LDAC) for previously untreated acute myeloid leukemia has been submitted to the Food and Drug Administration by Genentech, which developed it.
Specifically, the sNDA is for these drug combinations in the treatment of AML patients ineligible for intensive chemotherapy, according to the announcement from Genentech.
The sNDA is based on results of two trials that included patients in this population. In the phase 1b M14-358 (NCT02203773), venetoclax was combined with either azacitidine or decitabine; patients treated with 400 mg of venetoclax had a complete remission rate of 73%, and the median overall survival across all doses of venetoclax was 17.5 months. Low white blood cell count with fever, low white blood cell count, anemia, low platelet count, and decreased potassium levels were the most common grade 3/4 adverse events (occurring in 10% or more of patients). In the phase 1b/2 study M14-387 (NCT02287233), venetoclax was used in combination with LDAC; patients treated with a 600-mg dose of venetoclax showed a complete response rate of 62%, and a median overall survival of 11.4 months. Low white blood cell count with fever, decreased potassium levels, pneumonia, disease progression, decreased phosphate levels, high blood pressure, and sepsis were the most common grade 3/4 adverse events seen in this study.
This sNDA follows FDA breakthrough therapy designations, based on these same trials, for these uses of venetoclax with either hypomethylating agents or LDAC. The FDA also recently approved venetoclax in combination with rituximab (Rituxan) for treatment of patients who have chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p depletion, and have been treated with at least one prior therapy.
“AML is an aggressive disease with the lowest survival rate of all leukemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible,” said Sandra Horning, MD, chief medical officer at Genentech.
More information is included in the full release.
A supplemental new drug application (sNDA) for venetoclax (Venclexta) used in combination with either a hypomethylating agent or low-dose cytarabine (LDAC) for previously untreated acute myeloid leukemia has been submitted to the Food and Drug Administration by Genentech, which developed it.
Specifically, the sNDA is for these drug combinations in the treatment of AML patients ineligible for intensive chemotherapy, according to the announcement from Genentech.
The sNDA is based on results of two trials that included patients in this population. In the phase 1b M14-358 (NCT02203773), venetoclax was combined with either azacitidine or decitabine; patients treated with 400 mg of venetoclax had a complete remission rate of 73%, and the median overall survival across all doses of venetoclax was 17.5 months. Low white blood cell count with fever, low white blood cell count, anemia, low platelet count, and decreased potassium levels were the most common grade 3/4 adverse events (occurring in 10% or more of patients). In the phase 1b/2 study M14-387 (NCT02287233), venetoclax was used in combination with LDAC; patients treated with a 600-mg dose of venetoclax showed a complete response rate of 62%, and a median overall survival of 11.4 months. Low white blood cell count with fever, decreased potassium levels, pneumonia, disease progression, decreased phosphate levels, high blood pressure, and sepsis were the most common grade 3/4 adverse events seen in this study.
This sNDA follows FDA breakthrough therapy designations, based on these same trials, for these uses of venetoclax with either hypomethylating agents or LDAC. The FDA also recently approved venetoclax in combination with rituximab (Rituxan) for treatment of patients who have chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p depletion, and have been treated with at least one prior therapy.
“AML is an aggressive disease with the lowest survival rate of all leukemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible,” said Sandra Horning, MD, chief medical officer at Genentech.
More information is included in the full release.
PNPs integrate behavioral, mental health in PC practice
Concerns about mental health (MH) care delivery for children are repeatedly identified by health care providers, described in the literature, and addressed through advocacy. Unfortunately, health inequities continue to exist, including the social stigma of an MH diagnosis, lower reimbursement for MH compared with medical care, and poor access to expert pediatric behavioral health providers. This is especially true for families living below the poverty line, who are more likely to have MH problems.1
An estimated 50% of primary care (PC) pediatric visits involve an MH or behavioral problem, yet only about 20% of these patients receive services.2 According to the Centers for Disease Control and Prevention, one out of seven children aged 2-8 years has a developmental or behavioral disorder.3 In children aged 3-17 years, 7% have ADHD, 2% have depressive disorders, and 3% have anxiety.3 In the 2015 National Youth Risk Behavior Surveillance survey, more than 29% of high school respondents stated that they felt so sad or hopeless during the past 12 months that they had stopped some of their usual activities, and 18% considered suicide.4 The incidence of violent acts committed by and affecting teens adds a critical need for creative provision of pediatric MH care.
MH integration in pediatric PC, supported by the National Association of Pediatric Nurse Practitioners, American Academy of Pediatrics, American Psychological Association, and many others is an avenue to provide quality MH services for children.5,6,7 In a coordinated or colocated model, a behavioral health specialist works with a pediatric provider either in consultation with the practice (coordinated) or in the same practice site where patients are referred (colocated).7 The collaborative care model places pediatric medical providers with care managers or behavioral health specialists to deliver care in one practice setting.
The use of pediatric nurse practitioners (PNPs) with advanced training in MH care is described in the literature as a different type of collaborative care model.8,9,10 PNPs assess, diagnose, and treat using pharmacologic and nonpharmacologic therapies. PNPs may offer evidence-based psychotherapy or refer for psychotherapy or parenting skills development. Those who have added knowledge and skills in MH care may seek validation of these competencies through completion of added certification as pediatric PC MH specialists (PMHS).11 Since 2011, there are more than 400 PMHSs certified in the United States. We share examples of services provided by PNPs across the United States.
At a federally qualified health center
Dawn Garzon Maaks, PhD, CPNP-PC, the current president of the National Association of Pediatric Nurse Practitioners, is certified as a PMHS and works in a federally-qualified health center in southwest Washington State. This center provides lifespan services for patients, with separate office spaces for MH/psychiatric care and PC. Within this colocated environment, Dr. Garzon Maaks spends about 75% of her time caring for children with developmental, behavioral, and MH problems in the MH clinic and 25% in the PC office, providing health maintenance and acute episodic care. She collaborates with psychiatrists and psychiatric mental health nurse practitioners by adding pediatric developmental and medical expertise and is welcomed by providers who have limited experience caring for children. While providing PC, she educates about issues such as resiliency, screening for substance abuse, and treatment of common pediatric mood disorders and ADHD. Her expertise also allows for MH care integration into PC visits, taking away the “stigma” which still is pervasive for patients referred to MH providers.
“What my position has taught me is that when primary and mental health care providers work closely, it improves outcomes for all patients seen. Through frequent consultation, our primary care physicians have increasing skills in caring for children with mild mental health issues, thus freeing up the mental health people to deal with the more significant cases. On the other hand, our mental health providers benefit from having the primary care expertise in diagnosing and treating common conditions that mimic mental health issues. This integration also significantly reduces stigma because families see their mental health professional in the primary care setting,” Dr. Garzon Maaks said.
At an urban/suburban PC practice
Another PNP MH expert, Dr. Susan Van Cleve, is certified as a PMHS and works as a subspecialist within an urban/suburban pediatric PC practice. Her team is composed of two PNPs and one registered nurse who is designated as the full time MH coordinator. This team cares for children and teens with mild to moderate MH disorders from within the practice. The registered nurse performs intake interviews, schedules patients, and sends out screening tools before visits and is available to families and providers in the practice on a dedicated phone line. She refers complex patients to local providers for more comprehensive care and follows them to ensure that appointments and referrals are made. Scheduling with the PNPs allows for longer appointments, comprehensive treatment including medication management if warranted, and close follow-up care. Patient types seen include those with concerns about developmental delays, autism spectrum disorder, disruptive behavior, ADHD, anxiety, and depression. Children or teens with more severe disorders are referred to colleagues in psychiatry or counseling services, or to pediatric or adolescent subspecialists in the community.
“The children and families I see seem to feel comfortable because our behavioral team is embedded in the pediatric practice, and we use the same office space. Families have easy access to our full-time registered nurse who is available to answer questions, provide resources and advice, lend support, or assist navigating the health system. This type of system increases access, enables us to provide comprehensive family-centered care, and supports the child and family,” said Dr. Van Cleve, clinical professor and primary care pediatric nurse practitioner program director at the University of Iowa College of Nursing, Iowa City.
As an educator
Naomi A. Schapiro, PhD, CPNP, is a professor of nursing at the University of California, San Francisco, and a PNP at a school-based health center with an integrated behavioral health model, managed by a federally qualified health center in a medically underserved area. She is the principle investigator of an Advanced Nursing Education Health Resources Service Administration grant supporting interprofessional training and practice collaboration to improve care and reduce health inequities for disadvantaged children and adolescents coping with both behavioral health conditions and chronic physical conditions, including obesity.11
Dr. Schapiro collaborates with a multidisciplinary, multi-university team, a local children’s hospital, a social work training program, and the county health care services agency to develop and implement a training program for pediatric PC providers to increase skills and self-confidence implementing American Academy of Pediatrics guidelines assessing and treating depression, ADHD, anxiety and trauma-related symptoms; triaging patients with nonsuicidal self-injury and suicidal ideation; and recognizing and referring patients with bipolar disorder and psychosis. These training modules are currently being recorded for online posting. As part of this interprofessional collaboration, Dr. Schapiro and her colleagues developed a “warmline” for decision support, staffed by a psychiatrist and two nurse practitioners available to PC providers in a network of 29 school-based health centers and two pediatric practices for complex decision making about medications or diagnostic dilemmas. Efforts are underway to continue and expand this program.
“As a faculty teaching PNP students enhanced behavioral health assessment skills, I have been proudest when students have been able to apply and disseminate these skills,” Dr. Schapiro said. “One of our recent PNP graduates was in a community primary care practicum when an adolescent thinking about suicide walked into the clinic with her father. Her preceptor wasn’t sure how to proceed, when the student said, ‘Wait! We just practiced this in class.’ The student pulled up her course website, and she and her preceptor walked through the assessment together, developed a safety plan with the teen and her father, and connected the teen with a therapist, avoiding an unnecessary ER visit and potential fragmentation of care.”
The need and expectation that pediatric PC providers incorporate MH services is well documented.2,12,13 PNPs who have additional training and expertise in assessing, diagnosing, and managing MH care are an excellent solution for addressing this problem. The benefits of this team-based approach to the pediatric health care home include decreasing stigma, increasing access, and providing comprehensive MH care to children and their families.
Dr. Haut works at Beacon Pediatrics, a large primary care practice in Rehoboth Beach, Del. She works part-time for Pediatrix Medical Group, serving the Pediatric Intensive Care Unit medical team at the Herman & Walter Samuelson Children’s Hospital at Sinai in Baltimore, and she serves as adjunct faculty at the University of Maryland School of Nursing, also in Baltimore. Other contributors to this article were Dawn Garzon Maaks, PhD, CPNP, PMHS; Naomi Schapiro, PhD, CPNP; Susan Van Cleve, DNP, RN, CPNP-PC, PMHS; and Laura Searcy, MN, APRN, PPCNP-BC. Ms. Searcy is on the medical staff at WellStar Kennestone Regional Medical Center in Marietta, Ga., delivering care to newborns. Dr. Haut and Ms. Searcy are members of the Pediatric News Consultant Advisory Board. Email them at [email protected].
References
1. “Best principles for integration of child psychiatry into the pediatric health home,” AACAP Executive Summary,2012, pages 1-13.
2. Pediatrics. 2009 Apr;123(4):1248-51.
3. Center for Disease Control and Prevention: Children’s Mental Health Data and Statistics.
4. MMWR Surveill Summ, 2016. doi:10.15585/mmwr.ss6506a1.
5. Pediatrics. 2015;135(5):909-17.
6. JAMA Pediatr. 2015;169(10):929-37.
7. “Integrating child psychology services into primary care,” by Tynan D, Woods K, and Carpenter J. American Psychological Association, 2014.
8. J Am Psychiatr Nurses Assoc. 2005;11(5): 276-82.
9. J Nurse Pract. 2013;9(4):243-8.
10. J Pediatr Health Care. 2013; 27(3):162-3.
11. Advanced Nursing Education Health Resources Service Administration grant (#D09HP26958).
12. J Nurse Pract. 2013:9(3):142-8.
13. Pediatrics. 2018;141(3):e20174082
Concerns about mental health (MH) care delivery for children are repeatedly identified by health care providers, described in the literature, and addressed through advocacy. Unfortunately, health inequities continue to exist, including the social stigma of an MH diagnosis, lower reimbursement for MH compared with medical care, and poor access to expert pediatric behavioral health providers. This is especially true for families living below the poverty line, who are more likely to have MH problems.1
An estimated 50% of primary care (PC) pediatric visits involve an MH or behavioral problem, yet only about 20% of these patients receive services.2 According to the Centers for Disease Control and Prevention, one out of seven children aged 2-8 years has a developmental or behavioral disorder.3 In children aged 3-17 years, 7% have ADHD, 2% have depressive disorders, and 3% have anxiety.3 In the 2015 National Youth Risk Behavior Surveillance survey, more than 29% of high school respondents stated that they felt so sad or hopeless during the past 12 months that they had stopped some of their usual activities, and 18% considered suicide.4 The incidence of violent acts committed by and affecting teens adds a critical need for creative provision of pediatric MH care.
MH integration in pediatric PC, supported by the National Association of Pediatric Nurse Practitioners, American Academy of Pediatrics, American Psychological Association, and many others is an avenue to provide quality MH services for children.5,6,7 In a coordinated or colocated model, a behavioral health specialist works with a pediatric provider either in consultation with the practice (coordinated) or in the same practice site where patients are referred (colocated).7 The collaborative care model places pediatric medical providers with care managers or behavioral health specialists to deliver care in one practice setting.
The use of pediatric nurse practitioners (PNPs) with advanced training in MH care is described in the literature as a different type of collaborative care model.8,9,10 PNPs assess, diagnose, and treat using pharmacologic and nonpharmacologic therapies. PNPs may offer evidence-based psychotherapy or refer for psychotherapy or parenting skills development. Those who have added knowledge and skills in MH care may seek validation of these competencies through completion of added certification as pediatric PC MH specialists (PMHS).11 Since 2011, there are more than 400 PMHSs certified in the United States. We share examples of services provided by PNPs across the United States.
At a federally qualified health center
Dawn Garzon Maaks, PhD, CPNP-PC, the current president of the National Association of Pediatric Nurse Practitioners, is certified as a PMHS and works in a federally-qualified health center in southwest Washington State. This center provides lifespan services for patients, with separate office spaces for MH/psychiatric care and PC. Within this colocated environment, Dr. Garzon Maaks spends about 75% of her time caring for children with developmental, behavioral, and MH problems in the MH clinic and 25% in the PC office, providing health maintenance and acute episodic care. She collaborates with psychiatrists and psychiatric mental health nurse practitioners by adding pediatric developmental and medical expertise and is welcomed by providers who have limited experience caring for children. While providing PC, she educates about issues such as resiliency, screening for substance abuse, and treatment of common pediatric mood disorders and ADHD. Her expertise also allows for MH care integration into PC visits, taking away the “stigma” which still is pervasive for patients referred to MH providers.
“What my position has taught me is that when primary and mental health care providers work closely, it improves outcomes for all patients seen. Through frequent consultation, our primary care physicians have increasing skills in caring for children with mild mental health issues, thus freeing up the mental health people to deal with the more significant cases. On the other hand, our mental health providers benefit from having the primary care expertise in diagnosing and treating common conditions that mimic mental health issues. This integration also significantly reduces stigma because families see their mental health professional in the primary care setting,” Dr. Garzon Maaks said.
At an urban/suburban PC practice
Another PNP MH expert, Dr. Susan Van Cleve, is certified as a PMHS and works as a subspecialist within an urban/suburban pediatric PC practice. Her team is composed of two PNPs and one registered nurse who is designated as the full time MH coordinator. This team cares for children and teens with mild to moderate MH disorders from within the practice. The registered nurse performs intake interviews, schedules patients, and sends out screening tools before visits and is available to families and providers in the practice on a dedicated phone line. She refers complex patients to local providers for more comprehensive care and follows them to ensure that appointments and referrals are made. Scheduling with the PNPs allows for longer appointments, comprehensive treatment including medication management if warranted, and close follow-up care. Patient types seen include those with concerns about developmental delays, autism spectrum disorder, disruptive behavior, ADHD, anxiety, and depression. Children or teens with more severe disorders are referred to colleagues in psychiatry or counseling services, or to pediatric or adolescent subspecialists in the community.
“The children and families I see seem to feel comfortable because our behavioral team is embedded in the pediatric practice, and we use the same office space. Families have easy access to our full-time registered nurse who is available to answer questions, provide resources and advice, lend support, or assist navigating the health system. This type of system increases access, enables us to provide comprehensive family-centered care, and supports the child and family,” said Dr. Van Cleve, clinical professor and primary care pediatric nurse practitioner program director at the University of Iowa College of Nursing, Iowa City.
As an educator
Naomi A. Schapiro, PhD, CPNP, is a professor of nursing at the University of California, San Francisco, and a PNP at a school-based health center with an integrated behavioral health model, managed by a federally qualified health center in a medically underserved area. She is the principle investigator of an Advanced Nursing Education Health Resources Service Administration grant supporting interprofessional training and practice collaboration to improve care and reduce health inequities for disadvantaged children and adolescents coping with both behavioral health conditions and chronic physical conditions, including obesity.11
Dr. Schapiro collaborates with a multidisciplinary, multi-university team, a local children’s hospital, a social work training program, and the county health care services agency to develop and implement a training program for pediatric PC providers to increase skills and self-confidence implementing American Academy of Pediatrics guidelines assessing and treating depression, ADHD, anxiety and trauma-related symptoms; triaging patients with nonsuicidal self-injury and suicidal ideation; and recognizing and referring patients with bipolar disorder and psychosis. These training modules are currently being recorded for online posting. As part of this interprofessional collaboration, Dr. Schapiro and her colleagues developed a “warmline” for decision support, staffed by a psychiatrist and two nurse practitioners available to PC providers in a network of 29 school-based health centers and two pediatric practices for complex decision making about medications or diagnostic dilemmas. Efforts are underway to continue and expand this program.
“As a faculty teaching PNP students enhanced behavioral health assessment skills, I have been proudest when students have been able to apply and disseminate these skills,” Dr. Schapiro said. “One of our recent PNP graduates was in a community primary care practicum when an adolescent thinking about suicide walked into the clinic with her father. Her preceptor wasn’t sure how to proceed, when the student said, ‘Wait! We just practiced this in class.’ The student pulled up her course website, and she and her preceptor walked through the assessment together, developed a safety plan with the teen and her father, and connected the teen with a therapist, avoiding an unnecessary ER visit and potential fragmentation of care.”
The need and expectation that pediatric PC providers incorporate MH services is well documented.2,12,13 PNPs who have additional training and expertise in assessing, diagnosing, and managing MH care are an excellent solution for addressing this problem. The benefits of this team-based approach to the pediatric health care home include decreasing stigma, increasing access, and providing comprehensive MH care to children and their families.
Dr. Haut works at Beacon Pediatrics, a large primary care practice in Rehoboth Beach, Del. She works part-time for Pediatrix Medical Group, serving the Pediatric Intensive Care Unit medical team at the Herman & Walter Samuelson Children’s Hospital at Sinai in Baltimore, and she serves as adjunct faculty at the University of Maryland School of Nursing, also in Baltimore. Other contributors to this article were Dawn Garzon Maaks, PhD, CPNP, PMHS; Naomi Schapiro, PhD, CPNP; Susan Van Cleve, DNP, RN, CPNP-PC, PMHS; and Laura Searcy, MN, APRN, PPCNP-BC. Ms. Searcy is on the medical staff at WellStar Kennestone Regional Medical Center in Marietta, Ga., delivering care to newborns. Dr. Haut and Ms. Searcy are members of the Pediatric News Consultant Advisory Board. Email them at [email protected].
References
1. “Best principles for integration of child psychiatry into the pediatric health home,” AACAP Executive Summary,2012, pages 1-13.
2. Pediatrics. 2009 Apr;123(4):1248-51.
3. Center for Disease Control and Prevention: Children’s Mental Health Data and Statistics.
4. MMWR Surveill Summ, 2016. doi:10.15585/mmwr.ss6506a1.
5. Pediatrics. 2015;135(5):909-17.
6. JAMA Pediatr. 2015;169(10):929-37.
7. “Integrating child psychology services into primary care,” by Tynan D, Woods K, and Carpenter J. American Psychological Association, 2014.
8. J Am Psychiatr Nurses Assoc. 2005;11(5): 276-82.
9. J Nurse Pract. 2013;9(4):243-8.
10. J Pediatr Health Care. 2013; 27(3):162-3.
11. Advanced Nursing Education Health Resources Service Administration grant (#D09HP26958).
12. J Nurse Pract. 2013:9(3):142-8.
13. Pediatrics. 2018;141(3):e20174082
Concerns about mental health (MH) care delivery for children are repeatedly identified by health care providers, described in the literature, and addressed through advocacy. Unfortunately, health inequities continue to exist, including the social stigma of an MH diagnosis, lower reimbursement for MH compared with medical care, and poor access to expert pediatric behavioral health providers. This is especially true for families living below the poverty line, who are more likely to have MH problems.1
An estimated 50% of primary care (PC) pediatric visits involve an MH or behavioral problem, yet only about 20% of these patients receive services.2 According to the Centers for Disease Control and Prevention, one out of seven children aged 2-8 years has a developmental or behavioral disorder.3 In children aged 3-17 years, 7% have ADHD, 2% have depressive disorders, and 3% have anxiety.3 In the 2015 National Youth Risk Behavior Surveillance survey, more than 29% of high school respondents stated that they felt so sad or hopeless during the past 12 months that they had stopped some of their usual activities, and 18% considered suicide.4 The incidence of violent acts committed by and affecting teens adds a critical need for creative provision of pediatric MH care.
MH integration in pediatric PC, supported by the National Association of Pediatric Nurse Practitioners, American Academy of Pediatrics, American Psychological Association, and many others is an avenue to provide quality MH services for children.5,6,7 In a coordinated or colocated model, a behavioral health specialist works with a pediatric provider either in consultation with the practice (coordinated) or in the same practice site where patients are referred (colocated).7 The collaborative care model places pediatric medical providers with care managers or behavioral health specialists to deliver care in one practice setting.
The use of pediatric nurse practitioners (PNPs) with advanced training in MH care is described in the literature as a different type of collaborative care model.8,9,10 PNPs assess, diagnose, and treat using pharmacologic and nonpharmacologic therapies. PNPs may offer evidence-based psychotherapy or refer for psychotherapy or parenting skills development. Those who have added knowledge and skills in MH care may seek validation of these competencies through completion of added certification as pediatric PC MH specialists (PMHS).11 Since 2011, there are more than 400 PMHSs certified in the United States. We share examples of services provided by PNPs across the United States.
At a federally qualified health center
Dawn Garzon Maaks, PhD, CPNP-PC, the current president of the National Association of Pediatric Nurse Practitioners, is certified as a PMHS and works in a federally-qualified health center in southwest Washington State. This center provides lifespan services for patients, with separate office spaces for MH/psychiatric care and PC. Within this colocated environment, Dr. Garzon Maaks spends about 75% of her time caring for children with developmental, behavioral, and MH problems in the MH clinic and 25% in the PC office, providing health maintenance and acute episodic care. She collaborates with psychiatrists and psychiatric mental health nurse practitioners by adding pediatric developmental and medical expertise and is welcomed by providers who have limited experience caring for children. While providing PC, she educates about issues such as resiliency, screening for substance abuse, and treatment of common pediatric mood disorders and ADHD. Her expertise also allows for MH care integration into PC visits, taking away the “stigma” which still is pervasive for patients referred to MH providers.
“What my position has taught me is that when primary and mental health care providers work closely, it improves outcomes for all patients seen. Through frequent consultation, our primary care physicians have increasing skills in caring for children with mild mental health issues, thus freeing up the mental health people to deal with the more significant cases. On the other hand, our mental health providers benefit from having the primary care expertise in diagnosing and treating common conditions that mimic mental health issues. This integration also significantly reduces stigma because families see their mental health professional in the primary care setting,” Dr. Garzon Maaks said.
At an urban/suburban PC practice
Another PNP MH expert, Dr. Susan Van Cleve, is certified as a PMHS and works as a subspecialist within an urban/suburban pediatric PC practice. Her team is composed of two PNPs and one registered nurse who is designated as the full time MH coordinator. This team cares for children and teens with mild to moderate MH disorders from within the practice. The registered nurse performs intake interviews, schedules patients, and sends out screening tools before visits and is available to families and providers in the practice on a dedicated phone line. She refers complex patients to local providers for more comprehensive care and follows them to ensure that appointments and referrals are made. Scheduling with the PNPs allows for longer appointments, comprehensive treatment including medication management if warranted, and close follow-up care. Patient types seen include those with concerns about developmental delays, autism spectrum disorder, disruptive behavior, ADHD, anxiety, and depression. Children or teens with more severe disorders are referred to colleagues in psychiatry or counseling services, or to pediatric or adolescent subspecialists in the community.
“The children and families I see seem to feel comfortable because our behavioral team is embedded in the pediatric practice, and we use the same office space. Families have easy access to our full-time registered nurse who is available to answer questions, provide resources and advice, lend support, or assist navigating the health system. This type of system increases access, enables us to provide comprehensive family-centered care, and supports the child and family,” said Dr. Van Cleve, clinical professor and primary care pediatric nurse practitioner program director at the University of Iowa College of Nursing, Iowa City.
As an educator
Naomi A. Schapiro, PhD, CPNP, is a professor of nursing at the University of California, San Francisco, and a PNP at a school-based health center with an integrated behavioral health model, managed by a federally qualified health center in a medically underserved area. She is the principle investigator of an Advanced Nursing Education Health Resources Service Administration grant supporting interprofessional training and practice collaboration to improve care and reduce health inequities for disadvantaged children and adolescents coping with both behavioral health conditions and chronic physical conditions, including obesity.11
Dr. Schapiro collaborates with a multidisciplinary, multi-university team, a local children’s hospital, a social work training program, and the county health care services agency to develop and implement a training program for pediatric PC providers to increase skills and self-confidence implementing American Academy of Pediatrics guidelines assessing and treating depression, ADHD, anxiety and trauma-related symptoms; triaging patients with nonsuicidal self-injury and suicidal ideation; and recognizing and referring patients with bipolar disorder and psychosis. These training modules are currently being recorded for online posting. As part of this interprofessional collaboration, Dr. Schapiro and her colleagues developed a “warmline” for decision support, staffed by a psychiatrist and two nurse practitioners available to PC providers in a network of 29 school-based health centers and two pediatric practices for complex decision making about medications or diagnostic dilemmas. Efforts are underway to continue and expand this program.
“As a faculty teaching PNP students enhanced behavioral health assessment skills, I have been proudest when students have been able to apply and disseminate these skills,” Dr. Schapiro said. “One of our recent PNP graduates was in a community primary care practicum when an adolescent thinking about suicide walked into the clinic with her father. Her preceptor wasn’t sure how to proceed, when the student said, ‘Wait! We just practiced this in class.’ The student pulled up her course website, and she and her preceptor walked through the assessment together, developed a safety plan with the teen and her father, and connected the teen with a therapist, avoiding an unnecessary ER visit and potential fragmentation of care.”
The need and expectation that pediatric PC providers incorporate MH services is well documented.2,12,13 PNPs who have additional training and expertise in assessing, diagnosing, and managing MH care are an excellent solution for addressing this problem. The benefits of this team-based approach to the pediatric health care home include decreasing stigma, increasing access, and providing comprehensive MH care to children and their families.
Dr. Haut works at Beacon Pediatrics, a large primary care practice in Rehoboth Beach, Del. She works part-time for Pediatrix Medical Group, serving the Pediatric Intensive Care Unit medical team at the Herman & Walter Samuelson Children’s Hospital at Sinai in Baltimore, and she serves as adjunct faculty at the University of Maryland School of Nursing, also in Baltimore. Other contributors to this article were Dawn Garzon Maaks, PhD, CPNP, PMHS; Naomi Schapiro, PhD, CPNP; Susan Van Cleve, DNP, RN, CPNP-PC, PMHS; and Laura Searcy, MN, APRN, PPCNP-BC. Ms. Searcy is on the medical staff at WellStar Kennestone Regional Medical Center in Marietta, Ga., delivering care to newborns. Dr. Haut and Ms. Searcy are members of the Pediatric News Consultant Advisory Board. Email them at [email protected].
References
1. “Best principles for integration of child psychiatry into the pediatric health home,” AACAP Executive Summary,2012, pages 1-13.
2. Pediatrics. 2009 Apr;123(4):1248-51.
3. Center for Disease Control and Prevention: Children’s Mental Health Data and Statistics.
4. MMWR Surveill Summ, 2016. doi:10.15585/mmwr.ss6506a1.
5. Pediatrics. 2015;135(5):909-17.
6. JAMA Pediatr. 2015;169(10):929-37.
7. “Integrating child psychology services into primary care,” by Tynan D, Woods K, and Carpenter J. American Psychological Association, 2014.
8. J Am Psychiatr Nurses Assoc. 2005;11(5): 276-82.
9. J Nurse Pract. 2013;9(4):243-8.
10. J Pediatr Health Care. 2013; 27(3):162-3.
11. Advanced Nursing Education Health Resources Service Administration grant (#D09HP26958).
12. J Nurse Pract. 2013:9(3):142-8.
13. Pediatrics. 2018;141(3):e20174082
Sleep may mediate healthy behavior in children
BALTIMORE – a 6-year follow-up of children in the Infant Feeding Practices Study II determined.
However, improving health in these children is more than a matter of simply seeing that they get more sleep, said lead investigator Jill Landsbaugh Kaar, PhD, of Children’s Hospital Colorado, Aurora, in presenting the results at the annual meeting of the Associated Professional Sleep Societies. “Perhaps there’s a potential pathway linking healthy eaters and obesity in children that may be mediated through sleep duration.”
The relationship between sleep, diet, and activity level may be more cyclical, rather than linear, Dr. Kaar said. “Poor sleep is typically linked to a poor diet or low levels of physical activity, and then linked to some outcome or disease,” she said. But her research indicates that those three factors – sleep, diet and activity – are more interrelated than one being causative of the others.
Noting that one in three adults and one in six children in the United States are either overweight or obese (JAMA. 2014 Feb 26;311[8]:806-14), Dr. Kaar said, “Childhood obesity prevention has really not been effective in reducing weight or preventing or limiting weight gain.” Such programs typically focus on one health behavior when each child has a unique pattern of health behaviors that influence weight.
Dr. Kaar’s research used data collected by the Centers for Disease Control and Prevention as part of a 6-year follow-up study of women from the Infant Feeding Practices Study II. Some 1,542 women completed mailed questionnaires about their 6-year-olds’ diet, activity, screen time, sleep duration, height, and weight. The statistical analysis grouped the children into health behavior patterns of diet, activity, and screen time and used a three-step mediation regression model to examine their hypothesis.
The analysis characterized children into three health behavior pattern groups: poorest eaters (22%), healthy children (37%), and active supereaters with the highest screen time (41%). The poorest eaters were more likely to be female (58%) and obese (18%) than the other groups, but even 10% of the healthy children group were obese.
In the first model, the poorest eaters had the highest risk of obesity. In the second model, both the poorest eaters and active supereaters had shorter sleep duration than healthy children – 9.46 and 9.59 hours a night, respectively, versus 9.97 hours for healthy children – “thus telling me that sleep was really driving that relationship,” Dr. Kaar said.
“Future interventions should consider that improving health behavior patterns by targeting someone’s diet or physical activity, that you’re also targeting them to improve sleep, and then through increasing sleep you will be influencing obesity,” she said. “Interventions and research studies in general really need to measure all of those health behaviors because they’re all related; it’s not just one of them leading to obesity risk.”
The next step for her research is to branch out beyond a one-center study, Dr. Kaar said.
Dr. Kaar reported having no financial relationships. An American Heart Association Scientist Development Award provided funding for the study.
BALTIMORE – a 6-year follow-up of children in the Infant Feeding Practices Study II determined.
However, improving health in these children is more than a matter of simply seeing that they get more sleep, said lead investigator Jill Landsbaugh Kaar, PhD, of Children’s Hospital Colorado, Aurora, in presenting the results at the annual meeting of the Associated Professional Sleep Societies. “Perhaps there’s a potential pathway linking healthy eaters and obesity in children that may be mediated through sleep duration.”
The relationship between sleep, diet, and activity level may be more cyclical, rather than linear, Dr. Kaar said. “Poor sleep is typically linked to a poor diet or low levels of physical activity, and then linked to some outcome or disease,” she said. But her research indicates that those three factors – sleep, diet and activity – are more interrelated than one being causative of the others.
Noting that one in three adults and one in six children in the United States are either overweight or obese (JAMA. 2014 Feb 26;311[8]:806-14), Dr. Kaar said, “Childhood obesity prevention has really not been effective in reducing weight or preventing or limiting weight gain.” Such programs typically focus on one health behavior when each child has a unique pattern of health behaviors that influence weight.
Dr. Kaar’s research used data collected by the Centers for Disease Control and Prevention as part of a 6-year follow-up study of women from the Infant Feeding Practices Study II. Some 1,542 women completed mailed questionnaires about their 6-year-olds’ diet, activity, screen time, sleep duration, height, and weight. The statistical analysis grouped the children into health behavior patterns of diet, activity, and screen time and used a three-step mediation regression model to examine their hypothesis.
The analysis characterized children into three health behavior pattern groups: poorest eaters (22%), healthy children (37%), and active supereaters with the highest screen time (41%). The poorest eaters were more likely to be female (58%) and obese (18%) than the other groups, but even 10% of the healthy children group were obese.
In the first model, the poorest eaters had the highest risk of obesity. In the second model, both the poorest eaters and active supereaters had shorter sleep duration than healthy children – 9.46 and 9.59 hours a night, respectively, versus 9.97 hours for healthy children – “thus telling me that sleep was really driving that relationship,” Dr. Kaar said.
“Future interventions should consider that improving health behavior patterns by targeting someone’s diet or physical activity, that you’re also targeting them to improve sleep, and then through increasing sleep you will be influencing obesity,” she said. “Interventions and research studies in general really need to measure all of those health behaviors because they’re all related; it’s not just one of them leading to obesity risk.”
The next step for her research is to branch out beyond a one-center study, Dr. Kaar said.
Dr. Kaar reported having no financial relationships. An American Heart Association Scientist Development Award provided funding for the study.
BALTIMORE – a 6-year follow-up of children in the Infant Feeding Practices Study II determined.
However, improving health in these children is more than a matter of simply seeing that they get more sleep, said lead investigator Jill Landsbaugh Kaar, PhD, of Children’s Hospital Colorado, Aurora, in presenting the results at the annual meeting of the Associated Professional Sleep Societies. “Perhaps there’s a potential pathway linking healthy eaters and obesity in children that may be mediated through sleep duration.”
The relationship between sleep, diet, and activity level may be more cyclical, rather than linear, Dr. Kaar said. “Poor sleep is typically linked to a poor diet or low levels of physical activity, and then linked to some outcome or disease,” she said. But her research indicates that those three factors – sleep, diet and activity – are more interrelated than one being causative of the others.
Noting that one in three adults and one in six children in the United States are either overweight or obese (JAMA. 2014 Feb 26;311[8]:806-14), Dr. Kaar said, “Childhood obesity prevention has really not been effective in reducing weight or preventing or limiting weight gain.” Such programs typically focus on one health behavior when each child has a unique pattern of health behaviors that influence weight.
Dr. Kaar’s research used data collected by the Centers for Disease Control and Prevention as part of a 6-year follow-up study of women from the Infant Feeding Practices Study II. Some 1,542 women completed mailed questionnaires about their 6-year-olds’ diet, activity, screen time, sleep duration, height, and weight. The statistical analysis grouped the children into health behavior patterns of diet, activity, and screen time and used a three-step mediation regression model to examine their hypothesis.
The analysis characterized children into three health behavior pattern groups: poorest eaters (22%), healthy children (37%), and active supereaters with the highest screen time (41%). The poorest eaters were more likely to be female (58%) and obese (18%) than the other groups, but even 10% of the healthy children group were obese.
In the first model, the poorest eaters had the highest risk of obesity. In the second model, both the poorest eaters and active supereaters had shorter sleep duration than healthy children – 9.46 and 9.59 hours a night, respectively, versus 9.97 hours for healthy children – “thus telling me that sleep was really driving that relationship,” Dr. Kaar said.
“Future interventions should consider that improving health behavior patterns by targeting someone’s diet or physical activity, that you’re also targeting them to improve sleep, and then through increasing sleep you will be influencing obesity,” she said. “Interventions and research studies in general really need to measure all of those health behaviors because they’re all related; it’s not just one of them leading to obesity risk.”
The next step for her research is to branch out beyond a one-center study, Dr. Kaar said.
Dr. Kaar reported having no financial relationships. An American Heart Association Scientist Development Award provided funding for the study.
REPORTING FROM SLEEP 2018
Key clinical point: Sleep may mediate how diet and activity influence weight in children.
Major finding: Healthy children had 9.97 hours of sleep per night versus 9.46 hours for poorest eaters.
Study details: A 6-year follow-up of 1,542 children in the Infant Feeding Practices Study II whose health behaviors were self-reported by mothers.
Disclosures: Dr. Kaar reported having no financial relationships. The study was funded through an American Heart Association Scientist Development Award.