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FDA approves generic decitabine for MDS
The U.S. Food and Drug Administration has approved Lupin’s decitabine product, a generic version of Otsuka Pharmaceutical Co. Ltd.’s Dacogen, to treat patients with myelodysplastic syndromes (MDS).
Lupin’s decitabine for injection (50 mg, single-dose vial) is approved to treat patients with intermediate-1, intermediate-2, and high-risk MDS.
This includes previously treated, untreated, de novo, and secondary MDS of all French-American-British subtypes—refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
The U.S. Food and Drug Administration has approved Lupin’s decitabine product, a generic version of Otsuka Pharmaceutical Co. Ltd.’s Dacogen, to treat patients with myelodysplastic syndromes (MDS).
Lupin’s decitabine for injection (50 mg, single-dose vial) is approved to treat patients with intermediate-1, intermediate-2, and high-risk MDS.
This includes previously treated, untreated, de novo, and secondary MDS of all French-American-British subtypes—refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
The U.S. Food and Drug Administration has approved Lupin’s decitabine product, a generic version of Otsuka Pharmaceutical Co. Ltd.’s Dacogen, to treat patients with myelodysplastic syndromes (MDS).
Lupin’s decitabine for injection (50 mg, single-dose vial) is approved to treat patients with intermediate-1, intermediate-2, and high-risk MDS.
This includes previously treated, untreated, de novo, and secondary MDS of all French-American-British subtypes—refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
Free advice seems to be history
The 2 short years in the cocoon of residency ended, and I was flying solo on the picturesque but sparsely populated coast of Maine. My colleagues and I were fulfilling our 2-year military obligations at the Brunswick Naval Air Station, hundreds of miles from the support systems our tertiary care centers had provided. As the only pediatrician on the dispensary staff, I felt particularly vulnerable.
At least I was in the same time zone in which I had trained. I still knew most of the beeper numbers or could remember the extensions and the first names of the department secretaries. Usually within minutes, the familiar and calming voice of one of my favorite subspecialists or pediatric mentors would set me on the path to the correct diagnosis and management plan. Of course, I could have asked one of the pediatricians in town for advice, and eventually, I did. But, in the beginning, I was embarrassed to reveal my soft underbelly to the townies.
Within a few months, I was moonlighting for a local pediatrician and, after 2 years, I joined him as a partner. However, it took another several years to wean myself off my dependency on the subspecialists at the big-city medical center where I had trained. To some extent, this was because in the 1970s and 1980s, Maine had few pediatric subspecialists.
Eventually, I developed my own list of favorite local consultants. While the quality of advice was the prime determinant in my choice of a consultant, availability was a close second. How easy was it to get the specialist on the phone? If the clinical situation was not terribly time sensitive and I knew the consultant always was painfully overbooked, I would ask my question in a short typed note, and even include a S.A.S.E. (self-addressed stamped envelope). This – of course – was before email had been invented.
How likely was the consultant going to provide the answer I wanted to hear? If I thought the patient needed P-E (pressure equalizer) tubes, I could choose any ENT specialist. If, on the other hand, I felt that watching and waiting was the better option, I would choose the physician I knew was least likely to advise surgery.
I am unaware that any of the physicians I consulted ever charged the patient for my phone calls or notes. In some cases, their reward came in the opportunity to perform surgery. I rarely received small gifts during the holidays from consultants who were trying to build their practices. And I never gave tokens of appreciation to consultants or their staff to secure their timely response to my pleas for help. However, I always included a personal thank-you note with the self-designed holiday cards I sent to my favorites. And when a consultant had bailed me out of a particularly challenging situation, I often sent a handwritten note in follow-up.
But, for me, the care and grooming of a good stable of consultants began with acknowledging that their time was at least as valuable as mine. The more carefully I crafted my question and the more complete the history I could provide, the more efficiently the consultant could provide me with the answer I needed.
Regrettably, but predictably, those days of free advice are fading away. The new revision of the CPT codes includes at least twelve codes for “interprofessional consultation.” Time is – and has always been – money. As everyone’s time is increasingly being gobbled up by electronic advancements that promised to save us time, no one seems to have time to make or answer that call that begins, “Can I ask you a quick question about a patient?”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
The 2 short years in the cocoon of residency ended, and I was flying solo on the picturesque but sparsely populated coast of Maine. My colleagues and I were fulfilling our 2-year military obligations at the Brunswick Naval Air Station, hundreds of miles from the support systems our tertiary care centers had provided. As the only pediatrician on the dispensary staff, I felt particularly vulnerable.
At least I was in the same time zone in which I had trained. I still knew most of the beeper numbers or could remember the extensions and the first names of the department secretaries. Usually within minutes, the familiar and calming voice of one of my favorite subspecialists or pediatric mentors would set me on the path to the correct diagnosis and management plan. Of course, I could have asked one of the pediatricians in town for advice, and eventually, I did. But, in the beginning, I was embarrassed to reveal my soft underbelly to the townies.
Within a few months, I was moonlighting for a local pediatrician and, after 2 years, I joined him as a partner. However, it took another several years to wean myself off my dependency on the subspecialists at the big-city medical center where I had trained. To some extent, this was because in the 1970s and 1980s, Maine had few pediatric subspecialists.
Eventually, I developed my own list of favorite local consultants. While the quality of advice was the prime determinant in my choice of a consultant, availability was a close second. How easy was it to get the specialist on the phone? If the clinical situation was not terribly time sensitive and I knew the consultant always was painfully overbooked, I would ask my question in a short typed note, and even include a S.A.S.E. (self-addressed stamped envelope). This – of course – was before email had been invented.
How likely was the consultant going to provide the answer I wanted to hear? If I thought the patient needed P-E (pressure equalizer) tubes, I could choose any ENT specialist. If, on the other hand, I felt that watching and waiting was the better option, I would choose the physician I knew was least likely to advise surgery.
I am unaware that any of the physicians I consulted ever charged the patient for my phone calls or notes. In some cases, their reward came in the opportunity to perform surgery. I rarely received small gifts during the holidays from consultants who were trying to build their practices. And I never gave tokens of appreciation to consultants or their staff to secure their timely response to my pleas for help. However, I always included a personal thank-you note with the self-designed holiday cards I sent to my favorites. And when a consultant had bailed me out of a particularly challenging situation, I often sent a handwritten note in follow-up.
But, for me, the care and grooming of a good stable of consultants began with acknowledging that their time was at least as valuable as mine. The more carefully I crafted my question and the more complete the history I could provide, the more efficiently the consultant could provide me with the answer I needed.
Regrettably, but predictably, those days of free advice are fading away. The new revision of the CPT codes includes at least twelve codes for “interprofessional consultation.” Time is – and has always been – money. As everyone’s time is increasingly being gobbled up by electronic advancements that promised to save us time, no one seems to have time to make or answer that call that begins, “Can I ask you a quick question about a patient?”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
The 2 short years in the cocoon of residency ended, and I was flying solo on the picturesque but sparsely populated coast of Maine. My colleagues and I were fulfilling our 2-year military obligations at the Brunswick Naval Air Station, hundreds of miles from the support systems our tertiary care centers had provided. As the only pediatrician on the dispensary staff, I felt particularly vulnerable.
At least I was in the same time zone in which I had trained. I still knew most of the beeper numbers or could remember the extensions and the first names of the department secretaries. Usually within minutes, the familiar and calming voice of one of my favorite subspecialists or pediatric mentors would set me on the path to the correct diagnosis and management plan. Of course, I could have asked one of the pediatricians in town for advice, and eventually, I did. But, in the beginning, I was embarrassed to reveal my soft underbelly to the townies.
Within a few months, I was moonlighting for a local pediatrician and, after 2 years, I joined him as a partner. However, it took another several years to wean myself off my dependency on the subspecialists at the big-city medical center where I had trained. To some extent, this was because in the 1970s and 1980s, Maine had few pediatric subspecialists.
Eventually, I developed my own list of favorite local consultants. While the quality of advice was the prime determinant in my choice of a consultant, availability was a close second. How easy was it to get the specialist on the phone? If the clinical situation was not terribly time sensitive and I knew the consultant always was painfully overbooked, I would ask my question in a short typed note, and even include a S.A.S.E. (self-addressed stamped envelope). This – of course – was before email had been invented.
How likely was the consultant going to provide the answer I wanted to hear? If I thought the patient needed P-E (pressure equalizer) tubes, I could choose any ENT specialist. If, on the other hand, I felt that watching and waiting was the better option, I would choose the physician I knew was least likely to advise surgery.
I am unaware that any of the physicians I consulted ever charged the patient for my phone calls or notes. In some cases, their reward came in the opportunity to perform surgery. I rarely received small gifts during the holidays from consultants who were trying to build their practices. And I never gave tokens of appreciation to consultants or their staff to secure their timely response to my pleas for help. However, I always included a personal thank-you note with the self-designed holiday cards I sent to my favorites. And when a consultant had bailed me out of a particularly challenging situation, I often sent a handwritten note in follow-up.
But, for me, the care and grooming of a good stable of consultants began with acknowledging that their time was at least as valuable as mine. The more carefully I crafted my question and the more complete the history I could provide, the more efficiently the consultant could provide me with the answer I needed.
Regrettably, but predictably, those days of free advice are fading away. The new revision of the CPT codes includes at least twelve codes for “interprofessional consultation.” Time is – and has always been – money. As everyone’s time is increasingly being gobbled up by electronic advancements that promised to save us time, no one seems to have time to make or answer that call that begins, “Can I ask you a quick question about a patient?”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Growing the pool of academic vascular surgeons
NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.
Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.
However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.
The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.
NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.
Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.
However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.
The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.
NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.
Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.
However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.
The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.
REPORTING FROM VEITHSYMPOSIUM
NHL patients report fear, isolation during chemo
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
FROM EUROPEAN JOURNAL OF ONCOLOGY NURSING
Key clinical point:
Major finding: Patients reported three themes while undergoing chemotherapy: living an emotional roller coaster, becoming dependent on others, and facing an uncertain future.
Study details: A qualitative study of six adults patients with non-Hodgkin lymphoma who were undergoing chemotherapy.
Disclosures: There was no outside funding for the study and the researchers reported having no financial disclosures.
Source: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Drug-coated balloon advantage persists in femoral artery disease
NEW YORK – John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.
The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.
Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.
In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.
Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.
NEW YORK – John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.
The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.
Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.
In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.
Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.
NEW YORK – John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.
The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.
Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.
In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.
Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.
REPORTING FROM VEITHSYMPOSIUM
Don’t just work hard; work hard at living
NEW YORK – “A physician falls overboard on a large cruise ship and passengers gather at the guard rail. The first passenger at the guardrail shakes his finger down at the drowning physician and says, ‘You need to learn how to swim!’ Another passenger says, ‘No, man, throw him a life preserver.’ ... Finally, a passenger says, ‘We need better guard rails.’ ”
That’s the analogy Cynthia K. Shortell, MD used to kick off her presentation on physician burnout and the need for resilience at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
“Which of these is right? Well, of course, the answer is they all are,” said Dr. Shortell, who is a professor of surgery at Duke University Durham, N.C. But certainly, only the life preserver answer was appropriate at that time for the drowning physician, she added.
Continuing the analogy, Dr. Shortell pointed out that surely there is a man overboard, with 1 in 20 surgeons reporting suicidal ideation. That rate jumps threefold if the surgeon has had a recent medical error. In addition, vascular surgeons in particular are within the top tier of specialties at risk for burnout.
“We do need better guardrails,” she said, and described the need to actively engage with the health care system to help solve these issues, including those involving electronic medical records and operating room inefficiency and use. In addition, there is a great need for additional services that are provided to other high-end professionals, including food, concierge service, gym access, and other services that help with tasks of daily life when physicians need to spend most of their time at the hospital.
But, in the end, Dr. Shortell said, “We do need to learn to swim. Ultimately, we do need to take a role in having responsibility to solve this problem on our own. We need to change the way we think about our work, and the way we think about our health, and the way our culture values working hard instead of working hard at living.”
Dr. Shortell also highlighted the need to deal with musculoskeletal issues arising from the way that surgeons operate. This, along with good leadership, are key factors in preventing and remediating burnout.
Dr. Shortell had no disclosures relevant to her talk.
NEW YORK – “A physician falls overboard on a large cruise ship and passengers gather at the guard rail. The first passenger at the guardrail shakes his finger down at the drowning physician and says, ‘You need to learn how to swim!’ Another passenger says, ‘No, man, throw him a life preserver.’ ... Finally, a passenger says, ‘We need better guard rails.’ ”
That’s the analogy Cynthia K. Shortell, MD used to kick off her presentation on physician burnout and the need for resilience at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
“Which of these is right? Well, of course, the answer is they all are,” said Dr. Shortell, who is a professor of surgery at Duke University Durham, N.C. But certainly, only the life preserver answer was appropriate at that time for the drowning physician, she added.
Continuing the analogy, Dr. Shortell pointed out that surely there is a man overboard, with 1 in 20 surgeons reporting suicidal ideation. That rate jumps threefold if the surgeon has had a recent medical error. In addition, vascular surgeons in particular are within the top tier of specialties at risk for burnout.
“We do need better guardrails,” she said, and described the need to actively engage with the health care system to help solve these issues, including those involving electronic medical records and operating room inefficiency and use. In addition, there is a great need for additional services that are provided to other high-end professionals, including food, concierge service, gym access, and other services that help with tasks of daily life when physicians need to spend most of their time at the hospital.
But, in the end, Dr. Shortell said, “We do need to learn to swim. Ultimately, we do need to take a role in having responsibility to solve this problem on our own. We need to change the way we think about our work, and the way we think about our health, and the way our culture values working hard instead of working hard at living.”
Dr. Shortell also highlighted the need to deal with musculoskeletal issues arising from the way that surgeons operate. This, along with good leadership, are key factors in preventing and remediating burnout.
Dr. Shortell had no disclosures relevant to her talk.
NEW YORK – “A physician falls overboard on a large cruise ship and passengers gather at the guard rail. The first passenger at the guardrail shakes his finger down at the drowning physician and says, ‘You need to learn how to swim!’ Another passenger says, ‘No, man, throw him a life preserver.’ ... Finally, a passenger says, ‘We need better guard rails.’ ”
That’s the analogy Cynthia K. Shortell, MD used to kick off her presentation on physician burnout and the need for resilience at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
“Which of these is right? Well, of course, the answer is they all are,” said Dr. Shortell, who is a professor of surgery at Duke University Durham, N.C. But certainly, only the life preserver answer was appropriate at that time for the drowning physician, she added.
Continuing the analogy, Dr. Shortell pointed out that surely there is a man overboard, with 1 in 20 surgeons reporting suicidal ideation. That rate jumps threefold if the surgeon has had a recent medical error. In addition, vascular surgeons in particular are within the top tier of specialties at risk for burnout.
“We do need better guardrails,” she said, and described the need to actively engage with the health care system to help solve these issues, including those involving electronic medical records and operating room inefficiency and use. In addition, there is a great need for additional services that are provided to other high-end professionals, including food, concierge service, gym access, and other services that help with tasks of daily life when physicians need to spend most of their time at the hospital.
But, in the end, Dr. Shortell said, “We do need to learn to swim. Ultimately, we do need to take a role in having responsibility to solve this problem on our own. We need to change the way we think about our work, and the way we think about our health, and the way our culture values working hard instead of working hard at living.”
Dr. Shortell also highlighted the need to deal with musculoskeletal issues arising from the way that surgeons operate. This, along with good leadership, are key factors in preventing and remediating burnout.
Dr. Shortell had no disclosures relevant to her talk.
REPORTING FROM THE VEITHSYMPOSIUM
What’s new with the SVS VQI?
NEW YORK – The Vascular Quality Initiative (VQI) is designed to improve the quality, safety, and effectiveness of vascular health care, but also reduce costs through the collection and exchange of information, according to Larry W. Kraiss, MD, professor of surgery, University of Utah, Salt Lake City.
The VQI consists of three major components: a federally accredited patient safety organization (PSO), a registry, and a distributed network of quality groups, which can also serve as a platform for internal quality improvement efforts.
Even though registries are considered less reliable than the venerated randomized clinical trial models are, registries have some unique advantages, according to Dr. Kraiss, who spoke at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. Randomized clinical trials (RCTs) are very expensive to conduct and are criticized for potentially not being generalizable because of their rigidly defined inclusion/exclusion criteria. Despite inherent problems with registry data, especially bias, there are now statistical methods to help account for the biases. Registry-controlled trials are going to be important to answer many questions that cannot be answered by RCTs. Such trials can be too costly or actually unethical to randomize under certain circumstances. Registries, however, provide real-world patient populations in greater numbers than RCTs can manage, including access to rare events that would otherwise not be detected.
The VQI holds an important place in this second tier and is an important source of information for clinical care.
The VQI has grown steadily since its inception, and there are more than 500 centers now participating, including 6 international centers, and 18 regional groups, according to Dr. Kraiss. There are more than 530,000 procedures contained within the VQI’s 12 registries, with more than half of them involving peripheral vascular interventions and carotid endarterectomies. “But there [are] a healthy number of cases in all of the other registries, which provide a very rich resource and evidence base,” he added.
The VQI is becoming very important in the regulatory framework, with the Food and Drug Administration embracing “real-world evidence” as a way to justify some of its decisions, and the VQI has been involved in this process. The VQI has coordinated several post-market surveillance programs, the two most important being in the areas of thoracic endovascular aortic repair (TEVAR) and transcarotid artery revascularization (TCAR), said Dr. Kraiss.
One of the important values of the VQI is the ability to examine benchmarks and to compare performance across centers. For example, looking at aortic abdominal aneurysm (AAA) repair data, the results showed that a number of centers were not following established Society for Vascular Society guidelines and that there were a substantial number of AAAs reported in the VQI that were treated when they were below the threshold for intervention and should have received routine observation only.
So, ultimately two of the greatest values of the VQI are the ability to use it as a means of local quality improvement, and to provide an avenue for important clinical research, Dr. Kraiss concluded.
Dr. Kraiss reported that they had no disclosures.
NEW YORK – The Vascular Quality Initiative (VQI) is designed to improve the quality, safety, and effectiveness of vascular health care, but also reduce costs through the collection and exchange of information, according to Larry W. Kraiss, MD, professor of surgery, University of Utah, Salt Lake City.
The VQI consists of three major components: a federally accredited patient safety organization (PSO), a registry, and a distributed network of quality groups, which can also serve as a platform for internal quality improvement efforts.
Even though registries are considered less reliable than the venerated randomized clinical trial models are, registries have some unique advantages, according to Dr. Kraiss, who spoke at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. Randomized clinical trials (RCTs) are very expensive to conduct and are criticized for potentially not being generalizable because of their rigidly defined inclusion/exclusion criteria. Despite inherent problems with registry data, especially bias, there are now statistical methods to help account for the biases. Registry-controlled trials are going to be important to answer many questions that cannot be answered by RCTs. Such trials can be too costly or actually unethical to randomize under certain circumstances. Registries, however, provide real-world patient populations in greater numbers than RCTs can manage, including access to rare events that would otherwise not be detected.
The VQI holds an important place in this second tier and is an important source of information for clinical care.
The VQI has grown steadily since its inception, and there are more than 500 centers now participating, including 6 international centers, and 18 regional groups, according to Dr. Kraiss. There are more than 530,000 procedures contained within the VQI’s 12 registries, with more than half of them involving peripheral vascular interventions and carotid endarterectomies. “But there [are] a healthy number of cases in all of the other registries, which provide a very rich resource and evidence base,” he added.
The VQI is becoming very important in the regulatory framework, with the Food and Drug Administration embracing “real-world evidence” as a way to justify some of its decisions, and the VQI has been involved in this process. The VQI has coordinated several post-market surveillance programs, the two most important being in the areas of thoracic endovascular aortic repair (TEVAR) and transcarotid artery revascularization (TCAR), said Dr. Kraiss.
One of the important values of the VQI is the ability to examine benchmarks and to compare performance across centers. For example, looking at aortic abdominal aneurysm (AAA) repair data, the results showed that a number of centers were not following established Society for Vascular Society guidelines and that there were a substantial number of AAAs reported in the VQI that were treated when they were below the threshold for intervention and should have received routine observation only.
So, ultimately two of the greatest values of the VQI are the ability to use it as a means of local quality improvement, and to provide an avenue for important clinical research, Dr. Kraiss concluded.
Dr. Kraiss reported that they had no disclosures.
NEW YORK – The Vascular Quality Initiative (VQI) is designed to improve the quality, safety, and effectiveness of vascular health care, but also reduce costs through the collection and exchange of information, according to Larry W. Kraiss, MD, professor of surgery, University of Utah, Salt Lake City.
The VQI consists of three major components: a federally accredited patient safety organization (PSO), a registry, and a distributed network of quality groups, which can also serve as a platform for internal quality improvement efforts.
Even though registries are considered less reliable than the venerated randomized clinical trial models are, registries have some unique advantages, according to Dr. Kraiss, who spoke at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. Randomized clinical trials (RCTs) are very expensive to conduct and are criticized for potentially not being generalizable because of their rigidly defined inclusion/exclusion criteria. Despite inherent problems with registry data, especially bias, there are now statistical methods to help account for the biases. Registry-controlled trials are going to be important to answer many questions that cannot be answered by RCTs. Such trials can be too costly or actually unethical to randomize under certain circumstances. Registries, however, provide real-world patient populations in greater numbers than RCTs can manage, including access to rare events that would otherwise not be detected.
The VQI holds an important place in this second tier and is an important source of information for clinical care.
The VQI has grown steadily since its inception, and there are more than 500 centers now participating, including 6 international centers, and 18 regional groups, according to Dr. Kraiss. There are more than 530,000 procedures contained within the VQI’s 12 registries, with more than half of them involving peripheral vascular interventions and carotid endarterectomies. “But there [are] a healthy number of cases in all of the other registries, which provide a very rich resource and evidence base,” he added.
The VQI is becoming very important in the regulatory framework, with the Food and Drug Administration embracing “real-world evidence” as a way to justify some of its decisions, and the VQI has been involved in this process. The VQI has coordinated several post-market surveillance programs, the two most important being in the areas of thoracic endovascular aortic repair (TEVAR) and transcarotid artery revascularization (TCAR), said Dr. Kraiss.
One of the important values of the VQI is the ability to examine benchmarks and to compare performance across centers. For example, looking at aortic abdominal aneurysm (AAA) repair data, the results showed that a number of centers were not following established Society for Vascular Society guidelines and that there were a substantial number of AAAs reported in the VQI that were treated when they were below the threshold for intervention and should have received routine observation only.
So, ultimately two of the greatest values of the VQI are the ability to use it as a means of local quality improvement, and to provide an avenue for important clinical research, Dr. Kraiss concluded.
Dr. Kraiss reported that they had no disclosures.
REPORTING FROM THE VEITHSYMPOSIUM
AHA 2018: Part I
Sandy Hook Promise: Four programs help people recognize signs of a threat
ORLANDO – “The caretaker of all living things” – that was the good-natured moniker 7-year-old Daniel Barden had earned from his family – according to his dad, Mark Barden. Daniel would pick up black ants and take them outside “to be with their families,” even when the ant bit his fingers.
A walk down the sidewalk after a rain would take three times longer than it should because Daniel stopped to pick up every worm on the pavement and put it in the grass, lest it dry out in the sun, Mr. Barden said with a chuckle at the annual meeting of the American Academy of Pediatrics.
Daniel was his youngest and full of pure joy, Mr. Barden said, but that ended with his son’s murder during the Sandy Hook Elementary mass shooting Dec. 14, 2012. To honor his son and work to reduce the likelihood of similar mass shootings, Mr. Barden, now the managing director of Sandy Hook Promise in Newtown, Conn., shared with the pediatrician audience the work of the organization formed by Sandy Hook parents to attempt to prevent gun violence before it happens.
“We’re moms and dads and a couple of families who have lost loved ones in that tragedy, and we are growing as an organization,” Mr. Barden said. “Our basic, most fundamental objective is to prevent other families from living with the pain I will live with for the rest of my life.”
Their mission involves “creating a culture engaged and committed to identifying, intervening, and getting help for individuals who may be at risk of hurting themselves or others,” Mr. Barden said.
Sandy Hook Promise accomplishes this goal by educating and empowering communities through their four programs: Start with Hello, SOS Suicide Prevention Program, SaySomething, and Safety Assessment & Intervention. The organization delivers these programs through multiple platforms, including national and local trainers, digital curriculum downloads, interactive online training videos, and using multilingual presenters and English and Spanish materials.
The organization also especially works with schools and student’s clubs to change their culture and feel empowered to speak up and do their part to prevent gun violence too.
These programs resulted from extensive qualitative and quantitative research that Sandy Hook Promise conducted after the shooting with academic researchers, law enforcement, educators, school administrators, mental health professionals, and social movement experts.
“As we see these stories play themselves out over and over again, we start to reveal the story of somebody who didn’t just snap overnight,” Mr. Barden said. Signs that a person may be at risk for committing mass violence include suicidality, preoccupation with weapons, talking about committing violent acts, and general signs of depression and anxiety. “If we can train people how to not only recognize but to look for those signs, we can make a sustainable difference,” he said.
Most mass shootings are planned at least 6 months in advance, he said. About 80% of school shooters tell someone about their plans, and 69% tell multiple people. Similarly, up to 70% of people who die by suicide tell someone they plan to do it or give some other warning sign.
Further, more than a third of violent threats and bullying occurs electronically, so students are well equipped to watch for the signs and report them if they know how and feel comfortable doing so.
Mr. Barden outlined the goals of each of the four Sandy Hook Promise programs.
Start With Hello
This program “teaches youth how to identify and minimize social isolation, marginalization, and rejection in order to create an inclusive, connected community,” Mr. Barden explained. The goals of the program are to reduce bullying, foster socialization, increase engagement, and change a culture from within.
SOS Signs of Suicide
This is Sandy Hook Promise’s newest program and is built on a program developed by the Federal Bureau of Investigation following the Virginia Tech shooting and adapted for school-based applications.
“It also develops a multidisciplinary team within the school who acts as various touch points who know how to recognize a potential warning sign and then triage that information and take steps to get to the root cause of that behavior and not just bandage the wound,” Mr. Barden explained.
SaySomething
The organization’s flagship program does the most to recruit student involvement in recognizing the signs of a potential threat, particularly in social media, and report the individual and their behavior to a trusted adult or through Sandy Hook Promise’s Anonymous Reporting System.
“The kids take this one, and they run with it and do amazing things with it,” Mr. Barden said, noting that it particularly helps students recognize warning signs on social media. “We have growing evidence of kids following this model, and we’ve already prevented mass shootings and numerous suicides with this.”
Safety Assessment & Intervention (SAI) program
This program “trains a multidisciplinary team how to identify, assess, and respond to threats and observed at-risk behaviors,” Mr. Barden said. SAI aims to create a safer, more open school environment with less violence, bullying, and threats. That includes reducing educators’ fear and anxiety, and leading students to have a more positive view of teachers and staff.
Students can report tips to the Anonymous Reporting System through the website, calling the hot line or via a free mobile app. Regardless of the method, the anonymous tips go to a 24/7 multilingual crisis center and, if needed, law enforcement. The crisis center contacts the appropriate school official via text, email, or a phone call, and the case is tracked in real time until it’s addressed, resolved, and closed.
All of these programs are freely available to any school or institution who wants to use them, Mr. Barden said, because the organization does not want cost to get in the way of any school or community that is taking advantage of tools to reduce the risk of violence.
In fact, more than 3.5 million youth and adults in more than 7,000 schools in every state have been trained in these programs, helping hundreds of youth access mental health and wellness help, he said. The program has reduced truancy, bullying, and other forms of violence and victimization, and it has intervened in multiple school shooting plans across the United States.
Mr. Barden wrapped up his address with his gratitude for pediatricians’ willingness to be partners in reducing gun violence.
“I want to tell you how much it means to me that you took the time to come here and listen to my story and the work I’m doing,” he said, “and how proud I am to be able to share it with you, and how proud I am to be able to honor that little kid who truly was the caretaker of all living things and to continue that spirit in his honor and in his absence.”
ORLANDO – “The caretaker of all living things” – that was the good-natured moniker 7-year-old Daniel Barden had earned from his family – according to his dad, Mark Barden. Daniel would pick up black ants and take them outside “to be with their families,” even when the ant bit his fingers.
A walk down the sidewalk after a rain would take three times longer than it should because Daniel stopped to pick up every worm on the pavement and put it in the grass, lest it dry out in the sun, Mr. Barden said with a chuckle at the annual meeting of the American Academy of Pediatrics.
Daniel was his youngest and full of pure joy, Mr. Barden said, but that ended with his son’s murder during the Sandy Hook Elementary mass shooting Dec. 14, 2012. To honor his son and work to reduce the likelihood of similar mass shootings, Mr. Barden, now the managing director of Sandy Hook Promise in Newtown, Conn., shared with the pediatrician audience the work of the organization formed by Sandy Hook parents to attempt to prevent gun violence before it happens.
“We’re moms and dads and a couple of families who have lost loved ones in that tragedy, and we are growing as an organization,” Mr. Barden said. “Our basic, most fundamental objective is to prevent other families from living with the pain I will live with for the rest of my life.”
Their mission involves “creating a culture engaged and committed to identifying, intervening, and getting help for individuals who may be at risk of hurting themselves or others,” Mr. Barden said.
Sandy Hook Promise accomplishes this goal by educating and empowering communities through their four programs: Start with Hello, SOS Suicide Prevention Program, SaySomething, and Safety Assessment & Intervention. The organization delivers these programs through multiple platforms, including national and local trainers, digital curriculum downloads, interactive online training videos, and using multilingual presenters and English and Spanish materials.
The organization also especially works with schools and student’s clubs to change their culture and feel empowered to speak up and do their part to prevent gun violence too.
These programs resulted from extensive qualitative and quantitative research that Sandy Hook Promise conducted after the shooting with academic researchers, law enforcement, educators, school administrators, mental health professionals, and social movement experts.
“As we see these stories play themselves out over and over again, we start to reveal the story of somebody who didn’t just snap overnight,” Mr. Barden said. Signs that a person may be at risk for committing mass violence include suicidality, preoccupation with weapons, talking about committing violent acts, and general signs of depression and anxiety. “If we can train people how to not only recognize but to look for those signs, we can make a sustainable difference,” he said.
Most mass shootings are planned at least 6 months in advance, he said. About 80% of school shooters tell someone about their plans, and 69% tell multiple people. Similarly, up to 70% of people who die by suicide tell someone they plan to do it or give some other warning sign.
Further, more than a third of violent threats and bullying occurs electronically, so students are well equipped to watch for the signs and report them if they know how and feel comfortable doing so.
Mr. Barden outlined the goals of each of the four Sandy Hook Promise programs.
Start With Hello
This program “teaches youth how to identify and minimize social isolation, marginalization, and rejection in order to create an inclusive, connected community,” Mr. Barden explained. The goals of the program are to reduce bullying, foster socialization, increase engagement, and change a culture from within.
SOS Signs of Suicide
This is Sandy Hook Promise’s newest program and is built on a program developed by the Federal Bureau of Investigation following the Virginia Tech shooting and adapted for school-based applications.
“It also develops a multidisciplinary team within the school who acts as various touch points who know how to recognize a potential warning sign and then triage that information and take steps to get to the root cause of that behavior and not just bandage the wound,” Mr. Barden explained.
SaySomething
The organization’s flagship program does the most to recruit student involvement in recognizing the signs of a potential threat, particularly in social media, and report the individual and their behavior to a trusted adult or through Sandy Hook Promise’s Anonymous Reporting System.
“The kids take this one, and they run with it and do amazing things with it,” Mr. Barden said, noting that it particularly helps students recognize warning signs on social media. “We have growing evidence of kids following this model, and we’ve already prevented mass shootings and numerous suicides with this.”
Safety Assessment & Intervention (SAI) program
This program “trains a multidisciplinary team how to identify, assess, and respond to threats and observed at-risk behaviors,” Mr. Barden said. SAI aims to create a safer, more open school environment with less violence, bullying, and threats. That includes reducing educators’ fear and anxiety, and leading students to have a more positive view of teachers and staff.
Students can report tips to the Anonymous Reporting System through the website, calling the hot line or via a free mobile app. Regardless of the method, the anonymous tips go to a 24/7 multilingual crisis center and, if needed, law enforcement. The crisis center contacts the appropriate school official via text, email, or a phone call, and the case is tracked in real time until it’s addressed, resolved, and closed.
All of these programs are freely available to any school or institution who wants to use them, Mr. Barden said, because the organization does not want cost to get in the way of any school or community that is taking advantage of tools to reduce the risk of violence.
In fact, more than 3.5 million youth and adults in more than 7,000 schools in every state have been trained in these programs, helping hundreds of youth access mental health and wellness help, he said. The program has reduced truancy, bullying, and other forms of violence and victimization, and it has intervened in multiple school shooting plans across the United States.
Mr. Barden wrapped up his address with his gratitude for pediatricians’ willingness to be partners in reducing gun violence.
“I want to tell you how much it means to me that you took the time to come here and listen to my story and the work I’m doing,” he said, “and how proud I am to be able to share it with you, and how proud I am to be able to honor that little kid who truly was the caretaker of all living things and to continue that spirit in his honor and in his absence.”
ORLANDO – “The caretaker of all living things” – that was the good-natured moniker 7-year-old Daniel Barden had earned from his family – according to his dad, Mark Barden. Daniel would pick up black ants and take them outside “to be with their families,” even when the ant bit his fingers.
A walk down the sidewalk after a rain would take three times longer than it should because Daniel stopped to pick up every worm on the pavement and put it in the grass, lest it dry out in the sun, Mr. Barden said with a chuckle at the annual meeting of the American Academy of Pediatrics.
Daniel was his youngest and full of pure joy, Mr. Barden said, but that ended with his son’s murder during the Sandy Hook Elementary mass shooting Dec. 14, 2012. To honor his son and work to reduce the likelihood of similar mass shootings, Mr. Barden, now the managing director of Sandy Hook Promise in Newtown, Conn., shared with the pediatrician audience the work of the organization formed by Sandy Hook parents to attempt to prevent gun violence before it happens.
“We’re moms and dads and a couple of families who have lost loved ones in that tragedy, and we are growing as an organization,” Mr. Barden said. “Our basic, most fundamental objective is to prevent other families from living with the pain I will live with for the rest of my life.”
Their mission involves “creating a culture engaged and committed to identifying, intervening, and getting help for individuals who may be at risk of hurting themselves or others,” Mr. Barden said.
Sandy Hook Promise accomplishes this goal by educating and empowering communities through their four programs: Start with Hello, SOS Suicide Prevention Program, SaySomething, and Safety Assessment & Intervention. The organization delivers these programs through multiple platforms, including national and local trainers, digital curriculum downloads, interactive online training videos, and using multilingual presenters and English and Spanish materials.
The organization also especially works with schools and student’s clubs to change their culture and feel empowered to speak up and do their part to prevent gun violence too.
These programs resulted from extensive qualitative and quantitative research that Sandy Hook Promise conducted after the shooting with academic researchers, law enforcement, educators, school administrators, mental health professionals, and social movement experts.
“As we see these stories play themselves out over and over again, we start to reveal the story of somebody who didn’t just snap overnight,” Mr. Barden said. Signs that a person may be at risk for committing mass violence include suicidality, preoccupation with weapons, talking about committing violent acts, and general signs of depression and anxiety. “If we can train people how to not only recognize but to look for those signs, we can make a sustainable difference,” he said.
Most mass shootings are planned at least 6 months in advance, he said. About 80% of school shooters tell someone about their plans, and 69% tell multiple people. Similarly, up to 70% of people who die by suicide tell someone they plan to do it or give some other warning sign.
Further, more than a third of violent threats and bullying occurs electronically, so students are well equipped to watch for the signs and report them if they know how and feel comfortable doing so.
Mr. Barden outlined the goals of each of the four Sandy Hook Promise programs.
Start With Hello
This program “teaches youth how to identify and minimize social isolation, marginalization, and rejection in order to create an inclusive, connected community,” Mr. Barden explained. The goals of the program are to reduce bullying, foster socialization, increase engagement, and change a culture from within.
SOS Signs of Suicide
This is Sandy Hook Promise’s newest program and is built on a program developed by the Federal Bureau of Investigation following the Virginia Tech shooting and adapted for school-based applications.
“It also develops a multidisciplinary team within the school who acts as various touch points who know how to recognize a potential warning sign and then triage that information and take steps to get to the root cause of that behavior and not just bandage the wound,” Mr. Barden explained.
SaySomething
The organization’s flagship program does the most to recruit student involvement in recognizing the signs of a potential threat, particularly in social media, and report the individual and their behavior to a trusted adult or through Sandy Hook Promise’s Anonymous Reporting System.
“The kids take this one, and they run with it and do amazing things with it,” Mr. Barden said, noting that it particularly helps students recognize warning signs on social media. “We have growing evidence of kids following this model, and we’ve already prevented mass shootings and numerous suicides with this.”
Safety Assessment & Intervention (SAI) program
This program “trains a multidisciplinary team how to identify, assess, and respond to threats and observed at-risk behaviors,” Mr. Barden said. SAI aims to create a safer, more open school environment with less violence, bullying, and threats. That includes reducing educators’ fear and anxiety, and leading students to have a more positive view of teachers and staff.
Students can report tips to the Anonymous Reporting System through the website, calling the hot line or via a free mobile app. Regardless of the method, the anonymous tips go to a 24/7 multilingual crisis center and, if needed, law enforcement. The crisis center contacts the appropriate school official via text, email, or a phone call, and the case is tracked in real time until it’s addressed, resolved, and closed.
All of these programs are freely available to any school or institution who wants to use them, Mr. Barden said, because the organization does not want cost to get in the way of any school or community that is taking advantage of tools to reduce the risk of violence.
In fact, more than 3.5 million youth and adults in more than 7,000 schools in every state have been trained in these programs, helping hundreds of youth access mental health and wellness help, he said. The program has reduced truancy, bullying, and other forms of violence and victimization, and it has intervened in multiple school shooting plans across the United States.
Mr. Barden wrapped up his address with his gratitude for pediatricians’ willingness to be partners in reducing gun violence.
“I want to tell you how much it means to me that you took the time to come here and listen to my story and the work I’m doing,” he said, “and how proud I am to be able to share it with you, and how proud I am to be able to honor that little kid who truly was the caretaker of all living things and to continue that spirit in his honor and in his absence.”
EXPERT ANALYSIS FROM AAP 18
R-CHOP looks viable as first line in follicular lymphoma
A decade of follow-up data suggest that patients with newly diagnosed follicular lymphoma may derive long-term benefit from first-line therapy with the R-CHOP regimen, according to investigators in Japan.
Among patients with untreated follicular and other indolent B-cell lymphomas enrolled in a randomized phase 2/3 trial, the 10-year progression-free survival (PFS) rate for patients assigned to R-CHOP-21 (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone every 3 weeks) was 33%, and the 10-year PFS rate for patients assigned to R-CHOP-14 (R-CHOP every 2 weeks with granulocyte colony-stimulating factor [G-CSF] support] was 39%, and these PFS rates did not differ between the treatment arms, Takashi Watanabe, MD, PhD, from Mie University in Tsu, Japan, and his colleagues reported in the Lancet Haematology.
They also found that, compared with therapeutic regimens prior to the introduction of rituximab, R-CHOP was associated with a reduced likelihood of histological transformation of follicular lymphoma into a poor-prognosis diffuse large B-cell lymphoma (DLBCL), with no apparent increase in risk of secondary malignancies.
“The gold-standard, first-line treatment in patients with advanced-stage follicular lymphoma remains undetermined. However, because of the reduction in incidence of transformation without an increase in either secondary malignancies or fatal infectious events, the R-CHOP regimen should be a candidate for standard treatment, particularly from the viewpoint of long-term follow-up,” the investigators wrote
The JCOG0203 trial, which began enrollment in September 2002, included patients with stage III or IV indolent B-cell lymphomas, including grades 1-3 follicular lymphoma, from 44 Japanese hospitals. The patients were randomly assigned to receive six cycles of either R-CHOP-14 plus G-CSF or R-CHOP-21 administered once daily for 6 days beginning on day 8 of every cycle). Patients did not receive rituximab maintenance in either group.
In the primary analysis of the trial, published in 2011, the investigators reported that in 299 patients there were no significant differences in either PFS or 6-year overall survival (OS).
In the current analysis, the investigators reported that, for 248 patients with grade 1-3a follicular lymphoma, the 8-year PFS rate was 39% and the 10-year PFS rate was 36%.
The cumulative incidence of histological transformation was 3.2% at 5 years, 8.5% at 8 years, and 9.3% 10 years after the last patient was enrolled.
“In our study, survival after histological transformation was still poor; therefore, reducing histological transformation remains a crucial issue for patients with follicular lymphoma,” the investigators wrote.
The cumulative incidence of secondary malignancies at 10 years was 8.1%, and the cumulative incidence of hematological secondary malignancies was 2.9%.
The investigators noted that the actual incidence of secondary solid tumors or hematologic malignancies apart from the setting of autologous stem cell transplants is not known and emphasized that patients should be followed beyond 10 years to ensure that the risk of secondary malignancies is not underestimated.
“Clinicians choosing a first-line treatment for patients with follicular lymphoma should be cautious of secondary malignancies caused by immunochemotherapy and severe complications of infectious diseases in the long-term follow-up – both of which could lead to death,” they advised.
The study was supported by the Ministry of Health, Labour and Welfare of Japan and by the National Cancer Center Research and Development Fund of Japan. Dr. Watanabe has received honoraria from Bristol-Myers Squibb, Takeda, Taisho Toyama, Celgene, Nippon Shinyaku, and Novartis and funding resources from TakaraBio and United Immunity to support the Department of Immuno-Gene Therapy at Mie University. Multiple coauthors reported similar relationships.
SOURCE: Watanabe T et al. Lancet Haematol. 2018 Nov;5(11):e520-31.
A decade of follow-up data suggest that patients with newly diagnosed follicular lymphoma may derive long-term benefit from first-line therapy with the R-CHOP regimen, according to investigators in Japan.
Among patients with untreated follicular and other indolent B-cell lymphomas enrolled in a randomized phase 2/3 trial, the 10-year progression-free survival (PFS) rate for patients assigned to R-CHOP-21 (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone every 3 weeks) was 33%, and the 10-year PFS rate for patients assigned to R-CHOP-14 (R-CHOP every 2 weeks with granulocyte colony-stimulating factor [G-CSF] support] was 39%, and these PFS rates did not differ between the treatment arms, Takashi Watanabe, MD, PhD, from Mie University in Tsu, Japan, and his colleagues reported in the Lancet Haematology.
They also found that, compared with therapeutic regimens prior to the introduction of rituximab, R-CHOP was associated with a reduced likelihood of histological transformation of follicular lymphoma into a poor-prognosis diffuse large B-cell lymphoma (DLBCL), with no apparent increase in risk of secondary malignancies.
“The gold-standard, first-line treatment in patients with advanced-stage follicular lymphoma remains undetermined. However, because of the reduction in incidence of transformation without an increase in either secondary malignancies or fatal infectious events, the R-CHOP regimen should be a candidate for standard treatment, particularly from the viewpoint of long-term follow-up,” the investigators wrote
The JCOG0203 trial, which began enrollment in September 2002, included patients with stage III or IV indolent B-cell lymphomas, including grades 1-3 follicular lymphoma, from 44 Japanese hospitals. The patients were randomly assigned to receive six cycles of either R-CHOP-14 plus G-CSF or R-CHOP-21 administered once daily for 6 days beginning on day 8 of every cycle). Patients did not receive rituximab maintenance in either group.
In the primary analysis of the trial, published in 2011, the investigators reported that in 299 patients there were no significant differences in either PFS or 6-year overall survival (OS).
In the current analysis, the investigators reported that, for 248 patients with grade 1-3a follicular lymphoma, the 8-year PFS rate was 39% and the 10-year PFS rate was 36%.
The cumulative incidence of histological transformation was 3.2% at 5 years, 8.5% at 8 years, and 9.3% 10 years after the last patient was enrolled.
“In our study, survival after histological transformation was still poor; therefore, reducing histological transformation remains a crucial issue for patients with follicular lymphoma,” the investigators wrote.
The cumulative incidence of secondary malignancies at 10 years was 8.1%, and the cumulative incidence of hematological secondary malignancies was 2.9%.
The investigators noted that the actual incidence of secondary solid tumors or hematologic malignancies apart from the setting of autologous stem cell transplants is not known and emphasized that patients should be followed beyond 10 years to ensure that the risk of secondary malignancies is not underestimated.
“Clinicians choosing a first-line treatment for patients with follicular lymphoma should be cautious of secondary malignancies caused by immunochemotherapy and severe complications of infectious diseases in the long-term follow-up – both of which could lead to death,” they advised.
The study was supported by the Ministry of Health, Labour and Welfare of Japan and by the National Cancer Center Research and Development Fund of Japan. Dr. Watanabe has received honoraria from Bristol-Myers Squibb, Takeda, Taisho Toyama, Celgene, Nippon Shinyaku, and Novartis and funding resources from TakaraBio and United Immunity to support the Department of Immuno-Gene Therapy at Mie University. Multiple coauthors reported similar relationships.
SOURCE: Watanabe T et al. Lancet Haematol. 2018 Nov;5(11):e520-31.
A decade of follow-up data suggest that patients with newly diagnosed follicular lymphoma may derive long-term benefit from first-line therapy with the R-CHOP regimen, according to investigators in Japan.
Among patients with untreated follicular and other indolent B-cell lymphomas enrolled in a randomized phase 2/3 trial, the 10-year progression-free survival (PFS) rate for patients assigned to R-CHOP-21 (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone every 3 weeks) was 33%, and the 10-year PFS rate for patients assigned to R-CHOP-14 (R-CHOP every 2 weeks with granulocyte colony-stimulating factor [G-CSF] support] was 39%, and these PFS rates did not differ between the treatment arms, Takashi Watanabe, MD, PhD, from Mie University in Tsu, Japan, and his colleagues reported in the Lancet Haematology.
They also found that, compared with therapeutic regimens prior to the introduction of rituximab, R-CHOP was associated with a reduced likelihood of histological transformation of follicular lymphoma into a poor-prognosis diffuse large B-cell lymphoma (DLBCL), with no apparent increase in risk of secondary malignancies.
“The gold-standard, first-line treatment in patients with advanced-stage follicular lymphoma remains undetermined. However, because of the reduction in incidence of transformation without an increase in either secondary malignancies or fatal infectious events, the R-CHOP regimen should be a candidate for standard treatment, particularly from the viewpoint of long-term follow-up,” the investigators wrote
The JCOG0203 trial, which began enrollment in September 2002, included patients with stage III or IV indolent B-cell lymphomas, including grades 1-3 follicular lymphoma, from 44 Japanese hospitals. The patients were randomly assigned to receive six cycles of either R-CHOP-14 plus G-CSF or R-CHOP-21 administered once daily for 6 days beginning on day 8 of every cycle). Patients did not receive rituximab maintenance in either group.
In the primary analysis of the trial, published in 2011, the investigators reported that in 299 patients there were no significant differences in either PFS or 6-year overall survival (OS).
In the current analysis, the investigators reported that, for 248 patients with grade 1-3a follicular lymphoma, the 8-year PFS rate was 39% and the 10-year PFS rate was 36%.
The cumulative incidence of histological transformation was 3.2% at 5 years, 8.5% at 8 years, and 9.3% 10 years after the last patient was enrolled.
“In our study, survival after histological transformation was still poor; therefore, reducing histological transformation remains a crucial issue for patients with follicular lymphoma,” the investigators wrote.
The cumulative incidence of secondary malignancies at 10 years was 8.1%, and the cumulative incidence of hematological secondary malignancies was 2.9%.
The investigators noted that the actual incidence of secondary solid tumors or hematologic malignancies apart from the setting of autologous stem cell transplants is not known and emphasized that patients should be followed beyond 10 years to ensure that the risk of secondary malignancies is not underestimated.
“Clinicians choosing a first-line treatment for patients with follicular lymphoma should be cautious of secondary malignancies caused by immunochemotherapy and severe complications of infectious diseases in the long-term follow-up – both of which could lead to death,” they advised.
The study was supported by the Ministry of Health, Labour and Welfare of Japan and by the National Cancer Center Research and Development Fund of Japan. Dr. Watanabe has received honoraria from Bristol-Myers Squibb, Takeda, Taisho Toyama, Celgene, Nippon Shinyaku, and Novartis and funding resources from TakaraBio and United Immunity to support the Department of Immuno-Gene Therapy at Mie University. Multiple coauthors reported similar relationships.
SOURCE: Watanabe T et al. Lancet Haematol. 2018 Nov;5(11):e520-31.
FROM LANCET HAEMATOLOGY
Key clinical point:
Major finding: Approximately one-third of patients treated with R-CHOP-14 plus G-CSF or R-CHOP-21 had no disease progression after 10 years of follow-up.
Study details: Long-term analysis of a randomized phase 2/3 trial in 299 patients with indolent B-cell lymphomas, including follicular lymphoma.
Disclosures: The study was supported by the Ministry of Health, Labor and Welfare of Japan and by the National Cancer Center Research and Development Fund of Japan. Dr. Wantanabe has received honoraria from Bristol-Myers Squibb, Takeda, Taisho Toyama, Celgene, Nippon Shinyaku, and Novartis and funding resources from TakaraBio and United Immunity to support the Department of Immuno-Gene Therapy in Mie University. Multiple coauthors reported similar relationships.
Source: Wantanabe T et al. Lancet Haematol. 2018 Nov;5(11):e520-31.