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Ixekizumab psoriasis outcomes, sliced and diced
WAIKOLOA, HAWAII – The highly selective interleukin-17A subunit inhibitor in the long-term extension phase of the randomized, controlled UNCOVER-3 (NCT01646177) trial, Craig L. Leonardi, MD, reported at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
However, the strict inclusion and exclusion criteria employed in randomized trials such as this raise questions about the broader applicability of the results in real-world clinical practice. So separately at the Hawaii seminar, Dr. Leonardi presented a single-center retrospective observational cohort study of the rapidity and duration of response to ixekizumab in his own clinical practice after the biologic received Food and Drug Administration marketing approval. Those results, too, were impressive and, in his view, highly generalizable.
“It is expected that this study cohort is generally representative of patients who are routinely seen at dermatology referral practices in the U.S.,” commented Dr. Leonardi, of Saint Louis University.
UNCOVER-3 included 1,346 psoriasis patients initially randomized 2:2:2:1 to double-blind subcutaneous ixekizumab (Taltz) at 80 mg either every 2 weeks or every 4 weeks after a 160-mg loading dose; subcutaneous etanercept at 50 mg twice weekly; or placebo for 12 weeks, followed by a switch to ixekizumab at 80 mg every 4 weeks from week 12 out to 3 years. The long-term efficacy analysis was restricted to patients who received the biologic according to what ultimately became the approved dosing schedule: a 160-mg loading dose, followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks. The safety analysis, in contrast, included everybody.
Dr. Leonardi presented the efficacy data using several different statistical methodologies, thereby providing an instructive lesson regarding the importance of examining the fine print when viewing clinical trial results. At one extreme is the as-observed analysis. Under this methodology, if a patient dropped out of UNCOVER-3 at, for example, week 11, the last measurement of treatment response, recorded at week 8, is carried forward by investigators and assumed to be valid for the rest of the study. Since week 8 may have been the last time the patient was doing well on the drug, the as-observed analysis can create a distorted overly favorable picture of the drug’s performance.
“Patients fall out because the drug isn’t working well or they’re having a side effect, so over time, you tend to enrich for patients who are doing very well with the as-observed analysis,” the dermatologist explained.
Historically, many industry-sponsored clinical trials reported efficacy outcomes using the as-observed analysis; however, the FDA is increasingly unwilling to accept that approach as the sole analytic method.
At the other extreme is the nonresponder imputation method.
“This is the most stringent statistical package that exists. In fact, when a patient isn’t observed at one of the observation points – for example, at week 8 say the patient has a flat tire and can’t make it to the clinic – they’re counted as a treatment failure. So it’s a very tough statistical package,” according to Dr. Leonardi.
Seventy-seven percent of the initial 1,346 randomized patients in UNCOVER-3 completed 156 weeks of follow-up. To illustrate the importance of paying attention to the details of statistical methodology utilized in reporting efficacy outcomes, he noted that the PASI 75 rate at 156 weeks in study completers on the approved dosing regimen was 97% by the as-observed method, dropping to a still robust 81% by nonresponder imputation. The PASI 90 and -100 rates and static Physician’s Global Assessment (sPGA) results followed suit (see graphic).
Real-world performance
Dr. Leonard’s analysis of ixekizumab’s performance in his own practice included 106 patients placed on the drug following its FDA approval in March 2016, 74% of whom were still on the drug 12 months later. The cohort had a mean disease duration of 15 years. Three-quarters of them had previously received biologic therapy for their psoriasis, most often a tumor necrosis factor inhibitor. The study efficacy endpoints were the sPGA and Dermatology Life Quality Index (DLQI).
Already at 1 month, 30% of ixekizumab-treated patients had an sPGA score of 0, meaning their skin was totally clear. Another 29% had an sPGA of 1, meaning almost clear. At 3 months, 53% of patients had an sPGA of 0 and 21% had an sPGA of 1. Among patients on treatment at 12 months, the rates were 39% and 24% for sPGAs of 0 and 1, respectively. And in patients with an sPGA of 0/1 at 3 months, 73% maintained that score at 12 months, including 47% with an sPGA of 0.
A DLQI score of 0/1, indicative of little or no disease effect upon a patient’s life, was present in 63% of ixekizumab-treated patients at 1 month, 84% at 3 months, and 73% at 12 months.
The value in pushing for PASI 100
The ixekizumab experience in the phase-3 UNCOVER clinical trial program provided the first-ever evidence that incrementally improving psoriasis also provides stepwise improvement in DLQI, a key patient-reported outcome. At week 12 under double-blind conditions, only 4% of ixekizumab-treated patients with less than a PASI 50 response had a DLQI of 0/1. The rate rose to 18.8% in those with a PASI 50 to less than PASI 75 response. In patients with a week-12 PASI 75 to less than PASI 90 response, the DLQI 0/1 rate climbed to 52.3%. At a PASI 90 to less than PASI 100 response, the rate was 66.9%. And 82.9% of patients with a PASI 100 had a DLQI of 0/1. Every step of the way, those DLQI rates were significantly different from each other.
These data are “fascinating,” Dr. Leonardi commented. “If you ever get any inquiries from the friendly insurance carrier and they want to know if you’re improving your patient’s life, this is the kind of data that supports that they’re being improved dramatically.”
Dr. Leonardi noted that ixekizumab isn’t unique in its high rate of clinical effectiveness. That distinction is shared by the other approved IL-17 inhibitors, secukinumab (Cosentyx) and brodalumab (Siliq), as well as the IL-23 inhibitor guselkumab (Tremfya). He refers to these biologics collectively as “high-performance skin-clearance drugs.” He has calculated the number needed to treat (NNT) to achieve a PASI 100 response – complete clearance of the disease – based upon clinical trial data filed with the FDA and/or in the package inserts. The numbers are eye-opening: an NTT of 2.6 for ixekizumab based upon data from the UNCOVER-2 trial, 2.4 for brodalumab, 2.7 for guselkumab, and 3.6 for secukinumab. To help put that into perspective, the NNTs for methotrexate and etanercept (Enbrel) – not so long ago considered state of the art medications for moderate to severe psoriasis – are 25 and 23.3, respectively.
The UNCOVER trial portfolio and Dr. Leonardi’s single-center retrospective study were funded by Eli Lilly, which markets ixekizumab. He reported serving as a consultant to and receiving research funding from that company and more than a dozen others.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The highly selective interleukin-17A subunit inhibitor in the long-term extension phase of the randomized, controlled UNCOVER-3 (NCT01646177) trial, Craig L. Leonardi, MD, reported at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
However, the strict inclusion and exclusion criteria employed in randomized trials such as this raise questions about the broader applicability of the results in real-world clinical practice. So separately at the Hawaii seminar, Dr. Leonardi presented a single-center retrospective observational cohort study of the rapidity and duration of response to ixekizumab in his own clinical practice after the biologic received Food and Drug Administration marketing approval. Those results, too, were impressive and, in his view, highly generalizable.
“It is expected that this study cohort is generally representative of patients who are routinely seen at dermatology referral practices in the U.S.,” commented Dr. Leonardi, of Saint Louis University.
UNCOVER-3 included 1,346 psoriasis patients initially randomized 2:2:2:1 to double-blind subcutaneous ixekizumab (Taltz) at 80 mg either every 2 weeks or every 4 weeks after a 160-mg loading dose; subcutaneous etanercept at 50 mg twice weekly; or placebo for 12 weeks, followed by a switch to ixekizumab at 80 mg every 4 weeks from week 12 out to 3 years. The long-term efficacy analysis was restricted to patients who received the biologic according to what ultimately became the approved dosing schedule: a 160-mg loading dose, followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks. The safety analysis, in contrast, included everybody.
Dr. Leonardi presented the efficacy data using several different statistical methodologies, thereby providing an instructive lesson regarding the importance of examining the fine print when viewing clinical trial results. At one extreme is the as-observed analysis. Under this methodology, if a patient dropped out of UNCOVER-3 at, for example, week 11, the last measurement of treatment response, recorded at week 8, is carried forward by investigators and assumed to be valid for the rest of the study. Since week 8 may have been the last time the patient was doing well on the drug, the as-observed analysis can create a distorted overly favorable picture of the drug’s performance.
“Patients fall out because the drug isn’t working well or they’re having a side effect, so over time, you tend to enrich for patients who are doing very well with the as-observed analysis,” the dermatologist explained.
Historically, many industry-sponsored clinical trials reported efficacy outcomes using the as-observed analysis; however, the FDA is increasingly unwilling to accept that approach as the sole analytic method.
At the other extreme is the nonresponder imputation method.
“This is the most stringent statistical package that exists. In fact, when a patient isn’t observed at one of the observation points – for example, at week 8 say the patient has a flat tire and can’t make it to the clinic – they’re counted as a treatment failure. So it’s a very tough statistical package,” according to Dr. Leonardi.
Seventy-seven percent of the initial 1,346 randomized patients in UNCOVER-3 completed 156 weeks of follow-up. To illustrate the importance of paying attention to the details of statistical methodology utilized in reporting efficacy outcomes, he noted that the PASI 75 rate at 156 weeks in study completers on the approved dosing regimen was 97% by the as-observed method, dropping to a still robust 81% by nonresponder imputation. The PASI 90 and -100 rates and static Physician’s Global Assessment (sPGA) results followed suit (see graphic).
Real-world performance
Dr. Leonard’s analysis of ixekizumab’s performance in his own practice included 106 patients placed on the drug following its FDA approval in March 2016, 74% of whom were still on the drug 12 months later. The cohort had a mean disease duration of 15 years. Three-quarters of them had previously received biologic therapy for their psoriasis, most often a tumor necrosis factor inhibitor. The study efficacy endpoints were the sPGA and Dermatology Life Quality Index (DLQI).
Already at 1 month, 30% of ixekizumab-treated patients had an sPGA score of 0, meaning their skin was totally clear. Another 29% had an sPGA of 1, meaning almost clear. At 3 months, 53% of patients had an sPGA of 0 and 21% had an sPGA of 1. Among patients on treatment at 12 months, the rates were 39% and 24% for sPGAs of 0 and 1, respectively. And in patients with an sPGA of 0/1 at 3 months, 73% maintained that score at 12 months, including 47% with an sPGA of 0.
A DLQI score of 0/1, indicative of little or no disease effect upon a patient’s life, was present in 63% of ixekizumab-treated patients at 1 month, 84% at 3 months, and 73% at 12 months.
The value in pushing for PASI 100
The ixekizumab experience in the phase-3 UNCOVER clinical trial program provided the first-ever evidence that incrementally improving psoriasis also provides stepwise improvement in DLQI, a key patient-reported outcome. At week 12 under double-blind conditions, only 4% of ixekizumab-treated patients with less than a PASI 50 response had a DLQI of 0/1. The rate rose to 18.8% in those with a PASI 50 to less than PASI 75 response. In patients with a week-12 PASI 75 to less than PASI 90 response, the DLQI 0/1 rate climbed to 52.3%. At a PASI 90 to less than PASI 100 response, the rate was 66.9%. And 82.9% of patients with a PASI 100 had a DLQI of 0/1. Every step of the way, those DLQI rates were significantly different from each other.
These data are “fascinating,” Dr. Leonardi commented. “If you ever get any inquiries from the friendly insurance carrier and they want to know if you’re improving your patient’s life, this is the kind of data that supports that they’re being improved dramatically.”
Dr. Leonardi noted that ixekizumab isn’t unique in its high rate of clinical effectiveness. That distinction is shared by the other approved IL-17 inhibitors, secukinumab (Cosentyx) and brodalumab (Siliq), as well as the IL-23 inhibitor guselkumab (Tremfya). He refers to these biologics collectively as “high-performance skin-clearance drugs.” He has calculated the number needed to treat (NNT) to achieve a PASI 100 response – complete clearance of the disease – based upon clinical trial data filed with the FDA and/or in the package inserts. The numbers are eye-opening: an NTT of 2.6 for ixekizumab based upon data from the UNCOVER-2 trial, 2.4 for brodalumab, 2.7 for guselkumab, and 3.6 for secukinumab. To help put that into perspective, the NNTs for methotrexate and etanercept (Enbrel) – not so long ago considered state of the art medications for moderate to severe psoriasis – are 25 and 23.3, respectively.
The UNCOVER trial portfolio and Dr. Leonardi’s single-center retrospective study were funded by Eli Lilly, which markets ixekizumab. He reported serving as a consultant to and receiving research funding from that company and more than a dozen others.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The highly selective interleukin-17A subunit inhibitor in the long-term extension phase of the randomized, controlled UNCOVER-3 (NCT01646177) trial, Craig L. Leonardi, MD, reported at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
However, the strict inclusion and exclusion criteria employed in randomized trials such as this raise questions about the broader applicability of the results in real-world clinical practice. So separately at the Hawaii seminar, Dr. Leonardi presented a single-center retrospective observational cohort study of the rapidity and duration of response to ixekizumab in his own clinical practice after the biologic received Food and Drug Administration marketing approval. Those results, too, were impressive and, in his view, highly generalizable.
“It is expected that this study cohort is generally representative of patients who are routinely seen at dermatology referral practices in the U.S.,” commented Dr. Leonardi, of Saint Louis University.
UNCOVER-3 included 1,346 psoriasis patients initially randomized 2:2:2:1 to double-blind subcutaneous ixekizumab (Taltz) at 80 mg either every 2 weeks or every 4 weeks after a 160-mg loading dose; subcutaneous etanercept at 50 mg twice weekly; or placebo for 12 weeks, followed by a switch to ixekizumab at 80 mg every 4 weeks from week 12 out to 3 years. The long-term efficacy analysis was restricted to patients who received the biologic according to what ultimately became the approved dosing schedule: a 160-mg loading dose, followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks. The safety analysis, in contrast, included everybody.
Dr. Leonardi presented the efficacy data using several different statistical methodologies, thereby providing an instructive lesson regarding the importance of examining the fine print when viewing clinical trial results. At one extreme is the as-observed analysis. Under this methodology, if a patient dropped out of UNCOVER-3 at, for example, week 11, the last measurement of treatment response, recorded at week 8, is carried forward by investigators and assumed to be valid for the rest of the study. Since week 8 may have been the last time the patient was doing well on the drug, the as-observed analysis can create a distorted overly favorable picture of the drug’s performance.
“Patients fall out because the drug isn’t working well or they’re having a side effect, so over time, you tend to enrich for patients who are doing very well with the as-observed analysis,” the dermatologist explained.
Historically, many industry-sponsored clinical trials reported efficacy outcomes using the as-observed analysis; however, the FDA is increasingly unwilling to accept that approach as the sole analytic method.
At the other extreme is the nonresponder imputation method.
“This is the most stringent statistical package that exists. In fact, when a patient isn’t observed at one of the observation points – for example, at week 8 say the patient has a flat tire and can’t make it to the clinic – they’re counted as a treatment failure. So it’s a very tough statistical package,” according to Dr. Leonardi.
Seventy-seven percent of the initial 1,346 randomized patients in UNCOVER-3 completed 156 weeks of follow-up. To illustrate the importance of paying attention to the details of statistical methodology utilized in reporting efficacy outcomes, he noted that the PASI 75 rate at 156 weeks in study completers on the approved dosing regimen was 97% by the as-observed method, dropping to a still robust 81% by nonresponder imputation. The PASI 90 and -100 rates and static Physician’s Global Assessment (sPGA) results followed suit (see graphic).
Real-world performance
Dr. Leonard’s analysis of ixekizumab’s performance in his own practice included 106 patients placed on the drug following its FDA approval in March 2016, 74% of whom were still on the drug 12 months later. The cohort had a mean disease duration of 15 years. Three-quarters of them had previously received biologic therapy for their psoriasis, most often a tumor necrosis factor inhibitor. The study efficacy endpoints were the sPGA and Dermatology Life Quality Index (DLQI).
Already at 1 month, 30% of ixekizumab-treated patients had an sPGA score of 0, meaning their skin was totally clear. Another 29% had an sPGA of 1, meaning almost clear. At 3 months, 53% of patients had an sPGA of 0 and 21% had an sPGA of 1. Among patients on treatment at 12 months, the rates were 39% and 24% for sPGAs of 0 and 1, respectively. And in patients with an sPGA of 0/1 at 3 months, 73% maintained that score at 12 months, including 47% with an sPGA of 0.
A DLQI score of 0/1, indicative of little or no disease effect upon a patient’s life, was present in 63% of ixekizumab-treated patients at 1 month, 84% at 3 months, and 73% at 12 months.
The value in pushing for PASI 100
The ixekizumab experience in the phase-3 UNCOVER clinical trial program provided the first-ever evidence that incrementally improving psoriasis also provides stepwise improvement in DLQI, a key patient-reported outcome. At week 12 under double-blind conditions, only 4% of ixekizumab-treated patients with less than a PASI 50 response had a DLQI of 0/1. The rate rose to 18.8% in those with a PASI 50 to less than PASI 75 response. In patients with a week-12 PASI 75 to less than PASI 90 response, the DLQI 0/1 rate climbed to 52.3%. At a PASI 90 to less than PASI 100 response, the rate was 66.9%. And 82.9% of patients with a PASI 100 had a DLQI of 0/1. Every step of the way, those DLQI rates were significantly different from each other.
These data are “fascinating,” Dr. Leonardi commented. “If you ever get any inquiries from the friendly insurance carrier and they want to know if you’re improving your patient’s life, this is the kind of data that supports that they’re being improved dramatically.”
Dr. Leonardi noted that ixekizumab isn’t unique in its high rate of clinical effectiveness. That distinction is shared by the other approved IL-17 inhibitors, secukinumab (Cosentyx) and brodalumab (Siliq), as well as the IL-23 inhibitor guselkumab (Tremfya). He refers to these biologics collectively as “high-performance skin-clearance drugs.” He has calculated the number needed to treat (NNT) to achieve a PASI 100 response – complete clearance of the disease – based upon clinical trial data filed with the FDA and/or in the package inserts. The numbers are eye-opening: an NTT of 2.6 for ixekizumab based upon data from the UNCOVER-2 trial, 2.4 for brodalumab, 2.7 for guselkumab, and 3.6 for secukinumab. To help put that into perspective, the NNTs for methotrexate and etanercept (Enbrel) – not so long ago considered state of the art medications for moderate to severe psoriasis – are 25 and 23.3, respectively.
The UNCOVER trial portfolio and Dr. Leonardi’s single-center retrospective study were funded by Eli Lilly, which markets ixekizumab. He reported serving as a consultant to and receiving research funding from that company and more than a dozen others.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
Ultrasound method predicts liver complications in pediatric transplant
HOUSTON – An ultrasound method for assessing liver stiffness might be useful for predicting which pediatric patients will develop a life-threatening complication of hematopoietic stem cell transplantation.
Shear wave elastography values predicted severe hepatic sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) at least 4 days before standard diagnostic criteria in most patients treated in a small, prospective, two-center study, Sherwin S. Chan, MD, PhD, said at the Transplantation & Cellular Therapy Meetings.
Early identification of SOS/VOD using elastography could be beneficial in light of data showing that timing is critical in the administration of defibrotide, a treatment recommended for severe and very severe patients, according to Dr. Chan, vice chair of radiology for the University of Missouri at Kansas City.
“If you’re able to initiate it early, you can really increase day 100 survival,” Dr. Chan said in an oral presentation.
The data presented included 54 pediatric patients undergoing transplantation at one of two institutions.
At one site, the patients underwent shear wave elastography evaluation 10 days before the conditioning regimen began, and again at 5 and 14 days after the transplant. At the other site, patients with suspected SOS/VOD were enrolled and underwent elastography every other day for up to 10 exams.
Those are very different imaging protocols, Dr. Chan acknowledged in his presentation, noting that the studies started independently and data were pooled as investigators at the two institutions became aware of one another’s work.
A total of 16 patients, or 30%, developed SOS/VOD, Dr. Chan reported. Of those 16 cases, 12 (75%) were severe or very severe by the recent European Society for Blood and Marrow Transplantation (EBMT) criteria.
Increased shear wave elastography velocity was the best predictor of severe SOS/VOD, according to Dr. Chan, with a cutoff value of 1.65 m/s being 92% sensitive and 67% specific for severe SOS/VOD.
That threshold was passed at least 4 days before severe grading or death in 9 out of the 12 severe cases, he added.
Accordingly, a prospective, multicenter trial has been initiated at a number of U.S. centers to investigate whether the findings of this study are generalizable to other patient populations, Dr. Chan said at the meeting held by the American Society of Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At this meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society: American Society for Transplantation and Cellular Therapy.
That prospective, multicenter trial is supported by Jazz Pharmaceuticals, according to Dr. Chan, who reported consulting with Jazz Pharmaceuticals in his disclosure statement.
SOURCE: Chan SS et al. TCT 2019, Abstract 55.
HOUSTON – An ultrasound method for assessing liver stiffness might be useful for predicting which pediatric patients will develop a life-threatening complication of hematopoietic stem cell transplantation.
Shear wave elastography values predicted severe hepatic sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) at least 4 days before standard diagnostic criteria in most patients treated in a small, prospective, two-center study, Sherwin S. Chan, MD, PhD, said at the Transplantation & Cellular Therapy Meetings.
Early identification of SOS/VOD using elastography could be beneficial in light of data showing that timing is critical in the administration of defibrotide, a treatment recommended for severe and very severe patients, according to Dr. Chan, vice chair of radiology for the University of Missouri at Kansas City.
“If you’re able to initiate it early, you can really increase day 100 survival,” Dr. Chan said in an oral presentation.
The data presented included 54 pediatric patients undergoing transplantation at one of two institutions.
At one site, the patients underwent shear wave elastography evaluation 10 days before the conditioning regimen began, and again at 5 and 14 days after the transplant. At the other site, patients with suspected SOS/VOD were enrolled and underwent elastography every other day for up to 10 exams.
Those are very different imaging protocols, Dr. Chan acknowledged in his presentation, noting that the studies started independently and data were pooled as investigators at the two institutions became aware of one another’s work.
A total of 16 patients, or 30%, developed SOS/VOD, Dr. Chan reported. Of those 16 cases, 12 (75%) were severe or very severe by the recent European Society for Blood and Marrow Transplantation (EBMT) criteria.
Increased shear wave elastography velocity was the best predictor of severe SOS/VOD, according to Dr. Chan, with a cutoff value of 1.65 m/s being 92% sensitive and 67% specific for severe SOS/VOD.
That threshold was passed at least 4 days before severe grading or death in 9 out of the 12 severe cases, he added.
Accordingly, a prospective, multicenter trial has been initiated at a number of U.S. centers to investigate whether the findings of this study are generalizable to other patient populations, Dr. Chan said at the meeting held by the American Society of Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At this meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society: American Society for Transplantation and Cellular Therapy.
That prospective, multicenter trial is supported by Jazz Pharmaceuticals, according to Dr. Chan, who reported consulting with Jazz Pharmaceuticals in his disclosure statement.
SOURCE: Chan SS et al. TCT 2019, Abstract 55.
HOUSTON – An ultrasound method for assessing liver stiffness might be useful for predicting which pediatric patients will develop a life-threatening complication of hematopoietic stem cell transplantation.
Shear wave elastography values predicted severe hepatic sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) at least 4 days before standard diagnostic criteria in most patients treated in a small, prospective, two-center study, Sherwin S. Chan, MD, PhD, said at the Transplantation & Cellular Therapy Meetings.
Early identification of SOS/VOD using elastography could be beneficial in light of data showing that timing is critical in the administration of defibrotide, a treatment recommended for severe and very severe patients, according to Dr. Chan, vice chair of radiology for the University of Missouri at Kansas City.
“If you’re able to initiate it early, you can really increase day 100 survival,” Dr. Chan said in an oral presentation.
The data presented included 54 pediatric patients undergoing transplantation at one of two institutions.
At one site, the patients underwent shear wave elastography evaluation 10 days before the conditioning regimen began, and again at 5 and 14 days after the transplant. At the other site, patients with suspected SOS/VOD were enrolled and underwent elastography every other day for up to 10 exams.
Those are very different imaging protocols, Dr. Chan acknowledged in his presentation, noting that the studies started independently and data were pooled as investigators at the two institutions became aware of one another’s work.
A total of 16 patients, or 30%, developed SOS/VOD, Dr. Chan reported. Of those 16 cases, 12 (75%) were severe or very severe by the recent European Society for Blood and Marrow Transplantation (EBMT) criteria.
Increased shear wave elastography velocity was the best predictor of severe SOS/VOD, according to Dr. Chan, with a cutoff value of 1.65 m/s being 92% sensitive and 67% specific for severe SOS/VOD.
That threshold was passed at least 4 days before severe grading or death in 9 out of the 12 severe cases, he added.
Accordingly, a prospective, multicenter trial has been initiated at a number of U.S. centers to investigate whether the findings of this study are generalizable to other patient populations, Dr. Chan said at the meeting held by the American Society of Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At this meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society: American Society for Transplantation and Cellular Therapy.
That prospective, multicenter trial is supported by Jazz Pharmaceuticals, according to Dr. Chan, who reported consulting with Jazz Pharmaceuticals in his disclosure statement.
SOURCE: Chan SS et al. TCT 2019, Abstract 55.
REPORTING FROM TCT 2019
Severe, uncontrolled asthma patients must avoid subcutaneous immunotherapy
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
REPORTING FROM AAAAI
Similar results for once- or twice-weekly carfilzomib in MM
Patients with newly diagnosed multiple myeloma have similar outcomes whether they receive carfilzomib once or twice a week, according to a pooled analysis of trial data.
Researchers found no significant difference in safety, progression-free survival (PFS), or overall survival (OS) whether patients received carfilzomib at 70 mg/m2 once a week or 36 mg/m2 twice a week.
Sara Bringhen, MD, PhD, of University of Turin, Italy, and her colleagues conducted this analysis and detailed the results in Haematologica.
The researchers pooled data from a phase 1/2 trial (NCT01857115) and a phase 2 trial (NCT01346787), both enrolling transplant-ineligible patients with newly diagnosed multiple myeloma.
In both studies, induction consisted of nine 4-week cycles of carfilzomib (given once or twice weekly), cyclophosphamide (300 mg on days 1, 8, and 15), and dexamethasone (40 mg on days 1, 8, 15, and 22). After induction, patients received carfilzomib maintenance (at either dose) until progression or intolerable toxicity.
The pooled analysis included 121 patients: 63 who received carfilzomib at 70 mg/m2 once weekly and 58 who received carfilzomib at 36 mg/m2 twice weekly.
There were no significant differences in baseline characteristics between the dosing groups. For the entire cohort, the median age at diagnosis was 72 years (range, 55-86), and the median follow-up was 39 months.
A total of 119 patients started induction (63 in the once-weekly group and 56 in the twice-weekly group), and 90 patients received maintenance (47 and 43, respectively). Patients received maintenance for a median of 17 months in the once-weekly group and 20 months in the twice-weekly group (P = .17).
There was no significant difference between the groups with regard to PFS or OS, either from enrollment or the start of maintenance.
From enrollment, the median PFS was 35.7 months in the once-weekly group and 35.5 months in the twice-weekly group (hazard ratio [HR] = 1.39; P = .26). The 3-year OS was 70% and 72%, respectively (HR = 1.27; P = .5).
From the start of maintenance, the 3-year PFS was 47% in the once-weekly group and 51% in the twice-weekly group (HR = 1.04; P = .92). The 3-year OS was 72% and 73%, respectively (HR = 0.82; P = .71).
There were no significant between-group differences in the rates of grade 3-5 adverse events (AEs) or the need for carfilzomib dose reduction or discontinuation.
Grade 3-5 hematologic AEs occurred in 24% of patients in the once-weekly group and 30% of those in the twice-weekly group. Grade 3-5 nonhematologic AEs occurred in 38% and 41%, respectively.
Twenty-nine percent of patients in the once-weekly group required a reduction in carfilzomib dose, as did 30% of patients in the twice-weekly group. Common AEs leading to dose reduction were acute kidney injury, infections, and hypertension.
AEs leading to carfilzomib discontinuation occurred in 27% of patients in the once-weekly group and 30% of those in the twice-weekly group. Common AEs leading to discontinuation were cardiac injury, infections, and thromboembolism.
Both trials were sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland in collaboration with Fondazione Neoplasie Sangue ONLUS and supported by funding from Amgen (Onyx Pharmaceuticals). Dr. Bringhen reported relationships with Amgen and other companies. Coauthor Antonio Palumbo, MD, is an employee of Takeda, and other authors reported relationships with a range of companies.
SOURCE: Bringhen S et al. Haematologica. 2019 Feb 7. doi: 10.3324/haematol.2018.208272.
Patients with newly diagnosed multiple myeloma have similar outcomes whether they receive carfilzomib once or twice a week, according to a pooled analysis of trial data.
Researchers found no significant difference in safety, progression-free survival (PFS), or overall survival (OS) whether patients received carfilzomib at 70 mg/m2 once a week or 36 mg/m2 twice a week.
Sara Bringhen, MD, PhD, of University of Turin, Italy, and her colleagues conducted this analysis and detailed the results in Haematologica.
The researchers pooled data from a phase 1/2 trial (NCT01857115) and a phase 2 trial (NCT01346787), both enrolling transplant-ineligible patients with newly diagnosed multiple myeloma.
In both studies, induction consisted of nine 4-week cycles of carfilzomib (given once or twice weekly), cyclophosphamide (300 mg on days 1, 8, and 15), and dexamethasone (40 mg on days 1, 8, 15, and 22). After induction, patients received carfilzomib maintenance (at either dose) until progression or intolerable toxicity.
The pooled analysis included 121 patients: 63 who received carfilzomib at 70 mg/m2 once weekly and 58 who received carfilzomib at 36 mg/m2 twice weekly.
There were no significant differences in baseline characteristics between the dosing groups. For the entire cohort, the median age at diagnosis was 72 years (range, 55-86), and the median follow-up was 39 months.
A total of 119 patients started induction (63 in the once-weekly group and 56 in the twice-weekly group), and 90 patients received maintenance (47 and 43, respectively). Patients received maintenance for a median of 17 months in the once-weekly group and 20 months in the twice-weekly group (P = .17).
There was no significant difference between the groups with regard to PFS or OS, either from enrollment or the start of maintenance.
From enrollment, the median PFS was 35.7 months in the once-weekly group and 35.5 months in the twice-weekly group (hazard ratio [HR] = 1.39; P = .26). The 3-year OS was 70% and 72%, respectively (HR = 1.27; P = .5).
From the start of maintenance, the 3-year PFS was 47% in the once-weekly group and 51% in the twice-weekly group (HR = 1.04; P = .92). The 3-year OS was 72% and 73%, respectively (HR = 0.82; P = .71).
There were no significant between-group differences in the rates of grade 3-5 adverse events (AEs) or the need for carfilzomib dose reduction or discontinuation.
Grade 3-5 hematologic AEs occurred in 24% of patients in the once-weekly group and 30% of those in the twice-weekly group. Grade 3-5 nonhematologic AEs occurred in 38% and 41%, respectively.
Twenty-nine percent of patients in the once-weekly group required a reduction in carfilzomib dose, as did 30% of patients in the twice-weekly group. Common AEs leading to dose reduction were acute kidney injury, infections, and hypertension.
AEs leading to carfilzomib discontinuation occurred in 27% of patients in the once-weekly group and 30% of those in the twice-weekly group. Common AEs leading to discontinuation were cardiac injury, infections, and thromboembolism.
Both trials were sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland in collaboration with Fondazione Neoplasie Sangue ONLUS and supported by funding from Amgen (Onyx Pharmaceuticals). Dr. Bringhen reported relationships with Amgen and other companies. Coauthor Antonio Palumbo, MD, is an employee of Takeda, and other authors reported relationships with a range of companies.
SOURCE: Bringhen S et al. Haematologica. 2019 Feb 7. doi: 10.3324/haematol.2018.208272.
Patients with newly diagnosed multiple myeloma have similar outcomes whether they receive carfilzomib once or twice a week, according to a pooled analysis of trial data.
Researchers found no significant difference in safety, progression-free survival (PFS), or overall survival (OS) whether patients received carfilzomib at 70 mg/m2 once a week or 36 mg/m2 twice a week.
Sara Bringhen, MD, PhD, of University of Turin, Italy, and her colleagues conducted this analysis and detailed the results in Haematologica.
The researchers pooled data from a phase 1/2 trial (NCT01857115) and a phase 2 trial (NCT01346787), both enrolling transplant-ineligible patients with newly diagnosed multiple myeloma.
In both studies, induction consisted of nine 4-week cycles of carfilzomib (given once or twice weekly), cyclophosphamide (300 mg on days 1, 8, and 15), and dexamethasone (40 mg on days 1, 8, 15, and 22). After induction, patients received carfilzomib maintenance (at either dose) until progression or intolerable toxicity.
The pooled analysis included 121 patients: 63 who received carfilzomib at 70 mg/m2 once weekly and 58 who received carfilzomib at 36 mg/m2 twice weekly.
There were no significant differences in baseline characteristics between the dosing groups. For the entire cohort, the median age at diagnosis was 72 years (range, 55-86), and the median follow-up was 39 months.
A total of 119 patients started induction (63 in the once-weekly group and 56 in the twice-weekly group), and 90 patients received maintenance (47 and 43, respectively). Patients received maintenance for a median of 17 months in the once-weekly group and 20 months in the twice-weekly group (P = .17).
There was no significant difference between the groups with regard to PFS or OS, either from enrollment or the start of maintenance.
From enrollment, the median PFS was 35.7 months in the once-weekly group and 35.5 months in the twice-weekly group (hazard ratio [HR] = 1.39; P = .26). The 3-year OS was 70% and 72%, respectively (HR = 1.27; P = .5).
From the start of maintenance, the 3-year PFS was 47% in the once-weekly group and 51% in the twice-weekly group (HR = 1.04; P = .92). The 3-year OS was 72% and 73%, respectively (HR = 0.82; P = .71).
There were no significant between-group differences in the rates of grade 3-5 adverse events (AEs) or the need for carfilzomib dose reduction or discontinuation.
Grade 3-5 hematologic AEs occurred in 24% of patients in the once-weekly group and 30% of those in the twice-weekly group. Grade 3-5 nonhematologic AEs occurred in 38% and 41%, respectively.
Twenty-nine percent of patients in the once-weekly group required a reduction in carfilzomib dose, as did 30% of patients in the twice-weekly group. Common AEs leading to dose reduction were acute kidney injury, infections, and hypertension.
AEs leading to carfilzomib discontinuation occurred in 27% of patients in the once-weekly group and 30% of those in the twice-weekly group. Common AEs leading to discontinuation were cardiac injury, infections, and thromboembolism.
Both trials were sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland in collaboration with Fondazione Neoplasie Sangue ONLUS and supported by funding from Amgen (Onyx Pharmaceuticals). Dr. Bringhen reported relationships with Amgen and other companies. Coauthor Antonio Palumbo, MD, is an employee of Takeda, and other authors reported relationships with a range of companies.
SOURCE: Bringhen S et al. Haematologica. 2019 Feb 7. doi: 10.3324/haematol.2018.208272.
FROM HAEMATOLOGICA
Physician PAC dollars support candidates against gun regulation
Despite many physician professional organizations endorsing policies that support firearm regulation, more of their political donations go to candidates who oppose those policies, according to a study of political action committee (PAC) campaign contributions during the 2016 election cycle. 
“Our analysis indicates that most of the largest physician organizations’ PACs contribute more to candidates whose stances on firearm policy are in direct opposition to evidence-based firearm policies and to their organization’s stances,” wrote lead author Jeremiah D. Schuur, MD, of Brown University, Providence, R.I., and his coauthors.
The study was published in JAMA Network Open.
This retrospective, cross sectional study examined contributions from the 25 largest physician organization–affiliated PACs during the 2016 election cycle and compared them to federal candidate support for firearm regulation.
Support for regulation was measured by voting history on U.S. House and Senate legislation proposing firearm background checks and their rating from the National Rifle Association Political Victory Fund (NRA-PVF).
Health care professional–related PACs in general contributed $23.7 million during the 2016 election cycle; 57% of that sum ($13.6 million) came from the 25 largest physician-affiliated PACs.
Of the 29 Senate incumbents running for reelection who voted on S.A. 4750, an amendment that would have expanded background checks, those who voted against it (n = 21) received $500,000 more in contributions than did those who voted for it (n = 8).
The findings were similar with H.R. 1217, a bill in the House of Representatives to expand background checks; the PACs contributed $2,878,675 more to candidates who did not cosponsor it (n = 227) than to cosponsors (n = 166).
In regard to ratings from the NRA-PVF, the 25 PACs gave $5.6 million to candidates with an A rating and $4.1 million to candidates with a rating other than A.
But the trend was somewhat different when it came to the 2015 call to action on firearm-related injury and death, endorsed by several physician groups. Among the nine PACs with affiliated organizations that had endorsed the call to action, eight contributed to more candidates who did not support firearm safety policies. But after adjustment for political factors, those nine PACs had a lower likelihood of donating to NRA-PVF A-rated candidates, compared with nonendorsing PACs (odds ratio, 0.76; 95% confidence interval, 0.58-0.99; P = .04).
“Although endorsement of firearm safety policies may reflect a small difference in political giving, it does not mean that a physicians’ organization has elevated firearm policy to the level of a contribution criteria for the PAC,” the researchers wrote.
The researchers noted that it is “unlikely that physician organization–affiliated PACs contribute to candidates because they are opposed to firearm regulation.” Rather, they said, these PACs consider a number of factors, including a candidates’ stance on malpractice reform, physician payment policies, and the Patient Protection and Affordable Care Act, as well as their chance of winning.
The authors reported having no conflicts of interest.
SOURCE: Schuur JD et al. JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7831.
Though national membership organizations have finally taken a lead in advocating for firearm safety, this study from Schuur et al. illustrates the disconnect between physician PACs and the physicians themselves, according to Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, of the University of Michigan, Ann Arbor.
The study comes in the wake of the NRA admonishing physicians to “stay in their lane,” which was met by a very vocal response via social and mass media. “Health care professionals demonstrated that, contrary to the NRA position, they have an undeniably central role and authority in addressing this public health problem through the direct care that they provide to patients and their families, prevention-based research, and advocacy for policy-level changes that make patients safer,” they wrote.
The coauthors noted the parallels to the American Medical Association previously calling for tobacco regulation while financially supporting politicians who felt otherwise. It’s a comparison that is meant as a cautionary tale; as more focus is placed on this particular issue, “medical PACs must consider the increasing physician voice on the need to address firearm-associated morbidity and mortality in the policy arena to reduce their experience with this issue in emergency bays, operating rooms, and clinics.”
Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, are with the University of Michigan, Ann Arbor. They reported having no conflicts of interest. Their comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7823 ).
Though national membership organizations have finally taken a lead in advocating for firearm safety, this study from Schuur et al. illustrates the disconnect between physician PACs and the physicians themselves, according to Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, of the University of Michigan, Ann Arbor.
The study comes in the wake of the NRA admonishing physicians to “stay in their lane,” which was met by a very vocal response via social and mass media. “Health care professionals demonstrated that, contrary to the NRA position, they have an undeniably central role and authority in addressing this public health problem through the direct care that they provide to patients and their families, prevention-based research, and advocacy for policy-level changes that make patients safer,” they wrote.
The coauthors noted the parallels to the American Medical Association previously calling for tobacco regulation while financially supporting politicians who felt otherwise. It’s a comparison that is meant as a cautionary tale; as more focus is placed on this particular issue, “medical PACs must consider the increasing physician voice on the need to address firearm-associated morbidity and mortality in the policy arena to reduce their experience with this issue in emergency bays, operating rooms, and clinics.”
Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, are with the University of Michigan, Ann Arbor. They reported having no conflicts of interest. Their comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7823 ).
Though national membership organizations have finally taken a lead in advocating for firearm safety, this study from Schuur et al. illustrates the disconnect between physician PACs and the physicians themselves, according to Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, of the University of Michigan, Ann Arbor.
The study comes in the wake of the NRA admonishing physicians to “stay in their lane,” which was met by a very vocal response via social and mass media. “Health care professionals demonstrated that, contrary to the NRA position, they have an undeniably central role and authority in addressing this public health problem through the direct care that they provide to patients and their families, prevention-based research, and advocacy for policy-level changes that make patients safer,” they wrote.
The coauthors noted the parallels to the American Medical Association previously calling for tobacco regulation while financially supporting politicians who felt otherwise. It’s a comparison that is meant as a cautionary tale; as more focus is placed on this particular issue, “medical PACs must consider the increasing physician voice on the need to address firearm-associated morbidity and mortality in the policy arena to reduce their experience with this issue in emergency bays, operating rooms, and clinics.”
Rebecca M. Cunningham, MD, Marc A. Zimmerman, PhD, and Patrick M. Carter, MD, are with the University of Michigan, Ann Arbor. They reported having no conflicts of interest. Their comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7823 ).
Despite many physician professional organizations endorsing policies that support firearm regulation, more of their political donations go to candidates who oppose those policies, according to a study of political action committee (PAC) campaign contributions during the 2016 election cycle.
“Our analysis indicates that most of the largest physician organizations’ PACs contribute more to candidates whose stances on firearm policy are in direct opposition to evidence-based firearm policies and to their organization’s stances,” wrote lead author Jeremiah D. Schuur, MD, of Brown University, Providence, R.I., and his coauthors.
The study was published in JAMA Network Open.
This retrospective, cross sectional study examined contributions from the 25 largest physician organization–affiliated PACs during the 2016 election cycle and compared them to federal candidate support for firearm regulation.
Support for regulation was measured by voting history on U.S. House and Senate legislation proposing firearm background checks and their rating from the National Rifle Association Political Victory Fund (NRA-PVF).
Health care professional–related PACs in general contributed $23.7 million during the 2016 election cycle; 57% of that sum ($13.6 million) came from the 25 largest physician-affiliated PACs.
Of the 29 Senate incumbents running for reelection who voted on S.A. 4750, an amendment that would have expanded background checks, those who voted against it (n = 21) received $500,000 more in contributions than did those who voted for it (n = 8).
The findings were similar with H.R. 1217, a bill in the House of Representatives to expand background checks; the PACs contributed $2,878,675 more to candidates who did not cosponsor it (n = 227) than to cosponsors (n = 166).
In regard to ratings from the NRA-PVF, the 25 PACs gave $5.6 million to candidates with an A rating and $4.1 million to candidates with a rating other than A.
But the trend was somewhat different when it came to the 2015 call to action on firearm-related injury and death, endorsed by several physician groups. Among the nine PACs with affiliated organizations that had endorsed the call to action, eight contributed to more candidates who did not support firearm safety policies. But after adjustment for political factors, those nine PACs had a lower likelihood of donating to NRA-PVF A-rated candidates, compared with nonendorsing PACs (odds ratio, 0.76; 95% confidence interval, 0.58-0.99; P = .04).
“Although endorsement of firearm safety policies may reflect a small difference in political giving, it does not mean that a physicians’ organization has elevated firearm policy to the level of a contribution criteria for the PAC,” the researchers wrote.
The researchers noted that it is “unlikely that physician organization–affiliated PACs contribute to candidates because they are opposed to firearm regulation.” Rather, they said, these PACs consider a number of factors, including a candidates’ stance on malpractice reform, physician payment policies, and the Patient Protection and Affordable Care Act, as well as their chance of winning.
The authors reported having no conflicts of interest.
SOURCE: Schuur JD et al. JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7831.
Despite many physician professional organizations endorsing policies that support firearm regulation, more of their political donations go to candidates who oppose those policies, according to a study of political action committee (PAC) campaign contributions during the 2016 election cycle.
“Our analysis indicates that most of the largest physician organizations’ PACs contribute more to candidates whose stances on firearm policy are in direct opposition to evidence-based firearm policies and to their organization’s stances,” wrote lead author Jeremiah D. Schuur, MD, of Brown University, Providence, R.I., and his coauthors.
The study was published in JAMA Network Open.
This retrospective, cross sectional study examined contributions from the 25 largest physician organization–affiliated PACs during the 2016 election cycle and compared them to federal candidate support for firearm regulation.
Support for regulation was measured by voting history on U.S. House and Senate legislation proposing firearm background checks and their rating from the National Rifle Association Political Victory Fund (NRA-PVF).
Health care professional–related PACs in general contributed $23.7 million during the 2016 election cycle; 57% of that sum ($13.6 million) came from the 25 largest physician-affiliated PACs.
Of the 29 Senate incumbents running for reelection who voted on S.A. 4750, an amendment that would have expanded background checks, those who voted against it (n = 21) received $500,000 more in contributions than did those who voted for it (n = 8).
The findings were similar with H.R. 1217, a bill in the House of Representatives to expand background checks; the PACs contributed $2,878,675 more to candidates who did not cosponsor it (n = 227) than to cosponsors (n = 166).
In regard to ratings from the NRA-PVF, the 25 PACs gave $5.6 million to candidates with an A rating and $4.1 million to candidates with a rating other than A.
But the trend was somewhat different when it came to the 2015 call to action on firearm-related injury and death, endorsed by several physician groups. Among the nine PACs with affiliated organizations that had endorsed the call to action, eight contributed to more candidates who did not support firearm safety policies. But after adjustment for political factors, those nine PACs had a lower likelihood of donating to NRA-PVF A-rated candidates, compared with nonendorsing PACs (odds ratio, 0.76; 95% confidence interval, 0.58-0.99; P = .04).
“Although endorsement of firearm safety policies may reflect a small difference in political giving, it does not mean that a physicians’ organization has elevated firearm policy to the level of a contribution criteria for the PAC,” the researchers wrote.
The researchers noted that it is “unlikely that physician organization–affiliated PACs contribute to candidates because they are opposed to firearm regulation.” Rather, they said, these PACs consider a number of factors, including a candidates’ stance on malpractice reform, physician payment policies, and the Patient Protection and Affordable Care Act, as well as their chance of winning.
The authors reported having no conflicts of interest.
SOURCE: Schuur JD et al. JAMA Netw Open. 2019 Feb 22. doi: 10.1001/jamanetworkopen.2018.7831.
FROM JAMA NETWORK OPEN
What is the ‘microbiome’ and how may it influence gynecologic cancers?
Bacteria are everywhere, good and bad alike! It is well known in the scientific community that microbes significantly outnumber the cells in the human body by at least 10 times. Joshua Lederberg, PhD, gave meaning to the term “microbiome” in 2001 as the “ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space.”1 This community of microorganisms comprises bacteria, fungi, viruses, archaea, and protists.
In 2007, the National Institutes of Health Human Microbiome Project was established to study the human microbiome starting with five specific sites – the gastrointestinal tract, the mouth, the vagina, the skin, and nasal cavity. The goal was not only to identify the microbes inhabiting a specific body site but also to establish a range of “normal” for resident microbes as well as sequence the genomes of these microbes.2 Much of the research predating this era focused on microorganisms in terms of disease potential rather than a focus on the benefits of resident microorganisms.
The richness – the number of microorganisms in an area – and diversity – the relative proportion of microorganisms in an environment – can vary regionally. The microbiota that contribute to the class of resident microorganisms in a specific body habitat can be described broadly as commensals or mutualistic. With commensal microorganisms, one partner benefits and the other is unaffected. On the other hand, mutualistic microorganisms allow both parties to derive benefit. For example, resident microorganisms in the gut aid in the absorption of nutrients and in the production of vitamin K. On mucosal surfaces and the skin, it is possible that these resident microorganisms prevent colonization of pathogenic microbes, which could aid in prevention of disease.3
The microbiota composition can be influenced by multiple factors such as age, diet, medications, environment, early microbial exposure, and host genetics. The gut microbiota, for example, can be significantly altered by dietary intake or antibiotic use. Alterations in the diversity of microbes in certain body habitats has been linked to several human diseases such as obesity, inflammatory bowel disease, and bacterial vaginosis.4
In women, there are differences noted in the composition of resident microorganisms soon after birth as well as at prepubertal, postpubertal, and postmenopausal transitions. At puberty, anaerobic and aerobic lactobacilli aid in maintaining vaginal pH. If the normal microbiota is suppressed, it allows for yeast and other bacteria to grow causing vaginitis, and dramatic shifts in the makeup of the vaginal microbiota can lead to bacterial vaginosis. Interestingly, research has shown that the pH and microbiome of the vagina differs by ethnicity. These differences in composition of the vaginal microbiome likely contribute to known differences in the acquisition of sexually transmitted infections and development of bacterial vaginosis. The microbiome is believed to have a complex role in regulating human health and disease, including cancer.
There is growing evidence to suggest the gut microbiome may play an important role in the pathogenesis of both obesity and cancer. Two divisions of bacteria predominate in the gut in humans and mice, Bacteroidetes and Firmicutes, and the relative ratio of these two divisions is dramatically affected by obesity, such that Bacteroidetes levels decrease and Firmicutes levels increase.5 The change in the microbial environment leads to a greater ability to harvest dietary energy, which would be conducive to cancer development.
The microbiome and gynecologic cancers
The presence and relative abundance of bacterial species in the vagina are affected by unique factors such as hormonal contraception, pregnancy, and menopause. There are researchers investigating alterations in the microbiome of the vagina and implications in persistence of high-risk human papillomavirus infections and HPV-induced carcinogenesis. There were significant differences found in the composition of the vaginal microbiota in healthy women, compared with women with low-grade squamous intraepithelial neoplasm and high-grade squamous intraepithelial neoplasm.6
Conceivably, the subsequent clinical questions are: Can we apply this data to diagnose women at risk for dysplasia or can we alter the vaginal microbiome to impact the clearance rate of the HPV virus in susceptible or infected women to decrease the long-term risk of cervical dysplasia or malignancy?
The upper reproductive tract in women – the uterus, fallopian tubes, and ovaries – had been presumed to be a sterile environment. However, we know that bacteria have been isolated in the pre- and postmenopausal uterus of healthy women. Therefore, there also are investigators seeking to establish the microbiome of normal uteri to accurately compare it with malignant uteri. Notably, there also is interest in how treatments for cancer – chemotherapy and radiation – ultimately can affect a woman’s vaginal and gut microbiome.
Currently, microbiome research has an expansive range. Women will greatly benefit from research seeking to define improved prevention, diagnosis, and treatment based on alterations of the microbiome for common gynecologic premalignant and malignant conditions.
Dr. Hawkins is a fellow of gynecologic oncology and Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. They had no conflicts of interest to disclose.
References
1. “ ’Ome Sweet ’Omics – a genealogical treasury of words,” by Joshua Lederberg, The Scientist, Apr 2, 2001.
2. Genome Res. 2009 Dec;19(12):2317-23.
3. “Normal Human Microbiota,” Jawetz, Melnick & Adelberg’s Medical Microbiology, 27th edition (New York, NY: McGraw-Hill, 2016).
4. Nature. 2012 Jun 13;486(7402):207-14.
5. Nature. 2006 Dec 21;444(7122):1027-31.
6. Oncol Lett. 2018 Dec; 16(6): 7035-47.
Bacteria are everywhere, good and bad alike! It is well known in the scientific community that microbes significantly outnumber the cells in the human body by at least 10 times. Joshua Lederberg, PhD, gave meaning to the term “microbiome” in 2001 as the “ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space.”1 This community of microorganisms comprises bacteria, fungi, viruses, archaea, and protists.
In 2007, the National Institutes of Health Human Microbiome Project was established to study the human microbiome starting with five specific sites – the gastrointestinal tract, the mouth, the vagina, the skin, and nasal cavity. The goal was not only to identify the microbes inhabiting a specific body site but also to establish a range of “normal” for resident microbes as well as sequence the genomes of these microbes.2 Much of the research predating this era focused on microorganisms in terms of disease potential rather than a focus on the benefits of resident microorganisms.
The richness – the number of microorganisms in an area – and diversity – the relative proportion of microorganisms in an environment – can vary regionally. The microbiota that contribute to the class of resident microorganisms in a specific body habitat can be described broadly as commensals or mutualistic. With commensal microorganisms, one partner benefits and the other is unaffected. On the other hand, mutualistic microorganisms allow both parties to derive benefit. For example, resident microorganisms in the gut aid in the absorption of nutrients and in the production of vitamin K. On mucosal surfaces and the skin, it is possible that these resident microorganisms prevent colonization of pathogenic microbes, which could aid in prevention of disease.3
The microbiota composition can be influenced by multiple factors such as age, diet, medications, environment, early microbial exposure, and host genetics. The gut microbiota, for example, can be significantly altered by dietary intake or antibiotic use. Alterations in the diversity of microbes in certain body habitats has been linked to several human diseases such as obesity, inflammatory bowel disease, and bacterial vaginosis.4
In women, there are differences noted in the composition of resident microorganisms soon after birth as well as at prepubertal, postpubertal, and postmenopausal transitions. At puberty, anaerobic and aerobic lactobacilli aid in maintaining vaginal pH. If the normal microbiota is suppressed, it allows for yeast and other bacteria to grow causing vaginitis, and dramatic shifts in the makeup of the vaginal microbiota can lead to bacterial vaginosis. Interestingly, research has shown that the pH and microbiome of the vagina differs by ethnicity. These differences in composition of the vaginal microbiome likely contribute to known differences in the acquisition of sexually transmitted infections and development of bacterial vaginosis. The microbiome is believed to have a complex role in regulating human health and disease, including cancer.
There is growing evidence to suggest the gut microbiome may play an important role in the pathogenesis of both obesity and cancer. Two divisions of bacteria predominate in the gut in humans and mice, Bacteroidetes and Firmicutes, and the relative ratio of these two divisions is dramatically affected by obesity, such that Bacteroidetes levels decrease and Firmicutes levels increase.5 The change in the microbial environment leads to a greater ability to harvest dietary energy, which would be conducive to cancer development.
The microbiome and gynecologic cancers
The presence and relative abundance of bacterial species in the vagina are affected by unique factors such as hormonal contraception, pregnancy, and menopause. There are researchers investigating alterations in the microbiome of the vagina and implications in persistence of high-risk human papillomavirus infections and HPV-induced carcinogenesis. There were significant differences found in the composition of the vaginal microbiota in healthy women, compared with women with low-grade squamous intraepithelial neoplasm and high-grade squamous intraepithelial neoplasm.6
Conceivably, the subsequent clinical questions are: Can we apply this data to diagnose women at risk for dysplasia or can we alter the vaginal microbiome to impact the clearance rate of the HPV virus in susceptible or infected women to decrease the long-term risk of cervical dysplasia or malignancy?
The upper reproductive tract in women – the uterus, fallopian tubes, and ovaries – had been presumed to be a sterile environment. However, we know that bacteria have been isolated in the pre- and postmenopausal uterus of healthy women. Therefore, there also are investigators seeking to establish the microbiome of normal uteri to accurately compare it with malignant uteri. Notably, there also is interest in how treatments for cancer – chemotherapy and radiation – ultimately can affect a woman’s vaginal and gut microbiome.
Currently, microbiome research has an expansive range. Women will greatly benefit from research seeking to define improved prevention, diagnosis, and treatment based on alterations of the microbiome for common gynecologic premalignant and malignant conditions.
Dr. Hawkins is a fellow of gynecologic oncology and Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. They had no conflicts of interest to disclose.
References
1. “ ’Ome Sweet ’Omics – a genealogical treasury of words,” by Joshua Lederberg, The Scientist, Apr 2, 2001.
2. Genome Res. 2009 Dec;19(12):2317-23.
3. “Normal Human Microbiota,” Jawetz, Melnick & Adelberg’s Medical Microbiology, 27th edition (New York, NY: McGraw-Hill, 2016).
4. Nature. 2012 Jun 13;486(7402):207-14.
5. Nature. 2006 Dec 21;444(7122):1027-31.
6. Oncol Lett. 2018 Dec; 16(6): 7035-47.
Bacteria are everywhere, good and bad alike! It is well known in the scientific community that microbes significantly outnumber the cells in the human body by at least 10 times. Joshua Lederberg, PhD, gave meaning to the term “microbiome” in 2001 as the “ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space.”1 This community of microorganisms comprises bacteria, fungi, viruses, archaea, and protists.
In 2007, the National Institutes of Health Human Microbiome Project was established to study the human microbiome starting with five specific sites – the gastrointestinal tract, the mouth, the vagina, the skin, and nasal cavity. The goal was not only to identify the microbes inhabiting a specific body site but also to establish a range of “normal” for resident microbes as well as sequence the genomes of these microbes.2 Much of the research predating this era focused on microorganisms in terms of disease potential rather than a focus on the benefits of resident microorganisms.
The richness – the number of microorganisms in an area – and diversity – the relative proportion of microorganisms in an environment – can vary regionally. The microbiota that contribute to the class of resident microorganisms in a specific body habitat can be described broadly as commensals or mutualistic. With commensal microorganisms, one partner benefits and the other is unaffected. On the other hand, mutualistic microorganisms allow both parties to derive benefit. For example, resident microorganisms in the gut aid in the absorption of nutrients and in the production of vitamin K. On mucosal surfaces and the skin, it is possible that these resident microorganisms prevent colonization of pathogenic microbes, which could aid in prevention of disease.3
The microbiota composition can be influenced by multiple factors such as age, diet, medications, environment, early microbial exposure, and host genetics. The gut microbiota, for example, can be significantly altered by dietary intake or antibiotic use. Alterations in the diversity of microbes in certain body habitats has been linked to several human diseases such as obesity, inflammatory bowel disease, and bacterial vaginosis.4
In women, there are differences noted in the composition of resident microorganisms soon after birth as well as at prepubertal, postpubertal, and postmenopausal transitions. At puberty, anaerobic and aerobic lactobacilli aid in maintaining vaginal pH. If the normal microbiota is suppressed, it allows for yeast and other bacteria to grow causing vaginitis, and dramatic shifts in the makeup of the vaginal microbiota can lead to bacterial vaginosis. Interestingly, research has shown that the pH and microbiome of the vagina differs by ethnicity. These differences in composition of the vaginal microbiome likely contribute to known differences in the acquisition of sexually transmitted infections and development of bacterial vaginosis. The microbiome is believed to have a complex role in regulating human health and disease, including cancer.
There is growing evidence to suggest the gut microbiome may play an important role in the pathogenesis of both obesity and cancer. Two divisions of bacteria predominate in the gut in humans and mice, Bacteroidetes and Firmicutes, and the relative ratio of these two divisions is dramatically affected by obesity, such that Bacteroidetes levels decrease and Firmicutes levels increase.5 The change in the microbial environment leads to a greater ability to harvest dietary energy, which would be conducive to cancer development.
The microbiome and gynecologic cancers
The presence and relative abundance of bacterial species in the vagina are affected by unique factors such as hormonal contraception, pregnancy, and menopause. There are researchers investigating alterations in the microbiome of the vagina and implications in persistence of high-risk human papillomavirus infections and HPV-induced carcinogenesis. There were significant differences found in the composition of the vaginal microbiota in healthy women, compared with women with low-grade squamous intraepithelial neoplasm and high-grade squamous intraepithelial neoplasm.6
Conceivably, the subsequent clinical questions are: Can we apply this data to diagnose women at risk for dysplasia or can we alter the vaginal microbiome to impact the clearance rate of the HPV virus in susceptible or infected women to decrease the long-term risk of cervical dysplasia or malignancy?
The upper reproductive tract in women – the uterus, fallopian tubes, and ovaries – had been presumed to be a sterile environment. However, we know that bacteria have been isolated in the pre- and postmenopausal uterus of healthy women. Therefore, there also are investigators seeking to establish the microbiome of normal uteri to accurately compare it with malignant uteri. Notably, there also is interest in how treatments for cancer – chemotherapy and radiation – ultimately can affect a woman’s vaginal and gut microbiome.
Currently, microbiome research has an expansive range. Women will greatly benefit from research seeking to define improved prevention, diagnosis, and treatment based on alterations of the microbiome for common gynecologic premalignant and malignant conditions.
Dr. Hawkins is a fellow of gynecologic oncology and Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. They had no conflicts of interest to disclose.
References
1. “ ’Ome Sweet ’Omics – a genealogical treasury of words,” by Joshua Lederberg, The Scientist, Apr 2, 2001.
2. Genome Res. 2009 Dec;19(12):2317-23.
3. “Normal Human Microbiota,” Jawetz, Melnick & Adelberg’s Medical Microbiology, 27th edition (New York, NY: McGraw-Hill, 2016).
4. Nature. 2012 Jun 13;486(7402):207-14.
5. Nature. 2006 Dec 21;444(7122):1027-31.
6. Oncol Lett. 2018 Dec; 16(6): 7035-47.
Final ‘Vision’ report addresses MOC woes
Whatever you do, change the name.
That was key among the final recommendations the Vision Initiative Commission submitted to the American Board of Medical Specialties on how to improve the maintenance of certification process.
“A new term that communicates the concept, intent, and expectations of continuing certification programs should be adopted by the ABMS in order to reengage disaffected diplomates and assure the public and other stakeholders that the certificate has enduring meaning and value,” according to the final report. A new term was not suggested.
The commission recommended a continuing certification system with four aims:
- Become a meaningful, contemporary, and relevant professional development activity for diplomates that ensures they remain up-to-date in their specialty.
- Demonstrate a commitment to professional self-regulation to both diplomates and the public.
- Align with international and national standards for certification programs.
- Provide a specialty-based credential that would be of value to diplomates and to multiple stakeholders, including patients, families, the public, and health care institutions.
Testing methods and situations must be simplified and updated, according to the report, which was submitted to ABMS on Feb. 12. Continuing certification “must change to incorporate longitudinal and other innovative formative assessment strategies that support learning, identify knowledge and skills gaps, and help diplomates stay current. The ABMS Boards must offer an alternative to burdensome highly secure, point-in-time examinations of knowledge.” In addition, the boards “must no longer use a single point-in-time examination or a series of single point-in-time assessments as the sole method to determine certification status.”
Instead, the commission recommends that ABMS “move quickly to formative assessment formats that are not characterized by high-stakes summative outcomes (pass/fail), specified time frames for high-stakes assessment, or require burdensome testing formats (such as testing centers or remote proctoring) that are inconsistent with the desired goals for continuing certification – support learning; identify knowledge and skills gaps; and help diplomates stay current.”
The commission also defined how the certification process should be used by other stakeholders.
“ABMS must demonstrate and communicate that continuing certification has value, meaning, and purpose in the health care environment,” the report states. “Hospitals, health systems, payers, and other health care organizations can independently decide what factors are used in credentialing and privileging decisions. ABMS must inform these organizations that continuing certification should not be the only criterion used in these decisions, and these organizations should use a wide portfolio of criteria in these decisions. ABMS must encourage hospitals, health systems, payers, and other health care organizations to not deny credentialing or privileging to a physician solely on the basis of certification status.”
Additionally, the commission report states that “ABMS and the ABMS Boards should collaborate with specialty societies, the [continuing medical education/continuing professional development] community, and other expert stakeholders to develop the infrastructure to support learning activities that produce data-driven advances in clinical practice. The ABMS Boards must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage.”
The report adds that the boards “should readily accept existing activities that diplomates are doing to advance their clinical practice and to provide credit for performing low-resource, high-impact activities as part of their daily practice routine.”
The commission’s final report incorporates a number of changes that physicians offered based on a draft version of the report.
The American College of Physicians commented that it “objects to the use of data regarding quality measures for individual diplomate certification status, because physician-level measures of quality are flawed, and because physician-level data inevitably leads to physician-level documentation burden. Flawed performance measures also often inadequately adjust for patient comorbidities and socioeconomic status, which leads to assessments that do not reflect the actual quality of care.”
Similarly, the American Society of Hematology noted in a statement that it “disagrees with the commission’s recommendation to retain the reporting of practice improvement activities as part of continuous certification due to direct and indirect costs needed to fulfill this requirement on top of requirements for engagement in quality improvement mandated by insurers, institutions, and health systems.”
While the draft report recommended that specialty boards provide aggregated feedback to medical societies, a more individualized dissemination on the gaps in knowledge would be more helpful, according to Doug Henley, MD, CEO of the American Academy of Family Physicians, who said that a more individualized approach would help his organization better provide CME to its members to help fill in the knowledge gaps.
“If we can identify these and use other processes and then target at the individual level to seek improvement, I think that will be a better outcome rather than just x learners don’t do well in diabetic care,” he said in an interview. “That doesn’t really help me in terms of who needs the real education in diabetic care versus who needs it for heart failure.”
The final recommendation notes that ABMS member boards “must collaborate with professional and/or CME/CPD organizations to share data and information to guide and support diplomate engagement in continuing certification.”
The document further clarifies that the boards should examine “the aggregated results from assessments to identify knowledge, skills, and other competency gaps,” and the aggregated data should be shared with specialty societies, CME/CPD providers, quality improvement professionals, and other health care organizations.
One weakness in the draft noted by Dr. Henley was the lack of a more forceful tone within the recommendations. Even though AMBS is not bound by its recommendations, he said that he would like to see stronger language throughout the document.
“We would certainly hope that the ABMS and the member boards will follow the direction of the Vision Commission very directly and succinctly,” he said. “That is why we suggested that some of the recommendations from the Vision Commission should use words like ‘should’ and ‘must’ and not just ‘encourage’ and words like that.”
That recommendation was taken and implemented in the final document.
Societies differed in how often participation in the certification process should occur.
The American College of Rheumatology in its comments challenged a recommendation that certification should be structured to expect participation on an annual basis.
“The ACR supports the importance of ongoing learning,” it stated. “However, no discussion is provided as to how and why the recommendation for annual participation by diplomates was conceived. For some ABMS Boards, an annual requirement will increase physician burden unless continuing certification is modified to a formative pathway. If this recommendation is to be retained, the commission would be encouraged to emphasize that inclusion of annual participation should be part of an overall program structure plan that supports a formative approach to assessment. In addition, the ACR requests that ABMS Boards allow exceptions without penalty to be made to this annual requirement to all for live events.”
The American College of Cardiology took a different point of view with regard to this recommendation.
In its comments, ACC stated that it “concurs with this recommendation. Annual participation is a feature of the ACC’s proposed maintenance of certification solution. The ACC believes that ABMS boards should recognize, and make allowances for, physicians who may, for valid reasons (illness, sabbatical, medical or family issue) may not participate in MOC for a period of a year.” ACC generally concurred with the recommendations in the draft.
The final document presented the commission’s view that the ABMS member boards “need to engage with diplomates on an ongoing basis instead of every 2, 5, or 10 years. The ABMS Boards should develop a diplomate engagement strategy and support the idea that diplomates are committed to learning and continually improving their practice, skills, and competencies. The ABMS Boards should expect that diplomates would engage in some learning, assessment, or advancing practice work annually.”
The American Gastroenterological Association, in its comment letter on the draft, said it was “greatly concerned” about the inclusion of practice improvement data, noting it is “debatable whether it is even within the appropriate domain of the boards to assume responsibility for clinical practice performance and quality assurance.”
The final report states that ABMS “must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage,” and added that “when appropriate, taking advantage of other organizations’ quality improvement and reporting activities should be maximized to avoid additional burdens on diplomates.”
ABMS and its board are not bound to follow any of the recommendations contained within the report, but the commission states that it “expects that the ABMS and the ABMS Boards, in collaboration with professional organizations and other stakeholders, will prioritize these recommendations and develop the necessary strategies and infrastructure to implement them.”
Whatever you do, change the name.
That was key among the final recommendations the Vision Initiative Commission submitted to the American Board of Medical Specialties on how to improve the maintenance of certification process.
“A new term that communicates the concept, intent, and expectations of continuing certification programs should be adopted by the ABMS in order to reengage disaffected diplomates and assure the public and other stakeholders that the certificate has enduring meaning and value,” according to the final report. A new term was not suggested.
The commission recommended a continuing certification system with four aims:
- Become a meaningful, contemporary, and relevant professional development activity for diplomates that ensures they remain up-to-date in their specialty.
- Demonstrate a commitment to professional self-regulation to both diplomates and the public.
- Align with international and national standards for certification programs.
- Provide a specialty-based credential that would be of value to diplomates and to multiple stakeholders, including patients, families, the public, and health care institutions.
Testing methods and situations must be simplified and updated, according to the report, which was submitted to ABMS on Feb. 12. Continuing certification “must change to incorporate longitudinal and other innovative formative assessment strategies that support learning, identify knowledge and skills gaps, and help diplomates stay current. The ABMS Boards must offer an alternative to burdensome highly secure, point-in-time examinations of knowledge.” In addition, the boards “must no longer use a single point-in-time examination or a series of single point-in-time assessments as the sole method to determine certification status.”
Instead, the commission recommends that ABMS “move quickly to formative assessment formats that are not characterized by high-stakes summative outcomes (pass/fail), specified time frames for high-stakes assessment, or require burdensome testing formats (such as testing centers or remote proctoring) that are inconsistent with the desired goals for continuing certification – support learning; identify knowledge and skills gaps; and help diplomates stay current.”
The commission also defined how the certification process should be used by other stakeholders.
“ABMS must demonstrate and communicate that continuing certification has value, meaning, and purpose in the health care environment,” the report states. “Hospitals, health systems, payers, and other health care organizations can independently decide what factors are used in credentialing and privileging decisions. ABMS must inform these organizations that continuing certification should not be the only criterion used in these decisions, and these organizations should use a wide portfolio of criteria in these decisions. ABMS must encourage hospitals, health systems, payers, and other health care organizations to not deny credentialing or privileging to a physician solely on the basis of certification status.”
Additionally, the commission report states that “ABMS and the ABMS Boards should collaborate with specialty societies, the [continuing medical education/continuing professional development] community, and other expert stakeholders to develop the infrastructure to support learning activities that produce data-driven advances in clinical practice. The ABMS Boards must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage.”
The report adds that the boards “should readily accept existing activities that diplomates are doing to advance their clinical practice and to provide credit for performing low-resource, high-impact activities as part of their daily practice routine.”
The commission’s final report incorporates a number of changes that physicians offered based on a draft version of the report.
The American College of Physicians commented that it “objects to the use of data regarding quality measures for individual diplomate certification status, because physician-level measures of quality are flawed, and because physician-level data inevitably leads to physician-level documentation burden. Flawed performance measures also often inadequately adjust for patient comorbidities and socioeconomic status, which leads to assessments that do not reflect the actual quality of care.”
Similarly, the American Society of Hematology noted in a statement that it “disagrees with the commission’s recommendation to retain the reporting of practice improvement activities as part of continuous certification due to direct and indirect costs needed to fulfill this requirement on top of requirements for engagement in quality improvement mandated by insurers, institutions, and health systems.”
While the draft report recommended that specialty boards provide aggregated feedback to medical societies, a more individualized dissemination on the gaps in knowledge would be more helpful, according to Doug Henley, MD, CEO of the American Academy of Family Physicians, who said that a more individualized approach would help his organization better provide CME to its members to help fill in the knowledge gaps.
“If we can identify these and use other processes and then target at the individual level to seek improvement, I think that will be a better outcome rather than just x learners don’t do well in diabetic care,” he said in an interview. “That doesn’t really help me in terms of who needs the real education in diabetic care versus who needs it for heart failure.”
The final recommendation notes that ABMS member boards “must collaborate with professional and/or CME/CPD organizations to share data and information to guide and support diplomate engagement in continuing certification.”
The document further clarifies that the boards should examine “the aggregated results from assessments to identify knowledge, skills, and other competency gaps,” and the aggregated data should be shared with specialty societies, CME/CPD providers, quality improvement professionals, and other health care organizations.
One weakness in the draft noted by Dr. Henley was the lack of a more forceful tone within the recommendations. Even though AMBS is not bound by its recommendations, he said that he would like to see stronger language throughout the document.
“We would certainly hope that the ABMS and the member boards will follow the direction of the Vision Commission very directly and succinctly,” he said. “That is why we suggested that some of the recommendations from the Vision Commission should use words like ‘should’ and ‘must’ and not just ‘encourage’ and words like that.”
That recommendation was taken and implemented in the final document.
Societies differed in how often participation in the certification process should occur.
The American College of Rheumatology in its comments challenged a recommendation that certification should be structured to expect participation on an annual basis.
“The ACR supports the importance of ongoing learning,” it stated. “However, no discussion is provided as to how and why the recommendation for annual participation by diplomates was conceived. For some ABMS Boards, an annual requirement will increase physician burden unless continuing certification is modified to a formative pathway. If this recommendation is to be retained, the commission would be encouraged to emphasize that inclusion of annual participation should be part of an overall program structure plan that supports a formative approach to assessment. In addition, the ACR requests that ABMS Boards allow exceptions without penalty to be made to this annual requirement to all for live events.”
The American College of Cardiology took a different point of view with regard to this recommendation.
In its comments, ACC stated that it “concurs with this recommendation. Annual participation is a feature of the ACC’s proposed maintenance of certification solution. The ACC believes that ABMS boards should recognize, and make allowances for, physicians who may, for valid reasons (illness, sabbatical, medical or family issue) may not participate in MOC for a period of a year.” ACC generally concurred with the recommendations in the draft.
The final document presented the commission’s view that the ABMS member boards “need to engage with diplomates on an ongoing basis instead of every 2, 5, or 10 years. The ABMS Boards should develop a diplomate engagement strategy and support the idea that diplomates are committed to learning and continually improving their practice, skills, and competencies. The ABMS Boards should expect that diplomates would engage in some learning, assessment, or advancing practice work annually.”
The American Gastroenterological Association, in its comment letter on the draft, said it was “greatly concerned” about the inclusion of practice improvement data, noting it is “debatable whether it is even within the appropriate domain of the boards to assume responsibility for clinical practice performance and quality assurance.”
The final report states that ABMS “must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage,” and added that “when appropriate, taking advantage of other organizations’ quality improvement and reporting activities should be maximized to avoid additional burdens on diplomates.”
ABMS and its board are not bound to follow any of the recommendations contained within the report, but the commission states that it “expects that the ABMS and the ABMS Boards, in collaboration with professional organizations and other stakeholders, will prioritize these recommendations and develop the necessary strategies and infrastructure to implement them.”
Whatever you do, change the name.
That was key among the final recommendations the Vision Initiative Commission submitted to the American Board of Medical Specialties on how to improve the maintenance of certification process.
“A new term that communicates the concept, intent, and expectations of continuing certification programs should be adopted by the ABMS in order to reengage disaffected diplomates and assure the public and other stakeholders that the certificate has enduring meaning and value,” according to the final report. A new term was not suggested.
The commission recommended a continuing certification system with four aims:
- Become a meaningful, contemporary, and relevant professional development activity for diplomates that ensures they remain up-to-date in their specialty.
- Demonstrate a commitment to professional self-regulation to both diplomates and the public.
- Align with international and national standards for certification programs.
- Provide a specialty-based credential that would be of value to diplomates and to multiple stakeholders, including patients, families, the public, and health care institutions.
Testing methods and situations must be simplified and updated, according to the report, which was submitted to ABMS on Feb. 12. Continuing certification “must change to incorporate longitudinal and other innovative formative assessment strategies that support learning, identify knowledge and skills gaps, and help diplomates stay current. The ABMS Boards must offer an alternative to burdensome highly secure, point-in-time examinations of knowledge.” In addition, the boards “must no longer use a single point-in-time examination or a series of single point-in-time assessments as the sole method to determine certification status.”
Instead, the commission recommends that ABMS “move quickly to formative assessment formats that are not characterized by high-stakes summative outcomes (pass/fail), specified time frames for high-stakes assessment, or require burdensome testing formats (such as testing centers or remote proctoring) that are inconsistent with the desired goals for continuing certification – support learning; identify knowledge and skills gaps; and help diplomates stay current.”
The commission also defined how the certification process should be used by other stakeholders.
“ABMS must demonstrate and communicate that continuing certification has value, meaning, and purpose in the health care environment,” the report states. “Hospitals, health systems, payers, and other health care organizations can independently decide what factors are used in credentialing and privileging decisions. ABMS must inform these organizations that continuing certification should not be the only criterion used in these decisions, and these organizations should use a wide portfolio of criteria in these decisions. ABMS must encourage hospitals, health systems, payers, and other health care organizations to not deny credentialing or privileging to a physician solely on the basis of certification status.”
Additionally, the commission report states that “ABMS and the ABMS Boards should collaborate with specialty societies, the [continuing medical education/continuing professional development] community, and other expert stakeholders to develop the infrastructure to support learning activities that produce data-driven advances in clinical practice. The ABMS Boards must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage.”
The report adds that the boards “should readily accept existing activities that diplomates are doing to advance their clinical practice and to provide credit for performing low-resource, high-impact activities as part of their daily practice routine.”
The commission’s final report incorporates a number of changes that physicians offered based on a draft version of the report.
The American College of Physicians commented that it “objects to the use of data regarding quality measures for individual diplomate certification status, because physician-level measures of quality are flawed, and because physician-level data inevitably leads to physician-level documentation burden. Flawed performance measures also often inadequately adjust for patient comorbidities and socioeconomic status, which leads to assessments that do not reflect the actual quality of care.”
Similarly, the American Society of Hematology noted in a statement that it “disagrees with the commission’s recommendation to retain the reporting of practice improvement activities as part of continuous certification due to direct and indirect costs needed to fulfill this requirement on top of requirements for engagement in quality improvement mandated by insurers, institutions, and health systems.”
While the draft report recommended that specialty boards provide aggregated feedback to medical societies, a more individualized dissemination on the gaps in knowledge would be more helpful, according to Doug Henley, MD, CEO of the American Academy of Family Physicians, who said that a more individualized approach would help his organization better provide CME to its members to help fill in the knowledge gaps.
“If we can identify these and use other processes and then target at the individual level to seek improvement, I think that will be a better outcome rather than just x learners don’t do well in diabetic care,” he said in an interview. “That doesn’t really help me in terms of who needs the real education in diabetic care versus who needs it for heart failure.”
The final recommendation notes that ABMS member boards “must collaborate with professional and/or CME/CPD organizations to share data and information to guide and support diplomate engagement in continuing certification.”
The document further clarifies that the boards should examine “the aggregated results from assessments to identify knowledge, skills, and other competency gaps,” and the aggregated data should be shared with specialty societies, CME/CPD providers, quality improvement professionals, and other health care organizations.
One weakness in the draft noted by Dr. Henley was the lack of a more forceful tone within the recommendations. Even though AMBS is not bound by its recommendations, he said that he would like to see stronger language throughout the document.
“We would certainly hope that the ABMS and the member boards will follow the direction of the Vision Commission very directly and succinctly,” he said. “That is why we suggested that some of the recommendations from the Vision Commission should use words like ‘should’ and ‘must’ and not just ‘encourage’ and words like that.”
That recommendation was taken and implemented in the final document.
Societies differed in how often participation in the certification process should occur.
The American College of Rheumatology in its comments challenged a recommendation that certification should be structured to expect participation on an annual basis.
“The ACR supports the importance of ongoing learning,” it stated. “However, no discussion is provided as to how and why the recommendation for annual participation by diplomates was conceived. For some ABMS Boards, an annual requirement will increase physician burden unless continuing certification is modified to a formative pathway. If this recommendation is to be retained, the commission would be encouraged to emphasize that inclusion of annual participation should be part of an overall program structure plan that supports a formative approach to assessment. In addition, the ACR requests that ABMS Boards allow exceptions without penalty to be made to this annual requirement to all for live events.”
The American College of Cardiology took a different point of view with regard to this recommendation.
In its comments, ACC stated that it “concurs with this recommendation. Annual participation is a feature of the ACC’s proposed maintenance of certification solution. The ACC believes that ABMS boards should recognize, and make allowances for, physicians who may, for valid reasons (illness, sabbatical, medical or family issue) may not participate in MOC for a period of a year.” ACC generally concurred with the recommendations in the draft.
The final document presented the commission’s view that the ABMS member boards “need to engage with diplomates on an ongoing basis instead of every 2, 5, or 10 years. The ABMS Boards should develop a diplomate engagement strategy and support the idea that diplomates are committed to learning and continually improving their practice, skills, and competencies. The ABMS Boards should expect that diplomates would engage in some learning, assessment, or advancing practice work annually.”
The American Gastroenterological Association, in its comment letter on the draft, said it was “greatly concerned” about the inclusion of practice improvement data, noting it is “debatable whether it is even within the appropriate domain of the boards to assume responsibility for clinical practice performance and quality assurance.”
The final report states that ABMS “must ensure that their continuing certification programs recognize and document participation in a wide range of quality assessment activities in which diplomates already engage,” and added that “when appropriate, taking advantage of other organizations’ quality improvement and reporting activities should be maximized to avoid additional burdens on diplomates.”
ABMS and its board are not bound to follow any of the recommendations contained within the report, but the commission states that it “expects that the ABMS and the ABMS Boards, in collaboration with professional organizations and other stakeholders, will prioritize these recommendations and develop the necessary strategies and infrastructure to implement them.”
Palliative care has improved for critically ill children, but challenges remain
SAN DIEGO – and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.
The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.
“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.
Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.
The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.
Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).
Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).
Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.
SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.
SAN DIEGO – and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.
The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.
“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.
Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.
The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.
Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).
Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).
Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.
SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.
SAN DIEGO – and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.
The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.
“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.
Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.
The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.
Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).
Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).
Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.
SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.
REPORTING FROM CCC48
Alisertib response rate in PTCL patients was 33%
An open-label randomized phase 3 trial of oral alisertib for relapsed/refractory peripheral T-cell lymphoma (rrPTCL) was terminated in 2015 after it became clear that it was not going to prove significantly superior to options already on the market.
A new report explains what happened. Oral Alisertib was compared to two agents approved for rrPTCL: intravenous pralatrexate (Folotyn) and romidepsin (Istodax), as well as a common off-label option, intravenous gemcitabine (Gemzar). In all, 138 adults were randomized to alisertib 50 mg two times per day on days 1-7, with a median of four 21-day cycles; 133 were randomized to a comparator, the majority to gemcitabine, and again with repeated cycles as tolerated (J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899).
Overall response rate (ORR) was 33% for alisertib versus 45% for the comparator arm (odds ratio, 0.60; 95% confidence interval, 0.33-1.08). Median progression-free survival was 115 days for alisertib versus 104 days for the comparators, a non–statistically significant difference (hazard ratio, 0.87; 95% CI, 0.637-1.178). Median overall survival was 415 days in the alisertib arm versus 367 days in the comparator arm, also not statistically significant (HR, 0.98; 95% CI, 0.707-1.369).
In patients with rrPTCL, alisertib “did not demonstrate superior efficacy over comparators,” concluded investigators led by oncologist Owen A. O’Connor, MD, PhD, of the Columbia University Medical Center, New York.
Another downside to this drug is that it was associated with adverse events in more than half of patients who took it. While 53% of alisertib patients developed anemia and 47% became neutropenic, in the comparator arm, only 34% and 31% developed anemia and neutropenia, respectively. Further, three deaths in the trial were judged to have be related to alisertib. An additional two deaths occurred in this trial; those were judged to have been related to the rival treatments.
Despite alisertib’s less than great results, the story of this drug’s use for rrPTCL may not be over.
There were hints of benefits for rrPCLT, which might play out in a more focused trial, maybe “in a subgroup of patients with PTCL who responded poorly to comparator agents,” perhaps as a last ditch option. There’s also “potential for treatment combinations of alisertib with novel agents,” the investigators said.
The ORR differences were driven mostly by better performance with the approved agents: ORR was 61% with romidepsin and 43% with pralatrexate; however, alisertib’s ORR (33%) was similar to that for gemcitabine (35%) with “the potential benefits of ... oral administration,” the researchers said.
Also, the number of patients who discontinued treatment because of adverse events was higher in the comparator arm (14%) than in the alisertib group (9%), and more comparator patients required dose reductions (33% versus 28%) because of drug side effects.
Alisertib binds to and inhibits Aurora A kinase (AAK), which is essential for mitosis; studies have demonstrated overexpression in PTCL, which supports AAK inhibition as a novel therapeutic strategy. Research on alisertib for other cancer indications continues, including breast and lung cancer and leukemia.
Most of the subjects in both study arms were white, and about two-thirds were men; the median age was 63 years in both arms.
The work was funded by alisertib maker Millennium Pharmaceuticals, a subsidiary of Takeda. Dr. O’Connor and other investigators reported various ties to Millennium and Takeda, including research funding, honoraria, and consulting work. The study included employees of the companies.
SOURCE: O’Connor OA et al. J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899.
An open-label randomized phase 3 trial of oral alisertib for relapsed/refractory peripheral T-cell lymphoma (rrPTCL) was terminated in 2015 after it became clear that it was not going to prove significantly superior to options already on the market.
A new report explains what happened. Oral Alisertib was compared to two agents approved for rrPTCL: intravenous pralatrexate (Folotyn) and romidepsin (Istodax), as well as a common off-label option, intravenous gemcitabine (Gemzar). In all, 138 adults were randomized to alisertib 50 mg two times per day on days 1-7, with a median of four 21-day cycles; 133 were randomized to a comparator, the majority to gemcitabine, and again with repeated cycles as tolerated (J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899).
Overall response rate (ORR) was 33% for alisertib versus 45% for the comparator arm (odds ratio, 0.60; 95% confidence interval, 0.33-1.08). Median progression-free survival was 115 days for alisertib versus 104 days for the comparators, a non–statistically significant difference (hazard ratio, 0.87; 95% CI, 0.637-1.178). Median overall survival was 415 days in the alisertib arm versus 367 days in the comparator arm, also not statistically significant (HR, 0.98; 95% CI, 0.707-1.369).
In patients with rrPTCL, alisertib “did not demonstrate superior efficacy over comparators,” concluded investigators led by oncologist Owen A. O’Connor, MD, PhD, of the Columbia University Medical Center, New York.
Another downside to this drug is that it was associated with adverse events in more than half of patients who took it. While 53% of alisertib patients developed anemia and 47% became neutropenic, in the comparator arm, only 34% and 31% developed anemia and neutropenia, respectively. Further, three deaths in the trial were judged to have be related to alisertib. An additional two deaths occurred in this trial; those were judged to have been related to the rival treatments.
Despite alisertib’s less than great results, the story of this drug’s use for rrPTCL may not be over.
There were hints of benefits for rrPCLT, which might play out in a more focused trial, maybe “in a subgroup of patients with PTCL who responded poorly to comparator agents,” perhaps as a last ditch option. There’s also “potential for treatment combinations of alisertib with novel agents,” the investigators said.
The ORR differences were driven mostly by better performance with the approved agents: ORR was 61% with romidepsin and 43% with pralatrexate; however, alisertib’s ORR (33%) was similar to that for gemcitabine (35%) with “the potential benefits of ... oral administration,” the researchers said.
Also, the number of patients who discontinued treatment because of adverse events was higher in the comparator arm (14%) than in the alisertib group (9%), and more comparator patients required dose reductions (33% versus 28%) because of drug side effects.
Alisertib binds to and inhibits Aurora A kinase (AAK), which is essential for mitosis; studies have demonstrated overexpression in PTCL, which supports AAK inhibition as a novel therapeutic strategy. Research on alisertib for other cancer indications continues, including breast and lung cancer and leukemia.
Most of the subjects in both study arms were white, and about two-thirds were men; the median age was 63 years in both arms.
The work was funded by alisertib maker Millennium Pharmaceuticals, a subsidiary of Takeda. Dr. O’Connor and other investigators reported various ties to Millennium and Takeda, including research funding, honoraria, and consulting work. The study included employees of the companies.
SOURCE: O’Connor OA et al. J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899.
An open-label randomized phase 3 trial of oral alisertib for relapsed/refractory peripheral T-cell lymphoma (rrPTCL) was terminated in 2015 after it became clear that it was not going to prove significantly superior to options already on the market.
A new report explains what happened. Oral Alisertib was compared to two agents approved for rrPTCL: intravenous pralatrexate (Folotyn) and romidepsin (Istodax), as well as a common off-label option, intravenous gemcitabine (Gemzar). In all, 138 adults were randomized to alisertib 50 mg two times per day on days 1-7, with a median of four 21-day cycles; 133 were randomized to a comparator, the majority to gemcitabine, and again with repeated cycles as tolerated (J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899).
Overall response rate (ORR) was 33% for alisertib versus 45% for the comparator arm (odds ratio, 0.60; 95% confidence interval, 0.33-1.08). Median progression-free survival was 115 days for alisertib versus 104 days for the comparators, a non–statistically significant difference (hazard ratio, 0.87; 95% CI, 0.637-1.178). Median overall survival was 415 days in the alisertib arm versus 367 days in the comparator arm, also not statistically significant (HR, 0.98; 95% CI, 0.707-1.369).
In patients with rrPTCL, alisertib “did not demonstrate superior efficacy over comparators,” concluded investigators led by oncologist Owen A. O’Connor, MD, PhD, of the Columbia University Medical Center, New York.
Another downside to this drug is that it was associated with adverse events in more than half of patients who took it. While 53% of alisertib patients developed anemia and 47% became neutropenic, in the comparator arm, only 34% and 31% developed anemia and neutropenia, respectively. Further, three deaths in the trial were judged to have be related to alisertib. An additional two deaths occurred in this trial; those were judged to have been related to the rival treatments.
Despite alisertib’s less than great results, the story of this drug’s use for rrPTCL may not be over.
There were hints of benefits for rrPCLT, which might play out in a more focused trial, maybe “in a subgroup of patients with PTCL who responded poorly to comparator agents,” perhaps as a last ditch option. There’s also “potential for treatment combinations of alisertib with novel agents,” the investigators said.
The ORR differences were driven mostly by better performance with the approved agents: ORR was 61% with romidepsin and 43% with pralatrexate; however, alisertib’s ORR (33%) was similar to that for gemcitabine (35%) with “the potential benefits of ... oral administration,” the researchers said.
Also, the number of patients who discontinued treatment because of adverse events was higher in the comparator arm (14%) than in the alisertib group (9%), and more comparator patients required dose reductions (33% versus 28%) because of drug side effects.
Alisertib binds to and inhibits Aurora A kinase (AAK), which is essential for mitosis; studies have demonstrated overexpression in PTCL, which supports AAK inhibition as a novel therapeutic strategy. Research on alisertib for other cancer indications continues, including breast and lung cancer and leukemia.
Most of the subjects in both study arms were white, and about two-thirds were men; the median age was 63 years in both arms.
The work was funded by alisertib maker Millennium Pharmaceuticals, a subsidiary of Takeda. Dr. O’Connor and other investigators reported various ties to Millennium and Takeda, including research funding, honoraria, and consulting work. The study included employees of the companies.
SOURCE: O’Connor OA et al. J Clin Oncol. 2019 Feb 1. doi: 10.1200/JCO.18.00899.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Protecting Older Women Against HIV Infection
Older women represent 56% of all women with HIV, and in a 2009 study, they had the highest rates of HIV- and AIDS-related deaths. But few HIV prevention and education programs focus on older women, says Christopher Coleman, PhD, MPH, department chair and professor, Department of Health Promotion and Disease Prevention, The University of Tennessee Health Science Center, College of Nursing. Moreover, sexual health studies mainly concentrate on younger women and reproductive health, not risk factors for HIV among older women.
Coleman says the “confluence of lack of knowledge and absent communication about HIV risk has created a significant health crisis” for this group. He reviewed 41 articles that provide some insight.
Ageism, biological factors, and lack of education all play a part. Some research has found that older women are less likely to engage in safe sex practices because they no longer use condoms to prevent pregnancy. The National AIDS Behavior Survey found that > 85% of respondents aged ≥ 50 years reported never using condoms or using them inconsistently. However, women in the postmenopausal age group are sexually active, and because they may be divorced or widowed, may not be in committed relationships. Also, age-related physical changes, such as thinning vaginal tissue and a weakened immune system, can make them more vulnerable to infection.
The problem is compounded when an older woman is unwilling to bring up the topic with health care providers—and health care providers are unwilling to believe that she is sexually active. Women aged > 50 years may also avoid seeking HIV testing due to social factors. And they may be prevented from traveling to health care or testing by poor physical health or other age-related issues.
We need new methods of reaching them, Coleman says. Existing HIV/AIDS instructional programs may not be effective tools for women with age-related comorbidities, such as cognitive, visual, or auditory deficits. Other options should be considered: For instance, small peer groups have been more successful than large groups, providing a sense of safety and belonging that encourages disclosure.
Health care providers should include education during routine office visits, Coleman advises, using non-ageist and nonstereotyping strategies and questions. Nurses are well positioned to educate women about the risks of HIV transmission; he says: discussing sexual activity with older women requires the “art of therapeutic communication without judgment.”
Older women represent 56% of all women with HIV, and in a 2009 study, they had the highest rates of HIV- and AIDS-related deaths. But few HIV prevention and education programs focus on older women, says Christopher Coleman, PhD, MPH, department chair and professor, Department of Health Promotion and Disease Prevention, The University of Tennessee Health Science Center, College of Nursing. Moreover, sexual health studies mainly concentrate on younger women and reproductive health, not risk factors for HIV among older women.
Coleman says the “confluence of lack of knowledge and absent communication about HIV risk has created a significant health crisis” for this group. He reviewed 41 articles that provide some insight.
Ageism, biological factors, and lack of education all play a part. Some research has found that older women are less likely to engage in safe sex practices because they no longer use condoms to prevent pregnancy. The National AIDS Behavior Survey found that > 85% of respondents aged ≥ 50 years reported never using condoms or using them inconsistently. However, women in the postmenopausal age group are sexually active, and because they may be divorced or widowed, may not be in committed relationships. Also, age-related physical changes, such as thinning vaginal tissue and a weakened immune system, can make them more vulnerable to infection.
The problem is compounded when an older woman is unwilling to bring up the topic with health care providers—and health care providers are unwilling to believe that she is sexually active. Women aged > 50 years may also avoid seeking HIV testing due to social factors. And they may be prevented from traveling to health care or testing by poor physical health or other age-related issues.
We need new methods of reaching them, Coleman says. Existing HIV/AIDS instructional programs may not be effective tools for women with age-related comorbidities, such as cognitive, visual, or auditory deficits. Other options should be considered: For instance, small peer groups have been more successful than large groups, providing a sense of safety and belonging that encourages disclosure.
Health care providers should include education during routine office visits, Coleman advises, using non-ageist and nonstereotyping strategies and questions. Nurses are well positioned to educate women about the risks of HIV transmission; he says: discussing sexual activity with older women requires the “art of therapeutic communication without judgment.”
Older women represent 56% of all women with HIV, and in a 2009 study, they had the highest rates of HIV- and AIDS-related deaths. But few HIV prevention and education programs focus on older women, says Christopher Coleman, PhD, MPH, department chair and professor, Department of Health Promotion and Disease Prevention, The University of Tennessee Health Science Center, College of Nursing. Moreover, sexual health studies mainly concentrate on younger women and reproductive health, not risk factors for HIV among older women.
Coleman says the “confluence of lack of knowledge and absent communication about HIV risk has created a significant health crisis” for this group. He reviewed 41 articles that provide some insight.
Ageism, biological factors, and lack of education all play a part. Some research has found that older women are less likely to engage in safe sex practices because they no longer use condoms to prevent pregnancy. The National AIDS Behavior Survey found that > 85% of respondents aged ≥ 50 years reported never using condoms or using them inconsistently. However, women in the postmenopausal age group are sexually active, and because they may be divorced or widowed, may not be in committed relationships. Also, age-related physical changes, such as thinning vaginal tissue and a weakened immune system, can make them more vulnerable to infection.
The problem is compounded when an older woman is unwilling to bring up the topic with health care providers—and health care providers are unwilling to believe that she is sexually active. Women aged > 50 years may also avoid seeking HIV testing due to social factors. And they may be prevented from traveling to health care or testing by poor physical health or other age-related issues.
We need new methods of reaching them, Coleman says. Existing HIV/AIDS instructional programs may not be effective tools for women with age-related comorbidities, such as cognitive, visual, or auditory deficits. Other options should be considered: For instance, small peer groups have been more successful than large groups, providing a sense of safety and belonging that encourages disclosure.
Health care providers should include education during routine office visits, Coleman advises, using non-ageist and nonstereotyping strategies and questions. Nurses are well positioned to educate women about the risks of HIV transmission; he says: discussing sexual activity with older women requires the “art of therapeutic communication without judgment.”