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‘Clear answer’: ALL study defies conventional wisdom
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASH 2022
‘Astonishing’ results: Skip salvage chemo, proceed to HSCT
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASH 2022
Post-transplant diet: Gruel no longer rules
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
AT ASH 2022
Global effort needed to widen access to HSCT
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASH 2022
Poorly matched stem cell transplants linked to ancestry
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
FROM ASH 2022
For minorities with PE: Less advanced treatment, more mortality
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
AT ASH 2022
No, you can’t see a different doctor: We need zero tolerance of patient bias
It was 1970. I was in my second year of medical school. I can remember the hurt and embarrassment as if it were yesterday.
Coming from the Deep South, I was very familiar with racial bias, but I did not expect it at that level and in that environment. From that point on, I was anxious at each patient encounter, concerned that this might happen again. And it did several times during my residency and fellowship.
The Occupational Safety and Health Administration defines workplace violence as “any act or threat of physical violence, harassment, intimidation, or other threatening disruptive behavior that occurs at the work site. It ranges from threats and verbal abuse to physical assaults.”
There is considerable media focus on incidents of physical violence against health care workers, but when patients, their families, or visitors openly display bias and request a different doctor, nurse, or technician for nonmedical reasons, the impact is profound. This is extremely hurtful to a professional who has worked long and hard to acquire skills and expertise. And, while speech may not constitute violence in the strictest sense of the word, there is growing evidence that it can be physically harmful through its effect on the nervous system, even if no physical contact is involved.
Incidents of bias occur regularly and are clearly on the rise. In most cases the request for a different health care worker is granted to honor the rights of the patient. The healthcare worker is left alone and emotionally wounded; the healthcare institutions are complicit.
This bias is mostly racial but can also be based on religion, sexual orientation, age, disability, body size, accent, or gender.
An entire issue of the American Medical Association Journal of Ethics was devoted to this topic. From recognizing that there are limits to what clinicians should be expected to tolerate when patients’ preferences express unjust bias, the issue also explored where those limits should be placed, why, and who is obliged to enforce them.
The newly adopted Mass General Patient Code of Conduct is evidence that health care systems are beginning to recognize this problem and that such behavior will not be tolerated.
But having a zero-tolerance policy is not enough. We must have procedures in place to discourage and mitigate the impact of patient bias.
A clear definition of what constitutes a bias incident is essential. All team members must be made aware of the procedures for reporting such incidents and the chain of command for escalation. Reporting should be encouraged, and resources must be made available to impacted team members. Surveillance, monitoring, and review are also essential as is clarification on when patient preferences should be honored.
The Mayo Clinic 5 Step Plan is an excellent example of a protocol to deal with patient bias against health care workers and is based on a thoughtful analysis of what constitutes an unreasonable request for a different clinician. I’m pleased to report that my health care system (Inova Health) is developing a similar protocol.
The health care setting should be a bias-free zone for both patients and health care workers. I have been a strong advocate of patients’ rights and worked hard to guard against bias and eliminate disparities in care, but health care workers have rights as well.
We should expect to be treated with respect.
The views expressed by the author are those of the author alone and do not represent the views of the Inova Health System. Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
It was 1970. I was in my second year of medical school. I can remember the hurt and embarrassment as if it were yesterday.
Coming from the Deep South, I was very familiar with racial bias, but I did not expect it at that level and in that environment. From that point on, I was anxious at each patient encounter, concerned that this might happen again. And it did several times during my residency and fellowship.
The Occupational Safety and Health Administration defines workplace violence as “any act or threat of physical violence, harassment, intimidation, or other threatening disruptive behavior that occurs at the work site. It ranges from threats and verbal abuse to physical assaults.”
There is considerable media focus on incidents of physical violence against health care workers, but when patients, their families, or visitors openly display bias and request a different doctor, nurse, or technician for nonmedical reasons, the impact is profound. This is extremely hurtful to a professional who has worked long and hard to acquire skills and expertise. And, while speech may not constitute violence in the strictest sense of the word, there is growing evidence that it can be physically harmful through its effect on the nervous system, even if no physical contact is involved.
Incidents of bias occur regularly and are clearly on the rise. In most cases the request for a different health care worker is granted to honor the rights of the patient. The healthcare worker is left alone and emotionally wounded; the healthcare institutions are complicit.
This bias is mostly racial but can also be based on religion, sexual orientation, age, disability, body size, accent, or gender.
An entire issue of the American Medical Association Journal of Ethics was devoted to this topic. From recognizing that there are limits to what clinicians should be expected to tolerate when patients’ preferences express unjust bias, the issue also explored where those limits should be placed, why, and who is obliged to enforce them.
The newly adopted Mass General Patient Code of Conduct is evidence that health care systems are beginning to recognize this problem and that such behavior will not be tolerated.
But having a zero-tolerance policy is not enough. We must have procedures in place to discourage and mitigate the impact of patient bias.
A clear definition of what constitutes a bias incident is essential. All team members must be made aware of the procedures for reporting such incidents and the chain of command for escalation. Reporting should be encouraged, and resources must be made available to impacted team members. Surveillance, monitoring, and review are also essential as is clarification on when patient preferences should be honored.
The Mayo Clinic 5 Step Plan is an excellent example of a protocol to deal with patient bias against health care workers and is based on a thoughtful analysis of what constitutes an unreasonable request for a different clinician. I’m pleased to report that my health care system (Inova Health) is developing a similar protocol.
The health care setting should be a bias-free zone for both patients and health care workers. I have been a strong advocate of patients’ rights and worked hard to guard against bias and eliminate disparities in care, but health care workers have rights as well.
We should expect to be treated with respect.
The views expressed by the author are those of the author alone and do not represent the views of the Inova Health System. Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
It was 1970. I was in my second year of medical school. I can remember the hurt and embarrassment as if it were yesterday.
Coming from the Deep South, I was very familiar with racial bias, but I did not expect it at that level and in that environment. From that point on, I was anxious at each patient encounter, concerned that this might happen again. And it did several times during my residency and fellowship.
The Occupational Safety and Health Administration defines workplace violence as “any act or threat of physical violence, harassment, intimidation, or other threatening disruptive behavior that occurs at the work site. It ranges from threats and verbal abuse to physical assaults.”
There is considerable media focus on incidents of physical violence against health care workers, but when patients, their families, or visitors openly display bias and request a different doctor, nurse, or technician for nonmedical reasons, the impact is profound. This is extremely hurtful to a professional who has worked long and hard to acquire skills and expertise. And, while speech may not constitute violence in the strictest sense of the word, there is growing evidence that it can be physically harmful through its effect on the nervous system, even if no physical contact is involved.
Incidents of bias occur regularly and are clearly on the rise. In most cases the request for a different health care worker is granted to honor the rights of the patient. The healthcare worker is left alone and emotionally wounded; the healthcare institutions are complicit.
This bias is mostly racial but can also be based on religion, sexual orientation, age, disability, body size, accent, or gender.
An entire issue of the American Medical Association Journal of Ethics was devoted to this topic. From recognizing that there are limits to what clinicians should be expected to tolerate when patients’ preferences express unjust bias, the issue also explored where those limits should be placed, why, and who is obliged to enforce them.
The newly adopted Mass General Patient Code of Conduct is evidence that health care systems are beginning to recognize this problem and that such behavior will not be tolerated.
But having a zero-tolerance policy is not enough. We must have procedures in place to discourage and mitigate the impact of patient bias.
A clear definition of what constitutes a bias incident is essential. All team members must be made aware of the procedures for reporting such incidents and the chain of command for escalation. Reporting should be encouraged, and resources must be made available to impacted team members. Surveillance, monitoring, and review are also essential as is clarification on when patient preferences should be honored.
The Mayo Clinic 5 Step Plan is an excellent example of a protocol to deal with patient bias against health care workers and is based on a thoughtful analysis of what constitutes an unreasonable request for a different clinician. I’m pleased to report that my health care system (Inova Health) is developing a similar protocol.
The health care setting should be a bias-free zone for both patients and health care workers. I have been a strong advocate of patients’ rights and worked hard to guard against bias and eliminate disparities in care, but health care workers have rights as well.
We should expect to be treated with respect.
The views expressed by the author are those of the author alone and do not represent the views of the Inova Health System. Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
States cracking down harder on docs who sexually abuse patients
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
It’s the latest example of states taking doctor sexual misconduct more seriously after longstanding criticism that medical boards have been too lenient.
The law, which takes effect in January 2023, requires the state’s medical board to permanently revoke these doctors’ licenses instead of allowing them to petition the board for reinstatement after 3 years.
“Physician licenses should not be reinstated after egregious sexual misconduct with patients. The doctor-patient relationship has to remain sacrosanct and trusted,” said Peter Yellowlees, MD, a professor of psychiatry at the University of California, Davis.
Although the vast majority of the nation’s estimated 1 million doctors don’t sexually abuse patients, the problem is a national one.
The Federation of State Medical Boards defines sexual misconduct as the exploitation of the physician-patient relationship in a sexual way. The exploitation may be verbal or physical and can occur in person or virtually.
The FSMB conducted a 2-year review of how medical boards handled cases of sexual misconduct, issuing a report in 2020 that contained 38 recommended actions.
Four states in addition to California have enacted laws that incorporate some FSMB recommendations. These include revoking doctors’ licenses after a single egregious act of sexual misconduct (including sexual assault), regardless of whether the physician was charged or convicted; increased reporting by hospitals and doctors of sexual misconduct; and training of physicians to recognize and report sexual misconduct.
The four state laws are:
- Georgia’s HB 458. It was signed into law in May 2021, and it authorizes the medical board to revoke or suspend a license if a physician is found guilty of sexually assaulting a patient in a criminal case. Doctors are required to report other doctors who have sexually abused patients and to take continuing medical education (CME) units on sexual misconduct.
- Florida’s SB 1934. This legislation was signed into law in June 2021, and it bars physicians charged with serious crimes such as sexual assault, sexual misconduct against patients, or possession of child pornography from seeing patients until those charges are resolved by the legal system.
- West Virginia’s SB 603. Signed into law in March 2022 it prohibits the medical board from issuing a license to a physician who engaged in sexual activity or misconduct with a patient whose license was revoked in another state or was involved in other violations.
- Tennessee HB 1045. It was signed into law in May 2021, and authorizes the medical board, upon learning of an indictment against a physician for a controlled substance violation or sexual offense, to immediately suspend the doctor’s ability to prescribe controlled substances until the doctor’s case is resolved.
A published study identified a total of 1,721 reports of physician sexual misconduct that were submitted to the National Practitioner Data Bank between 2000 and 2019. The annual incidence of sexual misconduct reports averaged 10.8 per 100,000 U.S. physician licensees, said the researchers.
In a groundbreaking 2016 investigation, the Atlanta Journal-Constitution reviewed thousands of documents and found more than 2,400 doctors whose sexual misconduct cases clearly involved patients since 1999.
Physician sexual misconduct is likely underreported
The actual incidence of physician-patient sexual misconduct is likely higher as a result of underreporting, according to the researchers.
Because a substantial power differential exists between patients and their physicians, the researchers noted, it follows that patient victims, like other sexual assault victims, may be unwilling or unable to report the incident in question.
Many violations involving physician sexual misconduct of patients never came to the attention of state regulators, according to the Journal-Constitution investigation. Reporting showed that hospitals, clinics, and fellow doctors fail to report sexual misconduct to regulators, despite laws in most states requiring them to do so.
Media investigations highlight medical board shortcomings
Public pressure on the California Medical Board increased after the Los Angeles Times investigated what happened to doctors who surrendered or had their licenses revoked after being reported for sexual abuse with patients. The Times revealed in 2021 that the board reinstated 10 of 17 doctors who petitioned for reinstatement.
They include Esmail Nadjmabadi, MD, of Bakersfield, Calif., who had sexually abused six female patients, including one in her mid-teens. The Times reported that, in 2009, he pleaded no contest to a criminal charge that he sexually exploited two or more women and surrendered his medical license the following year.
Five years later, Dr. Nadjmabadi petitioned the medical board to be reinstated and the board approved his request.
The California board has also reinstated several doctors who underwent sex offender rehabilitation. Board members rely heavily on a doctor’s evidence of rehabilitation, usually with the testimony of therapists hired by the doctor, and no input from the patients who were harmed, according to the Times’ investigation.
High-profile sexual misconduct or abuse cases involving Larry Nassar, MD, and Robert Anderson, MD, in Michigan; Richard Strauss, MD, in Ohio; and Ricardo Cruciani, MD, in New York, added to the mounting criticism that medical boards were too lenient in their handling of complaints of sexual misconduct.
Another state tackles sexual misconduct
Ohio’s medical board created an administrative rule stating that licensed physicians have a legal and ethical duty to report colleagues for sexual misconduct with patients and to complete a 1-hour CME training. Failure to report sexual misconduct complaints can lead to a doctor being permanently stripped of his license.
This happened to Robert S. Geiger, MD, in 2016 after not reporting his colleague James Bressi, MD, to the medical board after receiving complaints that Dr. Bressi was sexually abusing female patients at their pain clinic.
Dr. Bressi was convicted of sexual misconduct with a patient, stripped of his medical license, and sentenced to 59 days in prison.
“I think all of these reforms are a step in the right direction and will help to deter doctors from committing sexual misconduct to some extent,” said California activist Marian Hollingsworth, cofounder of the Patient Safety League.
But there’s room for improvement, she said, since “most states fall short in not requiring medical boards to notify law enforcement when they get a complaint of doctor sexual misconduct so the public can be aware of it.”
A version of this article first appeared on Medscape.com.
Postpartum hemorrhage rates and risk factors rising
The rate of postpartum hemorrhage for hospital deliveries in the United States increased significantly over a 20-year period, according to data from more than 76 million delivery hospitalizations from the National Inpatient Sample.
Postpartum hemorrhage remains the leading cause of maternal morbidity and mortality worldwide, and many clinical and patient-level risk factors appear to be on the rise, wrote Chiara M. Corbetta-Rastelli, MD, of the University of California, San Francisco, and colleagues.
Although practice changes have been introduced to reduce postpartum hemorrhage, recent trends in postpartum hemorrhage risk and outcomes in the context of such changes as hemorrhage safety bundles have not been examined, they said.
In a study published in Obstetrics & Gynecology, the researchers reviewed data from hospitalizations for females aged 15-54 years for deliveries between 2000 and 2019 using the National Inpatient Sample. They used a regression analysis to estimate average annual percentage changes (AAPC). Their objectives were to characterize trends and also to assess the association between risk factors and the occurrence of postpartum hemorrhage and related interventions. Demographics, clinical factors, and hospital characteristics were mainly similar between the group of patients with postpartum hemorrhage and those with no postpartum hemorrhage.
Approximately 3% (2.3 million) of 76.7 million hospitalizations for delivery were complicated by postpartum hemorrhage during the study period, and the annual rate increased from 2.7% to 4.3%.
Overall, 21.4% of individuals with delivery hospitalizations complicated by postpartum hemorrhage had one postpartum risk factor, and 1.4% had two or more risk factors. The number of individuals with at least one risk factor for postpartum hemorrhage increased significantly, from 18.6% to 26.9%, during the study period, with an annual percentage change of 1.9%.
Compared with deliveries in individuals without risk factors, individuals with one risk factor had slightly higher odds of postpartum hemorrhage (odds ratio, 1.14), but those with two or more risk factors were more than twice as likely to experience postpartum hemorrhage as those with no risk factors (OR, 2.31).
The researchers also examined the association of specific risk factors and interventions related to hemorrhage, notably blood transfusion and peripartum hysterectomy. Blood transfusions in individuals with postpartum hemorrhage increased from 5.4% to 16.7% between 2000 and 2011, (AAPC, 10.2%) then decreased from 16.7% to 12.6% from 2011 to 2019 (AAPC, –3.9%).
Peripartum hysterectomy in the study population increased from 1.4% to 2.4% from 2000 to 2009 (AAPC 5.0%), remained steady from 2009 to 2016, and then decreased from 2.1% to 0.9% from 2016 to 2019 (AAPC –27%).
Other risk factors associated with postpartum hemorrhage itself and with blood transfusion and hysterectomy in the setting of postpartum hemorrhage included prior cesarean delivery with placenta previa or accreta, placenta previa without prior cesarean delivery, and antepartum hemorrhage or placental abruption, the researchers noted.
“In addition to placental abnormalities, risk factors such as preeclampsia with severe features, polyhydramnios, and uterine leiomyomas demonstrated the highest rates of increase in our data,” they wrote in their discussion. These trends may lead to continuing increases in postpartum hemorrhage risk, which was not fully explained by the increase in risk factors seen in the current study, the researchers said.
The study findings were limited by several factors, including the use of billing codes that could lead to misclassification of diagnoses, as well as possible differences in the definition and coding for postpartum hemorrhage among hospitals, the researchers noted. Other limitations were the exclusion of cases of readmission for postpartum hemorrhage and lack of clinical details involving use of medications or nonoperative interventions, they said.
Notably, the study finding of stable to decreasing peripartum hysterectomy rates in hospitalized patients with postpartum hemorrhage conflicts with another recent study showing an increase in peripartum hysterectomy from 2009 to 2020, but this difference may reflect changes in billing, indications for hysterectomy, or study modeling, they said.
The current study was strengthened by the use of a large database to analyze population trends, a contemporary study period, and the inclusion of meaningful outcomes such as peripartum hysterectomy, the researchers wrote.
The shift in blood transfusion and peripartum hysterectomy may reflect the implementation of protocols to promote early intervention and identification of postpartum hemorrhage, they concluded.
Interventions can have an effect
“Hemorrhage remains a leading cause of maternal mortality in the United States and blood transfusion is the most common severe maternal morbidity,” Catherine M. Albright, MD, MS, associate professor of maternal-fetal medicine at the University of Washington, Seattle, said in an interview. “It is important to understand the current state, especially given that many hospitals have implemented policies and procedures to better identify and treat postpartum hemorrhage,” she said.
Dr. Albright said, “I was pleased to see that they did not just look at a diagnosis of postpartum hemorrhage but rather also looked at complications arising from postpartum hemorrhage, such as blood transfusion or hysterectomy.”
Postpartum hemorrhage is often a clinical diagnosis that uses estimated blood loss, a notoriously inaccurate measure, said Dr. Albright. “Additionally, the definitions of postpartum hemorrhage, as well as the ICD codes, changed during the time period of the study,” she noted. “These factors all could lead to both underreporting and overreporting of the true incidence of postpartum hemorrhage. Blood transfusion and hysterectomy are more objective outcomes and demonstrate true morbidity,” she said.
“Most of the risk factors that are listed in the article are not modifiable during that pregnancy,” said Dr. Albright. For example, a history of a prior cesarean or having a twin pregnancy is not something that can be changed, she said. “Many of the other risk factors or associated clinical factors, such as obesity, chronic hypertension, and pregestational diabetes, are modifiable, but before pregnancy. Universal and easy access to primary medical care prior to and between pregnancies may help to mitigate some of these factors,” she noted.
Looking ahead, “It would be helpful to ensure that these types of data are available at the state and hospital level; this will allow for local evaluation of programs that are in place to reduce postpartum hemorrhage risk and improve identification and treatment,” Dr. Albright said.
The study received no outside funding. Dr. Corbetta-Rastelli and Dr. Albright had no financial conflicts to disclose.
The rate of postpartum hemorrhage for hospital deliveries in the United States increased significantly over a 20-year period, according to data from more than 76 million delivery hospitalizations from the National Inpatient Sample.
Postpartum hemorrhage remains the leading cause of maternal morbidity and mortality worldwide, and many clinical and patient-level risk factors appear to be on the rise, wrote Chiara M. Corbetta-Rastelli, MD, of the University of California, San Francisco, and colleagues.
Although practice changes have been introduced to reduce postpartum hemorrhage, recent trends in postpartum hemorrhage risk and outcomes in the context of such changes as hemorrhage safety bundles have not been examined, they said.
In a study published in Obstetrics & Gynecology, the researchers reviewed data from hospitalizations for females aged 15-54 years for deliveries between 2000 and 2019 using the National Inpatient Sample. They used a regression analysis to estimate average annual percentage changes (AAPC). Their objectives were to characterize trends and also to assess the association between risk factors and the occurrence of postpartum hemorrhage and related interventions. Demographics, clinical factors, and hospital characteristics were mainly similar between the group of patients with postpartum hemorrhage and those with no postpartum hemorrhage.
Approximately 3% (2.3 million) of 76.7 million hospitalizations for delivery were complicated by postpartum hemorrhage during the study period, and the annual rate increased from 2.7% to 4.3%.
Overall, 21.4% of individuals with delivery hospitalizations complicated by postpartum hemorrhage had one postpartum risk factor, and 1.4% had two or more risk factors. The number of individuals with at least one risk factor for postpartum hemorrhage increased significantly, from 18.6% to 26.9%, during the study period, with an annual percentage change of 1.9%.
Compared with deliveries in individuals without risk factors, individuals with one risk factor had slightly higher odds of postpartum hemorrhage (odds ratio, 1.14), but those with two or more risk factors were more than twice as likely to experience postpartum hemorrhage as those with no risk factors (OR, 2.31).
The researchers also examined the association of specific risk factors and interventions related to hemorrhage, notably blood transfusion and peripartum hysterectomy. Blood transfusions in individuals with postpartum hemorrhage increased from 5.4% to 16.7% between 2000 and 2011, (AAPC, 10.2%) then decreased from 16.7% to 12.6% from 2011 to 2019 (AAPC, –3.9%).
Peripartum hysterectomy in the study population increased from 1.4% to 2.4% from 2000 to 2009 (AAPC 5.0%), remained steady from 2009 to 2016, and then decreased from 2.1% to 0.9% from 2016 to 2019 (AAPC –27%).
Other risk factors associated with postpartum hemorrhage itself and with blood transfusion and hysterectomy in the setting of postpartum hemorrhage included prior cesarean delivery with placenta previa or accreta, placenta previa without prior cesarean delivery, and antepartum hemorrhage or placental abruption, the researchers noted.
“In addition to placental abnormalities, risk factors such as preeclampsia with severe features, polyhydramnios, and uterine leiomyomas demonstrated the highest rates of increase in our data,” they wrote in their discussion. These trends may lead to continuing increases in postpartum hemorrhage risk, which was not fully explained by the increase in risk factors seen in the current study, the researchers said.
The study findings were limited by several factors, including the use of billing codes that could lead to misclassification of diagnoses, as well as possible differences in the definition and coding for postpartum hemorrhage among hospitals, the researchers noted. Other limitations were the exclusion of cases of readmission for postpartum hemorrhage and lack of clinical details involving use of medications or nonoperative interventions, they said.
Notably, the study finding of stable to decreasing peripartum hysterectomy rates in hospitalized patients with postpartum hemorrhage conflicts with another recent study showing an increase in peripartum hysterectomy from 2009 to 2020, but this difference may reflect changes in billing, indications for hysterectomy, or study modeling, they said.
The current study was strengthened by the use of a large database to analyze population trends, a contemporary study period, and the inclusion of meaningful outcomes such as peripartum hysterectomy, the researchers wrote.
The shift in blood transfusion and peripartum hysterectomy may reflect the implementation of protocols to promote early intervention and identification of postpartum hemorrhage, they concluded.
Interventions can have an effect
“Hemorrhage remains a leading cause of maternal mortality in the United States and blood transfusion is the most common severe maternal morbidity,” Catherine M. Albright, MD, MS, associate professor of maternal-fetal medicine at the University of Washington, Seattle, said in an interview. “It is important to understand the current state, especially given that many hospitals have implemented policies and procedures to better identify and treat postpartum hemorrhage,” she said.
Dr. Albright said, “I was pleased to see that they did not just look at a diagnosis of postpartum hemorrhage but rather also looked at complications arising from postpartum hemorrhage, such as blood transfusion or hysterectomy.”
Postpartum hemorrhage is often a clinical diagnosis that uses estimated blood loss, a notoriously inaccurate measure, said Dr. Albright. “Additionally, the definitions of postpartum hemorrhage, as well as the ICD codes, changed during the time period of the study,” she noted. “These factors all could lead to both underreporting and overreporting of the true incidence of postpartum hemorrhage. Blood transfusion and hysterectomy are more objective outcomes and demonstrate true morbidity,” she said.
“Most of the risk factors that are listed in the article are not modifiable during that pregnancy,” said Dr. Albright. For example, a history of a prior cesarean or having a twin pregnancy is not something that can be changed, she said. “Many of the other risk factors or associated clinical factors, such as obesity, chronic hypertension, and pregestational diabetes, are modifiable, but before pregnancy. Universal and easy access to primary medical care prior to and between pregnancies may help to mitigate some of these factors,” she noted.
Looking ahead, “It would be helpful to ensure that these types of data are available at the state and hospital level; this will allow for local evaluation of programs that are in place to reduce postpartum hemorrhage risk and improve identification and treatment,” Dr. Albright said.
The study received no outside funding. Dr. Corbetta-Rastelli and Dr. Albright had no financial conflicts to disclose.
The rate of postpartum hemorrhage for hospital deliveries in the United States increased significantly over a 20-year period, according to data from more than 76 million delivery hospitalizations from the National Inpatient Sample.
Postpartum hemorrhage remains the leading cause of maternal morbidity and mortality worldwide, and many clinical and patient-level risk factors appear to be on the rise, wrote Chiara M. Corbetta-Rastelli, MD, of the University of California, San Francisco, and colleagues.
Although practice changes have been introduced to reduce postpartum hemorrhage, recent trends in postpartum hemorrhage risk and outcomes in the context of such changes as hemorrhage safety bundles have not been examined, they said.
In a study published in Obstetrics & Gynecology, the researchers reviewed data from hospitalizations for females aged 15-54 years for deliveries between 2000 and 2019 using the National Inpatient Sample. They used a regression analysis to estimate average annual percentage changes (AAPC). Their objectives were to characterize trends and also to assess the association between risk factors and the occurrence of postpartum hemorrhage and related interventions. Demographics, clinical factors, and hospital characteristics were mainly similar between the group of patients with postpartum hemorrhage and those with no postpartum hemorrhage.
Approximately 3% (2.3 million) of 76.7 million hospitalizations for delivery were complicated by postpartum hemorrhage during the study period, and the annual rate increased from 2.7% to 4.3%.
Overall, 21.4% of individuals with delivery hospitalizations complicated by postpartum hemorrhage had one postpartum risk factor, and 1.4% had two or more risk factors. The number of individuals with at least one risk factor for postpartum hemorrhage increased significantly, from 18.6% to 26.9%, during the study period, with an annual percentage change of 1.9%.
Compared with deliveries in individuals without risk factors, individuals with one risk factor had slightly higher odds of postpartum hemorrhage (odds ratio, 1.14), but those with two or more risk factors were more than twice as likely to experience postpartum hemorrhage as those with no risk factors (OR, 2.31).
The researchers also examined the association of specific risk factors and interventions related to hemorrhage, notably blood transfusion and peripartum hysterectomy. Blood transfusions in individuals with postpartum hemorrhage increased from 5.4% to 16.7% between 2000 and 2011, (AAPC, 10.2%) then decreased from 16.7% to 12.6% from 2011 to 2019 (AAPC, –3.9%).
Peripartum hysterectomy in the study population increased from 1.4% to 2.4% from 2000 to 2009 (AAPC 5.0%), remained steady from 2009 to 2016, and then decreased from 2.1% to 0.9% from 2016 to 2019 (AAPC –27%).
Other risk factors associated with postpartum hemorrhage itself and with blood transfusion and hysterectomy in the setting of postpartum hemorrhage included prior cesarean delivery with placenta previa or accreta, placenta previa without prior cesarean delivery, and antepartum hemorrhage or placental abruption, the researchers noted.
“In addition to placental abnormalities, risk factors such as preeclampsia with severe features, polyhydramnios, and uterine leiomyomas demonstrated the highest rates of increase in our data,” they wrote in their discussion. These trends may lead to continuing increases in postpartum hemorrhage risk, which was not fully explained by the increase in risk factors seen in the current study, the researchers said.
The study findings were limited by several factors, including the use of billing codes that could lead to misclassification of diagnoses, as well as possible differences in the definition and coding for postpartum hemorrhage among hospitals, the researchers noted. Other limitations were the exclusion of cases of readmission for postpartum hemorrhage and lack of clinical details involving use of medications or nonoperative interventions, they said.
Notably, the study finding of stable to decreasing peripartum hysterectomy rates in hospitalized patients with postpartum hemorrhage conflicts with another recent study showing an increase in peripartum hysterectomy from 2009 to 2020, but this difference may reflect changes in billing, indications for hysterectomy, or study modeling, they said.
The current study was strengthened by the use of a large database to analyze population trends, a contemporary study period, and the inclusion of meaningful outcomes such as peripartum hysterectomy, the researchers wrote.
The shift in blood transfusion and peripartum hysterectomy may reflect the implementation of protocols to promote early intervention and identification of postpartum hemorrhage, they concluded.
Interventions can have an effect
“Hemorrhage remains a leading cause of maternal mortality in the United States and blood transfusion is the most common severe maternal morbidity,” Catherine M. Albright, MD, MS, associate professor of maternal-fetal medicine at the University of Washington, Seattle, said in an interview. “It is important to understand the current state, especially given that many hospitals have implemented policies and procedures to better identify and treat postpartum hemorrhage,” she said.
Dr. Albright said, “I was pleased to see that they did not just look at a diagnosis of postpartum hemorrhage but rather also looked at complications arising from postpartum hemorrhage, such as blood transfusion or hysterectomy.”
Postpartum hemorrhage is often a clinical diagnosis that uses estimated blood loss, a notoriously inaccurate measure, said Dr. Albright. “Additionally, the definitions of postpartum hemorrhage, as well as the ICD codes, changed during the time period of the study,” she noted. “These factors all could lead to both underreporting and overreporting of the true incidence of postpartum hemorrhage. Blood transfusion and hysterectomy are more objective outcomes and demonstrate true morbidity,” she said.
“Most of the risk factors that are listed in the article are not modifiable during that pregnancy,” said Dr. Albright. For example, a history of a prior cesarean or having a twin pregnancy is not something that can be changed, she said. “Many of the other risk factors or associated clinical factors, such as obesity, chronic hypertension, and pregestational diabetes, are modifiable, but before pregnancy. Universal and easy access to primary medical care prior to and between pregnancies may help to mitigate some of these factors,” she noted.
Looking ahead, “It would be helpful to ensure that these types of data are available at the state and hospital level; this will allow for local evaluation of programs that are in place to reduce postpartum hemorrhage risk and improve identification and treatment,” Dr. Albright said.
The study received no outside funding. Dr. Corbetta-Rastelli and Dr. Albright had no financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Everyone wins when losers get paid
Bribery really is the solution to all of life’s problems
Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.
The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.
Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.
The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.
The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
More green space, less medicine
Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.
If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.
We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.
In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.
Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.
“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”
The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
Said the toilet to the engineer: Do you hear what I hear?
A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.
Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.
She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.
The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.
They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.
Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.
That would be a heroic toilet indeed.
Bribery really is the solution to all of life’s problems
Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.
The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.
Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.
The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.
The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
More green space, less medicine
Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.
If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.
We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.
In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.
Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.
“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”
The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
Said the toilet to the engineer: Do you hear what I hear?
A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.
Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.
She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.
The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.
They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.
Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.
That would be a heroic toilet indeed.
Bribery really is the solution to all of life’s problems
Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.
The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.
Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.
The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.
The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
More green space, less medicine
Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.
If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.
We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.
In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.
Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.
“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”
The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
Said the toilet to the engineer: Do you hear what I hear?
A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.
Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.
She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.
The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.
They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.
Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.
That would be a heroic toilet indeed.