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Insulin rationing common, ‘surprising’ even among privately insured
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.
The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.
Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.
The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.
The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.
And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.
“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.
Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.
“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
Uninsured, privately insured, and younger people more likely to ration
Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.
The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.
The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.
In 2021, questions about insulin rationing were added to the NHIS for the first time.
The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.
Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).
Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.
“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.
By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.
People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
‘It’s a complicated system’
Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.
“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”
He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”
But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”
What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”
All of this puts clinicians in a difficult spot, he said.
“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”
Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
VA Center Dramatically Shrinks Wait Times for Bone Marrow Biopsies
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
FDA approved acalabrutinib tablet for MCL, CLL, SLL
These include adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.
Approval of the tablet formulation of the selective Bruton tyrosine kinase inhibitor was based on the ELEVATE-PLUS trials, which showed bioequivalence with the capsule. The tablet had the same efficacy and safety profile with the same dosing strength and schedule, AstraZeneca said in a press release.
The benefit of the tablet formulation is that patients with acid reflux and other problems can take it with proton pump inhibitors, antacids, and H2-receptor antagonists, the company noted.
A version of this article first appeared on Medscape.com.
These include adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.
Approval of the tablet formulation of the selective Bruton tyrosine kinase inhibitor was based on the ELEVATE-PLUS trials, which showed bioequivalence with the capsule. The tablet had the same efficacy and safety profile with the same dosing strength and schedule, AstraZeneca said in a press release.
The benefit of the tablet formulation is that patients with acid reflux and other problems can take it with proton pump inhibitors, antacids, and H2-receptor antagonists, the company noted.
A version of this article first appeared on Medscape.com.
These include adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.
Approval of the tablet formulation of the selective Bruton tyrosine kinase inhibitor was based on the ELEVATE-PLUS trials, which showed bioequivalence with the capsule. The tablet had the same efficacy and safety profile with the same dosing strength and schedule, AstraZeneca said in a press release.
The benefit of the tablet formulation is that patients with acid reflux and other problems can take it with proton pump inhibitors, antacids, and H2-receptor antagonists, the company noted.
A version of this article first appeared on Medscape.com.
In VA Oncology, Discussion Groups Are Transforming the Workplace
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.
Vaccinium myrtillus (bilberry seed oil) extract
A member of the Ericaceae family, bilberry (Vaccinium myrtillus) is native to northern Europe and North America, and its fruit is known to contain myriad polyphenols that display potent antioxidant and anti-inflammatory activity.1,2 Also known as European blueberry or whortleberry, this perennial deciduous shrub is also one of the richest sources of the polyphenolic pigments anthocyanins.3-5 Indeed, anthocyanins impart the blue/black color to bilberries and other berries and are thought to be the primary bioactive constituents of berries associated with numerous health benefits.3,6 They are also known to confer anti-allergic, anticancer, and wound healing activity.4 Overall, bilberry has also been reported to exert anti-inflammatory, lipid-lowering, and antimicrobial activity.3 In this column, the focus will be on the chemical constituents and properties of V. myrtillus that indicate potential or applicability for skin care.
Active ingredients of bilberry
Bilberry seed oil contains unsaturated fatty acids such as linoleic acid and alpha-linolenic acid, which exhibit anti-inflammatory activity and contribute to the suppression of tyrosinase. For instance, Ando et al. showed, in 1998, that linoleic and alpha-linolenic acids lighten UV-induced skin hyperpigmentation. Their in vitro experiments using cultured murine melanoma cells and in vivo study of the topical application of either acid to the UV-induced hyperpigmented dorsal skin of guinea pigs revealed pigment-lightening effects that they partly ascribed to inhibited melanin synthesis by active melanocytes and accelerated desquamation of epidermal melanin pigment.7
A 2009 comparative study of the anthocyanin composition as well as antimicrobial and antioxidant activities delivered by bilberry and blueberry fruits and their skins by Burdulis et al. revealed robust functions in both fruits. Cyanidin was found to be an active anthocyanidin in bilberry. Cultivars of both fruits demonstrated antimicrobial and antioxidant activity, with bilberry fruit skin demonstrating potent antiradical activity.8
The anthocyanins of V. myrtillus are reputed to impart protection against cardiovascular disorders, age-induced oxidative stress, inflammatory responses, and various degenerative conditions, as well ameliorate neuronal and cognitive brain functions and ocular health.6
In 2012, Bornsek et al. demonstrated that bilberry (and blueberry) anthocyanins function as potent intracellular antioxidants, which may account for their noted health benefits despite relatively low bioavailability.9
Six years later, a chemical composition study of wild bilberry found in Montenegro, Brasanac-Vukanovic et al. determined that chlorogenic acid was the most prevalent phenolic constituent, followed by protocatechuic acid, with resveratrol, isoquercetin, quercetin, and hyperoside also found to be abundant. In vitro assays indicated significant antioxidant activity exhibited by these compounds.10
Activity against allergic contact dermatitis
Yamaura et al. used a mouse model, in 2011, to determine that the anthocyanins from a bilberry extract attenuated various symptoms of chronic allergic contact dermatitis, particularly alleviating pruritus.8 A year later, Yamaura et al. used a BALB/c mouse model of allergic contact dermatitis to compare the antipruritic effect of anthocyanin-rich quality-controlled bilberry extract and anthocyanidin-rich degraded extract. The investigators found that anthocyanins, but not anthocyanidins, derived from bilberry exert an antipruritic effect, likely through their inhibitory action on mast cell degranulation. They concluded that anthocyanin-rich bilberry extract could act as an effective oral supplement to treat pruritic symptoms of skin disorders such as chronic allergic contact dermatitis and atopic dermatitis.11
Antioxidant and anti-inflammatory activity
Bilberries, consumed since ancient times, are reputed to function as potent antioxidants because of a wide array of phenolic constituents, and this fruit is gaining interest for use in pharmaceuticals.12
In 2008, Svobodová et al. assessed possible UVA preventive properties of V. myrtillus fruit extract in a human keratinocyte cell line (HaCaT), finding that pre- or posttreatment mitigated UVA-induced harm. They also observed a significant decrease in UVA-caused reactive oxygen species (ROS) formation and the prevention or attenuation of UVA-stimulated peroxidation of membrane lipids. Intracellular glutathione was also protected. The investigators attributed the array of cytoprotective effects conferred by V. myrtillus extract primarily to its constituent anthocyanins.2 A year later, they found that the phenolic fraction of V. myrtillus fruits inhibited UVB-induced damage to HaCaT keratinocytes in vitro.13
In 2014, Calò and Marabini used HaCaT keratinocytes to ascertain whether a water-soluble V. myrtillus extract could mitigate UVA- and UVB-induced damage. They found that the extract diminished UVB-induced cytotoxicity and genotoxicity at lower doses, decreasing lipid peroxidation but exerting no effect on reactive oxygen species generated by UVB. The extract attenuated genotoxicity induced by UVA as well as ROS and apoptosis. Overall, the investigators concluded that V. myrtillus extract demonstrated antioxidant activity, particularly against UVA exposure.14
Four years later, Bucci et al. developed nanoberries, an ultradeformable liposome carrying V. myrtillus ethanolic extract, and determined that the preparation could penetrate the stratum corneum safely and suggested potential for yielding protection against photodamage.15
Skin preparations
In 2021, Tadic et al. developed an oil-in-water (O/W) cream containing wild bilberry leaf extracts and seed oil. The leaves contained copious phenolic acids (particularly chlorogenic acid), flavonoids (especially isoquercetin), and resveratrol. The seed oil was rife with alpha-linolenic, linoleic, and oleic acids. The investigators conducted an in vivo study over 30 days in 25 healthy volunteers (20 women, 5 men; mean age 23.36 ± 0.64 years). They found that the O/W cream successfully increased stratum corneum hydration, enhanced skin barrier function, and maintained skin pH after topical application. The cream was also well tolerated. In vitro assays also indicated that the bilberry isolates displayed notable antioxidant capacity (stronger in the case of the leaves). Tadic et al. suggested that skin disorders characterized by oxidative stress and/or xerosis may be appropriate targets for topically applied bilberry cream.1
Early in 2022, Ruscinc et al. reported on their efforts to incorporate V. myrtillus extract into a multifunctional sunscreen. In vitro and in vivo tests revealed that while sun protection factor was lowered in the presence of the extract, the samples were safe and photostable. The researchers concluded that further study is necessary to elucidate the effect of V. myrtillus extract on photoprotection.16
V. myrtillus has been consumed by human beings for many generations. Skin care formulations based on this ingredient have not been associated with adverse events. Notably, the Environmental Working Group has rated V. myrtillus (bilberry seed) oil as very safe.17
Summary
While research, particularly in the form of randomized controlled trials, is called for, because the fatty acids it contains have been shown to suppress tyrosinase. Currently, this botanical agent seems to be most suited for sensitive, aging skin and for skin with an uneven tone, particularly postinflammatory pigmentation and melasma.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, an SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at dermnews@mdedge.com.
References
1. Tadic VM et al. Antioxidants (Basel). 2021 Mar 16;10(3):465.
2. Svobodová A et al. Biofactors. 2008;33(4):249-66.
3. Chu WK et al. Bilberry (Vaccinium myrtillus L.), in Benzie IFF, Wachtel-Galor S, eds., “Herbal Medicine: Biomolecular and Clinical Aspects,” 2nd ed. (Boca Raton, Fla.: CRC Press/Taylor & Francis, 2011, Chapter 4).
4. Yamaura K et al. Pharmacognosy Res. 2011 Jul;3(3):173-7.
5. Stefanescu BE et al. Molecules. 2019 May 29;24(11):2046.
6. Smeriglio A et al. Mini Rev Med Chem. 2014;14(7):567-84.
7. Ando H et al. Arch Dermatol Res. 1998 Jul;290(7):375-81.
8. Burdulis D et al. Acta Pol Pharm. 2009 Jul-Aug;66(4):399-408.
9. Bornsek SM et al. Food Chem. 2012 Oct 15;134(4):1878-84.
10. Brasanac-Vukanovic S et al. Molecules. 2018 Jul 26;23(8):1864.
11. Yamaura K et al. J Food Sci. 2012 Dec;77(12):H262-7.
12. Pires TCSP et al. Curr Pharm Des. 2020;26(16):1917-28.
13. Svobodová A et al. J Dermatol Sci. 2009 Dec;56(3):196-204.
14. Calò R, Marabini L. J Photochem Photobiol B. 2014 Mar 5;132:27-35.
15. Bucci P et al. J Cosmet Dermatol. 2018 Oct;17(5):889-99.
16. Ruscinc N et al. J Cosmet Dermatol. 2022 Jan 13.
17. Environmental Working Group’s Skin Deep website. Vaccinium Myrtillus Bilberry Seed Oil. Accessed October 18, 2022.
A member of the Ericaceae family, bilberry (Vaccinium myrtillus) is native to northern Europe and North America, and its fruit is known to contain myriad polyphenols that display potent antioxidant and anti-inflammatory activity.1,2 Also known as European blueberry or whortleberry, this perennial deciduous shrub is also one of the richest sources of the polyphenolic pigments anthocyanins.3-5 Indeed, anthocyanins impart the blue/black color to bilberries and other berries and are thought to be the primary bioactive constituents of berries associated with numerous health benefits.3,6 They are also known to confer anti-allergic, anticancer, and wound healing activity.4 Overall, bilberry has also been reported to exert anti-inflammatory, lipid-lowering, and antimicrobial activity.3 In this column, the focus will be on the chemical constituents and properties of V. myrtillus that indicate potential or applicability for skin care.
Active ingredients of bilberry
Bilberry seed oil contains unsaturated fatty acids such as linoleic acid and alpha-linolenic acid, which exhibit anti-inflammatory activity and contribute to the suppression of tyrosinase. For instance, Ando et al. showed, in 1998, that linoleic and alpha-linolenic acids lighten UV-induced skin hyperpigmentation. Their in vitro experiments using cultured murine melanoma cells and in vivo study of the topical application of either acid to the UV-induced hyperpigmented dorsal skin of guinea pigs revealed pigment-lightening effects that they partly ascribed to inhibited melanin synthesis by active melanocytes and accelerated desquamation of epidermal melanin pigment.7
A 2009 comparative study of the anthocyanin composition as well as antimicrobial and antioxidant activities delivered by bilberry and blueberry fruits and their skins by Burdulis et al. revealed robust functions in both fruits. Cyanidin was found to be an active anthocyanidin in bilberry. Cultivars of both fruits demonstrated antimicrobial and antioxidant activity, with bilberry fruit skin demonstrating potent antiradical activity.8
The anthocyanins of V. myrtillus are reputed to impart protection against cardiovascular disorders, age-induced oxidative stress, inflammatory responses, and various degenerative conditions, as well ameliorate neuronal and cognitive brain functions and ocular health.6
In 2012, Bornsek et al. demonstrated that bilberry (and blueberry) anthocyanins function as potent intracellular antioxidants, which may account for their noted health benefits despite relatively low bioavailability.9
Six years later, a chemical composition study of wild bilberry found in Montenegro, Brasanac-Vukanovic et al. determined that chlorogenic acid was the most prevalent phenolic constituent, followed by protocatechuic acid, with resveratrol, isoquercetin, quercetin, and hyperoside also found to be abundant. In vitro assays indicated significant antioxidant activity exhibited by these compounds.10
Activity against allergic contact dermatitis
Yamaura et al. used a mouse model, in 2011, to determine that the anthocyanins from a bilberry extract attenuated various symptoms of chronic allergic contact dermatitis, particularly alleviating pruritus.8 A year later, Yamaura et al. used a BALB/c mouse model of allergic contact dermatitis to compare the antipruritic effect of anthocyanin-rich quality-controlled bilberry extract and anthocyanidin-rich degraded extract. The investigators found that anthocyanins, but not anthocyanidins, derived from bilberry exert an antipruritic effect, likely through their inhibitory action on mast cell degranulation. They concluded that anthocyanin-rich bilberry extract could act as an effective oral supplement to treat pruritic symptoms of skin disorders such as chronic allergic contact dermatitis and atopic dermatitis.11
Antioxidant and anti-inflammatory activity
Bilberries, consumed since ancient times, are reputed to function as potent antioxidants because of a wide array of phenolic constituents, and this fruit is gaining interest for use in pharmaceuticals.12
In 2008, Svobodová et al. assessed possible UVA preventive properties of V. myrtillus fruit extract in a human keratinocyte cell line (HaCaT), finding that pre- or posttreatment mitigated UVA-induced harm. They also observed a significant decrease in UVA-caused reactive oxygen species (ROS) formation and the prevention or attenuation of UVA-stimulated peroxidation of membrane lipids. Intracellular glutathione was also protected. The investigators attributed the array of cytoprotective effects conferred by V. myrtillus extract primarily to its constituent anthocyanins.2 A year later, they found that the phenolic fraction of V. myrtillus fruits inhibited UVB-induced damage to HaCaT keratinocytes in vitro.13
In 2014, Calò and Marabini used HaCaT keratinocytes to ascertain whether a water-soluble V. myrtillus extract could mitigate UVA- and UVB-induced damage. They found that the extract diminished UVB-induced cytotoxicity and genotoxicity at lower doses, decreasing lipid peroxidation but exerting no effect on reactive oxygen species generated by UVB. The extract attenuated genotoxicity induced by UVA as well as ROS and apoptosis. Overall, the investigators concluded that V. myrtillus extract demonstrated antioxidant activity, particularly against UVA exposure.14
Four years later, Bucci et al. developed nanoberries, an ultradeformable liposome carrying V. myrtillus ethanolic extract, and determined that the preparation could penetrate the stratum corneum safely and suggested potential for yielding protection against photodamage.15
Skin preparations
In 2021, Tadic et al. developed an oil-in-water (O/W) cream containing wild bilberry leaf extracts and seed oil. The leaves contained copious phenolic acids (particularly chlorogenic acid), flavonoids (especially isoquercetin), and resveratrol. The seed oil was rife with alpha-linolenic, linoleic, and oleic acids. The investigators conducted an in vivo study over 30 days in 25 healthy volunteers (20 women, 5 men; mean age 23.36 ± 0.64 years). They found that the O/W cream successfully increased stratum corneum hydration, enhanced skin barrier function, and maintained skin pH after topical application. The cream was also well tolerated. In vitro assays also indicated that the bilberry isolates displayed notable antioxidant capacity (stronger in the case of the leaves). Tadic et al. suggested that skin disorders characterized by oxidative stress and/or xerosis may be appropriate targets for topically applied bilberry cream.1
Early in 2022, Ruscinc et al. reported on their efforts to incorporate V. myrtillus extract into a multifunctional sunscreen. In vitro and in vivo tests revealed that while sun protection factor was lowered in the presence of the extract, the samples were safe and photostable. The researchers concluded that further study is necessary to elucidate the effect of V. myrtillus extract on photoprotection.16
V. myrtillus has been consumed by human beings for many generations. Skin care formulations based on this ingredient have not been associated with adverse events. Notably, the Environmental Working Group has rated V. myrtillus (bilberry seed) oil as very safe.17
Summary
While research, particularly in the form of randomized controlled trials, is called for, because the fatty acids it contains have been shown to suppress tyrosinase. Currently, this botanical agent seems to be most suited for sensitive, aging skin and for skin with an uneven tone, particularly postinflammatory pigmentation and melasma.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, an SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at dermnews@mdedge.com.
References
1. Tadic VM et al. Antioxidants (Basel). 2021 Mar 16;10(3):465.
2. Svobodová A et al. Biofactors. 2008;33(4):249-66.
3. Chu WK et al. Bilberry (Vaccinium myrtillus L.), in Benzie IFF, Wachtel-Galor S, eds., “Herbal Medicine: Biomolecular and Clinical Aspects,” 2nd ed. (Boca Raton, Fla.: CRC Press/Taylor & Francis, 2011, Chapter 4).
4. Yamaura K et al. Pharmacognosy Res. 2011 Jul;3(3):173-7.
5. Stefanescu BE et al. Molecules. 2019 May 29;24(11):2046.
6. Smeriglio A et al. Mini Rev Med Chem. 2014;14(7):567-84.
7. Ando H et al. Arch Dermatol Res. 1998 Jul;290(7):375-81.
8. Burdulis D et al. Acta Pol Pharm. 2009 Jul-Aug;66(4):399-408.
9. Bornsek SM et al. Food Chem. 2012 Oct 15;134(4):1878-84.
10. Brasanac-Vukanovic S et al. Molecules. 2018 Jul 26;23(8):1864.
11. Yamaura K et al. J Food Sci. 2012 Dec;77(12):H262-7.
12. Pires TCSP et al. Curr Pharm Des. 2020;26(16):1917-28.
13. Svobodová A et al. J Dermatol Sci. 2009 Dec;56(3):196-204.
14. Calò R, Marabini L. J Photochem Photobiol B. 2014 Mar 5;132:27-35.
15. Bucci P et al. J Cosmet Dermatol. 2018 Oct;17(5):889-99.
16. Ruscinc N et al. J Cosmet Dermatol. 2022 Jan 13.
17. Environmental Working Group’s Skin Deep website. Vaccinium Myrtillus Bilberry Seed Oil. Accessed October 18, 2022.
A member of the Ericaceae family, bilberry (Vaccinium myrtillus) is native to northern Europe and North America, and its fruit is known to contain myriad polyphenols that display potent antioxidant and anti-inflammatory activity.1,2 Also known as European blueberry or whortleberry, this perennial deciduous shrub is also one of the richest sources of the polyphenolic pigments anthocyanins.3-5 Indeed, anthocyanins impart the blue/black color to bilberries and other berries and are thought to be the primary bioactive constituents of berries associated with numerous health benefits.3,6 They are also known to confer anti-allergic, anticancer, and wound healing activity.4 Overall, bilberry has also been reported to exert anti-inflammatory, lipid-lowering, and antimicrobial activity.3 In this column, the focus will be on the chemical constituents and properties of V. myrtillus that indicate potential or applicability for skin care.
Active ingredients of bilberry
Bilberry seed oil contains unsaturated fatty acids such as linoleic acid and alpha-linolenic acid, which exhibit anti-inflammatory activity and contribute to the suppression of tyrosinase. For instance, Ando et al. showed, in 1998, that linoleic and alpha-linolenic acids lighten UV-induced skin hyperpigmentation. Their in vitro experiments using cultured murine melanoma cells and in vivo study of the topical application of either acid to the UV-induced hyperpigmented dorsal skin of guinea pigs revealed pigment-lightening effects that they partly ascribed to inhibited melanin synthesis by active melanocytes and accelerated desquamation of epidermal melanin pigment.7
A 2009 comparative study of the anthocyanin composition as well as antimicrobial and antioxidant activities delivered by bilberry and blueberry fruits and their skins by Burdulis et al. revealed robust functions in both fruits. Cyanidin was found to be an active anthocyanidin in bilberry. Cultivars of both fruits demonstrated antimicrobial and antioxidant activity, with bilberry fruit skin demonstrating potent antiradical activity.8
The anthocyanins of V. myrtillus are reputed to impart protection against cardiovascular disorders, age-induced oxidative stress, inflammatory responses, and various degenerative conditions, as well ameliorate neuronal and cognitive brain functions and ocular health.6
In 2012, Bornsek et al. demonstrated that bilberry (and blueberry) anthocyanins function as potent intracellular antioxidants, which may account for their noted health benefits despite relatively low bioavailability.9
Six years later, a chemical composition study of wild bilberry found in Montenegro, Brasanac-Vukanovic et al. determined that chlorogenic acid was the most prevalent phenolic constituent, followed by protocatechuic acid, with resveratrol, isoquercetin, quercetin, and hyperoside also found to be abundant. In vitro assays indicated significant antioxidant activity exhibited by these compounds.10
Activity against allergic contact dermatitis
Yamaura et al. used a mouse model, in 2011, to determine that the anthocyanins from a bilberry extract attenuated various symptoms of chronic allergic contact dermatitis, particularly alleviating pruritus.8 A year later, Yamaura et al. used a BALB/c mouse model of allergic contact dermatitis to compare the antipruritic effect of anthocyanin-rich quality-controlled bilberry extract and anthocyanidin-rich degraded extract. The investigators found that anthocyanins, but not anthocyanidins, derived from bilberry exert an antipruritic effect, likely through their inhibitory action on mast cell degranulation. They concluded that anthocyanin-rich bilberry extract could act as an effective oral supplement to treat pruritic symptoms of skin disorders such as chronic allergic contact dermatitis and atopic dermatitis.11
Antioxidant and anti-inflammatory activity
Bilberries, consumed since ancient times, are reputed to function as potent antioxidants because of a wide array of phenolic constituents, and this fruit is gaining interest for use in pharmaceuticals.12
In 2008, Svobodová et al. assessed possible UVA preventive properties of V. myrtillus fruit extract in a human keratinocyte cell line (HaCaT), finding that pre- or posttreatment mitigated UVA-induced harm. They also observed a significant decrease in UVA-caused reactive oxygen species (ROS) formation and the prevention or attenuation of UVA-stimulated peroxidation of membrane lipids. Intracellular glutathione was also protected. The investigators attributed the array of cytoprotective effects conferred by V. myrtillus extract primarily to its constituent anthocyanins.2 A year later, they found that the phenolic fraction of V. myrtillus fruits inhibited UVB-induced damage to HaCaT keratinocytes in vitro.13
In 2014, Calò and Marabini used HaCaT keratinocytes to ascertain whether a water-soluble V. myrtillus extract could mitigate UVA- and UVB-induced damage. They found that the extract diminished UVB-induced cytotoxicity and genotoxicity at lower doses, decreasing lipid peroxidation but exerting no effect on reactive oxygen species generated by UVB. The extract attenuated genotoxicity induced by UVA as well as ROS and apoptosis. Overall, the investigators concluded that V. myrtillus extract demonstrated antioxidant activity, particularly against UVA exposure.14
Four years later, Bucci et al. developed nanoberries, an ultradeformable liposome carrying V. myrtillus ethanolic extract, and determined that the preparation could penetrate the stratum corneum safely and suggested potential for yielding protection against photodamage.15
Skin preparations
In 2021, Tadic et al. developed an oil-in-water (O/W) cream containing wild bilberry leaf extracts and seed oil. The leaves contained copious phenolic acids (particularly chlorogenic acid), flavonoids (especially isoquercetin), and resveratrol. The seed oil was rife with alpha-linolenic, linoleic, and oleic acids. The investigators conducted an in vivo study over 30 days in 25 healthy volunteers (20 women, 5 men; mean age 23.36 ± 0.64 years). They found that the O/W cream successfully increased stratum corneum hydration, enhanced skin barrier function, and maintained skin pH after topical application. The cream was also well tolerated. In vitro assays also indicated that the bilberry isolates displayed notable antioxidant capacity (stronger in the case of the leaves). Tadic et al. suggested that skin disorders characterized by oxidative stress and/or xerosis may be appropriate targets for topically applied bilberry cream.1
Early in 2022, Ruscinc et al. reported on their efforts to incorporate V. myrtillus extract into a multifunctional sunscreen. In vitro and in vivo tests revealed that while sun protection factor was lowered in the presence of the extract, the samples were safe and photostable. The researchers concluded that further study is necessary to elucidate the effect of V. myrtillus extract on photoprotection.16
V. myrtillus has been consumed by human beings for many generations. Skin care formulations based on this ingredient have not been associated with adverse events. Notably, the Environmental Working Group has rated V. myrtillus (bilberry seed) oil as very safe.17
Summary
While research, particularly in the form of randomized controlled trials, is called for, because the fatty acids it contains have been shown to suppress tyrosinase. Currently, this botanical agent seems to be most suited for sensitive, aging skin and for skin with an uneven tone, particularly postinflammatory pigmentation and melasma.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, an SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at dermnews@mdedge.com.
References
1. Tadic VM et al. Antioxidants (Basel). 2021 Mar 16;10(3):465.
2. Svobodová A et al. Biofactors. 2008;33(4):249-66.
3. Chu WK et al. Bilberry (Vaccinium myrtillus L.), in Benzie IFF, Wachtel-Galor S, eds., “Herbal Medicine: Biomolecular and Clinical Aspects,” 2nd ed. (Boca Raton, Fla.: CRC Press/Taylor & Francis, 2011, Chapter 4).
4. Yamaura K et al. Pharmacognosy Res. 2011 Jul;3(3):173-7.
5. Stefanescu BE et al. Molecules. 2019 May 29;24(11):2046.
6. Smeriglio A et al. Mini Rev Med Chem. 2014;14(7):567-84.
7. Ando H et al. Arch Dermatol Res. 1998 Jul;290(7):375-81.
8. Burdulis D et al. Acta Pol Pharm. 2009 Jul-Aug;66(4):399-408.
9. Bornsek SM et al. Food Chem. 2012 Oct 15;134(4):1878-84.
10. Brasanac-Vukanovic S et al. Molecules. 2018 Jul 26;23(8):1864.
11. Yamaura K et al. J Food Sci. 2012 Dec;77(12):H262-7.
12. Pires TCSP et al. Curr Pharm Des. 2020;26(16):1917-28.
13. Svobodová A et al. J Dermatol Sci. 2009 Dec;56(3):196-204.
14. Calò R, Marabini L. J Photochem Photobiol B. 2014 Mar 5;132:27-35.
15. Bucci P et al. J Cosmet Dermatol. 2018 Oct;17(5):889-99.
16. Ruscinc N et al. J Cosmet Dermatol. 2022 Jan 13.
17. Environmental Working Group’s Skin Deep website. Vaccinium Myrtillus Bilberry Seed Oil. Accessed October 18, 2022.
Pulse oximetry unreliable for carbon monoxide diagnoses
researchers said at the annual European Emergency Medicine Congress.
A review of the literature found that the approach, while simple and easy to do, does not identify carbon monoxide poisoning almost a quarter of the time.
“This method is not accurate enough and should not be used in clinical practice,” said Mathilde Papin, MD, a researcher in the emergency department at Nantes (France) University.
Carbon monoxide poisoning is one of the world’s most common causes of poisoning deaths. When people are exposed to the colorless, odorless carbon monoxide, it enters their bloodstream and attaches to hemoglobin, a transporter of oxygen, thereby starving the body of oxygen. It can be treated with oxygen, but the problem is that its symptoms can be similar to infections, such as the flu, and can be difficult to diagnose.
A blood test is available, measuring the amount of hemoglobin that’s attached to carbon dioxide. But, the researchers said, a test is needed that can be done quickly right in the ambulance or emergency room.
“A blood test is reliable, but not practical,” Dr. Papin said.
One quick and simple method is pulse oximetry, in which a device is placed on the finger. A lower level of oxygen saturation could be a sign of oxygen displacement from carbon monoxide poisoning. However, the approach has delivered mixed results.
Researchers led a systematic review and meta-analysis and searched for all trials that compared pulse oximetry with blood tests. They found 19 and were able to combine the results of 11 of them, which amounted to data on more than 2,000 people, some with carbon monoxide poisoning and some healthy.
Pulse oximetry had a sensitivity of 77% and a specificity of 83%, with an overall accuracy of 86%. Dr. Papin said this is not good enough, pointing to the relatively low sensitivity.
“At 23%, the false negative rate with pulse oximetry is too high for reliably triaging patients with suspected carbon monoxide poisoning,” she said.
Dr. Papin noted that the findings were not all that surprising, given the experience at her own center.
“The idea of this meta-analysis came from the clinical impression that this device was not as accurate as it should be in everyday use in our ED,” she said. Pulse oximetry is also routinely used in prehospital care, she said, adding to the importance of finding an alternative approach. Dr. Papin and her team are now planning to evaluate a method of faster screening of carbon monoxide levels in the capillaries.
James Chenoweth, MD, of the department of emergency medicine at the University of California, Davis, who has researched carbon monoxide treatment, said the findings show how the clinical value of pulse oximetry is limited in this context.
“In the right clinical setting” – such as smoking inhalation – “a low oxygen saturation on pulse oximetry may suggest the need for definitive testing for CO poisoning, but it can’t be used to definitively rule in or out the presence of carboxyhemoglobin,” he said. “I wouldn’t say that it should not be used, but clinicians should be aware of the potential pitfall of being falsely reassured if the pulse oximetry is normal.”
This study did not receive any specific funding. Dr. Papin and Dr. Chenoweth have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers said at the annual European Emergency Medicine Congress.
A review of the literature found that the approach, while simple and easy to do, does not identify carbon monoxide poisoning almost a quarter of the time.
“This method is not accurate enough and should not be used in clinical practice,” said Mathilde Papin, MD, a researcher in the emergency department at Nantes (France) University.
Carbon monoxide poisoning is one of the world’s most common causes of poisoning deaths. When people are exposed to the colorless, odorless carbon monoxide, it enters their bloodstream and attaches to hemoglobin, a transporter of oxygen, thereby starving the body of oxygen. It can be treated with oxygen, but the problem is that its symptoms can be similar to infections, such as the flu, and can be difficult to diagnose.
A blood test is available, measuring the amount of hemoglobin that’s attached to carbon dioxide. But, the researchers said, a test is needed that can be done quickly right in the ambulance or emergency room.
“A blood test is reliable, but not practical,” Dr. Papin said.
One quick and simple method is pulse oximetry, in which a device is placed on the finger. A lower level of oxygen saturation could be a sign of oxygen displacement from carbon monoxide poisoning. However, the approach has delivered mixed results.
Researchers led a systematic review and meta-analysis and searched for all trials that compared pulse oximetry with blood tests. They found 19 and were able to combine the results of 11 of them, which amounted to data on more than 2,000 people, some with carbon monoxide poisoning and some healthy.
Pulse oximetry had a sensitivity of 77% and a specificity of 83%, with an overall accuracy of 86%. Dr. Papin said this is not good enough, pointing to the relatively low sensitivity.
“At 23%, the false negative rate with pulse oximetry is too high for reliably triaging patients with suspected carbon monoxide poisoning,” she said.
Dr. Papin noted that the findings were not all that surprising, given the experience at her own center.
“The idea of this meta-analysis came from the clinical impression that this device was not as accurate as it should be in everyday use in our ED,” she said. Pulse oximetry is also routinely used in prehospital care, she said, adding to the importance of finding an alternative approach. Dr. Papin and her team are now planning to evaluate a method of faster screening of carbon monoxide levels in the capillaries.
James Chenoweth, MD, of the department of emergency medicine at the University of California, Davis, who has researched carbon monoxide treatment, said the findings show how the clinical value of pulse oximetry is limited in this context.
“In the right clinical setting” – such as smoking inhalation – “a low oxygen saturation on pulse oximetry may suggest the need for definitive testing for CO poisoning, but it can’t be used to definitively rule in or out the presence of carboxyhemoglobin,” he said. “I wouldn’t say that it should not be used, but clinicians should be aware of the potential pitfall of being falsely reassured if the pulse oximetry is normal.”
This study did not receive any specific funding. Dr. Papin and Dr. Chenoweth have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers said at the annual European Emergency Medicine Congress.
A review of the literature found that the approach, while simple and easy to do, does not identify carbon monoxide poisoning almost a quarter of the time.
“This method is not accurate enough and should not be used in clinical practice,” said Mathilde Papin, MD, a researcher in the emergency department at Nantes (France) University.
Carbon monoxide poisoning is one of the world’s most common causes of poisoning deaths. When people are exposed to the colorless, odorless carbon monoxide, it enters their bloodstream and attaches to hemoglobin, a transporter of oxygen, thereby starving the body of oxygen. It can be treated with oxygen, but the problem is that its symptoms can be similar to infections, such as the flu, and can be difficult to diagnose.
A blood test is available, measuring the amount of hemoglobin that’s attached to carbon dioxide. But, the researchers said, a test is needed that can be done quickly right in the ambulance or emergency room.
“A blood test is reliable, but not practical,” Dr. Papin said.
One quick and simple method is pulse oximetry, in which a device is placed on the finger. A lower level of oxygen saturation could be a sign of oxygen displacement from carbon monoxide poisoning. However, the approach has delivered mixed results.
Researchers led a systematic review and meta-analysis and searched for all trials that compared pulse oximetry with blood tests. They found 19 and were able to combine the results of 11 of them, which amounted to data on more than 2,000 people, some with carbon monoxide poisoning and some healthy.
Pulse oximetry had a sensitivity of 77% and a specificity of 83%, with an overall accuracy of 86%. Dr. Papin said this is not good enough, pointing to the relatively low sensitivity.
“At 23%, the false negative rate with pulse oximetry is too high for reliably triaging patients with suspected carbon monoxide poisoning,” she said.
Dr. Papin noted that the findings were not all that surprising, given the experience at her own center.
“The idea of this meta-analysis came from the clinical impression that this device was not as accurate as it should be in everyday use in our ED,” she said. Pulse oximetry is also routinely used in prehospital care, she said, adding to the importance of finding an alternative approach. Dr. Papin and her team are now planning to evaluate a method of faster screening of carbon monoxide levels in the capillaries.
James Chenoweth, MD, of the department of emergency medicine at the University of California, Davis, who has researched carbon monoxide treatment, said the findings show how the clinical value of pulse oximetry is limited in this context.
“In the right clinical setting” – such as smoking inhalation – “a low oxygen saturation on pulse oximetry may suggest the need for definitive testing for CO poisoning, but it can’t be used to definitively rule in or out the presence of carboxyhemoglobin,” he said. “I wouldn’t say that it should not be used, but clinicians should be aware of the potential pitfall of being falsely reassured if the pulse oximetry is normal.”
This study did not receive any specific funding. Dr. Papin and Dr. Chenoweth have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EUSEM 2022
Diabetes becoming less potent risk factor for CVD events
Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.
The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.
“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”
However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”
The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.
Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.
Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.
People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.
The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.
Shift in practice
The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”
“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.
Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”
Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.
And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.
However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”
Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.
Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.
Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.
The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.
“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”
However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”
The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.
Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.
Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.
People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.
The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.
Shift in practice
The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”
“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.
Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”
Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.
And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.
However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”
Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.
Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.
Diabetes persists as a risk factor for cardiovascular events, but where it once meant the same risk of heart attack or stroke as cardiovascular disease itself, a large Canadian population study reports that’s no longer the case. Thanks to advances in diabetes management over the past quarter century, diabetes is no longer considered equivalent to CVD as a risk factor for cardiovascular events, researchers from the University of Toronto reported.
The retrospective, population-based study used administrative data from Ontario’s provincial universal health care system. The researchers created five population-based cohorts of adults at 5-year intervals from 1994 to 2014, consisting of 1.87 million adults in the first cohort and 1.5 million in the last. In that 20-year span, the prevalence of diabetes in this population tripled, from 3.1% to 9%.
“In the last 25 years we’ve seen wholesale changes in the way people approach diabetes,” lead study author Calvin Ke, MD, PhD, an endocrinologist and assistant professor at the University of Toronto, said in an interview. “Part of the findings show that diabetes and cardiovascular disease were equivalent for risk of cardiovascular events in 1994, but by 2014 that was not the case.”
However, Dr. Ke added, “Diabetes is still a very strong cardiovascular risk factor.”
The investigators for the study, reported as a research letter in JAMA, analyzed the risk of cardiovascular events in four subgroups: those who had both diabetes and CVD, CVD only, diabetes only, and no CVD or diabetes.
Between 1994 and 2014, the cardiovascular event rates declined significantly among people with diabetes alone, compared with people with no disease: from 28.4 to 12.7 per 1,000 person-years, or an absolute risk increase (ARI) of 4.4% and a relative risk (RR) more than double (2.06), in 1994 to 14 vs. 8 per 1,000 person-years, and an ARI of 2% and RR less than double (1.58) 20 years later.
Among people with CVD only, those values shifted from 36.1 per 1,000 person-years, ARI of 5.1% and RR of 2.16 in 1994 to 23.9, ARI of 3.7% and RR still more than double (2.06) in 2014.
People with both CVD and diabetes had the highest CVD event rates across all 5-year cohorts: 74 per 1,000 person-years, ARI of 12% and RR almost four times greater (3.81) in 1994 than people with no disease. By 2014, the ARI in this group was 7.6% and the RR 3.10.
The investigators calculated that event rates from 1994 to 2014 declined across all four subgroups, with rate ratios of 0.49 for diabetes only, 0.66 for CVD only, 0.60 for both diabetes and CVD, and 0.63 for neither disease.
Shift in practice
The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”
“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Dr. Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Dr. Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Dr. Ke said.
Dr. Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”
Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.
And the findings, Dr. Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.
However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”
Managing diabetes continues to be “particularly important,” Dr. Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.
Dr. Ke and Dr. Deedwania have no relevant financial relationships to disclose.
FROM JAMA
Large trial of home-based COPD rehab shows positive results
NASHVILLE – The first multicenter randomized controlled trial of a home-based rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) showed highly positive results, according to findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
At the end of 12 weeks, those randomly assigned to the intervention had a significant and clinically meaningful improvement in all domains of the Chronic Respiratory Questionnaire (CRQ), including activity levels and emotional well-being, reported Roberto P. Benzo, MD, a consultant in the division of pulmonary and critical care medicine, Mayo Clinic, Rochester, Minn.
Presenting soon-to-be-published data, Dr. Benzo said that the intervention is based on a tablet-based app. The tablet is programmed to upload data captured from an activity monitor and pulse oximeter. Along with documentation of app usage, this information can then be downloaded for the remote coach to review with the patient.
The primary outcome of the randomized study were the physical and emotional domains of the CRQ quality of life, but a long list of secondary outcomes – including physical activity, symptoms of depression, sleep quality, and health care utilization, such as emergency room visits – was also analyzed.
In addition to the significant benefit on the primary outcomes, the home-based rehabilitation program relative to a wait list for intervention was associated with benefit or a trend for benefit on essentially every outcome measured. Health care utilization was a possible exception, but even then, the absolute number of visits was lower in the treatment arm.
“With a study period of only 12 weeks, we were limited to our ability to show a difference in emergency room visits,” said Dr. Benzo, who also noted that the study was conducted during the COVID-19 pandemic, when hospital visits were already occurring at a lower than usual rate. Based on the other findings, he suspects that a reduction in health care utilization could also be shown in more typical circumstances, particularly with a longer follow-up.
In the study, 375 patients with COPD were randomly assigned to a home health care regimen delivered by an app with remote coaching or to a wait list and usual care. The median age was 69 years. Fifty-nine percent were women. The median FEV1 at enrollment was 45% of predicted.
The patients were able to access their own data to monitor their progress at any time, not just at the time of coaching, but contact with the remote coach occurred on a weekly basis. Patients rated their level of energy, how they felt generally, and their progress toward daily goals, which was also captured on the app and could be discussed with the coach during the review of the previous week’s activity.
At 12 weeks, the favorable 0.54-point change (P < .001) and 0.51 change (P < .001) in the physical and emotional summary scores, respectively, met the criteria for a clinically meaningful change, Dr. Benzo reported. There were also significantly favorable changes from baseline and relative to controls in CRQ domains of self-management, sleep quality, and depression (all P ≤ .01).
Other data collected are supportive. For example, Dr. Benzo reported that those in the rehabilitation group took 624 more steps on average per day than those in the control group. The experimental group also spent nearly an hour more performing moderate or greater levels of activity.
“The app promotes behavioral change,” said Dr. Benzo, who said that this “completely home-based model” of rehabilitation is likely to be cost-effective given the relatively low costs of remote coaching and reasonable costs of the activity monitor, tablet, and other equipment.
Importantly, home-based rehabilitation is a billable practice under currently available CPT codes, according to Dr. Benzo, who believes this approach is not only effective but “feasible and practical.”
Two clinicians active in the care of patients with COPD believe this approach could fulfill an unmet need if further validated. Andrew Berman, MD, professor of medicine, New Jersey Medical School, Newark, thinks the premise is sound.
“Digital competency is still a big issue as is access to adequate quality Internet, but this could be a very useful approach for many individuals, and it avoids visits to a center, which could be a big advantage for patients,” Dr. Berman said.
Abebaw M. Johannes, PhD, a professor of physical therapy at Azusa Pacific University, Azusa, Calif., agreed. He said that home-based remote coaching could be a way of overcoming the current hurdles of participating in institutional-based programs
“This is clearly an unmet need in COPD,” he said.
The development of more effective and patient-friendly programs is what was driving this research, according to Dr. Benzo. He cited data suggesting that only about 30% of patients with COPD are participating in rehabilitation programs once discharged from the hospital despite the evidence that they can improve quality of life. For many of these patients, a home-based program might be the answer.
Dr. Benzo, Dr. Berman, and Dr. Johannes reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NASHVILLE – The first multicenter randomized controlled trial of a home-based rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) showed highly positive results, according to findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
At the end of 12 weeks, those randomly assigned to the intervention had a significant and clinically meaningful improvement in all domains of the Chronic Respiratory Questionnaire (CRQ), including activity levels and emotional well-being, reported Roberto P. Benzo, MD, a consultant in the division of pulmonary and critical care medicine, Mayo Clinic, Rochester, Minn.
Presenting soon-to-be-published data, Dr. Benzo said that the intervention is based on a tablet-based app. The tablet is programmed to upload data captured from an activity monitor and pulse oximeter. Along with documentation of app usage, this information can then be downloaded for the remote coach to review with the patient.
The primary outcome of the randomized study were the physical and emotional domains of the CRQ quality of life, but a long list of secondary outcomes – including physical activity, symptoms of depression, sleep quality, and health care utilization, such as emergency room visits – was also analyzed.
In addition to the significant benefit on the primary outcomes, the home-based rehabilitation program relative to a wait list for intervention was associated with benefit or a trend for benefit on essentially every outcome measured. Health care utilization was a possible exception, but even then, the absolute number of visits was lower in the treatment arm.
“With a study period of only 12 weeks, we were limited to our ability to show a difference in emergency room visits,” said Dr. Benzo, who also noted that the study was conducted during the COVID-19 pandemic, when hospital visits were already occurring at a lower than usual rate. Based on the other findings, he suspects that a reduction in health care utilization could also be shown in more typical circumstances, particularly with a longer follow-up.
In the study, 375 patients with COPD were randomly assigned to a home health care regimen delivered by an app with remote coaching or to a wait list and usual care. The median age was 69 years. Fifty-nine percent were women. The median FEV1 at enrollment was 45% of predicted.
The patients were able to access their own data to monitor their progress at any time, not just at the time of coaching, but contact with the remote coach occurred on a weekly basis. Patients rated their level of energy, how they felt generally, and their progress toward daily goals, which was also captured on the app and could be discussed with the coach during the review of the previous week’s activity.
At 12 weeks, the favorable 0.54-point change (P < .001) and 0.51 change (P < .001) in the physical and emotional summary scores, respectively, met the criteria for a clinically meaningful change, Dr. Benzo reported. There were also significantly favorable changes from baseline and relative to controls in CRQ domains of self-management, sleep quality, and depression (all P ≤ .01).
Other data collected are supportive. For example, Dr. Benzo reported that those in the rehabilitation group took 624 more steps on average per day than those in the control group. The experimental group also spent nearly an hour more performing moderate or greater levels of activity.
“The app promotes behavioral change,” said Dr. Benzo, who said that this “completely home-based model” of rehabilitation is likely to be cost-effective given the relatively low costs of remote coaching and reasonable costs of the activity monitor, tablet, and other equipment.
Importantly, home-based rehabilitation is a billable practice under currently available CPT codes, according to Dr. Benzo, who believes this approach is not only effective but “feasible and practical.”
Two clinicians active in the care of patients with COPD believe this approach could fulfill an unmet need if further validated. Andrew Berman, MD, professor of medicine, New Jersey Medical School, Newark, thinks the premise is sound.
“Digital competency is still a big issue as is access to adequate quality Internet, but this could be a very useful approach for many individuals, and it avoids visits to a center, which could be a big advantage for patients,” Dr. Berman said.
Abebaw M. Johannes, PhD, a professor of physical therapy at Azusa Pacific University, Azusa, Calif., agreed. He said that home-based remote coaching could be a way of overcoming the current hurdles of participating in institutional-based programs
“This is clearly an unmet need in COPD,” he said.
The development of more effective and patient-friendly programs is what was driving this research, according to Dr. Benzo. He cited data suggesting that only about 30% of patients with COPD are participating in rehabilitation programs once discharged from the hospital despite the evidence that they can improve quality of life. For many of these patients, a home-based program might be the answer.
Dr. Benzo, Dr. Berman, and Dr. Johannes reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NASHVILLE – The first multicenter randomized controlled trial of a home-based rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) showed highly positive results, according to findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
At the end of 12 weeks, those randomly assigned to the intervention had a significant and clinically meaningful improvement in all domains of the Chronic Respiratory Questionnaire (CRQ), including activity levels and emotional well-being, reported Roberto P. Benzo, MD, a consultant in the division of pulmonary and critical care medicine, Mayo Clinic, Rochester, Minn.
Presenting soon-to-be-published data, Dr. Benzo said that the intervention is based on a tablet-based app. The tablet is programmed to upload data captured from an activity monitor and pulse oximeter. Along with documentation of app usage, this information can then be downloaded for the remote coach to review with the patient.
The primary outcome of the randomized study were the physical and emotional domains of the CRQ quality of life, but a long list of secondary outcomes – including physical activity, symptoms of depression, sleep quality, and health care utilization, such as emergency room visits – was also analyzed.
In addition to the significant benefit on the primary outcomes, the home-based rehabilitation program relative to a wait list for intervention was associated with benefit or a trend for benefit on essentially every outcome measured. Health care utilization was a possible exception, but even then, the absolute number of visits was lower in the treatment arm.
“With a study period of only 12 weeks, we were limited to our ability to show a difference in emergency room visits,” said Dr. Benzo, who also noted that the study was conducted during the COVID-19 pandemic, when hospital visits were already occurring at a lower than usual rate. Based on the other findings, he suspects that a reduction in health care utilization could also be shown in more typical circumstances, particularly with a longer follow-up.
In the study, 375 patients with COPD were randomly assigned to a home health care regimen delivered by an app with remote coaching or to a wait list and usual care. The median age was 69 years. Fifty-nine percent were women. The median FEV1 at enrollment was 45% of predicted.
The patients were able to access their own data to monitor their progress at any time, not just at the time of coaching, but contact with the remote coach occurred on a weekly basis. Patients rated their level of energy, how they felt generally, and their progress toward daily goals, which was also captured on the app and could be discussed with the coach during the review of the previous week’s activity.
At 12 weeks, the favorable 0.54-point change (P < .001) and 0.51 change (P < .001) in the physical and emotional summary scores, respectively, met the criteria for a clinically meaningful change, Dr. Benzo reported. There were also significantly favorable changes from baseline and relative to controls in CRQ domains of self-management, sleep quality, and depression (all P ≤ .01).
Other data collected are supportive. For example, Dr. Benzo reported that those in the rehabilitation group took 624 more steps on average per day than those in the control group. The experimental group also spent nearly an hour more performing moderate or greater levels of activity.
“The app promotes behavioral change,” said Dr. Benzo, who said that this “completely home-based model” of rehabilitation is likely to be cost-effective given the relatively low costs of remote coaching and reasonable costs of the activity monitor, tablet, and other equipment.
Importantly, home-based rehabilitation is a billable practice under currently available CPT codes, according to Dr. Benzo, who believes this approach is not only effective but “feasible and practical.”
Two clinicians active in the care of patients with COPD believe this approach could fulfill an unmet need if further validated. Andrew Berman, MD, professor of medicine, New Jersey Medical School, Newark, thinks the premise is sound.
“Digital competency is still a big issue as is access to adequate quality Internet, but this could be a very useful approach for many individuals, and it avoids visits to a center, which could be a big advantage for patients,” Dr. Berman said.
Abebaw M. Johannes, PhD, a professor of physical therapy at Azusa Pacific University, Azusa, Calif., agreed. He said that home-based remote coaching could be a way of overcoming the current hurdles of participating in institutional-based programs
“This is clearly an unmet need in COPD,” he said.
The development of more effective and patient-friendly programs is what was driving this research, according to Dr. Benzo. He cited data suggesting that only about 30% of patients with COPD are participating in rehabilitation programs once discharged from the hospital despite the evidence that they can improve quality of life. For many of these patients, a home-based program might be the answer.
Dr. Benzo, Dr. Berman, and Dr. Johannes reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CHEST 2022
Commentary: Postpartum hemorrhage and acute chest pain obstetric emergencies, October 2022
The three PPH articles examine the use of preventive B-Lynch suture, risk factors for failure of intrauterine tamponade, and trend changes in risk factors for PPH. Kuwabara and colleagues looked at the effectiveness of preventative B-Lynch sutures in patients at high risk for PPH. Their retrospective observational study included 38 of 663 patients who underwent cesarean section (CS) who received the B-Lynch procedure at their tertiary perinatal medical center in Gifu, Japan, between January 2019 and May 2021. Overall, 92% of patients who received the B-Lynch suture showed no apparent postoperative bleeding within 2 hours after the CS. A total of 24 patients required blood transfusion, none required hysterectomy, and only one patient with a twin pregnancy required additional treatment because of secondary PPH 5 days after the CS. This suggests that earlier use of B-Lynch sutures could be considered in patients at high risk for atony.
Gibier and colleagues examined risk factors for uterine tamponade failure in women with PPH. This was a population-based retrospective cohort study of 1761 women with deliveries complicated by PPH who underwent intrauterine tamponade within 24 hours of PPH to manage persistent bleeding. They noted that the intrauterine tamponade failure rate was 11.1%. Risk for intrauterine tamponade failure was higher in women with CS (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0). They concluded that CS, preeclampsia, and uterine rupture were significant risk factors for failures in this procedure.
Sade and colleagues examined trend changes in the individual contribution of risk factors for PPH over more than two decades. Their population-based, retrospective, nested, case-control study included 285,992 pregnancies and suggested that, in their hospital setting in Israel, risks from perineal or vaginal tears were increasing while large-for-gestational-age fetuses decreased and other risk factors remained stable.
Finally, Wu and colleagues examined incidence and outcomes of AHRCP diseases during pregnancy and the puerperium. This observational analysis examined 41,174,101 patients hospitalized for pregnancy and during the puerperium in the National Inpatient Sample (NIS) database from January 1, 2008, to December 31, 2017. The study noted that 40,285 patients were diagnosed with AHRCP diseases during this period. The NIS is the largest publicly available all-payer database in the United States. The investigators found that the incidence of AHRCP diseases increased significantly between 2002 and 2017, especially pulmonary embolism in the puerperium. Although mortality showed a downward trend, it is still at a high level. They suggested that we should strengthen monitoring and management of AHRCP in pregnancy and puerperium, especially for Black women, those in the lowest-income households, and parturients over 35 years of age.
The three PPH articles examine the use of preventive B-Lynch suture, risk factors for failure of intrauterine tamponade, and trend changes in risk factors for PPH. Kuwabara and colleagues looked at the effectiveness of preventative B-Lynch sutures in patients at high risk for PPH. Their retrospective observational study included 38 of 663 patients who underwent cesarean section (CS) who received the B-Lynch procedure at their tertiary perinatal medical center in Gifu, Japan, between January 2019 and May 2021. Overall, 92% of patients who received the B-Lynch suture showed no apparent postoperative bleeding within 2 hours after the CS. A total of 24 patients required blood transfusion, none required hysterectomy, and only one patient with a twin pregnancy required additional treatment because of secondary PPH 5 days after the CS. This suggests that earlier use of B-Lynch sutures could be considered in patients at high risk for atony.
Gibier and colleagues examined risk factors for uterine tamponade failure in women with PPH. This was a population-based retrospective cohort study of 1761 women with deliveries complicated by PPH who underwent intrauterine tamponade within 24 hours of PPH to manage persistent bleeding. They noted that the intrauterine tamponade failure rate was 11.1%. Risk for intrauterine tamponade failure was higher in women with CS (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0). They concluded that CS, preeclampsia, and uterine rupture were significant risk factors for failures in this procedure.
Sade and colleagues examined trend changes in the individual contribution of risk factors for PPH over more than two decades. Their population-based, retrospective, nested, case-control study included 285,992 pregnancies and suggested that, in their hospital setting in Israel, risks from perineal or vaginal tears were increasing while large-for-gestational-age fetuses decreased and other risk factors remained stable.
Finally, Wu and colleagues examined incidence and outcomes of AHRCP diseases during pregnancy and the puerperium. This observational analysis examined 41,174,101 patients hospitalized for pregnancy and during the puerperium in the National Inpatient Sample (NIS) database from January 1, 2008, to December 31, 2017. The study noted that 40,285 patients were diagnosed with AHRCP diseases during this period. The NIS is the largest publicly available all-payer database in the United States. The investigators found that the incidence of AHRCP diseases increased significantly between 2002 and 2017, especially pulmonary embolism in the puerperium. Although mortality showed a downward trend, it is still at a high level. They suggested that we should strengthen monitoring and management of AHRCP in pregnancy and puerperium, especially for Black women, those in the lowest-income households, and parturients over 35 years of age.
The three PPH articles examine the use of preventive B-Lynch suture, risk factors for failure of intrauterine tamponade, and trend changes in risk factors for PPH. Kuwabara and colleagues looked at the effectiveness of preventative B-Lynch sutures in patients at high risk for PPH. Their retrospective observational study included 38 of 663 patients who underwent cesarean section (CS) who received the B-Lynch procedure at their tertiary perinatal medical center in Gifu, Japan, between January 2019 and May 2021. Overall, 92% of patients who received the B-Lynch suture showed no apparent postoperative bleeding within 2 hours after the CS. A total of 24 patients required blood transfusion, none required hysterectomy, and only one patient with a twin pregnancy required additional treatment because of secondary PPH 5 days after the CS. This suggests that earlier use of B-Lynch sutures could be considered in patients at high risk for atony.
Gibier and colleagues examined risk factors for uterine tamponade failure in women with PPH. This was a population-based retrospective cohort study of 1761 women with deliveries complicated by PPH who underwent intrauterine tamponade within 24 hours of PPH to manage persistent bleeding. They noted that the intrauterine tamponade failure rate was 11.1%. Risk for intrauterine tamponade failure was higher in women with CS (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0). They concluded that CS, preeclampsia, and uterine rupture were significant risk factors for failures in this procedure.
Sade and colleagues examined trend changes in the individual contribution of risk factors for PPH over more than two decades. Their population-based, retrospective, nested, case-control study included 285,992 pregnancies and suggested that, in their hospital setting in Israel, risks from perineal or vaginal tears were increasing while large-for-gestational-age fetuses decreased and other risk factors remained stable.
Finally, Wu and colleagues examined incidence and outcomes of AHRCP diseases during pregnancy and the puerperium. This observational analysis examined 41,174,101 patients hospitalized for pregnancy and during the puerperium in the National Inpatient Sample (NIS) database from January 1, 2008, to December 31, 2017. The study noted that 40,285 patients were diagnosed with AHRCP diseases during this period. The NIS is the largest publicly available all-payer database in the United States. The investigators found that the incidence of AHRCP diseases increased significantly between 2002 and 2017, especially pulmonary embolism in the puerperium. Although mortality showed a downward trend, it is still at a high level. They suggested that we should strengthen monitoring and management of AHRCP in pregnancy and puerperium, especially for Black women, those in the lowest-income households, and parturients over 35 years of age.
The ‘root cause’ visit
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com
“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”
It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”
Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.
There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.
Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.
Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.
Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).
Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”
You’ll have to do better, George.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com